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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 Wheres 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 NShotas@aabb.org

4 Learning Objectives

5

6

7 CLIA

8 CLIA

9 CLIA CMS Top 10 Condition Level Deficiencies: Jan. 2013 (Jan.2012) - D6000 Mod. complexity LD qual./resp (1) - D2016 Successful PT participation (2) - D2000 PT enrollment (3) - D6076 High complexity director qual./resp (4) - D5400 Analytic Systems (QC) (6) https://www.cms.gov/Regulations-and- Guidance/Legislation/CLIA/Interpretive_Guidelines_for_Labo ratories.html

10 D6000 (42CFR493.1403) Moderate complexity LD qual./resp. The laboratory must have a director who meets the qualification requirements of 493.1405 and provides overall management and direction in accordance with 493.1407 D2016 (42CFR493.803) 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 (42CFR493.801) 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 (42CFR493.1441) High complexity director qual./resp. The laboratory must have a director who meets the qualification requirements of 493.1443 and provides overall management and direction in accordance with 493.1445 D5400 (42CFR493.1250) Analytic Systems (QC) Each laboratory that performs nonwaived testing must meet the applicable analytic systems requirements in 493.1251 through 493.1283. The laboratory must monitor and evaluate the overall quality of the analytic systems and correct identified problems as specified in 493.1289 for each specialty and subspecialty of testing performed CMS Top 10 Condition Level Deficiencies: Citation explanations

11 CLIA CMS Top 10 Condition Level Deficiencies - D6063 Mod. complexity TP (5) -D6033 Technical consultant qual./resp. (7) -D5024 Hematology (8) -D6168 High complexity TP (10) -D6108 Personnel High Complexity (?? )

12 D6063 (42CFR493.1421) Mod. Complexity Testing Personnel The laboratory must have sufficient number of individuals meeting the qualifications of 493.1423, to perform the functions specified in 493.1425 for the volume and complexity of tests performed D6033 (42CFR493.1409) Technical consultant qual./resp. The laboratory must have a technical consultant who meets the qualification requirements of 493.1411 and provides technical oversight in accordance with 493.1413. D5024 (42CFR493.1215) Hematology If the laboratory provides services in the specialty of Hematology, the laboratory must meet the requirements specified in 493.1230 through 493.1256, 493.1269 and 493.1281 through 493.1299. D6168 (42CFR 493.1487) 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 §493.1489 to perform the functions of high complexity personnel as defined in §493.1495 for the volume and complexity of testing performed D6108 (42CFR 493.1447) High Complexity Testing Personnel (Technical Supervisor ) The laboratory must have a technical supervisor who meets the qualification requirements as defined in 493.1449 and provides technical supervision in accordance with 493.1451. CMS Top 10 Condition Level Deficiencies: Citation explanations

13 CLIA CMS Top 10 Deficiencies D5413 Policy for proper reagent storage (1) D5217 Verify accuracy non-PTd tests (2) D5791 Analytic Systems QA (3) D5403 Procedure manual (4) D5411 Follow mfgrs. instructions (6) D6000 Mod. complexity LD qual./resp. (9) D5439 Calibration verification (5) D5805 Gen lab systems QA (7) D5417 Use of expired reagents (10) D6021 Personnel moderate complexity (??) Source CMS CLIA database 2/2012

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15 Ref NoFrequencyShort DescriptionLong Description 21 CFR 606.100(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 606.100(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 606.160(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. Biologics FY 2012 Inspectional Observation Summaries (FY 2010) http://www.fda.gov/ICECI/EnforcementActions/ucm255532.htm#biologics

16 Ref NoFrequencyShort DescriptionLong Description 21 CFR 606.16 0(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 606.16 0(b) 25 (24) Required records Failure to maintain [donor] [processing] [storage and distribution] [compatibility testing] [quality control] [general] records. 21 CFR 606.16 0 (a)(1) 18 (13) Legibility and indelibility Records are [illegible] [not indelible]. 21 CFR 606.65 (e) 17 (12) Following manufacturer's instructions Failure to use supplies and reagents in a manner consistent with instructions provided by the manufacturer. Biologics FY 2012 Inspectional Observation Summaries (FY 2010) http://www.fda.gov/ICECI/EnforcementActions/ucm255532.htm#biologics

17 Ref NoFrequencyShort DescriptionLong Description 21 CFR 606.171 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 606.20 (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 606.100 (c) 15 (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. Biologics FY 2012 Inspectional Observation Summaries (FY 2010) http://www.fda.gov/ICECI/EnforcementActions/ucm255532.htm#biologics

