All common checklist

Question 1

COM.01000, 2, PT Procedure

Answer 1

The laboratory has written procedures for proficiency testing sufficient for the extent and complexity of testing done in the laboratory. NOTE: must have written procedures for the proper handling, analysis, review and reporting of proficiency testing materials. There must be written procedure(s) for investigation and correction of problems that are identified by unacceptable proficiency testing results. The laboratory should also have procedure(s) for investigation of results that, although acceptable show bias or trends suggesting a problem.

Question 2

COM.01100, 2, Ungraded PT Challenges

Answer 2

“The laboratory has a procedure for assessing its performance on PT challenges that were intended to be graded, but were not. NOTE: This requirement addresses PT challenges that were intended to be graded, but were not, for reasons such as: 1) the laboratory submitted its results after the cut-off date, 2) the laboratory did not submit results, 3) the laboratory did not complete the result form correctly (for example, submitting the wrong method code or recording the result in the wrong place). Also, if possible, the laboratory should assess its performance on PT challenges that were not graded because of lack of consensus. For guidance on the approach to these situations, refer to appendix I in the CAP Laboratory Accreditation Manual for listing of PT exception codes and actions. Evidence of Compliance:

Records of review and evaluation of ungraded PT challenges”

Question 3

COM.01200, 1, Activity Menu

Answer 3

“The laboratory’s current CAP Activity Menu accurately reflects the testing performed. NOTE: The Activity Menu should at all times reflect the laboratory’s current testing. The accuracy of the Activity Menu can be assessed by inquiry of responsible individuals, and by examination of the laboratory’s test requisition(s), computer order screens, procedure manuals, or patient reports. All tests listed on the CAP Master Activity Menu performed by the laboratory must be reflected on its activity menu, and those that have been discontinued must have been removed.

In order to ensure proper customization of the checklists, the laboratory should also ensure that the activity menu is accurate for non-test activities, such as methods and types of services offered.

Some activities are included on the Master Activity Menu using more generic groupings or panels instead of listing the individual tests. The Master Activity Menu represents only those analytes that are directly measured. Calculations are not included, with a few exceptions (e.g. INR, hematocrit).

Question 4

COM.01300, 2, PT Participation

Answer 4

“The laboratory participates in the appropriate required proficiency testing (PT)external quality assessment (EQA) program accepted by CAP for the patient testing performed.
NOTE : This checklist requirement applies to both waived and nonwaived tests.

NOTE 3: If unable to participate, however, the laboratory must implement an alternative assessment procedure for the affected analytes. For regulated analytes, if the CAP and CAP-accepted PT programs are oversubscribed, CMS requires the laboratory to attempt to enroll in another CMS-approved PT program.

NOTE 5: Proficiency testing for HER2 is method specific, the laboratory must participate in PT for each method.

Enroll in an appropriate PT Program
Send PT materials to the staining facility for preparation, and
Interpret the resulting stains using the same procedures that are used for patient specimens

B. HER2 interpretation by FISH (or ISH): If the laboratory sends its FISH (or ISH) slides for hybridization to another facility, the laboratory must perform an alternative assessment of the test twice annually and may not participate in formal (external) PT.

Records such as CAP order form or purchase order indicating that the laboratory is enrolled in CAP PT Programs for all analytes that CAP requires PT OR record of completedsubmitted result forms for all analytes on the activity menu”

Question 5

COM.01400, 2, Attestation Page

Answer 5

“The proficiency testing attestation statement is signed by the laboratory director or designee and the individual performing the testing. NOTE: Physical signatures must appear on the original paper attestation form. A listing of typed names on the attestation statement does not meet the intent of the requirement. Evidence of Compliance:

Appropriately signed attestation statement from submitted PT result forms”

Question 6

COM.01500, 2, Alternative Performance Assessment

Answer 6

“For tests for which CAP does not require PT, the laboratory at least semi-annually exercises an alternative performance assessment system for determining the reliability of analytic testing. NOTE 1: Appropriate alternative performance assessment procedures include participation in an external PT program not required by CAP; participation in an ungradededucational PT program; split sample analysis with reference or other laboratories, split samples with an established in-house method, clinical validation by chart review, or other suitable and documented means. It is the responsibility of the laboratory director to define such alternative assessment procedures and the criteria for successful performance in accordance with good clinical and scientific laboratory practice.

List of tests defined by the laboratory as requiring alternative assessments AND
Records of those assessments”

Question 7

COM.01600, 2, PT Integration Routine Workload

Answer 7

“The laboratory integrates all proficiency testing samples within the routine laboratory workload, and those samples are analyzed by personnel who routinely test patientclient samples, using the same primary method systems as for patientclientdonor samples. NOTE: Duplicate analysis of any proficiency sample is acceptable only if patientclient specimens are routinely analyzed in the same manner. With respect to morphologic examinations (identification of cell types and microorganisms; review of electrophoretic patterns, etc.), group review and consensus identifications are permitted only for unknown samples that would ordinarily be reviewed by more than one person in an actual patient sample.

