On December 31, 2015 the ability to use Equivalent Quality Control (EQC) policies will expire. Laboratories will be required to either follow the quality control regulations as outlined in CLIA 88 or develop an Individualized Quality Control Plan (IQCP) to replace the current EQC option. This plan is the new alternative CLIA quality control (QC) option that will provide for equivalent quality testing to meet the CLIA regulations for nonwaived tests. The IQCP process includes a Risk Assessment (RA), Quality Control Plan (QCP), and Quality Assessment (QA). An IQCP must address the potential failures and errors identified in the entire testing process: preanalytic, analytic and postanalytic phases of testing 1. Using the Centers for Medicare & Medicaid Services (CMS) and CDC publication, Developing an IQCP, a Step by Step Guide, Akers Bio has developed the following tools to make your transition to IQCP easier. The workbook is located on both the CLIA and CDC websites 2. It provides explanations and templates to guide each lab through the requirements of an IQCP. Please bear in mind that while Akers Bio has provided a useful template, CMS expects your IQCP to reflect your laboratory conditions and not what Akers Bio might assume about your laboratory operation or conditions. Review the supplied template thoroughly and customize to your individual laboratory. Your laboratory director is responsible for deciding whether the laboratory will utilize IQCP for the Akers Bio PIFA Heparin/PF4 Rapid Assay and for ensuring that the quality control plan (QCP) developed effectively meets the IQCP requirements. The Akers Bio PIFA Heparin/PF4 Rapid Assay is a FDA cleared device, categorized moderately complex under CLIA. This test is a candidate for an IQCP because Akers Bio s Instructions For Use recommend performing external QC less frequently than required by CLIA. If you are a current user of this product, much of the information needed to perform the risk assessment (RA) for the PIFA Heparin/PF4 Assay has likely been accumulated in the process of routine operations in the laboratory. For example, verification of manufacturer s performance specifications, QC performance, personnel training and a device lot log can all be used to support your RA. 1 "CLIA Brochures - Centers for Medicare & Medicaid Services." Centers for Medicare & Medicaid Services. Web. 13 July 2015. <http://www.cms.gov/regulations-and-guidance/legislation/clia/ CLIA_Brochures.html>. 2 "Developing an IQCP - A Step-By-Step Guide." CDC. Web. 13 July 2015. <http://wwwn.cdc.gov/clia/resources/iqcp/>. OR IQCP Workbook - Developing an IQCP - A Step-By-Step Guide." CMS. Web. 13 July 2015. <http://www.cms.gov/regulations-and-guidance/legislation/clia/individualized_ Quality_Control_Plan _IQCP.html>. Page 1 of 17
On the following page Akers Bio has provided a general template relating to common specimen risks associated with the Akers Bio PIFA Heparin/PF4 Rapid Assay. Some risks are inherent to laboratory testing in general, and procedures should exist to handle these risks. Akers Bio has not included these risks or actions taken by your laboratory to control them. As a manufacturer, Akers Bio may offer suggestions and provide input to your laboratory concerning the specifics of your IQCP, but your laboratory must develop and perform its own IQCP. ASSESSING THE SPECIMEN RISKS Questions to Consider Relating to Specimen 1. Are written procedures available and followed for managing unacceptable specimens? In your laboratory, is there a general procedure for specimen rejection which is established and followed? Add the following PIFA requirements to your laboratory s existing protocols related to the above: Anticoagulated samples are not suitable for test with this assay and must not be used. Frozen, thawed, hemolyzed, icteric, lipemic (of an excessive nature), bacterial contaminated specimens, or controls from other test kits should not be used, and can produce erroneous results. Risk can be reduced to acceptable levels by TRAINING. Use the supplied Quiz to document training. 2. Does your laboratory have a procedure to handle specimens which are improperly labeled? If yes, reference in your Risk Assessment Findings. This procedure will be reviewed in your Quality Assessment. Page 2 of 17
