Title of Rule and Other Identifying Information: Chapter 246-338 WAC, Medical test site rules.

     Purpose of the Proposal and Its Anticipated Effects, Including Any Changes in Existing Rules: The intent of the medical test sites law, RCW 70.42.005, is to meet the requirements of federal laws licensing and regulating medical testing. The proposal amends chapter 246-338 WAC, Medical test site rules. The amendments are at the request of the federal Centers for Medicare and Medicaid Services, following a review of the state rules for exemption from federal legislation (CLIA). The federal CLIA regulations were amended on January 24, 2003. The amendments included quality control provisions, personnel qualifications, patient test management requirements, quality assurance requirements and consensus required for grading proficiency testing challenges. The proposed amendments to the medical test site rules incorporate the changes that were made in the CLIA regulations, along with housekeeping changes.

     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 for sites performing clinical laboratory testing.

     Statutory Authority for Adoption: RCW 70.42.220.

     Statute Being Implemented: Chapter 70.42 RCW.

     Rule is necessary because of federal law, 42 C.R.F. [C.F.R.] Part 493.

     Name of Proponent: Department of Health, governmental.

     Name of Agency Personnel Responsible for Drafting and Implementation: Gail Neuenschwander, 1610 N.E. 150th Street, Shoreline, WA 98155, (206) 361-2805; and Enforcement: Gary Bennett, 310 Israel Road S.E., Tumwater, WA 98501-5567, (360) 236-2905.

October 31, 2004

M. C. Selecky

Secretary

OTS-7375.3

AMENDATORY SECTION(Amending WSR 00-06-079, filed 3/1/00, effective 4/1/00)

WAC 246-338-010   Definitions.   For the purposes of this chapter, the following words and phrases have these meanings unless the context clearly indicates otherwise.

     (1) "Accreditation organization" means a public or private organization or agency approved by ((HCFA)) CMS as having standards which are consistent with federal law and regulation, and judged by the department to be equivalent to this chapter.

     (2) "Authorized person" means any individual allowed by Washington state law or rule to order tests or receive test results.

     (3) "Biannual verification" means a system for verifying the accuracy of test results, at least twice a calendar year, for those tests for which proficiency testing is not required by the department.

     (4) "Calibration" means a process of testing and adjusting an instrument, kit, or test system to provide a known relationship between the measurement response and the value of the substance that is being measured by the test procedure.

     (5) "Calibration verification" means the assaying of ((calibration)) materials of known concentration in the same manner as patient samples to confirm that the calibration of the instrument, kit, or test system has remained stable throughout the laboratory's reportable range for patient test results.

     (6) "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.

     (7) "Case" means any slide or group of slides, from one patient specimen source, submitted to a medical test site, at one time, for the purpose of cytological or histological examination.

     (8) "CDC" means the federal Centers for Disease Control and Prevention.

     (9) "CMS" means the federal Centers for Medicare Medicaid Services.

     (10) "CLIA" means Section 353 of the Public Health Service Act, Clinical Laboratory Improvement Amendments of 1988, and regulations implementing the federal amendments, 42 CFR Part 493-Laboratory Requirements in effect on September 22, 2003.

     (((10))) (11) "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.

     (((11))) (12) "Control slide" means a preparation of a material known to produce a specific reaction which is fixed on a glass slide and is used in the process of quality control.

     (((12))) (13) "Days" means calendar days.

     (((13))) (14) "Deemed status" means recognition that the requirements of an accreditation organization have been judged to be equal to, or more stringent than, the requirements of this chapter and the CLIA requirements, and the accreditation organization has agreed to comply with all requirements of this chapter and CLIA.

     (((14))) (15) "Deficiency" means a finding from an inspection or complaint investigation that is not in compliance with this chapter and requires corrective action.

     (((15))) (16) "Department" means the department of health.

     (((16))) (17) "Direct staff time" means all state employees' work time; travel time; telephone contacts and staff or management conferences; and expenses involved with a complaint investigation or an on-site follow-up visit.

     (((17))) (18) "Director," defined as the designated test site supervisor in RCW 70.42.010, means the individual responsible for the technical functions of the medical test site. This person must meet the qualifications for Laboratory Director, listed in 42 CFR Part 493 Subpart M - Personnel for ((Moderate and High Complexity)) Nonwaived Testing.

     (((18))) (19) "Disciplinary action" means license or certificate of waiver denial, suspension, condition, revocation, civil fine, or any combination of the preceding actions, taken by the department against a medical test site.

     (((19))) (20) "Facility" means one or more locations within one campus or complex where tests are performed under one owner.

     (((20))) (21) "Forensic" means investigative testing in which the results are never used for clinical diagnosis, or referral to a health care provider for treatment of an individual.

     (((21) "HCFA" means the federal Health Care Financing Administration.))

     (22) "HHS" means the federal Department of Health and Human Services.

     (23) "High complexity" means a test system, assay, or examination that is categorized under CLIA as a high complexity test.

     (((23))) (24) "May" means permissive or discretionary.

