WSR 00-19-084

EXPEDITED ADOPTION

DEPARTMENT OF HEALTH


[ Filed September 20, 2000, 9:23 a.m. ]

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

Purpose: The proposed changes correct typographical errors, word omissions, and clarify language without changing any of the requirements.

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 correction of typographical errors, word omissions, and language changes for clarity and consistency.

Reasons Supporting Proposal: The proposed changes will not change the requirements or the effect of the rule.

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 are corrections of typographical errors, word omissions and language clarification. There are no changes in the requirements of the rules or the effect of the rules.

Proposal Changes the Following Existing Rules: The proposed changes correct typographical errors, word omissions, and clarify language in WAC 246-338-020, 246-338-028, 246-338-060, 246-338-070, 246-338-090, and 246-338-990.

NOTICE

THIS RULE IS BEING PROPOSED TO BE ADOPTED USING AN EXPEDITED RULE-MAKING PROCESS THAT WILL ELIMINATE THE NEED FOR THE AGENCY TO HOLD PUBLIC HEARINGS, PREPARE A SMALL BUSINESS ECONOMIC IMPACT STATEMENT, OR PROVIDE RESPONSES TO THE CRITERIA FOR A SIGNIFICANT LEGISLATIVE RULE. IF YOU OBJECT TO THIS RULE BEING ADOPTED USING THE EXPEDITED RULE-MAKING PROCESS, YOU MUST EXPRESS YOUR OBJECTIONS IN WRITING AND THEY MUST BE SENT TO Theresa Phillips, Rules Coordinator, Department of Health, Facilities and Services Licensing, P.O. Box 47852, Olympia, WA 98504-7852 , AND RECEIVED BY November 20, 2000.


September 19, 2000

M. C. Selecky

Secretary

OTS-4255.1


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

WAC 246-338-020
Licensure--Types of medical test site licenses.

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)) Dentistry.

(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, 70.42.060 and chapter 70.42 RCW. 00-06-079, 246-338-020, filed 3/1/00, effective 4/1/00. 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.]


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

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

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


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

WAC 246-338-060
Personnel.

(1) Medical test site owners must:

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

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

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

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

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

(3) Medical test site directors must:

(a) Establish and approve policies for:

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

(ii) Maintaining an ongoing quality assurance program;

(iii) Supervision of testing; and

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

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

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

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

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

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

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

[Statutory Authority: RCW 70.42.005, 70.42.060 and chapter 70.42 RCW. 00-06-079, 246-338-060, filed 3/1/00, effective 4/1/00. Statutory Authority: RCW 70.42.005. 97-14-113, 246-338-060, filed 7/2/97, effective 8/2/97. Statutory Authority: Chapter 70.42 RCW. 93-18-091 (Order 390), 246-338-060, filed 9/1/93, effective 10/2/93; 91-21-062 (Order 205), 246-338-060, filed 10/16/91, effective 10/16/91. Statutory Authority: RCW 43.70.040. 91-02-049 (Order 121), recodified as 246-338-060, filed 12/27/90, effective 1/31/91. Statutory Authority: Chapter 70.42 RCW. 90-20-017 (Order 090), 248-38-060, filed 9/21/90, effective 10/22/90.]


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

WAC 246-338-070
Records.

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 initials 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, 70.42.060 and chapter 70.42 RCW. 00-06-079, 246-338-070, filed 3/1/00, effective 4/1/00. Statutory Authority: RCW 70.42.005. 97-14-113, 246-338-070, filed 7/2/97, effective 8/2/97. Statutory Authority: Chapter 70.42 RCW. 93-18-091 (Order 390), 246-338-070, filed 9/1/93, effective 10/2/93; 91-21-062 (Order 205), 246-338-070, filed 10/16/91, effective 10/16/91. Statutory Authority: RCW 43.70.040. 91-02-049 (Order 121), recodified as 246-338-070, filed 12/27/90, effective 1/31/91. Statutory Authority: Chapter 70.42 RCW. 90-20-017 (Order 090), 248-38-070, filed 9/21/90, effective 10/22/90.]


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

WAC 246-338-090
Quality control.