Risk Assessment Components What are our possible sources of error? What can go wrong? Gather information, from the manufacturer s instructions and other resources, on how we should be performing the testing process. Specimen Collection Can our identified sources of error be reduced? /No Not Applicable (N/A) How can we reduce the identified sources of error? Indicate how to reduce possible error sources. Internal controls Actions taken by laboratory Safeguards in the test system or laboratory practices SPECIMEN Manufacturer s instructions FRESH Serum must be used with the PIFA Heparin/PF4 Rapid Assay. Do not use frozen and/or thawed specimens. Train testing personnel to verify use of proper specimen collection tubes. Use Quiz supplied by Manufacturer. Whole Blood specimens must be collected in Red Top Tubes ONLY. Plain, Glass Red Top tubes OR Plastic, Red Top Tubes, with Clot Activator must be used to obtain patient specimens; no other collection tubes are recommended for use, including gel serum separation tubes (SST). Train testing personnel not to use frozen and/or thawed specimens or SST tubes. Use Quiz supplied by Manufacturer. Page 3 of 17
Specimen Preparation: Manufacturer s instructions SPECIMEN In accordance with CLSI Guideline H18-A3, Procedures for the Handling and Processing of Blood Specimens, serum should be separated from contact with cells within a maximum of 2 hours of the draw. Clot Activation: Patient specimens must be allowed to clot before centrifugation. Consult Collection Tube Manufacturer s instructions for mixing protocols and recommended clotting times (clotting times range from thirty (30) to sixty (60) minutes). Centrifugation: The specimen should be centrifuged at the end of the clotting period in strict accordance with the Collection Tube Manufacturer s instructions for speed and duration of centrifugation. IMPORTANT: Patient specimen should not stand on the clot for longer than 60 minutes after centrifugation or the PIFA test result may be invalid. Train phlebotomy team, central specimen processing personnel to insure protocols of collection tubes are appropriately followed (this is not specific to the PIFA test and should be already controlled). Train testing personnel to remove specimen from clot within 60 minutes after centrifugation. Verify training using Quiz supplied by Manufacturer. Testing time frame/stability of specimen: Manufacturer s instructions Specimen Storage Properly prepared serum that has been removed from the clot, but cannot be tested immediately, should be stored refrigerated (2-8 C; 36-46 F) for no longer than 72 hours. Train processing or testing personnel (as applicable) to verify and document: Collection time and time of receipt in laboratory Proper storage and processing of specimen Note: Any refrigerated serum should reach an ambient temperature prior to performing the test. Verify training using Quiz supplied by Manufacturer. Page 4 of 17
On the following page, Akers Bio has provided a general template relating to test system risks associated with the Akers Bio PIFA Heparin/PF4 Rapid Assay. Some risks are inherent to laboratory testing in general, and procedures should exist to handle these risks. Akers Bio has not included these risks or actions taken by your laboratory to control them. As a manufacturer, Akers Bio may offer suggestions and provide input to your laboratory concerning the specifics of your IQCP, but your laboratory must develop and perform its own IQCP. ASSESSING THE TEST SYSTEM RISKS Questions to Consider Relating to the Test System 1. Does the laboratory have established corrective action policies and procedures, to include corrective action for out of range controls? 2. Does the laboratory document corrective actions taken, to include resolutions, and review and share with testing personnel? Your laboratory should have procedures in place addressing questions #1 and #2 above. Please reference in your Risk Assessment Findings. This procedure will be reviewed in your Quality Assessment. 3. Does the laboratory have an adequate manual or electronic system(s) in place to accurately and reliably transmit patient results in a timely manner from data entry point to final report destination? 4. Are final results reviewed by a laboratory supervisor within 24 hours? 5. Does the laboratory have a Laboratory Information System (LIS)? If so, are there procedures to monitor the accuracy and completeness of the information being transmitted to the LIS? Akers Bio is not qualified to comment on your risks associated with your reporting system but has referenced some of the relevant questions from the IQCP workbook. Page 5 of 17
Risk Assessment Components TEST SYSTEM What are our possible sources of error? What can go wrong? Gather information, from the manufacturer s instructions and other resources, on how we should be performing the testing process. QC Results: Manufacturer s instructions - test system does not prevent patient results from being reported when QC is unacceptable. Internal Device Control: Manufacturer s instructions - If RED fails to appear in the Heparin/PF4 device CONTROL Window, beyond the 10 minute mark, the TEST result is considered invalid. The test system is not able to detect the following: If inadequate specimen volume is used If the device has warmed to an ambient temperature (18-27 C; 64-81 F) in the individual foil sealed pouch, for