     (((24))) (25) "Medical test site" or "test site" means any facility or site, public or private, which analyzes materials derived from the human body for the purposes of health care, treatment, or screening. A medical test site does not mean:

     (a) A facility or site, including a residence, where a test approved for home use by the Federal Food and Drug Administration is used by an individual to test himself or herself without direct supervision or guidance by another and where this test is not part of a commercial transaction; or

     (b) A facility or site performing tests solely for forensic purposes.

     (((25))) (26) "Moderate complexity" means a test system, assay, or examination that is categorized under CLIA as a moderate complexity test.

     (((26))) (27) "Must" means compliance is mandatory.

     (((27))) (28) "Nonwaived" means all tests categorized under CLIA as:

     (a) Moderate complexity tests, including provider-performed microscopic procedures; or

     (b) High complexity tests.

     (((28))) (29) "Owner" means the person, corporation, or entity legally responsible for the business requiring licensure or a certificate of waiver as a medical test site under chapter 70.42 RCW.

     (((29))) (30) "Performance specification" means a value or range of values for a test that describe its accuracy, precision, analytical sensitivity, analytical specificity, reportable range and reference range.

     (((30))) (31) "Person" means any individual, public organization, private organization, agent, agency, corporation, firm, association, partnership, or business.

     (((31))) (32) "Physician" means an individual with a doctor of medicine, doctor of osteopathy, doctor of podiatric medicine, or equivalent degree who is a licensed professional under chapter 18.71 RCW Physicians; chapter 18.57 RCW Osteopathy--Osteopathic medicine and surgery; or chapter 18.22 RCW Podiatric medicine and surgery.

     (((32))) (33) "Provider-performed microscopic procedures" means only those moderate complexity tests listed under WAC 246-338-020 (2)(b)(i) through (x), when the tests are performed in conjunction with a patient's visit by a licensed professional meeting qualifications specified in WAC 246-338-020 (2)(a)(i) through (vi).

     (((33))) (34) "Provisional license" means an interim approval issued by the department to the owner of a medical test site.

     (((34))) (35) "Records" means books, files, reports, or other documentation necessary to show compliance with the quality control and quality assurance requirements under this chapter.

     (((35))) (36) "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.

     (((36))) (37) "Specialty" means a group of similar subspecialties or tests. The specialties for a medical test site are as follows:

     (a) Chemistry;

     (b) Cytogenetics;

     (c) Diagnostic immunology;

     (d) Immunohematology;

     (e) Hematology;

     (f) Histocompatibility;

     (g) Microbiology;

     (h) Pathology; and

     (i) Radiobioassay.

     (((37))) (38) "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.

     (((38))) (39) "Subspecialty" means a group of similar tests. The subspecialties of a specialty for a medical test site are as follows, for:

     (a) Chemistry, the subspecialties are routine chemistry, urinalysis, endocrinology, and toxicology((, and other chemistry));

     (b) Diagnostic immunology, the subspecialties are syphilis serology and general immunology;

     (c) Immunohematology, the subspecialties are ((blood group)) ABO Grouping and Rh typing, antibody detection, antibody identification, ((crossmatching, and other immunohematology)) and compatibility testing;

     (d) Hematology, the subspecialties are routine hematology((,)) and coagulation((, and other hematology));

     (e) Microbiology, the subspecialties are bacteriology, mycology, parasitology, virology, and mycobacteriology; and

     (f) Pathology, the subspecialties are histopathology (including dermatopathology), diagnostic cytology, and oral pathology.

     (((39))) (40) "Supervision" means authoritative procedural guidance by an individual qualified under 42 CFR Part 493 Subpart M - Personnel for ((Moderate and High Complexity)) Non-waived Testing, assuming the responsibility for the accomplishment of a function or activity by technical personnel.

     (((40))) (41) "Technical personnel" means individuals employed to perform any test or part of a test.

     (((41))) (42) "Test" means any examination or procedure conducted on a sample taken from the human body.

     (((42))) (43) "Validation inspection" means an on-site inspection by the department of an accredited medical test site to determine that the accreditation organization's regulations are equivalent to this chapter and are enforced.

     (((43))) (44) "Waived test" means a test system that is:

     (a) Cleared by the Food and Drug Administration for home use; or

     (b) A simple laboratory examination or procedure that has an insignificant risk of an erroneous result.

     In order for a test system to be waived, it must be approved for waiver under CLIA.

     (((44))) (45) "Will" means compliance is mandatory.

[Statutory Authority: RCW 70.42.005, 70.42.060 and chapter 70.42 RCW. 00-06-079, § 246-338-010, filed 3/1/00, effective 4/1/00. Statutory Authority: Chapter 70.42 RCW. 94-17-099, § 246-338-010, filed 8/17/94, effective 9/17/94; 93-18-091 (Order 390), § 246-338-010, filed 9/1/93, effective 10/2/93; 91-21-062 (Order 205), § 246-338-010, filed 10/16/91, effective 10/16/91. Statutory Authority: RCW 43.70.040. 91-02-049 (Order 121), recodified as § 246-338-010, filed 12/27/90, effective 1/31/91. Statutory Authority: Chapter 70.42 RCW. 90-20-017 (Order 090), § 248-38-010, filed 9/21/90, effective 10/22/90.]

