WSR 14-03-050
[Filed January 9, 2014, 2:31 p.m.]
Original Notice.
Proposal is exempt under RCW 34.05.310(4) or 34.05.330(1).
Title of Rule and Other Identifying Information: WAC 246-338-070 Records (for medical test site), proposed amendments to medical test site record retention requirements for blood/blood components and individual products, and updates to histopathology report recordkeeping requirements.
Hearing Location(s): Department of Health, Town Center 2, Conference Room 158, 111 Israel Road S.E., Tumwater, WA 98501, on February 26, 2014, at 10:00 a.m.
Date of Intended Adoption: February 28, 2014.
Submit Written Comments to: Susan Walker, Department of Health, Lab Quality Assurance/Medical Test Sites, 20425 72nd Avenue South, Suite 310, Kent, WA 98032, e-mail, fax (253) 395-6365, by February 26, 2014.
Assistance for Persons with Disabilities: Contact Susan Walker by February 19, 2014, TTY (800) 833-6388 or 711.
Purpose of the Proposal and Its Anticipated Effects, Including Any Changes in Existing Rules: The proposed rule amendments are in response to Centers for Medicare and Medicaid Services' (CMS) 2013 audit findings for the department's lab quality assurance/medical test site program. The proposed amendments comply with federal regulations 21 C.F.R. 606.160 (b)(3)(ii), (b)(3)(v), and (7)(d) regarding records retention for blood or blood components and individual product records retention. The proposed rule amendments also update histopathology report recordkeeping requirements per CMS' clinical laboratory improvement amendments (CLIA) guidelines. Compliance ensures the department adheres to federal standards applicable to all United States facilities that test human specimens for health assessment or to diagnose, prevent, or treat disease, and maintains its CLIA exempt status for another six years per Public Law 100-578.
Reasons Supporting Proposal: To ensure quality standards for laboratory testing per 42 C.F.R. 493.1273 (d) and (e) and retain a CLIA exempt status, the department must comply with federal regulations established in 21 C.F.R. 606.160 (b)(3)(ii), (b)(3)(v), and (7)(d) regarding records retention of blood or blood components and other individual records retention. These were noted as findings from a 2013 CMS audit of the lab quality assurance/medical test site program and must be amended to reinstate its exempt state status. The department must also revise rules to update histopathology report recordkeeping per CLIA guidelines.
Statutory Authority for Adoption: RCW 70.42.220.
Statute Being Implemented: RCW 70.42.005 and 70.42.060.
Rule is necessary because of federal law, 42 C.F.R. 493.1273 (d) and (e) and 21 C.F.R. 606.160 (b)(3)(ii), (b)(3)(v), and (7)(d), Public Law 100-578.
Name of Proponent: Department of health, governmental.
Name of Agency Personnel Responsible for Drafting: Maura Craig, 111 Israel Road S.E., Tumwater, WA 98504, (360) 236-4997; Implementation and Enforcement: Susan Walker, 20425 72nd Avenue South, Suite 310, Kent, WA 98032, (253) 395-6745.
No small business economic impact statement has been prepared under chapter 19.85 RCW. Under RCW 19.85.025 and 34.05.310 (4)(c), a small business economic impact statement is not required for proposed rules that adopt or incorporate by reference, without material change, federal statutes or regulations, Washington state law, the rules of other Washington state agencies, or national consensus codes that generally establish industry standards.
A cost-benefit analysis is not required under RCW 34.05.328. The agency did not complete a cost-benefit analysis under RCW 34.05.328. RCW 34.05.328 (5)(b)(iii) exempts rules that adopt or incorporate by reference without material change federal statutes or regulations, Washington state law, the rules of other Washington state agencies, or national consensus codes that generally establish industry standards.
January 8, 2014
John Wiesman, DrPH, MPH
AMENDATORY SECTION (Amending WSR 05-04-040, filed 1/27/05, effective 3/19/05)
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 patient identification;
(b) Name and address or other suitable identifiers of the authorized person ordering the test;
(c) Date of specimen collection, and time, if appropriate;
(d) Source of specimen, if appropriate;
(e) Type of test ordered;
(f) Sex, and age or date of birth, of the patient; 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 had a previous abnormal report, treatment, or biopsy.
(a) Consist of instrument printouts, worksheets, accession logs, corrective action logs, and other records that ensure reliable identification of patient specimens as they are processed and tested to assure that accurate test results are reported; and
(b) Include:
(i) The patient's name or other method of specimen identification;
(ii) The date and time the specimen was received;
(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:
(i) Name and address of the medical test site, or where applicable, the name and address of each medical test site performing each test;
(ii) Patient's name and identification number, or a unique patient identifier and identification number;
(iii) Date reported;
(iv) Time reported, if appropriate;
(v) Specimen source, when appropriate, and any information regarding specimen rejection or limitation; and
(vi) Name of the test performed, test result, and units of measurement, if applicable.
(a) Distinguish between unsatisfactory specimens and negative results;
(b) Provide narrative descriptions for any abnormal results, such as the 2001 Bethesda system of terminology as published in the Journal of the American Medical Association, 2002, Volume 287, pages 2114-2119; and
(c) Include the signature or initials of the technical supervisor, or an electronic signature authorized by the technical supervisor, for nongynecological preparations and gynecological preparations interpreted to be showing reactive or reparative changes, atypical squamous or glandular cells of undetermined significance, or to be in the premalignant (dysplasia, cervical intraepithelial neoplasia or all squamous intraepithelial neoplasia lesions including human papillomavirus-associated changes) or malignant category.
(5) HISTOPATHOLOGY REPORTS must include the signature or initials of the technical supervisor or an electronic signature authorized by the technical supervisor on all reports. Reports must be signed by the same qualified individual who performs the diagnostic interpretation and evaluation, and must utilize appropriate terminology such as the SnoMed system.
(a) Use the International System for Human Cytogenetic Nomenclature on final reports;
(b) Include the number of cells counted and analyzed; and
(c) Include a summary and interpretation of the observations.
(7) If a specimen is referred to another laboratory for testing, the medical test site must:
(a) Report the essential elements of the referred test results without alterations that could affect the clinical interpretation of the results; and
(b) Retain or be able to produce an exact duplicate of each testing report from the referral laboratory.
(8) The medical test site must retain records, slides, and tissues as described in Table 070-1, under storage conditions that ensure proper preservation.
(9) If the medical test site ceases operation, it must make provisions to ensure that all records and, as applicable, slides, blocks and tissue are retained and available for the time frames specified in Table 070-1.
Table 070-1 Record/Slide/Tissue Retention Schedule
Two Years
Five Years
Ten Years
General Requirements for all Laboratory Specialties
Test requisitions or equivalent;
Test records, including instrument printouts if applicable;
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
Transfusion Services((*))
Test requisitions or equivalent;
Individual product records*
Test records;
Test reports;
Quality control records; and
Quality assurance records
All cytology slides, from date of examination of the slide
All cytology reports
Histopathology/Oral Pathology
Specimen blocks, from date of examination
All histopathology and oral pathology reports; and
Stained slides, from date of examination of the slide
Histopathology/Oral Pathology-Tissues
Retain remnants of tissue specimens in an appropriate preserved state until the portions submitted for microscopic examination have been examined and diagnosed
Instrument/method Validation Studies
For life of instrument/method plus two years
Must be retained for no less than ((five)) ten years in accordance with 21 C.F.R. 606.160 (7)(d).