[27 Pa.B. 2703]
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Annex A
TITLE 28. HEALTH AND SAFETY
PART IV. HEALTH FACILITIES
Subpart A. GENERAL PROVISIONS
CHAPTER 51. GENERAL INFORMATION
GENERAL PROVISIONS Sec.
51.1. Legal base, scope and definitions. 51.2. Licensed facilities. 51.3. Notification. 51.4. Change in ownership; change in management. 51.5. Building occupancy. CIVIL RIGHTS
51.11. Civil rights compliance 51.12. Nondiscriminatory policy. 51.13. Civil rights compliance records. RESTRICTION OF PROVISION OF HEALTH CARE SERVICES
51.21. Surgery. 51.22. Cardiac catheterization. 51.23. Positron emission tomography. 51.24. Lithotripsy. EXCEPTIONS
51.31. Principle. 51.32. Exceptions for innovative programs. 51.33. Requests for exceptions. 51.34. Revocation of exceptions.
GENERAL PROVISIONS § 51.1. Legal base, scope and definitions.
(a) This subpart implements the act (35 P. S. §§ 448.101--448.904b).
(b) This subpart contains standards which are applicable to all entities licensed as health care facilities under the act. It also identifies specific health care services which are restricted to specified health care facilities.
(c) The following words and terms, when used in this subpart have the following meanings, unless the context closely indicates otherwise:
Act--The Health Care Facilities Act (35 P. S. §§ 448.101--448.904b).
Department--The Department of Health of the Commonwealth.
§ 51.2. Licensed facilities.
The Department licenses the following health care facilities under the act:
(1) Ambulatory surgical facilities.
(2) General hospitals.
(3) Special hospitals.
(4) Long-term care nursing facilities.
(5) Birth centers.
(6) Home health care agencies.
(7) Cancer treatment centers.
§ 51.3. Notification.
(a) A health care facility shall notify the Department in writing at least 30 days prior to the intended commencement of a health care service which has not been previously provided at that facility.
(b) A health care facility shall notify the Department in writing at least 30 days prior to the intended date of providing services in new beds it intends to add to its approved complement of beds.
(c) A health care facility shall provide similar notice at least 30 days prior to the effective date it intends to cease providing an existing health care service or reduce its licensed bed complement.
(d) A health care facility shall notify the Department in writing at least 30 days prior to the initiation of the design phase of any proposed new construction, alteration or renovation to the facility.
(e) If a health care facility is in possession of information which shows that the facility is not in compliance with any of the Department's regulations which are applicable to that health care facility, it shall immediately notify the Department in writing of its noncompliance. The notification shall include sufficient detail and information to alert the Department as to the reason for the failure to comply and the steps which the health care facility shall take to bring it into compliance with the regulation.
(f) If a health care facility is aware of a situation or the occurrence of an event at the facility which could compromise quality assurance or patient safety, the facility shall immediately notify the Department in writing. The notification shall include sufficient detail and information to alert the Department as to the reason for its occurrence and the steps which the health care facility shall take to rectify the situation.
(g) A health care facility shall send the written notification required under subsections (a)--(f) to the director of the division in the Department responsible for the licensure of the health care facility.
(h) A health care facility may not commence the provision of new health care services or provide services in new beds until it has been informed by the Department that it is in compliance with all licensure requirements.
§ 51.4. Change in ownership; change in management.
(a) A health care facility shall notify the Department in writing at least 30 days prior to any transfer involving 5% or more of the stock or equity of the health care facility.
(b) A health care facility shall notify the Department in writing at least 90 days prior to a change in ownership or a change in the form of ownership or name of the facility. A change in ownership shall mean any transfer of the controlling interest in a health care facility.
(c) A health care facility shall notify the Department in writing within 30 days after a change of management of a health care facility. A change in management occurs when the persons responsible for the day to day operation of the health care facility change.
§ 51.5. Building occupancy.
(a) New construction, alterations or renovations that provide space for patient or resident rooms or services may not be used or occupied until authorization for the occupancy has been received from the Department.
