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Where's the Beef? Recipes to "Beef Up" Those Weak Areas in Your Transfusion Service Assessment/inspection report statistics show that there are certain.

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Presentation on theme: "Where's the Beef? Recipes to "Beef Up" Those Weak Areas in Your Transfusion Service Assessment/inspection report statistics show that there are certain."— Presentation transcript:

1 Where's the Beef? Recipes to "Beef Up" Those Weak Areas in Your Transfusion Service
Assessment/inspection report statistics show that there are certain standards and requirements that Transfusion Services struggle with the most. This session will address those weaknesses and how you can identify areas in your own Transfusion Service that need some attention. Practical ideas and examples will be shared on ways you can strengthen, control and "beef up" those vulnerable weak spots in your operations and quality systems.

2 Recipes to "Beef Up" Those Weak Areas in Your Transfusion Service
Where’s the Beef? Recipes to "Beef Up" Those Weak Areas in Your Transfusion Service

3 The Meat of the Matter Nancy M. Shotas, MT(ASCP)BB, CQA(ASQ)
AABB Staff Lead Assessor

4 Learning Objectives Identify the elements and processes in Transfusion Services that are most often found to be weak or out-of-compliance at inspection time. Describe ways to pinpoint weaknesses in your own department and develop an action plan to correct them. Discuss and share examples of documents and tools that can be used to "beef up" your operations and quality systems. I have listed the session’s Learning Objectives, and we’ll begin focusing on the first objective, shown here in red (beef) color!!!

5 To start, we know that beef comes from a COW, OF COURSE!!!

6 AND WE ALL KNOW THAT THERE ARE DIFFERENT CUTS OF MEAT, JUST LIKE THERE ARE VARIOUS REGULATORY AND ACCREDITING AGENCIES. TO GET TO THE MEAT OF THIS DISCUSSION, VARIOUS REGULATORY AND ACCREDITING AGENCIES WERE SOLICITED TO PROVIDE THEIR MOST COMMON DEFICIENCIES / NONCONFORMANCES.

7 CLIA Here are the organizations that have assisted us with their top deficiencies, nonconformances. The top line are the regulators. In the middle are two programs that offer Hospital AND Laboratory Accreditation. On the third line, the AABB provides more specific accreditation (transfusion and cellular therapies); CAP and COLA are specific for laboratory accreditation, which would include transfusion services. Please note that although we did not get a response directly from COLA, we will share a list of their top deficiencies as found on the internet. As I continue in my part of the presentation, I want to advise you that, although our title and objectives focus on Transfusion Services, we are listing all top items for each agency, even though they may not be specific to transfusion services. We know many items overlap with general laboratory requirements (ex. proficiency and competency), so it would be best to include rather than exclude.

8 CLIA We’ll be starting with CMS / CLIA.
Many blood banks and transfusion services obtain their CLIA certification by virtue of accreditation by a CMS-approved accreditation organization, and are not routinely surveyed by CLIA surveyors. They are routinely surveyed by representatives of their chosen accreditation organization. The following deficiencies do not include deficiencies cited by the accreditation organizations. It only includes data from laboratories surveyed directly by CLIA surveyors. My former lab WAS inspected by CMS, because they were performing a validation survey of the lab’s accrediting agencies, HFAP.

9 CMS’ Top 10 Condition Level Deficiencies: Jan. 2013 (Jan.2012)
- D Mod. complexity LD qual./resp (1) - D Successful PT participation (2) - D PT enrollment (3) - D High complexity director qual./resp (4) - D Analytic Systems (QC) (6) https://www.cms.gov/Regulations-and-Guidance/Legislation/CLIA/Interpretive_Guidelines_for_Laboratories.html Condition level deficiencies are the more serious deficiencies The citation numbers (on the left) are explained in CMS/CLIA Interpretive Guidelines for Laboratories …the web address is posted at the bottom of the slide for you to access at your leisure. The list presented is from January of this year. In RED, in parentheses, is the top ten spot the deficiency held in January of The top 4 are STILL the top 4. As we continue, you’ll see that items 5 and 6 on the list switched positions from the previous year. For the sake of the presentation and your easy reference afterward, I will present the detail after each slide, but I don’t plan on reading EACH detailed explanation. CLIA

10 CMS’ Top 10 Condition Level Deficiencies: Citation explanations
D6000 (42CFR ) Moderate complexity LD qual./resp. The laboratory must have a director who meets the qualification requirements of and provides overall management and direction in accordance with D2016 (42CFR ) Successful PT participation Each laboratory performing nonwaived testing must successfully participate in a PT program approved by CMS as described in subpart I of this part for each specialty, subspecialty and analyte or test in which the laboratory is certified under CLIA. D2000 (42CFR ) PT enrollment Each laboratory must enroll in a PT program that meets the criteria in subpart I and is approved by HHS. The laboratory must enroll for each specialty and subspecialty, and must test the samples in the same manner as patients’ specimens D6076 (42CFR ) High complexity director qual./resp. The laboratory must have a director who meets the qualification requirements of and provides overall management and direction in accordance with D5400 (42CFR ) Analytic Systems (QC) Each laboratory that performs nonwaived testing must meet the applicable analytic systems requirements in through The laboratory must monitor and evaluate the overall quality of the analytic systems and correct identified problems as specified in for each specialty and subspecialty of testing performed The 2 areas of focus on this slide (for our presentation, the MEAT of the matter) are Qualifications of Leadership (lab director) and Testing Personnel AND Proficiency Testing

11 CMS’ Top 10 Condition Level Deficiencies
-D Mod. complexity TP (5) -D Technical consultant qual./resp. (7) -D Hematology (8) -D High complexity TP (10) -D Personnel High Complexity (?? ) D 5012 Syphilis Serology held the 9 spot and got knocked off the top 10, with Personnel for High Complexity testing joining the list! Your Lab Manager may be responsible for ensuring all personnel meet the CLIA requirements for personnel, and for keeping the files. (mine was, so I never cared!). A few years back, as long as we could prove our certifications (ex. ASCP card), that was adequate. Now they want people’s diplomas or transcripts! That may be why we see the qualifications so prevalent on the top ten! The meat of the matter on this slide continues to be Qualifications of Leadership and Testing Personnel. CLIA

12 CMS’ Top 10 Condition Level Deficiencies: Citation explanations
D6063 (42CFR ) Mod. Complexity Testing Personnel The laboratory must have sufficient number of individuals meeting the qualifications of , to perform the functions specified in for the volume and complexity of tests performed D6033 (42CFR ) Technical consultant qual./resp. The laboratory must have a technical consultant who meets the qualification requirements of and provides technical oversight in accordance with D5024 (42CFR ) Hematology If the laboratory provides services in the specialty of Hematology, the laboratory must meet the requirements specified in through , and through D6168 (42CFR ) High complexity Testing Personnel The laboratory must have sufficient numbers of individuals who meet the qualification requirements concerning State licensure, if applicable, and the educational requirements for High complexity personnel as defined in § to perform the functions of high complexity personnel as defined in § for the volume and complexity of testing performed D6108 (42CFR ) High Complexity Testing Personnel (Technical Supervisor) The laboratory must have a technical supervisor who meets the qualification requirements as defined in and provides technical supervision in accordance with

13 CMS’ Top 10 Deficiencies CLIA
D Policy for proper reagent storage (1) D Verify accuracy non-PT’d tests (2) D Analytic Systems’ QA (3) D Procedure manual (4) D Follow mfgr’s. instructions (6) D Mod. complexity LD qual./resp. (9) D Calibration verification (5) D Gen lab systems QA (7) D Use of expired reagents (10) D Personnel moderate complexity (??) Source CMS CLIA database 2/2012 This slide lists the top 10 deficiencies overall (include both condition-level and standard-level deficiencies. ) Once again, The list presented is from January of this year. In RED, in parentheses, is the top ten spot the deficiency held in January of The top 4 are STILL the top 4. D6201 LD responsibility – QA plan held the #8 spot and got knocked off the top 10 This slide presents the Process Control (use of materials; Proficiency Testing; QA/QC activities; Procedure manuals; Equipment / test calibration and accuracy verification CLIA

14 Also, you should know that FDA does not inspect all transfusion services.  They only inspect the registered transfusion services.  The authority for overseeing transfusion services that are exempt from registering under 21 CFR (f) is assigned to CMS.  However, FDA does go into all transfusion services to investigate transfusion fatalities, even the unregistered transfusion services, but these investigations do not usually involved the issuance of a 483.

