Rhode Island Code of Regulations › Title 216 - Department of health › Chapter 60 - Laboratories and Medical Examiner › Subchapter 05 - State Laboratory › Part 4 - Clinical Laboratories and Stations (216-RICR-60-05-4) › Section 216-RICR-60-05-4.10 - Physical Plant and Equipment

Current through June 14, 2024
4.10.1
Physical 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.