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

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.

Where’s the Beef?

Recipes to "Beef Up" Those Weak Areas in Your Transfusion Service

The Meat of the Matter

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

[email protected]

mailto:[email protected]

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.

CLIA

http://www.fda.gov/

http://www.fda.gov/

http://www.aabb.org/

http://www.cap.org/apps/cap.portal

CLIA

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_Laboratories.html

https://www.cms.gov/Regulations-and-Guidance/Legislation/CLIA/Interpretive_Guidelines_for_Laboratories.html

https://www.cms.gov/Regulations-and-Guidance/Legislation/CLIA/Interpretive_Guidelines_for_Laboratories.html

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

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 (?? )

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

CLIA

CMS’ Top 10 Deficiencies

• D5413 Policy for proper reagent storage (1)• D5217 Verify accuracy non-PT’d tests (2)• D5791 Analytic Systems’ QA (3)• D5403 Procedure manual (4)• D5411 Follow mfgr’s. 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

Ref No Frequency Short Description Long 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


21 CFR 606.160(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 recordsFailure 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.



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.



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.

21CFR606.100(b)(15)

10(??)

Schedules and Procedures forEquipment &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.


http://www.aabb.org/

AABB: General Summary of Most Common Nonconformances

• Organization Participation in Management reviews are missing Processes are not writtenSOPs are not followed as written

• ResourcesTraining: missing documentationCompetency : 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 taskInclusive dates of employment missing

• Supplier and Customer IssuesNo documentation or omitted documentation of inspection at

receipt

AABB (cont): General Summary of Most Common Nonconformances

• EquipmentNo record of what is considered critical equipmentEquipment omitted from the critical equipment listEquipment lacking a unique ID number Do not follow manufacturer’s instructions Qualification of Equipment: IQ, OQ, PQNo evidence of investigation & follow-upAlarm set for the limit (either high or low temp) that

would sound/alert when the storage temp is out of range and considered unacceptable

AABB (cont.): General Summary of Most Common Nonconformances

• Process ControlNo documentation of process validationIncomplete documentation of changes made to existing proceduresChange control process not followed as per SOPNo set process for determining if PT is performed for each CLIA

regulated testReview 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 properlyIncorrect storage temp rangesFailure to follow manufacturer’s instructionsRBC appropriate temperature verified on returned units (or

validated process)


• Documents and RecordsProcesses & procedures for document control are not completeUse of only current and valid documents not demonstrated Reviews are incomplete or not timelyNo list of labelsNo list of forms or forms omitted from the master listNo review or missing annual reviewsUsing outdated references / No process for review of current

references


• 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

http://www.cap.org/apps/cap.portal

CAP Top Deficiencies 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.


GEN.54400 Personnel 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 state4. Certification, if required by state or employer5. 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 education7. 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.


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.

Requirement ID Requirement

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


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 / transplantation2. Establishing criteria for transfusion3. Reviewing cases not meeting transfusion audit criteria4. Monitoring transfusion practices



Requirement ID RequirementTRM.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.




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 controls2. Instrument function checks3. Temperature records



Requirement ID RequirementTRM.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.



TJC: Top Standards Compliance Issues for 2012Laboratory and Point-of-Care Testing

Standard Description

QSA.01.01.01 The laboratory participates in CMS-approved proficiency testing programs for all regulated analytes.

HR.01.06.01 Staff are competent to perform their responsibilities.

QSA.02.03.01 The laboratory performs calibration verification.

DC.02.03.01 The laboratory report is complete and is in the patient’s clinical record.

QSA.01.02.01 The laboratory maintains records of its participation in a proficiency testing program.

TJC: Top Standards Compliance Issues for 2012Laboratory and Point-of-Care Testing

Standard DescriptionQSA.02.08.01 The laboratory performs correlations to evaluate the

results of the same test performed with different methodologies or instruments or at different locations.

TS.03.01.01 The organization uses standardized procedures for managing tissues.

QSA.02.04.01 The laboratory evaluates instrument-based testing with electronic or internal systems prior to using them for routine quality control.

QSA.01.03.01 The laboratory has a process for handling and testing proficiency testing samples.

WT.05.01.01 The organization maintains records for waived testing.

TJC: Hospital Requests For Improvement Jul-Dec 2011Standard 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

TJC: Hospital Requests For Improvement Jul-Dec 2011

Standard DescriptionPC.05.01.09

Follows 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 processUP.01.01.01

Standardized pre-op verification list, including blood product availability (and other laboratory reports)

NPSG.01.01.01

Label in front of patient

TJC: Laboratory Requests For Improvement Jul-Dec 2011Standard Description

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 patient’s 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.

TJC: Laboratory Requests For Improvement Jul-Dec 2011 (cont)

Standard DescriptionQSA.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 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.

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)

TJC: Tissue Findings- Lab Jul – Dec 2011Standard 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.