(b) The Department will conduct an onsite survey of the new or remodeled part of a health care facility prior to granting approval for occupancy.
(c) A health care facility shall request a preoccupancy survey at least 2 weeks prior to the anticipated occupancy of the facility or an addition or remodeled part thereof. The Department will conduct an onsite survey of the new or remodeled portion of the health care facility prior to granting approval for occupancy. The Department may give the authorization to occupy the new or remodeled portion of the health care facility orally. If oral authorization for occupancy is given, the Department will provide the health care facility with written confirmation of the oral authorization within 30 days.
CIVIL RIGHTS § 51.11. Civil rights compliance.
A health care facility shall comply with all civil rights laws. The Department may make onsite visits at its discretion to verify the civil rights compliance status of the health care facility.
§ 51.12. Nondiscriminatory policy.
(a) A health care facility shall have a nondiscriminatory policy which applies to all patients or residents and staff. The policy shall include a prohibition on the segregation of buildings, wings, floors and rooms for reasons of race, color, national origin, ancestry, age, sex, religion, handicap or disability. The nondiscriminatory policy shall also address the following:
(1) Inpatient or outpatient admission or care.
(2) Assigning patients or residents to rooms, floors and sections.
(3) Asking patients or residents about roommate preferences.
(4) Assignments of staff to patient or resident services.
(5) Staff privileges of professionally qualified personnel.
(6) Utilization of the health care facility.
(7) Transfers of patients or residents from their rooms.
(b) A health care facility is required to comply with Title VI of the Civil Rights Act of 1964 (42 U.S.C.A. §§ 2000e--2000e-17) and the Pennsylvania Human Relations Act (43 P. S. §§ 951--962.2) and to sign the following statement prior to receiving an initial license:
''This facility has agreed to comply with the provisions of the Federal Civil Rights Act of 1964 and the Pennsylvania Human Relations Act and all requirements imposed pursuant thereto to the end that no person shall, on the grounds of race, color, national origin, ancestry, age, sex, religious creed, or disability, be excluded from participation in, be denied benefits of, or otherwise be subject to discrimination in the provision of any care or service.''§ 51.13. Civil rights compliance records.
(a) A health care facility shall maintain the following records to show compliance with § 51.12 (relating to nondiscriminatory policy):
(1) A copy of the health care facility's admission policy which includes the date of its adoption, which sets forth in clear terms nondiscriminatory practices with regard to race, color, national origin, creed, ancestry, age, sex, religion, handicap or disability.
(2) Copies of signed and dated annual notification to physicians, social workers and others who normally refer patients or residents of the health care facility's nondiscrimination policy.
(3) A copy of a signed and dated annual notification to employes of the health care facility's nondiscrimination policy.
(4) Evidence that the nondiscriminatory practices of the health care facility have been publicized in the community at least annually, by one of the following methods: newspapers, television, radio, brochure or yellow pages.
(5) Other records or reports as may be required by the Department.
(b) Copies of the health care facility's nondiscriminatory policy shall be posted in locations accessible to the facility's staff and the general public.
(c) The health care facility shall provide the Department with a signed and dated copy of the nondiscriminatory policy within 30 days of the effective date of any change in the policy.
RESTRICTION OF PROVISION OF HEALTH CARE SERVICES § 51.21. Surgery.
Surgery shall be performed only in an acute care hospital or in a Class A, Class B or Class C ambulatory surgical facility.
§ 51.22. Cardiac catheterization.
Cardiac catheterization shall be performed only in an acute care hospital.
§ 51.23. Positron emission tomography.
Positron emission tomography (PET) scanning services shall be provided only in a hospital which complies with the regulations of the Department governing radiology and nuclear medicine services.
§ 51.24. Lithotripsy.
Lithotripsy services shall be provided only in a hospital or ambulatory surgical facility authorized to provide anesthesia services under its license.
EXCEPTIONS § 51.31. Principle.
