Washington State Register, Issue 14-09
| Jurisdiction | Washington |
| Library | Washington Register |
| Year | 2014 |
Washington State Register, Issue 14-09 WSR 14-09-001
[ 1 ] Permanent
WSR 14-09-001
PERMANENT RULES
DEPARTMENT OF HEALTH
[Filed April 2, 2014, 2:53 p.m., effective May 3, 2014]
Effective Date of Rule: Thirty-one days after filing.
Purpose: WAC 246-338-070 Records (for medical test
sites), adopting amended rule for medical test site record
retention requirements for blood/blood components and indi-
vidual products, and updates to histopathology report record-
keeping requirements.
Citation of Existing Rules Affected by this Order:
Amending WAC 246-338-070 Records (for medical test
sites).
Statutory Authority for Adoption: RCW 70.42.220.
Other Authority: 42 C.F.R. 493.1273 (d) and (e) and 21
C.F.R. 606.160 (b)(3)(ii), (v), and (7)(d) a.
Adopted under notice filed as WSR 14-03-050 on Janu-
ary 9, 2014.
Number of Sections Adopted in Order to Comply with
Federal Statute: New 0, Amended 1, Repealed 0; Federal
Rules or Standards: New 0, Amended 0, Repealed 0; or
Recently Enacted State Statutes: New 0, Amended 0,
Repealed 0.
Number of Sections Adopted at Request of a Nongov-
ernmental Entity: New 0, Amended 0, Repealed 0.
Number of Sections Adopted on the Agency's Own Ini-
tiative: New 0, Amended 0, Repealed 0.
Number of Sections Adopted in Order to Clarify,
Streamline, or Reform Agency Procedures: New 0, Amended
0, Repealed 0.
Number of Sections Adopted Using Negotiated Rule
Making: New 0, Amended 0, Repealed 0; Pilot Rule Making:
New 0, Amended 0, Repealed 0; or Other Alternative Rule
Making: New 0, Amended 1, Repealed 0.
Date Adopted: April 2, 2014
Jessica Todorovich
Deputy Secretary
for John Wiesman, DrPH, MPH
Secretary
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 informa-
tion, 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 abnor-
mal report, treatment, or biopsy.
(2) TEST RECORD SYSTEMS must:
(a) Consist of instrument printouts, worksheets, acces-
sion logs, corrective action logs, and other records that ensure
reliable identification of patient specimens as they are pro-
cessed and tested to assure that accurate test results are
reported; and
(b) Include:
(i) The patient's name or other method of specimen iden-
tification;
(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 infor-
mation regarding specimen rejection or limitation; and
(vi) Name of the test performed, test result, and units of
measurement, if applicable.
(4) CYTOLOGY REPORTS must:
(a) Distinguish between unsatisfactory specimens and
negative results;
(b) Provide narrative descriptions for any abnormal
results, such as the 2001 Bethesda system of terminology as
published in the Journal of the American Medical Associa-
tion, 2002, Volume 287, pages 2114-2119; and
(c) Include the signature or initials of the technical super-
visor, or an electronic signature authorized by the technical
supervisor, for nongynecological preparations and gyneco-
logical preparations interpreted to be showing reactive or
reparative changes, atypical squamous or glandular cells of
undetermined significance, or to be in the premalignant (dys-
plasia, cervical intraepithelial neoplasia or all squamous
intraepithelial neoplasia lesions including human papilloma-
virus-associated changes) or malignant category.
(5) HISTOPATHOLOGY REPORTS must in clude the signa-
ture or initials of the technical supervisor or an electronic sig-
nature 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.
(6) CYTOGENETICS REPORTS must:
(a) Use the International System for Human Cytogenetic
Nomenclature on final reports;
(b) Include the number of cells counted and analyzed;
and
WSR 14-09-001 Washington State Register, Issue 14-09
Permanent [ 2 ]
(c) Include a summary and interpretation of the observa-
tions.
(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 inter-
pretation 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
(a) General Requirements
for all Laboratory Spe-
cialties
•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 proce-
dures for all specialty
areas
(b) Transfusion Ser-
vices((*))
•Test requisitions or
equivalent;
•Individual product
records*
•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/Oral
Pathology
•Specimen blocks, from
date of examination
•
•
All histopathology
and oral pathology
reports; and
Stained slides, from
date of examination of
the slide
(e) Histopathology/Oral
Pathology-Tissues
Retain remnants of tissue specimens in an appropriate preserved state until the portions sub-
mitted for microscopic examination have been examined and diagnosed
(f) Instrument/method Val-
idation Studies
For life of instrument/method plus two years
Washington State Register, Issue 14-09 WSR 14-09-003
[ 3 ] Permanent
WSR 14-09-002
PERMANENT RULES
DEPARTMENT OF HEALTH
[Filed April 3, 2014, 9:23 a.m., effective May 4, 2014]
Effective Date of Rule: Thirty-one days after filing.
