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PA Bulletin, Doc. No. 22-2017

RULES AND REGULATIONS

Title 28—HEALTH AND SAFETY

DEPARTMENT OF HEALTH

[28 PA. CODE CHS. 201, 203, 204, 205 AND 207]

Long-Term Care Nursing Facilities

[52 Pa.B. 8065]
[Saturday, December 24, 2022]

 The Department of Health (Department), after consultation with the Health Policy Board, amends §§ 201.23 and 207.4, Chapters 203 and 205, and adds Chapter 204 in Subpart C (relating to long-term care facilities), to read as set forth in Annex A. This is the second of four final-form rulemakings for long-term care nursing facilities being promulgated by the Department.

 The contents for the four final-form rulemaking packages are as follows:

Rulemaking 1—General Applicability and Definitions

§ 201.1. Applicability.

§ 201.2. Requirements.

§ 201.3. Definitions.

§ 211.12. Nursing services. (Withdrawn on final-form.)

Rulemaking 2—General Operation and Physical Requirements

§ 201.23. Closure of facility.

Chapter 203. Application of Life Safety Code for Long-Term Care Nursing Facilities. (Reserved on final-form.)

Chapter 204. Physical Environment and Equipment Standards for Construction, Alteration or Renovation of Long-Term Care Nursing Facilities after July 1, 2023.

Chapter 205. Physical Environment and Equipment Standards for Long-Term Care Nursing Facilities Construction, Alteration or Renovation Approved before July 1, 2023.

§ 207.4. Ice containers and storage. (Reserved on final-form.)

Rulemaking 3—Applications for Ownership, Management and Changes of Ownership; Health and Safety

§ 201.12. Application for license of a new facility or change in ownership.

§ 201.12a. Notice and opportunity to comment (New section on final-form.)

§ 201.12b. Evaluation of application for license of a new facility or change in ownership. (Section renumbered on final-form.)

§ 201.13. Issuance of license for a new facility or change in ownership.

§ 201.13a. Regular license. (New section on final-form.)

§ 201.13b. Provisional license. (New section on final-form.)

§ 201.13c. License renewal. (Section renumbered on final-form.)

§ 201.14. Responsibility of licensee.

§ 201.15. Restrictions on license.

§ 201.15a. Enforcement. (New section on final-form.)

§ 201.15b. Appeals. (New section on final-form.)

§ 201.17. Location.

§ 201.22. Prevention, control and surveillance of tuberculosis (TB).

§ 209.1. Fire department service. (Reserved on final-form.)

§ 209.7. Disaster preparedness. (Reserved on final-form.)

§ 209.8. Fire drills. (Reserved on final-form.)

§ 211.1. Reportable diseases.

Rulemaking 4—Qualifications, Training, Job Duties, Recordkeeping, Program Standards, and Resident Rights and Services

§ 201.18. Management.

§ 201.19. Personnel records.

§ 201.20. Staff development.

§ 201.21. Use of outside resources.

§ 201.24. Admission policy.

§ 201.25. Discharge policy. (Reserved on final-form.)

§ 201.26. Resident representative.

§ 201.29. Resident rights.

§ 201.30. Access requirements. (Reserved on final-form.)

§ 201.31. Transfer agreement.

§ 207.2. Administrator's responsibility. (Reserved on final-form.)

§ 209.3. Smoking.

§ 211.2. Medical director.

§ 211.3. Verbal and telephone orders.

§ 211.4. Procedure in event of death.

§ 211.5. Medical records.

§ 211.6. Dietary services.

§ 211.7. Physician assistants and certified registered nurse practitioners.

§ 211.8. Use of restraints.

§ 211.9. Pharmacy services.

§ 211.10. Resident care policies.

§ 211.11. Resident care plan. (Reserved on final-form.)

§ 211.12. Nursing services. (Consolidated amendments on final-form.)

§ 211.15. Dental services.

§ 211.16. Social services.

§ 211.17. Pet therapy.

Comments on Multiple Packages; Stakeholder Engagement

 The Department received comments during the public comment periods of all four proposed rulemaking packages expressing concern with the Department's decision to divide the long-term care nursing facility regulations into separate rulemakings. As previously provided, the Department divided the regulatory packages as follows: Rulemaking 1—General Applicability and Definitions; Rulemaking 2—General Operation and Physical Requirements; Rulemaking 3—Applications for Ownership, Management and Changes of Ownership; Health and Safety; and Rulemaking 4—Qualifications, Training, Job Duties, Recordkeeping, Program Standards, and Resident Rights and Services.

 Although the Department intended to provide succinct areas for review and comment, commentators expressed some difficulty in reviewing sections of the regulations without the context of the remaining regulatory chapters and concern that multiple regulatory packages may lead to a lack of clarity and confusion for the regulated community and the public. Commentators also requested that the Department consider comments on all four proposed rulemaking packages outside of the 30-day comment period for each proposed package, or that the Department withdraw or resubmit all four proposed rulemaking packages as one package with an additional 30-day comment period. The Department also received comments regarding concern related to recent engagement with stakeholders, given that the Long-Term Care Work Group (LTC Work Group) last formally met in 2018 and was disbanded during the start of the novel coronavirus (COVID-19) pandemic.

 In commenting on proposed Rulemaking 1, the Independent Regulatory Review Commission (IRRC) acknowledged the Department's authority to promulgate regulations as it deems appropriate. However, IRRC requested the Department to consider the regulated communities comments and the requests regarding the separate rulemakings. IRRC specifically asked the Department to explain why its approach in dividing the amendments into multiple packages was reasonable. IRRC asked whether it was in the public interest or reasonable to expect the regulated community to hold multiple proposed regulations simultaneously in mind while reviewing a proposed regulation. IRRC also asked that the Department ensure that amendments be consistent across the packages, and that the interrelation and any impacts between the packages be clearly presented for the regulated community.

 In commenting on Rulemaking 2, IRRC again echoed concerns that separate rulemakings have the potential consequence of inconsistencies and errors across the four packages. IRRC inquired whether having multiple regulatory packages is in the public interest, whether it protects the public health, safety and welfare, and whether it is reasonable and lacks ambiguity. IRRC also asked the Department to: (1) identify in the final-form preamble any provisions which assume approval of Rulemaking 1 as final-form; (2) cross-reference these provisions to the relevant provisions in Rulemaking 1; and (3) explain the impact if Rulemaking 1 is not approved before or at the same time as Rulemaking 2. IRRC recommended that the Department deliver each of the four individual packages as final-form rulemakings on the same day. In addition, IRRC, in its comment for proposed Rulemaking 3 and Rulemaking 4 expressed the same concerns as in the previous proposed rulemakings, but additionally suggested that the Department consider issuing an Advance Notice of Final Rulemaking to assist in reaching consensus.

Response

 At the outset, the Department recognized that the changes to the long-term care nursing facility regulations would be numerous and complex, whether presented in one giant package or in multiple packages. A large single package would have been unwieldy and would likely have been presented around the date that the fourth regulatory package was completed and submitted (May 11, 2022). A later publication date would have resulted in less opportunity for comments, less time for the commentators to study the material and deliberate, and less time for necessary and valuable stakeholder engagement. Further, the regulated communities' input throughout this process informed the administration and legislature's investment in this year's budget. As such, the decision was made to continue with the changes in smaller, separate, more digestible packages. As provided previously, the Department initially decided to divide the proposed amendments to the six regulatory chapters under Subpart C into multiple packages to allow the public and interested parties a greater opportunity to thoroughly examine and digest the distinct proposed regulatory amendments over a longer period of time. In dividing these six chapters over four rulemakings, the public and interested parties would be permitted to provide more detailed comments and allow the Department to focus more closely on comments, provide a thoroughly considered response to questions and comments, and tailor the remaining proposed packages based on additional public and stakeholder input.

 Further, in response to these public comments, the Department has considered all public comments and IRRC's comments across all four proposed rulemakings before drafting these four final-form rulemakings. In addition, based on comments received, the Department is submitting all four final-form rulemakings to IRRC, the legislative standing committees and the public commentators together on the same day. The drafting and submitting of all four final-form rulemakings together at the end of the last public comment periods allows interested parties and the public to vet and comment on each package separately, as well as in relation to the other packages. Throughout this process, the Department has continued to accept and review comments and be available to meet with stakeholders. If a commentator believed that a proposed amendment in Rulemaking 4 did not align with a proposed amendment in Rulemaking 1, the commentator could submit a comment to that effect for consideration by the Department during the public comment period for the proposed Rulemaking 4.

 The Department did, in fact, take into consideration comments received on proposed Rulemakings 1 and 2, when drafting proposed Rulemakings 3 and 4. This is as evidenced by the proposal to expressly include text from the Centers for Medicare & Medicaid (CMS), State Operations Manual, Appendix PP into the text of the regulation. See for example, proposed Rulemaking 4 and proposed § 201.29(o) (relating to resident's rights). This inclusion of specific text was based on comments received by commentators and IRRC in proposed Rulemaking 1. The Department also consolidated the total number of proposed packages from five to four packages in response to both public and IRRC comments received in proposed Rulemaking 1.

 In addition to considering comments on the four proposed packages during and outside of the four public comment periods, the Department met with stakeholders on four occasions following the receipt of public comments to discuss their concerns and to gain additional insight into comments that were received. The first of these meetings, for proposed Rulemakings 1 and 2, occurred on December 15, 2021. Representatives from the American Association of Retired Persons (AARP), Alzheimer's Association—Delaware Valley and Greater Pennsylvania Chapters, Center for Advocacy for the Rights & Interests of the Elderly (CARIE), Community Legal Services, LeadingAge, Pennsylvania Health Care Association (PHCA), Pennsylvania Coalition of Affiliated Healthcare and Living Communities (PACAH) and SEIU Healthcare Pennsylvania attended that meeting. The second meeting, for proposed Rulemaking 3 occurred on June 8, 2022. Representatives from AARP, Alzheimer's Association, CARIE, Community Legal Services, LeadingAge, PHCA, Pennsylvania Health Law Project (PHLP), and SEIU again attended that stakeholder meeting. The Department explicitly stressed to stakeholders during this June 8, 2022, meeting that it would be considering comments on all proposed rulemakings, and that it would welcome any additional comments or feedback that stakeholders might have after the meeting regarding proposed amendments to the various regulatory chapters. The Department also indicated in a press release on proposed Rulemaking 4, issued on June 3, 2022, that it would be considering comments on all four proposed rulemakings before submitting final-form rulemakings. The third meeting with stakeholders, for proposed Rulemaking 4, occurred on August 3, 2022. Present at that meeting were representatives from AARP, Alzheimer's Association, CARIE, PHCA, Pennsylvania Health Funders Collaborative (PHFC), and SEIU. The Department held the fourth meeting on August 17, 2022. At this meeting, the Department presented stakeholders with an overview of the changes that were made from the proposed rulemaking to the final-form rulemaking in response to their comments, on all four rulemakings, and provided them with an opportunity to comment and provide feedback on the final-form rulemakings. Present at that meeting were representatives from Alzheimer's Association, CARIE, Community Legal Services, County Commissioners Association of Pennsylvania (CCAP), Disability Rights, LeadingAge, PHCA, PHFC and SEIU.

 After consideration of all comments received on the four proposed rulemaking packages, the Department firmly supports its decision in splitting the six long-term care nursing facility chapters into multiple packages. While the Department appreciates the comments and suggestion for one consolidated package, one is not needed at this stage due to the public, the regulated community and advocates full and continued opportunity to offer input on all the long-term care nursing facilities' regulations, throughout the four separate public comment periods, the first of which occurred over a year ago, as well as during the stakeholder meetings that occurred from 2021 through August 2022. In addition, as mentioned previously, at the meeting on August 17, 2022, the Department provided stakeholders an overview of the changes that were adopted on all four rulemakings, to ensure that stakeholders fully understand all amendments. At that meeting, the Department also permitted stakeholders the opportunity to further comment on the final-form amendments and incorporated this feedback into these final-form rulemakings. Finally, as previously noted, splitting the regulations into multiple, separate packages benefited the public, regulated community and advocates because it allowed the Department to incorporate their feedback as it moved forward with the drafting of subsequent packages, which promoted the public interest, health, safety and welfare by improving the overall quality of the proposed rulemakings.

 The Department has, in each of the four final-form rulemaking preambles, discussed and responded to all comments received on the contents of the four proposed rulemakings, regardless of when the comment was received. The Department adds cross-references, as appropriate, where comments received on one package relate to another package to further aid in the review of the four packages together in their entirety. For example, in proposed Rulemaking 1, the Department received comments requesting that staff, other than nursing personnel, be considered when determining whether a facility has met the minimum number of direct resident care hours in § 211.12(i) (relating to nursing services). In response to this comment, the types of individuals required for the minimum number of direct resident care hours was intentionally addressed in proposed Rulemaking 4 and generated additional comments during that proposed rulemaking's public comment period. The Department has, therefore, indicated in § 211.12(i) of the preamble for final-form Rulemaking 1, that it received comments on this topic and provided a cross-reference to the more in-depth discussion of this topic in the preamble for final-form Rulemaking 4. Further, to provide additional clarity and readability, the Department moved the proposed language relating to direct resident care hours from proposed Rulemaking 1 to final-form Rulemaking 4. Finally, the Department has noted where one rulemaking assumes the approval of another rulemaking. Through this extended review and public comment process, the Department has been transparent in its proposals and has responded to these comments through each final-form rulemaking.

Background and Need for Amendments

 The percentage of adults 65 years of age or older in this Commonwealth is increasing. In 2010, approximately 15% of Pennsylvanians were 65 years of age or older. In 2017, this number increased to 17.8%. In 2020, just under 20% of the population in this Commonwealth was 65 years of age or older. For every 10 individuals under 25 years of age lost in this Commonwealth since 2010, the State gained 21 persons 65 years of age or older. This Commonwealth also has a higher percentage of older adults when compared to other states. In 2017, this Commonwealth ranked fifth in the Nation in the number (2.2 million) of older adults and seventh in percentage (17.8%). The increase in older Pennsylvanians is expected to continue. It has been estimated that by 2030, there will be 38 older Pennsylvanians (65 years of age or older) for every 100-working age Pennsylvanians (15 years of age to 64 years of age). Penn State Harrisburg, Pennsylvania State Data Center (July 2018). Population Characteristics and Change: 2010 to 2017 (Research Brief). Retrieved from https://pasdc.hbg.psu.edu/data/research-briefs/pa-population-estimates; Penn State Harrisburg, Pennsylvania State Data Center (July 2018). Trends in Pennsylvania's Population by Age (June 2022). (Research Brief). Retrieved from https://pasdc.hbg.psu.edu/sdc/pasdc_files/researchbriefs/June_2022.pdf.

 As the number of older Pennsylvanians increases, the number of those needing long-term care nursing will also increase. It has been estimated that an individual turning 65 years of age today has an almost 70% chance of needing some type of long-term services or support during the remainder of their lifetime; 20% will need long-term care support for longer than 5 years. More people use long-term care services at home and for longer; however, approximately 35% utilize nursing facilities for this type of care. Administration for Community Living. (February 2020). How Much Care Will You Need? Retrieved from https://acl.gov/ltc/basic-needs/how-much-care-will-you-need. Approximately 72,000 individuals reside in the 682 long-term care nursing facilities currently licensed by the Department.

 The COVID-19 pandemic highlighted the vulnerability of older adults, with a larger percentage of deaths occurring in individuals 65 years of age and older. Centers for Disease Control and Prevention (CDC). Demographic Trends of COVID-19 Cases and Deaths in the US Reported to CDC. Retrieved from https://covid.cdc.gov/covid-data-tracker/#demographics. See also, CDC. COVID-19 Weekly Cases and Deaths per 100,000 Population by Age, Race/Ethnicity and Sex, United States, March 1, 2020—June 25, 2022. Retrieved from https://covid.cdc.gov/covid-data-tracker/#demographicsovertime. Further, it is estimated that at least a quarter of COVID-19 deaths occurred in long-term care nursing Further, it is estimated that deaths of residents in long-term care facilities accounted for at least 34% of all COVID-19 deaths in the United States during the time that the CDC tracked this data. https://covidtracking.com/analysis-updates/what-we-know-about-the-impact-of-the-pandemic-on-our-most-vulnerable-community. In this Commonwealth alone, there have been approximately 11,443 confirmed deaths of residents in long-term care nursing facilities since January 2020. AARP (September 15, 2022). AARP Nursing Home COVID-19 Dashboard Fact Sheets. Retrieved from https://www.aarp.org/ppi/issues/caregiving/info-2020/nursing-home-covid-states.html.

 The repercussions of the COVID-19 pandemic have reached far beyond the direct, physical effects of contracting the COVID-19 virus. Lockdowns intended to protect vulnerable residents at the beginning of the COVID-19 pandemic led to social isolation and loneliness because residents were prevented from having in-person contact with their loved ones. This led to an increase in depression and anxiety, cognitive decline and in some cases, physical deterioration, among residents who were already fearful of contracting the virus. Levere, M., Rowan, P., & Wysocki, A. (2021). ''The Adverse Effects of the COVID-19 Pandemic on Nursing Home Resident Well-Being.'' Journal of the American Medical Directors Association, 22(5), 948-954.e2. Retrieved from https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7980137/. Nursing service personnel, who were already stressed before the COVID-19 pandemic, incurred additional stress from, among other things, shortages in personal protective equipment (PPE), limited access to COVID-19 testing supplies, fear of contracting COVID-19 while at work and spreading it to others, concern for residents under their care, lack of public support and recognition, and an increase in workloads due to the additional protective measures needed to prevent spread of COVID-19 and other nursing service personnel leaving the workforce. White, E.M., Wetle, T.F., Reddy, A. & Baier, R.R. (2021). ''Front-line Nursing Home Staff Experiences During the COVID-19 Pandemic.'' Journal of the American Medical Directors Association, 22(1), 199-203. Retrieved from https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7685055/.

 The Department's long-term care nursing facilities regulations have not been updated since 1999, with the last significant update occurring in 1997 after the 1996 amendment to the Health Care Facilities Act (the HCFA or act) (35 P.S. §§ 448.101—448.904b). Since that time, there have been substantial changes in the means of delivering care and providing a safe environment for residents in long-term care nursing facilities, with the COVID-19 pandemic further highlighting the need for change. The Department has been attempting to complete this much needed reform since before the COVID-19 pandemic, in late 2017. At that time, the Department sought assistance and advice from members of the LTC Work Group. The Department worked with the LTC Work Group regularly in 2018. The members of the LTC Work Group were drawn from a diverse background and included representatives from urban and rural long-term care facilities and various stakeholder organizations and consumer groups that work in the area of resident care and delivery of services. The LTC Work Group members consisted of representatives from the following organizations: American Institute of Financial Gerontology; Baker Tilly Virchow Krause, LLP; Berks Heim and Rehabilitation; Fulton County Medical Center; Garden Spot Community; HCR ManorCare; Inglis House; Landis Communities; Leading Age; Legg Consulting Services; LIFE Pittsburgh; Luzerne County Community College; The Meadows at Blue Ridge; Mennonite Home; Lutheran Senior Life Passavant Community; PACAH; Pennsylvania Home Care Association; University of Pittsburgh; and Valley View Nursing Home. The following State agencies participated: Department of Aging; the Department of Human Services (DHS); and the Department of Military and Veterans Affairs (DMVA).

 The members of the LTC Work Group met regularly during 2018 with the LTC Work Group's primary focus being the simplification and modernization of the existing long-term care regulations. After these discussions were complete, the Department reviewed the recommendations of the LTC Work Group and consulted with other potentially impacted agencies in 2019 and 2020. In 2020, 2021 and 2022, the Department continued its efforts to draft amendments to the long-term care nursing facility regulations while also handling the day-to-day challenges of protecting the residents of those facilities, who were being hit the hardest by the COVID-19 pandemic.

 As discussed previously, in response to concerns raised by IRRC and commentators, the Department ramped up its communications with stakeholders by holding the first of four stakeholder meetings, beginning in December 2021, to address comments received on proposed for Rulemaking 1 and this rulemaking. The Department held a second meeting with stakeholders in June 2022 after the public comment and IRRC comment periods ended for proposed Rulemaking 3, and a third stakeholder meeting in August 2022 after the public and IRRC comment periods ended for proposed Rulemaking 4. The Department held a fourth stakeholder meeting on August 17, 2022, to provide an overview of changes from the proposed rulemakings to these final-form rulemakings and permitted stakeholders to provide additional feedback and comments on amendments during this meeting.

 The discussions with stakeholders and the comments received on the four proposed rulemakings have made it abundantly clear that amendments to the current long-term care nursing facility regulations are desperately needed and must not be delayed any longer. Commentators expressed in comments to all four groups that they were pleased to see the Department updating these regulations. The comments in support of amending the regulations can generally be summarized as follows:

 • Amendments are long overdue.

 • Revisions to existing regulations are urgently needed.

 • COVID-19 had a devastating impact on facilities and highlighted the need for revisions.

 • Regulations need to be updated to provide additional protection to residents.