If the laboratory uses multiple methods for an analyte, proficiency samples should be analyzed by the primary method. The educational purposes of proficiency testing are best served by a rotation that allows all technologists to be involved in the proficiency testing program. Proficiency testing records must be retained and can be an important part of the competency and continuing education documentation in the personnel files of the individuals. When external proficiency testing materials are not available, the semi-annual alternative performance assessment process should also be integrated within the routine workload, if practical. Evidence of Compliance:

Written policy describing proper handling of PT specimens AND
Instrument printout andor work records AND
Completed attestation pages from submitted PT result forms”

Question 8

COM.01700, 2, PT Evaluation

Answer 8

“There is ongoing evaluation of PT and alternative assessment results, with prompt corrective action taken for unacceptable results. NOTE: Primary records related to PT and alternative assessment testing are retained for two years (unless a longer retention period is required elsewhere in this checklist for specific analytes or disciplines). These include all instrument tapes, work cards, computer printouts, evaluation reports, evidence of review, and documentation of follow-upcorrective action.

For laboratories outside the US, PT failures relating to problems with shipping and specimen stability should include working with local customs and health regulators to ensure appropriate transit of proficiency testing specimens. Evidence of Compliance:

Records of ongoing, timely review of all PT reports and alternative assessment results by the laboratory director or designee AND
Records of investigation of unacceptable PT and alternative assessment results including records of corrective action that is appropriate to the nature and magnitude of the problem”

Question 9

COM.01800, 2, PT Interlaboratory Communication

Answer 9

There is a policy that prohibits interlaboratory communication about proficiency testing samples until after the deadline for submission of data to the proficiency testing provider. NOTE: There is a strict prohibition against interlaboratory communications about proficiency testing samples until after the deadline for submission of data to the proficiency testing provider. The laboratory director is responsible for enforcing this prohibition. Documentation of training on the handling of PT samples and prevention of interlaboratory communication is strongly recommended.

Question 10

COM.01900, 2, PT Referral

Answer 10

“There is a policy that prohibits referral of proficiency testing specimens to another laboratory or acceptance from another laboratory. NOTE: This prohibition takes precedence over the requirement that proficiency testing specimens be handled in the same manner as patient specimens. For example, a laboratory’s routine procedure for review of abnormal blood smears might be referral of the smear to a pathologist located at another site. For proficiency testing specimens, the referring laboratory must NOT follow its routine procedure in this situation. Rather, the laboratory must submit a PT result of test not performed since the review does not occur within the referring laboratory.

For laboratories subject to US regulations, this applies even if the second laboratory is in the same health care system. It is the responsibility of the laboratory director to ensure that this prohibition is enforced.

Documentation of training on referral and acceptance of PT samples is strongly recommended.

Question 11

COM.04000, 2, Documented QMQC Plan

Answer 11

“The laboratory has a written quality managementquality control (QMQC) program. NOTE: The program must ensure quality throughout the pre-analytic, analytic, and post-analytic (reporting) phases of testing, including patient identification and preparation; specimen collection, identification, preservation, transportation, and processing; and accurate, timely result reporting. The program must be capable of detecting problems in the laboratory’s systems, and identifying opportunities for system improvement. The laboratory must be able to develop plans of correctivepreventive action based on data from its QM system.

All QM requirements in the Laboratory General Checklist pertain to the laboratory. Evidence of Compliance: Records reflecting conformance with the program as designed AND
Results of quality surveillance”

Question 12

COM.04050, 2, Unusual Laboratory Results

Answer 12

“There is a documented system in operation to detect and correct significant clerical and analytical errors, and unusual laboratory results, in a timely manner. NOTE: One common method is review of results by a qualified person (technologist, supervisor, pathologist) before release from the laboratory, but there is no requirement for supervisory review of all reported data for single analyte tests that do not include interpretation. In computerized laboratories, there should be automatic traps for improbable results. The system for detecting clerical errors, significant analytical errors, and unusual laboratory results must provide for timely correction of errors, i.e. before results become available for clinical decision making. For confirmed errors detected after reporting, corrections must be promptly made and reported to the ordering physician or referring laboratory, as applicable.

Each procedure must include a listing of common situations that may cause analytically inaccurate results, together with a defined protocol for dealing with such analytic errors or interferences. This may require alternate testing methods; in some situations, it may not be possible to report results for some or all of the tests requested.

The intent of this requirement is NOT to require verification of all results outside the reference (normal) range. Evidence of Compliance: Records of review of results OR records of consistent implementation of the error detection system(s) defined in the procedure AND
Records of timely corrective action of identified errors”

Question 13

COM.04100, 2, Supervisory Result Review

Answer 13

“In the absence of on-site supervisors, high complexity testing performed by trained high school graduates qualifying as high complexity testing personnel is reviewed by the laboratory director or supervisorgeneral supervisor within 24 hours. NOTE: The CAP does NOT require supervisory review of all test results before or after reporting to patient records. Rather, this requirement is intended to address only that situation for high complexity testing performed by trained high school graduates qualifying under the CLIA regulation 42CFR493.1489(b)(5)(i)(A)(B) when a qualified supervisorgeneral supervisor is not present.

The qualifications to perform high complexity testing can be accessed using the following link: CAP Personnel Requirements by Testing Complexity. Evidence of Compliance: Written policy defining the review process and personnel whose results require review AND
Records of result review for specified personnel”

Question 14

COM.04150, 2, Specimen Collection Manual

Answer 14

“There is a documented procedure describing methods for patient identification, patient preparation, specimen collection and labeling, specimen preservation, and conditions for transportation, and storage before testing, consistent with good laboratory practice. NOTE: The proximity of the patient to the test site does not preclude the need for proper identification systems to prevent reporting of one patient’s result to another’s record. Refer to the Specimen Collection section of the Laboratory General Checklist for additional information.

