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Section 6: TEST PROCEDURES



PROCEDURE MANUAL - LABORATORY DIRECTOR ANNUAL REVIEW

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The director will sign each individual procedure upon talcing the position oflaboratory director. If the lab director remains the same, he/she may sign off the entire manual on this form after the first year. If the lab director changes, the new director must sign ALL the test procedures again and then may sign off the entire manual annually.

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EMPLOYEE TEST PROCEDURE REVIEW

All laboratory personnel will review the technical procedures found in the laboratory manual. All procedures are to be done as written in that manual. Any questions about the procedures shall be directed to and answered by the laboratory supervisor, the laboratory director or the laboratory technical consultant.

REVIEWDATE

NAME/SIGNATURE

TITLE

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PROCEDURE MANUAL

The laboratory procedure manual contain complete and specific information and instructions for every test (waived and non-waived) performed in the laboratory. CMS requirements for information required in written procedures is found in section 493.1211 of CLIA regulations (Federal Register 2/28/92). Manufacturer package inserts and instrument operators manuals may be used if they meet the CLIA requirements. If the package inserts or operators manuals do not contain all the required information, they must be supplemented with the necessary information or the procedure can be re­ written according to the guidelines.

WHYWRITEA PROCEDUREMANUAL?

Written procedure manuals contain essential information concerning the specimen, reagents, equipment, test results, and step by step directions for performing the test. Written procedures must reflect the test procedure actually emp loyed in the laboratory.

A procedure manual is extremely useful for:

l. Training new personnel to perform new tests

2. Refreshing the laboratorian about these test steps for infrequently performed tests

3. Serving as a daily reminder of test procedures

4. Troubleshootingunexpected results

5. Standardizing test procedures, especially if more than one person is responsible for performing the same test.

HELPFUL HINTS:

l . Use a 3-ring notebook

2. Start each procedure on a new page

3. Use tabs and a table of contents for easy reference

4. Cover pages with plastic or other reagent proof material if procedure will be frequently used and removed from notebook

5. Add package inserts to all written procedures

6. Include up-to-date manufacturer's product literature or copies of pages from procedure texts.

7. Type all procedures on computer or word processor - so editing is easy if needed.



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- CLIA REGULATIONS FOR THE WRITTEN TECHNICAL PROCEDURE

From page 7164 of the Federal Register/ Vol. 57, No. 40 / February 28, 1992


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§ 93.1211 Stan rd; Procedure manual.

(a) A written procedure manual for the performance of all analytical methods used by the laboratory must be readily available and followed by laboratory personnel. Textbooks may be used as supplements to these writ.ten_ descriptions but may not be used 1rt lieu of the laboratory's written procedures for testing or examining specimens.

(b) The procedure manual musl include, when applicable lo the test procedure: · ·.

'(1) Requirements .for specimen. . collection and processing, and criteria for specimen rejection;

(2) Procedures for icroscopic. examinations, including the detection of inadequately prepared slides;

(3) Step-by-step performance o the procedure, including test calculations and interpretation of results;

( ) Preparation of slides, solutions. calibrators, controls, reagents, stains and other materials used in testing;

(5) Calibra tion. and calibration verification procedures;

(6) The reportable range for patient test results as established or verified in

§ 493.1213;

(7) Control procedures;

(8) Remedial action to be taken when calibration or control results fail to meet the laboratory's criteria for acceptability;

(9) Limitations in methodologies, including interfering substances;

(10) Reference range (normal values);

(11) Imminent life-threatening laboratory results or "panic values":

(12) Pertinent literature references:

(13) Appropriate criteria for specimen storage and preservation to ensure specimen integrity until testing is completed;


(14) The laboratory's system for reporting patient results including, when appropriate, the protocol for reporting panic values; ·

(15) Description of the course of action to be taken in the event that a test system becomes inoperable; and

(16) Criteria for the referral of specimens including procedures for specimen submission and handling as described in § 493.1103.

(c) Manufacturers' package inserts or operator manuals may be used, when applicable, to meet the requirements of paragraphs (b)(l) through (b)(13) of this section. Any of the items under paragraphs (b)(l) through (b)(13) of this section not provided by the . manufacturer must be-provided by the laboratory.