15 Biologics FY 2012 Inspectional Observation Summaries (FY 2010)
Ref No Frequency Short Description Long Description 21 CFR (b) 151 (111) Maintained and followed Written standard operating procedures including all steps to be followed in the [collection] [processing] [compatibility testing] [storage] [distribution] of blood and blood components for [homologous transfusion] [autologous transfusion] [further manufacturing purposes] are not always [maintained] [followed] [maintained on the premises].  21 CFR (c) 48 (37) Thorough investigations Failure to [perform a thorough investigation] [make a record of the conclusions and follow-up] of [an unexplained discrepancy] [a failure of a lot or unit to meet any of its specifications].  21 CFR (a)(1) 40 (26) Person performing, test results, interpretation Records fail to [identify the person performing the work] [include dates of the various entries] [show test results] [include interpretation of the results] [show the expiration date assigned to specific products] [be as detailed as necessary] so as to provide a complete history of the work performed.  Meat of the matter: Procedure manuals; Process Control: QA (error mgmt)/QC Document control / traceability The list presented is from FY In RED, in parentheses, is the frequency of the deficiency in FY2010. The top 7 are STILL the top 7. As we continue, you’ll see that there wasn’t much of a change with the other items either.

16 Biologics FY 2012 Inspectional Observation Summaries (FY 2010)
Ref No Frequency Short Description Long Description 21 CFR (a)(1) 34 (23) Concurrent documentation Records are not concurrently maintained with the performance of each significant step in the [collection] [processing] [compatibility testing] [storage] [distribution] of each unit of blood and blood components so that all steps can be clearly traced.  21 CFR (b) 25 (24) Required records Failure to maintain [donor] [processing] [storage and distribution] [compatibility testing] [quality control] [general] records.  21 CFR (a)(1) 18 (13) Legibility and indelibility Records are [illegible] [not indelible].  21 CFR (e) 17 (12) Following manufacturer's instructions Failure to use supplies and reagents in a manner consistent with instructions provided by the manufacturer.  The first 3 of these relate to Documents / records; the latter, process control (use of materials according to manufacturer’s instructions)

17 Biologics FY 2012 Inspectional Observation Summaries (FY 2010)
Ref No Frequency Short Description Long Description 21 CFR 17 (23) Biological product deviation report Failure to submit a biological product deviation report [within 45 days from the date you acquired information suggesting that a reportable event occurred].  21 CFR (b) 15 (20) Qualifications of responsible personnel The personnel responsible for the [collection] [processing] [compatibility testing] [storage] [distribution] of blood or blood components are not adequate in [number] [educational background] [training and experience, including professional training as necessary]  to assure competent performance of their assigned functions, and to ensure that the final product has the safety, purity, potency, identity and effectiveness it purports or is represented to possess.  21 CFR (c) (12) Record review prior to release All records pertinent to a lot or unit were not reviewed before the release or distribution of a lot or unit of final product.  The first, for BPDR, is Error Mgmt (Deviations, Nonconformances, Adverse Events); second: qualifications of personnel; third: Process Control (QC review)

18 Biologics FY 2012 Inspectional Observation Summaries (FY 2010)
Ref No Frequency Short Description Long Description 21 CFR (b) 15 (9) Equipment calibration frequency Equipment used in the [collection][processing][compatibility testing][storage and distribution] of blood and blood components is not observed, standardized and calibrated with at least the frequency required.  21CFR (b)(15) 10 (??) Schedules and Procedures for Equipment & Calibration The standard operating procedure fails to include a written description of schedules and procedures for equipment maintenance and calibration. (a) (15) Equipment observed, standardized, calibrated Equipment used in the [collection] [processing] [compatibility testing] [storage and distribution] of blood and blood components is not [observed] [standardized] [calibrated] on a regularly scheduled basis as prescribed in the SOP Manual.  Equipment Monitoring and Maintenance

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20 AABB: General Summary of Most Common Nonconformances
Organization Participation in Management reviews are missing Processes are not written SOPs are not followed as written Resources Training: missing documentation Competency : Missing annual competency Not performed twice within the first year of employment Competence assessments do not include all CLIA requirements Missing review or approval from those designated to review task Inclusive dates of employment missing Supplier and Customer Issues No documentation or omitted documentation of inspection at receipt The bullet points presented are observances of the most common nonconformances of AABB Assessments utilizing the 28th edition of Standards for Blood Banks and Transfusion Services. They are organized by the Quality System Essentials.

21 AABB (cont): General Summary of Most Common Nonconformances
Equipment No record of what is considered critical equipment Equipment omitted from the critical equipment list Equipment lacking a unique ID number Do not follow manufacturer’s instructions Qualification of Equipment: IQ, OQ, PQ No evidence of investigation & follow-up Alarm set for the limit (either high or low temp) that would sound/alert when the storage temp is out of range and considered unacceptable

22 AABB (cont.): General Summary of Most Common Nonconformances
Process Control No documentation of process validation Incomplete documentation of changes made to existing procedures Change control process not followed as per SOP No set process for determining if PT is performed for each CLIA regulated test Review of QC results are not done in a timely manner or not performed at all. Corrective action for out of range results are not documented and/or not documented properly Incorrect storage temp ranges Failure to follow manufacturer’s instructions RBC appropriate temperature verified on returned units (or validated process)

23 AABB (cont.): General Summary of Most Common Nonconformances
Documents and Records Processes & procedures for document control are not complete Use of only current and valid documents not demonstrated Reviews are incomplete or not timely No list of labels No list of forms or forms omitted from the master list No review or missing annual reviews Using outdated references / No process for review of current references

24 AABB (cont.): General Summary of Most Common Nonconformances
Process Improvement through Corrective and Preventative Action Evaluation to ensure corrective action taken is effective is not documented Assessments: Internal and External Transfusing facility does not monitor Ordering Practices

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26 CAP Top Deficiencies GEN.55550
Requirement Description GEN.55550 Competency Assessment: The competency of each person to perform his/her assigned duties is assessed. COM.01200 Activity Menu: The laboratory’s current CAP Activity Menu accurately reflects the testing performed. GEN.20375 Document Control: The laboratory has a document control system. COM.01700 PT evaluation: There is ongoing evaluation of PT and alternative assessment results, with prompt corrective action taken for unacceptable results.. COM.10000 Complete procedure manual: A complete procedure manual is available at the workbench or in the work area. COM.01100 Ungraded PT challenges: The laboratory has a procedure for assessing its performance on PT challenges that were intended to be graded, but were not. COM.01400 PT attestation page: The proficiency testing attestation statement is signed by the laboratory director or designee and the individual performing the testing. These are the most recent CAP TOP 10 deficiencies. Competency assessment, document control, proficiency testing, Procedure manual are the meat of the matter on this slide.

27 CAP Top Deficiencies GEN.54400
Requirement Description GEN.54400 Personnel records: Personnel records are maintained on all current technical personnel and personnel records include all of the following: Copy of academic diploma or transcript. Summary of training and experience. Laboratory personnel license, if required by state Certification, if required by state or employer Description of current duties and responsibilities as specified by the laboratory director: a) Procedures the individual is authorized to perform b) Whether supervision is required for specimen processing, test performance or result reporting. c) Whether supervisory or director review is required to report patient test results. 6. Records of continuing education 7. Records of radiation exposure where applicable (such as in vivo radiation testing), but not required for low exposure levels such as in-vitro testing. 8. Work-related incident and/or accident records. 9. Dates of employment. Personnel records, including qualifications!

