WSR 00-03-073

PROPOSED RULES

DEPARTMENT OF HEALTH


[ Filed January 19, 2000, 9:50 a.m. ]

Original Notice.

Preproposal statement of inquiry was filed as WSR 98-17-100.

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

Purpose: The proposed changes are to improve the organization, clarify the wording, and update references in the rule. There is only one substantive change in the requirements for medical test sites, which is an increase in the acceptable passing score for HIV proficiency testing from 80% to 100%.

Statutory Authority for Adoption: RCW 70.42.005, 70.42.060.

Statute Being Implemented: Chapter 70.42 RCW.

Summary: Proposed changes to chapter 246-338 WAC include reorganization and rewriting of requirements for clarity and ease of use for licensees and updating references.

Reasons Supporting Proposal: The proposed changes will improve the organization and readability of the rules, making it easier for licensees to locate information and understand the requirements for medical test sites. The proposed change in the acceptable passing score for HIV proficiency testing will ensure that HIV testing procedures are monitored for the highest level of accuracy.

Name of Agency Personnel Responsible for Drafting and Implementation: Gail Neuenschwander, 1610 N.E. 150th Street, Seattle, 98155-9701, (206) 361-2805; and Enforcement: Gary Bennett, 2725 Harrison Avenue, Olympia, 98504-7852, (360) 705-6652.

Name of Proponent: Washington State 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 that perform clinical laboratory testing in the state. The state law was passed to take the place of federal regulation (CLIA). The proposed changes will continue to meet the federal regulations and will improve the organization of the rule and clarify the requirements for the licensees. Tables have been added to the rule to increase the ease of locating specific requirements. The increase in the acceptable passing score for HIV testing from 80% to 100% will ensure that HIV testing procedures are monitored for the highest level of accuracy.

Proposal Changes the Following Existing Rules: The proposed changes amend all sections of the existing chapter 246-338 WAC. The changes improve the organization of the chapter by clearly indicating how to apply for a license; how to renew a license; and what are the requirements for each type of license. Tables are used to assist licensees in finding specific information.

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.

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

Hearing Location: Department of Health, Target Plaza, Training Room, 2725 Harrison Avenue N.W., Suite 500, Olympia, WA 98502, on February 22, 2000, at 10:00 a.m.

Assistance for Persons with Disabilities: Contact Theresa Phillips, by January 25, 2000, TDD (800) 833-6388, or (360) 705-6652.

Submit Written Comments to: Gail Neuenschwander, Office of Laboratory Quality Assurance, 1610 N.E. 150th Street, Shoreline, WA 98155, or e-mail gail.neueschwander@doh.wa.gov, fax (206) 361-2813, by February 21, 2000.

Date of Intended Adoption: February 25, 2000.

January 18, 2000

M. C. Selecky

Secretary

OTS-3588.2


AMENDATORY SECTION(Amending Order 121, filed 12/27/90, effective 1/31/91)

WAC 246-338-001
Purpose.

The purpose of this chapter is to implement chapter 70.42 RCW, by establishing ((minimum)) licensing standards for medical test sites, consistent with federal law and regulation, related to quality control, quality assurance, ((recordkeeping)) records, personnel requirements, proficiency testing, and licensure waivers.

[Statutory Authority: RCW 43.70.040. 91-02-049 (Order 121), recodified as 246-338-001, filed 12/27/90, effective 1/31/91. Statutory Authority: Chapter 70.42 RCW. 90-20-017 (Order 090), 248-38-001, filed 9/21/90, effective 10/22/90.]


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

WAC 246-338-010
Definitions.

For the purposes of ((chapter 70.42 RCW and)) this chapter, the following words and phrases have these meanings unless the context clearly indicates otherwise.

(1) "Accreditation ((body)) organization" means a public or private organization or agency ((which accredits, certifies, or licenses medical test sites, by establishing and monitoring standards judged by the department to be)) approved by HCFA 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 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.

(((4) "Certificate of waiver" means a medical test site performing one or more of the tests listed under WAC 246-338-030(11), and no other tests.

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

(9) "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.

(10) "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) "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) "Days" means calendar days.

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

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

(((7) "Designated test site supervisor")) (16) "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) "Director," defined as the designated test site supervisor in RCW 70.42.010, means the ((available)) individual responsible for the technical functions of the medical test site ((and meeting)). This person must meet the qualifications for Laboratory Director, listed in 42 CFR Part 493 Subpart M - Personnel for Moderate and High Complexity Testing.

