Title 7 . Health and Social Services

Chapter 12 . Assistance for Community Health Facilities

Section 850. Laboratory testing service requirements

7 AAC 12.850. Laboratory testing service requirements

(a) A laboratory must comply with the requirements for testing services set out in this section.

(b) Bacteriology services must comply with the following requirements:

(1) chemical and biological solutions, reagents and antisera must be tested for reactivity and deterioration each day they are used, and discs and strips which are used daily, must be tested at least once a week;

(2) staining materials must be tested weekly for intended reactivity by concurrent application to smears of microorganisms with predictable staining characteristics; and

(3) each batch of medium must be tested before or concurrently with use with selected organisms to confirm required growth characteristics, selectivity, enrichment, and biochemical response.

(c) Mycology services must be in compliance with the provisions of (b) of this section.

(d) Parasitology services must comply with the following requirements:

(1) a reference collection of slides, photographs, or gross specimens of identified parasites must be available and used in the laboratory for appropriate comparison with diagnostic specimens; and

(2) a calibrated ocular micrometer must be used for determining the size of ova and parasites when size is a critical factor.

(e) Virology services must be in compliance with the following requirements:

(1) systems for the isolation of viruses and reagents for the identification of viruses must be available to cover the entire range of viruses which are etiologically related to those clinical diseases for which laboratory testing services are offered;

(2) records must be maintained which reflect the systems used and the reactions observed;

(3) in tests for the identification of viruses, controls must be employed which will identify erroneous results; and

(4) if serodiagnostic tests for virus diseases are performed, the requirements for quality control set out in (f)(1) - (f)(4) of this section must be met.

(f) Serology services must be in compliance with the following requirements:

(1) serologic tests on unknown specimens must be run concurrently with a positive control serum of known titer or controls of graded reactivity plus a negative control in order to detect variations in reactivity levels;

(2) controls for all test components including, but not limited to, antigens, complement, and erythrocyte indicator systems, must be used to ensure reactivity and uniform dosage;

(3) test results must be reported only after the predetermined reactivity pattern of the controls is obtained;

(4) each new lot of reagent must be tested concurrently with one of known acceptable reactivity before the new reagent is placed in routine use; and

(5) equipment, glassware, reagents, controls, and techniques for tests for syphilis must conform to those recommended in the Manual of Tests for Syphilis 1969, U.S. Public Health Service Publication No. 411, January, 1969.

(g) Clinical chemistry services must be in compliance with the following requirements:

(1) each instrument or device must be recalibrated or rechecked at least once each day that it is used;

(2) records which document the routine precision of each method, automated or manual, and its recalibrated schedule must be maintained and made available to laboratory personnel and the department;

(3) at least one standard and one reference or control sample must be included with each test run on unknown specimens;

(4) control limits for standards and reference samples must be recorded along with a record of the action taken when test results are outside acceptable limits; and

(5) screening or qualitative chemical urinalysis must be checked daily by use of suitable reference samples.

(h) Immunohematology services must be in compliance with the following requirements:

(1) ABO grouping must be performed by testing unknown red cells with anti-A and anti-B grouping serums licensed under 21 C.F.R. Part 610 as in effect April 30, 1983, or possessing equivalent potency, using the technique for which the serum is specifically designed to be effective;

(2) for confirmation of ABO grouping, the unknown serum must be tested with known A1 and B red cells;

(3) the Rh o (D) type must be determined by testing unknown red cells with anti-Rh o (anti-D) typing serum licensed under 21 C.F.R. Part 610 or possessing equivalent potency, using the technique for which the serum used is specifically designed to be effective;

(4) anti CD, DE, and CDE sera used for donor typing must be federally licensed or of equivalent potency;

(5) all Rh o (D) negative blood specimens (except recipients) must be tested for the Rh o (D) variant (Du);

(6) a control system of patient cells suspended appropriately with an anti-D reagent in use must be used when the test is performed in a protein medium; and

(7) the reliability of reagents (antisera, known test cells and antiglobulin-Coombs serum) which are used for ABO grouping, Rh typing, antibody detection, and compatibility determinations must be tested for reactivity on each day of use and when a new lot of reagents is first used, unless the laboratory keeps records which demonstrate that accuracy is high and such frequency of testing is unnecessary.

