WSR 97-11-039

PROPOSED RULES

DEPARTMENT OF HEALTH

[Filed May 15, 1997, 4:21 p.m.]

Original Notice.

Exempt from preproposal statement of inquiry under RCW 34.05.310(4).

Title of Rule: Chapter 246-338 WAC, Medical test site rules.

Purpose: To establish in WAC the rules for licensure of medical test sites for implementation of chapter 70.42 RCW.

Statutory Authority for Adoption: RCW 70.42.005.

Statute Being Implemented: Chapter 70.42 RCW.

Summary: Chapter 246-338 WAC, Medical test site rules, is amended. Amendments include housekeeping changes and changes required to meet the requirements of federal laws that license sites that perform clinical laboratory testing. The amendments are at the request of the federal Health Care Financing Administration, following a review of the state rules for exemption from federal legislation (CLIA).

Reasons Supporting Proposal: The amendments will bring the state medical test site rules into compliance with federal legislation and will allow the state to continue its exemption from federal regulation.

Name of Agency Personnel Responsible for Drafting: Gail Neuenschwander, Department of Health, (206) 361-2805; Implementation and Enforcement: Martha G. Simon, Department of Health, (206) 361-2806.

Name of Proponent: Department of Health, governmental.

Rule is not necessitated by federal law, federal or state court decision.

Explanation of Rule, its Purpose, and Anticipated Effects: The medical test site rule licenses all sites in the state that perform clinical laboratory testing. The state law (chapter 70.42 RCW) was passed to take the place of federal regulation (CLIA). In order to renew the state exemption from CLIA, the federal Health Care Financing Administration reviewed the medical test site rules and identified areas that need changing or clarification to meet the federal CLIA requirements. These changes will allow the state to maintain its exemption from CLIA, and maintain the current level of activity necessary to assess and assure the quality of clinical laboratory testing in the state.

Proposal Changes the Following Existing Rules: The amendments clarify requirements for sites holding a certificate of waiver and provider performed microscopic procedures license; add additional tests to the list of waived tests; remove outdated language in licensure and personnel sections; clarify language in record-keeping section; change the requirements for retention of cytology reports from five years to ten years; clarify language in the quality control section; add specific requirements for mycology reagent checks, virus culture identification, and manual coagulation testing; specify the stain required for cytology gynecologic smears; cross reference the CLIA histocompatibility standards; and specify that the medical test site license will be revoked for one year if the licensee intentionally refers its proficiency testing samples to another medical test site or laboratory for analysis.

No small business economic impact statement has been prepared under chapter 19.85 RCW. This proposal is exempt under RCW 34.05.310(4) and therefore does not require a small business economic impact statement.

Section 201, chapter 403, Laws of 1995, does not apply to this rule adoption. Section 201, chapter 403, Laws of 1995 do not apply to rules that adopt without material change, federal statutes or regulations (RCW 34.05.328 (5)(b)(iii)).

Hearing Location: Department of Health, 1112 S.E. Quince, Executive Conference Room, Olympia, WA 98504-7890, on June 24, 1997, at 1:00 p.m.

Assistance for Persons with Disabilities: Contact Jennifer Hart by June 17, 1997, TDD (800) 833-6388, or FAX (206) 361-2813.

Submit Written Comments to: Gail Neuenschwander, 1610 N.E. 150th Street, Seattle, WA 98155-9701, FAX (206) 361-2813, by June 20, 1997.

Date of Intended Adoption: June 24, 1997.

May 14, 1997

Bruce A. Miyahara

Secretary

AMENDATORY SECTION (Amending WSR 94-17-099, filed 8/17/94, effective 9/17/94)

WAC 246-338-020 Licensure of the medical test sites. (1) After July 1, 1990, no person shall advertise, operate, manage, own, conduct, open, or maintain a medical test site without first obtaining from the department, a license or a certificate of waiver as described under chapter 70.42 RCW and this chapter.

(2) Applicants requesting a medical test site license or renewal shall:

(a) Submit a completed application and fee for the appropriate category of license to the department on forms furnished by the department, including signature of the owner;

(b) Submit a completed application and fee for provider-performed microscopic procedures if the medical test site:

(i) Restricts its testing performance to waived tests as listed under WAC 246-338-030(11) and one or more of the tests listed in this section, unless specifically allowed or disallowed under federal law and regulation:

(((i))) (A) Wet mounts, including, but not limited to, preparations of vaginal, cervical or skin specimens;

(((ii))) (B) Potassium hydroxide (KOH) preparations;

(((iii))) (C) Pinworm examinations;

(((iv))) (D) Fern tests;

(((v))) (E) Post-coital direct, qualitative examinations of vaginal or cervical mucous;

(((vi))) (F) Urine sediment examinations;

(((vii))) (G) Nasal smears for eosinophils;

(((viii))) (H) Post vasectomy qualitative semen analysis; and

(((ix))) (I) Any other tests specifically categorized under federal law and regulation as provider-performed microscopic procedures; and

(ii) Meets the requirements of this chapter for personnel, recordkeeping, quality control, quality assurance and, if applicable, proficiency testing;

(c) File a separate application for each facility except under the following conditions:

(i) If the medical test site is not at a fixed location and moves from testing site to testing site, or uses a temporary testing location such as a health fair, the medical test site may apply for a single license for the home base location;

(ii) If the medical test site is a not-for-profit or state or local government laboratory that engages in limited public health testing at different locations, the owner may file an application for a single license;

(d) Furnish full and complete information to the department in writing, as required for proper administration of rules implementing chapter 70.42 RCW including:

(i) Name, address, and phone number of the medical test site;

(ii) Name, address, and phone number of the owner of the medical test site;

(iii) Number and types of tests performed, planned, or projected;

(iv) Names and qualifications including educational background, training, and experience of the designated test site supervisor;

(v) Names and qualifications including educational background, training, and experience of technical personnel, if requested by the department, in order to determine consistency with federal law and regulation;

(vi) Name of proficiency testing program or programs used by the medical test site and a copy of the enrollment form for initial application;

(vii) Other information as required to implement chapter 70.42 RCW; and

(viii) Methodologies for tests performed, when the department determines the information is necessary, consistent with federal law and regulation.