18 Ref NoFrequencyShort DescriptionLong Description 21 CFR 606.60 (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 606.100 (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. 21 CFR 606.60 (a) 10 (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. Biologics FY 2012 Inspectional Observation Summaries (FY 2010) http://www.fda.gov/ICECI/EnforcementActions/ucm255532.htm#biologics

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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

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

27 CAP Top Deficiencies RequirementDescription GEN.54400Personnel records: Personnel records are maintained on all current technical personnel and personnel records include all of the following: 1.Copy of academic diploma or transcript. 2.Summary of training and experience. 3.Laboratory personnel license, if required by state 4.Certification, if required by state or employer 5.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.

28 CAP Top Deficiencies RequirementDescription COM.10300Knowledge 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.75400Annual fire drill: Fire drills are conducted at least annually.

29 Requirement IDRequirement TRM.05000 ?? 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. College of American Pathologists: Most Common Accreditation Deficiencies: 2011 Transfusion Medicine

30 Requirement IDRequirement 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 College of American Pathologists: Most Common Accreditation Deficiencies: 2011 Transfusion Medicine

31 Requirement IDRequirement 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. College of American Pathologists: Most Common Accreditation Deficiencies: 2011 Transfusion Medicine

32 Requirement IDRequirement 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 College of American Pathologists: Most Common Accreditation Deficiencies: 2011 Transfusion Medicine

33 Requirement IDRequirement 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. College of American Pathologists: Most Common Accreditation Deficiencies: 2011 Transfusion Medicine

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35 TJC: Top Standards Compliance Issues for 2012 Laboratory and Point-of-Care Testing StandardDescription QSA.01.01.01The laboratory participates in CMS-approved proficiency testing programs for all regulated analytes. HR.01.06.01Staff are competent to perform their responsibilities. QSA.02.03.01The laboratory performs calibration verification. DC.02.03.01The laboratory report is complete and is in the patients clinical record. QSA.01.02.01The laboratory maintains records of its participation in a proficiency testing program.

36 TJC: Top Standards Compliance Issues for 2012 Laboratory and Point-of-Care Testing StandardDescription QSA.02.08.01The laboratory performs correlations to evaluate the results of the same test performed with different methodologies or instruments or at different locations. TS.03.01.01The organization uses standardized procedures for managing tissues. QSA.02.04.01The laboratory evaluates instrument-based testing with electronic or internal systems prior to using them for routine quality control. QSA.01.03.01The laboratory has a process for handling and testing proficiency testing samples. WT.05.01.01The organization maintains records for waived testing.

37 TJC: Hospital Requests For Improvement Jul-Dec 2011 Standard Description EC.02.05.03 Emergency power for blood storage system HR.01.02.01 Special training provided for transfusion administration MS.05.01.01 Medical staff involved in PI activities for blood & blood use NPSG.01.01.01 Two identifiers used to ID patient for transfusion NPSG.01.03.01 Two persons verify patient ID and product for transfusion NPSG.01.03.01 One of the 2 persons verifying patient ID and product for transfusion is the transfusionist NPSG.01.03.01 Two persons verify patient ID and product for transfusion; the second is qualified PC.02.01.01 Transfusions administered per law & medical staff policy PC.03.01.01 Transfusion administration equipment is available for operative and other high-risk procedures

38 TJC: Hospital Requests For Improvement Jul-Dec 2011 StandardDescription PC.05.01.09Follows HIV/HCV Notification (Look back) policies PI.01.01.01 Organization collects data on blood and blood use, and all reported and confirmed transfusion reactions RI.01.03.01 Informed consent process UP.01.01.01 Standardized pre-op verification list, including blood product availability (and other laboratory reports) NPSG.01.01.01Label in front of patient

39 TJC: Laboratory Requests For Improvement Jul-Dec 2011 StandardDescription QSA.05.18.01 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.05.19.05 The interpretation of the transfusion reaction workup provided by the transfusion service director is documented in the patients clinical record. NPSG.01.01.01 Label containers used for blood and other specimens in the presence of the patient NPSG.01.01.01 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.05.01.01 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.