28 CAP Top Deficiencies Requirement Description COM.10300
Knowledge of procedures: 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. GEN.75400 Annual fire drill: Fire drills are conducted at least annually. COM has to do with Process Control / Change Control (including training if indicated)

29 There is adequate space for administrative and clerical functions
College of American Pathologists: Most Common Accreditation Deficiencies: 2011 Transfusion Medicine Requirement ID Requirement TRM ?? COM.01200 The laboratory's current CAP Activity Menu accurately reflects the testing performed. TRM.60200 There is adequate space for technical work (bench space), instruments and equipment. TRM.42110 The laboratory has developed a plan to reduce the risk of transfusion-related acute lung injury (TRALI). TRM.60100 There is adequate space for administrative and clerical functions TRM.30575 The facility has a plan to implement a system to reduce the risk of mistransfusion for non-emergent red cell transfusions. TRM.60400 There is adequate space for blood storage refrigerators and freezers, reagent refrigerators, and platelet rotators. The next 3 slides were part of the original presentation, and have not been updated (but I thought it would be best to include them). They are more specific to the CAP’s Transfusion Medicine Checklist. The 1st item: could not find TRM on current checklists ( ). But have added the Requirement Code from the All Common Checklist

30 2. Establishing criteria for transfusion
College of American Pathologists: Most Common Accreditation Deficiencies: 2011 Transfusion Medicine Requirement ID Requirement TRM.42305 A designated physician has developed a therapeutic plan for patients undergoing therapeutic phlebotomies and the goals for the therapeutic phlebotomy have been clearly stated. TRM.40875 There is documentation that the transfusion service medical director participates in: 1. The development of policies, processes, & procedures regarding recipient consent for transfusion / transplantation 2. Establishing criteria for transfusion 3. Reviewing cases not meeting transfusion audit criteria 4. Monitoring transfusion practices Process Control; Blood utilization

31 College of American Pathologists: Most Common Accreditation Deficiencies: 2011 Transfusion Medicine
Requirement ID Requirement TRM.42135 The transfusion service has a procedure for managing quarantines, recalls, and market withdrawals issued by its blood suppliers. TRM.42310 The physician's order for therapeutic phlebotomy, includes at a minimum, the frequency, the volume to be removed and the laboratory values to be monitored. TRM.31450 If the laboratory uses more than one instrument/method to test for a given analyte, the instruments/methods are checked against each other at least twice a year for correlation of results. TRM.31150 There is documentation of at least annual review of all policies and procedures by the current laboratory director or designee. Lookback; process control; Test / Equipment calibration, accuracy verification; Procedures/Records/ Document Control: NOW is every 2 years!

32 1. Reactivity of reagents and their controls
College of American Pathologists: Most Common Accreditation Deficiencies: 2011 Transfusion Medicine Requirement ID Requirement TRM.32000 All instruments and equipment used by the transfusion service laboratory are clean, well maintained and calibrated properly. TRM.31227 Current package inserts are available for the typing sera and other critical materials used by the laboratory. TRM.41025 Personnel involved in transfusion are trained in the identification of transfusion recipients and blood components, and in observation of recipients during and after transfusion, with in-service education at least annually. TRM.30000 There is documentation of ongoing evaluation by the laboratory director or designee of all of the following. 1. Reactivity of reagents and their controls 2. Instrument function checks 3. Temperature records Equipment Monitoring / Maintenance; Manufacturer’s instructions; Training of transfusionists; ECQC Review

33 There is an agreement or understanding between the
College of American Pathologists: Most Common Accreditation Deficiencies: 2011 Transfusion Medicine Requirement ID Requirement TRM.31000 A complete procedure manual is available at the workbench or in the work area. TRM.30866 There is an agreement or understanding between the transfusion service and the clinical areas for which it provides transfusion/transplantation support (e.g. surgery, emergency room, patient care units) to ensure provision of blood, blood components and tissue on a timely basis. TRM.10150 There is ongoing evaluation of PT and alternative assessment results, with prompt corrective action taken for unacceptable results. TRM.41650 Criteria for the recognition of transfusion reactions are documented, and there is documentation of at least annual in- service education on the recognition of such reactions. Procedure manual; Service agreement; Proficiency Testing; Training of transfusionists

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35 TJC: Top Standards Compliance Issues for 2012 Laboratory and Point-of-Care Testing
Description QSA The laboratory participates in CMS-approved proficiency testing programs for all regulated analytes. HR Staff are competent to perform their responsibilities. QSA The laboratory performs calibration verification. DC The laboratory report is complete and is in the patient’s clinical record. QSA The laboratory maintains records of its participation in a proficiency testing program. Next are the most recent TJC TOP 10 deficiencies. Looking at the 1st five Proficiency testing; competency assessment; equipment calibration verification; document control

36 TJC: Top Standards Compliance Issues for 2012 Laboratory and Point-of-Care Testing
Description QSA The laboratory performs correlations to evaluate the results of the same test performed with different methodologies or instruments or at different locations. TS The organization uses standardized procedures for managing tissues. QSA The laboratory evaluates instrument-based testing with electronic or internal systems prior to using them for routine quality control. QSA The laboratory has a process for handling and testing proficiency testing samples. WT The organization maintains records for waived testing. Correlation studies; SOPs (for tissues); equipment monitoring/maintenance; proficiency testing; document control/records

37 TJC: Hospital Requests For Improvement Jul-Dec 2011
Standard Description EC Emergency power for blood storage system HR Special training provided for transfusion administration MS Medical staff involved in PI activities for blood & blood use NPSG Two identifiers used to ID patient for transfusion NPSG Two persons verify patient ID and product for transfusion One of the 2 persons verifying patient ID and product for transfusion is the transfusionist Two persons verify patient ID and product for transfusion; the second is qualified PC Transfusions administered per law & medical staff policy PC Transfusion administration equipment is available for operative and other high-risk procedures The next 5 slides were part of the original presentation, and have not been updated (but I thought it would be best to include them). They are more specific to the TJC’s Transfusion Medicine standards. Equipment; Process Control (training of transfusionists; transfusion specifics) blood utilization;

38 TJC: Hospital Requests For Improvement Jul-Dec 2011
Standard Description PC Follows HIV/HCV Notification (Look back) policies PI Organization collects data on blood and blood use, and all reported and confirmed transfusion reactions RI Informed consent process UP Standardized pre-op verification list, including blood product availability (and other laboratory reports) NPSG Label in front of patient Lookback ; blood utilization; process Control

39 TJC: Laboratory Requests For Improvement Jul-Dec 2011
Standard Description QSA The organization follows its policies and procedures that guide the monitoring of the patient and the reporting of suspected transfusion-related adverse events during blood and blood component administration. QSA The interpretation of the transfusion reaction workup provided by the transfusion service director is documented in the patient’s clinical record. NPSG Label containers used for blood and other specimens in the presence of the patient Use at least two patient identifiers when administering blood or blood components; when collecting blood samples and other specimens for clinical testing; and when providing other treatments or procedures QSA The blood transfusion service director or an individual qualified as a technical supervisor in immunohematology conducts an annual review of the policies and procedures of the blood transfusion service. The annual review is documented. Process Control (blood administration policies/procedures) Document Control: annual review????

40 TJC: Laboratory Requests For Improvement Jul-Dec 2011 (cont)
Standard Description QSA The laboratory follows its policies and procedures for the blood transfusion service. QSA Policies and procedures that guide the monitoring of the patient and the reporting of suspected transfusion-related adverse events during blood and blood component administration address the following: monitoring, criteria, protocol for event, immediate reporting to MD and lab QSA The laboratory’s written policies and procedures to leukoreduce blood and blood components address: Leukocyte reduction to less than 5 x 10^6 for apheresis platelets and red blood cells. The transfusion service director has oversight of policies, processes, and procedures related to the blood transfusion service, including blood administration. The policies and procedures for the blood transfusion service are current and are revised whenever standards of practice change PI The laboratory collects data on the following: The use of blood and blood components. (See also LD , EP 2) Process control: PPP for blood administration; leukoreduction of components Blood utilization

41 TJC: Tissue Findings- Lab Jul – Dec 2011
Standard Description TS The organization confirms that tissue suppliers are registered with the U.S. Food and Drug Administration (FDA) as a tissue establishment and maintain a state license when required. The organization verifies at the time of receipt that package integrity is met and transport temperature range was controlled and acceptable for tissues requiring a controlled environment. This verification is documented. Refrigerators, freezers, nitrogen tanks, and other storage equipment used to store tissues at a controlled temperature have functional alarms and an emergency back-up plan. The organization maintains daily records to demonstrate that tissues requiring a controlled environment are stored at the required temperatures. TS The organization documents the dates, times, and staff involved when tissue is accepted, prepared, and issued. TS The organization has a written procedure to investigate tissue adverse events, including disease transmission or other complications that are suspected of being directly related to the use of tissue. These are their top deficiencies noted specifically for tissues

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43 Accreditation Organization Standard # Corresponding CLIA Regulation
Most Frequent Deficiencies for CY AOA-HFAP Accreditation Organization Standard # Standard Description Corresponding CLIA Regulation Routine Chemistry Proficiency Testing (a) Hematology Proficiency Testing (a) Comparison of Test Results (a) Essential Conditions (b)(1-4) Toxicology Proficiency Testing (a) Tests Not Included in PT (c)(1-2) Endocrinology Proficiency Testing (a) Verification of Performance Specifications (b)(1)(i-ii) Laboratory Director – Personnel Competency (e)(13) Postanalytic Systems Quality Assurance (a) Proficiency Testing Equipment / Test calibration, accuracy verification Qualifications: Leadership QA