The Department may grant exceptions to this part when the policy and objectives contained in this part are otherwise met, or when compliance would create an unreasonable hardship and an exception would not impair or endanger the health, safety or welfare of a patient or resident.
§ 51.32. Exceptions for innovative programs.
This part is not intended to restrict the efforts of a health care facility to develop innovative and improved programs of management, clinical practice, physical renovation or structural design. Whenever this part appears to preclude any program which may improve the capacity of the health care facility to deliver higher quality care and services or to operate more efficiently without compromising patient or resident care, the Department encourages the health care facility to request appropriate exceptions under this chapter.
§ 51.33. Requests for exceptions.
(a) A health care facility shall make requests for exceptions to the Department in writing.
(b) The Department will retain the requests on file and document whether they have been approved or disapproved.
(c) If the Department proposes to approve an exception, it may request public comment on the exception by notice in the Pennsylvania Bulletin.
(d) The health care facility shall retain approved requests on file during the period the exception remains in effect.
§ 51.34. Revocation of exceptions.
(a) An exception granted under this chapter may be revoked by the Department for good reason. The Department will provide notice of the revocation in writing and will include the reason for the revocation and the date upon which the exception will be terminated.
(b) In revoking an exception, the Department will provide for a reasonable period of time between the date of written notice of the revocation and the date of termination of an exception to afford the health care facility an opportunity to come into compliance with the applicable regulations.
(c) If a health care facility wishes to request a reconsideration of a denial or revocation of an exception, it shall do so in writing to the director of the appropriate division within 30 days after service of the adverse notification.
Subpart [A] B. GENERAL AND SPECIAL HOSPITALS
CHAPTER 136. OPEN HEART SURGICAL SERVICES GENERAL PROVISIONS
Sec.
136.1. Principle. 136.2. Definitions. PROGRAM, SERVICE AND PERSONNEL REQUIREMENTS
136.11. Director. 136.12. Medical staff. 136.13. Nursing staff. 136.14. Support team in the operating room. 136.15. Other support services. 136.16. Rapid mobilization. 136.17. Observation of patients. 136.18. Postoperative care. 136.19. Education and training. 136.20. Pediatric open heart surgery--supplementary criteria. 136.21. Quality management and improvement.
GENERAL PROVISIONS § 136.1. Principle.
Adult open heart surgical services and pediatric open and closed heart surgical services shall be performed only in hospitals and shall be performed in accordance with accepted and prevailing standards of medical practice.
§ 136.2. Definitions.
The following words and terms, when used in this chapter, have the following meanings, unless the context clearly indicates otherwise:
Board certified--A physician licensed to practice medicine in this Commonwealth who has successfully passed an examination and has maintained certification in the relevant medical specialty or subspecialty area, or both, recognized by one of the following groups:
(i) The American Board of Medical Specialties.
(ii) The American Osteopathic Association.
(iii) The foreign equivalent of either group listed in subparagraph (i) or (ii).
Board eligible--A physician licensed to practice medicine in this Commonwealth who has completed the preliminary requirements necessary to take a certification examination offered by a medical specialty board recognized by the American Board of Medical Specialties, the American Osteopathic Association or the foreign equivalent of either group, and who is presently eligible to take the examination and is within 3 years of attaining eligibility.
CABG--Coronary artery bypass graft--A type of open heart procedure wherein a section of a blood vessel is taken from another part of the body to create an alternative path for blood to flow around a narrow or blocked portion of a coronary artery.
Cardiac intensive care service--Service provided to an open heart surgery patient immediately after surgery. This service is provided in a specially equipped area in a facility wherein the highest level of medical care is available. This area shall be equipped to provide invasive monitoring, including arterial pressure, Swan-Ganz catheters and intra-aortic balloon pumps.
Cardiac surgical service--Those personnel involved in the preparation, operation and postoperative care of patients receiving cardiac surgery.
Onsite--In the physical structure at which open heart surgical services are being offered or in an adjoining structure.