 Unfortunately, while commentators agree for the most part that an update to the regulations is needed, they do not agree on the extent of the update needed. Some commentators strongly argued that the Department's proposed amendments do not go far enough in protecting residents, while other commentators strongly argued that the Department's proposed amendments go too far and result in a fiscal impact. The Department has considered all comments it received both in favor of and against the proposed amendments and has responded to those comments. In considering those comments and balancing the competing interest of the parties in this regulatory review process, the Department has made revisions from the proposed rulemakings to these final-form rulemakings. The Department has also provided explanations to comments received in the preambles for each of the four final-form rulemakings, as explained previously.

Public Comments

 In response to proposed Rulemaking 2, the Department received comments from 20 public commentators and comments from IRRC. These comments are discussed in further detail as follows.

Description of amendments / summary of comments and responses

Chapter 201. Applicability, Definitions, Ownership and General Operation of Long-Term Care Nursing Facilities

General comment(s)

 A few commentators suggested that the Department add § 201.0 at the beginning of this chapter to provide enumerated purposes for the Department's regulation of long-term care nursing facilities. Commentators suggested that the proposed purpose section include the following purposes: (1) to enhance the health and welfare of citizens in this Commonwealth by making the health care and long-term services and supports delivery system responsive and adequate to the needs of its citizens; (2) to assure that new health care services and facilities are efficiently and effectively used; (3) to ensure that health care services and facilities meet and will continue to meet high quality standards; (4) to respect the right that all citizens have to receive quality, humane, courteous and dignified care; (5) to ensure nursing facility residents can maintain their individuality and make choices about how they want to live; (6) to foster responsible private operation and ownership of health care facilities; and (7) to encourage innovation and continuous development of improved methods of health care delivery to nursing home residents.

 The Department appreciates this comment and agrees with the provision of quality services and care in an effective and efficient manner; however, this proposed language is largely duplicative of the purpose statement set forth in statute under section 102 of the HCFA (35 P.S. § 448.102). Section 102 states in full:

The General Assembly finds that the health and welfare of Pennsylvania citizens will be enhanced by the orderly and economical distribution of health care resources to prevent needless duplication of services. Such distribution of resources will be furthered by governmental involvement to coordinate the health care system. Such a system will enhance the public health and welfare by making the delivery system responsive and adequate to the needs of its citizens and assuring that new health care services and facilities are efficiently and effectively used; that health care services and facilities continue to meet high quality standards; and, that all citizens receive humane, courteous, and dignified treatment. In developing such a coordinated health care system, it is the policy of the Commonwealth to foster responsible private operation and ownership of health care facilities, to encourage innovation and continuous development of improved methods of health care and to aid efficient and effective planning using local health systems agencies. It is the intent of the General Assembly that the Department of Health foster a sound health care system which provides for quality care at appropriate health care facilities throughout the Commonwealth.

 The language suggested by commentators for proposed § 201.0 is lifted directly from the purpose statement in the act with minimal changes. The Department follows the Pennsylvania Code & Bulletin Style Manual in drafting regulations. Under § 2.10 (relating to purpose section) of the Pennsylvania Code & Bulletin Style Manual, purpose statements should only be included in regulations when necessary. Since this language is duplicative, the Department declines to reproduce this language in this final-form rulemaking.

§ 201.23. Closure of facility

 This section is amended from the proposed rulemaking to this final-form rulemaking. Although the Department retains the cross-reference at the beginning of this section to the closure requirements in 42 CFR 483.70(l) and (m) (relating to administration), the Department makes amendments to each subsection, described as follows.

Subsection (a)

 Subsection (a) remains deleted from the proposed rulemaking to this final-form rulemaking. The Department proposed to delete subsection (a) as duplicative of Federal requirements for a facility to provide a 60-day notice of closure to the Department, and existing § 51.3(c) (relating to notification), which requires notice at least 60 days prior to a facility ceasing to provide an existing health care service or reducing its bed complement. Commentators requested that the Department retain this subsection, instead of deleting it because it provides for greater protections than the Federal requirements by requiring that notice be provided to the Department at least 90 days prior to closure, rather than 60 days as required by 42 CFR 483.70(l)(1)(i). Commentators were generally concerned that the reduction in the number of days' notice would negatively affect residents who need more time, not less, to prepare in the event of a facility closure. IRRC asked if the reduction from 90 days to 60 days affects notice to residents. IRRC asked the Department to explain the reasonableness and feasibility of reducing the notice timeframe, and how doing so protects the health, safety and welfare of residents, if the amendment from 90 days to 60 days affects residents.

 Under existing § 201.23(a) (relating to closure of facility), facilities must provide notice to the Department at least 90 days prior to closure. However, there is no specific timeframe in which facilities must provide notice to residents. Instead, under existing requirements, notice to residents is required under existing § 201.23(b) and (c) within a ''sufficient time'' for an orderly transfer. After carefully considering public comments and IRRC's comments regarding the timing of and requirements for notice of a facility closure, the Department adds subsections (c.1), (c.2) and (c.3), to provide a specific timeframe to further protect residents, while addressing the realities surrounding closure of facilities. Subsections (c.1), (c.2) and (c.3) address the timing and communication of a facility closure plan as explained more fully as follows.

Subsection (b)

 Subsection (b) remains deleted from the proposed rulemaking to this final-form rulemaking. The Department proposed to delete subsection (b), which requires the licensee of a facility to notify the resident or resident's responsible person of the closure of a facility, because under 42 CFR 483.70(l)(1), the administrator of a facility is required to give notice to certain agencies and individuals, including residents and their legal representatives or other responsible parties. Commentators requested that the Department not delete subsection (b) but instead improve it by requiring that notice be provided to residents and resident representatives not only in writing, but also in the manner that the resident and resident representatives prefer contact. Commentators also requested that language be added to require certain information to be included in the notice and that the notice be provided to certain individuals. In response to these comments, the Department adds subsections (c.3) and (c.4) to this final-form rulemaking, as explained more fully as follows.

Subsection (c)

 Subsection (c) remains deleted from the proposed rulemaking to this final-form rulemaking. The Department proposed to delete this subsection, which requires a facility to give a resident or the resident's responsible person sufficient time to effectuate an orderly transfer. IRRC noted that the Department, in proposing to delete this section, relied on its proposed incorporation by reference of CMS' State Operations Manual, Appendix PP, in proposed Rulemaking 1, by indicating that it expected a facility's closure plan to include certain elements from Appendix PP that include addressing the orderly transfer of residents. IRRC asked the Department in comment to proposed Rulemaking 1 to delete the incorporation by reference of Appendix PP. IRRC asked in comment to this proposed rulemaking, ''If Appendix PP is removed, how will that impact requirements for closure plans for facilities?'' IRRC also requested that the Department clarify in this final-form rulemaking, the requirements for a facility closure plan.

 In response to IRRC's comment on proposed Rulemaking 1, the Department has removed the incorporation of Appendix PP from the regulations. Further, in response to public comments, the Department has added provisions related to closure plan requirements because it provides greater protection to residents and greater clarity to the regulated community. To avoid the impact of having no closure plan requirements, the Department adds subsections (c.1)—(c.3).

 Commentators also expressed concern over the deletion of subsection (c) because requiring a plan is not the same as ensuring an orderly transfer. The Department agrees that an orderly transfer is distinct from notice of a closure. Under 42 CFR 483.15(c)(7) (relating to admission, transfer, and discharge rights), a facility must also ''provide and document sufficient preparation and orientation to residents to ensure a safe and orderly transfer or discharge from the facility'' (emphasis added). This is already required of all facilities, including the three private-pay facilities, under the partial incorporation of the Federal requirements under existing § 201.2 (relating to requirements).

Subsection (c.1)

 As noted previously, subsection (c.1) is added from the proposed rulemaking to this final-form rulemaking, at the request of commentators and IRRC. Under subsection (c.1), a facility will be required to develop a closure plan that includes the following:

 (1) The identification of those who will be responsible for the daily operation and management of the facility during the closure process.

 (2) The roles and responsibilities, and contact information, for the facility owner and the administrator or any replacement or temporary manager during the closure process.

 (3) Assurance that no new residents will be admitted to the facility after the written notice of closure is provided under subsection (c.3).

 (4) A plan for identifying and assessing available facilities to which residents can be transferred, taking into consideration each resident's individual best interests and resident's goals, preferences and needs regarding services, location and setting. This shall include:

 (i) Interviewing each resident and resident representative, if applicable, to determine each resident's goals, preferences and needs.

 (ii) Offering the opportunity, to each resident and resident representative, if applicable, to obtain information regarding options within the community.

 (iii) Providing residents and resident representatives, if applicable, with information or access to information regarding providers and services.

 (5) A plan for the communication and transfer of resident information, including medical records.

 (6) Provisions for the ongoing operations and management of the facility, its residents and staff during the closure process, that include the following:

 (i) Payment of salaries and expenses.

 (ii) Continuation of appropriate staffing and resources to meet the needs of the residents, including provision of medications, services, supplies and treatment.

 (iii) Ongoing accounting, maintenance and reporting of resident personal funds.

 (iv) Labeling, safekeeping and appropriate transfer of each resident's personal belongings.

 These requirements align with guidance in section F845 of Appendix PP, and will ensure that all facilities, including the three private-pay facilities, are held to the same standards for the contents of a closure plan.

Subsection (c.2)

 Subsection (c.2) is added from the proposed rulemaking to this final-form rulemaking. After carefully reviewing and considering public comments, the Department agrees that a longer notice period to the Department is needed to review a facility's closure plan. However, since communication between facilities and the Department is now submitted through electronic means (instead of the lengthier process of regular mail), the Department adds a provision that requires notice to the Department 75 days prior to the proposed date of closure. This time period will allow the Department 15 days to review and approve a facility closure plan.

 Specifically, under 42 CFR 483.70(l)(1), a facility is required to provide written notification to the Department, at least 60 days prior to the date of closure. However, under 42 CFR 483.70(l)(3), this written notice must include ''the plan, that has been approved by the State, for the transfer and adequate relocation of the residents of the facility by a date that would be specified by the State prior to closure.'' (emphasis added). The plan for the transfer and relocation of residents is part of the closure plan, which will be required under new subsection (c.1)(4). The Department will need time to review and approve the closure plan before the facility provides notice to the other individuals listed in 42 CFR 483.70(l)(1). The Department is therefore, adding subsection (c.2), on this final-form rulemaking, to require that a facility submit its notice of closure and the closure plan, developed under subsection (c.1) at least 75 days prior to the proposed date of closure.

 The Department selected 75 days based on several factors. Specifically, in practice, the Department does not need more than 15 days to review and approve a closure plan. Additionally, most facility closures that the Department has overseen recently are due to a lack of adequate cashflow. Requiring facilities to submit a closure plan and notice of closure 90 days in advance of its proposed closure date may serve only to exacerbate the facility's financial issues and ability to effectuate safe and timely relocation of residents while providing no additional benefit to either the Department, residents, interested parties or the facilities.

Subsection (c.3)

 Subsection (c.3) is added from the proposed rulemaking to this final-form rulemaking. As noted previously, commentators requested that the Department not delete subsection (b) but retain it and add additional individuals to the list of individuals under 42 CFR 483.70(l)(1) to whom notice must be provided. Commentators also requested that the Department add language to require that notice be in writing, and that notice be given in a language and manner that the resident or resident representative can understand. Under 42 CFR 483.70(l)(1), an administrator of a facility is required to provide written notice of the closure of the facility to the State Survey Agency (the Department), the State Long-Term Care Ombudsman and residents of the facility and their legal representatives or other responsible parties.

 After reviewing these various comments, the Department agrees with commentators, and in the interest of safeguarding residents' rights, adds a requirement that notice, as well as the transfer and relocation plan of residents, be provided to residents and their resident representatives in writing or in a language or manner they understand. The Department also adds to subsection (c.3) a requirement that the written notice of closure and the closure plan be provided to employees of the facility, the Office of the State Long-Term Care Ombudsman, and DHS, which oversees the MA Managed Care Organizations. Adding these additional individuals and organizations to this requirement will ensure that all applicable agencies and personnel are advised of the closure, which will help ensure that resident relocation and transition occurs more seamlessly. The Department agrees with commentators that the notice of closure, which includes certain pertinent information set forth as follows, should be distributed to these additional interested parties to ensure a cogent and concurrent response to a facility closure. The Department maintains the 60-day notice requirement to align with the Federal requirements. In response to commentators' concerns that 60 days is not enough, the Department notes that, if needed, the Department may extend the time that a facility remains open under subsection (e) for an additional 30 days to ensure a safe and orderly transfer of residents. These provisions work together to protect the health, safety and welfare of residents.

 Commentators requested that the Department also require that the notice of closure be provided to various other persons and entities, including designated family members of each resident, the facility's resident council, the facility's family council, labor organizations that represent the facility's workforce, county commissioners, the County or Municipal Health Department, if one exists, and a representative of the local officials of the city or town where the facility is located. After carefully considering these comments and balancing competing interests between consumer advocates and facility stakeholders, the Department declines to explicitly name these additional parties in this final-form rulemaking. As provided under this final-form rulemaking, notice would be provided to residents, their resident representatives (which includes a family member designated by the resident), employees of the facility, the Office of the State Long-term Care Ombudsman and DHS.

 Further, designated family members would also be ''other responsible parties'' under 42 CFR 483.70(l)(1), which provides facility closure requirements. Additionally, because the resident council of a facility is comprised of residents, it will necessarily receive notice of closure when the residents receive notice. Family councils do not exist at every facility, but family members may receive the notice if they are named as a resident representative. Since the Department has added a requirement that a facility's employees receive notice of the closure, it would be incumbent upon the employees to inform their respective labor organizations of the facility closure should they choose to do so. The Department declines to include a requirement that notice be provided to county commissioners or representatives of the local officials of the city or town where the facility is located. These parties are not part of the closure or relocation process. Because county or municipal health departments do not possess regulatory oversight of facility closures, the Department likewise declines to require a facility to provide these entities with notice of closure.

Subsection (c.4)

 Subsection (c.4) is added from the proposed rulemaking to this final-form rulemaking, based on public comment, to include additional basic elements for the notice of closure. Under subsection (c.4), the notice to the groups and individuals listed in 42 CFR 483.70(l)(1) and in subsection (c.2) must include the proposed date of closure, the contact information for the facility representative delegated by the facility to respond to questions about the closure, the contact information for the office of the State Long-Term Care Ombudsman, and the transfer and relocation plan. These items are added at the request of commentators and reflect the most salient and important information related to a facility closure.

 Commentators also requested that the Department require that the notice of closure include other items, such as the reasons leading to closure, the provision of a public information session, the ability for interested parties to file comments with the Department and a catch-all provision for other information that may be specified by the Department. In balancing the competing interests related to closure plans, the Department declines to add these additional provisions to the notice of closure. The importance of the notice of closure is to advise residents and other interested parties that the facility will close on a date certain, provide a facility contact to answer closure-related questions, and advise residents and interested parties of the facility's plan to transfer and relocate residents. Additional information is extraneous, an additional requirement and detracts from the purpose of the notice of closure.

Subsection (d)

 Subsection (d) is unchanged from the proposed rulemaking to this final-form rulemaking. Subsection (d) prohibits a long-term care nursing facility from requiring a resident to leave the facility less than 30 days after notice is given, unless the Department deems removal is necessary for the health and safety of residents. As explained, on the proposed rulemaking, the Department retains subsection (d), without amendment, because this requirement is not covered within the Federal requirements, and the Department determined it was necessary to keep this provision to ensure the health and safety of residents during the closure of a facility. IRRC asked, ''What is the benefit of having a 60-day notice requirement to residents if the facility can require a resident to leave on day 31?'' This subsection provides a protective window in which the resident may refuse a transfer facilitated by the facility and locate a facility on their own. After 30 days, the facility may initiate a transfer or discharge for residents who have not yet arranged to leave on their own. Further, the facility-initiated transfer or discharge would be subject to transfer and discharge requirements in 42 CFR 483.15(c)(4) and this subpart.

Subsection (e)

 Subsection (e) is unchanged from the proposed rulemaking to this final-form rulemaking. Subsection (e) permits the Department to require that a facility remain open for an additional 30 days when an orderly transfer cannot be effectuated within 30 days. As explained on the proposed rulemaking, the Department retains subsection (e), without amendment, because this requirement is not covered within the Federal requirements, and the Department determined it was necessary to keep this provision to ensure the health and safety of residents during the closure of a facility.

Subsection (f)

 Subsection (f) is unchanged from the proposed rulemaking to this final-form rulemaking. Subsection (f) permits the Department to monitor the transfer of residents. As explained in the proposed rulemaking, the Department retains subsection (f), without amendment, because this requirement is not covered within the Federal requirements, and the Department determined it was necessary to keep this provision to ensure the health and safety of residents during the closure of a facility. Commentators requested that the Department add a provision requiring the Department to appoint a single person to oversee implementation of the facility's closure plan and be onsite at the facility daily. After careful consideration, the Department declines to add this provision. The Department adds subsection (c.1), that requires identification of those responsible for daily operations and management during the closure process. Further, the contact information for the facility owner, the administrator or any replacement or temporary manager during the closure process is also required. The purpose of this information is for the Department to maintain frequent communication with a facility that is closing, including status calls, the submission of daily reports and monitoring surveys. In addition, the Department notes that representatives from the Office of the Local and State Ombudsman are often involved in the closure process as well.

Subsection (g)

 Subsection (g) is retained from the proposed rulemaking to this final-form rulemaking, with amendments, based on comments received in response to the Department's proposed deletion of this subsection. The Department had proposed to delete subsection (g) because it referred to an ''outdated'' requirement that a licensee file proof of financial responsibility with the Department. Commentators, however, requested that the Department not delete this subsection because simply submitting a plan for closure that provides for continued payment of salaries and expenses is not evidence of a facility's ability to pay for salaries and expenses. IRRC noted commentators' concerns that a closure plan is not proof of financial responsibility and their concerns that the deletion of subsection (g) would put residents and caregivers at risk. IRRC asked the Department to explain the need for eliminating this provision and to explain how requiring a ''plan'' versus ''proof'' is reasonable and protects the public health, safety and welfare of residents.

 After further consideration, the Department agrees with commentators and these comments and on this final-form rulemaking, adds the requirement in subsection (g) back into the regulation. As discussed, in its closure plan, a facility must include a plan outlining the ability to pay salaries and expenses. The Department acknowledges that a plan is different than an affirmative showing of proof that a facility will be able to continue to meet its financial obligations while it is closing. As such, the Department retains the language in existing subsection (g), on this final-form rulemaking, with two amendments. The Department makes a grammatical amendment by replacing the word ''insure'' with the word ''ensure.'' The Department also amends subsection (g) on this final-form rulemaking to align with the notice of closure timeline set forth in subsection (c.3), by requiring proof of financial responsibility to ensure that the facility continue to operate in a satisfactory manner until closure of the facility, instead of 30 days, following the notice of intent to close.

Other comments

 A commentator provided the Department with a detailed mark-up of § 201.23, with additional requirements that would expand § 201.23 into 26 subsections. Several other commentators wrote in support of this detailed mark-up. The Department thoroughly reviewed the mark-up language, comparing it to the existing regulation and the Federal requirements, and discussed the reason-ableness of adding each one of these proposed subsections into regulation. Following is a general summary of this discussion with the Department's decision points.

 These commentators seek to have a facility, intending to close, hold a public information session in conjunction with the Department. This public information session would be held at least 60 days prior to the intended date of closure and would be subject to public notice requirements developed by the Department. In balancing the competing interest of advocates and industry stakeholders, the Department declines to include this additional requirement in this final-form rulemaking. Through the closure plan and notice of closure requirements added to this section on this final-form rulemaking, interested parties can obtain and review relevant information pertaining to the intended closure of the facility. Interested persons that are concerned with the closure or any perceived issues surrounding the closure may also contact the Department, the facility, the office of the State Long-term Care Ombudsman or submit a complaint. Information on how to submit a complaint to the Department can be found on the Department's web site at https://www.health.pa.gov/topics/facilities/nursing%20 homes/Pages/Nursing%20Homes.aspx. Due to these public processes, there is limited benefit to requiring both the Department and the facility to jointly pursue an additional requirement for a public information session.

 The commentators also request that the Department add a requirement to prevent a facility from transferring any residents unless and until the Department approves the facility's closure plan. To provide additional clarity and in response to comments, the Department adds subsection (c.2) to require a facility to submit its closure plan to the Department for approval. In practice, the Department not only reviews and approves closure plans, but maintains frequent communication with facilities, including status calls, the submission of daily reports to monitor the transfer or residents and monitoring surveys during a facility closure, to ensure that residents are transferred in a safe and efficient manner. As such, this provision is not needed. Additionally, the Department notes that adding this prohibition might prevent short-term residents from being transferred or discharged while the Department is reviewing the closure plan. The Department, therefore, declines to add this language.

 The commentators request that the Department add a requirement to prevent a facility from accepting new residents after submission of a closure plan. The Department agrees with this recommendation and it is addressed under the new subsection (c.1)(3).