Identification requirements apply to aliquots as well as to primary specimens. “

Question 15

COM.04200, 2, InstrumentEquipment Record Review

Answer 15

Instrument and equipment maintenance and function check records are reviewed and assessed at least monthly by the laboratory director or designee.

Question 16

COM.04250, 2, Comparability of InstrumentsMethods

Answer 16

“If the laboratory uses more than one nonwaived instrumentmethod to test for a given analyte, the instrumentsmethods are checked against each other at least twice a year for comparability of results. NOTE: This requirement applies to tests performed on the same or different instrument makesmodels or by different methods. The purpose of the requirement is to evaluate the relationship between test results using different methodologies, instruments, or testing sites. This comparison is required only for nonwaived instrumentsmethods accredited under a single CAP number. The laboratory must establish a protocol for this check that includes acceptance criteria.

Quality control data may be used for this comparison for tests performed on the same instrument platform, with both control materials and reagents of the same manufacturer and lot number.

Otherwise, the use of human samples, rather than stabilized commercial controls, is preferred to avoid potential matrix effects. The use of pooled patient samples is acceptable since there is no change in matrix. In cases when availability or pre-analytical stability of patientclient specimens is a limiting factor, alternative protocols based on QC or reference materials may be necessary but the materials used should be validated (when applicable) to have the same response as fresh human samples for the instrumentsmethods involved.

This requirement only applies when the instrumentsreagents are producing the same reportable result. For example, some laboratories may use multiple aPTT reagents with variable sensitivity to the lupus anticoagulant. If these are defined as separate tests, then this requirement does not apply unless each type of aPTT test is performed on more than one analyzer.

For Microbiology testing, this requirement applies when two instruments (same or different manufacturers) are used to detect the same analyte. Two or more detectors or incubation cells connected to a single data collection, analysis and reporting computer need not be considered separate systems (e.g. multiple incubation and monitoring cells in a continuous monitoring blood culture instrument, two identical blood culture instruments connected to a single computer system, or multiple thermocycler cells in a real time polymerase chain reaction instrument). This checklist requirement does not apply to multiple analytical methods (e.g. antigen typing versus culture or detection of DNA versus a biochemical characteristic) designed to detect the same analyte. Evidence of Compliance:

Written procedure for performing instrumentmethod comparison AND Records of comparability studies reflecting performance at least twice per year with appropriate specimen types”

Question 17

COM.04300, 2, Comparability CriteriaCorrective Action

Answer 17

“Acceptability criteria are defined for comparability of instrumentsmethods used to test the same analyte, with documentation of corrective actions when the criteria are not met. NOTE: Statistically defined acceptability limits should be used for quantitative assays. Evidence of Compliance:

Records of comparability studies with evidence of review and corrective action, as appropriate”

Question 18

COM.10000, 2, Procedure Manual

Answer 18

COM.10100, 2, Procedure Manual Review

Question 19

COM.10200, 2, New Procedure Review

Answer 19

“The laboratory director reviews and approves all new technical policies and procedures, as well as substantial changes to existing documents, before implementation. NOTE: This review may not be delegated to designees in laboratories subject to the CLIA regulations.

Paperelectronic signature review is required. A secure electronic signature is desirable, but not required. Evidence of Compliance: Policy on procedure review AND Records of policyprocedure approval”

Question 20

COM.10250, 2, New Procedure Review (Not Subject to US Regulations)

Answer 20

“For laboratories not subject to US regulations, the laboratory director or designee reviews and approves all new technical policies and procedures, as well as substantial changes to existing documents before implementation. NOTE: Paperelectronic signature review is required. A secure electronic signature is desirable, but not required. Evidence of Compliance:

Policy on procedure review AND
Records of policyprocedure approval”

Question 21

COM.10300, 2, Knowledge of Procedures

Answer 21

“The laboratory has a system documenting that all personnel are knowledgeable about the contents of procedure manuals (including changes) relevant to the scope of their testing activities. NOTE: The form of this system is at the discretion of the laboratory director. Annual procedure sign-off by testing personnel is not specifically required. Evidence of Compliance:

Records indicating that the testing personnel have read the procedures, new and revised, OR records of another documented method approved by the laboratory director”

Question 22

COM.10300, 2, Knowledge of Procedures

Answer 22

“The laboratory has a system documenting that all personnel are knowledgeable about the contents of procedure manuals (including changes) relevant to the scope of their testing activities. NOTE: The form of this system is at the discretion of the laboratory director. Annual procedure sign-off by testing personnel is not specifically required. Evidence of Compliance:

Records indicating that the testing personnel have read the procedures, new and revised, OR records of another documented method approved by the laboratory director”

Question 23

COM.29950, 2, Reference Intervals

Answer 23

“All patientclient results are reported with reference (normal) intervals or interpretations as appropriate. NOTE: The laboratory must report reference (normal) intervals or interpretations with patientclient results, where such exist. This is important to allow proper interpretation of patientclient data. Age- andor sex-specific reference ranges (normal values) or interpretive ranges must be reported with patient test results, as applicable. In addition, the use of high and low flags (generally available with a computerized laboratory information system) is recommended. It is not necessary to include reference intervals when test results are reported as part of a treatment protocol that includes clinical actions, which are based on the test result.