(((8))) (18) "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.

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

(((10) "Federal law and regulation" 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.

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

(((12) "Licensed test" means all tests categorized as provider-performed microscopic procedures or moderate or high complexity tests consistent with federal law and regulation and not specifically listed as waived under WAC 246-338-030(11), or defined as forensic under subsection (11) of this section.

(13) "Limited public health testing" means a combination of fifteen or less waived tests, as listed under WAC 246-338-030(11), or tests of moderate complexity, as defined under subsection (12) of this section;

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

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

(23) "May" means permissive or discretionary ((on the part of the department)).

(((15))) (24) "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.

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

(26) "Must" means compliance is mandatory.

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

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

(b) High complexity tests.

(28) "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.

(((17))) (29) "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.

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

(((19))) (31) "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.

(((20))) (32) "Provider-performed microscopic procedures" means only those moderate complexity tests listed under WAC 246-338-020 (2)(b)(i) through (((xix))) (x), when the tests are performed in conjunction with a patient's visit by a licensed professional meeting ((one or more of the following)) qualifications((:

(a) Physician licensed under chapter 18.71 RCW, Physicians; chapter 18.57 RCW, Osteopathy -- Osteopathic medicine and surgery; or chapter 18.22 RCW, Podiatric medicine and surgery;

(b) Advanced registered nurse practitioner, licensed under chapter 18.88 RCW, Registered nurses;

(c) Midwife licensed under chapter 18.50 RCW, Midwifery;

(d) Physician assistant licensed under chapter 18.71A RCW, Physician assistants; or

(e) Naturopath licensed under chapter 18.36A RCW, Naturopathy)) specified in WAC 246-338-020 (2)(a)(i) through (vi).

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

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

(((23) "Shall" means compliance is mandatory.

(24))) (35) "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) "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.

(((25))) (37) "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) "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, toxicology, and other chemistry;

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

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

(d) Hematology, the subspecialties are routine hematology, 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.

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

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

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

(42) "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) "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) "Will" means compliance is mandatory.

[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.]


AMENDATORY SECTION(Amending WSR 97-14-113, filed 7/2/97, effective 8/2/97)

WAC 246-338-020
Licensure--Types of ((the)) medical test site((s)) licenses.

(((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:

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

(B) Potassium hydroxide (KOH) preparations;

(C) Pinworm examinations;

(D) Fern tests;

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

(F) Urine sediment examinations;

(G) Nasal smears for eosinophils;

(H) Post vasectomy qualitative semen analysis; and

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

(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.)) After July 1, 1990, any person advertising, operating, managing, owning, conducting, opening, or maintaining a medical test site must first obtain a license from the department. License types are described in Table 020-1.

(1) Certificate of waiver.

Applicable if the medical test site performs only the tests classified as waived.

(2) Provider performed microscopic procedures (PPMP).

Applicable if the medical test site restricts its testing performance to one or more of the following moderate complexity tests performed by one of the licensed professionals listed, in conjunction with a patient's visit. In addition, the medical test site can perform tests classified as waived with this type of license.

(a) PPMP may be performed only by one of the following licensed professionals:

(i) Physician licensed under chapter 18.71 RCW, Physicians; chapter 18.57 RCW, Osteopathy--Osteopathic medicine and surgery; or chapter 18.22 RCW, Podiatric medicine and surgery;

(ii) Advanced registered nurse practitioner, licensed under chapter 18.79 RCW, Nursing care;

(iii) Midwife licensed under chapter 18.50 RCW, Midwifery;

(iv) Physician assistant licensed under chapter 18.71A RCW, Physician assistants;

(v) Naturopath licensed under chapter 18.36A RCW, Naturopathy; or

(vi) Dentist licensed under chapter 18.32 RCW, Dentists.

(b) Microscopic procedures authorized under a PPMP license are:

(i) All direct wet mount preparations for the presence or absence of bacteria, fungi, parasites, and human cellular elements;

(ii) All potassium hydroxide (KOH) preparations;

(iii) Pinworm examinations;

(iv) Fern tests;

(v) Postcoital direct, qualitative examinations of vaginal or cervical mucous;

(vi) Urine sediment examinations;

(vii) Nasal smears for granulocytes;

(viii) Fecal leukocyte examinations;

(ix) Qualitative semen analysis (limited to the presence or absence of sperm and detection of motility); and

(x) Any other tests subsequently categorized under CLIA as provider-performed microscopy procedures.