 The commentators also suggest a procedure for the submission of closure plans to the Department, that would include a public comment period and a public information session prior to approval of the closure plan, and a procedure for the submission of an amended closure plan, in the event of disapproval. As explained previously, under the closure plan and notice of closure requirements added to this section on this final-form rulemaking, interested parties can obtain and review relevant information pertaining to the intended closure of the facility. Interested persons that are concerned with the closure or any perceived issues surrounding the closure may contact the Department, the facility, the office of the State Long-term Care Ombudsman or submit a complaint. Information on how to submit a complaint to the Department can be found on the Department's web site at https://www.health.pa.gov/topics/facilities/nursing%20 homes/Pages/Nursing%20Homes.aspx. As provided previously, given the additional procedures added to this final-form rulemaking, there is limited benefit to requiring both the Department and the facility to jointly pursue a public information session. As a result, the Department declines to add any provision providing for public information sessions or public comment in relation to closure plans. The Department additionally reiterates that its concern in the event of a facility closure is that the residents are transferred safely and there is no decline in the quality of services provided to residents or decline in the health, safety and welfare of the residents during the closure process. In practice, the Department reviews closure plans and where needed, requests that amendments be made to the plans prior to issuing its approval. If a closure plan continues to be deficient, even after amendment, the Department may, under section 814 of the act (35 P.S. § 448.814), institute a temporary manager and take other corrective actions to ensure that the residents are safely cared for until a safe transfer can be effectuated. Additional corrective actions available to the Department include requiring the facility to rectify the deficiency, having the facility submit a plan of corrective action, banning new admissions from the facility or revoking a facility's license. Id.

 The commentators also request that the Department add a provision to state that a closure plan is deemed approved if the Department fails to act within 20 working days. As stated previously, the Department typically requires no more than a few days to review and approve or seek amendment of a closure plan. The Department declines to add this limitation to this final-form rulemaking, as it needs to explicitly ensure that all closure plans meet necessary regulations and requirements. Allowing a process through which a closure plan would be automatically approved would place residents at risk if the closure plan was inadequate to ensure their health and safety during the closure process.

 The commentators also request that the Department add a requirement that the facility post an initial notice and provide a second notice of closure after the Department approves the closure plan. After carefully considering this comment and balancing the interests for notice and also the resources during the closure process, the Department declines to include this requirement in regulation. Under subsection (c.2), the facility must provide a notice of closure and closure plan to the Department at least 75 days in advance of closure. Once the Department approves the closure plan and notice of closure, the notice may then be distributed to residents and other interested parties. Due to this process, there is not an additional benefit to providing another notice of closure separate from what is already provided for in subsections (c.2), (c.3) and (c.4).

 The commentators request that the Department add a provision to require a facility to provide at least weekly updates to the Department on closure status in addition to other provisions. The Department declines to add this language. As mentioned previously, the Department maintains frequent communication with a facility that is closing, including status calls, the submission of daily reports to monitor the transfer of residents, and monitoring surveys during a facility closure. Further, section 813(a) of the act (35 P.S. § 448.813(a)) provides the Department with authority to enter and inspect facilities for the purpose of determining the adequacy of the care and treatment provided to residents. Section 802.1 of the act (35 P.S. § 448.802a) also defines ''survey'' as an announced or unannounced examination which may include an onsite visit, for the purpose of determining a facility's compliance with licensure requirements. Therefore, the Department may conduct an announced or unannounced survey of a facility that is closing should the Department receive any indication that the facility is not following the closure plan.

 The commentators also request that the Department add a provision that gives the Secretary of the Department the authority to waive or modify all closure timeframes in the event of an involuntary facility closure. The Department declines to add this provision, as the sanctions process available to the Department under § 51.41 (relating to violations, penalties) would cover the process suggested by commentators. The Department also refers commentators to § 201.15a (relating to enforcement), in final-form Rulemaking 3, that outlines the enforcement actions that are available to the Department. That section applies to the entirety of this subpart, including § 201.23.

 The commentators request that the Department include a provision that includes explicit penalties and sanctions for a facility's failure to comply with the provisions of § 201.23. The Department appreciates the concern regarding compliance; however, this addition is unnecessary. As such, the Department declines to add this provision, and notes that the existing sanction provisions in § 51.41 apply if a facility fails to comply with § 201.23. The Department also refers commentators to § 201.15a, in final-form Rulemaking 3, that outlines the enforcement actions that are available to the Department. That section applies to the entirety of this subpart, including § 201.23.

 The commentators request that the Department add a requirement that a facility is explicitly liable to the Department for funds expended by the Department to provide care and relocation services for residents and for funds expended to use a temporary manager. Section 817(c) of the act (35 P.S. § 448.817(c)) provides that funds collected because of an assessment of a civil penalty, may be used to provide temporary management and to relocate residents, among other things, when all other sources of funding have been exhausted. The act, however, does not give the Department the authority to require a facility to reimburse it for the expenditure of these funds. The Department will not be adopting this recommendation.

 The commentators request that the Department add language that a temporary manager may be appointed if a facility fails to comply with notice of closure provisions, fails to implement an appropriate relocation plan or transfers residents prior to the 60-day notice period. As provided previously, there are existing enforcement provisions for provider violations. Under section 814(b) of the act, the Department is authorized to appoint temporary management to ensure the health and safety of residents. This authority is also echoed in these final-form rulemakings, based on the review and consideration of additional public comments. The Department also refers commentators to § 201.15a, in final-form Rulemaking 3, that outlines the enforcement actions that are available to the Department. That section applies to the entirety of this subpart, including § 201.23. The Department declines to adopt this recommendation.

 The commentators request that the Department add a provision to indicate that failure to ensure appropriate notice to and relocation of all residents may result in a finding of abuse or neglect as defined under the Older Adults Protective Services Act (OAPSA) (35 P.S. §§ 10225.101—10225.5102) or the Adult Protective Services Act (35 P.S. §§ 10210.101—10210.704). The Department declines to add this provision to this final-form rulemaking, as it is unnecessary. Those acts and accompanying regulations provide for the identification and reporting of abuse. It is not necessary for the Department to expand on those provisions within this final-form rulemaking. The Department further notes that it investigates complaints of abuse and neglect in facilities and will continue to do so during the closure process.

 Finally, commentators requested the Department add a forfeiture provision in the event that a facility fails to comply and abandons the facility and residents, resulting in an immediate and substantial threat to the health and safety of residents. After careful consideration, the Department declines to add this provision. Regardless of the reason for closure, any facility that closes would be required to apply for an application for subsequent licensure and would be subject to the comprehensive requirements related to prior ownership, adjudicated or settled civil actions, financial reporting, ownership structure and a public comment process as described in final-form Rulemaking 3 § 201.12 (relating to application for license of a new facility or change in ownership).

Chapter 203. Application of Life Safety Code for long-term care nursing facilities

 Chapter 203 remains deleted from the proposed rulemaking to this final-form rulemaking. Commentators supported the deletion of this chapter. Section 203.1 (relating to application of the Life Safety Code) is the only section within this chapter. The Department proposed to delete § 203.1, and by extension, this chapter, as part of its process to streamline Federal and State requirements for long-term care nursing facilities for clarity and consistency. The National Fire Protection Association (NFPA) 101, Life Safety Code, 2012 Edition, is incorporated by reference in the Federal requirements for long-term care nursing facilities at 42 CFR 483.73(g)(1)(vii) (relating to emergency preparedness). Therefore, it is not necessary to have a separate provision within the State requirements regarding the applicability of the Life Safety Code. Deletion of this chapter assumes approval of final-form Rulemaking 1, which expands the adoption of the Federal requirements in § 201.2.

Chapter 204. Physical environment and equipment standards for construction, alteration or renovation of long-term care nursing facilities

 The Department retains Chapter 204 from the proposed rulemaking to this final-form rulemaking, but with amendments, as explained more fully as follows. As explained in the proposed rulemaking, the Department has decided to separate regulatory provisions pertaining to construction, alteration or renovation of long-term care nursing facilities into two chapters to clarify what standards apply to new versus existing construction, alteration or renovation. The Department had proposed to make Chapter 204 applicable to plans for construction, alteration or renovation of long-term care nursing facilities approved on or after 6 months from the publication date of this final-form rulemaking. However, given the estimated timing of this final-form rulemaking, and to be consistent with the effective date established for other sections of the final-form rulemakings, the Department has decided to make Chapter 204 applicable to plans for construction, alteration or renovation approved on or after July 1, 2023. Existing Chapter 205 (relating to physical plant and equipment standards for long-term care nursing facilities), as amended, will continue to be the baseline standard for all construction, alteration or renovation of long-term care nursing facilities performed based on plans that were approved by the Department before July 1, 2023, the effective date of Chapter 204.

 A commentator expressed concern that there is no definition or threshold as to what classifies as ''construction,'' ''alteration'' or ''renovation.'' IRRC requested that the Department define these terms to provide clarity for the regulated community. The term ''construction, alteration or renovation'' is already used in § 51.3(d) and is already understood by the regulated community. However, to be responsive to the concern raised by the commentator and IRRC, the Department deletes the existing definition for ''alteration'' in § 201.3 (relating to definitions) and adds a new definition for the term ''construction, alteration or renovation'' to § 201.3 in final-form Rulemaking 1. The Department chose to use the term ''construction, alteration or renovation'' to align with the use of this term in § 51.3(d). The term ''construction, alteration or renovation'' is defined as ''the erection, building, remodeling, modernization, improvement, extension or expansion of a facility, or the conversion of a building or portion thereof to a facility.'' For the purposes of the requirements in Chapters 204 and 205, there is no distinction between the terms ''construction,'' ''alteration'' or ''renovation.'' A facility will need to submit plans for any work that falls within the scope of this definition. In response to concerns from commentators that facilities could be restricted from making small changes to improve the physical environment for residents, the Department notes that it does not intend for the definition of ''construction, alteration or renovation'' to encompass work that consists of part-for-part replacement or regular facility maintenance. For clarity, the Department adds language to the definition of ''construction, alteration or renovation'' to reflect this intention.

 The Department, in this final-form rulemaking, amends the title of Chapter 204 to replace the words ''alterations, renovations or construction'' with the words ''construction, alteration or renovation'' to align with the use of this term and definition in § 201.3 in final-form Rulemaking 1, as explained previously. The Department has made amendments throughout Chapter 204, as well, for consistency in the use of this term, as indicated more specifically below.

 Commentators and IRRC expressed concern regarding certain provisions of Chapter 205 that were not carried over into Chapter 204. The Department, in the proposed rulemaking, explained which sections and subsections of Chapter 205 were being carried over into Chapter 204 because they were not covered by the 2018 edition of the Facility Guidelines Institute's (FGI) Guidelines for Design and Construction of Residential Health, Care, and Support Facilities (Guidelines). The Department explained that it was only copying provisions from Chapter 205 into Chapter 204 that go above and beyond the 2018 FGI Guidelines. IRRC asked the Department to clarify, in response to commentators' concerns, specifically which provisions are not copied from Chapter 205 into Chapter 204 because they are addressed in the 2018 Guidelines. In response to this comment, the Department has completed a crosswalk with citations to the specific sections in the 2018 FGI Guidelines for the provisions in Chapter 205 that are not being copied into the new Chapter 204. The Department has provided these citations in each section discussed as follows, as well as a summary at the end of the discussion of this chapter. While performing this crosswalk, the Department identified additional provisions that are added to Chapter 204. These amendments are described as follows, as well.

§ 204.1. Application of guidelines for design and construction of residential health, care and support facilities

Subsection (a)

 Subsection (a) is amended from the proposed to this final-form rulemaking. The Department proposed in subsection (a) to adopt the 2018 FGI Guidelines as the minimum standard for construction, alteration or renovation for plans approved on or after the effective date of Chapter 204. The Department, in this final-form rulemaking, amends subsection (a) to indicate that this subsection applies to plans for construction, alteration or renovation approved on or after July 1, 2023, as explained previously. The Department also amends subsection (a) in this final-form rulemaking to replace the words ''alterations, renovations and construction'' with the words ''construction, alteration or renovation'' for consistency in the use of this terminology.

 Commentators, citing to concerns over the length of time it takes to update regulations, requested that the Department amend subsection (a) to allow for adoption of future versions of the FGI Guidelines and not specifically reference the 2018 version. IRRC further requested that the Department explain how requiring facilities to comply with the 2018 FGI Guidelines is not an improper delegation of authority given that this document is not subject to regulatory review requirements.

 In response to these comments, the Department notes that it is explicitly incorporating only the 2018 edition of the FGI Guidelines—a specific edition of the FGI Guidelines and is not allowing for the adoption of future editions in the regulations because doing so would constitute an improper delegation of authority. The Department may not delegate its authority to make rules and regulations by adopting a private organization's future recommendations. See, for example., Protz v. Workers' Compensation Appeal Board (Derry Area Sch. Dist.), 161 A.3d 827 (Pa. 2017) (holding that a provision in the Workers' Compensation Act, requiring a physician to apply the methodology set forth in the most recent version of the American Medical Association Guides to the Evaluation of Permanent Impairment, was an unconstitutional delegation of legislative authority). This non-delegation doctrine does not, however, prohibit the adoption of a particular set of standards which are already in existence at the time of the adoption. Id.; Pennsylvania AFL-CIO v. Commonwealth, 219 A.3d 306 (Pa. Cmwlth. 2019).

 The Department's adoption of the 2018 edition of the FGI Guidelines does not constitute an impermissible delegation of authority because it is a specific edition, and the Department carefully reviewed the necessity for application of these standards to long-term care nursing facilities. The 2018 edition of the FGI Guidelines is a specific edition, with new editions of the Guidelines being published every 4 years. The Department, on the proposed rulemaking, indicated that the 2018 edition of the FGI Guidelines would be incorporated in regulation and provided the public with the opportunity to review and offer comment through the regulatory review process. The adoption of the 2018 FGI Guidelines does not circumvent the regulatory review process. As indicated in the proposed rulemaking, the Department plans to review and update the regulations through the regulatory promulgation process, as necessary, to incorporate new editions of the FGI Guidelines. The FGI recently updated the Guidelines in May 2022. The Department has not had an opportunity yet to review and consider these updates, but will do so and then update the regulations, at a future date, if necessary to incorporate these newer construction requirements.

Subsection (b)

 Subsection (b) is amended from the proposed rulemaking to this final-form rulemaking. As explained in the proposed rulemaking, subsection (b) will require all facilities to comply with the standards set forth in Chapter 205 for construction, alteration or renovation approved prior to the effective date of Chapter 204. The Department, on this final-form rulemaking, amends subsection (b) to indicate that this subsection applies to plans for construction, alteration or renovation approved before July 1, 2023, which will be the effective date of Chapter 204, as explained previously. The Department also amends subsection (b) in this final-form rulemaking to replace the words ''alterations, renovations and construction'' with the words ''construction, alteration or renovation'' for consistency in the use of this terminology.

 The Department recognizes that a broad, overall adoption of the FGI Guidelines to all long-term care nursing facilities, regardless of when plans were approved or when the construction, alteration or renovation occurred, will impose an undue burden on those facilities that are presently operating under the requirements set forth in Chapter 205. Subsection (b) allows these facilities to continue to operate under the requirements set forth in Chapter 205 until they wish to perform any new construction, alteration or renovation. Construction, alteration or renovation plans approved on or after July 1, 2023, will fall under subsection (a) of the Chapter 204. This is further clarified by subsection (c), described as follows.

Subsection (c)

 Subsection (c) is amended from the proposed rulemaking to this final-form rulemaking. Commentators indicated they understood the intent of this subsection but were concerned that the wording would permit facilities to allow buildings to deteriorate and fall out of compliance where they had once met the FGI Guidelines but did not maintain those standards. IRRC asked for clarification as to the circumstances under which a facility would be deemed to be compliant. The Department believes that the confusion expressed from commentators is due to the first sentence of this subsection. In response to those comments, the Department, therefore, deletes this sentence from this final-form rulemaking. As explained in the proposed rulemaking, under subsection (c), a long-term care nursing facility must meet the requirements that were in effect at the time of approval of the plans for construction, alteration or renovation. The Department intends to hold facilities to the standards that were in effect at the time the plans for construction, alteration or renovation were approved. A facility must remain in compliance with those standards until the time that they perform new construction, alteration or renovation. At that time, the facility will need to comply with the standards that are in effect at the time that their plans for construction, alteration or renovation are approved by the Department. To be clear, a facility will not be allowed to fall into disrepair. A facility will be cited if it is not in compliance with the standards that were in effect at the time that its plans for construction, alteration or renovation were approved. The Department also amends subsection (c) in this final-form rulemaking to replace the words ''alterations, renovations and construction'' with the words ''construction, alteration or renovation'' for consistency in the use of this terminology.

§ 204.2. Building plans

 The Department proposed to delete existing § 205.4 (relating to building plans) and copy several provisions from that section into this section. Section 205.4 is deleted because all plans for construction, alteration or renovation approved on or after July 1, 2023, the effective date of the regulation, will need to meet the requirements of § 204.2 (relating to building plans).

 In response to commentators and IRRC, the Department provides the following explanation for why certain provisions of § 205.4 were not carried over into the new requirements in § 204.2. The Department did not copy the requirements of existing § 205.4(a) and (b) into § 204.2 because these requirements are duplicative of existing requirements in § 51.3(d) (relating to notification). Section 51.3(d) applies to all healthcare facilities licensed by the Department, including long-term care nursing facilities. Section 51.3(d) requires that a facility submit architectural plans and blueprints of proposed new construction, alteration or renovation to the Department for approval before beginning new construction, alteration or renovation. Section 205.4(c) is copied to § 204.2(b), as noted as follows. Section 205.4(d) is replaced with new language in § 204.2(c), which clarifies construction to begin within 2 years of the Department's approval of the plans submitted under § 51.3(d) and to be completed within 5 years.

 The Department did not copy the requirements of existing § 205.4(e) into § 204.2 because these requirements do not accurately reflect modern practices concerning plan submissions. Under § 51.3(d), facilities are currently required to submit plans for construction or renovation that demonstrate compliance with the applicable regulations and codes for each individual project. The minimum elements that must be included in each plan will vary widely depending on what type of construction, alteration or renovation is being performed. It is the intent of the Department to not require facilities to include extraneous information when submitting construction plans for approval. Plans will differ based on a variety of factors such as, the portion of the facility undergoing construction (for example, resident rooms, corridors, workstations), the type of construction being performed (for example, upgrading electrical work, installing new plumbing, new buildings) and other ancillary factors that are all but impossible for the Department to account for in a rigid checklist of requirements for every plan. In practice, a universal set of standards applicable to each distinct plan that is submitted to the Department is unworkable, provides an additional requirement on regulated industry and does not achieve the Department's goal to assure compliance with applicable regulations and codes. Information regarding the submission of plans can be found on the Department's web site at https://www.health.pa.gov/topics/facilities/safety/Pages/Review.aspx.

 However, § 204.2 is amended from the proposed rulemaking to this final-form rulemaking. The Department adds new language to the beginning of this section in subsection (a) to indicate that the Department will post instructions for the submission of plans for construction, alteration or renovation on its public web site. As a result of this addition, the remaining proposed subsections are renumbered accordingly and this is described more fully as follows.

Subsection (a)

 Subsection (a) is amended from the proposed rulemaking to this final-form rulemaking. As noted previously, the Department has added language, in this final-form rulemaking, to indicate that the Department will post instructions for the submission of plans for construction, alteration or renovation on its public web site.

 A commentator suggested that the Department add language to require a facility to provide written plans, architectural renderings, and a plain language description of alterations or renovations to the resident and family councils of the facility, as well as the Office of the Local Long-Term Care Ombudsman. After careful consideration, the Department declines to make this amendment. The primary goal of the Department's licensure regulations is to ensure that residents are safe, healthy and comfortable. The Department considers the sharing of construction, alteration or renovation plans to be a best practice, and declines to add a requirement for the sharing of items, such as architectural plans, which may be difficult for lay persons to understand. It is also the Department's experience that generally facilities that are conducting construction, alteration or renovation are proud of these upgrades to the facility and generally voluntarily promote and share plans with the resident council.

Subsection (b)

 The language that was proposed in subsection (a) is moved to subsection (b), in this final-form rulemaking, without amendment. The Department maintained the language from existing § 205.4(c), with the addition of a cross-reference to § 51.3(d) to clarify that this subsection applies to plans approved under that section. Subsection (b) reflects the current practice that a licensee or prospective licensee be allowed to present and discuss plans with the Department. If differences occur and cannot be resolved, the licensee or prospective licensee may seek an administrative hearing.

 A commentator sought clarification as to what the term ''prospective licensee'' means and suggested that the Department use the term ''applicant'' instead and add a corresponding definition for that term. The commentator proposed that the term ''applicant'' be defined as, ''the entity applying for licensure, whether initial licensure for a new facility or transfer of ownership licensure for an existing facility that would, if approved by the Department, be transferred to the new owner.'' Although the Department appreciates this comment, the Department declines to add the term ''applicant'' to the regulation and instead retains the term ''prospective licensee'' since ''licensee'' is already a defined term. The Department also declines to add a definition for the additional term ''prospective licensee.'' The term ''licensee'' is presently defined in § 201.3 as, ''the individual, partnership, association or corporate entity including a public agency or religious or fraternal or philanthropic organization authorized to operate a licensed facility.'' The Department is not amending this definition in this final-form rulemaking. The term ''prospective'' is commonly understood and is defined as ''relating to or effective in the future; likely to come about; likely to be or become'' in Webster's dictionary. Merriam-Webster. ''Prospective.'' Retrieved from https://www.merriam-webster.com/dictionary/prospective. As the term ''prospective'' is generally understood by its ordinary dictionary meaning, it is unnecessary to include a separate definition for the term ''prospective licensee.'' See also 1 Pa.C.S. § 1903 (relating to words and phrases).