(e) Submit to inspections by the Health Care Financing Administration (HCFA) or HCFA agents as a condition of licensure or approval, for the purpose of validation or in response to a complaint against the medical test site; and

(f) Authorize the department to release to HCFA or HCFA agents all records and information requested by HCFA;

(3) The owner or applicant shall submit an application and fee to the department thirty days prior to the expiration date of the current license.

(4) The department shall:

(a) Issue or renew a license for the medical test site, valid for two years, when the applicant or owner meets the requirements of chapter 70.42 RCW and this chapter, subject to subsection (7) of this section;

(b) Terminate a provisional license, at the time a two-year license for the medical test site is issued;

(c) Establish fees to be paid under WAC 246-338-990;

(d) Prohibit transfer or reassignment of a license without thirty days prior written notice to the department and the department's approval;

(e) Examine records of the medical test site, if the department believes a person is conducting tests without an appropriate license;

(f) Give written notice of any violations to the medical test site, including a statement of deficiencies observed and requirements to:

(i) Present a written plan of correction to the department within fourteen days following the date of postmark; and

(ii) Comply within a specified time, not to exceed sixty days, after department approval of a written plan of correction;

(g) Allow the owner a reasonable period of time, not to exceed sixty days, to correct a deficiency unless the deficiency is an immediate threat to life, health, or safety.

(5) The department shall also issue a license for a medical test site if the medical test site:

(a) Is accredited, certified, or licensed by an accreditation body under WAC 246-338-040; and

(b) Submits to the department:

(i) Information defined under subsection (2)(a) and (d) of this section;

(ii) Proof of accreditation, certification or licensure by an accreditation body within eleven months of issuance of the medical test site license; and

(c) Authorizes the accrediting body to submit, upon request from the department:

(i) On-site inspection results;

(ii) Statement of deficiencies;

(iii) Plan of correction for the deficiencies cited;

(iv) Any disciplinary action and results of any disciplinary action taken by the accreditation body against the medical test site; and

(v) Any records or other information about the medical test site required for the department to determine whether or not standards are consistent with chapter 70.42 RCW and this chapter.

(6) The department shall require the owner of a medical test site to reapply for a medical test site license if:

(a) Proof of accreditation is not supplied to the department within eleven months of issuance of the medical test site license; or

(b) The medical test site has its accreditation denied or terminated by the accreditation body.

(7) The department may:

(a) Issue, to a medical test site applying for licensure for the first time a provisional license valid for a period of time not to exceed two years from date of issue;

(b) Conduct on-site review of a medical test site at any time to determine compliance with chapter 70.42 RCW and this chapter; and

(c) Initiate disciplinary action, as described under chapter 70.42 RCW and this chapter, if the owner or applicant fails to comply with chapter 70.42 RCW and this chapter, consistent with chapter 34.05 RCW, Administrative Procedure Act.

(8) The department may((:

(a))) extend a license for a period not to exceed six months beyond the expiration date of the license((; or

(b) Issue a license for a period of one year for applications for licensure or renewal submitted during September 1993 to August 1995)).

(9) The owner shall notify the department, in writing, at least thirty days prior to the date of a proposed change of ownership and provide the following information:

(a) Full name, address, and location of the current owner and prospective new owner, if known;

(b) Name and address of the medical test site and the new name of the medical test site, if known;

(c) Changes in technical personnel and supervisors, if known; and

(d) The date of the proposed change of ownership.

(10) The prospective new owner shall submit the information required under subsection (2)(a) and (d) of this section, at least thirty days prior to the change of ownership.

(11) The owner shall inform the department within thirty days, in writing, of:

(a) The date of opening or closing the medical test site; and

(b) Any changes in:

(i) Name;

(ii) Location; or

(iii) Designated test site supervisor.

(12) The owner shall inform the department within six months, in writing, of any changes in:

(a) Tests, specialties and subspecialties; and

(b) Test methodology.

[Statutory Authority: Chapter 70.42 RCW. 94-17-099, 246-338-020, filed 8/17/94, effective 9/17/94; 93-18-091 (Order 390), 246-338-020, filed 9/1/93, effective 10/2/93; 91-21-062 (Order 205), 246-338-020, filed 10/16/91, effective 10/16/91. Statutory Authority: RCW 43.70.040. 91-02-049 (Order 121), recodified as 246-338-020, filed 12/27/90, effective 1/31/91. Statutory Authority: Chapter 70.42 RCW. 90-20-017 (Order 090), 248-38-020, filed 9/21/90, effective 10/22/90.]

AMENDATORY SECTION (Amending WSR 94-17-099, filed 8/17/94, effective 9/17/94)

WAC 246-338-030 Waiver from licensure of medical test sites. (1) The department shall grant a certificate of waiver to a medical test site performing only the tests listed under this section.