Open heart surgery--A surgical procedure to repair acquired or congenital diseases of the heart. The procedure shall do one of the following:
(i) Include the use of an extracorporeal pump oxygenator (heart lung machine) to perform the functions of the circulatory system during the surgery.
(ii) Employ minimally invasive procedures, which do not routinely involve the use of the extracorporeal pump oxygenator to perform the same types of surgical procedures, although its presence is required because, in a certain number of cases, this approach may have to be abandoned in favor of the other method.
Open heart surgery program--A service established by a hospital to evaluate, operate on and provide postoperative care to individuals with cardiovascular illness who require surgical intervention.
Operating room--The room wherein the open heart surgery is performed.
Pediatric heart surgery--Includes both open heart and closed heart procedures for patients under 18 years of age whose physical development precludes them from being handled as an adult when receiving these procedures.
Surgical suite--That area of the hospital wherein the patient is brought for open heart surgery and which is dedicated to the preparation of the surgical team and the patient for open heart surgery and to the actual performance of that surgery.
Twenty-four hours per day--Refers to the availability or onsite presence of specific personnel, support services or equipment on a 24-hour-per-day, 7-days-a-week basis.
PROGRAM, SERVICE AND PERSONNEL REQUIREMENTS § 136.11. Director.
The Director of the open heart surgery program shall be a Board certified surgeon whose training emphasized cardiac surgery.
§ 136.12. Medical staff.
Supporting medical staff of the service shall include:
(1) Board certified or Board eligible surgeons whose training emphasized cardiac surgery. There shall be a sufficient number of surgeons within the service to allow for 24-hour-per-day continuous coverage. In a pediatric service, these surgeons shall have expertise in the special problems of pediatric patients.
(2) A Board certified medical cardiologist with subspecialty certification in cardiovascular disease or who has demonstrated competence as determined by peer review. A pediatric open heart surgery program shall include a board certified pediatric cardiologist.
(3) A cardiac catheterization team with interventional ability on call 24 hours per day.
(4) A Board certified anesthesiologist experienced in open heart anesthesia. There shall be a sufficient number of anesthesiologists within the service for 24-hour-per-day continuous coverage. The anesthesiologists in a service performing pediatric surgery shall have experience in pediatric anesthesia.
(5) A physician who is Board certified in anatomic and clinical pathology.
§ 136.13. Nursing staff.
(a) Nursing personnel shall include nurses with specialized education which includes theory, advanced technical skills and supervised experience in a surgical intensive care unit or in a postoperative cardiovascular unit before assuming primary responsibility for the nursing care of open heart patients.
(b) There shall be nursing service goals and objectives, standards of nursing practice, procedure manuals and written job descriptions for each level of personnel which shall include the following:
(1) A means for assessing the nursing care needs of the patients and determining adequate staffing to meet those needs.
(2) Staffing patterns that are adequate to meet the nursing goals, standards of practice and the needs of the patients.
(3) An adequate number of licensed and unlicensed assistive personnel to assure that staffing levels meet the total nursing needs of the patient.
(4) Nursing personnel assigned to duties consistent with their training, experience and scope of practice, where applicable.
(c) Surgical suite nursing services shall be under the direction and supervision of a registered professional nurse with specific education and experience in dealing with cardiovascular patients.
§ 136.14. Support team in the operating room.
(a) The operating room support team shall include:
(1) A circulating registered professional nurse and additional nursing personnel as required.
(2) A perfusionist. Each open heart procedure shall have a designated perfusionist in attendance. This individual shall have training, experience, and, preferably, certification in the techniques of cardiopulmonary bypass. The perfusionist's duties shall include the operation of the extracorporeal pump oxygenator (heart-lung machine) in accordance with the requirements of the operating surgeon. The perfusionist shall have immediate access to hospital and surgeon specific procedure manuals for the conduct of cardiopulmonary bypass during all open heart procedures.
(b) There shall be a sufficient number of extracorporeal pump oxygenators and perfusionists to allow 24-hour-per-day coverage.
