UAMS DEPARTMENT OF PATHOLOGY AND LABORATORY SERVICES QUALITY PLAN

 I.                   Introduction: 

            To ensure the highest quality of laboratory services, the University Hospital 
            of Arkansas laboratories have developed the following plan to guide the
            full range of quality assurance, quality control, and continuous quality
            improvement activities.

            A.        This plan provides for implementation and execution of all pre-analytical
                        through post-analytical quality assurance activities.  These include, but are
                        not limited to, such processes a positive sample handling and procedure
                        development as well as accurate results reporting and personnel
                        competency documentation.

             B.        The quality plan includes provision for the design and review of a
                        comprehensive quality control program, including procedure manuals,
                        calibration verification, review of control material results, active
                        instrument maintenance and temperature checks, calibration of pipettes
                        and other laboratory equipment.

             C.        Lastly, the plan sets the framework for the implementation and
                        documentation of a continuous quality improvement program within
                        the laboratory, allowing the laboratory to continuously monitor and       
                        improve its daily activities to provide the most efficient, highest quality
                        lab services possible.

 II.                Quality Assurance

             A.                 Proficiency Testing

                         1.        The University Hospital of Arkansas laboratory is a CAP accredited
                                    Laboratory and as such, participates in the CAP Inter-laboratory
                                    Comparison proficiency testing program.

                         2.        The labs are enrolled in the appropriate CAP surveys available to
                                    cover the scope of patient testing performed.

                         3.         For analytes where proficiency testing is not available, the
                                    performance of the assay should be validated by another method
                                    (i.e., assayed serum, regional pools, etc.) twice a year.
                                    Methods of compliance are kept in the laboratory section where these tests are
                                    performed. 

     4.         Proficiency testing samples are integrated into the routine laboratory workload.

                        5.         The laboratory director, his designee or the supervisor of the lab section where
                                    the testing was performed, reviews the proficiency or alternative method testing
                                    results.

                        6.         When proficiency testing or alternative performance assessment results are
                                    unacceptable, the section supervisor will respond with the appropriate
                                    investigation and corrective action which is reviewed by the Medical Director.

                         7.        All proficiency testing results and corrective action are filed for review.  

      8.        Inter-laboratory communication about proficiency tests samples is prohibited before
       submission of results to the proficiency test provider. 
       It is also prohibited to refer proficiency testing to an outside laboratory. 

     9.         In the event a Proficiency test challenge was not graded due to lack of consensus,
       or our lab failed to submit results or method code, the section supervisor would
       investigate the cause, document corrective action and assess the performance of  
       our results (if available) with the CAP final results.  If we fail to receive the PT kit
       or need to obtain another kit,
CAP may be contacted to determine if extra PT kits are
       available so that we may perform, evaluate and document results to assess performance.
       Other methods used to assess performance might include those we use for tests for
       which there are no external PT. 

B.                 Analytical Quality Assurance System Design 

                        1.         Each laboratory section should develop procedures, which adhere
                                    to and promote the quality and policies set by the Department of
                                    Pathology & Laboratory Services.  These procedures should define
                                    goals for monitoring analytical performance, establish tolerance
                                    limits for quality control, and establish corrective action steps and
                                    documentation. 

                        2.         Sectional procedures should identify the delegation of
                                    responsibilities for the process and review of the various activities
                                    that occur within the section. 

                        3.         Quality assurance for analytical processes may include the
                                    following elements, as applicable: 

a)         Establishment of a system of periodic review of patient and
                        quality control results, maintenance records, temperature
                        checks, etc. 

b)         Establishment of a system which ensures positive identification
                        of patients and their samples from collection through results
                        reporting. 

c)         Establishment of procedures to ensure the integrity of the
                        reported results which includes positive sample identification
                        as well as maintaining the optimum integrity of the sample to
                        be tested. 

d)         Establishment of a system designed to compare results of the
                        same test performed by different methodologies or at different
                        sites at least twice per year. 

e)         Establishment of a program of self-inspection to ensure the
                        efficiency and accuracy of procedures and results as well as
                        competency of personnel performing analytical testing. 

f)          Establishment of procedures to detect clerical errors and steps
                        to document corrective action appropriately. 

g)         Establishment of a system for laboratory records retention.
     Records are kept for a minimum of two years. 

                        4.         The Laboratory Information System provides the framework for all
                                    laboratory activities. 