40 TJC: Laboratory Requests For Improvement Jul-Dec 2011 (cont) Standard Description QSA.05.01.01 The laboratory follows its policies and procedures for the blood transfusion service. QSA.05.18.01 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.05.14.01 The laboratorys 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. QSA.05.01.01 The transfusion service director has oversight of policies, processes, and procedures related to the blood transfusion service, including blood administration. QSA.05.01.01 The policies and procedures for the blood transfusion service are current and are revised whenever standards of practice change PI.01.01.01 The laboratory collects data on the following: The use of blood and blood components. (See also LD.04.04.01, EP 2)

41 TJC: Tissue Findings- Lab Jul – Dec 2011 Standard Description TS.03.01.01 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. TS.03.01.01 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. TS.03.01.01 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. TS.03.01.01 The organization maintains daily records to demonstrate that tissues requiring a controlled environment are stored at the required temperatures. TS.03.02.01 The organization documents the dates, times, and staff involved when tissue is accepted, prepared, and issued. TS.03.03.01 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.

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43 Accreditation Organization Standard # Standard Description Corresponding CLIA Regulation 07.07.02Routine Chemistry Proficiency Testing493.841(a) 07.11.05Hematology Proficiency Testing493.851(a) 06.08.01Comparison of Test Results493.1281(a) 06.02.01Essential Conditions493.1252(b)(1-4) 07.09.01Toxicology Proficiency Testing493.845(a) 04.01.03Tests Not Included in PT493.1236(c)(1-2) 07.08.01Endocrinology Proficiency Testing493.843(a) 06.03.01 Verification of Performance Specifications 493.1253(b)(1)(i-ii) 02.01.22 Laboratory Director – Personnel Competency 493.1445(e)(13) 05.03.17Postanalytic Systems Quality Assurance493.1299(a) Most Frequent Deficiencies for CY 2011 AOA-HFAP

44 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. 03.01.00 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. §493.1101(a) 06.08.06 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 laboratorys 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. §493.1282(b)(2) 06.08.01 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. §493.1281(a) Additional information from AOA-HFAP

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46 COLA : Most Frequent Deficiencies for 2008-2010 1 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

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

48 The Meat of the Matter is????

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

50 Where Did the Beef Come From? Suzanne H. Butch, MA, MLS(ASCP) CM, SBB CM University of Michigan Hospitals & Health Centers butchs#@umich.edu

51 Good Laboratory Practices AABB CAP Joint Commission COLA Regulatory agencies (CMS, FDA)

52 Its In The Book Code of Federal Regulations – 21 CFR 600s – Then came CLIA (42 CFR 493) – Oh, 21 CFR 200s apply

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

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 493.1236 – (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.

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.

58 CAP – Proficiency Testing 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. 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).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 [42CFR493.1236(a)(2)]

59 Competency Assessment It means that all 6 of the elements are required for CLIA testing Sec. 493.1451 (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;

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 493.1235 and 42 CFR 493.1451

62 Competency Assessment - CAP Laboratory General Checklist 07.29.2013 GEN.55500 Competency Assessment Phase II The competency of each person to perform his/her assigned duties is assessed.

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

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.

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.

66 Procedure Manual - CLIA 42CFR 493.1445 Standard; Laboratory director responsibilities. (14) Ensure that an approved procedure manual is available to all personnel responsible for any aspect of the testing process;

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

68 Procedure Manual Review- AABB 28 th ed. BB/TS Standard 6.1.4 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 07/29/2013 COM.10100 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.

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 – Dont change without reviewing other agency requirements

71 Recipes and Tools to "Beef Up" Your Transfusion Service Sheri Goertzen, MT(ASCP)BB, CLS(CA) Childrens Hospital Central California sgoertzen@childrenscentralcal.org

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 Wendys popular slogan – Wheres the substance? – Wheres the quality?

74 Wheres our Beef? What can we do to increase the strength and quality of our operations? In our Transfusion Services….

75 The Beef Challenge

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!

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

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)

79 Variance Tracking System

80

81 Quality Dashboard VarianceComplaintAccidentNear-Miss Pre- Analytic 6 Hemolyzed 3 QNS 4 Missing initials 3 No label on tube Analytic 1 QC/Reagent 1 Prod. Selection 1 TAT Delay1 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

82 Think outside the box… If you feel like youre beating a dead horse… Replace it with a unicorn!

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

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

85 Competency Testing – Divide your operations into Test Systems – Purposefully cover all Test Systems – Create problem-solving scenarios on topics you know staff have struggled Tools to Beef Up Pre-analytic Analytic Post-Analytic