 A commentator asked what is meant by the phrase ''if differences occur.'' In response to this question, the Department first notes that this is existing language used in the Department's current regulations. As applied, it means that the Department works with licensees and prospective licensees and attempts to resolve questions and disputes concerning plans for construction, alteration or renovation without the need for an administrative hearing. However, if the Department and the facility are at an impasse and further discussions will not resolve the perceived issue with the plans for construction, alteration or renovation, the facility may seek an administrative hearing in accordance with 1 Pa. Code Part II (relating to General Rules of Administrative Practice and Procedure).

 A commentator also asked whether the Department provides licensees and prospective licensees with a written decision regarding plans for construction, alteration or renovation that includes a notice of appeal rights. Historically, the Department has never had a licensee or prospective licensee appeal a decision regarding plans for construction, alteration or renovation because the Department generally works with licensees and prospective licensees to resolve any issues that may arise with plans. If there is a disagreement between the Department and a licensee or prospective licensee regarding plans for construction, alteration or renovation, the licensee or prospective licensee may, as indicated in the language of this subsection, seek an administrative hearing in accordance with 1 Pa. Code Part II.

Subsection (c)

 The language that was proposed in subsection (b) is moved to subsection (c), in this final-form rulemaking, but with one amendment. The words ''alterations, renovations or construction'' are replaced with the words ''construction, alteration or renovation'' for consistency in the use of that terminology. The Department proposed in this subsection to require construction, alteration or renovation to begin within 2 years of the Department's approval and to be completed within 5 years of the Department's approval. A commentator suggested adding the words ''date of the'' before ''Department's approval.'' Although the Department appreciates this comment, the Department declines to make this amendment in this final-form rulemaking due to consistency with the 2-year limitation language and readability. Further, the suggested language does not add anything substantive to the regulation.

 As explained in the proposed rulemaking, building and construction codes are typically updated every 3 years to 4 years. The Department has received and approved numerous plans that were never completed due to financial and other issues. The Department has also received and approved plans for renovation of an entire building that was never fully completed. Placing a 5-year time limit on the completion of construction, alteration or renovation will prevent a facility from having plans approved but then proceeding to build at a much later date when codes that were applicable at the time of the approval no longer apply. The 5-year time limit also reflects the Department's current practice of contacting facilities after 4 1/2 years to inform them that they have 6 months left to complete approved projects or resubmit plans under current codes.

Subsection (d)

 The language that was proposed in subsection (c) is moved to subsection (d), in this final-form rulemaking, but with minor amendments. The words ''alterations, renovations or construction'' are replaced with the words ''construction, alteration or renovation'' for consistency in the use of that terminology. The Department also replaces the cross-reference to subsection (b) with a cross-reference to subsection (c) due to the language in subsection (b) being moved to subsection (c). The Department did not receive any comments on this subsection. As explained in the proposed rulemaking, the addition of subsection (d) contemplates circumstances in which a facility may need to request an extension of time for completion of a project, such as an extremely large project involving multiple stories above and below ground.

Subsection (e)

 The language that was proposed in subsections (d) and (e) is deleted from this final-form rulemaking. The Department, in this final-form rulemaking, adds language to subsection (e) to require a facility to obtain approval from the Department before using an area of the facility for resident care when that area has not been occupied or used by residents for 1 year or more.

 The Department had proposed in subsection (d) to add language stating that any part of a facility that has not been occupied or used for 1 year or more may not be used by the facility for any purpose except as provided for in this section. The Department had proposed in subsection (e) to require a facility to submit architectural plans and blueprints related to occupancy or use if a facility intends to occupy or use a space that has been unoccupied or unused for 1 year or more.

 Commentators and IRRC asked what is meant by the terms ''any part'' and ''occupied or used'' in proposed subsection (d). Commentators also asked if using a space for storage would constitute ''use'' and whether subsection (d) would apply to a room that has been left unoccupied for a year. Some commentators expressed concern that the requirement in proposed subsection (e) would be an additional barrier for facilities to overcome to return to full operation and provide access to residents in need of services. Specifically, commentators stated that facilities have already needed to limit admissions and available beds due to staffing issues and there is concern that the cost to update those unoccupied beds to newer requirements will result in the facilities simply delicensing those beds, reducing available capacity. A commentator also suggested that the Department should have the ability to approve a new use in situations where no additional work, or minor work, is needed to utilize the portion of the facility for the desired purpose, without the need for the facility to comply with the requirements of this subsection. IRRC asked the Department to clarify the language of both proposed subsections (d) and (e), and to explain how the final-form regulation is reasonable and feasible, and how it protects the public health, safety and welfare.

 After carefully considering the comments from public commentators and IRRC, the Department agrees and deletes the language that was proposed in subsections (d) and (e). The Department, however, adds language in subsection (e), in this final-form rulemaking, to balance resident health and safety by simply requiring a facility to obtain approval from the Department before using an area of the facility for resident care when that area has not been occupied or used by residents for 1 year or more. The intent of final-form subsection (e) is to prevent facilities from allowing portions of the facility to fall into disrepair if they are not used or occupied. As explained in the proposed rulemaking, the Department has encountered situations where facilities want to reopen a portion of the facility that has been closed for years. Building codes and construction codes change over time. Even if the facility intends to use that area for the same purpose, the area may no longer be suitable for that purpose if it has been unoccupied or unused for a year or more, or even safe for residents as the area may have been allowed to deteriorate. The Department adds the words ''for resident care'' after the words ''area of the facility'' and ''by residents'' after ''occupied or used'' to clarify what is meant by an ''area of the facility'' and ''occupied or used.''

 The Department deleted the language in proposed subsection (e) to automatically require architectural plans and blueprints any time a portion of the facility has gone unoccupied or unused for 1 year or more to address commentators' concerns regarding the need to update areas of a facility to comply with newer codes that may not need to be updated. The Department recognizes that there may be situations where an area has not been used or occupied but remains in good condition and safe for occupancy. The Department also notes, as it did at the beginning of this chapter, in response to concerns regarding completion of minor work, that it does not intend for the definition of ''construction, alteration or renovation'' to encompass work that consists of part-for-part replacement or regular facility maintenance. Requiring a facility to obtain approval from the Department before using an area for resident care that has not been occupied or used by residents for 1 year or more will allow the Department to inspect the area that the facility intends to use for resident care to ensure that it has not fallen into disrepair and still meets the appropriate standards for the health, safety and welfare of residents.

 IRRC and commentators raised concerns to proposed subsection (d) as to how facilities would be able to respond rapidly in emergency situations such as the COVID-19 pandemic where it became necessary to isolate people and spread them out to the maximum extent possible. In the event of a broad-based emergency, such as the COVID-19 pandemic, CMS can issue waivers allowing for flexibility with regards to Federal requirements. CMS did so during the COVID-19 pandemic by utilizing 1135 waivers under section 1230b-5 of the Social Security Act (42 U.S.C.A. § 1320b-5). Further, to the extent there is a disaster emergency, under 35 Pa.C.S. § 7301 (relating to general authority of Governor), the Governor may also utilize emergency powers under the Emergency Management Services Code in coping with the disaster emergency, including the suspension of regulations and regulatory statutes, if needed. Additionally, by virtue of the expansion of the incorporation of the Federal requirements in § 201.2 in final-form Rulemaking 1, all facilities, including private-pay facilities, will be required to implement an emergency preparedness program under 42 CFR 483.73 that addresses various emergency scenarios and requires facilities to draft plans, enact policies and provide training to help facilities respond to various potential emergency situations as outlined by risk assessments. (This assumes approval of final-form Rulemaking 1). The Department additionally adds new § 204.20 (relating to airborne infection isolation room) to this final-form rulemaking, described as follows, which will require facilities to provide at least one airborne infection isolation room to isolate residents to prevent the spread of communicable diseases. Finally, in the event of an emergency, a facility may also submit a request for an exception under the existing exceptions process in § 51.33 (relating to requests for exceptions) for the Department's consideration.

 Commentators also asked the Department to add language requiring water systems to undergo thorough flushing and disinfecting to prevent residents from being exposed to bacteria that could result in illness or death. Due to the existing Federal requirement, the Department declines to make this amendment. Under 42 CFR 483.80(a)(1) (relating to infection control), a facility must establish an infection prevention and control program that includes ''a system for preventing, identifying, reporting, investigating, and controlling infections and communicable diseases.'' This would include the prevention of waterborne illnesses, such as Legionnaires' disease. Facilities that participate in Medicare or Medical Assistance (MA) are currently required to comply with 42 CFR 483.80(a)(1). Although private-pay facilities are currently required to have an infection prevention and control program, the additional requirements may be a new requirement for the three private-pay facilities under the expanded adoption of the Federal requirements in § 201.2, in final-form Rulemaking 1. This assumes approval of final-form Rulemaking 1.

 For proposed subsection (e), some commentators expressed concern that facilities might move residents around to avoid having a space go unoccupied or unused for a year. These commentators also asked that the Department add language requiring a facility to provide notice before moving a resident. After careful consideration, the Department declines to add this provision because a resident has the right to receive written notice, including the reason for the change, before the resident's room in the facility is changed under 42 CFR 483.10(e)(6) (relating to resident rights). Facilities, including the three private-pay facilities, are currently required to comply with this notice requirement under existing § 201.2, which adopts the Federal requirements at 42 CFR Part 483, Subpart B (relating to requirements for long term care facilities), in part.

 The Department also declines to add language requiring that notice be provided to a resident before moving the resident to another room due to existing Federal requirements. Under 42 CFR 483.10(e)(6), a facility is required to notify a resident in writing if the facility intends to change a resident's room and provide a reason for the move. The resident has the right to refuse the move to another room in the facility if the purpose of the move is solely for the convenience of staff under 42 CFR 483.10(e)(7). Facilities, including the three private-pay facilities are required currently to comply with these requirements, under existing § 201.2, which adopts the Federal requirements at 42 CFR Part 483, Subpart B, in part.

Other comments

 One commentator requested that the Department add a new subsection to § 204.2 to allow a facility to request an exception to proposed subsections (d) and (e) for an area that has been unused or unoccupied for 1 year or more in the event of disease outbreak. The proposed exception request would be effective for no more than 30 days to allow the facility time to submit architectural plans and blueprints related to its occupancy or use to the Department as required under § 51.3(d) and receive approval from the Department to continue to operate. This amendment is unnecessary due to the Department's amendment to subsection (e), described previously, to eliminate the requirement for submission of additional plans and blueprints for unoccupied space.

§ 204.3. Buildings and grounds; general

 The title of this section is amended from the proposed rulemaking to this final-form rulemaking to add ''and grounds'' after the word ''buildings'' at the request of a commentator. This amendment more accurately reflects the contents of this section. Several provisions of Chapter 205 are carried over into this section, as described more fully as follows.

Subsection (a)

 Subsection (a) is amended from the proposed rulemaking to this final-form rulemaking. The Department had proposed to copy § 205.1 (relating to location or site) into subsection (a) without amendment because this requirement goes above and beyond the requirements in the 2018 FGI Guidelines. Commentators, however, expressed confusion over the use of the word ''area'' in this subsection, asking that the Department clarify whether this is a reference to the safety of the geographical area where the facility is located. A commentator also expressed confusion over the use of the words ''conducive to health and safety.'' In response to these comments, the Department adds the qualifiers ''that is geographically and environmentally'' before the word ''conducive'' to clarify that a facility shall be located in an area that is both geographically and environmentally conducive to the health and safety of residents. The Department would not, for example, want a facility to be built on top of a subway station, or in an area where residents might be exposed to environmental hazards. The Department notes, as well, that facilities must adhere to the Life Safety Code, which is incorporated by reference in 42 CFR 483.73(g)(1), and other applicable construction and zoning ordinances for construction, alteration and renovation projects, which also ensures compliance with subsection (a).

Subsection (b)

 Subsection (b) is amended from the proposed rulemaking to this final-form rulemaking at the request of IRRC to replace the word ''before'' with the word ''if.'' The Department agrees and has added this language. As explained in the proposed rulemaking, the requirement in § 205.6(a) (relating to function of building) is copied into subsection (b), with one minor grammatical amendment, because this requirement goes above and beyond the requirements in the 2018 FGI Guidelines.

 A commentator expressed similar concerns with this subsection as with subsection (a). Under subsection (b), no part of a building may be used for a purpose that interferes with or jeopardizes the health and safety of residents. The commentator indicated that it was not clear what purposes would be covered by this provision and expressed concern that this language could be interpreted to mean that no part of the building could be used for cooking as there are residents that could be harmed by knives or fire involved in cooking. The Department's number one priority is the health, safety and welfare of residents. The Department applies a common-sense interpretation and ordinary dictionary definition to the words ''interferes with or jeopardizes'' in the context of a resident's health and safety and would not cite a facility for having an area dedicated for cooking if that area meets the requirements of the act and this subpart. The Department notes that subsection (b) also requires special authorization if part of the building is to be used for a purpose other than health care. This language mirrors the language in existing § 205.6(a). Facilities have requested exceptions under that subsection, which have been granted by the Department. The Department would anticipate continuing to receive similar exception requests under this subsection.

Subsection (c)

 Subsection (c) is unchanged from the proposed rulemaking to this final-form rulemaking. As explained in the proposed rulemaking, the requirement in § 205.6(b) is copied into subsection (c) because this requirement goes above and beyond the requirements in the 2018 FGI Guidelines.

 Commentators questioned whether the allowance in this subsection for administrators' family members to reside in a newly constructed facility remains appropriate. These commentators indicate that although this was the practice in the past, it appears to now be outdated. Although the Department is unaware of this provision being currently utilized, the Department is concerned that the removal of the ability of the administrator's family members to reside at the facility may make it difficult to obtain and retain administrators. Additionally, it may be important to allow administrators' family members to reside in a care-focused portion of a facility, and removal of this language might prevent family members needing that care from residing in the facility. The Department, therefore, declines to remove this language from the regulation.

Subsection (d)

 Subsection (d) is amended from the proposed rulemaking to this final-form rulemaking. The Department had proposed to copy § 205.2(a) into this subsection without amendment because this requirement goes above and beyond the requirements in the 2018 FGI Guidelines.

 A commentator asked what is meant by the term ''service areas'' in the first sentence of this subsection. The term ''service areas'' could include, for example, a loading dock, dumpster or other outdoor maintenance area that is separate from outdoor areas that would be used by residents. A commentator also asked, with respect to the second sentence in this subsection, why only a facility with site limitations can provide balcony areas. Upon further consideration, the Department agrees and does not intend for this sentence to be limiting. Therefore, the Department has removed ''with site limitations'' from the second sentence to make it clear that any facility may provide rooftop or balcony areas so long as adequate protective enclosures are provided.

 Commentators also requested that the term ''adequate protective enclosures'' in the second sentence be defined or more fully described. Facilities are generally responsible for providing a safe environment for residents and are further responsible for assessing what is necessary to create a safe environment. Adequate protective enclosures could vary based on the acuity of the residents in the facility and could include, for example, railings or plexiglass or cinderblock walls. It is also not common in the Department's experience for facilities to have rooftop or balcony areas for residents. It is much more common for outdoor areas to be on the ground level, due to safety concerns. The Department, therefore, declines to add a definition for this term.

Subsection (e)

 Subsection (e) is unchanged from the proposed rulemaking to this final-form rulemaking. As explained in the proposed rulemaking, the Department copies § 205.2(b) into this subsection because this requirement goes above and beyond the requirements in the 2018 FGI Guidelines.

§ 204.4. Basement

 Section 204.4 is amended from the proposed rulemaking to this final-form rulemaking. The Department had proposed to copy language from § 205.7 (relating to basement or cellar) with minor amendments, because that requirement goes above and beyond the requirements in the 2018 FGI Guidelines. In this final-form rulemaking, the Department moves this language into subsection (a) and creates subsection (b). In subsection (b), the Department copies language from § 205.10(e) (relating to doors), which prohibits a door to a basement from being in a resident's room but removes the outdated term ''cellar.'' When comparing the provisions of Chapter 205 to the FGI Guidelines, the Department discovered that this requirement is not covered by the 2018 FGI Guidelines. The Department does not believe that there would ever be a reason for a basement door to be in a resident's room, but is adding it in this final-form rulemaking, out of an abundance of caution, to ensure the health and safety of residents.

 The remaining provisions of § 205.10 were not carried over to Chapter 204 and continue to not be carried over in this final-form rulemaking. In response to commentators and IRRC, the Department provides the following explanation for why the remaining provisions of § 205.10 were not carried over into the new requirements in Chapter 204. Section 205.10(a)—(d) are not carried over to Chapter 204 because requirements for door openings can be found in section 2.4-2.2.4.2 of the 2018 FGI Guidelines. Additional requirements for doors are in the Life Safety Code at sections 7.2.1—7.2.1.4.5.2, 18.2.2.2—18.2.2.2.10.2 and 19.2.2.2—19.2.2.2.10.2. Section 205.10(f) is not carried over because the requirement for screens is covered by section 2.4-2.2.4.3 of the 2018 FGI Guidelines.

 One commentator expressed concern that under the regulations, residents might be moved into basements under certain situations. The commentator stated that under no circumstances is it acceptable to utilize a space below grade as a bedroom. The Department agrees and points this commentator to § 204.5(b) (relating to resident rooms), which states that the basement of a facility may not be used for resident rooms.

§ 204.5. Resident rooms

Subsection (a)

 Subsection (a) is unchanged from the proposed rulemaking to this final-form rulemaking. As explained in the proposed rulemaking, the Department copies § 205.20(a) (relating to resident bedrooms) into subsection (a) to align with terminology used by CMS. This requirement is necessary in Chapter 204 because it goes above and beyond the requirements in the 2018 FGI Guidelines.

Subsection (b)

 Subsection (b) is unchanged from the proposed rulemaking to this final-form rulemaking. As explained in the proposed rulemaking, this new provision is added at the request of the LTC Work Group to prohibit a facility from using a basement for resident rooms.

Subsection (c)

 Subsection (c) is unchanged from the proposed rulemaking to this final-form rulemaking. As explained in the proposed rulemaking, the Department copies § 205.20(b) and (c) into subsection (c) with no substantive amendments, because these requirements go above and beyond the 2018 FGI Guidelines.

Subsection (d)

 Subsection (d) is unchanged from the proposed rulemaking to this final-form rulemaking. As explained in the proposed rulemaking, the Department adds subsection (d), at the request of the LTC Work Group, to clarify that a resident shall have a choice in the placement of the resident's bed in the room. The Department added ''unless the placement presents a safety hazard'' to the LTC Work Group's recommended language.

 Commentators asked the Department to revise this subsection to be more specific as to what constitutes a safety hazard. These commentators were concerned that without a definition, facilities will have too much leeway to deny residents' choices and preferences. Commentators also asked that the Department add language to allow a resident, who has the capacity, a certain level of risk or informed decision making, as well as language that would prevent a facility from using arbitrary or ambiguous reasons as a basis for denying the resident's wishes. IRRC asked the Department to clarify this provision or explain the reasonableness of retaining this language in this final-form rulemaking. IRRC noted that this comment also applies to § 205.22 (relating to placement of beds).

 In balancing the competing interests for resident autonomy and choice with also the need for health and safety requirements, the Department declines to amend this subsection. The addition of ''unless the placement presents a safety hazard'' is not only reasonable, but critical to ensure the safety of residents. As explained in the proposed rulemaking, the Department supports a resident's ability to choose where a bed is placed in the room but can envision circumstances where a resident's choice of bed placement could pose a health or safety hazard, such as placement near a radiator, heat source or blocking a doorway. In those circumstances, the health and safety of the resident needs to come first. Safety hazards must be determined through an evaluation of the resident's needs and an assessment of the physical environment. A safety hazard for one resident may not necessarily be a safety hazard for another resident, based on the resident's acuity, and a facility will need to determine this on a case-by-case basis. Additionally, if the Department receives a complaint regarding this subsection, the Department will ask the facility why the resident's preference was not considered and will attempt to resolve the complaint in a manner that addresses the resident's concerns and preferences while also ensuring safe placement of the bed.

Subsection (e)

 Subsection (e) is unchanged from the proposed rulemaking to this final-form rulemaking. As explained in the proposed rulemaking, the Department copies § 205.22 into subsection (e) with amendment. Specifically, the Department added on proposed, ''unless the resident chooses to do so and the placement does not pose a safety hazard'' to align with the language in subsection (d). The Department did not receive any comments specifically on this subsection but did receive comments regarding the addition of this language in subsection (d), addressed previously.

Subsection (f)

 Subsection (f) is unchanged from the proposed rulemaking to this final-form rulemaking. As explained in the proposed rulemaking, the Department copies § 205.72 (relating to furniture) into this subsection, without amendment. Commentators requested that the Department require education to residents about the right to have a locked drawer or cabinet. Commentators request that this occur during the resident's first care plan meeting, and that the resident be specifically informed of the right to have a locked drawer or cabinet, and the need to inform staff when the key is lost, the drawer is broken or when something is stolen. The Department, in proposed Rulemaking 4, proposed to add requirements for admission policies and procedures in § 201.24(e)(5) (relating to admission policy), which would include assisting the resident, if needed, in creating a homelike environment and settling personal possessions in the room to which the resident has been assigned. In response to commentators' concerns, on this final-form rulemaking, the Department amends § 201.24(e)(5), by removing the words ''if needed'' and adding the words ''and securing'' after the word ''settling'' to ensure that facilities have policies and procedures in place to assist residents in securing their personal possessions.