     (2) The department may at any time examine records of the medical test site to determine compliance with chapter 70.42 RCW and this chapter.

     (3) The department will:

     (a) Provide written notice of deficiencies to the medical test site; and

     (b) Allow the owner a reasonable period of time, not to exceed sixty days after department approval of the written plan of correction, to correct a deficiency unless the deficiency is an immediate threat to public health, safety, or welfare.

     (4) The medical test site must:

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

     (b) Comply with the written plan of correction within a specified time, not to exceed sixty days, after department approval of the written plan of correction which must detail how and when the medical test site will correct the deficiencies;

     (c) Submit to inspections by ((HCFA)) CMS or ((HCFA)) CMS agents as a condition of licensure for the purpose of validation or in response to a complaint against the medical test site;

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

     (e) Cooperate with any on-site review conducted by the department; and

     (f) Authorize the accreditation organization to submit, upon request of the department:

     (i) On-site inspection results;

     (ii) Reports of deficiencies;

     (iii) Plans of corrections for deficiencies cited;

     (iv) Any disciplinary or enforcement action taken by the accreditation organization against the medical test site and results of any disciplinary or enforcement action taken by the accreditation organization 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.

[Statutory Authority: RCW 70.42.005, 70.42.060. 01-02-069, § 246-338-028, filed 12/29/00, effective 1/29/01. Statutory Authority: RCW 70.42.005, 70.42.060 and chapter 70.42 RCW. 00-06-079, § 246-338-028, filed 3/1/00, effective 4/1/00.]

     (2) The ((HCFA)) CMS-approved accreditation organizations are:

     (a) American Association of Blood Banks (AABB);

     (b) American Osteopathic Association (AOA);

     (c) American Society of ((Histocompatability)) Histocompatibility and Immunogenetics (ASHI);

     (d) College of American Pathologists (CAP);

     (e) COLA; and

     (f) Joint Commission on Accreditation of Healthcare Organizations (JCAHO).

     (3) The accreditation organizations must:

     (a) Allow the department to have jurisdiction to investigate complaints, do random on-site validation inspections, and take disciplinary action against a medical test site if indicated;

     (b) Notify the department within fifteen days of any medical test site that:

     (i) Has had its accreditation withdrawn, revoked, or limited;

     (ii) Is sanctioned as a result of a routine inspection or complaint investigation; or

     (iii) When adverse action has been taken for unsuccessful proficiency testing performance;

     (c) Notify the department within five days of any deficiency that jeopardizes the public health, safety, or welfare; and

     (d) Provide the department with a list of inspection schedules, as requested, for the purpose of conducting on-site validation inspections.

     (4) The department will:

     (a) Revoke deemed status from any organization which has deeming authority removed by ((HCFA)) CMS; and

     (b) Notify the medical test site if approval of an accreditation organization is withdrawn by the department.

[Statutory Authority: RCW 70.42.005, 70.42.060 and chapter 70.42 RCW. 00-06-079, § 246-338-040, filed 3/1/00, effective 4/1/00. Statutory Authority: Chapter 70.42 RCW. 93-18-091 (Order 390), § 246-338-040, filed 9/1/93, effective 10/2/93; 91-21-062 (Order 205), § 246-338-040, filed 10/16/91, effective 10/16/91. Statutory Authority: RCW 43.70.040. 91-02-049 (Order 121), recodified as § 246-338-040, filed 12/27/90, effective 1/31/91. Statutory Authority: Chapter 70.42 RCW. 90-20-017 (Order 090), § 248-38-040, filed 9/21/90, effective 10/22/90.]

     (a) Comply with federal proficiency testing requirements listed in 42 CFR Part 493-Laboratory Requirements, Subparts H and I;

     (b) Submit to the department a copy of proficiency testing enrollment confirmation form(s) for the tests the medical test site will perform during the following calendar year, by December 31st of each year; and

     (c) Authorize the proficiency testing program to release to the department all data required to determine the medical test site's compliance with this section.

     (2) The department will:

     (a) Recognize only those proficiency testing programs approved by ((HCFA)) HHS; and

     (b) Furnish, upon request:

     (i) A copy of 42 CFR Part 493 Subparts H and I;

     (ii) A list of the proficiency testing programs approved by ((HCFA)) HHS; and

     (iii) A list of tests that must be covered by proficiency testing.

     (3) The department will evaluate proficiency testing results by using the following criteria:

     (a) An evaluation of scores for the last three testing events of proficiency testing samples including:

     (i) Tests;

     (ii) Subspecialties; and

     (iii) Specialties;

     (b) Maintenance of a minimum acceptable score of eighty percent for all tests, subspecialties, and specialties except one hundred percent for:

     (i) ABO ((group and D(Rh))) grouping and Rh typing;

     (ii) Compatibility testing; and

     (iii) Antihuman immunodeficiency virus;

     (c) Unsatisfactory performance occurs when:

     (i) Unsatisfactory scores are obtained in any specialty or Subspecialty in a testing event; or

     (ii) An unsatisfactory score is obtained on a single test in a testing event.