(d) Prpcedures must be app.roved, signed, and dated by the director.

(e) Procedures must be re-approved, signed and dated if the directorship of the laboratory changes.

(f) Each change in a procedure must be approved, signed, and ated by the current director of the laboratory.

(g) The laboratory must maintain a copy of each procedure with the dates of initial use and discontinuance. These records must be retained for two years after a procedure has been discontinued.


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REVIEW AND UPDATE OF PROCEDURE MANUAL


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1. The Jaboratory director wi1l sign and date each procedure and operator manual upon taking the job of director. If a new director is named, the new director will sign and date each procedure and operator manual. A form to record procedure review fo1lows this page. If a new procedure is introduced the director will sign the new procedure. This initial review may not be designated.

2.. After reviewing and signing each procedure, the director or qualified designee will sign the annual review page. If there are no changes during the year the annual review page only needs to be signed. A form to record this is found on the second page (6-2) of this chapter.

3. Manual will be updated as needed to reflect current tests performed. If a test is discontinued, the procedures be will have date discontinued noted and be retained for 2 years after discontinuance.

4. lf a procedure changes, is modified or does not reflect what is actually being done in the laboratory, changes will be noted on the director review form and signed by director. This may not be delegated.

5. If directorship changes this change and new director must be reported to CLIA and if

applicable outside surveying agency used.

6. The director will establish panic or alert values for tests performed.

TESTS AND PROCEDURES NOT FOUND IN TIDS MANUAL

The following tests are found in separate procedure manuals or ins trument operator manuals:

1.

2.

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4.

.. Director must review and sign operator manuals annually.


P.O.C. Consultants LLC, 2 Russ Farm Way, Delanco, N. J. 08075, (856) 824-0800


DIRECTOR REVIEW OF PROCEDURE

PROCEDURE NAME:

COMPANY/MANUFACTURER:

DATE: DIRECTOR'S NAME:

DATE: DIRECTOR'S NAME:

DATE: DIRECTOR'S NAME:

DATE: DIRECTOR'S NAME:

PROCEDURE REV ISION:

DATE:

APPROVED BY:

PROCEDURE REVISION:

DATE:

APPROVED BY:

record revisions made to th1"s oroced ure

PROCEDURAL NOTES:

PROCEDURE NAME:

DATE DISCONTINUED:

DIRECTOR'S OR TECHNICAL CONSULTANT INITIALS:

DATE PROCEDURE CAN BE DISCARDED:

(2 years from date discontinued)

YOU MAY COPY TIDS PAGE AS NEEDED


NORMAL/PANIC VALUES FOR TESTS PERFORMED

TEST NORMAL RANGE PANIC VALUE


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Policy: Panic, alert and stat test values will be reported to the ordering or covering physician immediately after testing. Panic values have been established by the laboratory director. Documentation of the communication will be noted on the patient report. If the ordering physician.iu:w1in the facility where the test is performed,document the communication on this log.

DA TE

PA TIENT

P A TIEN T/fES T ID #

T EST

PERSON NOTIFIED

BYWHO

TIME

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P.O.C. Consultants, LLC 2·Russ Farm Way , Delanco, N.J. 08075


Policy: If an error is made on a patient's test and the specimen is still available, rerun the test as soon as possible. Contact the physician with the new test result and make a written notation on record and report. If the specimen is not available, notify the ordering physician, contact the patient, explain the problem, redraw the specimen and run a new test(at nocharge to the patient). Complete thisform. On the old report place a large "X" and mark it Corrected Report Issued. Write the words "Corrected Report" on the new report. Keep the old report and a copy of the new report with this form in the QA manual. Retain for 2 years.

Patient Name:

Patient ID: Accession #:

Test:

Date Specimen Collected: Time Specimen Collected:

Incorrect Resnlt:

Corrected Result:

Person notified of incident:

Notification date and time:

Description of Incident:

Corrective Action Taken:

Corrected result reoorted to:

Time:

Date:

Method:



INDEX OF TESTS FOUND IN TIDS MANUAL

TEST PRODUCT OR INSTRUMENT Date

Discontinued*

* All discontinued tests will be retained for 2 years. Date will also be recorded on test procedure.


TEST PERFORMED IN-HOUSE