 In response to commentators and IRRC, who asked the Department to clarify why certain provisions of Chapter 205 were not carried over to Chapter 204, § 205.20(d) and (f) are not carried over because 42 CFR 483.90(e)(1)(ii) (relating to physical environment) provides minimum square footage requirements for resident rooms and requires that rooms ''measure at least 80 square feet per resident in multiple resident bedrooms, and at least 100 square feet in single resident rooms.'' Facilities, including the three private-pay facilities, are currently required to comply with this provision under existing § 201.2.

 Additionally, § 205.20(e) and (g) are not carried over to Chapter 204 because these requirements apply to facilities that were licensed before 1975. Facilities that perform new construction, alteration or renovation will be required to comply with newer requirements set forth in Chapter 204.

 Commentators requested that the Department add an additional subsection to § 204.5 to prohibit facilities from housing more than two residents in a room, although they feel strongly that all rooms should be single occupancy. The Department declines to add this requirement to regulation due to existing Federal requirements. Under 42 CFR 483.90(e)(1)(i), bedrooms must accommodate no more than two residents for facilities that receive approval of construction after November 28, 2016. Facilities that participate in Medicare or MA are already required to comply with this requirement. With the expansion of the incorporation of the Federal requirements in final-form Rulemaking 1, the requirement in 42 CFR 483.90(e)(1)(i) could potentially impact the three private-pay facilities, if they perform new construction, alteration or renovation under this Chapter. This assumes approval of final-form Rulemaking 1, which expands the adoption of the Federal requirements in § 201.2.

§ 204.6. Locks

 Section 204.6 (relating to locks) is unchanged from the proposed rulemaking to this final-form rulemaking. As explained in the proposed rulemaking, the Department copies language from existing § 205.14 (relating to locks) into this section, without amendment, because this requirement goes above and beyond the requirements in the 2018 FGI Guidelines. Commentators requested that the Department add a requirement that staff must knock prior to entering a resident's room and a requirement for a doorbell outside of each resident's room. These commentators noted that there is little dignity, respect or privacy in staff just walking into resident rooms unannounced. The Department declines to make this amendment. The Department considers knocking and requesting permission to enter to fall within a resident's preferences, subject to an emergency, which is covered by 42 CFR 483.10(e)(3), which provides that a resident has the right to reside and receive services in the facility with reasonable accommodation of resident needs and preferences except when to do so would endanger the health or safety of the resident or other residents. Facilities that participate in Medicare or MA are currently required to comply with 42 CFR 483.10(e)(3). This will be a new requirement for the three private-pay facilities under the expanded adoption of the Federal requirements in § 201.2, in final-form Rulemaking 1. This assumes approval of final-form Rulemaking 1. There is no fiscal impact associated with this provision.

§ 204.7. Laundry

 Section 204.7 (relating to laundry) is unchanged from the proposed rulemaking to this final-form rulemaking. As explained in the proposed rulemaking, the Department copies language from existing § 205.26(e) (relating to laundry) into this section, with no amendment because this provision goes above and beyond what is required in the 2018 FGI Guidelines.

 In response to commentators and IRRC, who requested that the Department clarify which provisions of Chapter 205 are not being carried over into Chapter 204, the Department is not carrying over § 205.26(a)—(d) because these requirements are covered by the 2018 FGI Guidelines at sections 3.1-4.6, 3.1-4.2.7, and 2.3-4.2.7, as adopted by the Department in § 204.1(a). Additionally, under 42 CFR 483.10(i)(3), a resident has a right to a safe, clean, comfortable and homelike environment, which includes the provision of clean bed and bath linens. Facilities, including the three private-pay facilities are currently required to comply with 42 CFR 483.10(i)(3) under existing § 201.2.

§ 204.8. Utility room

 Section 204.8 (relating to utility room) is unchanged from the proposed rulemaking to this final-form rulemaking. As explained in the proposed rulemaking, the Department copies language from § 205.33(a) (relating to utility room) into this section, with two amendments. In the proposed rulemaking, the Department deleted the phrase ''near the nurses' station'' in the first sentence and deletes the last sentence regarding nursing stations in its entirety. The Department eliminates the requirement that utility rooms be located near nursing stations for two reasons: (1) the long-term care nursing industry has begun to shift away from the use of the term ''nurses' station'' in favor of terms such as ''workstations'' that focus more on person centered care; and (2) it is more appropriate to have utility rooms located near resident rooms or other locations where they are needed for easier access. The remaining language in § 205.33(a) is being copied into this section because it goes above and beyond what is required in the 2018 FGI Guidelines.

 In response to commentators and IRRC, who requested the Department to clarify which provisions of Chapter 205 are not being carried over into Chapter 204, the Department is not carrying over § 205.33(b) and (c) because these requirements are covered by the 2018 FGI Guidelines at sections 2.3-4.2.5 and 2.3-4.2.6, as adopted by the Department in § 204.1.

§ 204.9. Bathing facilities

Subsection (a)

 Subsection (a) is unchanged from the proposed rulemaking to this final-form rulemaking. As explained in the proposed rulemaking, the Department copied § 205.36(a) (relating to bathing facilities) into this subsection, with amendment. In the proposed rulemaking, the Department replaced the word ''bedrooms'' with the word ''rooms'' to align with terminology used by CMS. The Department copied this requirement into this section because it goes above and beyond what is required in the 2018 FGI Guidelines.

Subsection (b)

 Subsection (b) is unchanged from the proposed rulemaking to this final-form rulemaking. The requirement in § 205.36(c) is copied into this subsection, without amendment. The Department copied this requirement into this section because it goes above and beyond what is required in the 2018 FGI Guidelines.

Subsection (c)

 Subsection (c) is unchanged from the proposed rulemaking to this final-form rulemaking. The requirement in § 205.36(e) is copied into this subsection, without amendment. The Department copied this requirement into this section because it goes above and beyond what is required in the 2018 FGI Guidelines.

Subsection (d)

 Subsection (d) is unchanged from the proposed rulemaking to this final-form rulemaking. As explained in the proposed rulemaking, the Department copied the requirement in § 205.36(h) into this subsection but removed outdated language regarding accessibility and measurements required for the bath area. The Department copied this requirement into this section because it goes above and beyond what is required in the 2018 FGI Guidelines.

 In response to commentators and IRRC, who requested the Department to clarify which provisions of Chapter 205 are not being carried over to Chapter 204, the Department is not carrying over § 205.36(b), (d), (f) and (g) because these requirements are covered by the 2018 FGI Guidelines at sections 3.1-4.2.3, 3.1-4.2.3.1, 2.5-2.3.3.2 and 3.1-4.2.3.2, as adopted by the Department in section 204.1. Additionally, the Department does not include subsection (b) from § 205.36 because although it is not difficult for a facility to provide 1 bathing fixture per 15 beds, in reality, multiple bathing fixtures are not utilized simultaneously, and the space designated as bathing fixtures could be better utilized by the facility. Additionally, for subsection (d), facilities typically performing new construction, alteration or renovation will include provisions for bathing in a bathroom attached to the resident's room. Where not provided or possible for certain renovation projects, the FGI Guidelines require a ratio of 1 bathing fixture per 20 residents. Subsection (f) is not carried forward to Chapter 204 because it conflicts with section 608.2 of the 2010 Americans with Disabilities Act Standards Standards for Accessible Design (ADA Standards), which requires transfer type shower compartments to be at least 36" by 36", standard roll-in type shower compartments to be at least 30" by 60" in size, and alternate roll-in type shower compartments to be 36" by 60". ADA.gov. 2010 ADA Standards for Accessible Design. Retrieved from https://www.ada.gov/regs2010/2010ADAStandards/2010ADAstandards.htm. Facilities, including the three private-pay facilities, are required to comply with ADA Standards. Subsection (g) is not carried forward because shower controls are covered under section 608.5 of the ADA Standards and section 2.5-2.3.3.2 of the FGI Guidelines.

§ 204.10. Toilet facilities

 The Department adds this section in this final-form rulemaking. As noted previously, commentators and IRRC requested that the Department clarify which provisions of Chapter 205 are not being carried over to Chapter 204. While reviewing Chapter 204 and the FGI Guidelines, the Department determined that there was no provision for toilet facilities for visitors of long-term care nursing facilities as set forth in existing § 205.38(f) (relating to toilet facilities). On this final-form rulemaking the Department corrects this oversight by copying the requirement from § 205.38(f) into this section, to require facilities to provide toilets and lavatories for visitors that are independent of the toilet facilities utilized by residents, with one amendment. The Department removes the words ''male and female'' because the prevailing general trend is that public restroom facilities do not need to be gender-specific. Due to this amendment, §§ 204.10—204.18 are renumbered, as explained as follows.

 In response to commentators and IRRC, who requested that Department clarify which provisions of Chapter 205 are not being carried over to Chapter 204, the Department is not carrying over § 205.38(a) and (e) because these requirements have been replaced by more up-to-date requirements at 42 CFR 483.90(f). With the expansion of the incorporation of the Federal requirements in final-form Rulemaking 1, this requirement could potentially impact the three private-pay facilities, if they perform new construction, alteration or renovation under this chapter. This assumes approval of final-form Rulemaking 1, which expands the adoption of the Federal requirements in § 201.2. The Department does not carry § 205.38(b) and (c) forward to Chapter 204 because these requirements are covered by the 2018 FGI Guidelines at section 3.1-2.2.2.6, as adopted by the Department in § 204.1. Section 205.38(d) is not carried forward to Chapter 204 because toilet training is part of a facility's rehab program in accordance with the 2018 FGI Guidelines at section 3.1-3.3.7.

§ 204.11. Equipment for bathrooms

 This section is renumbered to § 204.11 (relating to equipment for bathrooms), in this final-form rulemaking, but otherwise, is not amended from the proposed rulemaking to this final-form rulemaking.

Subsection (a)

 Subsection (a) is unchanged from the proposed rulemaking to this final-form rulemaking. As explained in the proposed rulemaking, the Department copies § 205.37(a) (relating to equipment for bathrooms) into this subsection, but replaces the language referring to a specific weight limit for grab bars in tubs and showers with the phrase ''to accommodate the residents' needs.'' The Department recognizes that there are a wide variety of reasons that a resident may be at risk for falling and has made this change in language to require long-term care nursing facilities to provide grab bars that will accommodate residents of any size and physical or mental condition. As noted, in the proposed rulemaking, the Department is retaining this requirement in Chapter 204 because it goes above and beyond what is required in the 2018 FGI Guidelines.

Subsection (b)

 Subsection (b) is unchanged from the proposed rulemaking to this final-form rulemaking. As explained in the proposed rulemaking, the Department copies § 205.37(b) into this subsection, but replaces the term ''nursing station'' with ''workstation'' because the long-term care nursing industry has begun to shift away from the use of the term ''nurses' station'' in favor of terms such as ''workstations'' that focus more on person-centered care. As noted in the proposed rulemaking, the Department is retaining this requirement in Chapter 204 because it goes above and beyond what is required in the 2018 FGI Guidelines.

Subsection (c)

 Subsection (c) is unchanged from the proposed rulemaking to this final-form rulemaking. As explained in the proposed rulemaking, the Department copies § 205.37(c) into this subsection, with only grammatical amendments because it goes above and beyond what is required in the 2018 FGI Guidelines.

Subsection (d)

 Subsection (d) is unchanged from the proposed rulemaking to this final-form rulemaking. As explained in the proposed rulemaking, the Department copies § 205.37(d) into this subsection, without amendment because it goes above and beyond what is required in the 2018 FGI Guidelines.

Subsection (e)

 Subsection (e) is unchanged from the proposed rulemaking to this final-form rulemaking. As explained in the proposed rulemaking, the Department copies § 205.37(e) into this subsection, without amendment because it goes above and beyond what is required in the 2018 FGI Guidelines.

§ 204.12. Toilet room equipment

 This section is renumbered to § 204.12 (relating to toilet room equipment), in this final-form rulemaking, but otherwise, is not amended from the proposed rulemaking to this final-form rulemaking. As noted in the proposed rulemaking, the Department copied language from § 205.39(b) (relating to toilet room equipment) into this section, with two amendments. First, the Department removed the phrase ''and an emergency call bell within reaching distance.'' Under the 2018 FGI Guidelines, at section 3.1-6.5.2, an emergency call device shall be accessible from each toilet, bathtub and shower used by residents. Second, the Department replaced the language referring to a specific weight limit for handrails or assist bars with the phrase ''of accommodating the residents' needs.'' The Department recognizes that there are a wide variety of reasons that a resident may be at risk for falling and has made this change in language to require long-term care nursing facilities to provide handrails or assist bars that will accommodate residents of any size and physical or mental condition. This provision goes above and beyond what is required in the 2018 FGI Guidelines.

 Commentators expressed concern that the Department did not carry the requirement from § 205.23 (relating to location of bedrooms) into this section. Section 205.23 requires a resident bedroom to have adjoining toilet facilities and to be conveniently located near bathing facilities. Commentators were also concerned that the Department failed to include a ratio for number of toilets to residents. The Department declines to amend this section due to existing Federal requirements. Under 42 CFR 483.90(f), resident rooms are required to be equipped with or located near toilet and bathing facilities, and for facilities that receive approval of construction after November 28, 2016, each resident room must have its own bathroom equipped with at least a commode and sink. Facilities that participate in Medicare or MA are already required to comply with this requirement. With the expansion of the incorporation of the Federal requirements in final-form Rulemaking 1, this requirement could potentially impact the three private-pay facilities, if they perform new construction, alteration or renovation under this chapter. This assumes approval of final-form Rulemaking 1, which expands the adoption of the Federal requirements in § 201.2.

 In response to commentators and IRRC, who requested the Department to clarify which provisions of Chapter 205 are not being carried over to Chapter 204, the Department is not carrying over § 205.39(a) because section 3.1-2.2.2.6 of the 2018 FGI Guidelines cover the requirements in § 205.39(a). Specifically, the 2018 FGI Guidelines provide that each resident shall have access to a toilet room without entering a general corridor. Additionally, toilet rooms must contain a toilet, a handwashing station, a mirror and individual storage for each resident.

§ 204.13. Linen

 This section is renumbered to § 204.13 (relating to linen), in this final-form rulemaking, but otherwise, is not amended from the proposed rulemaking to this final-form rulemaking. As explained in the proposed rulemaking, the Department copied language from § 205.74 (relating to linen) into this section without amendment, because this requirement goes above and beyond what is required in the 2018 FGI Guidelines.

§ 204.14. Supplies

 This section is renumbered to § 204.14 (relating to supplies), in this final-form rulemaking, but otherwise, is not amended from the proposed rulemaking to this final-form rulemaking. As explained in the proposed rulemaking, the Department copied language from § 205.75 (relating to supplies) into this section without amendment because this requirement goes above and beyond what is required in the 2018 FGI Guidelines.

§ 204.15. Windows

 This section is renumbered to § 204.15 (relating to windows), in this final-form rulemaking, but otherwise, is not amended from the proposed rulemaking to this final-form rulemaking. As noted, in the proposed rulemaking, the Department copies existing language from § 205.19 (relating to windows and windowsills) into this section, with minor amendment. In addition to minor grammatical amendments, the Department replaced the word ''bedrooms'' with ''rooms'' in this section to align with terminology used by CMS. The Department copies this provision into this section because it goes above and beyond what is required in the 2018 FGI Guidelines.

§ 204.16. Dining

 This section is renumbered to § 204.16 (relating to dining), in this final-form rulemaking, but otherwise, is not amended from the proposed rulemaking to this final-form rulemaking. As noted, in the proposed rulemaking, the Department copied language from § 205.24(a) (relating to dining room) into this section, with one amendment. The Department deleted the last sentence indicating, ''these areas shall be well lighted and well ventilated.'' This language is not necessary because lighting requirements are covered within the FGI Guidelines at section 2.5-7. The remaining language in this provision, regarding space for dining areas, is copied into this section because it goes above and beyond what is required in the 2018 FGI Guidelines.

 In response to commentators and IRRC, who requested that the Department clarify which provisions of Chapter 205 are not being carried over to Chapter 204, the Department is not carrying over § 205.24(b) because these requirements are covered by the 2018 FGI Guidelines at section 2.3-2.3.3.2, as adopted by the Department in § 204.1 of this final-form rulemaking.

§ 204.17. Lounge and recreation

 This section is renumbered to § 204.17 (relating to lounge and recreation), in this final-form rulemaking, but otherwise, is not amended from the proposed rulemaking to this final-form rulemaking. As noted, in the proposed rulemaking, the Department copies language from § 205.27 (relating to lounge and recreation rooms) into this section, without amendment because this provision goes above and beyond what is required in the 2018 FGI Guidelines.

§ 204.18. Storage

 This section is renumbered to § 204.18 (relating to storage), in this final-form rulemaking, but otherwise, is not amended from the proposed rulemaking to this final-form rulemaking. As explained, in the proposed rulemaking, the Department copied language from § 205.31 (relating to storage) into this section, without amendment because this provision goes above and beyond what is required in the 2018 FGI Guidelines.

§ 204.19. Plumbing, heating ventilation and air conditioning (HVAC) and electrical

 This section is renumbered to § 204.19 (relating to plumbing, heating, ventilation and air conditioning (HVAC) and electrical, in this final-form rulemaking, but otherwise, is not amended from the proposed rulemaking to this final-form rulemaking. As explained in the proposed rulemaking, this catch-all section is new and replaces the requirements for new construction in §§ 205.61—205.68 (relating to mechanical and electrical requirements). Under this section, all building systems, such as plumbing, HVAC and electrical systems, must comply with all State and local codes. This language is similar to existing language in § 205.61(a) (relating to heating requirements for existing and new construction), but expanded to include all building systems, such as plumbing, HVAC and electrical systems.

 While this catch-all section is intended to replace the requirements for new construction in §§ 205.61—205.68, the Department is also not carrying forward these requirements because they are already covered by the Federal requirements, the Life Safety Code or the 2018 FGI Guidelines. Section 205.61(b) is not carried over to Chapter 204 because it is encompassed by the Federal requirements at 42 CFR 483.25(d) (relating to quality of care) which require a facility to ensure that residents are free from accident hazards and subject to adequate supervision to prevent accidents. Facilities, including the three private-pay facilities, are required to comply with 42 CFR 483.25(d) under existing § 201.2. The Life Safety Code contains additional provisions for HVAC in sections 9.2.1, 9.2.2, and Chapter 43. Section 205.62 (relating to special heating requirements for new construction) is not carried over to Chapter 204 because the requirements in that section are covered in the Life Safety Code in Chapter 43. Section 205.63 (relating to plumbing and piping systems required for existing and new construction) is not carried over to Chapter 204 because these requirements are covered by the 2018 FGI Guidelines at sections 2.5-2.2.3 and 2.5-1, as adopted by the Department in § 204.1.

 Section 205.64 (relating to special plumbing and piping systems requirements for new construction) is not carried over to Chapter 204 because the requirements are covered by the 2018 FGI Guidelines at section 2.5-2, as adopted by the Department in § 204.1. These requirements are also covered by the Federal requirements at 42 CFR 483.90(b). Facilities that participate in Medicare or MA are currently required to comply with 42 CFR 483.90(b). The expansion of the adoption of the Federal requirements in § 201.2 in final-form Rulemaking 1 will make this a new requirement for the three private-pay facilities. This assumes approval of final-form Rulemaking 1. As with other building system requirements, the FGI Guidelines defers to local and State codes first but provides additional specific plumbing requirements for facilities. Section 205.66 (relating to special ventilation requirements for new construction) is not carried over to Chapter 204 because these requirements are covered by the 2018 FGI Guidelines at sections 2.5-3, 3.1-6.3 and 3.1-1, as adopted by the Department in § 204.1. These requirements are also covered by the Federal requirements at 42 CFR 483.90(i). Facilities, including the three private-pay facilities, are required to comply with 42 CFR 483.90(i) under existing § 201.2. The Life Safety Code contains additional requirements at sections 9.2.1 and 9.2.2.

 Section 205.67 (relating to electric requirements for existing and new construction) is not carried over to Chapter 204 because these requirements are covered by the 2018 FGI Guidelines at sections 3.1-6.7 and 3.1-6.5-2, as adopted by the Department in § 204.1. The Life Safety Code contains additional requirements at sections 18 and 19.2.9. NFPA 99, Standards for Health Care Facilities Code, incorporated by reference in 42 CFR 483.90(j)(1)(i), contains additional requirements at section 6.3.2.2.6.2. Facilities that participate in Medicare or MA are currently required to comply with 42 CFR 483.90(j)(1)(i). The expansion of the adoption of the Federal requirements in § 201.2 in final-form Rulemaking 1 will make this a new requirement for the three private-pay facilities. This assumes approval of final-form Rulemaking 1. Finally, § 205.68 (relating to special electrical requirements for new construction) is not carried over to Chapter 204 because these requirements are covered by the 2018 FGI Guidelines at section 3.1-6.7, as adopted by the Department in § 204.1 of this rulemaking. Additionally, the requirements in § 205.68 are covered by the Federal requirements at 42 CFR 483.90(d). Facilities that participate in Medicare or MA are currently required to comply with 42 CFR 483.90(d). The expansion of the adoption of the Federal requirements in § 201.2 in final-form Rulemaking 1 will make this a new requirement for the three private-pay facilities. This assumes approval of final-form Rulemaking 1.