     (4) Unsatisfactory performance on two of any three successive testing events is considered unsuccessful participation, and will result in the following actions:

     (a) The department will mail a letter to the director stating that the medical test site may choose to:

     (i) Discontinue patient testing for the identified test, specialty or subspecialty; or

     (ii) Follow a directed plan of correction; and

     (b) The medical test site must notify the department, within fifteen days of receipt of the notice of the decision to:

     (i) Discontinue testing patient specimens for the identified test, subspecialty or specialty; or

     (ii) Agree to a directed plan of correction.

     (5) Continued unsatisfactory performance for a test, specialty or subspecialty in either of the next two consecutive sets of proficiency testing samples, after completing a directed plan of correction, will result in the following action:

     (a) The department will send, by certified mail, a notice to the owner and director of the medical test site to cease performing the identified test, subspecialty, or specialty; and

     (b) The owner must notify the department in writing within fifteen days of the receipt of the notice of the decision to voluntarily stop performing tests on patient specimens for the identified test, subspecialty, or specialty.

     (6) The owner may petition the department for reinstatement of approval to perform tests on patient specimens after demonstrating satisfactory performance on two successive testing events of proficiency testing samples for the identified test, subspecialty, or specialty.

     (7) The department will notify the owner in writing, within fifteen days of receipt of petition, of the decision related to the request for reinstatement.

[Statutory Authority: RCW 70.42.005, 70.42.060 and chapter 70.42 RCW. 00-06-079, § 246-338-050, filed 3/1/00, effective 4/1/00. Statutory Authority: Chapter 70.42 RCW. 94-17-099, § 246-338-050, filed 8/17/94, effective 9/17/94; 93-18-091 (Order 390), § 246-338-050, filed 9/1/93, effective 10/2/93; 91-21-062 (Order 205), § 246-338-050, filed 10/16/91, effective 10/16/91. Statutory Authority: RCW 43.70.040. 91-02-049 (Order 121), recodified as § 246-338-050, filed 12/27/90, effective 1/31/91. Statutory Authority: Chapter 70.42 RCW. 90-20-017 (Order 090), § 248-38-050, filed 9/21/90, effective 10/22/90.]

     (a) Have a director responsible for the overall technical supervision and management of the test site personnel including oversight of the performance of test procedures and reporting of test results;

     (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)) Non-waived Testing((, with the following exception:

     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)).

     (2) The department will furnish a copy of 42 CFR Part 493 Subpart M upon request.

     (3) Medical test site directors must:

     (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 test 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 director to an on-site technical person during testing.

[Statutory Authority: RCW 70.42.005, 70.42.060. 01-02-069, § 246-338-060, filed 12/29/00, effective 1/29/01. Statutory Authority: RCW 70.42.005, 70.42.060 and chapter 70.42 RCW. 00-06-079, § 246-338-060, filed 3/1/00, effective 4/1/00. Statutory Authority: RCW 70.42.005. 97-14-113, § 246-338-060, filed 7/2/97, effective 8/2/97. 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.]

     (1) REQUISITIONS must include the following information, in written or electronic form:

     (a) Patient name, identification number, or other method of ((specimen)) patient identification;

     (b) Name and address or other suitable identifiers 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 or date of birth, of the patient((, if appropriate)); and

     (g) For cytology and histopathology specimens:

     (i) Pertinent clinical information; and

     (ii) For Pap smears:

     (A) Date of last menstrual period; and

     (B) Indication whether the patient ((has history of cervical cancer or its precursors)) had a previous abnormal report, treatment, or biopsy.

     (2) TEST RECORD SYSTEMS must:

     (a) Consist of instrument printouts, worksheets, accession logs, corrective action logs, and other records that ensure reliable identification of patient specimens as they are processed and tested to assure that accurate test results are reported; and

     (b) Include:

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

     (ii) The date and time the specimen was received((, and time, if appropriate));

     (iii) The reason for specimen rejection or limitation;

     (iv) The date of specimen testing; and

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

     (3) TEST REPORTS must:

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

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

     (c) Include ((the)):

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

     (((d) Include:

     (i))) (ii) Patient's name and identification number, or a unique patient identifier and identification number;

     (iii) Date reported;

     (((ii))) (iv) Time reported, if appropriate;

     (((iii))) (v) Specimen source, when appropriate, and any information regarding specimen rejection or limitation; and

     (((iv))) (vi) Name of the test performed, test result, and units of measurement, if applicable.

     (4) CYTOLOGY REPORTS must:

     (a) Distinguish between unsatisfactory specimens and negative results;

     (b) Provide narrative descriptions for any abnormal results, such as the 2001 Bethesda system of terminology as published in the Journal of the American Medical Association, ((1989)) 2002, Volume ((262)) 287, pages ((931-934)) 2114-2119; and

     (c) Include the signature or initials of the technical supervisor, or an electronic signature authorized by the technical supervisor, for nongynecological preparations and gynecological preparations interpreted to be showing reactive or reparative changes, atypical squamous or glandular cells of undetermined significance, or to be in the premalignant (dysplasia, cervical intraepithelial neoplasia or all squamous intraepithelial neoplasia lesions including human papillomavirus-associated changes) or malignant category.