Accreditation Organization Standard #

Standard Description Corresponding CLIA Regulation

07.07.02 Routine Chemistry Proficiency Testing 493.841(a)

07.11.05 Hematology Proficiency Testing 493.851(a)

06.08.01 Comparison of Test Results 493.1281(a)

06.02.01 Essential Conditions 493.1252(b)(1-4)

07.09.01 Toxicology Proficiency Testing 493.845(a)

04.01.03 Tests Not Included in PT 493.1236(c)(1-2)

07.08.01 Endocrinology Proficiency Testing 493.843(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)

05.03.17 Postanalytic Systems Quality Assurance 493.1299(a)

Most Frequent Deficiencies for CY 2011 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.• 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 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. §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

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

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

The Meat of the Matter is????

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

Where Did the Beef Come From?

Suzanne H. Butch, MA, MLS(ASCP)CM, SBBCM

University of Michigan Hospitals & Health Centers butchs#@umich.edu

Good Laboratory Practices

• AABB• CAP• Joint Commission• COLA• Regulatory agencies (CMS, FDA)

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

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

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

Examples

• Proficiency testing

• Competency assessment

• Procedure manuals

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.

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.

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).

• 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)]

http://www.cap.org/apps/docs/laboratory_accreditation/checklists/checklist_reference_links.doc

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;

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.

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

Competency Assessment - CAP

• Laboratory General Checklist 07.29.2013GEN.55500 Competency Assessment Phase IIThe competency of each person to perform his/her assigned duties is assessed.

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

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.

Procedure Manual – CLIA42 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 proceduresmust be approved, signed, anddated by the current laboratory directorbefore use.

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;

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

Procedure Manual Review- AABB28th 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.

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.

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

Recipes and Tools to "Beef Up" Your Transfusion Service

Sheri Goertzen, MT(ASCP)BB, CLS(CA)Children’s Hospital Central California

[email protected]

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.

• Wendy’s popular slogan– Where’s the substance?– Where’s the quality?

• Where’s our Beef?

• What can we do to increase the strength and quality of our operations?

In our Transfusion Services….

The Beef Challenge

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!

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

http://www.bing.com/images/search?q=easy+button&id=EA40DBA71D17BC50E0A5D23645412C02C1D4930E&FORM=IQFRBA

http://www.bing.com/images/search?q=easy+button&id=EA40DBA71D17BC50E0A5D23645412C02C1D4930E&FORM=IQFRBA

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)



Quality Dashboard

Variance Complaint Accident Near-Miss

Pre-Analytic

6 Hemolyzed3 QNS4 Missing initials3 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

Think outside the box…

• If you feel like you’re beating a dead horse…

• Replace it with a unicorn!

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

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

• 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

Competency ScheduleApril 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

Ask for the reference for each answer.

Competency Test – Written

Competency Test – Written

Ask for suggestions.

Use these to improve your procedures/processes.

Provide feedback on each Comment/Suggestion.

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.aspx

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

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.

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


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: ___________________________

BLOOD CENTER OF XYZ, INC. 1234 Your Street

Wherever you’re at, IL

RECORD OF EMPLOYEE ANNUAL COMPETENCY REVIEWS = SatisfactoryU = UnsatisfactoryEmployee 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: _____________________

S U Comments1. Direct Observation: Employee performs test steps

according to current applicable SOP(s) listed above.

2. Test result within acceptable range ofSample 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: _____________ _____________

COMPETENCY ASSESSMENTREMINDER #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.



COMPETENCY ASSESSMENTREMINDER #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



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

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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.

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.

Oct. 2012

T510 Pooling Cryoprecipitate 8-10

T510F01 Pool Log 4-11

2 year review starting in Nov. 2012!!!

Document Change Request Form – top section

Document Change Request Form – bottom section

AABB Accreditation Program Scale: 3= Adequate in all respectsTransfusion Service Activities Tool 2= Adequate with minor departures

27th Edition, Standards 1= Below acceptable standards6.0 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

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:_________________

Annotated CAP Checklist

Quality Dashboard

Internal Assessments

Date Tool Summary Corrective Action Plan

QSE: Equipment (1) 04/10/12 AABB TS ToolScore = 100% None at this time

QSE: Equipment (2) Computer Systems

06/08/12 AABB TS ToolScore = 100% None at this time

QSE: Supplier & Customer

06/15/12 AABB TS ToolScore = 100% None at this time

Focus Audit: Signed Delivery Slips

07/01/12 Internal Audit Form

Score = 94.3%6 of 106 slipsfound lackingsignature.

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.

None at this time

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.

• 3.2.3.1: Performance specifications established by the manufacturer shall be met.

NEW!

NEW!

NEW!

NEW!

Equipment : New Standards• 3.5.1 Calibration

– 3.5.1.2 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.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!

Using tools like these, we can ensure…

We’re “beefed up” through out our entire transfusion service!

Thanks to:

Suzanne H. Butch, MA, MLS(ASCP)CM, SBBCM

University of Michigan Hospitals & Health Centers

butchs#@umich.edu

Thanks to:

Sheri Goertzen, MT(ASCP)BB, CLS(CA)[email protected]

Questions

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

[email protected]

mailto:[email protected]