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Pennsylvania Code



CHAPTER 565. LABORATORY AND RADIOLOGY SERVICES

LABORATORY SERVICES

Sec.


565.1.    Principle.
565.2.    Laboratory service policy.
565.3.    Functions.
565.4.    Records.

RADIOLOGY SERVICES


565.11.    Principle.
565.12.    Radiology service policy.
565.13.    Organization and staffing.
565.14.    Policies.
565.15.    Records.
565.16.    Facilities.

Authority

   The provisions of this Chapter 565 issued under Chapter 8 of the Health Care Facilities Act (35 P. S. § §  448.801a—448.820), specifically sections 448.801a and 448.803; section 2101(a) and (g) of The Administrative Code of 1929 (71 P. S. §  532(a) and (g)), unless otherwise noted.

Source

   The provisions of this Chapter 565 adopted January 23, 1987, effective March 25, 1987, 17 Pa.B. 376, unless otherwise noted.

LABORATORY SERVICES


§ 565.1. Principle.

 The ASF shall have procedures for obtaining routine and emergency laboratory services to meet the needs of patients.

§ 565.2. Laboratory service policy.

 Laboratory services shall be provided under The Clinical Laboratory Act (35 P. S. § §  2151—2165) and Chapter 5 (relating to clinical laboratories).

§ 565.3. Functions.

 Laboratory functions shall include:

   (1)  Performing tests in a timely manner.

   (2)  Distributing test results within 24 hours after completion of a test and maintaining a copy of the results in the laboratory.

§ 565.4. Records.

 Dated reports of services performed shall be made a part of the patient’s medical record.

RADIOLOGY SERVICES


§ 565.11. Principle.

 Radiology services provided or made available shall meet the needs of the patients and shall be provided in accordance with ethical and professional standards of the American Society of Radiologic Technologists and the American College of Radiology.

§ 565.12. Radiology service policy.

 (a)  The service shall be provided by contract or directly by the ASF.

 (b)  Applicable provisions of the Department of Environmental Protection regulations in 25 Pa. Code Chapters 221—233 and 25 Pa. Code § §  235.1 and 235.11—235.15, and the United States Nuclear Regulatory Commission regulations in 10 CFR Chapter I (relating to Nuclear Regulatory Commission) shall be met by the ASF or its contracted radiology service.

Source

   The provisions of this §  565.12 amended October 22, 1999, effective November 22, 1999, 29 Pa.B. 5583. Immediately preceding text appears at serial page (256584).

§ 565.13. Organization and staffing.

 (a)  Radiology services provided by the ASF shall be directed by a person who is qualified to assume professional, organizational and administrative responsibility for the quality of services rendered.

 (b)  Sufficient adequately trained, certified and experienced personnel shall be available to supervise and conduct the work of the radiology services.

Source

   The provisions of this §  565.13 amended October 22, 1999, effective November 22, 1999, 29 Pa.B. 5583. Immediately preceding text appears at serial page (256584).

§ 565.14. Policies.

 (a)  Policies shall address the quality aspects of radiology services including, but not limited to:

   (1)  Performing radiology services only upon the written order of a practitioner, which shall be accompanied by a concise statement of the reason for the examination.

   (2)  Limiting the use of radioactive sources to qualified persons in the organization who have been granted privileges for the use on the basis of their training, experience and current competence.

   (3)  Storing and retaining of films.

 (b)  Policies shall address the safety aspects of radiology services including, but not limited to:

   (1)  Regulation of the use, removal, handling and storage of radioactive material.

   (2)  Precautions against electrical, mechanical and radiation hazards.

   (3)  Proper shielding where radiation sources are used.

   (4)  Wearing of acceptable monitoring devices by personnel who might be exposed to radiation in an area with a radiation hazard.

   (5)  Maintenance of radiation exposure records on personnel.

   (6)  Instructions to personnel in safety precautions and in dealing with emergency radiation hazards.

   (7)  Periodic evaluation by qualified personnel of radiation sources and of safety measures followed, including calibration of equipment in compliance with Federal and Commonwealth statutes and regulations and local ordinances.

§ 565.15. Records.

 Authenticated, dated reports of services performed shall be made a part of the patient’s medical record, in a timely manner not to exceed 30 days.

Source

   The provisions of this §  565.15 amended October 22, 1999, effective November 22, 1999, 29 Pa.B. 5583. Immediately preceding text appears at serial page (256585).

§ 565.16. Facilities.

 If radiology services are provided by the ASF, adequate space, equipment and supplies shall be provided to perform the volume of work with optimal accuracy, precision, efficiency and safety.



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