1. 1. Clinical laboratory services and pathology services are provided through a laboratory that holds a certificate of accreditation, certificate of compliance, or certificate of waiver 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, certificate of compliance, or certificate of waiver in subsection (1) is provided to the Department for review upon the Department’s request;

3. 3. The ICF/IID:

   1. a. Is able to provide the clinical laboratory services delineated in the ICF/IID’s scope of services when needed by the residents,
   2. b. Obtains specimens for the clinical laboratory services delineated in the ICF/IID’s scope of services without transporting the residents from the ICF/IID’s premises, and
   3. c. Has the examination of the specimens performed by a clinical laboratory;

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

   1. a. Available to the ordering physician within 24 hours after the test:

      1. i. Is complete with results if the test is performed at a laboratory on the ICF/IID’s premises, or
      2. ii. Result is received if the test is performed at a laboratory outside of the ICF/IID’s premises; and
   2. b. Documented in a resident’s medical record;

5. 5. If a test result is obtained that indicates a resident may have an emergency medical condition, as established in policies and procedures, personnel notify:

   1. a. The ordering physician,
   2. b. A registered nurse in the resident’s assigned unit,
   3. c. The ICF/IID’s administrator, or
   4. d. The director of nursing;
6. 6. If a clinical laboratory report is completed on a resident, a copy of the report is included in the resident’s medical record;

7. 7. If the ICF/IID provides blood or blood products, policies and procedures are established, documented, and implemented for:

   1. a. Procuring, storing, transfusing, and disposing of blood or 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; and
8. 8. Expired laboratory supplies are discarded according to policies and procedures.

If clinical laboratory services are authorized to be provided on an ICF/IID’s premises, an administrator shall ensure that:

Historical Note

Adopted as an emergency effective October 26, 1988, pursuant to A.R.S. § 41-1026, valid for only 90 days (Supp. 88-4). Emergency expired. Readopted without change as an emergency effective January 27, 1989, pursuant to A.R.S. § 41-1026, valid for only 90 days (Supp. 89-1). Emergency expired. Readopted without change as an emergency effective April 27, 1989, pursuant to A.R.S. § 41-1026, valid for only 90 days (Supp. 89-2). Emergency expired. Readopted without change as an emergency effective July 31, 1989, pursuant to A.R.S. § 41-1026, valid for only 90 days (Supp. 89-3). Permanent rules adopted effective October 30, 1989 (Supp. 89-4). Section repealed effective April 4, 1994 (Supp. 94-2). New Section made 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). Section R9-10-518 renumbered to R9-10-2118; new Section R9-10-518 made by exempt rulemaking at 25 A.A.R. 1222, effective April 25, 2019 (Supp. 19-2). Amended by final expedited rulemaking at 31 A.A.R. 1263 (April 18, 2025), with an immediate effective date of April 1, 2025 (Supp. 25-2).