44 The top 3 repeat deficiencies for CY 2011.
Additional information from AOA-HFAP 6% of laboratories surveyed were cited for CMS Condition-Level deficiency related to Personnel Competency Assessment. Repeat Deficiencies: The top 3 repeat deficiencies for CY 2011. Facilities. The laboratory must be constructed, arranged, and maintained to ensure the space, ventilation, and utilities necessary for conducting all phases of the testing process. § (a) Calibration / Control Failures. The laboratory must document all corrective actions taken, including actions taken when results of control or calibration materials, or both, fail to meet the laboratory’s established criteria for acceptability. All patient test results obtained in the unacceptable test run and since the last acceptable test run must be evaluated to determine if patient test results have been adversely affected. The laboratory must take the corrective action necessary to ensure the reporting of accurate and reliable patient test results. § (b)(2) Comparison of Test Results. If a laboratory performs the same test using different methodologies or instruments, or performs the same test at multiple testing sites, the laboratory must have a system that twice a year evaluates and defines the relationship between test results using the different methodologies, instruments, or testing sites. § (a) Competency Assessment Test / Equipment calibration accuracy verification.

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46 COLA : Most Frequent Deficiencies for 2008-2010
lacking procedure for voluntary FDA reporting of device-related adverse events  2 not verifying materials used as controls by repetitive testing to meet manufacturer's established parameters for mean and standard deviation 3 not labeling specimens with a unique patient identifier composed of two individual identifiers and the source of the specimen (when appropriate) 4 not performing calibration verification according to the manufacturer's instructions including: the number, type and concentration of materials to be used; use of materials at low, medium and high values within the reportable range as determined by the laboratory; acceptable limits for calibration verification, once every 6 months or more often, if required by laboratory procedures 5 not following manufacturer's instructions for the use of reagents, controls and kits Process Control Equipment / Test calibration, accuracy verification Procedures / Records/ Document Control

47 COLA: Most Frequent Deficiencies for 2008-2010
6 one or more laboratory employees not adequately fulfilling the responsibilities for the positions they hold 7 not preparing and plotting quality control data for each quantitative test performed with each testing event, or not calculating statistical indices to permit the laboratory to assess continued accuracy and precision of the method 8 personnel records not containing documentation of education and experience to qualify employees for the positions they hold in the laboratory 9 not documenting personnel education in the FDA procedure for voluntary reporting of device-related injuries and/or malfunctions; and 10 laboratory director or qualified designee not regularly reviewing the quality control data with laboratory personnel Qualifications: Testing personnel Process Control / Equipment / Test calibration, accuracy verification; QA Procedures / Records / Document Control

48 The Meat of the Matter is????
I have presented a lot of information………if you raised your eyebrows, cringed, looked at your neighbor or possibly stopped breathing during this presentation, I may have mentioned something that you need to BEEF UP! Attempts to collate this information for better focus for the next presenters led to some recurrent themes

49 Meat of the matter? Qualifications: leadership & personnel
Proficiency Testing Competency Assessment Process control Procedures, Records and Document control QA: Variance tracking including thorough documentation &, if needed, investigations Equipment / test: calibration, accuracy verification In no particular order

50 Where Did the Beef Come From?
Suzanne H. Butch, MA, MLS(ASCP)CM, SBBCM University of Michigan Hospitals & Health Centers

51 Good Laboratory Practices
AABB CAP Joint Commission COLA Regulatory agencies (CMS, FDA) Every organization that comes to visit you all talk about good laboratory practices; a lot of these are no brainers! The problem sometimes is getting things actually DONE! It doesn’t take rocket science to say we have to document things that we do, and that it has to be legible, and that people have to be qualified and trained. You have to remember that although CAP may be your accrediting organization, other rules may apply (for example, FDA; CMS)

52 It’s In The Book Code of Federal Regulations 21 CFR 600’s
Then came CLIA (42 CFR 493) Oh, 21 CFR 200’s apply Best way to have the most current information is on-line. Books may be handy at times, but they can become outdated very quickly. Also, changes that are made may not become fully evident. For years, we needed an exemption from the FDA if we wanted thawed FFP to expire 24 hours from thaw time, and not 6 hours, as the CFR defined. It changed just over a year ago, but I’m sure you didn’t hear the announcement on the 6 o’clock news. FDA regulations that we originally cared about we in the 600’s; then CLIA; then the 200’s, and now regulations about electronic signatures, electronic records in the 21 CFR Part 11

53 Deemed Status The FDA or CMS deems that the requirements for accreditation by an agency is equal or greater than those printed in the CFR The inspections required are performed by the agency deemed equivalent rather than the federal agency You are then held to all of the standards of the equivalent agency even if they exceed CLIA or FDA You have to comply with ALL of the requirements of the agency you choose.

54 And… The requirements differ- There are different interpretations
different cycles of doing updates different levels of concern and higher requirements by some agencies Understanding the Grading System

55 Examples Proficiency testing Competency assessment Procedure manuals

56 CLIA- Proficiency Testing
(b) The laboratory must verify the accuracy of the following: (1) Any analyte or subspecialty without analytes listed in subpart I of this part that is not evaluated or scored by a CMS-approved proficiency testing program. (2) Any analyte, specialty or subspecialty assigned a proficiency testing score that does not reflect laboratory test performance (that is, when the proficiency testing program does not obtain the agreement required for scoring as specified in subpart I of this part, or the laboratory receives a zero score for nonparticipation, or late return of results). ALSO STATES: (d) All proficiency testing evaluation and verification activities must be documented. PROFICIENCY TESTING: All require follow-up &/ or corrective action for any result that is incorrect or ungraded. HOW they state it varies: CLIA: “any analyte, specialty or subspecialty assigned a proficiency testing score that does not reflect laboratory test performance (HUH????) ……...yada yada yada

57 AABB- Proficiency Testing
5.1.2 Proficiency Testing Program …... Results shall be reviewed and corrective action taken, where appropriate, when expected results are not achieved. AABB talks about review and corrective action when expected results are not achieved. NOT MUCH DETAIL. Don’t forget, with AABB, if you see the pen symbol, it means you have to have documentation.

58 CAP – Proficiency Testing
COM Ungraded PT Challenges 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 1 in the CAP Laboratory Accreditation Manual (http://www.cap.org/apps/docs/laboratory_accreditation/checklists/checklist_reference_links.doc). Evidence of Compliance: ✓ Records of review and evaluation of ungraded PT challenges REFERENCES Department of Health and Human Services, Centers for Medicare & Medicaid Services. Clinical laboratory improvement amendments of 1988; final rule. Fed Register. 2003(Jan 24):3705 [42CFR (a)(2)] CAP even spells out that they want you evaluating all that were intended to be graded, but were not. There are subtle differences, yet you need to Best to make sure you evaluate AND document this review of any that were not 100%.

59 Competency Assessment
It means that all 6 of the elements are required for “CLIA” testing Sec (8) …The procedures for evaluation of the competency of the staff must include, but are not limited to– (i) Direct observations of routine patient test performance, including patient preparation, if applicable, specimen handling, processing and testing; (ii) Monitoring the recording and reporting of test results; (iii) Review of intermediate test results or worksheets, quality control records, proficiency testing results, and preventive maintenance records; All organizations are now agreeing that there are 6 elements required for CLIA testing. These 6 do not apply to ex. someone pooling platelets.

60 Competency Assessment- CLIA
(iv) Direct observation of performance of instrument maintenance and function checks; (v) Assessment of test performance through testing previously analyzed specimens, internal blind testing samples or external proficiency testing samples; and (vi) Assessment of problem solving skills; and (9) Evaluating and documenting the performance of individuals responsible for high complexity testing at least semiannually during the first year the individual tests patient specimens. Thereafter, evaluations must be performed at least annually unless test methodology or instrumentation changes, in which case, prior to reporting patient test results, the individual's performance must be reevaluated to include the use of the new test methodology or instrumentation.

