Haw. Code R. § 11-110.1-16 - Licensed clinical laboratories and laboratories with class I or class II permits: clinical laboratory procedures

(a) All technical procedures used shall be standard procedures which are generally accepted by authorities in the specialties of laboratory medicine or which are approved by the department. Each technical procedure shall be initially approved, signed, and dated by the laboratory director. Each change in a procedure shall be approved, signed, and dated by the laboratory director.

(b) Except as otherwise provided in this chapter, a clinical laboratory shall examine specimens only at the request of an authorized person.

(c) The result of a test shall be reported only to the authorized person who ordered the test and the designee(s) of the person who ordered the test. No diagnosis or treatment may be made part of the laboratory report, except for reports made by a licensed physician if such reports are-signed by the physician.

(d) All specimens accepted by a clinical laboratory shall be tested on its premises. However, specimens for infrequently performed tests, or those not included within its permit or specialties stated on its license, or those requiring specialized equipment and skill, may be forwarded to another laboratory acceptable to the department. The reports of the results of such tests shall be sent by the testing laboratory to the forwarding clinical laboratory. The forwarding laboratory shall send a copy of such reports to the authorized person requesting the test, and shall indicate thereon the name and address of the laboratory in which the test was actually performed.

(e) The clinical laboratory director shall report to the department all laboratory findings which indicate the presumptive presence of any disease required to be reported pursuant to chapter 11-156, entitled "Communicable Diseases," or as required by other statutes or rules.

Notes

Haw. Code R. § 11-110.1-16

[Eff JUL 05 2007] (Auth: HRS § 321-11) (Imp: HRS § 321-11)