10A NCAC 13S .0325       LABORATORY SERVICES

(a)  Each clinic shall have the capability to provide or obtain laboratory tests required in connection with the procedure to be performed.

(b)  The governing authority shall establish written policies regarding which surgical specimens require examination by a pathologist.

(c)  Each patient shall have the following performed and a record of the results placed in the patient's medical record prior to the abortion:

(1)           pregnancy testing, except when a positive diagnosis of pregnancy has been established by ultrasound;

(2)           anemia testing (hemoglobin or hematocrit); and

(3)           Rh factor testing.

(d)  Patients requiring the administration of blood shall be transferred to a local hospital having blood bank facilities.

(e)  The clinic shall maintain a manual in a location accessible by employees, that includes the procedures, instructions, and manufacturer's instructions for each test procedure performed, including:

(1)           sources of reagents, standard and calibration procedures, and quality control procedures; and

(2)           information concerning the basis for the listed "normal" ranges.

(f)  The clinic shall perform and document, at least quarterly, calibration of equipment and validation of test results.

History Note:        Authority G.S. 131E-153.5; 143B-165;

Codifier determined that findings of need did not meet criteria for emergency rule on October 30, 2023;

Emergency Rule Eff. November 14, 2023;

Temporary Adoption Eff. February 8, 2024.