6 Colo. Code Regs. § 1011-1 Chapter 04, pt. 16

Current through Register Vol. 47, No. 17, September 10, 2024

Part 16 - LABORATORY SERVICES

16.1 Clinical Pathology

(A) Clinical pathology services shall be made available as required by the needs of the medical staff. Emergency laboratory services shall be available twenty-four (24) hours per day, seven (7) days per week.

(B) The laboratory shall be under the supervision of a physician certified in clinical pathology, either on a full-time, part-time, or consulting basis. This individual shall provide, at a minimum, monthly consultative visits.

(C) There shall be a sufficient number of clinical laboratory technologists, qualified by education, training, competencies, and experience, to promptly and proficiently perform the laboratory tests and examinations required of them.

(D) All clinical pathology services shall be ordered by a physician or a licensed independent practitioner.

(E) Clinical pathology services shall comply with the requirements set forth in the Clinical Laboratory Improvement Amendments (CLIA).

(F) A manual outlining all procedures performed in the laboratory shall be complete and readily available for reference.

(G) The conditions and procedures for referring specimens to another laboratory shall be in writing and available in the laboratory.

(H) Procedures for the adequate precautions for discarding specimens shall be in use, including sterilization, incineration, or both.

(I) A record system shall be established which ensures that specimens are adequately identified, properly processed, and permanently recorded.

(J) Duplicate copies of all reports shall be kept in the laboratory in a manner, which permits ready identification and accessibility for two (2) years.

(K) All equipment shall be in good working order, be routinely checked and be precise in terms of calibration.

(L) If tests are performed in the specialties of mycobacteriology, mycology, and/or virology, the laboratory shall be equipped with a microbiological safety cabinet, with an adequately filtered exhaust system.

(M) Vacuum breakers must be present on sinks where specimens are handled or discarded to ensure that the water supply is not contaminated.

16.2 Blood Banking

(A) The hospital shall provide for the procurement, storage, and transfusion of blood as needed for routine and emergency cases.

(B) Standards of the American Association of Blood Banks shall be used; or the hospital shall substitute alternate standards, which are safe and adequate for the collection and administration of blood and blood products, and are based on nationally-recognized guidelines and standards of practice.

(C) Blood and blood products shall only be administered upon order of a physician or other licensed independent practitioner.

(D) Before administering a blood transfusion, the following shall be authenticated by the individual administering the transfusion and one other individual (or an automated, electronic identification system, such as bar coding):

1) patient;

2) patient's blood specimen;

3) type, crossmatch, and expiration date of donor blood.

(E) Records must be kept which show the complete receipt and disposition of blood.

(F) Each unit of blood typed and cross-matched for transfusion must be adequately identified.

(G) The hospital shall develop and implement policies and procedures to ensure the safe storage and transfusion of blood products.

(H) Refrigerators used to store blood shall have a recording thermometer and an adequate alarm system. The refrigerator shall be on the emergency power source.

6 CCR 1011-1 Chapter 04, pt. 16