(c) A back-up extracorporeal pump oxygenator shall be available during all open heart procedures.
§ 136.15. Other support services.
(a) Supportive services within the hospital shall include the following, which shall be provided 24 hours per day and shall be either available or onsite, as noted:
(1) Medicine (cardiology onsite; availability of nuclear cardiology; hematology; pulmonary; nephrology; neurology; and infectious disease).
(2) Anesthesiology shall be available.
(3) Clinical laboratory services, onsite for blood banking, hematology, blood chemistry and urinalysis. These services shall be under the same direct management and quality assurance programs as the main hospital laboratories.
(4) Diagnostic radiology, including bedside X-rays, onsite.
(5) Cardiac catheterization and interventional angiography laboratory, available.
(6) Respiratory care services, available.
(7) Cardiac intensive care service, onsite.
(8) Inpatient service for continuing care after transfer from the intensive care unit.
(9) Emergency department, staffed onsite with an advanced cardiac life support certified physician.
(10) Cardiographic laboratory, including continuous electrocardiogram monitoring, available.
(11) Echocardiography service (this may or may not be a part of the cardiographic laboratory), available.
(12) Installation of pacemakers, available.
(13) Organized and designated cardiopulmonary resuscitation team, onsite.
(14) Bioengineering service, available.
(15) Peripheral vascular surgery and a noninvasive vascular laboratory, available.
(16) Acute inpatient dialysis, available.
(b) An operating room shall be specifically equipped for cardiac surgery, and the room and support facilities should be of adequate size, as per Inter-society Commission on Heart Disease requirements or American College of Cardiology/American Hospital Association Guidelines.
§ 136.16. Rapid mobilization.
(a) An open heart surgery program shall have the capability for rapid mobilization of the cardiac surgical service and support team members for emergency procedures, 24 hours per day.
(b) There shall be an on-call schedule of physicians established and posted at each patient unit and other areas where cardiac surgical patients are admitted and at the communications center of the hospital to ensure that there is 24-hour-per-day emergency care and peri-operative care available.
§ 136.17. Observation of patients.
A cardiac surgical care service shall include the capability of visual observation of all patients.
§ 136.18. Postoperative care.
(a) An intensive surgical care service shall be available immediately after surgery to provide invasive monitoring, including Swan-Ganz catheter, arterial pressure and intra-aortic balloon pumps.
(b) The cardiac surgical service shall be responsible for postoperative care and involved in discharge planning of patients.
§ 136.19. Education and training.
The staff of the open heart surgical program shall engage in the following activities:
(1) Ongoing programs of continuing education in cardiovascular care.
(2) Provision of training and consultation services with other providers of cardiovascular care and others.
(3) Patient and family education.
§ 136.20. Pediatric open heart surgery--supplementary criteria.
(a) A hospital which provides pediatric open heart surgery shall meet the standards in this chapter for a cardiovascular surgery program for adults.
(b) In addition, the following criteria shall be met by a pediatric open heart surgery program:
(1) The facility shall be capable of providing definitive diagnostic and therapeutic services for children with all types of cardiovascular disease.
(2) A diagnostic laboratory with radiographic and cardiac catheterization equipment generally similar to that for adults. Bi-plane cineangiography shall be readily available 24 hours per day, and laboratories (both catheterization and general chemical) shall be equipped for small volume samples.
(3) Surgical equipment appropriate for newborns, infants and children.
(4) Intensive care facilities for newborns (as defined by current American Academy of Pediatrics/American College of Obstetrics and Gynecology Guidelines for Perinatal Care), infants and children.
(5) Staff, including nurses and technicians, responsible for care of the pediatric patient shall have experience and training in pediatrics. Specialty staff shall include cardiac surgeons, anesthesiologists and cardiologists who have special training and experience in the care of the pediatric patient and shall be available 24 hours per day.
§ 136.21. Quality management and improvement.
(a) A hospital performing open heart surgery shall maintain patient data on the following:
(1) Mortality/morbidity.