a minimum of 30 minutes prior to performing the test. If the test is performed outside of its intended use as described in the manufacturer s instructions. If the limitations to the test system are ignored. Can our identified sources of error be reduced? /No Not Applicable (N/A) How can we reduce the identified sources of error? Indicate how to reduce possible error sources. Internal controls Actions taken by laboratory Safeguards in the test system or laboratory practices Insure testing personnel review QC results prior to running the assay. Document QC results in PIFA Heparin/PF4 Assay QC log (which should already exist in your facility). Report patient results only when QC is acceptable. Train testing personnel on this issue and verify training using Quiz. Insure testing personnel review internal device control results prior to reporting results. Report patient results only when QC is acceptable. Train testing personnel on this issue and verify training using Quiz. Insure procedures are written according to the manufacturer s instructions for this test. Train testing personnel on manufacturer s instructions. Verify training using Quiz supplied by Manufacturer. The laboratory should have a procedure that defines and documents pipette calibration as well as competency of personnel using pipettes. If personnel using the test have been trained Page 6 of 17
On the following page, Akers Bio has provided a general template relating to common reagent risks associated with the Akers Bio PIFA Heparin/PF4 Rapid Assay. Some risks are inherent to laboratory testing in general, and procedures should exist to handle these risks. Akers Bio has not included these risks or actions taken by your laboratory to control them. As a manufacturer, Akers Bio may offer suggestions and provide input to your laboratory concerning the specifics of your IQCP, but your laboratory must develop and perform its own IQCP. ASSESSING REAGENT RISKS Questions to Consider Relating to the Reagent 1. Is the integrity of reagents checked when received? 2. What would happen if reagents are shipped to the laboratory at a time when staff are not available to ensure proper storage (e.g. a weekend or holiday)? What would happen if there was a delay in receipt of reagents from Receiving Department? Your laboratory should have procedures in place addressing questions #1 and #2 above. Please reference in your Risk Assessment Findings. This procedure will be reviewed in your Quality Assessment. If you do not have such procedures in place, add Incoming receipt, check of reagent integrity to reagent risk assessment that follows. This risk would be reduced by training personnel and verifying effectiveness of training using the supplied Manufacturer Quiz. 3. Are all reagents removed from storage and disposed of when they have reached their expiration date? There should be a general laboratory procedure in place that deals with this scenario. Please reference in your Risk Assessment Findings. This procedure will be reviewed in your Quality Assessment. If you not such procedures in place, the possibility of use of expired reagent has already been covered in the reagent risk assessment that follows. This risk would be reduced by training personnel and verifying effectiveness of training using the supplied Manufacturer Quiz. 4. Are lot numbers recorded in a log (when new lots are received and when beginning use of different lot numbers)? 5. Is there a procedure for evaluating new lot numbers before beginning use for patient testing? The following Reagent Risk Assessment implies that tracking of lot control exists in the laboratory. It is required for the recommended QC to be effectively implemented. If there is no procedure/log in place, create a lot log for use specifically with the PIFA Assay. Page 7 of 17
Risk Assessment Components What are our possible sources of error? What can go wrong? Gather information, from the manufacturer s instructions and other resources, on how we should be performing the testing process. Reagent expiration date - the test system s QC does not detect the use of expired reagents prior to testing. Manufacturer s Instructions: Do not use after expiration date. Can our identified sources of error be reduced? /No Not Applicable (N/A) How can we reduce the identified sources of error? Indicate how to reduce possible error sources. Internal controls Actions taken by laboratory Safeguards in the test system or laboratory practices Train testing personnel to check kit/device expiration dates prior to use. Verify training using Quiz supplied by Manufacturer. Reagent storage prevent reagent degradation during storage and use. REAGENT Manufacturer s Instructions: The PIFA MiniReactors must be stored refrigerated at 2-8 C (36-46 F). Do not expose the PIFA MiniReactors to temperatures greater than 40 C (104 F) or below 0 C (32 F). Testing the external positive and negative controls. Manufacturer s instructions: It is recommended that a positive and negative control be utilized in the following circumstances: 1) during the initial use of a new lot of PIFA Heparin/PF4 Rapid Assay devices, and 2) after running 100 tests of the same lot of devices. Kits/devices with different lot numbers should not be mixed unless lots have met QC testing requirements. Monitor storage conditions kit/device for refrigerated storage (2-8 C). Monitor kit delivery/receipt activities.