61 Competency Assessment - AABB
2.1.3 Evaluations of competency shall be performed before independent performance of assigned activities and at specified intervals.* * 42 CFR and 42 CFR AABB’s 28th edition of BB/TS Standards doesn’t provide the detail about competency, but refers you to the CFR, which means follow the CFR (in updating this presentation, and rereading the standard, I question (does the asterisk apply a) to the word “intervals”, OR b) to the whole statement? ….ANSWER: PICK b!!!

62 Competency Assessment - CAP
Laboratory General Checklist GEN Competency Assessment Phase II The competency of each person to perform his/her assigned duties is assessed. The CAP requirement for Competency looks simple also!

63 Competency Assessment - CAP
Retraining and reassessment of employee competency must occur when problems are identified with employee performance. Elements of competency assessment include but are not limited to: 1. Direct observations of routine patient test performance, including, as applicable, patient identification and preparation; and specimen collection, handling, processing and testing 2. Monitoring the recording and reporting of test results, including, as applicable, reporting critical results 3. Review of intermediate test results or worksheets, quality control records, proficiency testing results, and preventive maintenance records 4. Direct observation of performance of instrument maintenance and function checks 5. Assessment of test performance through testing previously analyzed specimens, internal blind testing samples or external proficiency testing samples; and 6. Evaluation of problem-solving skills BUT THEN THEY SPELL IT OUT! Here they first include all 6 CLIA elements of competency

64 Competency Assessment CAP
The laboratory must identify the test systems that an employee uses to generate patient test results. Competency must be evaluated and documented for all testing personnel for each test system. A TEST SYSTEM is the process that includes pre-analytic, analytic, and post-analytic steps used to produce a test result or set of results. A test system may be manual, automated, multi-channel or single use and can include reagents, components, equipment or instruments required to produce results. A test system may encompass multiple identical analyzers or devices. Different test systems may be used for the same analyte. And then they go into some great detail defining TEST SYSTEM.

65 Procedure Manual – CLIA 42 CFR 493.1251
(a) A written procedure manual for all tests, assays, and examinations performed by the laboratory must be available to, and followed by, laboratory personnel. (d) Procedures and changes in procedures must be approved, signed, and dated by the current laboratory director before use. Who signs procedure manual? AABB says medical director.

66 Procedure Manual - CLIA
42CFR Standard; Laboratory director responsibilities. (14) Ensure that an approved procedure manual is available to all personnel responsible for any aspect of the testing process; CLIA says the person whose name is on the CLIA certificate! The Lab Director! Caution in your larger institutions!!!! May need more signatures if you also have a medical director for your Blood Bank. Good news, is that most agencies are changing annual review to review EVERY TWO YEARS. Once again, make sure that all of your accrediting agencies have switched to this! If your facility is being assessed for multiple disciplines, make sure you pay attention to EACH set of standards. Different standards are revised at different times.

67 Who is the Laboratory Director?
Medical Director - maybe AABB and CAP think this is a necessary role Technical Supervisor – maybe Must be a physician in the Transfusion Service The person on the CLIA certificate - BINGO Terminology and qualifications are the key: ex. At my former institution, the Lab manager’s official title is Lab director; is the CLIA sense, the medical director is the Lab director. Is it time to standardize titles to be consistent with CLIA???? Who knows!

68 Procedure Manual Review- AABB 28th ed. BB/TS
Standard Review of each policy, process and procedure shall be performed by an authorized individual at a minimum every two years.

69 Procedure Manual Review- CAP
07/29/ COM Procedure Manual Review Phase II There is documentation of review of all technical policies and procedures by the current laboratory director or designee at least every two years. NOTE: The director must ensure that the collection of testing policies and technical protocols is complete, current, and has been thoroughly reviewed by a knowledgeable person. Technical approaches must be scientifically valid and clinically relevant. To minimize the burden on the laboratory and reviewer(s), it is suggested that a schedule be developed whereby roughly 1/24 of all procedures are reviewed monthly. Paper/electronic signature review must be at the level of each procedure, or as multiple signatures on a listing of named procedures. A single signature on a Title Page or Index of all procedures is not sufficient documentation that each procedure has been carefully reviewed. Signature or initials on each page of a procedure is not required. CAP expects review of TECHNICAL procedures every 2 years! What about CLIA? They don’t specify a time frame. Just state they should be signed by the current medical director (of course, the procedures should be up-to-date with your operations, manufacturer’s instructions, etc. )

70 Summary While all agencies expect good laboratory practices
Some have more detailed requirements Meeting one set of requirements does not mean all agency requirements are met To remain compliant Review changes as they occur Don’t change without reviewing other agency requirements

71 Recipes and Tools to "Beef Up" Your Transfusion Service
Thanks to Sheri Goertzen,; I’ll be bringing up the rump of the roast and talking about some Recipes and Tools we can use to “Beef Up” our Transfusion Services. Sheri Goertzen, MT(ASCP)BB, CLS(CA) Children’s Hospital Central California

72 Learning Objectives Identify the elements and processes in Transfusion Services that are most often found to be weak or out-of-compliance at inspection time. Describe ways to pinpoint weaknesses in your own department and develop an action plan to correct them. Discuss and share examples of documents and tools that can be used to "beef up" your operations and quality systems.

73 Wendy’s popular slogan
Where’s the substance? Where’s the quality? I’m a huge fan of the Food Network, and over the summer they showed a really interesting story about the fast food giants of our time. It was fascinating to learn that Dave Thomas, founder of “Wendy’s”, came up with the “Where’s the Beef?” slogan to try to focus the public’s attention to the differences between Wendy’s burgers and the other popular fast-food burgers of the day. He wanted people to realize that his burgers had measurably more substance, and were of a higher quality than his competitors. That wildly popular slogan quickly took off and developed a life of its own. People soon began using “Where’s the Beef?” as an all-inclusive phrase you could use to question the quality and substance of practically anything. (And apparently it even had its own Milton Bradley board game for a while!)

74 In our Transfusion Services….
Where’s our Beef? What can we do to increase the strength and quality of our operations? Well, the phrase can still be used to ask a valid question about our Transfusion Services? Where’s our Beef? What about our operations has strength and substance? Is Quality built into all of our products? Where might we do a self-inspection and lift up a giant sized bun requirement just to find a severely undersized burger patty of an effort? And what can we do to find those spots so we can take action to increase the strength and quality of our operations?

75 The Beef Challenge So are we up to the “Beef Challenge”? Of course we are!! We better be !!!! So let’s explore the kinds of things we have in our recipe box to help us find those weak spots and beef them up!

76 Recurring Problems… Repeated errors or complaints
Reminder memos to staff FDA reportable errors Unacceptable PT results Track and trend Pay attention to these red flags! The most logical place to begin to look for system issues that need improvement are… recurring problems. This seems so simple, but I think we often get wrapped up trying to cope with day-to-day operations that we sometimes just resolve to accept certain recurring problems as ongoing issues that we just have to learn to live with. Maybe we need to look again with fresh eyes. Where are we repeatedly seeing errors or getting complaints? Are we having to send out reminder memos to staff about a certain process or procedure? Maybe over and over? Are we seeing any kind of pattern in FDA reportable errors? Have we seen problems with unacceptable Proficiency Testing results? It’s very important to track and trend all of these events so that we don’t miss these nice little red flags warning us that we may have some weak spots that need some attention!

77 Variance Tracking System
If possible, document and track all variances initially in one place “One-Stop-Problem-Shop” Easier to overlook a trend if you use multiple systems to track and report on various types of errors Classify, Categorize, Grade Internal Reports External Reports: Hospital, FDA/CBER, NHSN How are we tracking our problems in the Transfusion Service? If possible, its best to document and track all variances initially in one place. A “One-Stop-Problem-Shop” makes it easy for staff to use the variance documenting system. They don’t have to remember that for specimen issues you document here, for equipment problems you document there, for mistakes you document somewhere else. Having a central repository for all variances makes it less confusing to use the system and will help you with developing comprehensive, meaningful reports and early detection of trends that might be happening. Many transfusion services use a Lab-Wide variance tracking system, some even use a hospital-wide system if it’s robust and detailed enough. Others find it most useful to develop a Transfusion Service specific variance system, and then integrate that system into the bigger, broader Lab and Hospital Quality Reporting systems. Whether you’re doing this on paper or in a computer, its helpful to Classify, Categorize, and Grade each variance. By doing this, you’re able to see those trends more easily when you lump the same or similar problems together. Using a computer for this makes it easy to generate Internal reports from your database. And of course, your internal variance system must integrate with other reporting that needs to be done external to your department, such as Hospital Quality/Risk Management, FDA/CBER, or the NHSN Hemovigilance reporting that many of us are now doing.