                                    a)         Real-time functions include order processing specimen identification
                                                and result reporting. 

                                    b)         The Laboratory Information System provides retrospective quality
                                                assurance reports which allow for review of patient results, detection
                                                and correction of errors, and measurement of laboratory efficiency. 

                                    c)         Usage of the Laboratory Information System is incorporated into
                                                the procedures developed by each laboratory section. 

                        5.         The Laboratory Information System will develop and maintain procedures
                                    which ensure the integrity, accuracy and security of the Laboratory Information
                                    System. 

C.                 Procedures 

                        1.         All laboratory sections will develop and maintain a procedure manual in
                                    compliance with the National Committee for Clinical Laboratory Standards
                                    document GP2-A3. 

                        2.         The Procedure manual must be available in the work area and all personnel
                                    performing testing must be familiar with the content of the procedure manual
                                    relevant to the scope of the activities they perform.  All testing personnel
                                    will be apprised of any procedural changes. 

                        3.         The procedure manual is reviewed annually by the laboratory director of
                                    designee.  If revisions are made to a procedure, the revisions must be
                                    documented and the procedure re-approved by the director or designee. 

                        4.         When a procedure is discontinued, a copy of that procedure is maintained
                                    for two years thereafter.  All procedures should be dated with the following:

                                    a)         initial date put into service

                                    b)         revision dates

       c)         date of retirement 

                        5.         All procedures will be reviewed and re-approved by the laboratory director
                                    should there be a change in directorship. 

D.                Specimen Handling 

                        1.         Each laboratory section will develop and maintain procedures that verify           
                                    sample identity and integrity.  The procedures will include any special
                                    handling required by various sample types, such as capillary samples,
                                    aliquots, dilutions, etc. 

                        2.         The procedure should outline each step of sample handling from receipt
                                    of the sample through reporting of results. 

                        3.         Laboratory procedures should include criteria for the rejection of
                                    unacceptable samples as well as directives for documentation that the
                                    sample has been rejected. 

                        4.         The procedure should list condition under which sub-optimal samples
                                    may be used for testing.  The procedure should provide for the documentation
                                    of the sub-optimal sample condition and how this may affect the interpretation
                                    of the test results. 

    5.          Specimen retention should be in compliance with accrediting and regulatory
       agencies. Serum and body fluids should be retained for at least 48 hours,
       urine specimens for 24 hours, blood films and permanently stained body fluid
       slides and microbiology slides should be retained for at least 7 days.  

E.                 Results Reporting 

                                    1.         Each test procedure, where applicable, should be evaluated for the
                                                following specifications prior to implementation:

                                                a)         accuracy

                                                b)         precision

                                                c)         analytic sensitivity

                                                d)         reportable range of patient test results

         e)         reference ranges for the population being tested

         f)         interferences which could affect results  

                       2.          The analytical measurement range (AMR) is the range of analyte values
       that a method can directly measure on the specimen without any dilution,
       concentration, or other pretreatment not part of the usual assay process. 
       Each laboratory establishes the AMR that provides acceptable results for
       the intended clinical use.  This range can be established or verified using
       appropriate reference materials; patient specimens, unaltered or altered
       (i.e., diluted or concentrated) with known analyte concentrations; or
       calibration materials.  If the AMR exceeds the range of values of the
       materials used for calibration or calibration verification, then the
       laboratory must establish criteria for verifying the acceptability over time,
       of the full AMR, and document compliance.  The AMR can be
       revalidated through the process of calibration verification every 6 months. 

       Apparent analyte concentrations that are lower or higher than the AMR
       do not routinely require repeat analysis if the result is reported as less than
       the lower limit, or greater than the upper limit, respectively, and the
       laboratory has evidence that the low result is not due to sampling/dilution
       errors, immunologic "hook effects," etc. 

                                 3.          The CRR (Clinically Reportable Range)is the range of analyte values that
       a method can measure, allowing for specimen dilution, concentration or
       other pretreatment used to extend the direct analytical measurement range. 
       Each laboratory establishes the CRR that provides acceptable results for
       the intended clinical use.  Patient specimens, frequently obtained from
       patients with disease conditions that produce very abnormal analyte
       concentrations/activities, are typically used in a dilution or concentration
       protocol to establish or verify the CRR.  Analyte values less than or
       greater than the CRR are usually reported as greater than or less than
       some measurable value. 

