Haw. Code R. § 11-110.1-13 - Licensed clinical laboratory; records

(a) Each licensed clinical laboratory shall retain a duplicate copy of the original report made for each specimen received for analysis for at least two years.

(b) Each licensed clinical laboratory shall have a record indicating the daily accession of specimens. The record shall contain the following information:

(1) The laboratory number or other identification of each specimen received by the laboratory;

(2) The name or other unique identification of the person from whom the specimen was taken;

(3) The name of the person or clinical laboratory who submitted the specimen;

(4) If the request for the test was oral and not followed by a written request, a written statement to that effect shall be made;

(5) The date and time, if applicable, the specimen was collected;

(6) The date and time the specimen was received by the clinical laboratory;

(7) If the specimen is forwarded to another laboratory, the name of the other laboratory, the date the specimen was forwarded to the other laboratory, the date it was tested, and the date the report of the findings of the tests was received from the other laboratory;

(8) The condition of unsatisfactory specimens when received (e.g., broken, leaked, hemolyzed, turbid, etc.);

(9) The actual tests performed;

(10) The results of the laboratory tests or cross reference to results;

(11) The date a report was sent to the department pursuant to section 11-110.1-16(e); and

(12) The name, the initials, or other identification of the person who performed each test, or in the case of a test involving performance by more than one person, the name, the initials, or other identification of the persons who actually supervised the test.

(c) All records and reports of each test performed, including the original or duplicates of original reports from another laboratory, shall be provided to representatives of the department on request. All records shall be retained by the laboratory for a period of at least two years, except for those records or reports that must be retained for a longer period under state or federal law.

(d) Each licensed clinical laboratory shall:

(1) Maintain current personnel records in the clinical laboratory or the personnel office. These records shall include a resume of each employee's training and experience, including dates of previous and current employment, and continuing education; and

(2) Annually submit to the department a list of its clinical laboratory director and testing personnel, including their job titles and license numbers and expiration dates if required for the level of testing the personnel perform.

Notes

Haw. Code R. § 11-110.1-13

[Eff JUL 05 2007] (Auth: HRS §§ 321-11, 321-13) (Imp: HRS §§ 321-11, 321-13)