Under some circumstances it may be appropriate to distribute lists or tables of reference intervals to all users and sites where reports are received. This system is usually fraught with difficulties, but if in place and rigidly controlled, it is acceptable. “

Question 24

COM.30000, 2, Critical Result Notification

Answer 24

“The laboratory has procedures for immediate notification of a physician (or other clinical personnel responsible for the patient’s care) when results of designated tests exceed established alert or critical values that are important for prompt patient management decisions. NOTE: Alert or critical results are those results that may require rapid clinical attention to avert significant patient morbidity or mortality. Each laboratory may define the critical values and critical results that pertain to its patient population. The laboratory may establish different critical results for specific patient subpopulations (for example, dialysis clinic patients). Critical results should be defined by the laboratory director, in consultation with the clinicians served.

Allowing clinicians to opt out of receiving critical results is strongly discouraged.

Records must be maintained showing prompt notification of the appropriate clinical individual after obtaining results in the critical range. These records should include: date, time, responsible laboratory individual, person notified (the person’s first name alone is not adequate documentation), and test results. Any problem encountered in accomplishing this task should be investigated to prevent recurrence.

Reference laboratories may report critical results directly to clinical personnel, or to the referring laboratory. The reference laboratory should have a written agreement with the referring laboratory that indicates to whom the reference laboratory reports critical results.

In the point-of-care setting, the identity of the testing individual and person notified need not be documented when the individual performing the test is the same person who treats the patient. In this circumstance, however, there must be documentation of the critical result, date, and time in the test report or elsewhere in the medical record. “

Question 25

COM.30100, 1, Critical Result Read-Back

Answer 25

“When critical results are communicated by phone, there is a policy that “read-back” of the results is requested and documented. NOTE: Transmission of critical results by electronic means (FAX or computer) is acceptable. If critical results are transmitted electronically, the laboratory should confirm receipt of the result by the intended recipient (e.g. by a phone call); however, no read-back is necessary. Evidence of Compliance:

Records of critical result notification with documentation of read-back”

Question 26

COM.30250, 2, Reagent HandlingStorage - Waived Tests

Answer 26

“For waived tests, the laboratory follows manufacturer instructions for handling and storing reagents, cartridges, test cards, etc. NOTE: There is no requirement to routinely label individual containers with date opened; however, a new expiration date must be recorded if opening the container changes the expiration date, storage requirement, etc.

If the manufacturer defines a required storage temperature range, the temperature of storage areas must be monitored and recorded daily. The two acceptable ways of recording temperatures are: 1) recording the numerical temperature, or 2) placing a mark on a graph that corresponds to a numerical temperature (either manually, or using a graphical recording device). The identity of the individual recording the temperature(s) must be documented (recording the initials of the individual is adequate).

The use of automated (including remote) temperature monitoring systems is acceptable, providing that laboratory personnel have ongoing immediate access to the temperature data, so that appropriate corrective action can be taken if a temperature is out of the acceptable range. The functionality of the system must be documented daily. Evidence of Compliance:

Written procedure consistent with manufacturer’s instructions for each waived test”

Question 27

COM.10500, 2, Discontinued Procedure

Answer 27

“When a procedure is discontinued, a paper or electronic copy is maintained for at least 2 years, recording initial date of use, and retirement date. NOTE 1: In transfusion medicine, procedures related to donor collection, transfusion, and administration of tissues and progenitor cells, procedures (paper or electronic) must be maintained for 5 years.

NOTE 2: For genetic testing, in order to meet the requirements of some states relating to the testing of minors (under the age of 21), it is recommended that laboratories retain procedures (paper or electronic) for at least 23 years (to cover the interval from fetal period to age 21). “

Question 28

COM.30300, 2, Reagent Labeling

Answer 28

“Reagents, calibrators, controls, and solutions are properly labeled, as applicable and appropriate, with the following elements.

1. Content and quantity, concentration or titer
2. Storage requirements
3. Date prepared or reconstituted by laboratory
4. Expiration date NOTE: The above elements may be recorded in a log (paper or electronic), rather than on the containers themselves, providing that all containers are identified so as to be traceable to the appropriate data in the log. While useful for inventory management, labeling with date received is not routinely required. There is no requirement to routinely label individual containers with date opened; however, a new expiration date must be recorded if opening the container changes the expiration date, storage requirement, etc. Evidence of Compliance:

Written policy defining elements required for reagent labeling”

Question 29

COM.30350, 2, Reagent Storage

Answer 29

“All reagents and media are stored and handled as recommended by the manufacturer. NOTE: Reagents and media must be stored and handled as recommended by the manufacturer to prevent environmentally-induced alterations that could affect reagent stability and test performance. Prepared reagents must be properly stored, mixed when appropriate, and discarded when stability parameters are exceeded.

If ambient storage temperature is indicated, there must be documentation that the defined ambient temperature is maintained and corrective action taken when tolerance limits are exceeded.

A frost-free freezer may be used to store reagents and controls provided that the function of these materials is not compromised. Storage conditions must remain within the specifications of the manufacturer of the reagent or control. Temperatures may be recorded using a continuous monitoring system or a maximumminimum thermometer. Thermal containers within the freezer may be used.

Patient samples may be stored in a frost-free freezer only if protected from thawing. The laboratory must be able to document that the temperatures stay within the defined range. Evidence of Compliance:

Records of reagent and media storage and handling consistent with manufacturer’s instructions, including refrigerator, freezer and room temperature monitoring, as applicable”

Question 30

COM.30400, 2, Reagent Expiration Date

Answer 30

“All reagents and media are used within their indicated expiration date. NOTE: The laboratory must assign an expiration date to any reagents and media that do not have a manufacturer-provided expiration date. The assigned expiration date should be based on known stability, frequency of use, storage conditions, and risk of deterioration.