(2) Applicants requesting a certificate of waiver or renewal shall:

(a) Submit a completed application and fee for initial certificate of waiver or renewal to the department on forms furnished by the department, including signature of the owner; ((and))

(b) File a separate application for each facility except under the following conditions:

(i) If the medical test site is not at a fixed location and moves from testing site to testing site, or uses a temporary testing location such as a health fair, the medical test site may apply for a single certificate of waiver for the home base location;

(ii) If the medical test site is a not-for-profit or state or local government laboratory that performs, at different locations, only those tests listed in subsection (11) of this section, the owner may file an application for a single certificate of waiver;

(c) Furnish full and complete information to the department in writing, as required for proper administration of rules to implement chapter 70.42 RCW including:

(i) Name, address, and phone number of the medical test site;

(ii) Name, address, and phone number of the owner of the medical test site;

(iii) Number and types of tests performed, planned or projected;

(iv) Names and qualifications including educational background, training and experience of the personnel directing and supervising the medical test site;

(v) Names and qualifications including educational background, training, and experience of personnel performing the test procedures, if requested by the department, in order to determine consistency with federal law and regulation;

(vi) Other information as required to implement chapter 70.42 RCW; and

(vii) Methodologies for tests performed, when the department determines the information is necessary consistent with federal law and regulation.

(3) The owner or applicant shall submit an application and fee to the department thirty days prior to the expiration date of the current certificate of waiver.

(4) The department shall:

(a) Grant a certificate of waiver or renewal of a certificate of waiver for the medical test site valid for two years when the applicant or owner meets the requirements of chapter 70.42 RCW and this chapter, subject to subsection (6) of this section;

(b) Establish fees to be paid under WAC 246-338-990; and

(c) Prohibit transfer or reassignment of a certificate of waiver without thirty days prior written notice to the department and the department's approval.

(5) The department may((:

(a))) extend a certificate of waiver for a period not to exceed six months beyond the expiration date of the certificate of waiver((; or

(b) Issue a certificate of waiver for a period of one year for initial or renewal applications submitted during September 1993 to August 1995)).

(6) If the department has reason to believe a waived site is conducting tests requiring a license, the department shall:

(a) Conduct on-site reviews of the medical test site;

(b) Examine records of the medical test site;

(c) Give written notice of any violations to the medical test site, including a statement of deficiencies observed and requirements to:

(i) Present a written plan of correction to the department within fourteen days following the date of postmark; and

(ii) Comply within a specified time not to exceed sixty days after department approval of a written plan of correction;

(d) Allow the owner a reasonable period of time, not to exceed sixty days, to correct a deficiency unless the deficiency is an immediate threat to life, health, or safety.

(7) The department may:

(a) Conduct on-site review of a medical test site at any time to determine compliance with chapter 70.42 RCW and this chapter; and

(b) Initiate disciplinary action, as described under chapter 70.42 RCW and this chapter, if the owner or applicant fails to comply with chapter 70.42 RCW and this chapter, consistent with chapter 34.05 RCW, Administrative Procedure Act.

(8) The owner shall notify the department, in writing, at least thirty days prior to the date of a proposed change of ownership and provide the following information:

(a) Full name, address, and location of the current owner and prospective new owner, if known;

(b) Name and address of the medical test site and the new name of the medical test site, if known;

(c) Changes in personnel directing the medical test site, if known; and

(d) The date of the proposed change of ownership.

(9) The prospective new owner shall submit the information required under subsection (2)(a) and (c) of this section, at least thirty days prior to the change of ownership.

(10) The owner shall inform the department within thirty days, in writing, of:

(a) The date of opening or closing the medical test site; and

(b) Any changes in:

(i) Name;

(ii) Location; or

(iii) Personnel directing the medical test site.

(11) The department shall grant a certificate of waiver if the medical test site performs only the tests listed in this section and no other tests unless specifically ((disallowed or)) allowed or disallowed under federal law and regulation, and follows manufacturer's instructions for performing the tests:

(a) Dipstick or tablet reagent urinalysis;

(b) Fecal and gastric occult blood;

(c) Ovulation tests-visual color comparison tests for human luteinizing hormone;

(d) Urine pregnancy tests-visual color comparison tests;

(e) Erythrocyte sedimentation rate-nonautomated;

(f) Hemoglobin-copper sulfate-nonautomated;

(g) Hemoglobin by single instrument with self-contained or component features to perform specimen/reagent interaction, providing direct measurement and readout using the Hemocue test system;

(h) Blood glucose by glucose monitoring devices cleared by the FDA specifically for home use;

(((h))) (i) Blood glucose using the Hemocue B-Glucose Photometer;

(j) Spun microhematocrit; ((and

(i) Hemoglobin by single analyte instruments with self-contained or component features to perform specimen/reagent interaction, providing direct measurement and readout.))

(k) Wampole STAT-CRIT hematocrit test;

(l) Accu-check InstantPlus cholesterol test system;

(m) Advanced Care cholesterol measuring system;

(n) Cholestech LDX test system for the measurement of total cholesterol, HDL cholesterol, triglyceride, and glucose;

(o) Chemtrak Accumeter cholesterol test system;

(p) Quidel QuickVue In-Line One-Step Strep A test;

(q) Binax NOW Strep A test;

(r) Quidel QuickVue One-Step H.pylori test for whole blood;

(s) Serim Pyloritek test for presumptive identification of H.pylori in gastric biopsy tissue; and

(t) Delta West CLOtest for presumptive identification of H.pylori in gastric biopsy tissue.

(12) The department will make additions or deletions to the list of waived tests under subsection (11) of this section, by rule, consistent with federal law and regulation.