* See question 1 & 2 of Assessing Reagent Risks section. Train testing personnel to perform external QC procedures, as described in the manufacturer s instructions. Verify effectiveness of training using Quiz supplied by Manufacturer. Note: This step implies that tracking of lot control exists in the laboratory. Train testing personnel not to mix device lots unless lots have been subject to QC testing. Verify effectiveness of training using Quiz supplied by Manufacturer. Page 8 of 17
On the following page Akers Bio has provided a general template relating to common environmental risks associated with the Akers Bio PIFA Heparin/PF4 Rapid Assay. Some risks are inherent to laboratory testing in general, and procedures should exist to handle these risks. Akers Bio has not included these risks or actions taken by your laboratory to control them (such as questions 3 & 4 below). As a manufacturer, Akers Bio may offer suggestions and provide input to your laboratory concerning the specifics of your IQCP, but your laboratory must develop and perform its own IQCP. ASSESSING ENVIRONMENT RISKS Questions to Consider Relating to the Environment 1. Are the manufacturer s instructions for maintaining the appropriate temperature for the test system followed? 2. Is lighting adequate to perform visual interpretation of test results? The test is run in ambient temperature and lighting conditions. No extraordinary environmental risk are associated with these requirements. 3. Does the laboratory have adequate space to perform testing, prevent cross contamination, and/or injury? 4. Is the testing area kept clean and clear of clutter and debris that could interfere with the testing process? The test is run in ambient conditions. No extraordinary environmental risk are associated with these requirements. Page 9 of 17
Risk Assessment Components What are our possible sources of error? What can go wrong? Gather information, from the manufacturer s instructions and other resources, on how we should be performing the testing process. Can our identified sources of error be reduced? /No Not Applicable (N/A) How can we reduce the identified sources of error? Indicate how to reduce possible error sources. Internal controls Actions taken by laboratory Safeguards in the test system or laboratory practices ENVIRONMENT Temperature Manufacturer s instructions: Remove the PIFA Heparin/PF4 MiniReactor from refrigeration And allow to sit in the foil sealed pouch at an ambient temperature (18-27 C; 64-81 F) for a minimum of 30 minutes. Record room temperature daily in the morning and afternoon. Train testing personnel on required pre-test preparation of the device. Verify training using Quiz supplied by Manufacturer Make sure the device is not cold to the touch. Lighting Manufacturer s instructions: Interpret the result in the Test Window in well-lit conditions. Train testing personnel on required conditions for result reading. Verify training using Quiz. Page 10 of 17
On the following page Akers Bio has provided a general template relating to common risks associated with Testing Personnel. It has been taken from the IQCP workbook cited in the beginning of this document and slightly modified. To operate under CLIA, your laboratory should already have competency assessment procedures in place. These procedures provide the Actions Taken by Laboratory used in column 4 to reduce risk. Akers Bio is not qualified to comment on risks associated with your reporting system but has simplified some of the recommendations from the IQCP workbook. As a manufacturer, Akers Bio may offer suggestions and provide input to your laboratory concerning the specifics of your IQCP, but your laboratory must develop and perform its own IQCP. ASSESSING TESTING PERSONNEL RISKS Questions to Consider Relating to Testing Personnel 1. Do laboratory personnel have a formal certification or license, if required by their state? 2. Does the laboratory have adequate personnel to perform testing in a safe and timely manner? 3. What controls are in place to check that Laboratory personnel are not making transcription errors when reporting results, either written or when using a LIS? 4. Does the laboratory have adequate personnel to perform patient testing in a safe and timely manner? 5. Do all testing personnel perform QC and PT? Page 11 of 17