Separate requirements for rare blood banking reagents are included in the Transfusion Medicine Checklist.

For laboratories not subject to US regulations and military laboratories in overseas locations, expired reagents may be used only under the following circumstances: 1) The reagents are unique, rare or difficult to obtain; or 2) Delivery of new shipments of reagents is delayed through causes not under control of the laboratory. The laboratory must document verification of the performance of expired reagents in accordance with written laboratory policy.

Laboratories subject to US regulations must not use expired reagents. Evidence of Compliance:

Written policy for evaluating reagents and media lacking manufacturer’s expiration date”

Question 31

COM.30450, 2, New Reagent Lot Confirmation of Acceptability

Answer 31

“New reagent lots andor shipments are checked against old reagent lots or with suitable reference material before or concurrently with being placed in service. NOTE: The purpose of this check is to confirm that the use of the new reagent lot or shipment does not affect patient results. Matrix interferences between different lots of reagents may impact the calibration status of instruments and consistency of patient results. Improper storage conditions during shipping of reagents may have a negative impact on their ability to perform or exhibit the same levels of reactivity as intended.

Qualitative: For qualitative nonwaived tests, minimum cross-checking includes retesting at least one positive and negative sample with known reactivity against the new reagent lot. A weakly positive sample should also be used in systems where patient results are reported in that fashion.

Examples of suitable reference materials for qualitative tests include:

1. Positive and negative patient samples tested on a previous lot;
2. Previously tested proficiency testing materials;
3. External QC materials tested on the previous lot;
4. Control strains of organisms or previously identified organisms for microbiology reagents used to detect or evaluate cultured microorganisms.

For flow cytometry reagents, please refer to the Reagents section of the Flow Cytometry Checklist.

Quantitative: For quantitative nonwaived tests, patient specimens should be used to compare a new lot against the old lot, when possible. Manufactured materials, such as proficiency testing (PT) or QC materials may be affected by matrix interference between different reagent lots, even if results show no change following a reagent lot change. The use of patient samples confirms the absence of matrix interference. Other than patient samples, the following materials may also be used:

1. Reference materials or QC products provided by the method manufacturer with method specific and reagent lot specific target values;
2. Proficiency testing materials with peer group established means;
3. QC materials with peer group established means based on interlaboratory comparison that is method specific and includes data from at least 10 laboratories;
4. Third party general purpose reference materials if the material is documented in the package insert or by the method manufacturer to be commutable with patient specimens for the method.
5. QC material used to test the current lot is adequate alone to check a new shipment of the same reagent lot, as there should be no change in potential matrix interactions between the QC material and different shipments of the same lot number of reagents.

For hematology analyzers, reservoirs containing testing reagents and cleaningdecontaminating solutions must be checked according to manufacturer’s instructions. Evidence of Compliance:

Written procedure for the confirmation of acceptability of new lots and shipments prior to use AND
Records of acceptability study of new reagentsshipments”

Question 32

COM.30500, 2, Reagent Kit Components

Answer 32

“If there are multiple components of a reagent kit, the laboratory uses components of reagent kits only within the kit lot unless otherwise specified by the manufacturer. Evidence of Compliance:

Written documentation defining allowable exceptions for mixing kit components from different lots”

Question 33

COM.30525, 2, Maintenance and Function Checks - Waived Tests

Answer 33

“For waived tests, the laboratory follows manufacturer instructions for instrument and equipment maintenance and function checks. Evidence of Compliance:

Written procedure consistent with manufacturer’s instructions for each waived test AND
Records for instrumentequipment maintenance and function checks as required by the manufacturer”

Question 34

COM.30550, 2, InstrumentEquipment Performance Verification

Answer 34

“The performance of all instruments and equipment is verified upon installation and after repair or reconditioning to ensure that they run according to expectations. NOTE: Performance verification is necessary after repairs or replacement of critical components of an instrument or item of equipment. Evidence of Compliance:

Written procedure for performance verification AND

Records of performance verification”

Question 35

COM.30575, 2, InstrumentOperation

Answer 35

There are documented standard procedures for start-up, operation and shutdown of instruments and equipment, as applicable. NOTE: These procedures must readily be available to the operator in the immediate vicinity of the instrument, and ideally should include a procedure for emergency shutdown. These may be separate approved procedures or included in the testing procedure for a specific analyte.

Question 36

COM.30600, 2, MaintenanceFunction Checks

Answer 36

“Appropriate maintenance and function checks are performed and documented for all instruments (e.g. analyzers) and equipment (e.g. centrifuges) following a defined schedule, at least as frequent as specified by the manufacturer. NOTE: There must be a schedule and procedure at the instrument for appropriate function checks and maintenance. These may include (but are not limited to) cleaning, electronic, mechanical and operational checks. The procedure and schedule must be as thorough and as frequent as specified by the manufacturer.

Function checks should be designed to detect drift, instability, or malfunction, before the problem is allowed to affect test results.

For equipment that have no standard frequency or requirement for maintenance and function checks, each laboratory should establish a schedule and procedure that reasonably reflects the workload and specifications of its equipment. “

Question 37

COM.30625, 2, Function Check Tolerance Limits

Answer 37

Tolerance limits for acceptable function are documented for specific instruments and equipment wherever appropriate, with documented corrective action when the limits are exceeded. NOTE: The defined tolerance limits must follow the manufacturer’s specified limits. Function checks must be within the defined tolerance limits prior to use for testing patient samples.