     (5) HISTOPATHOLOGY REPORTS must include the signature or initials of the technical supervisor or an electronic signature authorized by the technical supervisor on all reports.

     (6) CYTOGENETICS REPORTS must:

     (a) Use ((appropriate)) the International System for Human Cytogenetic Nomenclature on final reports;

     (b) Include the number of cells counted and ((karyotyped)) analyzed; and

     (c) Include ((an)) a summary and interpretation of the ((karyotypes findings)) observations.

     (7) If a specimen is referred to another laboratory for testing, the medical test site must:

     (a) Report the essential elements of the referred test results without alterations that could affect the clinical interpretation of the results; and

     (b) Retain or be able to produce an exact duplicate of each testing report from the referral laboratory.

     (8) The medical test site must retain records, slides, and tissues as described in Table 070-1, under storage conditions that ensure proper preservation.

     (9) If the medical test site ceases operation, it must make provisions to ensure that all records and, as applicable, slides, blocks and tissue are retained and available for the time frames specified in Table 070-1.

Table 070-1 Record/Slide/Tissue Retention Schedule

*	Must be retained for no less than five years in accordance with 21 CFR ((Part 606, Subpart I)) 606.160(d).

[Statutory Authority: RCW 70.42.005, 70.42.060. 01-02-069, § 246-338-070, filed 12/29/00, effective 1/29/01. Statutory Authority: RCW 70.42.005, 70.42.060 and chapter 70.42 RCW. 00-06-079, § 246-338-070, filed 3/1/00, effective 4/1/00. Statutory Authority: RCW 70.42.005. 97-14-113, § 246-338-070, filed 7/2/97, effective 8/2/97. 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.]

     (1) The medical test site must establish and implement a written quality assurance plan, including policies and procedures, designed to:

     (a) Monitor, evaluate, and review quality control data, proficiency testing results, and test results, including biannual verification of:

     (i) Accuracy of test results for:

     (A) Tests that are not covered by proficiency testing; ((and))

     (B) Tests that are covered by proficiency testing but have unsatisfactory scores, are not scored by the proficiency testing program, or where scoring does not reflect actual test performance (e.g., the proficiency testing program does not obtain the agreement required for scoring); and

     (ii) Relationship between test results when the medical test site performs the same test on different instruments or at different locations within the medical test site;

     (b) Identify and correct problems;

     (c) Establish and maintain accurate, reliable, and prompt reporting of test results;

     (d) Verify all tests performed and reported by the medical test site conform to specified performance criteria in quality control under WAC 246-338-090; ((and))

     (e) Establish and maintain the adequacy and competency of the technical personnel; and

     (f) Establish and follow written policies and procedures that ensure positive identification and optimum integrity of a patient's specimen from the time of collection or receipt of the specimen through completion of testing and reporting of results.

     (2) The quality assurance plan must include mechanisms or systems to:

     (a) Establish and apply criteria for specimen acceptance and rejection;

     (b) Notify the appropriate individuals as soon as possible when test results indicate potential life-threatening conditions;

     (c) Assess problems identified during quality assurance reviews and discuss them with the appropriate staff;

     (d) Evaluate all test reporting systems to verify accurate and reliable reporting, transmittal, storage, and retrieval of data;

     (e) Document all action taken to identify and correct problems or potential problems;

     (f) Issue corrected reports when indicated;

     (g) Provide appropriate instructions for specimen collection, handling, preservation, and transportation; ((and))

     (h) Ensure that specimens are properly labeled, including patient name or unique patient identifier and, when appropriate, specimen source;

     (i) Ensure confidentiality of patient information throughout all phases of the testing process; and

     (j) Provide clients updates of testing changes that would affect test results or the interpretation of test results.

     (3) The medical test site must establish criteria for and maintain appropriate documentation of any remedial action taken in response to quality control, quality assurance, personnel, proficiency testing, and transfusion reaction investigations.

     (4) When results of control or calibration materials fail to meet the established criteria for acceptability, the medical test site must have a system in place to determine if patient test results have been adversely affected. The system must include:

     (a) A review of all patient test results obtained in the unacceptable test run; and

     (b) A review of all patient test results since the last acceptable test run.

     (5) The medical test site must have a system in place to assure:

     (a) All complaints and problems reported to the medical test site are documented and investigated when appropriate; and

     (b) Corrective actions are instituted as necessary.

     (((5))) (6) The owner must:

     (a) Maintain adequate space, facilities, and essential utilities for the performance and reporting of tests;

     (b) Ensure that molecular amplification procedures that are not contained in closed systems have a unidirectional workflow. This must include separate areas for specimen preparation, amplification and production detection, and as applicable, reagent preparation;

     (c) Establish, ((post)) make accessible, and observe safety precautions to ensure protection from physical, chemical, biochemical, and electrical hazards and biohazards; and

     (((c))) (d) Establish and implement policies and procedures for infectious and hazardous medical wastes consistent with local, state, and federal authorities.

     (((6))) (7) Information that must be available to authorized persons ordering or utilizing the test results includes:

     (a) A list of test methods, including performance specifications;

     (b) Reference ranges; and

     (c) Test method limitations.