Purpose: WAC 246-980-065 Home care aide provisional
certification, adoption of a new section to establish a process
for the department of health to issue a provisional home care
aide certification to a long-term care worker who is limited-
English proficient. This new rule allows these applicants
additional time to comply with the certification requirements
in chapter 18.88B RCW pursuant to SHB 1629 (chapter 259,
Laws of 2013).
Statutory Authority for Adoption: Chapter 259, Laws of
2013 (SHB 1629), RCW 18.88B.035.
Adopted under notice filed as WSR 14-02-028 on
December 20, 2013.
Number of Sections Adopted in Order to Comply with
Federal Statute: New 0, Amended 0, Repealed 0; Federal
Rules or Standards: New 0, Amended 0, Repealed 0; or
Recently Enacted State Statutes: New 1, Amended 0,
Repealed 0.
Number of Sections Adopted at Request of a Nongov-
ernmental Entity: New 0, Amended 0, Repealed 0.
Number of Sections Adopted on the Agency's Own Ini-
tiative: New 0, Amended 0, Repealed 0.
Number of Sections Adopted in Order to Clarify,
Streamline, or Reform Agency Procedures: New 0, Amended
0, Repealed 0.
Number of Sections Adopted Using Negotiated Rule
Making: New 0, Amended 0, Repealed 0; Pilot Rule Making:
New 0, Amended 0, Repealed 0; or Other Alternative Rule
Making: New 1, Amended 0, Repealed 0.
Date Adopted: April 3, 2014.
Jessica Todorovich
Deputy Secretary
for John Wiesman, DrPH, MPH
Secretary
REQUIREMENTS FOR A
PROVISIONAL CERTIFICATION
NEW SECTION
WAC 246-980-065 Home care aide provisional certi-
fication. (1) The department may issue a provisional certifi-
cation to a long-term care worker who is limited-English pro-
ficient and submits:
(a) A request for a provisional certification; and
(b) Verification of his or her date of hire as a long-term
care worker, as follows:
(i) For individual providers, verification of the appli-
cant's date of hire submitted directly by the department of
social and health services; or
(ii) For all other applicants, a form supplied by the
department and completed by the employer who hired the
applicant as a long-term care worker, verifying the appli-
cant's date of hire.
(2) A provisional certification will be issued only once.
(3) A provisional certification will take effect two hun-
dred days from the applicant's date of hire as a long-term care
worker, as defined in WAC 246-980-010(2).
(4) A provisional certification will expire two hundred
sixty days from the applicant's date of hire as a long-term care
worker. The applicant must stop working on the two hundred
sixtieth day of employment if the certification has not been
granted for any reason.
(5) A request for provisional certification may be denied
pursuant to chapter 18.130 RCW, the Uniform Disciplinary
Act, or based on RCW 18.88B.080.
(6) For the purposes of this section, "limited-English
proficient" means that an individual is limited in his or her
ability to read, write, or speak English.
(7) Provisional certifications will not be issued after
March 1, 2016.
WSR 14-09-003
PERMANENT RULES
DEPARTMENT OF HEALTH
[Filed April 3, 2014, 9:29 a.m., effective May 4, 2014]
Effective Date of Rule: Thirty-one days after filing.
Purpose: WAC 246-282-005 Minimum performance
standards, 246-282-006 Washington state Vibrio parahaemo-
lyticus control plan, 246-282-010 Definitions; clarify refer-
ences to the United States Food and Drug Administration,
National Shellfish Sanitation Program, Guide for the Control
of Molluscan Shellfish. All changes to the rules are editorial
only and clarify the language without changing the effect.
Citation of Existing Rules Affected by this Order:
Amending WAC 246-282-005, 246-282-006, and 246-282-
010.
Statutory Authority for Adoption: RCW 60.30.030.
Adopted under notice filed as WSR 14-05-084 on Febru-
ary 18, 2014.
Number of Sections Adopted in Order to Comply with
Federal Statute: New 0, Amended 0, Repealed 0; Federal
Rules or Standards: New 0, Amended 0, Repealed 0; or
Recently Enacted State Statutes: New 0, Amended 0,
Repealed 0.
Number of Sections Adopted at Request of a Nongov-
ernmental Entity: New 0, Amended 0, Repealed 0.
Number of Sections Adopted on the Agency's Own Ini-
tiative: New 0, Amended 3, Repealed 0.
Number of Sections Adopted in Order to Clarify,
Streamline, or Reform Agency Procedures: New 0, Amended
3, Repealed 0.
Number of Sections Adopted Using Negotiated Rule
Making: New 0, Amended 0, Repealed 0; Pilot Rule Making:
New 0, Amended 0, Repealed 0; or Other Alternative Rule
Making: New 0, Amended 3, Repealed 0.
Date Adopted: April 3, 2014.
Jessica Todorovich
Deputy Secretary
for John Wiesman, DrPH, MPH
Secretary
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