UMG/UDL Point of Care Policy 10/19/2001

UMG/UDL Point of Care Policy 10/19/2001

D:\Wordfiles\EGM\POC\Procedures\General\POCT quality control procedure.DOC

/ University
Diagnostic
Laboratories

POCT Program PROCEDURE

Procedure: POINT OF CARE TESTING: UMG-UDL Quality Control Program

Prepared by / Date Adopted / Supersedes Procedure
E. G. Martin, Ph.D. / 1996 / UDL-UMG Quality Control Program
Revision Date / Revision Summary
4/28/99 / Updated procedure to Word format. Remove references to outpatient services.
10/16/01 / Update to Word XP format. Clarification of wording.
Review Date / Revision Date / Signature
10/16/01
Distributed to / Copies / Distributed to / Copies
Point of Care Testing Areas / 1

I.  Purpose

The purpose of the quality control program is to monitor the quality of technical services provided by the Point of Care Testing staff and to ensure that problems related to these are identified and addressed.

The monitoring system is designed to be compatible with the standards of the College of American Pathologists and CLIA 88.

II.  Responsibilities

A.  It is the responsibility of the Point of Care testing staff to successfully complete quality control on all testing performed.

B.  A periodic evaluation to insure proper patient ID and preparation, specimen collection, specimen ID and specimen preservation and processing, along with accurate result reporting will be conducted by UDL central administration.

C.  External Quality Control specimens will be analyzed by testing personnel on a rotating basis within a POCT site.

D.  External Quality Control specimens will be analyzed at a minimum of once per shift, with the first Quality Control analyzed before or simultaneously with the first patient sample being tested.

E.  It is the responsibility of the Point of Care Testing site supervisor to review all quality control on a daily basis.

F.  The POCT site supervisor will submit QC data to UDL central administration on a monthly basis for review and central maintenance records.

G.  At his discretion, the UDL Medical Director may assign specific duties for the monitoring of performance and the correction of problems identified by the monitoring system to other individuals at the Point of Care Testing sites

III.  Scope

The UDL provides technical support to the activities of UMG Point of Care Testing sites. The services provided may change from time to time to meet the needs of our faculty and patients.

IV.  Elements of the Quality Control Program

Quality control is an ongoing process designed to insure that an analytic system is functioning correctly. The basic premise of most quality control systems is that known samples are tested simultaneously with patient unknowns and the results compared with expected results. Failure to obtain the expected values results in a series of actions designed to protect the patient and personnel from aberrant and incorrect data.

V.  Principle

Most diagnostic manufacturers include internal control materials which are expected to be handled in the same manners that patient samples are handled and which are expected to return a known result during the performance of the analytical assay. Most manufacturers maintain a database which permits unexpected results to be reported and reviewed for errors in test performance versus possible reagent stability problems. In addition to these internal control materials, which are commonly referred to as ‘calibrators’, good laboratory practice usually involves the incorporation of external quality control materials which are either purchased or prepared to test the effectiveness of an assay.

Clinical testing methods and performance will be made available to any requesting individual. All physicians will be informed of significant changes in analytic methodology that will result in significant changes in the test results or their interpretation.

VI.  Quality Control Failures

In the event of a quality control failure, the testing site must take a series of actions designed to:

A.  Prevent the release of false data derived from the assay.

B.  Commence a series of steps designed to isolate the problem to either assay components, equipment malfunction of assay performance.

C.  Establish a means to follow-up and review the areas indicated by the QC failures.

D.  Document corrective action directly on a QC sheet.

VII.  Recommended Range of Controls Used

The recommended range of controls is specified in the Quality Control section of each testing procedure.

VIII.  Recommended Frequency of Quality Control Samples

A.  Daily, as frequent as patient samples are analyzed covering the range of expected patient results;

B.  Each time an instrument has been serviced to verify proper operation;

C.  Each time testing personnel are suspicious of possible testing malfunction, e.g., unexpected patterns of patient results which raise the possibility of malfunction;

D.  Each time a new reagent lot number or new test kit lot number is introduced.

IX.  Crossover Studies

A.  Reagents and control materials are subject to manufacturing variances on a lot to lot basis. While some manufacturers perform internal lot comparisons, testing sites should verify the quality of a new lot of reagents and control materials before using them with patient samples.

B.  Crossover studies will be performed on new lots of control materials by running the assay a sufficient number of times to permit determination of the mean of result and to allow comparison of the mean value to the manufacturer’s reported control assay value.

C.  A new lot number of controls or in the case of diagnostic kits containing controls, the assay lot must be formally accepted or rejected by the Point of Care testing site supervisor and reviewed by the supervisor. Any corrective actions will be noted.

X.  Acceptable Limits

Acceptable limits will be defined for each particular assay in the assay procedure protocol.

All QC data will be submitted to the UMG/UDL supervisor or his designee on a monthly basis to be reviewed and maintained.

XI.  Corrective Actions

A.  If a QC failure occurs:

1.  Determine the cause of the failure.

2.  One of the first steps in examining a QC failure is to suspect the quality of the reagents, controls, or the performance of the instrumentation. Consequently it is often useful to utilize a different lot of reagent and repeat the procedure.

3.  In the face of a QC failure, do not release results without UDL-Supervisory approval. If the problem can be identified and solved internally, indicate the corrective action taken on the QC Log. For example, if you repeat the QC and it is now found to be within range, record the new result and indicate whether you repeated the same QC sample from the same lot of reagent or whether you employed a different QC sample or a different reagent lot.

4.  If the problem cannot be readily identified:

a)  Contact and document the contact with the technical support department of the control manufacturer and verify your specific performance.

b)  Request a service visit on the applicable instrument or send the instrument for service.

5.  Document ALL QC actions DIRECTLY on the QC sheet to permit rapid review.

XII.  QC Review

All QC results must be reviewed on a regular basis.

A.  The Point of Care testing site supervisor will review and document QC on a daily basis. As necessary the site supervisor will institute corrective action for 'out of compliance' procedures. The site supervisor is responsible for submitting QC data to the UDL administrative offices (Medical Education Bldg. Rm. 212) for potential further review and central storage.

B.  The site supervisor will also review and document QC on a monthly basis.

1.  The purpose of this process is to:

a)  Review ongoing technical problems and their resolution.

b)  Review problem cases

c)  Review QC failures

XIII.  Action to Improve Services and to Resolve Problems

A.  All problems identified by the monitoring system will be corrected, documented and brought forth at the Quality Assurance meetings quarterly.

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