 Commentators requested that the Department amend this section to require facilities to ensure safe ventilation practices and to regularly evaluate these practices. One commentator requested that the Department add COVID-19 ventilation requirements to this section. Other commentators requested that the Department add requirements in this section and in § 205.66(i) to require HEPA filtration systems be installed in facilities. The Department declines to amend this section to incorporate any specific ventilation requirements. HEPA filtration systems may not necessarily be appropriate in all settings. For example, a wall unit that pulls in air from the outside would not be HEPA-compliant. If a facility wants to provide fresh airflow to a room, installing an appropriate unit may also be at odds with HEPA air filtration requirements. The 2018 FGI Guidelines provide HVAC requirements at section 2.5-3, and State and local codes may provide additional requirements for facilities. The Department also does not believe it is prudent to require a specific type of air-filtration system to be installed in facilities when there is alternative technology that may be better suited for individual facilities.

§ 204.20. Airborne infection isolation room

 This section is added in this final-form rulemaking. This section is based on the infection control provisions in § 205.21 (relating to special care room) but is updated to align with the Department's adoption of the 2018 FGI Guidelines. Under this section, a facility will be required to have at least one airborne infection isolation room for isolating residents as necessary to prevent the spread of infections in accordance with the 2018 edition of the FGI Guidelines. Based on a facility's assessment, a facility may have more than one airborne infection isolation room in accordance with the 2018 FGI Guidelines. The requirements for an airborne infection isolation room are at section 3.1-2.2.4.1 of the 2018 FGI Guidelines. The Department realized, while performing its crosswalk of Chapter 205 to the 2018 FGI Guidelines, that although the 2018 FGI Guidelines state what is required for an airborne isolation room, it does not actually require a facility to have one. Rather than copy that requirement from § 205.21 into this section, the Department adds the specific requirement to have at least one airborne infection isolation room to align with more current standards found in the 2018 FGI Guidelines.

Other comments

 Commentators recommended that the Department add an additional section to permit a facility to repurpose rooms, permit cohorting or move residents as necessary to implement infection controls during an outbreak of infection. The Department declines to add this section. Facilities, including the three private-pay facilities, will be required to establish and maintain infection prevention and control programs under 42 CFR 483.80 and those programs should consider the best methods to minimize the spread of communicable disease. Facilities that participate in Medicare or MA are already required to comply with 42 CFR 483.80. The requirements under 42 CFR 483.80 will be new for the three private-pay facilities, if final-form Rulemaking 1 is approved. Additionally, all facilities, including the three private-pay facilities, will be required, based on the expansion of the incorporation of the Federal requirements in final-form Rulemaking 1 at § 201.2, to have disaster and emergency preparedness plans under 42 CFR 483.73, which address an all-hazards approach and encompass scenarios such as a pandemic or outbreak of communicable disease. This also assumes approval of final-form Rulemaking 1. The Department further notes that not all diseases are the same. Therefore, cohorting may not be a necessary part of an infection response in all cases. During the COVID-19 pandemic, the Department addressed the movement and cohorting of residents through its Pennsylvania Health Alert Network communications and expects to utilize this health alert, advisor and update tool in the future as well.

 Commentators also requested that the Department add a section requiring that stations for hand cleaning and sanitizing be installed outside every resident room and at least every 20 feet in hallways and common areas. The Department declines to add this section. The Department chooses to promote hand hygiene generally and not only as a means of infection control and prevention. Additionally, the Life Safety Code addresses the installation and location of hand sanitizer stations at sections 18.3.2.6 and 19.3.2.6. The Life Safety Code provides spacing specifications in terms of where hand sanitizer stations may be installed and other considerations for resident safety to ensure residents have safe access and to prevent accidental consumption or other accidents. There are also requirements related to the amount of hand sanitizer that can be stored in one place and how it must be stored, as hand sanitizer is flammable. Additionally, the Life Safety Code contains comprehensive fire safety requirements related to hand sanitizer dispensers. Finally, there are infection prevention and control standards related to hand hygiene for staff in the Federal requirements, and this should be covered in the facilities' infection prevention and control program under 42 CFR 483.80(a)(2)(vi). Facilities that participate in Medicare or MA are currently required to comply with 42 CFR 483.80(a)(2)(vi). This requirement will extend to the three private-pay facilities by virtue of the expansion of the adoption of the Federal requirements in § 201.2 in final-form Rulemaking 1. This assumes approval of final-form Rulemaking 1.

 Finally, the Department provides the following list, in response to commentators and IRRC, who requested the Department to clarify which provisions of Chapter 205 are not being carried over to Chapter 204. This list is in addition to the sections and subsections that were previously identified throughout the preamble for Chapter 204. The Department does not carry over § 205.8 (relating to ceiling heights) because these requirements are covered by the 2018 FGI Guidelines at section 2.4-2.2.3, as adopted by the Department in § 204.1 in this final-form rulemaking. The Life Safety Code also contains requirements at section 7.1.5. The Department does not carry § 205.9(a) (relating to corridors) because this subsection is covered by the Federal requirements at 42 CFR 483.90(i)(3). The Department also does not carry over § 205.9(b) because this requirement is covered by the Life Safety Code. Further, the Department does not carry over § 205.9(c) because this requirement is covered by the Life Safety Code at section 7.1.10. The Department does not carry over § 205.12 (relating to elevators) because this requirement is covered by the 2018 FGI Guidelines at section 3.1-6.9, as adopted by the Department in § 204.1 of this final-form rulemaking. The Department also does not carry over § 205.13 (relating to floors) because these requirements are covered by the 2018 FGI Guidelines at sections 2.4-2.3.2, 2.4-2.3.2.1, 2.4-2.3.2.5, 2.4-2.3.2.6, and 2.4-2.3.2.7, as adopted by the Department in § 204.1 of this final-form rulemaking.

 The Department does not carry over § 205.16 (relating to stairs) because these requirements are covered by the 2018 FGI Guidelines at section 7.1.10, as adopted by the Department in § 204.1. The Department does not carry over § 205.17 (relating to stairways) because these requirements are outdated and inapplicable to the functioning of a facility. The Department does not carry over § 205.23 (relating to location of bedrooms) because these requirements are covered by the Federal requirements at 42 CFR 483.90(f). Under 42 CFR 483.90(f), each resident room must be equipped with or located near toilet and bathing facilities. For facilities that receive approval of construction after November 28, 2016, each resident room must have its own bathroom equipped with at least a commode and a sink. This will be a new requirement for the three private-pay facilities based on the expansion of the adoption of the Federal requirements in § 201.2 in final-form Rulemaking 1. This assumes approval of final-form Rulemaking 1. The Department does not carry over § 205.25 (relating to kitchen) because these requirements are covered by the 2018 FGI Guidelines at sections 2.3-4.5 and 3.1-4.5, as adopted by the Department in § 204.1.

 The Department does not carry over § 205.28(a) and (c) (relating to nurses' station) because these requirements are covered by the 2018 FGI Guidelines at sections 2.3-4.2.2, 3.1-4.2.1.1, 3.1-4.1.2, 3.1-4.2.2 and 3.1-6.5.2, as adopted by the Department in § 204.1. The Department does not carry over § 205.28(b) because there has been a shift from requiring centralized nursing stations to create a more homelike environment for residents instead of a more rigid, traditional institutional facility.

 The Department does not carry over § 205.32 (relating to janitor closet) because these requirements are covered by the 2018 FGI Guidelines at sections 2.3-4.9 and 2.3-4.5.3.10, as adopted by the Department in § 204.1. The Department does not carry over § 205.40 (relating to lavatory facilities) because these requirements are covered by the Federal requirements at 42 CFR 483.90(f). These requirements are also covered by the 2018 FGI Guidelines at section 3.1-2.2.2.6, as adopted by the Department in § 204.1. The Department does not carry over § 205.71 (relating to bed and furnishings) because these requirements are also covered by the Federal requirements at 42 CFR 483.90(e).

Chapter 205. Physical environment and equipment standards for long-term care nursing facilities construction, alteration or renovation approved before July 1, 2023.

 The title of Chapter 205 is amended from the proposed rulemaking to this final-form rulemaking. The Department amends the title from the proposed rulemaking to this final-form rulemaking by adding July 1, 2023, as the date after which any construction, alteration or renovation approved by the Department must comply with the provisions of Chapter 204. As explained in the proposed rulemaking, the Department has decided to separate regulatory provisions pertaining to construction, alteration or renovation of long-term care nursing facilities into two chapters to clarify the specific standards that apply to new versus existing construction, alteration or renovation. The Department had proposed to make Chapter 204 applicable to plans for construction, alteration or renovation of long-term care nursing facilities approved on or after 6 months from the publication date of this final-form rulemaking. However, given the estimated timing of this final-form rulemaking, and to be consistent with the effective date established for other sections of the regulations, the Department has decided to make Chapter 204 applicable to plans for construction, alteration or renovation approved on or after July 1, 2023. Existing Chapter 205, as amended, will continue to be the baseline standard for all construction, alteration or renovation of long-term care nursing facilities performed based on plans that were approved by the Department before July 1, 2023, the effective date of Chapter 204.

Buildings and grounds

§ 205.4. Building plans

 This section remains deleted from the proposed rulemaking to this final-form rulemaking. Section 205.4 is deleted because all plans for construction, alteration or renovation approved on or after July 1, 2023, will need to meet the requirements of § 204.2, as described previously.

§ 205.6. Function of building

 This section is unchanged from the proposed rulemaking to this final-form rulemaking. As explained in the proposed rulemaking, the Department amends the term ''employes'' to ''employees'' in subsection (b) to reflect the current use and spelling of this term.

 A commentator expressed concerns with subsection (a), which the Department did not propose to amend. Under subsection (a), no part of a building may be used for a purpose that interferes with or jeopardizes the health and safety of residents. The commentator indicated that it was not clear what purposes would be covered by this provision and expressed concern that this language could be interpreted to mean that no part of the building could be used for cooking as there are residents that could be harmed by knives or fire involved in cooking. As explained previously in § 204.3(b) (relating to building and grounds; general) to the same comment, the Department's number one priority is the health, safety and welfare of residents. The Department applies a common-sense interpretation and dictionary definition to the words ''interferes with or jeopardizes'' in the context of a resident's health and safety and would not cite a facility for having an area dedicated for cooking if that area meets the requirements of the act and this subpart. The Department notes that subsection (a) also requires special authorization if part of the building is to be used for a purpose other than health care. Facilities have requested exceptions under this subsection, which have been granted by the Department. The Department would anticipate continuing to receive similar exception requests under this subsection.

 Commentators suggested that the Department add a grandfather clause to subsection (b) for non-resident family members currently residing in a facility, as it is only appropriate for residents to reside at a facility. The Department declines to add this language. As explained, in § 204.3(c) to similar comments, the Department fears that removal of the ability of the administrator's family members to reside at the facility may make it difficult to obtain and retain administrators. Additionally, it may be important to allow administrators' family members to reside in a care-focused portion of a facility, and removal of this language might prevent family members needing that care from residing in the facility. The Department, therefore, declines to remove this language from the regulation.

§ 205.7. Basement or cellar.

 This section is unchanged from the proposed rulemaking to this final-form rulemaking. As explained in the proposed rulemaking, the Department removes the words ''and the like'' as grammatically unnecessary and because they are duplicative of the words ''such as.'' The Department also replaces the word ''areas'' with the phrase ''any part of the basement'' for clarity.

Minimum Physical Environment Standards

 This heading is unchanged from the proposed rulemaking to this final-form rulemaking. As explained in the proposed rulemaking, the Department replaces the word ''plant'' with the word ''environment'' in this heading to reflect current terminology used in the long-term care nursing environment.

§ 205.21. Special care room

 This section is unchanged from the proposed rulemaking to this final-form rulemaking. As explained in the proposed rulemaking, the Department deletes language in this section that pertains to new construction. Plans for construction, alteration or renovation approved on or after July 1, 2023, will be required to comply with the requirements in Chapter 204.

§ 205.22. Placement of beds

 This section is unchanged from the proposed rulemaking to this final-form rulemaking. As explained in the proposed rulemaking, the Department replaces the phrase ''adequate provisions are made for resident comfort and safety'' with the phrase ''the resident chooses to do so and such placement does not pose a safety hazard.'' The Department is making this amendment, at the request of the LTC Work Group, to clarify that a resident has a choice in the placement of the resident's bed in the room. However, the Department also adds language to clarify that the resident has this choice unless the placement of the bed presents a safety hazard.

 Commentators asked the Department to revise this section to be more specific as to what constitutes a safety hazard. These commentators were concerned that without a definition, facilities will have too much leeway to deny residents' choices and preferences. Commentators also asked that the Department add language to allow a resident, who has the capacity, a certain level of risk or informed decision making, as well as language that would prevent a facility from using arbitrary or ambiguous reasons as a basis for denying the resident's wishes. IRRC also asked the Department to clarify this provision or explain the reasonableness of retaining this language in this final-form rulemaking.

 As provided previously, in balancing the competing interests for resident autonomy and choice with also the need for health and safety requirements the Department declines to amend this section. As explained in response to the same comments to § 204.5(d), the addition of ''unless the placement presents a safety hazard'' is not only reasonable, but critical to ensure the safety of residents. As explained in the proposed rulemaking, the Department supports a resident's ability to choose where a bed is placed in the room but can envision circumstances where a resident's choice of bed placement could pose a health or safety hazard, such as placement near a radiator or heat source or blocking a doorway. In those circumstances, the health and safety of the resident needs to come first. Safety hazards must be determined through an evaluation of the resident's needs and an assessment of the physical environment. A safety hazard for one resident may not necessarily be a safety hazard for another resident, based on the resident's acuity, and a facility will need to determine this on a case-by-case basis. Additionally, if the Department receives a complaint regarding this subsection, the Department will ask the facility why the resident's preference was not considered and will attempt to resolve the complaint in a manner that addresses the resident's concerns and preferences while also ensuring safe placement of the bed.

Mechanical and electrical requirements

§ 205.61. Heating requirements for existing construction

 This section is unchanged from the proposed rulemaking to this final-form rulemaking. As noted, in the proposed rulemaking, the Department removes the words ''and new'' from the title of this section. Plans for construction, alteration or renovation approved on or after July 1, 2023, will be required to comply with the requirements in the new Chapter 204.

§ 205.62. Special heating requirements for new construction

 This section remains deleted from this final-form rulemaking. Plans for construction, alteration or renovation approved on or after July 1, 2023, will be required to comply with the requirements in the new Chapter 204.

§ 205.63. Plumbing and piping systems required for existing construction

 This section is unchanged from the proposed rulemaking to this final-form rulemaking. As explained, in the proposed rulemaking, the Department removes the words ''and new'' from the title of this section. Plans for construction, alteration or renovation approved on or after July 1, 2023, will be required to comply with the requirements in the new Chapter 204.

§ 205.64. Special plumbing and piping systems requirements for new construction

 This section remains deleted in this final-form rulemaking. Plans for construction, alteration or renovation approved on or after July 1, 2023, will be required to comply with the requirements in the new Chapter 204.

§ 205.66. Special ventilation requirements for new construction

 This section remains deleted in this final-form rulemaking. Plans for construction, alteration or renovation approved on or after July 1, 2023, will be required to conform to the requirements in the new Chapter 204. Commentators requested that the Department not delete this section and instead add a requirement to subsection (i) for HEPA filtration systems. The Department has determined neither to retain nor amend this section to incorporate any specific ventilation requirements. HEPA filtration systems may not necessarily be appropriate in all settings. For example, a wall unit that pulls in air from the outside would not be HEPA-compliant. If a facility wants to provide fresh airflow to a room, installing an appropriate unit may also be at odds with HEPA air filtration requirements. The 2018 FGI Guidelines provide HVAC requirements at section 2.5-3, and State and local codes may provide additional requirements for facilities. The Department does not believe it is prudent to require a specific type of air-filtration system to be installed in facilities when there is alternative technology that may be better suited for individual facilities and maintaining compliance with all HVAC requirements required by the 2018 FGI Guidelines.

§ 205.67. Electric requirements for existing construction

 This section is unchanged from the proposed rulemaking to this final-form rulemaking. As explained in the proposed rulemaking, the Department removes the words ''and new'' from the title of this section. Plans for construction, alteration or renovation approved on or after July 1, 2023, will be required to comply with the requirements in Chapter 204.

§ 205.68. Special electrical requirements for new construction

 This section remains deleted in this final-form rulemaking. Plans for construction, alteration or renovation approved on or after July 1, 2023, will be required to comply with the requirements in the new Chapter 204.

§ 205.101. Scope

 This section is amended from the proposed rulemaking to this final-form rulemaking. The Department replaces the words ''alterations, renovations and construction'' with the words ''construction, alteration or renovation'' for consistency in the use of these words elsewhere in the regulation. The Department also replaces the blank space and Editor's Note with ''July 1, 2023'' to indicate, as noted previously, that Chapter 205 applies to construction, alteration or renovation approved before July 1, 2023.

Other comments

 Commentators requested that the Department add a section to ensure that residents have access to Wi-Fi, broadband or Internet technology, as well as devices to keep up with current events, engage in activities and remain connected to the outside world. Commentators pointed out that the ability to send and receive e-mail and participate in Zoom calls were critical for families and residents to stay in touch during the COVID-19 pandemic. The Department declines to add this requirement, as this is already covered under the Federal requirements. Under 42 CFR 483.10(g)(7)(ii), the facility must provide reasonable access to the Internet, to the extent available to the facility and under 42 CFR 483.10(g)(9), the resident must have reasonable access to electronic communications such as e-mail and video communications and for Internet research, if access is available to the facility, or at the resident's expense if any additional expense is incurred by the facility to provide access to the resident. Facilities that participate in Medicare or MA are currently required to comply with these requirements. However, this will be a new requirement for private-pay facilities due to the expansion of the incorporation of the Federal requirements in § 201.2, in final-form Rulemaking 1. This assumes approval of final-form Rulemaking 1.

Chapter 207. Housekeeping and maintenance standards for long-term care nursing facilities

Housekeeping and maintenance

§ 207.4. Ice containers and storage

 This section remains deleted in this final-form rulemaking. A commentator expressed concern that the Department referenced CMS' State Operations Manual, Appendix PP, as its rationale for deleting this section. IRRC asked the Department to retain this section or amend it to include the specific requirements from Appendix PP with which a facility must comply. Upon further review, however, the Department has determined that this section is not needed because of Federal requirements. Specifically, the Federal requirement at 42 CFR 483.60(i)(2) (relating to food and nutrition requirements) requires that a facility store, prepare, distribute and serve food in accordance with professional standards for food service safety. This existing requirement sufficiently covers the prior requirement in § 207.4 (relating to ice containers and storage) for ice containers and storage without the need to retain or amend this provision. The deletion of § 207.4 assumes approval of final-form Rulemaking 1, as the requirement that food be stored, prepared and distributed ''in accordance with professional standards for food service safety'' in 42 CFR 483.60(i)(2) will be a new requirement for private-pay facilities due to the expansion of the incorporation of the Federal requirements in § 201.2. Other facilities participate in Medicare or MA and thus are already required to comply with the Federal requirements.

Other comments

 A commentator expressed concern that there is no provision in the regulations permitting access for ordained clergy regardless of emergency public health declarations or other states of emergency. During the COVID-19 pandemic, the Department did not bar access to the practice of religion. Instead, the Department followed CMS guidance regarding general limitation related to facility access based on disease exposure at https://www.cms.gov/files/document/qso-20-39-nh.pdf. That guidance provided that clergy members should continue to be allowed access to facilities if they were not subject to a work exclusion due to an exposure to COVID-19 or show signs or symptoms of COVID-19 after being screened. As emergency situations are not a one-size-fits-all proposition, the Department believes it would be detrimental to attempt to include, in regulation, an explicit list of persons authorized to have access to a facility during any state of emergency. The Department prefers instead to assess each state of emergency individually and will provide guidance to facilities, regarding facility access, in conjunction with CMS and other relevant authorities, such as the Centers for Disease Control and Prevention (CDC).

 A commentator stated that they would like to see a requirement that anyone working in a long-term care nursing facility be vaccinated against flu, COVID-19 and any other contagious disease for which there is a vaccine. This requirement is already partially provided for in 42 CFR 483.80(i), which requires a facility to develop and implement policies and procedures to ensure that all staff are fully vaccinated for COVID-19. Facilities that participate in Medicare or MA are required to comply with this requirement. The three private-pay facilities will be required to comply with 42 CFR 483.80(i), by virtue of the Department's expansion of the incorporation of the Federal requirements in § 201.2, in final-form Rulemaking 1. This assumes approval of final-form Rulemaking 1. With respect to influenza and other contagious diseases, the Department strongly encourages staff to obtain available vaccines but does not require vaccination and declines to add this requirement to regulation.