Question 38

COM.30650, 2, Instrument Troubleshooting

Answer 38

Instructions are provided for minor troubleshooting and repairs of instruments (such as manufacturer’s service manual).

Question 39

COM.30675, 2, InstrumentEquipment Records

Answer 39

Instrument and equipment maintenance, function check, performance verification, and service and repair records (or copies) are promptly available to, and usable by, the technical staff operating the equipment. NOTE: Effective utilization of instruments and equipment by the technical staff depends upon the prompt availability of the records (copies are acceptable) to detect trends or malfunctions. Offsite storage, such as with centralized medical maintenance or computer files, is acceptable if the inspector is satisfied that the records can be promptly retrieved.

Question 40

COM.30700, 2, Thermometric Standard Device

Answer 40

“An appropriate thermometric standard device of known accuracy (guaranteed by manufacturer to meet NIST Standards or traceable to NIST Standards) is available. NOTE: Thermometric standard devices must be recalibrated, recertified, or replaced prior to the date of expiration of the guarantee of calibration or they are subject to requirements for non-certified thermometers.

Thermometers should be periodically evaluated for damage (e.g. separation of columns). Thermometers with obvious damage should be rechecked for continued use. Evidence of Compliance:

Thermometer certificate of accuracy AND
Policy for the continued use of certified thermometers”

Question 41

COM.30725, 2, Non-certified Thermometers

Answer 41

“All non-certified thermometers in use are checked against an appropriate thermometric standard device before initial use and as defined by laboratory policy. NOTE: Non-certified thermometers used in transfusion medicine, including blood-warmer thermometers, must be checked at least annually.

If digital or other displays of temperatures on equipment are used for daily monitoring, the laboratory must verify that the readout is accurate. The display must be checked initially and following manufacturer’s instructions. Evidence of Compliance:

Written procedure defining verification of non-certified thermometers AND
Written policy for rechecking of non-certified thermometers AND
Records of verification “

Question 42

COM.30750, 2, Temperature Checks

Answer 42

“Temperatures are checked and recorded each day of use for all temperature-dependent equipment and environments using a calibrated thermometer. NOTE: Temperature-dependent equipment (e.g. refrigerators, freezers, incubators) containing reagents andor patientclient specimens must be monitored daily, as equipment failures could affect accuracy of patientclient test results. Items such as water baths and heat blocks used for procedures need only be checked on days of patientclient testing.

If specific instruments, equipment, kits, or supplies have specified ambient temperature ranges for proper operation or use, there must be documentation that the specified ambient temperature is maintained and corrective action taken when tolerance limits are exceeded.

The two acceptable ways of recording temperatures are: 1) recording the numerical temperature, or 2) placing a mark on a graph that corresponds to a numerical temperature (either manually, or using a graphical recording device). The identity of the individual recording the temperature(s) must be documented (recording the initials of the individual is adequate).

The use of automated (including remote) temperature monitoring systems is acceptable, providing that laboratory personnel have ongoing immediate access to the temperature data, so that appropriate corrective action can be taken if a temperature is out of the acceptable range. The daily functionality of the system must be documented.

For heat blocks or dry baths, thermocouple probes may be used as an alternative method for checking the temperature. “

Question 43

COM.30775, 2, Temperature Range

Answer 43

“Acceptable ranges have been defined for all temperature-dependent equipment and environments (including test-dependent ambient temperature) in accordance with the manufacturer instructions. Evidence of Compliance:

Temperature log or record with defined acceptable range”

Question 44

COM.30800, 2, Temperature Corrective Action

Answer 44

There is evidence of corrective action taken if acceptable temperature ranges for temperature-dependent equipment are exceeded, including evaluation of contents of refrigerators and freezers for adverse effects. NOTE: If acceptable temperature ranges for refrigerators andor freezers are exceeded, stored reagents, controls, calibrators, etc. must be checked to confirm the accuracy or quality of the material before use and documented. The check should follow a defined protocol or procedure.

Question 45

COM.40000, 2, Method ValidationVerification Approval

Answer 45

“There is a summary statement, signed by the laboratory director (or designee who meets CAP director qualifications) prior to use in patient testing, documenting evaluation of validationverification studies and approval of each test for clinical use. NOTE: This checklist item is applicable only to tests implemented after June 15, 2009.

The summary statement must include a written assessment of the validationverification study, including the acceptability of the data. The summary must also include a statement approving the test for clinical use with the approval signature such as, This validation study has been reviewed, and the performance of the method is considered acceptable for patient testing.

For an FDA-clearedapproved test, a summary of the verification data must address analytic performance specifications, including analytic accuracy, precision, interferences, and reportable range, as applicable.

In addition, for modified FDA-clearedapproved tests or LDTs, the summary must address analytical sensitivity, analytical specificity and any other parameter that is considered important to assure that the analytical performance of a test (e.g. specimen stability, reagent stability, linearity, carryover, and cross-contamination, etc.), as appropriate and applicable.

If the laboratory makes clinical claims about its tests, the summary must address the validation of these claims.