(13) If the medical test site adds tests not included under subsection (11) of this section, the owner shall apply for licensure as defined under chapter 70.42 RCW and WAC 246-338-020.

[Statutory Authority: Chapter 70.42 RCW. 94-17-099, 246-338-030, filed 8/17/94, effective 9/17/94; 93-18-091 (Order 390), 246-338-030, filed 9/1/93, effective 10/2/93; 91-21-062 (Order 205), 246-338-030, filed 10/16/91, effective 10/16/91. Statutory Authority: RCW 43.70.040. 91-02-049 (Order 121), recodified as 246-338-030, filed 12/27/90, effective 1/31/91. Statutory Authority: Chapter 70.42 RCW. 90-20-017 (Order 090), 248-38-030, filed 9/21/90, effective 10/22/90.]

AMENDATORY SECTION (Amending Order 390, filed 9/1/93, effective 10/2/93)

WAC 246-338-060 Personnel. (1) Owners shall ensure medical test sites:

(a) Have a designated test site supervisor responsible for:

(i) The overall technical supervision and management of the test site personnel; and

(ii) Performing and reporting of testing procedures;

(b) Have technical personnel, competent to perform tests and report test results; and

(c) Meet the standards for personnel qualifications and responsibilities in compliance with federal regulation, as listed in 42 CFR Part 493 Subpart M-Personnel for Moderate and High Complexity Testing, with the following exception((s)):

(((i))) A person that achieved a satisfactory grade through an examination conducted by or under the sponsorship of the United States Public Health Service for director, on or before July 1, 1970, would qualify as a director, technical supervisor, technical consultant, general supervisor and testing personnel for the specialties in which a satisfactory grade was achieved for moderate and high complexity testing((; and

(ii) A person that has completed 60 semester hours of academic credit including chemistry and biology as well as a structured curriculum in medical laboratory techniques at an accredited institution would qualify as testing personnel for high complexity testing)).

(2) The department, upon request, shall furnish 42 CFR Part 493 Subpart M.

(3) Owners of medical test sites shall establish, post and observe safety precautions to ensure protection from physical, chemical, biochemical and electrical hazards and biohazardous materials.

(4) Designated test site supervisors shall:

(a) Establish and approve policies for:

(i) Performing, recording, and reporting of tests;

(ii) Maintaining an ongoing quality assurance program;

(iii) Supervision of testing; and

(iv) Compliance with chapter 70.42 RCW and this chapter;

(b) Evaluate, verify, and document the following related to technical personnel:

(i) Education, experience, and training in test performance and reporting tests results;

(ii) Sufficient numbers to cover the scope and complexity of the services provided;

(iii) Access to training appropriate for the type and complexity of the test site services offered; and

(iv) Maintenance of competency to perform test procedures and report test results;

(c) Be present, on call, or delegate the duties of the designated test site supervisor to an on-site technical person during testing.

[Statutory Authority: Chapter 70.42 RCW. 93-18-091 (Order 390), 246-338-060, filed 9/1/93, effective 10/2/93; 91-21-062 (Order 205), 246-338-060, filed 10/16/91, effective 10/16/91. Statutory Authority: RCW 43.70.040. 91-02-049 (Order 121), recodified as 246-338-060, filed 12/27/90, effective 1/31/91. Statutory Authority: Chapter 70.42 RCW. 90-20-017 (Order 090), 248-38-060, filed 9/21/90, effective 10/22/90.]

AMENDATORY SECTION (Amending Order 390, filed 9/1/93, effective 10/2/93)

WAC 246-338-070 Recordkeeping. The medical test site shall:

(1) Unless specified otherwise in subsection (2)(a), (b), and (c) of this section, maintain for two years:

(a) Test requisitions or equivalent;

(b) Test records;

(c) Test reports;

(((c))) (d) Quality control records;

(((d))) (e) Quality assurance records; and

(((e))) (f) Discontinued procedures.

(2) Maintain:

(a) The items listed in subsection (1)(a), (b), (c), (d), and (e) of this section for transfusion services for five years;

(b) Abnormal cytology and all histology reports for ten years; and

(c) Normal cytology reports for ((five)) ten years.

(3) Request the following written information to accompany a test requisition:

(a) Patient's name or other method of specimen identification;

(b) Name or other suitable identifier of the authorized person ordering the test;

(c) Date of specimen collection, and time if appropriate;

(d) Source of specimen, if appropriate;

(e) Type of test ordered;

(f) Sex and age of the patient, if appropriate; and

(g) For cytology and histology specimens:

(i) Pertinent clinical information; and

(ii) For pap smears:

(A) The last menstrual period; and

(B) Indication whether the patient has history of cervical cancer or its precursors.

(4) Assure specimen records include:

(a) A medical test site identification;

(b) The patient's name or other method of specimen identification;

(c) The date the specimen was received at the medical test site, and time if appropriate;

(d) The reason for specimen rejection or limitation;

(e) The date of specimen testing; and

(f) The identification of the personnel who performed the test.

(5) Assure that test reports:

(a) Are maintained in a manner permitting identification and reasonable accessibility;

(b) Are released only to authorized persons or designees;

(c) Include the name of the medical test site, or where applicable, the name and address of each medical test site performing each test;

(d) Include the date reported;

(e) Include the time reported, if appropriate;

(f) Include any information regarding specimen rejection or limitation; ((and))

(g) Include the test performed, test result, and units of measurement, if applicable; and

(h) Include the exact language of the report from the testing facility, if the specimen was referred to another medical test site for testing.

