Standard - Special Requirements - Viral Serology (HIV Testing)

(A) The laboratory shall reexamine every positive patient specimen and conduct a confirmatory test (differentfromthe firstand having greater specificity) or arrange for a confirmatory test to be conducted when a positive specimen is found. (B) (1) Pursuant to St. 1986, c. 241 both the identity of the subject of HIV tests and the test results are confidential and may not be released to anyone except the subject of the test without first receiving the subject's written consent. (2) The laboratory shall maintain written procedureswhich protect the identity of the subject while the specimen is in process and ensure that the results are disclosed only to the patients' physician, in accordance with 105 CMR 180.290(E). (C) The laboratory shall maintain written procedures which ensure that before the test is performed a form is included in the file which indicates that the patient has given written consent for the test based on an explanation of the following: (1) the voluntary nature of the procedure for patients who are not blood donors; (2) the purpose of the test; (3) an interpretation of the test and significance of test results, including the limitations; (4) the availability of additional information and counseling as necessary. (5) the fact that the test has been ordered and that the results willbe recorded inhospitalrecord. (D) The clinical laboratory shall forward to the Department for approval a copy of the procedures developed in accordance with 105 CMR 180.300(A) through (C) together with its application, pursuant to 105 CMR 180.030, to perform tests in Viral Serology. (E) In addition to 105 CMR 180.300(A) through (D), if a clinical laboratory operated by a hospital or clinic performs the HIV test for other than purposes of blood donor screening, there must be written documentationthat the test has been ordered consistent with criteria established byaninternalreview mechanism within the hospital or clinic. Internal review shall focus on the factors set forth in 105 CMR 180.300(C). (F) When a licensed laboratory acts as a collection station for specimens to be examined by a laboratorywhich is not subject to 105 CMR 180.000, it shallconformto the requirements set forthin 105 CMR 180.300(B) through (E).