Risk Assessment Components What are our possible sources of error? What can go wrong? Gather information, from the manufacturer s instructions and other resources, on how we should be performing the testing process. Improperly trained personnel Can our identified sources of error be reduced? /No Not Applicable (N/A) How can we reduce the identified sources of error? Indicate how to reduce possible error sources. Internal controls Actions taken by laboratory Safeguards in the test system or laboratory practices Train testing personnel on specimen requirements, and proper performance of test according to manufacturer instructions. Verify effectiveness of training using Quiz. Competency assessment does not include all CLIA required elements. Evaluate competency assessment policy and procedures, rewrite to include all CLIA required elements. TESTING PERSONNEL Perform and document competency assessment for all testing personnel. Competency assessments required for new employees at least every six months, and annually thereafter, or when test methodology and test system changes Verbal reporting of test results prior to LIS entry Update policy to require testing personnel do not verbally release results until they are entered into the LIS. Page 12 of 17
Quality Control Plan for the Akers Bio PIFA Heparin Platelet Factor 4 Rapid Assay Based on the risks identified on the previous pages, the following Quality Control Plan has been developed. You may need to add or delete portions of the plan based on the requirements of your laboratory. This plan covers general elements that you most likely are already tracking. While you state the frequency and acceptance criteria in this IQCP, the monitoring activity is used for many purposes and does not need to be recorded specifically for this IQCP. This space left intentionally blank. Page 13 of 17
Quality Control Plan for the Akers Bio PIFA Heparin Platelet Factor 4 Rapid Assay [Insert Facility Name Here] Type of Quality control Temperature Checks Room Temperature Refrigerator Frequency Record room temperature daily. Record refrigerator daily. Criteria for Acceptability (Range of Acceptance Values) 20 C 25 C (Room); adjust if rqd 2 C 8 C (Refrigerator) Record on temperature logs. Kit/device Storage With each Kit Document date kits placed in refrigeration on box. Verify specimen collection tubes for acceptability upon receipt in the laboratory. With each specimen Refer to your lab s specimen Rejection Policy and record all improperly collected tubes on specimen rejection log sheet. Verify specimen collection time and time serum separated from the cells. Serum should be separated from contact with cells within a maximum of 2 hours of the draw. With each specimen If the time to separation is greater than 2 hours, reject sample. View time of sample collection upon completion of sample processing. Calibration of pipettes Annually Verify pipettes pass calibration. Device Internal Quality Control External Quality Control Positive Negative Proficiency testing (PT) Training Competency Assessment Performed with each device It is recommended that a positive and negative control be utilized: 1) during the initial use of a new lot of PIFA H/PF4 Rapid Assay devices, AND 2) after running 100 tests of the same lot of devices. As required by your compliance body (e.g. CAP) With each new testing personnel and when indicated. Six months and one year after initial training, annually thereafter. If RED fails to appear in the Heparin/PF4 device CONTROL Window, beyond the10 minute mark, the TEST result is considered invalid. Control result must read positive or negative. Results must be recorded on quality control log sheet and verified prior to reporting patient results. Submit to PT supplier. Ensure that all personnel participate in performing proficiency testing. Successful demonstration of test performance. Acceptable quiz results. Document training. All testing personnel must successfully meet all six CLIA elements for competency assessment. Laboratory Director: Date: Page 14 of 17
Quality Assessment Monitoring and Review for the Akers Bio PIFA Heparin Platelet Factor 4 Rapid Assay Quality Assessment (QA) is used to determine if the quality activities you have put in place are working according to your Quality Control Plan. Each laboratory must establish a review system for the ongoing monitoring of the effectiveness of their QCP. The CMS and CDC publication, Developing an IQCP, a Step by Step Guide has a very helpful appendix (Appendix E) at the back on the workbook listing QA activities which can help you reduce the occurrence or enhance the detection of potential failures and errors 3. Based on the risks identified on the previous pages and the Quality Control Plan developed to address those risks, the following Quality