(6) Assure cytology reports:

(a) Distinguish between unsatisfactory specimen and negative results; and

(b) Contain narrative descriptions for any abnormal results, such as the Bethesda system of terminology as published in the Journal of the American Medical Association, 1989, Volume 262, pages 931-934, for any abnormal results.

(7) Establish and make available for use by authorized persons ordering or utilizing the test results:

(a) Reference ranges; and

(b) A list of test methods, including performance specifications.

(8) Issue corrected reports when indicated.

(9) Establish criteria for and maintain appropriate documentation of:

(a) Temperature-controlled spaces and equipment;

(b) Preventive maintenance activities;

(c) Equipment function checks;

(d) Procedure calibrations;

(e) Validation, precision, and accuracy checks;

(f) Expiration date, lot numbers, and other pertinent information for:

(i) Reagents;

(ii) Solutions;

(iii) Culture media;

(iv) Controls, as defined in WAC 246-338-090;

(v) Calibrators, as defined in WAC 246-338-090;

(vi) Standards, as defined in WAC 246-338-090;

(vii) Reference materials, as defined in WAC 246-338-090; and

(viii) Other testing materials;

(g) Testing of quality control samples; and

(h) Any remedial action taken in response to quality control, quality assurance, personnel, and proficiency testing.

(10) Refer specimens for testing only to a medical test site with a valid license, or to an interstate laboratory with a valid CLIA certificate.

(11) Maintain, or be able to reproduce, a copy of the report for all specimens that are referred for testing.

[Statutory Authority: Chapter 70.42 RCW. 93-18-091 (Order 390), 246-338-070, filed 9/1/93, effective 10/2/93; 91-21-062 (Order 205), 246-338-070, filed 10/16/91, effective 10/16/91. Statutory Authority: RCW 43.70.040. 91-02-049 (Order 121), recodified as 246-338-070, filed 12/27/90, effective 1/31/91. Statutory Authority: Chapter 70.42 RCW. 90-20-017 (Order 090), 248-38-070, filed 9/21/90, effective 10/22/90.]

AMENDATORY SECTION (Amending Order 390, filed 9/1/93, effective 10/2/93)

WAC 246-338-090 Quality control. (1) For the purpose of this section, the following words and phrases have the following meanings, unless the context clearly indicates another meaning:

(a) "ABO, A, A₁, B, O, anti-A, anti-B, anti-D, anti Rh_o, Rh_o (D), HLA, HLA-A, B, and DR" means taxonomy classifications for blood groups, types, cells, sera, or antisera;

(b) "Calibrator" means a material, solution, or lyophilized preparation designed to be used in calibration. The values or concentrations of the analytes of interest in the calibration material are known within limits ascertained during its preparation or before use;

(c) "Control" means a material, solution, lyophilized preparation, or pool of collected serum designed to be used in the process of quality control. The concentrations of the analytes of interest in the control material are known within limits ascertained during its preparation or before routine use;

(d) "Control slide" means a preparation fixed on a glass slide used in the process of quality control;

(e) "Reference material" means a material or substance, calibrator, control or standard where one or more properties are sufficiently well established for use in calibrating a process or for use in quality control;

(f) "Standard" means a reference material of fixed and known chemical composition capable of being prepared in essentially pure form, or any certified reference material generally accepted or officially recognized as the unique standard for the assay regardless of level or purity of the analyte content.

(2) The medical test site shall use quality control procedures providing and assuring accurate and reliable test results and reports, meeting the requirements of this chapter.

(3) The medical test site shall have written procedures and policies available in the work area including:

(a) Analytical methods used by the technical personnel;

(b) Specimen collection and processing procedures;

(c) Preparation of solutions, reagents, and stains;

(d) Calibration procedures;

(e) Proper maintenance of equipment;

(f) Quality assurance policies;

(g) Quality control procedures;

(h) Corrective actions when quality control results deviate from expected values or patterns;

(i) Procedures for reporting test results;

(j) Limitations of methodologies; and

(k) Alternative or backup methods for performing tests including the use of a reference facility if applicable.

(4) The medical test site shall perform quality control complying with the requirements of this section for each specialty and subspecialty as follows:

(a) At least as frequently as specified in this section;

(b) More frequently if recommended by the manufacturer of the instrument or test procedure; or

(c) More frequently if specified by the medical test site

(5) The medical test site shall:

(a) Perform procedural calibration or recalibration, in accordance with manufacturer's instructions((, when)):

(i) When recommended by the manufacturer((;)) or

(((ii))) specified by the medical test site's established schedule, with at least the frequency recommended by the manufacturer; and

(ii) When calibration fails to meet the medical test site's acceptable limits;

(b) Perform calibration verification using materials appropriate for verifying the minimal, mid-point and maximum points of the reportable range, unless the medical test site can demonstrate an alternative method of assuring the accuracy of the procedure throughout the reportable range for patient test results:

(i) When a complete change of reagents for a procedure is introduced;

(ii) When there is major preventive maintenance or replacement of critical parts of equipment or instrumentation;

(iii) When controls begin to reflect an unusual trend or are outside acceptable range limits; or

(iv) At least every six months;

(c) If patient values are above the maximum or below the minimum calibration point or the linear range:

(i) Report the patient results as greater than the upper limit or less than the lower limit or an equivalent designation; or

(ii) Use an appropriate procedure to rerun the sample allowing results to fall within the established linear range;

(d) Perform quality control:

(i) For quantitative tests:

(((i))) (A) To include two reference materials of different concentrations each day of testing unknown samples, if these reference materials are available; or

(((ii))) (B) Have an equivalent mechanism to assure the quality, accuracy, and precision of the test, if reference materials are not available; and