The CRR is usually a characteristic of the assay technology and is
established at the time of initial validation of a method in a laboratory. 
Once established, it does not need to be re-evaluated unless there are
instrumentation or methodology changes for the analyte.  The CRR does
not need to be revalidated every 6 months.  

                                    4.         The preceding evaluations should be documented.

                                                a)         Should there be a significant change in analytic methodology,
                                                            the evaluations may need to be repeated.

                                                b)         If a revision of the reference range is required, the laboratory
                                                            must notify its clients. 

                                    5.         Laboratory procedures should include any steps necessary to verify
                                                results prior to their release, such as repeat of the test or dilution of the
                                                sample if the test results exceed their reportable range. 

                                    6.         The laboratory will have a procedure for the immediate notification of
                                                appropriate patient care personnel when results of certain tests are outside
                                                “critical” limits.  Critical values require a read back to confirm correct
                                                communication.
  The critical limits should:

                                                a)         be established

                                                b)         be easily identified

         c)         have documentation of notification of the proper individual 

                                    7.         The Delta Variance function of the Laboratory Information System (LIS)
                                                is designed to detect clinically significant changes in patient values for
                                                specified tests.  This function enables the technologist to detect possible
                                                specimen handling errors, clerical errors, or analytical errors in a patient’s
                                                results before the results are released to the patient’s chart. 

       8.         The laboratory should have defined turnaround times for each test
                            and a procedure to notify clients, if necessary, in the case of delayed
                            results. 

                                    9.         All laboratory orders are received through the Laboratory Information
                                                System and all laboratory performed or reference test results are
                                                reported through the Laboratory Information System.  This allows for:

                                                a)         the results to be paired with the original order

                                                b)         any performance notes to be documented

         c)          the results to be reported appropriately 

                                    10.       The laboratory will develop and maintain procedures for the proper
                                                handling, performance and reporting of test specimens received from
                                                other laboratories and those referred to other laboratories. 

                                    11.        Errors in reporting patient results will be corrected as soon as possible
                                                by notifying the nurse or physician and entering the corrected results in
                                                the LIS with the previously reported results also displayed.  Should a
                                                major error in reporting multiple patient results be found, the lab will, in
                                                consultation with the Pathology staff, develop and implement an
                                                appropriate plan of notifying medical staff and correcting the results.  The
                                                underlying reasons for the error will be analyzed and steps will be taken
                                                to prevent such problems in the future.

F.                  Assay Performance 

                                    1.         Laboratory procedures should include the verification of assay
                                                reagents.                                   

                                    2.         All reagents must be properly labeled as appropriate with the
                                                following elements:

                                                a)         content

                                                b)         quantity

                                                c)         concentration

                                                d)         storage requirements

                                                e)         date  prepared or reconstituted

         f)          expiration date 

                                    3.         Components of reagent kits must be used within the kit lot number
                                                unless exceptions are noted by the manufacturer.                                   

       4.         Each laboratory section should establish guidelines for calibration
                            and calibration verification of test procedures to ensure the continued
                            accuracy of the analytical methods.  All calibrations and calibration
                            verifications should be documented. 

       5.         Procedures should specify the proper calibrators or standards to be used
                            for calibration of each procedure.  All calibrators/standards should be
                            properly labeled as to:  

                                                a)         content

                                                b)         concentration or calibration values

                                                c)         date placed in service

         d)          expiration date 

                                                The above information should be recorded on the calibrator or readily
                                                available.  The calibrators should be of a compatible matrix with the
                                                analytical system to be calibrated and have a known value appropriate
                                                to the reportable range of the method.                                   

6.         Calibration procedures should include provisions for performance of
                        linearity on the system on initial set-up and guidelines for linearity
                        checks if an assay fails set criteria. Criteria for performing calibration
                        verification may include after major maintenance, as recommended by
                        manufacturer or at least every six months or at reagent lot changes if
                        accuracy of control data and patient results are affected.                                   

7.         The laboratory should define the reagent grade of water necessary for
                        each procedure and have documentation of the following:

                                                a)         definition of the nature and frequency of water testing to
                                                            ensure the quality of water needed for laboratory procedures

                                                b)         evaluation of its source water for high concentration of silicate

                                                c)         specified checks and corrective action taken if these checks do
                                                            not meet specified criteria 

G.                Quality Control 

                                    1.         Each laboratory section will establish and maintain written procedures
                                                which direct the quality control program for testing performed in that
                                               
section.                                   