 Commentators expressed generally that there needs to be comprehensive reform in the areas of direct care staffing, training, infection prevention and control requirements, emergency and pandemic preparedness planning requirements, application for licensure and change in ownership procedures, and resident rights. A commentator suggested that the Department revise the regulations to require more disclosure and public notice to prevent irresponsible owners from acquiring facilities in this Commonwealth. Another commentator stated that staff of facilities should be paid more so that they do not leave. Requirements for applications for licensure of new facilities and for changes in ownership are addressed in final-form Rulemaking 3 at § 201.12 (relating to application for license). Infection prevention and control, and emergency preparedness, are also addressed in final-form Rulemaking 3. Direct care staffing is addressed in both final-form Rulemaking 1 and Rulemaking 4 at § 211.12 (relating to nursing services). Training and resident rights are addressed in final-form Rulemaking 4 at §§ 201.20 and 201.29 (relating to staff development; and resident rights), respectively.

Fiscal Impact and Paperwork Requirements

Fiscal Impact

 In response to the comments and concerns raised during the September 15, 2021 Senate Health and Human Services and Aging and Youth Committees joint legislative hearing, throughout the public comment process, and in other discussions, the Governor's Fiscal Year (FY) 2022-2023 budget proposal proposed an MA rate increase of $190 million; $91 million in State funding to be matched with $99 million in Federal funds for the first 6 months of calendar year 2023 and a proposed $250 million one-time investment of American Rescue Plan Act (ARPA) funds in long-term living programs, including direct one-time funding for all facilities to support their workforce and help them to hire more staff to meet the requirements of the forthcoming regulations. The funding was proposed to be provided to facilities in advance of the expected staffing increases to allow facilities to stabilize their existing workforce and recruit additional staff prior to the regulatory increases going into effect.

 Following the Governor's budget proposal, industry stakeholders called for $294 million in MA funding in the Commonwealth's FY 2022-2023 budget. The FY 2022-2023 Appropriations Act signed by Governor Tom Wolf included bipartisan support for a historic increase in one-time and ongoing funding for facilities. As enacted, $147 million in State funding was appropriated to support implementation of the Department's regulations. Specifically, this funding will be used to support a 17.5% Medicaid rate increase beginning January 1, 2023, which allows facilities time to ramp up staffing to meet the direct care staffing hours required on July 1, 2023. Assuming Federal approval, these State funds will be matched with an additional $159 million in Federal funds, totaling $306 million in Medicaid funding for the first 6 months of calendar year 2023. Nursing facilities will also receive $131 million in one-time ARPA funding during FY 2022-2023. A detailed fiscal impact for the regulated community, the Commonwealth and local government is as follows:

Regulated community

 The amendments will apply to all 682 long-term care nursing facilities licensed by the Department. These facilities provide health services to more than 72,000 residents. This total includes 19 county-owned and operated facilities, 6 veterans' homes that are operated by the Department of Miliary and Veterans Affairs (DMVA), 654 privately-owned facilities that participate in Medicare or MA and 3 private-pay facilities that do not participate in Medicare or MA.

 There will be little to no financial impact to any of these facilities due to the deletion of subsections in § 201.23 (relating to closure of facility) that are duplicative of the Federal requirements. All but 3 of the 682 long-term care nursing facilities participate in Medicare or MA and thus, are already required to comply with existing Federal requirements in 42 CFR 483.70(l) and (m) (relating to administration) for the closure of a facility. Although the specific requirements under 42 CFR 483.70(l) and (m) are new for the three private-pay facilities, the general requirement to provide notice of a facility closure is not new. Prior to this final-form rulemaking, the Department's existing regulations required notification to the Department and to residents and a resident's responsible person when a facility was closing. The additional requirements regarding identification of responsible individuals during the closure is anticipated to be a nominal cost. Further, these three facilities will only incur a cost under 42 CFR 483.70(l), which requires the facility to provide notice of a closure if they close. Under 42 CFR 483.70(m), these three facilities will be required to have in place policies and procedures to ensure that the administrator's duties and responsibilities involve providing the appropriate notices in the event of a closure. This will be a new paperwork requirement for these three facilities.

 The addition of subsections (c.1)—(c.4) to § 201.23 in this final-form rulemaking adds clarity to the regulation by incorporating the requirements for a closure plan to require that notice include additional information and be provided to additional individuals who have an interest in the closure of a facility. As noted previously, the 682 facilities licensed by the Department will only be impacted by these amendments if they close. Further, the fiscal impact regarding providing notice of the closure is anticipated to be minimal. Under this final-form rulemaking, facilities will have to provide written notice of a proposed closure to residents, resident representatives, employees, the Office of the State Long-Term Care Ombudsman and DHS.

 The deletion of Chapter 203 will not result in an additional cost to the regulated community. Long-term care nursing facilities are required to comply with Chapter 203 and the Life Safety Code currently. The deletion of this Chapter merely aligns this requirement with the expansion of the incorporation by reference of the Federal requirements in § 201.2 in final-form Rulemaking 1. The Life Safety Code is incorporated by reference in the Federal requirements for long-term care nursing facilities at 42 CFR 483.73(g)(1). The deletion of Chapter 203 to align with the Federal requirements will benefit the regulated community by eliminating duplication between Federal and State regulations to ensure a smooth and streamlined survey process.

 The Department's separation of new standards for construction, alteration or renovation from existing standards into two chapters, new Chapter 204 and existing Chapter 205, will add clarity to the survey process for long-term care nursing facilities by making it clear which standards apply to plans for new construction, alteration or renovation versus older, existing construction, alteration or renovation. The addition of Chapter 204 and the requirement that long-term care nursing facilities comply with the FGI Guidelines will result in a minimal additional cost to those long-term care nursing facilities that submit plans for construction, alteration or renovation after the effective date of Chapter 204.

 Firstly, the FGI Guidelines will only apply to new construction, alteration or renovation. They will not apply to existing facilities that are not making any changes or facilities that are only performing regular facility maintenance, such as making cosmetic upgrades, for example paint, new flooring or changing light fixtures. Secondly, the costs associated with compliance with the FGI Guidelines relate to patient care items. That is, the major cost factor to new construction of long-term care facilities and renovations and alterations to existing facilities is square footage; specifically square footage requirements for rooms and spaces that have specific materials and equipment to support these rooms and spaces. The addition of the 2018 FGI Guidelines for long-term care facilities, however, does not specifically add square footage to any new construction, renovation or alteration. Further, the Department maintains the existing square footage requirements under this final-form rulemaking. Instead, the FGI Guidelines provide the design team with requirements that promote a physical environment that is safe for residents, promotes home-like environments and provides up-to-date and relevant requirements to today's challenges in facilities.

 Specifically, facility ownership essentially determines the ultimate cost of any new construction, renovation or alteration project. Decisions to keep the facility ''as-is'' only incurs costs to maintain the facility; whereas business decisions to complete new construction, renovation or alteration projects will be decided by the scope approved by ownership. Further, facilities are required to comply with the requirements of the Uniform Construction Code (UCC), initially adopted by the Department of Labor and Industry in April 2004 and updated to the 2018 edition, effective February 14, 2022. Likewise, facilities are already required to comply with the requirements of the 2012 edition of the National Fire Protection Association's (NFPA) 101, Life Safety Code for State licensure and Federal certification purposes, effective July 5, 2016.

 Existing requirements related to UCC and Life Safety Code compliance affect construction, renovation and alteration costs significantly, as these codes determine requirements such as, but not limited to:

 1. Type of construction of the building;

 2. Fire protection systems, such as sprinkler and fire alarm systems;

 3. Hazardous area protection;

 4. Heating, Ventilating and Air Conditioning (HVAC);

 5. Normal and emergency electrical systems;

 6. Means of egress requirements;

 7. Smoke and fire compartments to support ''defend in place'' evacuation principles;

 8. Medical gas requirements;

 9. Plumbing requirements, and the like.

 However, these same types of costs are not reflected under the 2018 FGI Guidelines. While the UCC and the Life Safety Code require the corridor width in a new health care occupancy to be 8 feet wide, the FGI Guidelines will add requirements that the flooring be non-slip and handrails provided for resident safety. Similarly, where sinks are required, the FGI Guidelines will provide requirements on the temperature of the water for proper handwashing hygiene and things such as the depth of the basin to limit the probability of splash and wet floors that may lead to falls. Where nurse call buttons are required, the FGI Guidelines will provide for considerations for residents that wish to move their bed within their room for resident preference. Further, where a dining room is already required, the FGI Guidelines will provide requirements on proper lighting, ensuring residents in wheelchairs are able to easily navigate the room, and requirements to promote smells from the food to permeate through the facility to encourage nutrition.

 As stated previously, ownership business decisions will ultimately determine the overall cost of any new construction, renovation or alteration. Whether decisions are made to only renovate two rooms, renovate one or more wings, complete alterations to replace emergency generators or HVAC equipment (and to what extent), use interior finishes and fixtures that are either higher or lower priced, or build an entire replacement facility, that will be made by facility ownership.

 New construction, renovations or alterations are already required to meet the UCC and Life Safety Code requirements. As important as it is to ensure a facility has code compliant electrical receptacles per the UCC and Life Safety Code, it is just as important to ensure the FGI requirements for proper placement of the receptacles so residents may have proper access. This is similar to where UCC will provide requirements to ensure the number of toilets in the facility will function; whereas the FGI Guidelines provide requirements on proper location and staff assistance to ensure residents have access and are provided a safe environment for fall protection. The examples are nearly endless, but the FGI Guidelines are paramount to supplementing existing codes that are written for all types of facilities (residential, commercial, industrial, and the like) to provide and promote safe environments for the unique and fragile population of the facilities.

 In addition, compliance with the FGI Guidelines will benefit long-term care nursing facilities by ensuring that any construction, alteration or renovation are built to current, updated standards for maintained health and safety versus existing facilities that have not built to these standards. Further, the amendments to Chapter 205 will not increase costs to long-term care nursing facilities, as the Department is only deleting language pertaining to new construction, alteration or renovation.

 The 682 licensed facilities will not incur any cost due to the deletion of § 207.4 to align with the Federal requirements. As noted, all but 3 of the 682 facilities participate in Medicare or MA and thus, already required to comply with the Federal requirements. The three private-pay facilities will not incur a cost due to the elimination of this requirement that is duplicative of the Federal requirements, as they are already required under existing § 207.4 to ensure that ice is properly stored and handled.

Commonwealth—Department

 The amendments will not increase costs to the Department. The Department's surveyors perform the function of surveying and inspecting long-term care nursing facilities for compliance with both Federal and State regulations. The elimination of subsections that are outdated and duplicative of the Federal requirements will streamline the survey process for long-term care nursing facilities and provide consistency and congruency to the stakeholder industry. This, in turn, will reduce confusion in the application of the standards that apply to long-term care nursing facilities. The deletion of Chapter 203 will also benefit the Department's surveyors and long-term care nursing facilities by eliminating duplication between Federal and State regulations to ensure a smooth and streamlined process. Further, separating new standards for construction, alteration or renovation from existing standards in Chapter 205 to new standards under Chapter 204, will also add clarity to the survey process and industry stakeholders by making it clear which standards apply to plans for new construction, alteration or renovation versus older, existing construction, alteration or renovation.

Commonwealth—DMVA

 Of the 682 long-term care nursing facilities licensed by the Department, six facilities are veterans' homes that are operated by the DMVA. These facilities are already required to comply with the Federal requirements and thus, are already required to comply with existing Federal requirements in 42 CFR 483.70(l) and (m) for the closure of a facility. The addition of subsections (c.1)—(c.4) to § 201.23 on this final-form rulemaking adds clarity to the regulation by incorporating the requirements for a closure plan and expanding upon the already existing notice requirement in 42 CFR 483.70(l) and (m) to require that notice include additional information and be provided to additional individuals who have an interest in the closure of a facility. Further, the DMVA-operated facilities licensed by the Department will only be impacted by providing this additional information under these amendments if they close. The Department anticipates the cost associated with providing this additional information to be nominal.

 The deletion of Chapter 203 will not result in an additional cost to the DMVA-operated facilities. Long-term care nursing facilities are required to comply with Chapter 203 and the Life Safety Code currently. The deletion of this Chapter merely aligns this requirement with the expansion of the incorporation by reference of the Federal requirements in § 201.2 in final-form Rulemaking 1. The Life Safety Code is incorporated by reference in the Federal requirements for long-term care nursing facilities at 42 CFR 483.73(g)(1). The deletion of Chapter 203 to align with the Federal requirements will benefit the regulated community by eliminating duplication between Federal and State regulations to ensure a smooth and streamlined survey process.

 The Department's separation of new standards for construction, alteration or renovation from existing standards into two chapters, new Chapter 204 and Chapter 205, will add clarity to the survey process for long-term care nursing facilities by making it clear which standards apply to plans for new construction, alteration or renovation versus older, existing construction, alteration or renovation. The addition of Chapter 204 and the requirement that long-term care nursing facilities comply with the FGI Guidelines will result in a cost to those long-term care nursing facilities that submit plans for construction, alteration or renovation after the effective date of Chapter 204. As provided previously, the Department considers the cost for complying with the FGI Guidelines to be minimal. In addition, compliance with the FGI Guidelines will benefit long-term care nursing facilities and their residents. Further, the amendments to Chapter 205 will not increase costs to long-term care nursing facilities, as the Department is only deleting language pertaining to new construction, alteration or renovation.

 The DMVA-operated licensed facilities will not incur any additional cost due to the deletion of § 207.4 to align with the Federal requirements. As noted, these facilities are already required to comply with the Federal requirements.

Commonwealth—DHS

 Although the provisions of this final-form rulemaking, which relate to general operations and physical requirements, will not have a cost impact to DHS, a substantial increase in funding for nursing facilities, including new nursing facility funding and increased MA payments beginning January 2023, was enacted under Act 2022-54 and appropriated under the General Appropriations Act of 2022 (Act 2022-1A).

Local government

 As mentioned previously, there are currently 19 county-owned long-term care nursing facilities, licensed by the Department. These facilities account for approximately 7.5% (6,524 beds) of licensed nursing facility beds across this Commonwealth. Allegheny County owns four of the nursing homes; the remaining homes are in the following 15 counties: Berks, Bradford, Bucks, Chester, Clinton, Crawford, Delaware, Erie, Indiana, Lehigh, Monroe, Northampton, Philadelphia, Warren and Westmoreland.

 County-owned long-term care nursing facilities participate in Medicare or MA and thus, are already required to comply with the Federal requirements and thus, are already required to comply with existing Federal requirements in 42 CFR 483.70(l) and (m) for the closure of a facility. The addition of subsections (c.1)—(c.4) to § 201.23 in this final-form rulemaking adds clarity to the regulation by incorporating the requirements for a closure plan and expanding upon the already existing notice requirement in 42 CFR 483.70(l) and (m) to require that notice include additional information and be provided to additional individuals who have an interest in the closure of a facility. The county-owned facilities licensed by the Department will only be impacted by these amendments if they close. Further, the Department anticipates that the cost associated with providing this additional information to be nominal.

 The deletion of Chapter 203 will not result in an additional cost to the county-owned facilities. Long-term care nursing facilities are required to comply with Chapter 203 and the Life Safety Code currently. The deletion of this chapter merely aligns this requirement with the expansion of the incorporation by reference of the Federal requirements in § 201.2 in final-form Rulemaking 1. The Life Safety Code is incorporated by reference in the Federal requirements for long-term care nursing facilities at 42 CFR 483.73(g)(1). The deletion of Chapter 203 to align with the Federal requirements will benefit the regulated community by eliminating duplication between Federal and State regulations to ensure a smooth and streamlined survey process.

 The Department's separation of new standards for construction, alteration or renovation from existing standards into two chapters, new Chapter 204 and Chapter 205, will add clarity to the survey process for long-term care nursing facilities by making it clear which standards apply to plans for new construction, alteration or renovation versus older, existing construction, alteration or renovation. The addition of Chapter 204 and the requirement that long-term care nursing facilities comply with the FGI Guidelines will result in a cost to those long-term care nursing facilities that submit plans for construction, alteration or renovation after the effective date of Chapter 204. As detailed previously, the Department considers the cost for complying with the FGI Guidelines to be minimal. In addition, compliance with the FGI Guidelines will benefit long-term care nursing facilities and their residents. Further, the amendments to Chapter 205 will not increase costs to long-term care nursing facilities, as the Department is only deleting language pertaining to new construction, alteration or renovation.

 The county-owned licensed facilities will not incur any additional cost due to the deletion of § 207.4, to align with the Federal requirements. As noted, these facilities participate in Medicare or MA and thus, are already required to comply with the Federal requirements.

Residents of long-term care nursing facilities

 The more than 72,000 individuals that reside in the 682 long-term care nursing facilities licensed by the Department will be affected by the amendments. Residents will be positively affected by the closure plan requirements in the event of a facility closure in § 201.23(c.1). Residents will also be positively affected by the expansion of the Federal notice requirements in State regulation to include additional information and to include additional individuals. The addition of new Chapter 204 and the requirement that long-term care nursing facilities comply with the FGI Guidelines for construction, alteration or renovation plans approved on or after July 1, 2023, will also positively affect residents by ensuring that facilities that complete new construction, alteration or renovation are meeting current construction standards. Residents are also benefiting from the health and safety requirements of an airborne infection isolation room and the maintaining of facility requirements for the health and safety of residents.

Paperwork Requirements

 The Department's adoption of 42 CFR 483.70(l) will result in a new paperwork requirement for the three private-pay facilities, by requiring that notice be provided to certain individuals in the event of a facility closure. The Department's expansion of this requirement in § 201.23(c.3) and (c.4) will impose additional paperwork requirements on all facilities, including those that already are required to comply with 42 CFR 483.70(l). However, this requirement will only affect facilities if they close. Under these provisions, a closing facility will have to provide notice of the closure to the Department, residents, resident representatives, employees, the State long-term care ombudsman program and DHS.

 The Department's adoption of 42 CFR 483.70(m) in § 201.23 will result in a new paperwork requirement for the three private-pay facilities that are licensed by the Department, by requiring these facilities to have in place policies and procedures to ensure that the administrator's duties and responsibilities involve providing the appropriate notices in the event of a closure.

 Licensees and prospective licensees are already required, under § 51.3(d) to submit architectural and blueprint plans to the Department for approval before performing any construction, alteration or renovation. The amendment to § 204.2 simply directs licensees and prospective licensees to the Department's web site for instructions on how to submit plans for construction, alteration or renovation.

Small Business Analysis

 A commentator asserted that the Department failed to give adequate attention to the financial and economic impact of the regulation on small businesses, and that simply stating that all minimum requirements apply to all facilities, regardless of whether they are a small business, is not an analysis. IRRC also asked if the Department has the ability, in conjunction with other State agencies, to access data to evaluate the potential impact on small businesses. IRRC asked that the Department calculate and address the impact of the final-form regulation on small businesses as required under the Regulatory Review Act (71 P.S. §§ 745.1—745.14).

 Under section 3 of the Regulatory Review Act (71 P.S. § 745.3), a small business is ''defined in accordance with the size standards described by the United States Small Business Administration's Small Business Size Regulations under 13 CFR Ch. 1 Part 121 (relating to Small Business Size Regulations) or its successor regulation.'' Under 13 CFR 121.101 (relating to what are SBA size standards?), the Small Business Administration's (SBA) ''size standards determine whether a business entity is small.'' Size standards are developed under the North America Industry Classification System (NAICS). The Department applied the NAICS standards to determine how many long-term care nursing facilities, licensed by the Department, are small businesses.

 The Department conducted a search on the NAICS web site to find the NAICS code for long-term care nursing facilities. The NAICS code for nursing care facilities (skilled nursing facilities) is 623110. The Department looked this code up in the table located at 13 CFR 121.201 (relating to what size standards has SBA identified by North American Industry Classification System codes?) and determined that a long-term care nursing facility is a small business if it has $30 million or less in annual receipts. The Department then pulled the latest long-term care nursing facility cost report from CMS to determine the impact to facilities that participate in Medicare or MA. The latest cost report data from CMS is 2018. Data.CMS.gov. Skilled Nursing Facility Cost Report. Retrieved from https://data.cms.gov/provider-compliance/cost-report/skilled-nursing-facility-cost-report/data. The Department applied current Federal Standards of Accounting to this data to determine each facility's annual receipts. Based on this analysis, the Department determined that 623 facilities that participate in Medicare or MA have $30 million or less in annual receipts. Although the data from CMS is from 2018, the Department believes that currently, at least the same number of facilities, if not more, would meet the definition of a small business. This analysis aligns with the Department's previous assumption that most long-term nursing facilities licensed by the Department meet the definition of a small businesses.

 The Department also asked stakeholders during the meetings held in 2021 and 2022 for assistance in determining the impact to small businesses. The stakeholders were not able to provide the Department with specific information regarding how the Department's proposed regulations would impact small businesses. However, during the stakeholder meeting for Rulemakings 1 and 2, a stakeholder suggested that the Department search GuideStar, which provides financial information regarding nonprofit entities, to determine whether the three private-pay facilities are small businesses. The Department searched the GuideStar web site at https://www.guidestar.org/ for the three private-pay facilities that are licensed by the Department. Based on this data, one of the private-pay facilities, Friends Home in Kennett/Linden Hall, meets the definition of a small business applying the NAICS standards. Another private-pay facility, Foulkeways at Gwynedd does not meet the definition of a small business based on its gross receipts. Data for the third private-pay facility, Dallastown Nursing Center, is not available on GuideStar, but for the purposes of this analysis, the Department assumes that Dallastown is a small business.

