1. 1. Clinical laboratory services and pathology services are provided by a hospital through a laboratory that holds a certificate of accreditation or certificate of compliance issued by the United States Department of Health and Human Services under the 1988 amendments to the Clinical Laboratories Improvement Act of 1967;
2. 2. A copy of the certificate of accreditation or certificate of compliance in subsection (1) is provided to the Department for review upon the Department’s request;
3. 3. A general hospital or a rural general hospital provides clinical laboratory services 24 hours a day on the hospital’s premises to meet the needs of a patient in an emergency;

4. 4. A special hospital whose patients require clinical laboratory services:

   1. a. Is able to provide clinical laboratory services when needed by the patients,
   2. b. Obtains specimens for clinical laboratory services without transporting the patients from the special hospital’s premises, and
   3. c. Has the examination of the specimens performed by a clinical laboratory on the special hospital’s premises or by arrangement with a clinical laboratory not on the special hospital’s premises;
5. 5. A hospital that provides clinical laboratory services 24 hours a day has on duty or on-call laboratory personnel authorized by policies and procedures to perform testing;
6. 6. A hospital that offers surgical services provides pathology services on the hospital’s premises or by contracted service to meet the needs of a patient;

7. 7. Clinical laboratory and pathology test results are:

   1. a. Available to the medical staff:

      1. i. Within 24 hours after the test is completed if the test is performed at a laboratory on the hospital’s premises, or
      2. ii. Within 24 hours after the test result is received if the test is performed at a laboratory not on the hospital’s premises; and
   2. b. Documented in a patient’s medical record;
8. 8. If a test result is obtained that indicates a patient may have an emergency medical condition, as established by medical staff, laboratory personnel notify the ordering medical staff member or a registered nurse in the patient’s assigned unit;
9. 9. If a clinical laboratory report, a pathology report, or an autopsy report is completed on a patient, a copy of the report is included in the patient’s medical record;

10. 10. Policies and procedures are established, documented, and implemented for:

    1. a. Procuring, storing, transfusing, and disposing of blood and blood products;
    2. b. Blood typing, antibody detection, and blood compatibility testing; and
    3. c. Investigating transfusion adverse reactions that specify a process for review through the quality management program;

11. 11. If blood and blood products are provided by contract, the contract includes:

    1. a. The availability of blood and blood products through the contract, and
    2. b. The process for delivery of blood and blood products through the contract; and
12. 12. Expired laboratory supplies are discarded according to policies and procedures.

An administrator shall ensure that:

Historical Note

Adopted effective February 23, 1979 (Supp. 79-1). Section repealed; new Section made by final rulemaking at 8 A.A.R. 2785, effective October 1, 2002 (Supp. 02-2). Amended by final rulemaking at 11 A.A.R. 536, effective March 5, 2005 (Supp. 05-1). Section R9-10-219 renumbered to R9-10-220; new Section R9-10-219 renumbered from R9-10-218 and amended by exempt rulemaking at 19 A.A.R. 2015, effective October 1, 2013 (Supp. 13-2). Amended by exempt rulemaking at 20 A.A.R. 1409, pursuant to Laws 2013, Ch. 10, § 13; effective July 1, 2014 (Supp. 14-2). Amended by final rulemaking at 25 A.A.R. 1583, effective October 1, 2019 (Supp. 19-3).