(3) Moderate/high complexity.

(a) Limited testing, low volume, Category A-J, as described in Table 990-1.

Applicable if the medical test site performs any tests that are not classified as waived or qualified as PPMP under subsection (2) of this section. Under this type of license, the medical test site may also perform tests classified as waived.

(b) Accredited.

Applicable if the medical test site performs any tests that are not classified as waived, and is accredited and inspected by an accreditation organization approved by the department under WAC 246-338-040. Under this type of license, the medical test site may also perform tests classified as waived.

020-1 Table of Requirements for Each License Type

LICENSE TYPE REQUIREMENTS INSPECTIONS
TYPE FREQUENCY
(1) Certificate of Waiver

Restrict testing to tests classified as waived.

Meet the requirements of WAC 246-338-020 Licensure--Types of Medical Test Site Licenses; WAC 246-338-022 Initial Application for Medical Test Site License; WAC 246-338-024 License Renewal/Reapplication Process; WAC 246-338-026 Notification Requirements; WAC 246-338-028 On-site Inspections.

Follow manufacturers' instructions for performing the test.

Complaint

Technical assistance

When indicated
(2) PPMP

Restrict testing to tests classified as PPMP or waived.

Meet the requirements of WAC 246-338-020 Licensure--Types of Medical Test Site Licenses; WAC 246-338-022 Initial Application for Medical Test Site License; WAC 246-338-024 License Renewal/Reapplication Process; WAC 246-338-026 Notification Requirements; WAC 246-338-028 On-site Inspections; WAC 246-338-050 Proficiency Testing (if applicable); WAC 246-338-060 Personnel; WAC 246-338-070 Records; WAC 246-338-080 Quality Assurance; WAC 246-338-090 Quality Control.

Follow manufacturers' instructions for performing the test.

Complaint

Technical assistance

When indicated
(3) Moderate/High Complexity
(a) Limited Testing, Low Volume, Category A-J

Perform tests classified as moderate or high complexity.

Meet the requirements of WAC 246-338-020 Licensure--Types of Medical Test Site Licenses; WAC 246-338-022 Initial Application for Medical Test Site License; WAC 246-338-024 License Renewal/Reapplication Process; WAC 246-338-026 Notification Requirements; WAC 246-338-028 On-site Inspections; WAC 246-338-050 Proficiency Testing (if applicable); WAC 246-338-060 Personnel; WAC 246-338-070 Records; WAC 246-338-080 Quality Assurance; WAC 246-338-090 Quality Control.

Follow manufacturers' instructions for performing test.

Initial

Routine

Complaint

On-site follow-up

Technical assistance

First 6 months of license

Every 2 years

When indicated

When indicated

When indicated

(b) Accredited

Perform tests classified as moderate or high complexity.

Meet the requirements of WAC 246-338-020 Licensure--Types of Medical Test Site Licenses; WAC 246-338-022 Initial Application for Medical Test Site License; WAC 246-338-024 License Renewal/Reapplication Process; WAC 246-338-026 Notification Requirements; WAC 246-338-028 On-site Inspections; WAC 246-338-050 Proficiency Testing (if applicable); WAC 246-338-060 Personnel; WAC 246-338-070 Records; WAC 246-338-080 Quality Assurance; WAC 246-338-090 Quality Control.

Follow manufacturers' instructions for performing the test.

Submit to the department upon request, or authorize the accreditation organization to submit:

Proof of accreditation;

On-site inspection results;

Statement of deficiencies;

Plan of correction for the deficiencies cited;

Any disciplinary action and results of any disciplinary action taken by the accreditation organization against the medical test site.

Validation

Complaint

On-site follow-up

Technical assistance

2.5 % of accredited sites annually

When indicated

When indicated

When indicated

[Statutory Authority: RCW 70.42.005. 97-14-113, 246-338-020, filed 7/2/97, effective 8/2/97. 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.]


NEW SECTION
WAC 246-338-022
Initial application for medical test site license.

(1) Application procedure.