Summary of validationverification studies with review and approval”

Question 46

COM.40100, 2, Intermittent Testing

Answer 46

“When a test is put back into production, the following requirements must be met:

1. PT or alternative assessment performed within 30 days prior to restarting patient testing
2. Method performance specifications verified, as applicable, within 30 days prior to restarting patient testing
3. Competency assessed for analysts within 12 months prior to restarting patient testing NOTE: This requirement applies to tests that are taken out of production for a time (for example, seasonal testing for influenza). A test is considered to be taken out of production when (1) patient testing is not offered AND (2) PT or alternative assessment, as applicable, is suspended. It does not apply to situations where a proficiency testing challenge is not performed due to a temporary, short-term situation, such as a reagent back order or an instrument breakdown. In those situations, the laboratory must perform alternative assessment for that testing event.

The laboratory should have written procedures for putting intermittent tests into production.

For tests for which PT is required by CAP, if a PT challenge is not offered during the 30-day period prior to restarting patient testing, the laboratory may perform an alternative assessment of the test. The laboratory must participate in the next scheduled PT event, if the Laboratory Accreditation Program requires external PT for that analyte. “

Question 47

COM.40200, 1, LDT List

Answer 47

“The laboratory documents the list of laboratory-developed tests (LDTs) it has implemented during the previous 2 years. NOTE: This list will help the inspector review the analytic validation data for these tests.

This includes tests developed in-house, and for laboratories subject to US regulations, tests using ASRs, and FDA-clearedapproved tests that have been modified by the laboratory. “

Question 48

COM.40250, 2, Manufacturer Instructions

Answer 48

“The laboratory follows manufacturer instructions or provides documentation of validation if the test has been modified. NOTE: Following manufacturer instructions includes performing quality control, calibration, calibration verification, and related functions as applicable to the scope of testing. Reagents, fluids, and disposable materials supplied by the laboratory must meet the specifications in the instructions.

If the laboratory modifies manufacturer instructions, the test is no longer an FDA clearedapproved test, and the modification(s) must be validated by the laboratory. Changes in the specimen type or collection device are examples of common modifications (see modification of manufacturer’s instructions in the Definition of Terms). Additional requirements for validationverification may be found in the discipline-specific checklists.

For waived tests, if manufacturer instructions are modified, the test is no longer considered waived, and requirements for high complexity testing apply. Evidence of Compliance:

Documentation of validation of established performance specifications (accuracy, precision, analytic sensitivity, analytic specificity, interferences, reference range, and reportable range) of any test that has been modified.”

Question 49

COM.40300, 2, Analytic AccuracyPrecision

Answer 49

“The laboratory verifies or establishes analytic accuracy and precision for each test. NOTE: Where current technology permits, accuracy is established by comparing results to a definitive or reference method, or may be verified by comparing results to an established comparative method. Use of reference materials or other materials with known concentrations or activities is suggested in establishing or verifying accuracy. Precision is established by repeat measurement of samples at varying concentrations or activities within-run and between-run over a period of time. Evidence of Compliance:

Written procedure for determining method performance characteristics, including accuracyprecision AND
Records of verification or establishment of analytic accuracy and precision for each test”

Question 50

COM.40400, 2, Analytic Sensitivity

Answer 50

“For modified FDA-clearedapproved tests or laboratory-developed tests (LDTs), the laboratory establishes the analytic sensitivity (lower detection limit) of each assay, as applicable. Evidence of Compliance:

Written procedure for determining method performance characteristics, including analytic sensitivity AND
Records of establishment of analytic sensitivity for each assay”

Question 51

COM.40450, 2, Analytical SpecificityInterfering Substances

Answer 51

“For modified FDA-clearedapproved tests or laboratory-developed tests (LDTs), the results of each validation study include a sufficient number of samples to establish the test’s analytical specificity. NOTE: The analytical specificity refers to the ability of a test or procedure to correctly identify or quantify an entity in the presence of interfering or cross-reactive substances that might be expected to be present. Laboratories are encouraged to review the published literature for guidance and provided confidence intervals to estimated performance characteristics. Evidence of Compliance:

Records of validation studies and published references used to establish analytical specificity”

Question 52

COM.40500, 2, Analytic Interferences

Answer 52

“The laboratory understands the analytic interferences for each test, and has an appropriate plan of action when they are present. NOTE: Interfering substances may pose a significant problem to the clinical laboratory and healthcare providers who may be misled by laboratory results that do not reflect patient clinical status. The laboratory must be aware of common interferences by performing studies (during LDT validation) or referencing studies performed elsewhere (such as by the instrument-reagent manufacturer). Evidence of Compliance:

Written procedure for determining method performance characteristics, including analytic interferences AND
Document listing known interferences for each test and plan of action when they are present”

Question 53

COM.40600, 2, Reportable Range

Answer 53

“The reportable range (analytic measurement range) is verifiedestablished for each analytic procedure before implementation. NOTE: The analytic measurement range (AMR) is the range of analyte values that a method can directly measure on the specimen without any dilution or concentration.

Expanded definitions and details of the AMR are provided in some of the section-specific checklists (e.g. Chemistry). Verification of the AMR may not apply to certain assays (for example, in immunology and coagulation).