78 Variance Tracking System
Detail the Variance: SBAR Situation, Background, Assessment, Recommendations Classification: Pre-Analytic, Analytic, Post-Analytic, Non-Analytic Internal, External Day, PM, Night, Weekend Category: Variance, Complaint, Accident, Near-Miss, Resource Issue, Safety, Communication, Personnel Grade (severity): 0 (no harm) – 4 (actual/potential for severe harm) This is an example of how you can set up your variance tracking system. Usually, you have staff fill out a simple standard report giving all of the details of the variance (either on paper, in the computer, or using some sort of an system). You can devise your form to ask the right questions to pull out the information needed. We use the SBAR format where the person is asked to describe the Situation, the Background, provide an Assessment of “what is the issue”, and Recommendations for corrective action. A person in management then follows-up and performs the classification, categorizes, grades and also documents whatever further corrective action was taken. If the variance requires external reporting, the supervisor or manager will also file that report. On a monthly or quarterly basis, all of the variances are summarized and reported in a QA report that gets reviewed by the medical director and moves up through the quality committee structure of your hospital.

79 Variance Tracking System
So here’s a sample of a lab-wide variance reporting system. The person discovering and reporting the problem fills out this top SBAR portion electronically, and once they file it, it goes to the lab management team or QA coordinator and is delegated for follow-up to the appropriate supervisor or technical specialist.

80 Variance Tracking System
That supervisor then classifies, categorizes and grades the incident, and also documents any follow-up that was needed and any additional counseling, training, process changes, or reporting that was done as part of the corrective action process.

81 Quality Dashboard Variance Complaint Accident Near-Miss Pre-Analytic
6 Hemolyzed 3 QNS 4 Missing initials 3 No label on tube Analytic 1 QC/Reagent 1 Prod. Selection 1 TAT Delay 1 SCD Leak Post-Analytic 1 Product Tag switch, fixed before issue 1 LIS Problem Non-Analytic 1 CVS Protocol – Pre-approved 1 SURG Sent Pick-Up Slip on wrong patient At the end of your quarter, you can summarize your incidents into a dashboard type of quality report, and this will often clue you right in on where your red flags are and where you should concentrate your improvement efforts. In this example, specimen problems are the big red flag winner. I also consider any “Near-Miss” as an immediate red flag, even if its just a one-time incident. If you continue to see anything re-appear from quarter to quarter such as complaints for Turnaround Time Delays, or leaking welds from a sterile connector, then that would also send up a red flag on an ongoing trend that should be investigated and corrective action taken.

82 Think outside the box… If you feel like you’re beating a dead horse…
Replace it with a unicorn! So… What about those problems you seem to see over and over again?? If you feel like you’re beating a dead horse…, chances are… the horse is truly dead and no amount of beating is going to bring him back to life. In other words… If you have a process that you chronically have trouble with, and you’ve trained, and retrained and reminded, and it’s still problematic … chances are… that part of your system is just… broken… terminally ill. If at all possible, don’t be afraid to think outside of the box and come up with a new way, a new recipe, to accomplish a process. Make sure you meet all regulatory and accreditation requirements, but don’t be afraid to dream and get creative. If it doesn’t work, you can always try something else! Here’s a Quick Example: Even after updating forms and retraining staff, we were still having trouble getting the “Release of Uncrossmatched Blood” form signed by the doctor and scanned into the EMR. Forms were disappearing or getting scanned in without the required physician signature. So… we took 3 giant steps back… and decided maybe we needed to try a totally different approach… [click] We dreamt up a Unicorn to replace our dying horse. We thought outside of the box and just recently implemented a new electronic way for the blood bank staff to place a computer order on the patient whenever we get a request for uncrossmatched blood. This order is simply a statement that the situation was “sufficiently urgent to require release of blood before completion of testing”, and we created this order to require electronic signing by the requesting physician. No more lost papers, no more missing signatures! So far, it seems to be working great!

83 Finding Those “Weak” Spots
Procedure Reviews Scheduled & Nonscheduled Written Competency Testing Questions most often missed Problems finding/citing references in the written procedure Self-Audits Bedside Blood Administration Tracer or Focus Audits Some other recipes that help us find our weak spots include things like: Procedure Reviews – both scheduled and nonscheduled Written Competency Testing. Pay special attention to the questions that are most often missed and the questions where staff have problems finding or citing the reference for the answer. Performing Self-Audits,… very, very important! This is a perfect place to get creative. We all have things we know are problems, but we’ve never really studied them enough to know how BIG of a problem they are. So create a self-audit tool and collect some data! Schedule and perform things such as Bedside Blood Administration audits, and Tracer or Focus Audits.

84 Finding Those “Weak” Spots
Ongoing Quality Monitors TAT, Wasted Products, Unacceptable Specimens, Wrong Orders, Reaction Statistics, Transfusions Exceeding 4 Hours, etc. Annotated CAP Checklists (Transfusion Medicine and All Common) Annotated AABB Assessment Tool “Changes to the Standards” Gap Analysis We also need to be measuring ongoing Quality Monitors… things such as Turn-around-times, Wasted Blood Products, Unacceptable Blood Bank Specimens, Orders placed in Error, Transfusion Reaction Statistics (are your nurses under-reporting reactions?), Transfusions Exceeding 4 Hours, and the list goes on and on of things you can measure, set thresholds, and trend… especially if you suspect problems. And of course, we are always wise to use the tools supplied by our accreditation agencies to perform audits of our own operations and processes. Using the CAP Checklists, the AABB Assessment Tool, and AABB’s “Changes to the Standards” can help us pin point where we fall short and where we should concentrate our efforts of process improvement.

85 Tools to “Beef Up” Competency Testing
Divide your operations into Test Systems Purposefully cover all Test Systems Create problem-solving scenarios on topics you know staff have struggled Pre-analytic Analytic Post-Analytic So now lets start sharing some ideas of specific tools we can use to “beef up” those areas we’ve discovered need a bit of help. One area that I think most of us struggle with is “competency testing”. How much is enough, what’s the best way to accomplish this, how do we know we’ve covered all of the things that need to be covered? As Suzanne said earlier, CAP requires that all of the Test Systems for CLIA regulated analytes be assessed using all 6 elements of competency assessment. Think of a “Test System” as a group of inter-related tasks that share the same training, skills, and competencies to produce a final test result or a finished product… such as tube testing, automated testing on an instrument or analyzer, rosette testing, titering, aliquoting, irradiating, etc. These Test Systems will span across the Pre-Analytic, Analytic, and Post-Analytic parts of testing. If you divide your operations into Test Systems such as this, you can feel confident that your competency program adequately addresses all of the Test Systems using all of the required elements because you carefully build your program and develop your assessment tools to purposefully cover all of the systems. When you create the problem-solving part of your competency program, make sure you come up with scenarios on topics that you know staff tend to struggle with or get easily confused. Making them work through these problems and find the reference for the answers will serve as “teaching moments” and help cement the correct practice in their minds. A laboratory must evaluate and document the competency of all testing personnel for each test system. A TEST SYSTEM is the process that includes pre-analytic, analytic, and post-analytic steps used to produce a test result or set of results. A test system may be manual, automated, multi-channel or single use and can include reagents, components, equipment or instruments required to produce results. A test system may encompass multiple identical analyzers or devices. Different test systems may be used for the same analyte. The laboratory must identify the test systems that an employee uses to generate patient test results. Many of the elements of competency assessment are performed during routine supervisory review of an employee. Documentation of these elements, including observation of test performance, results reporting, instrument maintenance, review of worksheets, recording QC, performance of PT, and demonstration of taking appropriate corrective actions are examples of daily activities that can be used to demonstrate competency. If elements of competency are assessed by routine supervisory review, the competency procedure must outline how this routine review is used to evaluate competency. Competency assessment by routine supervisory review may be documented by a checklist. For nonwaived test systems, all the above six elements must be assessed annually (unless any are not applicable to the test system). For waived test systems, the laboratory may select which elements to assess.