Applicants requesting a medical test site license must:

(a) Submit a completed application on forms furnished by the department, signed by the owner or authorized representative;

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

(i) If the 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 and performs a combination of fifteen or less of either waived or moderate complexity test procedures at different locations, the owner may file an application for a single license;

(c) Furnish full and complete information to the department in writing:

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

(ii) Name of owner;

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

(iv) Name and qualifications including educational background, training, and experience of the director;

(v) Names and qualifications including educational background, training, and experience of technical personnel, if requested by the department;

(vi) Name of proficiency testing program or programs used by the medical test site and a copy of the enrollment confirmation form, if applicable;

(vii) Methodologies for tests performed, if requested by the department; and

(viii) Other information as requested by the department;

(d) Submit the designated fee in the time period indicated, upon receipt of a fee statement from the department;

(e) If applying for an accredited license, submit proof of accreditation by an approved accreditation organization. If application has been made to an accreditation organization, submit a copy of the application, followed by proof of accreditation within eleven months of issuance of the medical test site license.

(2) Issuing an initial license.

(a) An initial license will be issued for a medical test site when the applicant:

(i) Submits a completed application and any information requested by the department;

(ii) Pays the designated license fee; and

(iii) Meets the requirements of chapter 70.42 RCW and this chapter.

(b) License expiration dates will be based on a two-year licensure cycle, expiring on October 31st of even-numbered years. The license period for an initial license begins the day of the month that payment is received and expires on October 31st of the current or next even-numbered year.

(c) The department may issue a provisional license valid for a period of up to two years when a medical test site applies for licensure for the first time.

(d) The department will terminate a provisional license at the time a two-year license for the medical test site is issued.

(e) License fees are listed under WAC 246-338-990.

[]


NEW SECTION
WAC 246-338-024
License renewal/reapplication process.

(1) The department will issue a renewal license for a medical test site when the owner:

(a) At least thirty days prior to the expiration date of the current license, submits a completed renewal application form, available from the department, in compliance with WAC 246-338-022(1) and submits the designated fee; and

(b) Meets the requirements of chapter 70.42 RCW and this chapter.

(2) A license is issued for a period of two years. License expiration dates are based on a two-year cycle, expiring on October 31st of even-numbered years.

(3) The department may extend a license for a period not to exceed six months beyond the expiration date of the license.

(4) The department will require the owner of the medical test site to reapply for a license if proof of accreditation is not supplied to the department within eleven months of issuance of an accredited license.

(5) The owner or applicant of a medical test site must reapply for licensure within thirty days, if the acceptance of approval of the accreditation body for the medical test site is denied or terminated.

(6) If at any time any of the changes listed in WAC 246-338-026 occur, the medical test site may require a different type of license than what the medical test site currently holds. If so, the owner must submit a reapplication form, within thirty days of the change, and pay applicable fees.

[]


NEW SECTION
WAC 246-338-026
Notification requirements.

(1) The owner must notify the department in writing at least thirty days prior to the date of opening or closing the medical test site.

(2) The owner must notify the department in writing within thirty days of any changes in:

(a) Name of site;

(b) Director;

(c) Location of site;

(d) Tests, specialties, and subspecialties; and

(e) Test methodologies.

(3) Proposed change of ownership. Transfer or reassignment of a license is prohibited without the department's approval, and must be initiated by the current owner sending a written notice to the department thirty days prior to transfer.

(a) The current owner of a medical test site must notify the department, in writing at least thirty days prior to the change and provide the following information:

(i) Name, address, and federal tax ID number of the medical test site;

(ii) Full name, address, and location of the current owner and prospective new owner; and

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

(b) The prospective new owner must submit the following information at least thirty days prior to the change of ownership:

(i) New name and federal tax ID number of the medical test site;

(ii) Changes in technical personnel and supervisors;

(iii) Any changes in tests, specialties, and subspecialties; and

(iv) Other information as requested by the department.

(4) The medical test site must authorize an approved accreditation organization to notify the department of the test site's compliance with the standards of the accreditation organization.

(5) The owner of an accredited license must notify the department in writing within thirty days of the medical test site having its accreditation denied or terminated by the accreditation organization or voluntarily dropping its accreditation status.

(6) The owner must notify the department in writing within thirty days of any convictions of fraud and abuse, false billing, or kickbacks under state or federal law.

[]


NEW SECTION
WAC 246-338-028
On-site inspections.

(1) The department may conduct an on-site review of a licensee or applicant at any time to determine compliance with chapter 70.42 RCW and this chapter as described in Table 020-1.

(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 or HCFA 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 to HCFA or HCFA 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 required for the department to determine whether or not standards are consistent with chapter 70.42 RCW and this chapter.

[]


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

WAC 246-338-040
Approval of accreditation ((bodies)) organizations.