     (((7))) (8) If the medical test site refers specimens to another site for testing, the site to which specimens are referred must have a valid medical test site license or meet equivalent requirements as determined by ((HCFA)) CMS.

[Statutory Authority: RCW 70.42.005, 70.42.060 and chapter 70.42 RCW. 00-06-079, § 246-338-080, filed 3/1/00, effective 4/1/00. Statutory Authority: Chapter 70.42 RCW. 93-18-091 (Order 390), § 246-338-080, filed 9/1/93, effective 10/2/93; 91-21-062 (Order 205), § 246-338-080, filed 10/16/91, effective 10/16/91. Statutory Authority: RCW 43.70.040. 91-02-049 (Order 121), recodified as § 246-338-080, filed 12/27/90, effective 1/31/91. Statutory Authority: Chapter 70.42 RCW. 90-20-017 (Order 090), § 248-38-080, filed 9/21/90, effective 10/22/90.]

     (1) The medical test site must have written procedures and policies available in the work area for:

     (a) Analytical methods used by the technical personnel including:

     (i) Principle;

     (ii) Specimen collection and processing procedures;

     (iii) Equipment/reagent/supplies required;

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

     (v) Test methodology;

     (vi) Quality control procedures;

     (vii) Procedures for reporting results (normal, abnormal, and critical values);

     (viii) Reference range;

     (ix) Troubleshooting guidelines - limitations of methodology;

     (x) Calibration procedures; and

     (xi) Pertinent literature references; and

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

     (2) The medical test site must establish written criteria for and maintain appropriate documentation of:

     (a) Temperature-controlled spaces and equipment;

     (b) Preventive maintenance activities;

     (c) Equipment function checks;

     (d) Procedure calibrations; and

     (e) Method/instrument validation procedures.

     (3) The medical test site must maintain documentation of:

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

     (i) Reagents;

     (ii) Solutions;

     (iii) Culture media;

     (iv) Controls;

     (v) Calibrators;

     (vi) Standards;

     (vii) Reference materials; and

     (viii) Other testing materials; and

     (b) Testing of quality control samples.

     (4) For quantitative tests, the medical test site must perform quality control as follows:

     (a) Include two reference materials of different concentrations each day of testing unknown samples, if these reference materials are available; or

     (b) ((Have an equivalent mechanism to assure the quality, accuracy, and precision of the test if reference materials are not available.)) Follow an equivalent quality testing procedure that meets federal CLIA regulations.

     (5) For qualitative tests, the medical test site must perform quality control as follows:

     (a) Use positive and negative reference material each day of testing unknown samples; or

     (b) ((Have an equivalent mechanism to assure the quality, accuracy, and precision of the test if reference materials are not available.)) Follow an equivalent quality testing procedure that meets federal CLIA regulations.

     (6) The medical test site must:

     (a) Use materials within their documented expiration date;

     (b) Not interchange components of kits with different lot numbers, unless specified by the manufacturer;

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

     (d) 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;

     (e) Make reference material limits readily available;

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

     (g) Rotate control material testing among all persons who perform the test;

     (h) Use calibration material from a different lot number than that used to establish a cut-off value or to calibrate the test system, if using calibration material as a control material; and

     (i) Comply with general quality control requirements as described in Table 090-1, unless otherwise specified in subsection (9)(a) through (l) of this section.

     (7) The medical test site must perform, when applicable:

     (a) Calibration and calibration ((checks)) verification for moderate and high complexity testing as described in Table 090-2;

     (b) ((Calibration and calibration verification for high complexity testing as described in Table 090-3;

     (c))) Validation for moderate complexity testing by verifying the following performance characteristics when the medical test site introduces a new procedure classified as moderate complexity:

     (i) Accuracy;

     (ii) Precision; ((and))

     (iii) Reportable range of patient test results; and

     (((d))) (iv) If using the reference range provided by the manufacturer, that it is appropriate for the patient population;

     (c) Validation for high complexity testing:

     (i) When the medical test site introduces a new procedure classified as high complexity;

     (ii) For each method that is developed in-house, is a modification of the manufacturer's test procedure, or is an instrument, kit or test system that has not been cleared by FDA; and

     (iii) By verifying the following performance characteristics:

     (A) Accuracy;

     (B) Precision;

     (C) Analytical sensitivity;

     (D) Analytical specificity to include interfering substances;

     (E) Reference ranges (normal values);

     (F) Reportable range of patient test results; and

     (G) Any other performance characteristic required for test performance.

     (8) When patient values are above the maximum or below the minimum calibration point or the reportable range, the medical test site must:

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

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

Table 090-1 General Quality Control Requirements

((Table 090-2 Calibration and Calibration Checks -- Moderate Complexity Testing

Table 090-((3)) 2 Calibration and Calibration ((Checks)) Verification -- Moderate and High Complexity Testing

     (a) Chemistry.

     Perform quality control procedures for chemistry as described in Table 090-((4)) 3 or follow an equivalent quality testing procedure that meets federal CLIA regulations.