(((e))) (ii) For qualitative tests, to include positive and negative reference material each day of testing unknown samples;

(e) Check each batch or shipment of reagents, discs, stains, antisera and identification systems for positive and negative reactivity:

(i) When prepared or opened;

(ii) For stains, each day of use, unless otherwise specified; and

(iii) For fluorescent stains, each time of use, unless otherwise specified;

(f) Determine the statistical limits for each lot number of unassayed reference materials through repeated testing;

(g) Use the manufacturer's reference material limits for assayed material, provided they are:

(i) Verified by the medical test site; and

(ii) Appropriate for the methods and instrument used by the medical test site;

(h) Make reference material limits readily available;

(i) Report patient results only when reference materials are within acceptable limits;

(j) Use materials within their documented expiration date and not interchange components of kits with different lot numbers, unless specified by manufacturer;

(k) For microbiology:

(i) Check each batch or shipment of reagents, discs, stains, antisera, and identification system for reactivity with positive and negative reference organisms including:

(A) Each time of use for fluorescent stains;

(B) Each day of use for:

(I) Stains, unless specifically stated otherwise in this section; DNA probes; reagents used in mycobacteriology; catalase, coagulase, beta-lactamase, and oxidase reagents; and

(II) Direct antigen detection systems, using positive and negative controls that evaluate both the extraction and reaction phase;

(C) Each week of use for Gram and acid-fast stains, bacitracin, optochin, ONPG, X, and V discs or strips; and

(D) Each month of use for antisera;

(ii) When testing antimicrobial susceptibility, check each new batch of media and each new lot of antimicrobial discs or other testing systems using approved reference organisms:

(A) Before initial use; and

(B) Each day of testing, or weekly, if the medical test site can meet the quality control requirements for antimicrobial disc susceptibility testing as outlined by the National Committee for Clinical Laboratory Standards (NCCLS), available upon request from the department;

(iii) Document zone sizes or minimum inhibitory concentration for reference organisms are within established limits;

(iv) Have available and use appropriate stock organisms for quality control purposes;

(v) Have available a collection of slides, photographs, gross specimens, or text books for reference sources to aid in identification of microorganisms;

(vi) Document appropriate steps in the identification of microorganisms on patient specimens;

(vii) Check each batch or shipment of noncommercial media for sterility, ability to support growth, and if appropriate, selectivity, inhibition, or biochemical response;

(viii) If commercially manufactured media quality control results are used:

(A) Verify that the product insert specifies that the quality control checks meet the requirements, as outlined by NCCLS, for media quality control;

(B) Keep records of the manufacturer's quality control results;

(C) Document visual inspection of the media before use; and

(D) Follow the manufacturer's specifications for using the media;

(ix) When performing ((susceptibility testing for)) mycology:

(A) For susceptibility testing:

(I) Test each drug each day of use with at least one control strain that is susceptible to the drug; and

(((B))) (II) Document that controls are within established limits before reporting patient results;

(B) Test reagents, used with biochemical tests and other test procedures used for identification, each week of use with an organism that produces a positive reaction;

(x) When performing parasitology:

(A) Use a calibrated ocular micrometer for determining the size of ova and parasites, if size is a critical parameter; and

(B) Check permanent stains using reference materials, each month of use;

(xi) When performing virus identification, simultaneously culture uninoculated cells or cell substrate controls as a negative control;

(l) For syphilis serology:

(i) Use equipment, glassware, reagents, reference materials, and techniques conforming to manufacturers' specifications;

(ii) Perform serologic tests on unknown specimens concurrently with a positive serum reference material with known titer or graded reactivity and a negative reference material; and

(iii) Employ reference materials for all test components to ensure reactivity;

(m) For general immunology:

(i) Perform serologic tests on unknown specimens with a positive and a negative reference material;

(ii) Employ reference materials for all test components to ensure reactivity; and

(iii) Report test results only when the predetermined reactivity pattern of the reference material is observed;

(n) For chemistry, when performing blood gas analysis, include:

(i) A two-point calibration and a reference material each eight hours of testing; and

(ii) A one-point calibration or reference material each time patient samples are tested, unless automated instrumentation internally verifies calibration at least every thirty minutes; or

(iii) Another calibration and reference material schedule, approved by the department as equivalent to this subsection;

(o) For hematology and coagulation:

(i) Use one level of reference material each eight hours of testing patient samples for manual blood counts;

(ii) Use two levels of reference materials:

(A) Each eight hours of testing for:

(((A))) (I) Instrumentation methods; and

(((B))) (II) Manual tilt tube method for coagulation; and

(B) Each reagent change for coagulation;

(iii) Run manual coagulation tests and cell counts in duplicate;

(p) For immunohematology, for the services offered:

(i) Perform ABO grouping by testing unknown red cells with Federal Food and Drug Administration approved anti-A and anti-B grouping sera;

(ii) Confirm ABO grouping of unknown serum with known A₁ and B red cells;

(iii) Determine the Rh_o(D) group by testing unknown red cells with anti-D (anti Rh_o) blood grouping serum;

(iv) Employ a control system capable of detecting false positive Rh test results, when required by the manufacturer; and

(v) Perform quality control checks of cells and antisera each day of use;

(q) For transfusion services:

(i) Perform ABO grouping, Rh_o (D) typing, antibody detection, and identification and compatibility testing as described by the Food and Drug Administration under 21 CFR Part 606, with the exception of 21 CFR Part 606.20a, Personnel, and 21 CFR Part 640;

(ii) Collect, store, process, distribute and date blood and blood products as described by the Food and Drug Administration under 21 CFR Parts 606, 610.53 and 640;