(2) Infections and complications (stroke, deep sternal wound, bleeding requiring reoperation, length of stay, and the like).
(3) Patient risk factors (age, medical history, and the like).
(4) Volume of procedures performed.
(b) The hospital shall provide this information to the Department on a quarterly basis, on a form prescribed by the Department. This data shall be integrated into the hospital's quality assurance program and used to ensure necessary corrections to improve outcomes.
(c) The Department will review the information submitted by the hospital and other relevant information which is available to assess the qualitative performance of the hospital's open heart surgery program. The Department will publish, by statement of policy, the values or standards, or both, for each of the factors reported to the Department.
(d) If the Department's review of this information raises concerns with the quality of care in an open heart surgery program, the Department will undertake a review of that program to determine if these concerns are valid. The hospital shall cooperate with the Department in this review.
CHAPTER 138. CARDIAC CATHETERIZATION SERVICES GENERAL PROVISIONS
Sec.
138.1 Principle. 138.2. Definitions. PROGRAM, SERVICE, PERSONNEL AND AGREEMENT REQUIREMENTS
138.11. Director. 138.12. Medical staff. 138.13. Nursing staff. 138.14. Programs and services. 138.15. High-risk cardiac catheterizations. 138.16. Transfer agreements for low-risk cardiac catheterization hospitals. 138.17. PTCA. 138.18. EPS. 138.19. Pediatric cardiac catheterizations. 138.20. Quality management and improvement.
GENERAL PROVISIONS § 138.1. Principle.
Cardiac catheterizations shall be performed only in hospitals and shall be performed in accordance with accepted and prevailing standards of medical practice.
§ 138.2. Definitions.
The following words and terms, when used in this chapter, have the following meanings, unless the context clearly indicates otherwise:
Board certified--A physician licensed to practice medicine in this Commonwealth who has successfully passed an examination and has maintained certification in the relevant medical specialty or subspecialty area, or both, recognized by one of the following groups:
(i) The American Board of Medical Specialties.
(ii) The American Osteopathic Association.
(iii) The foreign equivalent of either group listed in subparagraph (i) or (ii).
Cardiac catheterization--A procedure used to diagnose and treat various cardiac and circulatory diseases that involves inserting a thin, pliable catheter, which is viewable by X-ray, into a major blood vessel of the arm or leg, and manipulating the tip of the catheter through veins or arteries to the heart.
EPS--Electrophysiology study--The use of blood vessel access to position electrode catheters in various intra cardiac locations with the help of fluoroscopy for the purpose of recording the timing of electrical events to assess the location and direction of impulse propagation.
High-risk cardiac catheterization--Cardiac catheterization which presents a high risk of significant cardiac complication. The term includes diagnostic cardiac catheterization procedures that present a high risk of significant cardiac complication, PTCA, pediatric cardiac catheterization and therapeutic electrophysiology except for the implantation of routine permanent pacemakers.
Low-risk cardiac catheterization--Cardiac catheterization which is not high-risk cardiac catheterization.
Onsite--In the physical structure at which cardiac catheterization services are being offered or in an adjoining structure.
PTCA--Percutaneous transluminal coronary angioplasty--A procedure which uses a balloon catheter, plaque removing device, laser device or mechanical stent to reopen collapsed, blocked or partially blocked arteries.
Pediatric cardiac catheterization--The performance of cardiac catheterization on a person who is younger than 18 years of age and whose physical development precludes that person from being handled as an adult when receiving the procedure.
Therapeutic electrophysiology--EPS used as or in combination with a therapeutic procedure, which includes procedures designed to induce ventricular or supraventricular tachycardia; activation sequence mapping of cardiac tachyarrhythmias; electrode catheter ablative procedures; and implantation of antitachyarrhytmia devices and implantable cardiovertor defibrillators.
Twenty-four hours per day-- Refers to the availability or onsite presence of specific personnel, support services or equipment on a 24-hour-per-day, 7-days-a-week basis.
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