Table 090-((4)) 3 Quality Control Procedures - Chemistry

     (i) Run patient and quality control samples in duplicate for manual cell counts;

     (ii) If reference material is unavailable, document the mechanism used to assure the quality, accuracy, and precision of the test; and

     (iii) Perform quality control procedures for hematology as described in Table 090-((5)) 4 or follow an equivalent quality testing procedure that meets federal CLIA regulations.

Table 090-((5)) 4 Quality Control Procedures -- Hematology

     (i) Run patient and quality control samples in duplicate for manual coagulation test (tilt tube);

     (ii) If reference material is unavailable, document the mechanism used to assure the quality, accuracy, and precision of the test; and

     (iii) Perform quality control procedures for coagulation as described in Table 090-((6)) 5 or follow an equivalent quality testing procedure that meets federal CLIA regulations.

Table 090-((6)) 5 Quality Control Procedures -- Coagulation

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

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

     (iii) Perform quality control procedures for general immunology as described in Table 090-((7)) 6 or follow an equivalent quality testing procedure that meets federal CLIA regulations.

Table 090-((7)) 6 Quality Control Procedures -- General Immunology

     (i) Use equipment, glassware, reagents, controls, and techniques that conform to manufacturer's specifications;

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

     (iii) Perform serologic tests on unknown specimens ((concurrently)) each day of testing with a positive serum reference material with known titer or graded reactivity and a negative reference material.

     (f) Microbiology.

     (i) Have available and use:

     (A) Appropriate stock organisms for quality control purposes; and

     (B) A collection of slides, photographs, gross specimens, or text books for reference sources to aid in identification of microorganisms;

     (ii) Document all steps (reactions) used in the identification of microorganisms on patient specimens;

     (iii) For antimicrobial susceptibility testing:

     (A) Record zone sizes or minimum inhibitory concentration for reference organisms; and

     (B) Zone sizes or minimum inhibitory concentration for reference organisms must be within established limits before reporting patient results; and

     (C) Perform quality control on antimicrobial susceptibility testing media as described in Table 090-((9)) 8;

     (iv) For noncommercial media, check each batch or shipment for sterility, ability to support growth and, if appropriate, selectivity, inhibition, or biochemical response;

     (v) For commercial media:

     (A) Verify that the product insert specifies that the quality control checks meet the requirements for media quality control as outlined by the ((National Committee for Clinical Laboratory Standards ())NCCLS(())), Quality Assurance for Commercially Prepared Microbiological Culture Media-Second Edition; Approved Standard (1996);

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

     (C) Document visual inspection of the media for proper filling of the plate, temperature or shipment damage, and contamination before use; and

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

     (vi) For microbiology subspecialties:

     (A) Bacteriology: Perform quality control procedures for bacteriology as described in Tables 090-((8)) 7 and 090-((9)) 8.

Table 090-((8)) 7 Quality Control Procedures -- Bacteriology

Table 090-((9)) 8 Quality Control Procedures -- Bacteriology - Media for Antimicrobial Susceptibility Testing

Table 090-((10)) 9 Quality Control Procedures -- Mycobacteriology

Table 090-((11)) 10 Quality Control Procedures -- Mycology

     (I) Have available and use:

     • Reference collection of slides or photographs and, if available, gross specimens for parasite identification; and

     • Calibrated ocular micrometer for determining the size of ova and parasites, if size is a critical parameter.

     (II) Check permanent stains each month of use with reference materials.

     (E) Virology:

     (I) Have available:

     • Host systems for isolation of viruses; and

     • Test methods for identification of viruses that cover the entire range of viruses that are etiologically related to the clinical diseases for which services are offered; and

     (II) Simultaneously culture uninoculated cells or cell substrate as a negative control when performing virus identification.

     (g) Histopathology: Include a control slide of known reactivity with each slide or group of slides for differential or special stains and document reactions.

     (h) Cytology.

     (i) Processing specimens:

     (A) Stain all gynecological smears using a Papanicolaou or a modified Papanicolaou staining method;

     (B) Have methods to prevent cross-contamination between gynecologic and nongynecologic specimens during the staining process; and

     (C) Stain nongynecological specimens that have a high potential for cross-contamination separately from other nongynecological specimens, and filter or change the stains following staining.

     (ii) Performing specimen examinations:

     (A) All cytology preparations must be evaluated on the premises of the medical test site;

     (B) Technical personnel must examine, unless federal law and regulation specify otherwise, no more than one hundred cytological slides ((by nonautomated microscopic technique)) (one patient specimen per slide; gynecologic, nongynecologic, or both) in a twenty-four-hour period and in no less than an eight-hour work period;

     (C) Previously examined negative, reactive, reparative, atypical, premalignant or malignant gynecological cases and previously examined nongynecologic cytology preparations and tissue pathology slides examined by a technical supervisor are not included in the one hundred slide limit;

     (D) Each nongynecologic slide preparation ((technique (automated, semi-automated, or liquid based) which)) made using liquid-based slide preparatory techniques that result((s)) in cell dispersion over one-half or less of the total available slide ((area and which is examined by nonautomated microscopic technique must)) may be counted as one-half slide; and

     (E) Records of the total number of slides examined by each individual at all sites during each twenty-four-hour period must be maintained.