(1) The department ((shall, under RCW 70.42.040,)) will recognize the accreditation ((bodies)) organizations granted deemed status by HCFA.

(2) ((The department, upon request, shall furnish a list of the deemed accreditation bodies.

(3) The department shall:

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

(b) Require the accreditation bodies to agree in writing to:

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

(ii) Notify the department within thirty days of any medical test that has had its accreditation withdrawn, revoked or limited.

(4) The department may deny or terminate the license for a medical test site, if the owner or applicant fails to authorize the accreditation body to notify the department of the test site's compliance with the standards of the accreditation body.

(5) The department shall notify the medical test site if an accreditation body loses department acceptance of approval as an accreditation body for the medical test site.

(6) The owner or applicant of a medical test site shall reapply for licensure within thirty days, if the acceptance of approval of the accreditation body for the medical test site is denied or terminated.)) The HCFA-approved accreditation organizations are:

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

(b) American Osteopathic Association (AOA);

(c) American Society of Histocompatability 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; and

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

[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.]


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

WAC 246-338-050
Proficiency testing.

(1) All licensed medical test sites, excluding those granted a certificate of waiver, ((shall)) must:

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

(b) Submit to the department((, by December 31 of each year,)) 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 ((shall)) will:

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

(b) Furnish, upon request:

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

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

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

(3) The department ((shall)) will evaluate proficiency testing results by using the following ((grading)) 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((o))) typing; ((and))

(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((;

(d) Unsuccessful participation occurs when a grade of unsatisfactory performance is obtained on a single test or in a specialty or subspecialty on two of any three successive testing events)).

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

(a) The department ((shall)) will mail a letter to the ((designated test site supervisor)) 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 ((shall)) 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) ((After completing a directed plan of correction, if a medical test site has)) 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 ((will occur)):

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

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

[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.]


AMENDATORY SECTION(Amending WSR 97-14-113, filed 7/2/97, effective 8/2/97)

WAC 246-338-060
Personnel.

(1) ((Owners shall ensure)) Medical test site((s)) owners must:

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

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

(ii) Performing)) including oversight of the performance of test procedures and reporting of ((testing procedures)) 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 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((, upon request, shall)) will furnish a copy of 42 CFR Part 493 Subpart M upon request.

(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)) Medical test site ((supervisors shall)) 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 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)) director to an on-site technical person during testing.

[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.]


AMENDATORY SECTION(Amending WSR 97-14-113, filed 7/2/97, effective 8/2/97)

WAC 246-338-070
((Recordkeeping.)) Records.

((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;

(d) Quality control records;

(e) Quality assurance records; and

(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 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;

(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.)) Medical test sites must maintain records as described in this section.

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

(a) Patient name, identification number, 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 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.

(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 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 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) Date reported;

(ii) Time reported, if appropriate;

(iii) Any information regarding specimen rejection or limitation; and

(iv) 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 Bethesda system of terminology as published in the Journal of the American Medical Association, 1989, Volume 262, pages 931-934; 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 initial of the technical supervisor or an electronic signature authorized by the technical supervisor on all reports.

(6) CYTOGENETICS REPORTS must:

(a) Use appropriate nomenclature on final reports;

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

(c) Include an interpretation of the karyotypes findings.

(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.

Table 070-1 Record/Slide/Tissue Retention Schedule

Two Years Five Years Ten Years
(a) General Requirements for all Laboratory Specialties Test requisitions or equivalent;
Test records;
Test reports;
Quality control records;
Quality assurance records;
Proficiency testing records;
Hard copy of report, or ability to reproduce a copy, for all specimens referred for testing; and
Discontinued procedures for all specialty areas
(b) Transfusion Services* Test requisitions or equivalent;
Test records;
Test reports;
Quality control records; and
Quality assurance records
(c) Cytology All cytology slides, from date of examination of the slide All cytology reports
(d) Histopathology Specimen blocks, from date of examination

All histopathology reports; and

Stained slides, from date of examination of the slide

(e) Histopathology-Tissues Retain remnants of tissue specimens in an appropriate preserved state until the portions submitted for microscopic examination have been examined and diagnosed
(f) Instrument/method Validation Studies For life of instrument/method plus two years

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

[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.]


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

WAC 246-338-080
Quality assurance.

