216 R.I. Code R. 216-RICR-60-05-4.10

Current through December 26, 2024

Section 216-RICR-60-05-4.10 - Physical Plant and Equipment

4.10.1Physical Facility, Equipment, and Supplies

A. General Requirements: Clinical Laboratories and stations shall be maintained in a manner that protects the health and safety of personnel and the public in accordance with all applicable state and local laws and codes. Where there is a difference between codes, the code having the more stringent standard shall apply.

B. Clinical Laboratories: Each clinical laboratory shall be housed in well-lighted, sanitary, properly ventilated quarters, equipped with hot and cold running water, toilet facilities and shall include adequate space to process and examine the specimens commensurate with the total workload. Furthermore, clinical laboratories shall:

1. Be in distinct and separate locations from living quarters unless provisions exist for separate entrances and plumbing fixtures;

2. Have ample workbench space, well-lighted and conveniently located to sink, water, gas and suction and electrical outlets as necessary;

3. Have adequate and proper storage space for volatile chemicals and inflammable solvents, located in non-hazardous areas in accordance with "Rhode Island State Fire Safety Code", R.I. Gen. Laws Chapter 23-28.1.

4. Have adequate temperature humidity controls as may be required for proper performance of tests and operation of instruments affected by variations in temperatures;

5. Have sufficient, consistent voltage levels at electrical sources to which automated equipment is connected;

6. Have adequate refrigerated storage facilities for reagents used in testing. Said facilities shall be conveniently located to the testing area(s);

7. Have on hand and readily available on the premises, all equipment, reagents and glassware necessary for the accurate performance of the clinical laboratory work;

8. Calibrate all precision equipment at regular intervals and maintain calibration logs that provide evidence of calibrations. Or, documentation of calibration by a qualified laboratory instrument service organization shall be acceptable; and

9. Have sharps containers assembled according to manufacturer's intended use(s) and shall ensure the use of biohazard containers at the point of generation of the medical waste.

C. Stations: each station shall be located in well-lighted, sanitary quarters with hot and cold running water, toilet facilities and shall have:

1. A blood drawing chair or cot;

2. A telephone; and

3. A procedure manual outlining steps to be taken in the event of an emergency;

4. A procedure manual, as required in §4.9.2(B) of this Part; and

5. Have sharps containers assembled according to manufacturer's intended use(s) and shall ensure the use of biohazard containers at the point of generation of the medical waste.

4.10.2Fire and Safety

A. Adequate fire and safety precautions shall be established and maintained. Safety instructions shall be posted for the protection of personnel and patients against physical, chemical, and biological hazards.

1. Personnel shall be given an orientation to the safety policies and procedures that shall be compiled in a safety manual and available at all times to all personnel.

4.10.3Medical Waste Disposal

Medical waste as defined in the Medical Waste Regulations of the Rhode Island Department of Environmental Management, 250-RICR- 140-15-1, shall be managed in accordance with the provisions of the aforementioned regulations.

216 R.I. Code R. 216-RICR-60-05-4.10