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 of use

Table 090-2 Calibration and Calibration Checks -- 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 Calibration and Calibration Checks -- 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 Quality Control Procedures -- 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 Quality Control Procedures -- 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 Quality Control Procedures -- 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)) text books for reference sources to aid in identification of microorganisms;

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

(iii) For antimicrobial susceptibility testing:

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

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

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

(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 Quality Control Procedures -- 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 Quality Control Procedures -- 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 NCCLS Performance Standards for Antimicrobial Disk Susceptibility Tests-Seventh Edition; Approved Standard (2000)


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

Table 090-10 Quality Control Procedures -- 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 tests 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 Quality Control Procedures -- 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

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

(F) The technical supervisor:

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

(II) Reviews all nongynecological cytological preparations; and

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

(G) All abnormal cytology reports are correlated with prior cytology reports and with histopathology reports if available, and the causes of any discrepancies are determined;

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

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

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

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

(i) Immunohematology/transfusion services.

(i) Perform ABO grouping, Rh (D) typing, antibody detection and identification, and compatibility testing as described by the Food and Drug Administration (FDA) under 21 CFR 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)) FDA approved anti-A and anti-B grouping sera;

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

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

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

(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)) FDA; and

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

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

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

Table 090-12 Quality Control Procedures -- 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, 70.42.060 and chapter 70.42 RCW. 00-06-079, 246-338-090, filed 3/1/00, effective 4/1/00. Statutory Authority: RCW 70.42.005. 97-14-113, 246-338-090, filed 7/2/97, effective 8/2/97. Statutory Authority: Chapter 70.42 RCW. 93-18-091 (Order 390), 246-338-090, filed 9/1/93, effective 10/2/93; 91-21-062 (Order 205), 246-338-090, filed 10/16/91, effective 10/16/91. Statutory Authority: RCW 43.70.040. 91-02-049 (Order 121), recodified as 246-338-090, filed 12/27/90, effective 1/31/91. Statutory Authority: Chapter 70.42 RCW. 90-20-017 (Order 090), 248-38-090, filed 9/21/90, effective 10/22/90.]


AMENDATORY SECTION(Amending WSR 99-24-061, filed 11/29/99, effective 12/30/99)

WAC 246-338-990
Fees.

(1) The department will assess and collect biennial fees for medical test sites as follows:

(a) Charge fees, based on the requirements authorized under RCW 70.42.090 and this section;

(b) Assess additional fees when ((a medical test site adds licensed tests)) changes listed in WAC 246-338-026 occur that ((result in a change of category)) require a different type of license than what the medical test site currently holds; and

(c) Determine fees according to criteria described in Table 990-1.

Table 990-1 License Categories and Fees
Category of License Number of Tests/Year Biennial Fee
Certificate of Waiver N/A $ 108
PPMP N/A $ 163
Accredited N/A $ 325
Limited Testing 1-750 tests $ 543
Low Volume 751-2,000 tests $1,086
Category A 2,001-10,000 tests, 1-3 specialties $1,629
Category B 2,001-10,000 tests, 4 or more specialties $1,955
Category C 10,001-25,000 tests, 1-3 specialties $2,281
Category D 10,001-25,000 tests, 4 or more specialties $2,715
Category E 25,001-50,000 tests $3,259
Category F 50,001-75,000 tests $3,802
Category G 75,001-100,000 tests $4,453
Category H 100,001-500,000 tests $5,105
Category I 500,001-1,000,000 tests $5,432
Category J > 1,000,000 tests $5,974
Follow-up survey for deficiencies Direct staff time
Complaint investigation Direct staff time
(2) The following programs are excluded from fee charges when performing only waived hematocrit or hemoglobin testing for nutritional evaluation and food distribution purposes:

(a) Women, infant and children programs (WIC); and

(b) Washington state migrant council.

[Statutory Authority: RCW 70.42.090. 99-24-061, 246-338-990, filed 11/29/99, effective 12/30/99; 96-12-011, 246-338-990, filed 5/24/96, effective 6/24/96. Statutory Authority: Chapter 70.42 RCW. 94-17-099, 246-338-990, filed 8/17/94, effective 9/17/94; 93-18-091 (Order 390), 246-338-990, filed 9/1/93, effective 10/2/93; 91-21-062 (Order 205), 246-338-990, filed 10/16/91, effective 10/16/91. Statutory Authority: RCW 43.70.040. 91-02-049 (Order 121), recodified as 246-338-990, filed 12/27/90, effective 1/31/91. Statutory Authority: Chapter 70.42 RCW. 90-20-017 (Order 090), 248-38-120, filed 9/21/90, effective 10/22/90.]

Washington State Code Reviser's Office