Each medical test site performing moderate complexity (including PPMP) or high complexity testing, or any combination of these tests, must establish and follow written policies and procedures for a comprehensive quality assurance program. The quality assurance program must be designed to monitor and evaluate the ongoing and overall quality of the total testing process (preanalytic, analytic, postanalytic). The medical test site's quality assurance program must evaluate the effectiveness of its policies and procedures; identify and correct problems; assure the accurate, reliable, and prompt reporting of test results; and assure the adequacy and competency of the staff. As necessary, the medical test site must revise policies and procedures based upon the results of those evaluations. The medical test site must meet the standards as they apply to the services offered, complexity of testing performed and test results reported, and the unique practices of each testing entity. All quality assurance activities must be documented.

(1) The medical test site ((shall)) 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 ((data)) results, and test results, including biannual ((evaluation)) verification of:

(i) Accuracy of test results for tests that are not covered by proficiency testing; 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.

(2) The quality assurance plan ((shall)) 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) ((Make available)) Issue corrected reports when indicated;

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

(((g) Make available to)) (h) 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) 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) The owner ((shall)) must:

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

(((4) The medical test site shall)) (b) Establish, post, and observe safety precautions to ensure protection from physical, chemical, biochemical, and electrical hazards and biohazards; and

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

(6) 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) 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.

[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.]


AMENDATORY SECTION(Amending WSR 97-14-113, filed 7/2/97, effective 8/2/97)

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 Rho, Rho (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:

(i) When recommended by the manufacturer or 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:

(A) To 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; and

(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 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

(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:

(I) Instrumentation methods; and

(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 Rho(D) group by testing unknown red cells with anti-D (anti Rho) 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, Rho (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;

(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;

(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;

(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

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

(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.

(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.

(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) 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 for moderate 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;

(d) 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

Control Material Frequency
(a) Each batch or shipment of reagents, discs, antisera, and identification systems Appropriate control materials for positive and negative reactivity When prepared or opened, unless otherwise specified
(b) Each batch or shipment of stains Appropriate control materials for positive and negative reactivity

When prepared or opened; and

Each day of use, unless otherwise specified

(c) Fluorescent stains Appropriate control materials for positive and negative reactivity Each time of use, unless otherwise specified
(d) Quality control for each specialty and subspecialty

Appropriate control materials; or

Equivalent mechanism to assure the quality, accuracy, and precision of the test if reference materials are not available

At least as frequently as specified in this section;

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

More frequently if specified by the medical test site

(e) Direct antigen detection systems without procedural controls Positive and negative controls that evaluate both the extraction and reaction phase

Each batch, shipment, and new lot number; and

Each day use

Table 090-2 Moderate Complexity Testing

Calibration Material Frequency
CALIBRATION Calibration material appropriate for methodology according to manufacturer's instructions

Initial on-site installation/implementation of instrument/method;

At the frequency recommended by the manufacturer;

When controls show trends, shifts, or are out of limits and other corrective action has not fixed the problem.

CHECK CALIBRATION Assayed material appropriate for methodology At least every six months.

Table 090-3 High Complexity Testing

Calibration Material Frequency
CALIBRATION Calibration materials appropriate for methodology

Initial on-site installation/implementation of instrument/method;

At the frequency recommended by the manufacturer; and

Whenever calibration verification fails to meet the medical test site's acceptable limits for calibration verification.

CALIBRATION VERIFICATION

Use assayed material, if available, at the lower, mid-point, and upper limits of procedure's reportable range; or

Demonstrate alternate method of assuring accuracy at the lower, mid-point, and upper limits of procedure's reportable range

At least every six months;

When there is a complete change of reagents (i.e., new lot number or different manufacturer) is introduced;

When major preventive maintenance is performed or there is a replacement of critical parts of equipment; or

When controls are outside of the medical test site's acceptable limits or exhibit trends.


(9) The medical test site must perform quality control procedures as described for each specialty and subspecialty in (a) through (l) of this subsection.

(a) Chemistry.

Perform quality control procedures for chemistry as described in Table 090-4.

Table 090-4 Quality Control Procedures - Chemistry

Subspecialty/Test Qualitative Quantitative
Control Material Frequency Control Material Frequency
Routine Chemistry Positive and negative reference material Each day of use Two levels of reference material in different concentrations Each day of use
Toxicology


GC/MS for drug screening


Urine drug screen


Analyte-specific control


Positive control containing at least one drug representative of each drug class to be reported; must go through each phase of use including extraction


With each run of patient specimens


With each run of patient specimens

Analyte-specific control With each analytical run
Urinalysis


Nonwaived instrument


Refractometer for specific gravity


Two levels of control material


Calibrate to zero with distilled water

One level of control material


Each day of use


Each day of use

Blood Gas Analysis



Two-point calibration and one reference material

One-point calibration or one reference material, or


Another calibration and reference material schedule, approved by the department


Each eight hours of testing


Each time patient sample is tested, unless automated instrument internally verifies calibration every thirty minutes

Electrophoresis One control containing fractions representative of those routinely reported in patient specimens In each electrophoretic cell One control containing fractions representative of those routinely reported in patient specimens In each electrophoretic cell

(b) Hematology.