       2.         The quality control procedure must include the following elements:

                                                a)         definition of an analytical run and performance frequency of
                                                            quality control for each test. For quantitative tests, controls 
                                                            should be run at more than one concentration level each day
                                                            of testing. Coagulation test systems require testing with 2
                                                            levels of control during each 8 hour period of testing and
                                                            with each change of reagents.

                                                b)         identification and usage of the control materials

         c)         procedures used to establish the acceptable limits of un-assayed
                              and assayed control materials where applicable

                                                d)         inclusion of both a positive and a negative control for applicable
                                                            qualitative tests

                                                e)         organization and evaluation of the quality control data

         f)          procedures for corrective action, when applicable

                                                g)         verification of quality control results before patient values are
                                                            reported

         h)         Controls should be tested in the same manner and by the same personnel
           as patient tests.

3.         The quality control procedures should be under active surveillance by the
            section supervisor or designee at least weekly with secondary review by
            the pathologist, lab director or designee at least monthly.  This review
            should be documented to include the date of review and reviewer’s
            initials.                                   

4.         Corrective action must be taken and properly documented prior to the
                        release of patient results.                                   

5.         Control specimens should be recorded in the Laboratory Information
                        System, where applicable, to approximate the same reporting mechanism
                        as patient results as well as to allow for long term results retrieval and
                        statistical evaluation. 

H.                Instruments and Equipment 

                             1.         The laboratory will purchase volumetric glassware of certified accuracy
                                                whenever possible. If non-certified volumetric glassware is purchased,
                                                all items must be checked for accuracy prior to use.                                     

2.         Volumetric pipettes should be stored segregated by size and type.  Any
                        glassware which becomes damaged or unable to be read will be
                        appropriately discarded.                                   

3.         Procedures for cleaning glassware should be developed to ensure
                        adequate washing and proper rinsing of reusable laboratory
                        glassware.                                   

4.         Laboratory sections should develop procedures for the periodic checks
                        of the following laboratory equipment:

                                                a)         automatic pipettes

                                                b)         dilutors

                                                c)         non-certified thermometers

                                                d)         temperature-dependent equipment

                                                e)         centrifuges

                                                f)          analytic balances                                   

5.         Procedures for checks of pipettes should provide for initial checks of
                        accuracy and precision before the device is placed into use.  The
                        procedure should include:

                                                a)         the process to verify accuracy and precision

                                                b)         the defined interval for rechecks

                                                c)         explanation for documentation of checks

                                                d)         how to perform corrective action 

6.         The procedure for checking temperature dependent equipment may      
                        be incorporated into other procedures or may be part of an instrument
                        maintenance procedure. 

The procedure should include:

                                                a)         definition of acceptable temperature ranges

                                                b)         steps to follow to record temperature

                                                c)         corrective action steps if acceptable limits are exceeded                                   

7.         Quality assurance procedures should provide for periodic checks and
                        cleaning of centrifuges as well as proper monitoring and servicing of
                        analytic balances. 

I.                   Multiple Analysis Automated Instruments and System 

                             1.         Each lab section which employs automated equipment or systems
                                                should develop and maintain procedures for the standard set-up and
                                                operation of the system.  Procedures should include:

                                                a)         evaluation of precision and accuracy

                                                b)         a schedule for, and record of, function checks and periodic
                                                            service procedures

                                                c)         a procedure for calibration and performance of quality control
                                                            materials                                   

2.         Each laboratory section employing automated systems should develop
                        procedures for recording and analyzing results of controls and other
                        function checks daily to detect instrument or process failure.                                   

3.         If multiple instruments perform the same assay, a procedure should be
                        developed to check for calibration agreement and patient result
                        correlation. 

4.         Current test methods including performance specifications, whether on  
            multiple test analyzers or independent tests, are available to clients upon 
            request.  

J.                  Instrument Maintenance 

                             1.         Each lab section should develop and maintain a procedure and/or
                                                schedule for instrument maintenance which verifies the critical
                                                operating characteristics of all instruments or components in use.                                   

2.         Maintenance procedures should define tolerance limits for
                        acceptable functions where appropriate and should include:

                                                a)         stepwise instructions for performing maintenance and/or
                                                            checks 

                                                b)         instructions for documentation of maintenance and/or checks                                   

3.         Procedures should include instructions for minor troubleshooting
                        and instrument repair, and may include or refer to manufacturer’s
                        service manual.                                   