The limits of the AMR are based on meeting accuracy and precision requirements such as the minimal limit of quantification or sensitivity, when applicable. In some cases, clinically relevant limits may be narrower than the potential analytical range, and the clinically relevant limit would be used as the limit of the reportable range. Evidence of Compliance:

Written policy for determining method performance characteristics, including reportable range AND

Records of verification or establishment of reportable ranges for each test”

Question 54

COM.40620, 2, Body Fluid Validation

Answer 54

“Testing of body fluid specimens using methods intended for other specimen types (e.g. blood or other fluid) have been validated by the laboratory for accuracy, precision, analytic sensitivity, analytic specificity, interferences, and reportable range. NOTE: This requirement applies directly to body fluid testing that the laboratory offers as a routine, orderable test. If the test is routinely performed on the fluid, there must be a written procedure. The laboratory director determines the extent of the method performance specifications relevant for clinical purposes. Method performance specifications for blood specimens may be used for body fluids if the laboratory can reasonably exclude the existence of matrix interferences affecting the latter either by reference in the procedure manual to published literature or by evaluation for interferences due to matrix effects by performing an appropriate study (e.g. a dilution study using admixtures of samples, spiking samples, further dilution). The reference range must be defined and reported with results, unless the value is reported in comparison to its concentration in blood. Reference range citations from the manufacturer’s insert or published literature citations may be used to determine the range (COM.50000).

For clinically unique samples where specimens are submitted with a unique request based on an unusual clinical concern in a specific patient or situation (e.g. pathologic states where the analyte is not normally found in the fluid type), it may not be possible to establish test performance characteristics. Protein and lipid content can vary considerably from specimen to specimen. Normal fluid samples may not be obtainable. In such cases, the result must be accompanied by a comment such as, The reference range and other method performance specifications have not been established for this body fluid. The test result must be integrated into the clinical context for interpretation. “

Question 55

COM.40630, 1, LDT Reporting

Answer 55

Reports for laboratory-developed tests (LDTs) contain a description of the method, a statement that the assay was developed by the laboratory, and appropriate performance characteristics. NOTE: Requirements for reports are given in the Results Reporting sections of the checklists. Laboratories subject to US regulations often include an LDT disclaimer as follows: This test was developed and its performance characteristics determined by ,insert laboratorycompany name,. It has not been cleared or approved by the FDA. The laboratory is regulated under CLIA as qualified to perform high-complexity testing. This test is used for clinical purposes. It should not be regarded as investigational or for research.

Question 56

COM.40640, 2, LDT Clinical Claims Validation

Answer 56

“All clinical claims made by the laboratory about a laboratory-developed test (LDT) are validated. NOTE: Clinical claims may include statements about a test’s diagnostic sensitivity and specificity, ability to predict the risk of a disease or condition, clinical usefulness, or cost-effectiveness. Clinical claims may be found on the test report or in other information distributed by the laboratory (websites, test catalogues, newsletters, memoranda, advertisements, etc.). Laboratories are not required to make clinical claims about a test, but any claims made by the laboratory must be validated. The laboratory should validate claims through a clinical study, but for rare conditions or well-accepted uses of a test, reference to published peer-reviewed literature is acceptable. Evidence of Compliance:

Records of clinical studies performed by the laboratory OR peer-reviewed literature that reasonably substantiate all claims made by the laboratory about a test”

Question 57

COM.40700, 2, Method Performance Specifications Availability

Answer 57

“The laboratory’s current test methods, including performance specifications and supporting validationverification data (analytic accuracy, precision, analytic sensitivity, interferences, reference range, and reportable range, as applicable), are available to clients of the laboratory and to the inspection team upon request. NOTE: The laboratory must also provide data on clinical performance claims to clients upon request if clinical performance claims are made. The laboratory may at its option require clients to agree to treat such data as confidential and not to share such data with any other party except as required by law.

The CAP inspection team is instructed to use the data solely for accreditation purposes. “

Question 58

COM.40800, 2, Analytic Methodology Changes

Answer 58

“If the laboratory changes its analytic methodology so that test results or their interpretations may be SIGNIFICANTLY different, the change is explained to clients. NOTE: This requirement can be accomplished in any of several different ways, depending on local circumstances. Some methods include directed mailings, laboratory newsletters or part of the test report itself. Evidence of Compliance:

Records such as directed mailings, laboratory newsletters or comment on the patient report advising of the change”

Question 59

COM.50000, 2, Reference Intervals EstablishedVerified

Answer 59

“The laboratory establishes or verifies its reference intervals (normal values). NOTE: Reference intervals are important to allow a clinician to assess patient results against an appropriate population. The reference range must be established or verified for each analyte and specimen source (e.g. blood, urine, cerebrospinal fluid), when appropriate. For example, a reference interval can be verified by testing samples from 20 healthy representative individuals; if no more than 2 results fall outside the proposed reference interval, that interval can be considered verified for the population studied (refer to CLSI guideline EP28-A3c, reference below).

If a formal reference interval study is not possible or practical, then the laboratory should carefully evaluate the use of published data for its own reference ranges, and retain documentation of this evaluation. For many analytes (e.g. therapeutic drugs and CSF total protein), literature references or a manufacturer’s package insert information may be appropriate. Evidence of Compliance:

Record of reference range study OR records of verification of manufacturer’s stated range when reference range study is not practical (e.g. unavailable normal population) OR other methods approved by the laboratorysection director”

Question 60

COM.50100, 2, Reference Interval Evaluation

Answer 60

“The laboratory evaluates the appropriateness of its reference intervals and takes corrective action if necessary. NOTE: Criteria for evaluation of reference intervals include:

1. Introduction of a new analyte to the test repertoire
2. Change of analytic methodology
3. Change in patient population

If it is determined that the range is no longer appropriate for the patient population, corrective action must be taken. Evidence of Compliance:

Records of evaluation and corrective action, if indicated”