86 Competency Schedule AprilOctober 1. Radiation Safety14. Type/Screen: Tube, Capture, Echo 2. Irradiation of Blood Products15. Crossmatch 3. Aliquoting Blood Products16. Antibody Identification 4. Use of COBE Blood Processor17. Blood Issue: Routine, Emergency 5. Exchange Transfusion Prep18. Transfusion Reaction Investigation 6. Platelet Volume Reduction19. Antigen Typing (Phenotyping) 7. Thawing Plasma and Cryo20. Platelet Antibody Titer (A & B) 8. Pooling Cryoprecipitate21. Back-up Product Label Printing 9. Label Check for Modified Products22. Back-up Patient History Look-up 10. Blood Storage Criteria23. Record-keeping and Documentation 11. Request Form Acceptability24. Age-Related, Critical Values 12. Use of Cell-Washers25. Quality Program 13. Retyping Donor Units26. Quality Auditing

87 Ask for the reference for each answer. Competency Test – Written

88 Ask for suggestions. Use these to improve your procedures/processes. Provide feedback on each Comment/Suggestion.

89 Source: Quest for Quality June 2013 Advance for Laboratory Directors, Managers, Technologists, Educators, Students http://laboratory-manager.advanceweb.com/Web-Extras/Online-Extras/Competency-Assessment.aspxhttp://laboratory-manager.advanceweb.com/Web-Extras/Online-Extras/Competency-Assessment.aspx REQUIRED METHODPOSSIBLE 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 Checklist documenting observation 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 BLOOD CENTER OF XYZ, INC. 1234 Your Street Wherever youre 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 SUComments 1. Direct Observation: Employee performs test steps according to current applicable SOP(s) listed above. 2. Test result within acceptable range of Sample 1Sample 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 http://laboratory-manager.advanceweb.com/Web-Extras/Online-Extras/Competency-Assessment.aspxhttp://laboratory-manager.advanceweb.com/Web-Extras/Online-Extras/Competency-Assessment.aspx

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 http://laboratory-manager.advanceweb.com/Web-Extras/Online-Extras/Competency-Assessment.aspxhttp://laboratory-manager.advanceweb.com/Web-Extras/Online-Extras/Competency-Assessment.aspx

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

96 SLG 10/5/12 SLG 10/5/12 SLG 10/5/12

97 SLG 10/5/12 SLG 10/5/12 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 facilitys 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 units 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.

100 Oct. 2012 T510 Pooling Cryoprecipitate 8-10 T510F01 Pool Log 4-11 2 year review starting in Nov. 2012!!!

101

102 Document Change Request Form – top section

103 Document Change Request Form – bottom section

104 AABB Accreditation Program Scale: 3= Adequate in all respects Transfusion Service Activities Tool 2= Adequate with minor departures 27th Edition, Standards 1= 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? 3 2 1 N/A

105 AABB Accreditation Program Transfusion Service Activities Tool 27th Edition, Standards Audit Summary Total points:___________ Total points possible:______________ % Score_______________ Assessed By: ______________________ Date:_________________ Explanation of any outliers: Supervisor Review: ______________________ Date:_________________ Action(s) taken to improve current system: Corrective action completion date:________________ Review for Effectiveness: Acceptable? Yes No Medical Director Review: ______________________ Date:_________________

106 Annotated CAP Checklist

107 Quality Dashboard Internal Assessments DateToolSummaryCorrective Action Plan QSE: Equipment (1) 04/10/12AABB TS Tool Score = 100% None at this time QSE: Equipment (2) Computer Systems 06/08/12AABB TS Tool Score = 100% None at this time QSE: Supplier & Customer 06/15/12AABB TS Tool Score = 100% None at this time Focus Audit: Signed Delivery Slips 07/01/12Internal 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 04/28/12Transfusion Tracer Audit Form No variances found. None at this time

108 Equipment : New Standards 3.2 Qualification of Equipment – 3.2.1 Installation Qualification: Equipment shall be installed per the manufacturers 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 manufacturers operational specifications. – 3.2.3 Performance Qualification: The BB/TS shall demonstrate that equipment performs as expected for its intended use. 3.2.3.1: Performance specifications established by the manufacturer shall be met. NEW!

109 Equipment : New Standards 3.5.1 Calibration – 3.5.1.2 Calibration procedures shall follow the manufacturers 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.31450 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!

110

111 Using tools like these, we can ensure… Were beefed up through out our entire transfusion service!

112 Thanks to: Suzanne H. Butch, MA, MLS(ASCP) CM, SBB CM University of Michigan Hospitals & Health Centers butchs#@umich.edu

113 Thanks to: Sheri Goertzen, MT(ASCP)BB, CLS(CA) sgoertzen@childrenscentralcal.org

114 Questions

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


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