86 Competency Schedule April October 1. Radiation Safety
14. Type/Screen: Tube, Capture, Echo 2. Irradiation of Blood Products 15. Crossmatch 3. Aliquoting Blood Products 16. Antibody Identification 4. Use of COBE Blood Processor 17. Blood Issue: Routine, Emergency 5. Exchange Transfusion Prep 18. Transfusion Reaction Investigation 6. Platelet Volume Reduction 19. Antigen Typing (Phenotyping) 7. Thawing Plasma and Cryo 20. Platelet Antibody Titer (A & B) 8. Pooling Cryoprecipitate 21. Back-up Product Label Printing 9. Label Check for Modified Products 22. Back-up Patient History Look-up 10. Blood Storage Criteria 23. Record-keeping and Documentation 11. Request Form Acceptability 24. Age-Related, Critical Values 12. Use of Cell-Washers 25. Quality Program 13. Retyping Donor Units 26. Quality Auditing This is an example of how you can divide your transfusion service operations into categories that cover all of the various Test Systems. Each year we make sure there are questions that cover all the categories on the written competency exams we give our staff. We choose to issue written competency exams in April and October, wet competency samples in January and July, and observed annual competencies in May and June. We’ve found that spreading portions of competency assessment over each quarter keeps it more manageable for us as far as the time required to complete it. But many labs like to do competency assessment all at one time, or coordinate it with each staff member’s performance appraisal. What ever works best for you! By the end of each year, every blood banker has been assessed using all 6 elements for each Test System and also had their annual cGMP training and post-test. You can incorporate some of this annual training and competency assessment into an on-line system such as “CHEX” or “MediaLab” if those systems are available to you.

87 Competency Test – Written
Here are just a couple of sample questions that were incorporated into a written competency test. The techs get points for answering the questions correctly, and also points for listing the appropriate reference. This forces the staff to go and find the information in the procedure, and keeps them familiar with the content in the procedure manual. It also helps you make sure that all the information staff needs for problem solving and answering questions can actually be found in the procedures. More than once, I have discovered weak spots in my own procedures by trying to locate the reference for an answer, and finding that the instructions are either missing or unclear or outdated, or perhaps not located where I thought they were. Ask for the reference for each answer.

88 Competency Test – Written
Here are a couple more sample questions on a competency test. I always finish off the test with a spot for staff to give feedback in the form of comments and suggestions. Over the years, I’ve gotten back some wonderful suggestions on ways to improve a procedure or a process. You can then use those suggestions to make those improvements, and give credit to the person who had the great idea! It’s important to always provide feedback to the staff on each of their comments and suggestions to let them know you’re seeking their input because you value their ideas, and you’re counting on them to be important stakeholders in the operations of the department. Ask for suggestions. Use these to improve your procedures/processes. Provide feedback on each Comment/Suggestion.

89 POSSIBLE REVIEWS / DOCUMENTATION
Source: “Quest for Quality” June 2013 Advance for Laboratory Directors, Managers, Technologists, Educators, Students REQUIRED METHOD POSSIBLE REVIEWS / DOCUMENTATION Direct observation of test performance Checklist documenting observation Monitoring test result recording & reporting Observation; checklist documenting observation; review of records – patient charts, test reports, instrument reports, etc. Review of worksheets, QC, PT & maintenance records Review of records – QC, PT, maintenance of records, etc. Direct observation of instrument maintenance Assessment of test performance (PT / blind samples) Review of records – PT scores, comparison of test results, etc. Assessment of problem-solving skills Quizzes, review of problem logs, review of non-conforming events and incidents, review of QC issues, review of specimen rejection issues, etc.

90 Try to keep things SIMPLE!!
EXAMPLE: Monitoring Test Results and Record Review are done daily and / or periodically by Technical Specialist or designee; concerns monitored by Error Management process. DATE OF REVIEW: _______________ By: ___________________________

91 RECORD OF EMPLOYEE ANNUAL COMPETENCY REVIEW S = Satisfactory
BLOOD CENTER OF XYZ, INC. 1234 Your Street Wherever you’re at, IL RECORD OF EMPLOYEE ANNUAL COMPETENCY REVIEW S = Satisfactory U = Unsatisfactory Employee Name: ____________________ Date: ________________ Test: ________________________________________________________ Applicable SOP(s): _________________________________________________ _________________________________________________ Sample 1 # ___________________ Sample 2 #______________________ Result: _____________________________________________________ TABLE: SEE NEXT SLIDE ___Employee is competent ___ Employee requires re-training/Re-trained date: ________________ Reviewer: _________________________ Date: _____________________

92 Test result within acceptable range of Sample 1 Sample 2
S U Comments 1. Direct Observation: Employee performs test steps according to current applicable SOP(s) listed above. 2. Test result within acceptable range of Sample 1 Sample 2 _____________ _____________ 3. Maintenance checks: A. Direct observation of: _______________ _______________ B. Record review dated: ______________ _______________ 4. Competency exam score ____________________ **includes problem solving skills question(s) Score must be > 90% 5. Proficiency samples tested during current year: _____________ _____________ _____________ 6. Review of recording and reporting of test results/QC records dated: _____________ _____________

93 COMPETENCY ASSESSMENT REMINDER #1:
testing personnel must be assessed semi-annually for the first year of patient testing, and annually thereafter. ­Must be demonstrated whenever new testing methods, kits and/or instruments are added to your laboratory's test menu. Source: “Quest for Quality” June 2013 Advance for Laboratory Directors, Managers, Technologists, Educators, Students

94 COMPETENCY ASSESSMENT REMINDER #2:
Is not limited to testing personnel Clinical consultants, technical consultants / technical supervisors and general supervisors must also have their competency to perform regulatory responsibilities evaluated. Competency of lab directors is not assessed directly since they are held to additional standards and criteria to confirm that they are fulfilling the responsibilities of their positions Source: “Quest for Quality” June 2013 Advance for Laboratory Directors, Managers, Technologists, Educators, Students

95 Self Audit – Changes to the Standards
New version of the Standards published every 18 months Create self-audit tool to ensure your operations are in compliance with any changes being made to the new standards Catch and correct potential nonconformances before your next AABB assessment As we all know, a new version of the Standards is published every 18 months. AABB traditionally posts a “Changes to the Standards” on their web page a few months prior to the new standards going into effect. It’s easy to do a self-audit to ensure your operations are in compliance with any changes being made to the new version of standards. Using a tool like this will help you catch and correct potential nonconformances before your next AABB assessment.

96 SLG 10/5/12 SLG 10/5/12 It’s easy to download the list of changes from the AABB Website and turn it into a self-audit tool like this that you can use to verify that you’ve reviewed your current policies, processes, and procedures and that they are in compliance with each of the changes being made. SLG 10/5/12

97 SLG 10/5/12 SLG 10/5/12 You can document any corrective actions needed that are discovered by this gap-analysis type of tool, and be confident that there won’t be any surprises at your next AABB assessment being caught unaware of a new or changed Standard. SLG 10/5/12

98 Standards for Blood Banks and Transfusion Services, 28th edition Summary of Significant Changes
The following table summarizes many of the significant changes made to the 27th edition of Standards for Blood Banks and Transfusion Services; it is not, however, exhaustive. Not all changes contained in the Standards have been incorporated in detail. Many of the changes that result in the reorganization of a section cannot be fully appreciated without consulting the 28th edition of Standards in conjunction with this table; therefore, the numbering follows that of the 28th edition and, where appropriate, the corresponding standard number in the 27th edition is included in parentheses. In cases where a standard has been re-numbered, but the substance of the standard has not changed, there is often no entry listed in the table. Like the crosswalk published with the Standards, this table is offered to assist individuals in updating their facility’s policies, processes, and procedures to conform to the 28th edition. Use of this table should not take the place of a thorough, line-by-line analysis of each standard. Please note that this summary includes examples of comments submitted by users of the document, along with the program unit’s rationale in making or not making a revision to the document.

99 Procedure Reviews The staff who use the procedures make excellent reviewers! Use staff from all shifts Guide them through the review process with a procedure audit form. Fix/update your procedures using their feedback and suggested edits. Procedure Reviews are excellent tools to help us find weaknesses in our department. The staff members who must use the procedures make excellent reviewers – probably better than the person who wrote the procedure! You can utilize staff from all shifts, even staff who are generalists and are only part-time blood bankers. Guide them through the review process by providing them with a simple-to-follow procedure audit form. Encourage them to make suggested edits, then you can use their feedback to update and improve your procedure. Give them credit for helping with procedure reviews on their next performance evaluation.