(iii) When provided by an outside entity, have an agreement approved by the director for procurement, transfer and availability of blood and blood products; and

(iv) Promptly investigate all transfusion reactions according to the medical test site's procedures;

(r) For histopathology:

(i) Use positive control slides for each special stain to check for intended level of reactivity;

(ii) Retain stained slides at least ten years and specimen blocks at least two years from the date of examination;

(iii) Retain remnants of tissue specimens in an appropriate preserved state until the portions submitted for microscopic examination have been examined and diagnosed; and

(iv) Include on all reports the signature or initials of the technical supervisor, as defined under 42 CFR Part 493 Subpart M;

(s) For cytology:

(i) Develop criteria for submission of material and the assessment of the adequacy of the sample submitted, including notifying the physician;

(ii) Retain all negative slides for five years from the date of examination of the slide;

(iii) Retain all abnormal slides for ten years from the date of examination;

(iv) Include in quality control the rescreening and documentation of benign gynecological slides as follows:

(A) One hundred percent of slides from patient with a known history of cervical cancer or its precursors; and

(B) Selection of benign slides for a total rescreening of a minimum of ten percent of all benign slides including patients identified in (s)(iv)(A) of this subsection; ((or

(C) Another method demonstrating equivalent effectiveness in discovering errors;))

(v) Assure that quality control is performed by a person meeting the personnel requirements for technical supervisor or general supervisor in cytology, as defined under 42 CFR Part 493 Subpart M;

(vi) Evaluate the results of the quality control rescreen prior to reporting results for the cases selected;

(vii) Review cytologic specimens or records of previous reviews, for the prior five years, if available, for each abnormal cytology result;

(viii) Correlate abnormal cytology reports with prior cytology reports and with histopathology reports, if available, and determine the cause of any discrepancies;

(ix) Document reviews of negative slides from cases known to have a history of abnormal slides;

(x) Evaluate and document technical personnel slide examination performance, comparing against the medical test site's overall statistics;

(xi) Evaluate and document significant discrepancies in examination of cytology slides;

(xii) Establish an annual statistical evaluation of the number of cytology cases examined, number of specimens processed by specimen type, volume of patient cases reported by diagnosis, number of cases where cytology and histology are discrepant, number of cases where histology results were unavailable for comparison and number of cases where rescreen of negative slides resulted in reclassification as abnormal;

(xiii) Stain all gynecologic smears with a Papanicolaou or modified Papanicolaou staining method;

(xiv) Take effective measures when staining to prevent cross-contamination between gynecologic and nongynecologic specimens;

(((xiv))) (xv) The technical supervisor shall:

(A) Confirm all gynecological smears interpreted to be outside normal limits;

(B) Review all nongynecological cytological preparations;

(C) Sign or initial all reports from (s)(xiv)(A) or (B) of this subsection; and

(D) Establish, document and reassess, at least every six months, the workload limits for each cytotechnologist;

(((xv))) (xvi) Technical personnel shall examine, unless federal law and regulation specify otherwise, no more than one hundred cytological slides in a twenty-four hour period and in no less than a eight-hour period; and

(((xvi))) (xvii) All slide preparations must be evaluated on the premises;

(t) For histocompatibility:

(i) Use applicable quality control standards for immunohematology, transfusion services, and diagnostic immunology as described in this chapter; and

(ii) ((For renal allotransplantation:

(A) Have available and follow criteria for:

(I) Selecting appropriate patient serum samples for crossmatching;

(II) The technique used in crossmatching;

(III) Preparation of donor lymphocytes for crossmatching;

(IV) Reporting crossmatch results;

(V) The preparation of lymphocytes for Human Leukocyte Antigen HLA-A, B and DR typing;

(VI) Selecting typing reagents; and

(VII) The assignment of HLA antigens;

(B) Have available:

(I) Serum specimens for all potential transplant recipients at initial typing, for periodic screening, for pretransplantation crossmatch, and following sensitizing events;

(II) Results of final crossmatches before an organ or tissue is transplanted; and

(III) A list of individuals for fresh panel bleeding if frozen panels are not used;

(C) Have appropriate storage and maintenance of both recipient sera and reagents;

(D) Indicate, when applicable:

(I) Source;

(II) Bleeding date;

(III) Identification number; and

(IV) Volume remaining for reagent typing sera inventory;

(E) Properly label and store:

(I) Cells;

(II) Complement;

(III) Buffers;

(IV) Dyes; and

(V) Reagents;

(F) Type all potential transplant recipient cells and cells from organ donors referred to the medical test site;

(G) Have adequate reagent trays for typing recipient and donor cells to define all HLA-A, B, and DR specificities as required to determine splits and cross-reactivity;

(H) Have a written policy establishing when antigen redefinition and retyping are required;

(I) Screen recipient sera for preformed antibodies with a suitable lymphocyte panel;

(J) Use a suitable cell panel for screening patient sera containing all the major HLA specificities and common splits;

(K) Use the mixed lymphocyte culture, or equivalent, to determine cellularly defined antigens;

(L) On each tray:

(I) Include positive and negative reference materials; and

(II) Use positive controls for specific cell types when applicable;

(M) Use controls to monitor the test components and each phase of the test system for:

(I) Each compatibility test; and

(II) Typing for disease associated antigens;

(N) Use quality control procedures to monitor the efficacy of the method if immunologic reagents are used to remove contaminating cells during the isolation of lymphocytes or lymphocyte subsets;

(O) Have each individual performing tests evaluate a previously tested specimen as an unknown on a monthly basis; and