(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.

Table 090-5 Hematology

Control Material Frequency
Automated Two levels of reference material in different concentrations Every eight hours that patient samples are tested
Manual Blood Counts One level of reference material Every eight hours that patient samples are tested
Qualitative Tests Positive and negative reference material Each day of testing

(c) Coagulation.

(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.

Table 090-6 Coagulation

Control Material Frequency
Automated Two levels of reference material in different concentrations

Every eight hours that patient samples are tested; and

Each time reagents are changed

Manual Tilt Tube Method Two levels of reference material in different concentrations

Every eight hours that patient samples are tested; and

Each time reagents are changed


(d) General immunology.

(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.

Table 090-7 General Immunology

Control Material Frequency
Serologic tests on unknown specimens Positive and negative reference material Each day of testing
Moderate complexity kits with procedural (internal) controls


Positive and negative reference material (external controls)


Procedural (internal) controls


When kit is opened


Each time patient sample is tested


(e) Syphilis serology.

(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 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 test 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;

(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 and 090-9.

Table 090-8 Bacteriology

Control Material Frequency
Reagents, disks, and identification systems Positive and negative reference organisms, unless otherwise specified Each batch, shipment, and new lot number unless otherwise specified
Stains, unless otherwise specified; DNA probes; catalase; coagulase; beta-lactamase; and oxidase reagents Positive and negative reference organisms

Each batch, shipment, and new lot number; and

Each day of use

Fluorescent stains Positive and negative reference organisms

Each batch, shipment, and new lot number; and

Each time of use

Gram and acid-fast stains, bacitracin, optochin, ONPG, X and V disks or strips Positive and negative reference organisms

Each batch, shipment, and new lot number; and

Each week of use

Direct antigen detection systems without procedural controls Positive and negative controls that evaluate both the extraction and reaction phase

Each batch, shipment, and new lot number; and

Each day of use

Moderate complexity test kits with procedural (internal) controls

Positive and negative reference material (external) controls

Procedural (internal) controls

Each batch, shipment, and new lot number

Each time patient sample is tested

Antisera Positive and negative reference material

Each batch, shipment, and new lot number; and

Each month of use

Table 090-9 Bacteriology - Media for Antimicrobial Susceptibility Testing

Control Material Frequency
Check each new batch of media and each new lot of antimicrobial disks or other testing systems (MIC) Approved reference organisms (ATCC organisms)

Before initial use and each day of testing; or

May be done weekly if the medical test site can meet the quality control requirements for antimicrobial disk susceptibility testing as outlined by Performance Standards for Antimicrobial Disk susceptibility Tests-Sixth Edition; Approved Standard (1997).


(B) Mycobacteriology: Perform quality control procedures for mycobacteriology as described in Table 090-10.

Table 090-10 Mycobacteriology

Control Material Frequency
Iron uptake test Acid-fast organism that produces a positive reaction and with an organism that produces a negative reaction Each day of use
All other reagents or test procedures used for mycobacteria identification unless otherwise specified Acid-fast organism that produces a positive reaction Each day of use
DNA probes Organisms that produce positive and negative reactions Each day of use
Acid-fast stains Acid-fast organism that produces a positive reaction Each week of use
Fluorochrome acid-fast stains Organisms that produce positive and negative reactivity Each week of use
Susceptibility test performed on Mycobacterium tuberculosis isolates Strain of M. tb susceptible to all antimycobacterial agents used Each week of use

(C) Mycology: Perform quality control procedures for mycology as described in Table 090-11.