4.         Instrument maintenance and function checks should be documented
                        by the technical operator.  Records of such checks, as well as service
                        calls and repairs, should be readily available to the technical
                        operating staff at or near the instrument to detect trends or
                        malfunctions. 

5.        In order to minimize the possibility that duplicate analyzers are out of
                    service at the same time, appropriate measures will be taken by all lab
                    staff to assure that acceptable quality control is achieved on any
                    analyzer on which maintenance or repairs have been performed before
                    beginning any maintenance or repairs procedures on the second analyzer.
                    The Clinical Lab Medical Director and Lab Manager on call must be notified
                    in the event that duplicate analyzers are out of service and lab work is
                    being significantly delayed.

III.             Personnel 

            A.        The laboratory should have an organizational plan, personnel policies and job
                        description in accordance with Human Resources requirements. 

            B.         The laboratory will be staffed by appropriately trained and certified individuals in
                        accordance with state and federal requirements. 

            C.        Appropriate personnel files will be maintained for each employee. 
 

IV.              Physical Facilities 

            A.        The laboratory should have adequate space for the overall workload so that the
                        quality of patient results, quality of control procedures, safety of personnel, and
                        patient care services are not compromised.           

  B.         The available space should be efficiently utilized, and kept clean and well
                        maintained.           

            C.        The laboratory should have adequate procedures and space for inventory, ordering
                        and storage of supplies and reagents.  The storage areas should be well-organized and
                        maintained. 

            D.        The laboratory should establish procedures to ensure the integrity of temperature-
                        controlled reagents. 

V.                 Laboratory Safety 

          A.        The laboratory will develop and maintain policies and procedures to ensure the
                        safety of laboratory personnel and patients.  These policies and procedures
                        should also ensure compliance with regulatory agencies.           

B.         Safety policies and procedures should be posted and/or readily available to all
            personnel. 

C.        Procedures should be developed to ensure that all occupational illnesses or
                        injuries are documented, treated, and evaluated.           

D.        Employees should receive training in use of fire fighting equipment and drills,
                        safe handling of electrical equipment and hazard controls.           

E.         The laboratory must develop a Chemical Hygiene Plan which develops safety
                        procedures for all hazardous chemicals used in the laboratory.  There must also
                        be annual review and evaluation of the effectiveness of the laboratory’s Chemical
                        Hygiene Plan.           

F.         Safety procedures should define a method for the disposal of all hazardous wastes
                        and a program to reduce the volume of hazardous waste generated by the
                        laboratory.           

G.        Safety procedures should include programs for emergency preparedness, evacuation
plans, radiation safety and procedures for biohazard control.           

H.        The laboratory’s safety program must include a documented policy for universal
                        precautions in accordance with the OSHA Standard on “Occupational Exposure
                        To Bloodborne Pathogens.”           

I.          The laboratory should provide for training of all applicable personnel in the proper
                        use of personal protective equipment (PPE), precautionary measures, and the
                        application of “universal precaution” to their work practices.           

J.          The laboratory should have in place a program for the follow-up procedure after
                        possible and known exposures to HIV, HBV, or HCV.           

K.        The laboratory should establish and periodically review procedures for safe work
                        practices. 

VI.              Quality Improvement 

          A.        The laboratory should establish a systematic program for the monitoring and
                        evaluation of the quality and appropriateness of its contribution to patient care.
                        Communication regarding quality issues is reviewed daily at morning report and/or
                        recorded in the Red Communication Book maintained by the Tech in Charge for
                        the evening and night shift.  Follow-up action, including variance and Patient
                        Safety Net reporting will be taken as necessary.
           

B.         The laboratory’s continuous quality improvement program should provide for
                        each laboratory section to participate in problem identification and resolution.           

C.        The program should provide for documentation of all problems and include steps
                        for investigation, monitoring and corrective action of problems. 

D.        The quality improvement program should include provisions for reporting
                        problems to appropriate individuals and an established quality improvement
                        committee.  The quality improvement committee should consist of:

                        1.         The Laboratory Director

                        2.         Professional laboratory personnel           

E.                  The continuous quality improvement program should be evaluated annually.         

 

**Policy review dates and signatures are available and on file in the laboratory.

(Original on file) 

 

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