(P) Participate in at least one national or regional cell exchange program, if available, or develop an exchange system with another medical test site;

(iii) When performing only transfusions, and nonrenal transplantation, excluding bone marrow and living transplants, meet all the requirements specified in this section except for the requirements for the performance of mixed lymphocyte cultures;

(iv) When performing bone marrow transplantation, meet all the requirements specified in this section including the performance of mixed lymphocyte cultures, or equivalent, to evaluate class II compatibility;

(v) When performing disease-associated studies, meet all the requirements specified in this section except for the performance of mixed lymphocyte cultures, antibody screening and crossmatching; and

(vi) Test donor for HIV reactivity)) Meet the standards for histocompatibility as listed in 42 CFR Part 493.1265, Condition: Histocompatibility, available from the department upon request;

(u) For cytogenetics:

(i) Document the:

(A) Number of metaphase chromosome spreads and cells counted and karyotyped;

(B) Number of chromosomes counted for each metaphase spread;

(C) Media used;

(D) Quality of banding; and

(E) Sufficient resolution to support the reported results;

(ii) Assure an adequate number of karyotypes are prepared for each patient, according to the indication given for performing cytogenetics study;

(iii) Use an adequate patient identification system for:

(A) Patient specimens;

(B) Photographs, photographic negatives, or computer stored images of metaphase spreads and karyotypes;

(C) Slides; and

(D) Records;

(iv) Include in the final report:

(A) The number of cells counted and karyotyped; and

(B) An interpretation of the karyotypes findings;

(v) Use appropriate nomenclature on final reports; and

(vi) When performing determination of sex by X and Y chromatin counts, perform confirmatory testing on all atypical results;

(v) For radiobioassay and radioimmunoassay:

(i) Check the counting equipment for stability each day of use with radioactive standards or reference sources; and

(ii) Meet Washington state radiation standards described under chapter 70.98 RCW, and chapter 402-10 through 402-24, 402-32 through 402-34, 402-62, and 402-70 WAC.

[Statutory Authority: Chapter 70.42 RCW. 93-18-091 (Order 390), 246-338-090, filed 9/1/93, effective 10/2/93; 91-21-062 (Order 205), 246-338-090, filed 10/16/91, effective 10/16/91. Statutory Authority: RCW 43.70.040. 91-02-049 (Order 121), recodified as 246-338-090, filed 12/27/90, effective 1/31/91. Statutory Authority: Chapter 70.42 RCW. 90-20-017 (Order 090), 248-38-090, filed 9/21/90, effective 10/22/90.]

AMENDATORY SECTION (Amending Order 390, filed 9/1/93, effective 10/2/93)

WAC 246-338-100 Disciplinary action. (1) The department may take disciplinary action against the license of a medical test site or an application for a license as a medical test site upon a determination that the licensee or applicant has engaged in or committed any of the following:

(a) Failure or refusal to comply with the requirements of chapter 70.42 RCW or the rules adopted under chapter 70.42 RCW;

(b) Knowingly, or with reason to know, made a false statement of a material fact in the application for a license or in any data attached thereto or in any record required by the department;

(c) Refused to allow representatives of the department to examine any book, record, or file required under this chapter;

(d) Willfully prevented, interfered with, or attempted to impede in any way, the work of a representative of the department; or

(e) Misrepresented or was fraudulent in any aspect of the owner's or applicant's business.

(2) Except as provided in subsection (3) of this section, the following actions may be taken against the applicant or licensee, individually or in any combination, as a disciplinary action:

(a) Denial of the license or renewal thereof;

(b) Conditions on the license which limit or cancel the test site's authority to conduct any tests or group of tests;

(c) Suspension of the license;

(d) Revocation of the license;

(e) Monetary penalties, not exceeding ten thousand dollars per violation.

(3) Upon a determination that the licensee or applicant has engaged in or committed any of the following described conduct, the sanction shall be as specified for that conduct. If more than one sanction is listed, the sanction may be ordered individually or in any combination:

(a) If the applicant was the holder of a license under chapter 70.42 RCW which was revoked for cause and never reissued by the department, then the license application may be denied;

(b) If the licensee willfully prevents or interferes with preservation of evidence of a known violation of chapter 70.42 RCW or the rules adopted under this chapter, a monetary penalty not exceeding ten thousand dollars per violation may be assessed or the license may be:

(i) Conditioned in a manner limiting or canceling the authority to conduct tests or groups of tests;

(ii) Suspended;

(iii) Revoked;

(c) If the licensee used false or fraudulent advertising, a monetary penalty not exceeding ten thousand dollars per violation may be assessed or the license may be suspended or revoked;

(d) If the licensee failed to pay any civil monetary penalty assessed by the department under chapter 70.42 RCW within twenty-eight days after the assessment becomes final, the license may be suspended or revoked;

(e) If the licensee intentionally referred its proficiency testing samples to another medical test site or laboratory for analysis, the license will be revoked for a period of at least one year and a monetary penalty not exceeding ten thousand dollars per violation may be assessed ((or the license may be:

(i) Conditioned in a manner limiting or canceling the authority to conduct tests or groups of tests;

(ii) Suspended;

(iii) Revoked)).

(4) The department may summarily suspend or revoke a license when the department finds continued licensure of a test site immediately jeopardizes the public health, safety, or welfare.

(5) The department shall give written notice of any disciplinary action taken by the department to the owner or applicant for licensure, including notice of the opportunity for a hearing.

(6) A medical test site, convicted of fraud and abuse, false billing or kickbacks under state law must report this information to the department within thirty days.