Table 090-11 Mycology

Control Material Frequency
Auxanographic medium for nitrate assimilation: Nitrate reagent Peptone control Each day of use
Susceptibility tests: Each drug

NOTE: Establish control limits and criteria for acceptable control results prior to reporting patient results

One control strain that is susceptible to the drug Each day of use
Acid-fast stains Organisms that produce positive and negative reactions Each week of use
Reagents for biochemical and other identification test procedures Organism that produces a positive reaction Each week of use
Commercial identification systems utilizing two or more substrates Organisms that verify positive and negative reactivity of each media type Each batch or shipment and each lot number

(D) Parasitology:

(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 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 slide preparation technique (automated, semi-automated, or liquid based) which results in cell dispersion over one-half or less of the total available slide area and which is examined by nonautomated microscopic technique must 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;

(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

One hundred percent of all slides from patients with a known history of cervical cancer or its precursors;

(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 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 under 21 CFR Part 606, and must also comply with 21 CFR Part 640.

(A) Perform ABO grouping:

(I) By concurrently testing unknown red cells with 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;

(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.

(ii) Blood and blood products:

(A) Collecting, processing, and distributing:

(I) Must comply with FDA requirements listed under 21 CFR Parts 606, 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 Food and Drug Administration; 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 Immunohematology

Reagent Control Material Frequency
ABO antisera Positive control Each day of use
Rh antisera

Positive and negative controls

Patient control to detect false positive Rh test results

Each day of use

When required by the manufacturer

Other antisera Positive and negative controls Each day of use
ABO reagent red cells Positive control Each day of use
Antibody screening cells Positive control using at least one known antibody Each day of use

(j) Histocompatibility.

(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: 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) 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; and

(iv) Perform confirmatory testing on all atypical results when performing 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. 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.]


AMENDATORY SECTION(Amending WSR 97-14-113, filed 7/2/97, effective 8/2/97)

WAC 246-338-100
Disciplinary action.

(1) Pursuant to chapter 34.05 RCW, 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)) deny a license to any applicant, or condition, suspend, or revoke the license of any licensee, or in addition to or in lieu thereof, assess monetary penalties of up to ten thousand dollars per violation, if the applicant or licensee:

(a) ((Failure or refusal)) Fails or refuses 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)) makes 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)) Refuses to allow representatives of the department to examine any book, record, or file required under this chapter;

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

(e) ((Misrepresented or was)) Misrepresents or is 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 department may impose the sanctions enumerated in subsection (1) of this section individually or in any combination.

(3) The sanction shall be as specified for ((that)) the following described conduct. If more than one sanction is listed, the department may impose 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.

(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)) will 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.))

[Statutory Authority: RCW 70.42.005. 97-14-113, 246-338-100, filed 7/2/97, effective 8/2/97. Statutory Authority: Chapter 70.42 RCW. 93-18-091 (Order 390), 246-338-100, filed 9/1/93, effective 10/2/93. Statutory Authority: RCW 43.70.040. 91-02-049 (Order 121), recodified as 246-338-100, filed 12/27/90, effective 1/31/91. Statutory Authority: Chapter 70.42 RCW. 90-20-017 (Order 090), 248-38-100, filed 9/21/90, effective 10/22/90.]


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

WAC 246-338-110
Adjudicative proceedings.

(1) A licensee or applicant ((contesting)) who contests a disciplinary action shall, within twenty-eight days of service of the notice of disciplinary action, file ((an application of)) a request for adjudicative proceeding with the Department of Health, ((Office of Professional Standards, 2413 Pacific Avenue)) Adjudicative Clerk, P.O. Box ((47872)) 47879, Olympia, WA 98504-((7872))7879.

(2) The adjudicative proceeding is governed by chapter 34.05 RCW, the Administrative Procedure Act, chapter 70.42 RCW, Medical test sites, this chapter, and chapter 246-10 WAC.

(3) Any licensee or applicant aggrieved upon issuance of the decision after the ((conduct of an)) adjudicative proceeding may, within sixty days of service of the adjudicative proceeding decision, petition the superior court for review of the decision under chapter 34.05 RCW.

[Statutory Authority: Chapter 70.42 RCW. 93-18-091 (Order 390), 246-338-110, filed 9/1/93, effective 10/2/93; 91-21-062 (Order 205), 246-338-110, filed 10/16/91, effective 10/16/91. Statutory Authority: RCW 43.70.040. 91-02-049 (Order 121), recodified as 246-338-110, filed 12/27/90, effective 1/31/91. Statutory Authority: Chapter 70.42 RCW. 90-20-017 (Order 090), 248-38-110, filed 9/21/90, effective 10/22/90.]


REPEALER

     The following section of the Washington Administrative Code is repealed:
WAC 246-338-030 Waiver from licensure of medical test sites.

Washington State Code Reviser's Office