 In sum, at least 91% of nursing facilities meet the definition of a small business. Consistent with the HCFA and function of licensure, the purpose of these regulatory amendments is to ensure the health, safety and welfare of all residents of long-term care nursing facilities in this Commonwealth by providing the minimum health and safety standards. Given that most facilities are a small business and the need for surveying for the health and safety of residents, the Department did not establish differing criteria for nursing facilities that are small business compared to the minority of facilities that are not small businesses. Further, in determining the minimum health and safety requirements, the department considered the myriad of received comments, feedback from meetings and stakeholder groups and attempted to balance the interests between consumers and the stakeholder industry. The Department's responsibility to ensure that residents receive safe, quality care applies to all residents of long-term care nursing facilities in this Commonwealth, and it is critical that all residents of long-term care nursing facilities receive the same level of high-quality care, regardless of whether the facility they reside in is a small business.

Statutory Authority

 Sections 601 and 803 of the HCFA (35 P.S. §§ 448.601 and 448.803) authorize the Department to promulgate, after consultation with the Health Policy Board, regulations necessary to carry out the purposes and provisions of the HCFA. Section 801.1 of the HCFA (35 P.S. § 448.801a) seeks to promote the public health and welfare through the establishment of regulations setting minimum standards for the operation of health care facilities. The minimum standards are to assure safe, adequate and efficient facilities and services and to promote the health, safety and adequate care of patients or residents of those facilities. In section 102 of the HCFA (35 P.S. § 448.102), the General Assembly has found that a purpose of the HCFA is, among other things, to assure that citizens receive humane, courteous and dignified treatment. Finally, section 201(12) of the HCFA (35 P.S. § 448.201(12)) provides the Department with explicit authority to enforce its rules and regulations promulgated under the HCFA.

 The Department also has the duty to protect the health of the people of this Commonwealth under section 2102(a) of The Administrative Code of 1929 (71 P.S. § 532(a)). The Department has general authority to promulgate regulations under section 2102(g) of The Administrative Code of 1929 (71 P.S. § 532(g)).

Effectiveness/Sunset Date

 This final-form rulemaking will become effective on July 1, 2023. A sunset date will not be imposed. The Department will monitor the regulations and update them as necessary.

Regulatory Review

 Under section 5(a) of the Regulatory Review Act (71 P.S. § 745.5(a)), on September 27, 2021, the Department submitted notice of this proposed rulemaking, published at 51 Pa.B. 6401 (October 9, 2021), to IRRC and the Chairpersons of the Senate Health and Human Services Committee and the House Health Committee for review and comment.

 Under section 5(c) of the Regulatory Review Act, 71 P.S. § 745.5(c), IRRC, the Senate Health and Human Services Committee and the House Health Committee were provided with copies of the comments received during the public comment period, as well as other documents when requested. In preparing the final-form rulemaking, the Department has considered all comments from IRRC, the Senate Health and Human Services Committee, the House Health Committee, and the public.

 Under section 5.1(j.2) of the Regulatory Review Act, 71 P.S. § 745.5a(j.2), on October 27, 2022, the final-form rulemaking was deemed approved by the Senate Health and Human Services Committee and the House Heath Committee. Under section 5.1(e) of the Regulatory Review Act, IRRC met on October 28, 2022, and approved the final-form rulemaking.

Contact Person

 Additional information regarding this final-form rulemaking may be obtained by contacting Ann Chronister, Director, Bureau of Long-Term Care Programs, 625 Forster Street, Rm. 526, Health and Welfare Building, Harrisburg, PA 17120, (717) 547-3131, or RA-DHLTCRegs@pa.gov. Persons with a disability may submit questions in an alternative format such as audio tape, Braille or by using V/TT (717) 783-6514 or the Pennsylvania Hamilton Relay Service at (800) 654-5984 (TT). Persons who require an alternative format of this document may contact Ann Chronister at the previous address or telephone number so that necessary arrangements can be made.

Findings

 The Department finds that:

 (1) Public notice of intention to adopt the regulations adopted by this order has been given under sections 201 and 202 of the act of July 31, 1968 (P.L. 769, No. 240) (45 P.S. §§ 1201 and 1202) referred to as the Commonwealth Documents Law, and the regulations promulgated under those sections at 1 Pa. Code §§ 7.1 and 7.2 (relating to notice of proposed rulemaking required; and adoption of regulations).

 (2) A public comment period was provided as required by law and all comments were considered in drafting this final-form rulemaking.

 (3) The amendments made to the final-form rulemaking do not enlarge the original purpose of the proposed rulemaking as published under section 201 of the act of July 31, 1968 (P.L. 769, No. 240) (45 P.S. § 1201).

 (4) The adoption of the regulations is necessary and appropriate for the administration of the act.

Order

 (1) The regulations of the Department in 28 Pa. Code Chapters 201, 203, 204, 205 and 207 are amended by amending §§ 201.23, 205.6, 205.7, 205.21, 205.22, 205.61, 205.63, 205.67 and 205.101, adding §§ 204.1—204.20 and deleting §§ 203.1, 205.4, 205.62, 205.64, 205.66, 205.68 and 207.4.

 (2) The Department shall submit this final-form rulemaking to the Office of Attorney General and the Office of General Counsel for approval as required by law.

 (3) The Department shall submit this final-form rulemaking to IRRC, the Senate Health and Human Services Committee and the House Health Committee as required by law.

 (4) The Department shall certify this final-form rulemaking, as approved for legality and form, and shall deposit it with the Legislative Reference Bureau as required by law.

 (5) This final-form rulemaking shall take effect on July 1, 2023.

DR. DENISE A. JOHNSON, 
Acting Secretary

 (Editor's Note: See 52 Pa.B. 7054 (November 12, 2022) for IRRC's approval order.)

Fiscal Note: 10-222. No fiscal impact; (8) recommends adoption.

Annex A

ITLE 28. HEALTH AND SAFETY

PART IV. HEALTH FACILITIES

Subpart C. LONG-TERM CARE FACILITIES

CHAPTER 201. APPLICABILITY, DEFINITIONS, OWNERSHIP AND GENERAL OPERATION OF LONG-TERM CARE NURSING FACILITIES

OWNERSHIP AND MANAGEMENT

§ 201.23. Closure of facility.

 In addition to the requirements set forth in 42 CFR 483.70(l) and (m) (relating to administration), the following conditions apply to the closure of a long-term care nursing facility:

 (a) [Reserved].

 (b) [Reserved].

 (c) [Reserved].

 (c.1) The facility shall develop a closure plan that includes all of the following:

 (1) The identification of those who will be responsible for the daily operation and management of the facility during the closure process.

 (2) The roles and responsibilities, and contact information, for the facility owner and the administrator or any replacement or temporary manager during the closure process.

 (3) Assurance that no new residents will be admitted to the facility after the written notice of closure is provided under subsection (c.3).

 (4) A plan for identifying and assessing available facilities to which residents can be transferred, taking into consideration each resident's individual best interests and resident's goals, preferences and needs regarding services, location and setting. This shall include all of the following:

 (i) Interviewing each resident and resident representative, if applicable, to determine each resident's goals, preferences and needs.

 (ii) Offering the opportunity, to each resident and resident representative, if applicable, to obtain information regarding options within the community.

 (iii) Providing residents and resident representatives, if applicable, with information or access to information regarding providers and services.

 (5) A plan for the communication and transfer of resident information, including of medical records.

 (6) Provisions for the ongoing operations and management of the facility, its residents and staff during the closure process, that include all of the following:

 (i) Payment of salaries and expenses.

 (ii) Continuation of appropriate staffing and resources to meet the needs of the residents, including provision of medications, services, supplies and treatment.

 (iii) Ongoing accounting, maintenance and reporting of resident personal funds.

 (iv) Labeling, safekeeping and appropriate transfer of each resident's personal belongings.

 (c.2) The facility shall provide the notice of closure and the closure plan developed under subsection (c.1) to the department for approval at least 75 days prior to the proposed date of closure.

 (c.3) At least 60 days before the proposed date of closure, the facility shall provide written notice of the proposed closure to the following:

 (1) Residents and their resident representatives, if applicable, in writing or in a language and manner they understand.

 (2) Employees of the facility.

 (3) The Office of the State Long-Term Care Ombudsman Program.

 (4) The Department of Human Services.

 (c.4) The written notice provided under subsections (c.2) and (c.3) shall contain all of the following:

 (1) The date of the proposed closure.

 (2) Contact information for the facility representative delegated to respond to questions about the closure.

 (3) Contact information for the Office of the State Long-Term Care Ombudsman Program.

 (4) The transfer and relocation plan of residents.

 (d) No resident in a facility may be required to leave the facility prior to 30 days following receipt of a written notice from the licensee of the intent to close the facility, except when the Department determines that removal of the resident at an earlier time is necessary for health and safety.

 (e) If an orderly transfer of the residents cannot be safely effected within 30 days, the Department may require the facility to remain open an additional 30 days.

 (f) The Department is permitted to monitor the transfer of residents.

 (g) The licensee of a facility shall file proof of financial responsibility with the Department to ensure that the facility continues to operate in a satisfactory manner until closure of the facility.

CHAPTER 203. [Reserved].

§ 203.1. [Reserved].

CHAPTER 204. PHYSICAL ENVIRONMENT AND EQUIPMENT STANDARDS FOR CONSTRUCTION, ALTERATION OR RENOVATION OF LONG-TERM CARE NURSING FACILITIES

§ 204.1. Application of Guidelines for Design and Construction of Residential Health, Care and Support Facilities.

 (a) In addition to the requirements set forth in this chapter, facility construction, alteration or renovation approved on or after July 1, 2023, shall comply with the 2018 edition of the Facility Guidelines Institute Guidelines for Design and Construction of Residential Health, Care, and Support Facilities.

 (b) Facility construction, alteration or renovation approved before July 1, 2023, shall comply with the standards set forth in Chapter 205 (relating to physical environment and equipment standards for existing long-term care nursing facilities).

 (c)  Construction, alteration or renovation shall meet the requirements in effect on the date that the facility's plans for construction, alteration or renovation are approved by the Department.

§ 204.2. Building plans.

 (a) A licensee or prospective licensee shall submit its plans for construction, alteration or renovation to the department. The Department will post instructions for submissions on its public web site.

 (b) A licensee or prospective licensee shall have the opportunity to present and discuss with the Department its purposes and plans concerning the requested changes indicated on architectural plans submitted under § 51.3(d) (relating to notification). If differences occur and cannot be resolved, an administrative hearing may be sought under 1 Pa. Code Part II (relating to General Rules of Administrative Practice and Procedure).

 (c) Construction, alteration or renovation approved by the Department shall begin within 2 years of the Department's approval and shall be completed within 5 years of the Department's approval.

 (d) A facility may seek an extension of the time periods under subsection (c) for beginning or completing an approved construction, alteration or renovation by written request to the Department. The Department may approve an extension for good cause shown.

 (e) A facility shall obtain approval from the Department before using an area of the facility for resident care when that area has not been occupied or used by residents for 1 year or more.

§ 204.3. Buildings and grounds; general.

 (a) A building to be used for and by residents shall be located in an area that is geographically and environmentally conducive to the health and safety of residents.

 (b) No part of a building may be used for a purpose that interferes with or jeopardizes the health and safety of residents. Special authorization shall be given by the Department's Division of Nursing Care Facilities if a part of the building is to be used for a purpose other than health care.

 (c) Only residents, employees, the licensee, the administrator or members of the administrator's immediate family may reside in the facility.

 (d) Grounds shall be adequate to provide necessary service areas and outdoor areas for residents. A facility may provide rooftop or balcony areas if adequate protective enclosures are provided.

 (e) A delivery area, service yard or parking area shall be located so that traffic does not cross an area commonly used by residents.

§ 204.4. Basement.

 (a) A basement may be used for storage, laundry, kitchen, heat, electric and water equipment. Approval from the Department's Division of Nursing Care Facilities shall be secured before any part of the basement may be used for other purposes, such as physical therapy, central supply and occupational therapy.

 (b) A door to a basement may not be located in a resident room.

§ 204.5. Resident rooms.

 (a) A bed for a resident may be placed only in a room approved by the Department as a resident room.

 (b) The basement of a facility may not be used for resident rooms.

 (c) The maximum number of residents who may be accommodated in a facility shall be indicated on the facility license. The number of resident rooms and the number of beds in a room may not exceed the maximum number approved by the Department.

 (d) A resident shall have a choice in the placement of the resident's bed in the room unless the placement presents a safety hazard.

 (e) A bed may not be placed close to a radiator, heat vent, air conditioner, direct glare of natural light or draft unless the resident chooses to do so and the placement does not pose a safety hazard.

 (f) A resident shall be provided with a drawer or cabinet in the resident's room that can be locked.

§ 204.6. Locks.

 A door into a room used by a resident may not be locked from the outside when the resident is in the room.

§ 204.7. Laundry.

 Equipment shall be made available and accessible for residents desiring to do their personal laundry.

§ 204.8. Utility room.

 The facility shall make provisions in each nursing unit for utility rooms. The nursing unit shall have separate soiled and clean workrooms. The rooms may not be more than 120 feet from the most remote room served.

§ 204.9. Bathing facilities.

 (a) A facility shall provide a general bathing area in each nursing unit to serve resident rooms that do not have adjoining bathrooms with a bathtub or shower.

 (b) Unless bathing fixtures are located in a separate room, there shall be compartments to permit privacy. Cubicle curtains may provide this privacy.

 (c) Each bathing room shall include a toilet and lavatory. If more than one tub or shower is in the bathing room, privacy shall be provided at each bathing facility and at the toilet.

 (d) The facility shall have at least one bathtub in each centralized bath area on each floor.

§ 204.10. Toilet Facilities.

 Toilets and lavatories, other than resident facilities, shall be provided for visitors in a facility.

§ 204.11. Equipment for bathrooms.

 (a) Grab bars shall be installed as necessary at each tub and shower for safety and convenience. Grab bars, accessories and anchorage shall have sufficient strength to accommodate the residents' needs.

 (b) The general bathroom or shower room used by residents shall have one emergency signal bell located in close proximity to the tub or shower and which registers at the workstation. An emergency signal bell shall also be located at each toilet unless a signal bell can be reached by the resident from both the toilet and tub or shower.

 (c) The facility shall make provisions to get residents in and out of bathtubs in a safe way to prevent injury to residents and personnel. The facility shall provide appropriate supervision and assistance to ensure the safety of all residents being bathed.

 (d) A dressing area shall be provided immediately adjacent to the shower stall and bathtub. In the dressing area, there shall be provisions for keeping clothes dry while bathing.

 (e) The facility shall ensure that water for baths and showers is at a safe and comfortable temperature before the resident is bathed.

§ 204.12. Toilet room equipment.

 Each toilet used by residents shall be provided with handrails or assist bars on each side capable of accommodating the residents' needs.

§ 204.13. Linen.

 The facility shall have available at all times a quantity of linens essential for proper care and comfort of residents.

§ 204.14. Supplies.

 Adequate supplies shall be available at all times to meet the residents' needs.

§ 204.15. Windows.

 (a) Each window opening in the exterior walls that are used for ventilation shall be effectively covered by screening.

 (b) A room with windows opening onto light or air shafts, or onto an exposure where the distance between the building or an obstruction higher than the windowsill is less than 20 feet, may not be used for resident rooms.

§ 204.16. Dining.

 The dining area shall be a minimum of 15 square feet per bed for the first 100 beds and 13 1/2 square feet per bed for beds over 100. This space is required in addition to the space required for lounge and recreation rooms.

§ 204.17. Lounge and recreation rooms.

 A recreation or lounge room shall be a minimum of 15 square feet of floor space per bed provided for the first 100 beds and 13 1/2 square feet for all beds over 100. A facility shall provide recreation or lounge rooms for residents on each floor.

§ 204.18. Storage.

 General storage space shall be provided for storage of supplies, furniture, equipment, residents' possessions and the like. Space provided for this purpose shall be commensurate with the needs of the nursing facility but may not be less than 10 square feet per bed.

§ 204.19. Plumbing, heating, ventilation, air conditioning and electrical.

 Building systems, such as plumbing, heating, ventilation, air conditioning and electrical must comply with all State and local codes.

§ 204.20 Airborne infection isolation room.

 A facility shall have at least one airborne infection isolation room for isolating residents as necessary to prevent the spread of airborne infections. An airborne infection isolation room shall be in accordance with the 2018 edition of the Facility Guidelines Institute Guidelines for Design and Construction of Residential Health, Care, and Support Facilities.

CHAPTER 205. PHYSICAL ENVIRONMENT AND EQUIPMENT STANDARDS FOR LONG-TERM CARE NURSING FACILITIES CONSTRUCTION, ALTERATION OR RENOVATION APPROVED BEFORE JULY 1, 2023.

BUILDINGS AND GROUNDS

§ 205.4. [Reserved].

§ 205.6. Function of building.

 (a) No part of a building may be used for a purpose which interferes with or jeopardizes the health and safety of residents. Special authorization shall be given by the Department's Division of Nursing Care Facilities if a part of the building is to be used for a purpose other than health care.

 (b) The only persons who may reside in the facility shall be residents, employees, the licensee, the administrator or members of the administrator's immediate family.

MINIMUM PHYSICAL ENVIRONMENT STANDARDS

§ 205.7. Basement or cellar.

 Basements or cellars may be used for storage, laundry, kitchen, heat, electric and water equipment. Approval from the Department's Division of Nursing Care Facilities shall be secured before any area of the basement may be used for other purposes, such as physical therapy, central supply and occupational therapy.

§ 205.21. Special care room.

 (a) Provisions shall be made for isolating a resident as necessary in a single room which is ventilated to the outside.

 (b) Provisions shall be available to identify this room with appropriate precautionary signs.

§ 205.22. Placement of beds.

 A bed may not be placed in proximity to radiators, heat vents, air conditioners, direct glare of natural light or drafts unless the resident chooses to do so and the placement does not pose a safety hazard.

MECHANICAL AND ELECTRICAL REQUIREMENTS

§ 205.61. Heating requirements for existing construction.

 (a) The heating system shall comply with local and State codes. If there is a conflict, the more stringent requirements shall apply.

 (b) Exposed heating pipes, hot water pipes or radiators in rooms and areas used by residents or within reach of residents, shall be covered or protected to prevent injury or burns to residents. This includes hot water or steam piping above 125°F.

§ 205.62. [Reserved].

§ 205.63. Plumbing and piping systems required for existing construction.

 (a) Potable ice may not be manufactured or stored in the soiled utility room.

 (b) Water distribution systems shall be designed and arranged to provide potable hot and cold water at hot and cold water outlets at all times. The system pressure shall be sufficient to operate fixture and equipment during maximum demand periods.

 (c) Hot water outlets accessible to residents shall be controlled so that the water temperature of the outlets does not exceed 110°F.

§ 205.64. [Reserved].

§ 205.66. [Reserved].

§ 205.67. Electric requirements for existing construction.

 (a) Artificial lighting shall be restricted to electric lighting.

 (b) Spaces occupied by people, machinery and equipment within buildings shall have electric lighting which is operational at all times.

 (c) Electric lights satisfactory for residents' activities shall be available.

 (d) Electric lights in rooms used by residents shall be placed or shaded to prevent direct glare to the eyes of residents.

 (e) Night lights shall be provided in bedrooms, stairways, corridors, bathrooms and toilet rooms used by residents.

 (f) Arrangements to transfer lighting from overhead fixtures to night light fixtures in stairways and corridors shall be designed so that switches can only select between two sets of fixtures and cannot extinguish both sets at the same time.

 (g) In addition to night lights, residents' bedrooms shall have general lighting. The light emitting surfaces of the night light may not be in direct view of a resident in a normal in-bed position.

 (h) A reading light shall be provided for each resident.

 (i) In each resident room there shall be grounding type receptacles as follows: one duplex receptacle on each side of the head of each bed except for parallel adjacent beds. Only one duplex receptacle is required between beds plus sufficient duplex receptacles to supply portable lights, television and motorized beds, if used, and one duplex receptacle on another wall.

 (j) A nurse's calling station—signal originating device—with cable with push button housing attached or other system approved by the Department shall be provided at each resident bed location so that it is accessible to the resident. Two cables and buttons serving adjacent beds may be served by one station. An emergency calling station within reach of the resident shall be provided at each bathing fixture and toilet unless a single bell can be reached by the resident from both the bathing fixture and the toilet. Cable and push button housing requirement will apply to those facilities constructed after July 1, 1987.

 (k) Calls shall register by a signal receiving and indicating device at the nurses' station, and shall activate a visible signal in the corridor at the resident's door. In multicorridor nursing units, additional visible signal indicators shall be installed at corridor intersections.

§ 205.68. [Reserved].

MISCELLANEOUS PROVISIONS

§ 205.101. Scope.

 This chapter applies to facility construction, alteration or renovation approved by the Department before July 1, 2023.

CHAPTER 207. HOUSEKEEPING AND MAINTENANCE STANDARDS FOR LONG-TERM CARE NURSING FACILITIES

HOUSEKEEPING AND MAINTENANCE

§ 207.4. [Reserved].

[Pa.B. Doc. No. 22-2017. Filed for public inspection December 23, 2022, 9:00 a.m.]



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