Assessment Plan has been developed. You may need to add or delete portions of the plan based on the requirements of your laboratory. This plan covers general elements that you are likely already tracking. While you state the frequency and acceptance criteria in this IQCP, the monitoring activity is used for many purposes and does not need to be recorded specifically for this IQCP. Records of the review should exist in your current systems and can be used for multiple reasons. You may find it easier to use a checklist to track Quality Assessment activities. The template below has been suggested in the Developing an IQCP, a Step by Step Guide 4. Alternately, you can use a combination of a checklist in a tabular form and detailed explanation of the QA activity which is being monitored. As your lab is performing many Quality Assessment activities, you should choose the format which most closely matches your needs. QA ACTIVITY (TO MONITOR) FREQUENCY ASSESSMENT OF QA ACTIVITY (Was there variation from established procedure?) CORRECTIVE ACTION (WHEN INDICATED) REVIEW PERFORMED DATE/ INITIALS (1) Temp Logs Monthly No NA 3-4 "Developing an IQCP - A Step-By-Step Guide." CDC. Web. 13 July 2015. <http://wwwn.cdc.gov/clia/resources/iqcp/>. OR "IQCP Workbook - Developing an IQCP - A Step-By-Step Guide." CMS. Web. 13 July 2015. <http://www.cms.gov/regulations-and-guidance/legislation/clia/individualized_ Quality_Control_Plan _IQCP.html>. Page 15 of 17
Quality Assessment Monitoring and Review for the Akers Bio PIFA Heparin Platelet Factor 4 Rapid Assay [Insert Facility Name Here] Stated below are the QA activities which will be monitored and the required frequency of monitoring. Record any variation from established policy and procedure and the corresponding corrective actions. 1. Review all temperature logs monthly for room and refrigerator to ensure temperatures were monitored according to the QCP, and appropriate corrective action(s) were taken for any temperatures that were out of range. 2. Review Specimen Receipt Log weekly for any unacceptable conditions, i.e. rejected samples, to ensure appropriate action(s) were taken. Samples could be rejected due to draw or processing time limits. If the number of unacceptable specimens or occurrences exceeds a threshold established by the laboratory, conduct training or another activity and monitor the effectiveness of the corrective action. 3. [Keep/Omit this section, specific to your lab] Perform an annual review of the procedure to handle specimens which are improperly labeled to insure this procedure is being followed and that corrective action(s) were taken for any unacceptable samples. 4. Review records quarterly which deal with the Incoming receipt of PIFA Heparin/PF4 kits to insure temperature specifications are being met. 5. [Keep/Omit this section, specific to your lab] Annually review reagent receipt policy and procedures to insure compliance. 6. [Keep/Omit this section, specific to your lab] Annually review reagent expiration policy and procedures to insure compliance. 7. Review pipette calibration records semi-annually to insure all pipettes used for the PIFA Heparin/PF4 Rapid Assay are within calibration. 8. Review manufacturer s instructions with each new lot/shipment of kits. Ensure changes are incorporated into the standard operating procedures as well as monitor any quality control problems found regarding lot-to-lot variability. 9. Review Internal QC Logs monthly to ensure appropriate corrective action(s) were taken for any unacceptable values. a. Review monthly to insure appropriate information captured relating to the internal device control. In your laboratory procedure for running the PIFA Heparin/PF4 test, be sure to include how you will handle the information provided by the device control. Will you only record if test is invalid? Include direction and then verify technicians performing appropriately monthly when checking QC logs. Page 16 of 17
Quality Assessment Monitoring and Review for the Akers Bio PIFA Heparin Platelet Factor 4 Rapid Assay b. Review QC logs and PIFA Heparin/PF4 device/kit lot logs monthly to insure positive and negative controls run during the initial use of a new lot of PIFA Heparin/PF4 Rapid Assay devices, AND after running 100 tests of the same lot of devices. 10. Review proficiency test results upon receipt and ensure appropriate corrective action(s) were taken for any unacceptable values. 11. With each new testing personnel, review training records to insure personnel are qualified to run PIFA Heparin/PF4 Rapid Assay. 12. Annually review CAPA policy and procedures to insure compliance. 13. Annually review policy and procedures for competency assessment and review personnel records/documentations to ensure competency assessments meet the CLIA required elements. Laboratory Director: Date: Page 17 of 17