100 2 year review starting in Nov. 2012!!!
Oct. 2012 2 year review starting in Nov. 2012!!! T510 Pooling Cryoprecipitate 8-10 T510F01 Pool Log 4-11 Here is a sample of a procedure review audit form. I find it handy to review all of the procedure’s associated forms at the same time the procedure is reviewed. Of course, with the new Standards going into effect Nov. 1, we can go to a 2 year review cycle, which we are all looking forward to! The audit form starts out with a section on appearance, which covers review of the title, header/footer, correct formatting, and font, and then moves into the section which guides the reviewer through a series of questions to ensure all aspects of the content of the procedure are correct and complete.

101 Here’s the bottom portion of this one page review form
Here’s the bottom portion of this one page review form. This is a handy way to standardize your process for documenting the review of your procedures and related forms, and for making sure your procedures are getting signed-off, on time, as being “reviewed” in the procedure manual.

102 Document Change Request Form – top section
If the reviewer finds something that needs updating, or ANYTIME someone is reading a procedure ... Encourage staff to let you know whenever they’ve found something that’s missing, incorrect, or outdated. This will become even more important as we move to a 2 year review cycle. You can use a tool such as this “Document Change Request Form” that any staff member can fill out and turn in which will standardize this process for your department. They fill out this top section letting you know what they found that needs to be changed and why.

103 Document Change Request Form – bottom section
Then you (or whoever will be making the updates) completes the bottom portion of the form, which also captures the risk assessment, whether a process validation will be needed for the changes, and whether staff retraining will be required. As changes are made, you can track and document the change control steps on this form as well. If you’re lucky to have a sophisticated document control software program, some of these programs include a document change request feature where all of this can be initiated electronically, right from the on-line procedure manual. For those of us that aren’t so lucky, a paper form like this works fine, or you could also develop something similar to this using an request system.

104 3 2 1 N/A Accreditation Requirement Answer all Assessor Questions
AABB Accreditation Program Scale: 3= Adequate in all respects Transfusion Service Activities Tool = Adequate with minor departures 27th Edition, Standards = Below acceptable standards 6.0 Documents and Records Date Due: October 2012 Accreditation Requirement Answer all Assessor Questions Score each requirement & list evidence of compliance. 6.0 Documents and Records The blood bank or transfusion service shall have policies, processes, and procedures to ensure that documents are identified, reviewed, approved, and retained and that records are created, stored, and archived in accordance with record retention policies. What is the process for: Identifying documents? Reviewing documents? Approving documents? Retaining documents? Creating records? Storing records? Archiving records? N/A I’m sure that many of us perform self-audits using the current AABB assessment tool. The entire tool can be downloaded and turned into an audit form. I like to divide the tool up into smaller sections and add a scoring system in the third column for each standard that requires the auditor score each requirement and list out the specific evidence of compliance. This is a very easy method of uncovering areas of weakness and nonconformance. If you use blood bank staff as your “assessors”, it also keeps them familiar with what the current standards require and why we do what we do.

105 Audit Summary Total points:___________ Total points
AABB Accreditation Program Transfusion Service Activities Tool th Edition, Standards Audit Summary Total points:___________ Total points possible:______________ % Score_______________ Assessed By: ______________________ Date:_________________ Explanation of any outliers: Supervisor Review: Action(s) taken to improve current system: Corrective action completion date:________________ Review for Effectiveness: Acceptable? Yes No Medical Director Review: You can add a summation page at the end of each section of the audit, and if you divide the assessment tool into smaller parts like this, you can build these audits into a monthly or quarterly self-audit program. When non-conformances are discovered, use the corrective action as part of your continuous improvement program.

106 Annotated CAP Checklist
Another easy tool to use is the CAP Checklist. If you’re CAP accredited, this customized tool is available on their Web page and is specific for your facility. You can download it as either a PDF or an Excel Spreadsheet and annotate each of the items with your “Evidence of Compliance”. This is a picture of the first page of the Excel version of the Transfusion Medicine checklist, and then we simply add a column to type in the references to whatever policy, procedure, form or report that proves our compliance with that checklist item. Make sure you also complete the ‘All Common’ and ‘Lab General’ checklists as well as the Transfusion Medicine checklist.

107 Quality Dashboard Internal Assessments Date Tool Summary
Corrective Action Plan QSE: Equipment (1) 04/10/12 AABB TS Tool Score = 100% None at this time QSE: Equipment (2) Computer Systems 06/08/12 QSE: Supplier & Customer 06/15/12 Focus Audit: Signed Delivery Slips 07/01/12 Internal Audit Form Score = 94.3% 6 of 106 slips found lacking signature. Staff informed of results. Reminded to be diligent in signing slips. Will repeat audit next quarter. Tracer Audit: Transfusion Rxn 04/28/12 Transfusion Tracer Audit Form No variances found. Again, you can summarize your quarterly audits into a dashboard type of quality report, and this makes it rather easy to pinpoint where efforts should be focused in order to make needed changes for improvement.

108 Equipment : New Standards
3.2 Qualification of Equipment 3.2.1 Installation Qualification: Equipment shall be installed per the manufacturer’s specifications. 3.2.2 Operational Qualification: The functionality of each piece of equipment and each component of a computer system shall be verified before actual use and shall meet the manufacturer’s operational specifications. 3.2.3 Performance Qualification: The BB/TS shall demonstrate that equipment performs as expected for its intended use. : Performance specifications established by the manufacturer shall be met. NEW! NEW! NEW! And finally, let’s mention possible weak spots with Equipment. There are 5 new Equipment standards in the 28th Edition. We all know that equipment (including computer systems) need to be fully qualified and validated prior to use on patients or products. This includes Installation Qualification, Operational Qualification, and Performance Qualification. Records of this qualification need to be retained 10 years after the retirement of the equipment. Does anyone notice a theme in all of these new equipment standards? (I’ve added the underlining to highlight it!) Yes, it’s very important that all aspects of our equipment qualification meet the manufacturer’s specifications. And what about the monitoring and maintenance of the equipment? NEW!

109 Equipment : New Standards
3.5.1 Calibration Calibration procedures shall follow the manufacturer’s written instructions and shall include: 1) Instructions for performing calibrations 2) Acceptance criteria 3) Actions to be taken when unsatisfactory results are obtained Accuracy Verification: Scheduled monitoring and maintenance, check methods, acceptance criteria TRM Comparability of Instrument/Method: If the laboratory uses more than one instrument/method to test for a given analyte, the instruments/methods are checked against each other at least twice a year for correlation of results. NEW! Here again, we see a new Standard which specifies that calibration procedures shall follow the manufacturer’s written instructions and shall include: Instructions for performing calibrations Acceptance criteria Actions to be taken when unsatisfactory results are obtained The same thing is also emphasized in Standard 3.5 which is about having a process for scheduled monitoring and maintenance of equipment that at minimum, is in accordance with manufacturer’s written instructions. The process shall include frequency of checks, check methods, acceptance criteria, and actions to be taken for unsatisfactory results. And I think some of us are still struggling a bit with the relatively new CAP requirement that we perform method correlation at least twice per year. This is becoming more and more important as so many of us have automated our testing and use various analyzers and back-up manual methods, to ensure that no matter what method we’ve used for testing, we are confident our results correlate appropriately and are accurate.

110 Here is a sample of a form to document your bi-annual correlation studies. You can list out the various methods you use across the top and the various tests and reagents down the side. One page is filled out per specimen tested using all of your methods. This makes for an easy to view comparison of results. As blood bankers, we know that we don’t expect the tube method and gel or solid phase analyzer methods to always give exactly the same result, due to the different nature of the test methods, so it’s important you state your acceptability criteria in your SOP. CAP allows QC data to be used as well as human samples to complete these correlation studies.

111 Using tools like these, we can ensure…
So in closing…we’ve talked about some recipes on how to locate the weak spots in our department operations, and we’ve shared some tools that we hope gave you some good ideas of ways to ensure that [click] We all stay as “beefed up” as we can throughout our entire transfusion service! We’re “beefed up” through out our entire transfusion service!

112 Thanks to: Suzanne H. Butch, MA, MLS(ASCP)CM, SBBCM
University of Michigan Hospitals & Health Centers

113 Sheri Goertzen, MT(ASCP)BB, CLS(CA)
Thanks to: Sheri Goertzen, MT(ASCP)BB, CLS(CA) If anyone would like electronic copies of any of the documents and tools I’ve shared today, please feel free to me and I would be more than happy to send them to you. Thank you! [ click ] (time for questions?) 08/22/12 = 22:26 08/29/12 = 25:00

114 Questions

115 Nancy M. Shotas, MT(ASCP)BB, CQA(ASQ)
AABB Staff Lead Assessor


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