(i) Hematology services must be in compliance with the following requirements:

(1) instruments and other devices that are used in hematological examination of specimens must be recalibrated, retested, or reinspected, as appropriate, each day they are used;

(2) each procedure for which standards and controls are available must be rechecked each day of use with standards or controls covering the entire range of expected values;

(3) the one-stage prothrombin time test and other related tests must be run in duplicate, unless the laboratory can demonstrate that low frequency of random error or high precision make such testing unnecessary;

(4) reference materials including hemoglobin pools and stabilized cells must be tested at least once each day they are used to insure accuracy of results; and

(5) the accuracy and precision of instruments or devices used for blood cell counts, hematocrit and hemoglobin measurements must be tested each day they are used.

(j) Exfoliative cytology must meet the following requirements:

(1) the laboratory director or an individual in a supervisory position who is either qualified as a cytotechnologist or who is otherwise qualified in the field of cytology must rescreen for proper staining and correct interpretation a random sample of at least 10 percent of the gynecological smears which have been interpreted by other laboratory personnel to be in one of the benign categories;

(2) all gynecological smears interpreted by screeners to be in the "suspicious" or positive categories must be confirmed by the laboratory director or by an individual in a supervisory position who is either qualified as a cytotechnologist or who is otherwise qualified in the field of cytology;

(3) the test report of all gynecological smear tests interpreted in (2) of this subsection must be signed by a physician qualified in pathology or cytology;

(4) all nongynecological cytological preparations, both positive and negative, must be reviewed by the laboratory director or by an individual in a supervisory position who is either qualified as a cytotechnologist or who is otherwise qualified in the field of cytology; and

(5) all smears must be retained for two years from date of examination.

(k) Histopathology and oral pathology must meet the following requirements:

(1) all special stains must be controlled for intended reactivity by the use of positive slides;

(2) stained slides must be retained for two years from date of examination;

(3) blocks must be retained for one year from date of examination; and

(4) remnants of tissue specimens must be retained in a fixative solution until those portions submitted for microscopy have been examined and a diagnosis made by a pathologist.

( l ) Radiobioassay services must be in compliance with the following requirements:

(1) counting equipment must be checked for stability with radioactive standards or other reference sources at least once each day the equipment is used;

(2) reference samples with known activity and within expected levels of normal samples must be processed quarterly in replicate; and

(3) for each method, records which document the routine precision and the recalibration schedule must be maintained and made available to laboratory personnel and to the department.

(m) Renal allotransplantation must comply with the following requirements:

(1) crossmatching of potential recipients and donors before transplantation must be performed with one or more techniques by using the most reactive and most recent sera;

(2) HL-A serologic typing of both donor and recipient must include at least those antigens that are detectable with serum that is capable of defining the same antigens that are definable by the National Institute of Health serum trays; and

(3) identify antibody against histocompatibility antigens in serum from potential recipients of organ or tissue grafts.

(n) Transfusions and bone marrow transplants must include the tests in (m)(1) and (m)(2) of this section.

(o) Disease association studies must comply with (m)(2) of this section.

(p) Mixed lymphocyte cultures or other recognized methods to detect cellular defined antigens must be performed in accordance with prescribed methods.

(q) Procedures must be established for the freezing of lymphocytes and for providing a comprehensive panel of fresh or frozen lymphocytes.

(r) The reactivity of cell panels used for antibody detection must be tested at least twice a month with appropriate known antisera.

(s) Histocompatibility testing must meet

(1) the control requirements set out in (h) of this section relating to immunohematology services; and

(2) the control requirements set out in (f)(1) - (f)(4) of this section relating to serology services.

(t) At least once each month each person performing histocompatibility tests must be given a previously tested specimen as an unknown in order to verify his or her ability to reproduce test results. The results of each test must be recorded.

(u) The laboratory must participate annually in at least one national or regional cell exchange program or, if no such program is available, the laboratory must develop an exchange program with another laboratory in order to validate interlaboratory test reproducibility.

(v) In this subsection, "cytotechnologist" means a person who is, by training and experience, qualified to make observations related to the formation, structure, and function of human cells for the purpose of providing information pertinent to medical diagnosis.

History: Eff. 11/19/83, Register 88

Authority: AS 18.05.040

AS 18.20.010

AS 18.20.060

Editor's note: The Manual of Tests for Syphilis 1969, United States Public Health Service Publication No. 411, January, 1969, cited in 7 AAC 12.850(f) (5) may be obtained from the Superintendent of Documents, U.S. Gov't Printing Office, Washington, D.C. 20402.