     (iii) Establish and implement a quality assurance program that ensures:

     (A) There is criteria for submission of material;

     (B) All providers submitting specimens are informed of these criteria;

     (C) All samples submitted are assessed for adequacy;

     (D) Records of initial examinations and rescreening results are available and documented;

     (E) Rescreening of benign gynecological slides is:

     (I) Performed by an individual who meets the personnel requirements for technical or general supervisor in cytology as defined under 42 CFR Part 493 Subpart M;

     (II) Completed before reporting patient results on those selected cases;

     (III) Performed and documented on:

     • No less than ten percent of the benign gynecological slides; and

     • Includes cases selected at random from the total caseload and from patients or groups of patients that are identified as having a high probability of developing cervical cancer, based on available patient information;

     (F) The technical supervisor:

     (I) Confirms all gynecological smears interpreted to be showing reactive or reparative changes, atypical squamous or glandular cells of undetermined significance, or to be in the premalignant (dysplasia, cervical intraepithelial neoplasia or all squamous intraepithelial neoplasia lesions including human papillomavirus-associated changes) or malignant category;

     (II) Reviews all nongynecological cytological preparations; and

     (III) Establishes, documents, and reassesses, at least every six months, the workload limits for each cytotechnologist;

     (G) All ((abnormal)) cytology reports with a diagnosis of high-grade squamous intraepithelial lesion (HSIL), adenocarcinoma, or other malignant neoplasms are correlated with prior cytology reports and with histopathology reports if available, and the causes of any discrepancies are determined;

     (H) Review of all normal or negative gynecological specimens received within the previous five years, if available in the laboratory system, or records of previous reviews, for each patient with a current high grade intraepithelial lesion or moderate dysplasia of CIN-2 or above;

     (I) Notification of the patient's physician if significant discrepancies are found that would affect patient care and issuance of an amended report;

     (J) 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; and

     (K) Evaluation and documentation of the performance of each individual examining slides against the medical test site's overall statistical values, with documentation of any discrepancies, including reasons for the deviation and corrective action, if appropriate.

     (i) Immunohematology/transfusion services.

     (i) Perform ABO grouping, Rh (D) typing, antibody detection and identification, and compatibility testing as described by the Food and Drug Administration (FDA) under 21 CFR Parts 606((,)) and ((must also comply with 21 CFR Part)) 640.

     (A) Perform ABO grouping:

     (I) By concurrently testing unknown red cells with FDA approved anti-A and anti-B grouping sera;

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

     (B) Perform Rh (D) typing by testing unknown red cells with anti-D (anti-Rh) blood grouping serum; and

     (C) Perform quality control procedures for immunohematology as described in Table 090-((12)) 11.

     (ii) Blood and blood products:

     (A) Collecting, processing, and distributing:

     (I) Must comply with FDA requirements listed under 21 CFR Parts 606, 610.40, 610.53, and 640; and

     (II) Must establish, document, and follow policies to ensure positive identification of a blood or blood product recipient.

     (B) Labeling and dating must comply with FDA requirements listed under 21 CFR 606((,)) Subpart G, and 610.53.

     (C) Storing:

     (I) There must be an adequate temperature alarm system that is regularly inspected.

     (II) The system must have an audible alarm system that monitors proper blood and blood product storage temperature over a twenty-four-hour period.

     (III) High and low temperature checks of the alarm system must be documented.

     (D) Collection of heterologous or autologous blood products on-site:

     (I) Must register with the FDA; and

     (II) Have a current copy of the form FDA 2830 "Blood Establishment Registration and Product Listing."

     (iii) Must have an agreement approved by the director for procurement, transfer, and availability to receive products from outside entities.

     (iv) Promptly investigate transfusion reactions according to established procedures, and take any necessary remedial action.

Table 090-((12)) 11 Quality Control Procedures -- Immunohematology

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

     (ii) Meet the standards for histocompatibility as listed in 42 CFR Part((493.1265, Condition)) 493.1278, Standard: Histocompatibility, available from the department upon request.

     (k) Cytogenetics.

     (i) Document:

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

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

     (C) Media used;

     (D) Reactions observed;

     (E) Quality of banding; and

     (((E))) (F) Sufficient resolution ((to support the reported results)) appropriate for the type of tissue or specimen and the type of study required based on the clinical information provided;

     (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; and

     (iv) Perform ((confirmatory testing on all atypical results when performing)) full chromosome analysis for determination of sex ((by X and Y chromatin counts)).

     (l) 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 chapters 246-220, 246-221, 246-222, 246-232, 246-233, 246-235, 246-239, 246-247, 246-249, and 246-254 WAC.

[Statutory Authority: RCW 70.42.005, 70.42.060. 01-02-069, § 246-338-090, filed 12/29/00, effective 1/29/01. Statutory Authority: RCW 70.42.005, 70.42.060 and chapter 70.42 RCW. 00-06-079, § 246-338-090, filed 3/1/00, effective 4/1/00. Statutory Authority: RCW 70.42.005. 97-14-113, § 246-338-090, filed 7/2/97, effective 8/2/97. 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.]

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