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COLA Resources, Inc. and COLA do not endorse, directly or indirectly, the presentations given at this conference or the products or services provided by the exhibiting vendors. Presentations are intended to be free of bias. The use of any particular product is for demonstration purposes only, and does not imply an endorsement of the product by the presenter or the sponsors of the symposium. © 2017 CRI

Pre & Post-analytic Issues

and

Quality Assessment in the Clinical Laboratory

John T. Daly, MD, FCAP

Chief Medical Officer, COLA

DESCRIPTION:

Most laboratory errors occur during the pre- and post-analytic phases. Learn about common errors and how to correct and prevent them. Quality Assessment (QA) monitors all phases of the testing process to ensure quality results and ongoing continuous improvement of lab operations. Learn how this process has evolved and how to perform effective QA in your lab that is both meaningful and meets the requirements. OBJECTIVES:

At the end of the session, participants will be able to: • Discuss pre and post-analytic phases of laboratory testing • Evaluate the potential for laboratory errors occurring in these phases • Discuss actions to avoid these errors • Reflect how detection/avoidance of these errors fit into a Quality Management

Plan • Define Quality Assessment • Summarize the role, structure and components of acceptable Quality

Assessment Plans • Utilize root cause analysis in QA • Outline how to develop a “culture of quality” in your laboratory

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John Daly, MD COLA Chief Medical Officer

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Discuss pre and post-analytic phases of laboratory testing

Evaluate the potential for laboratory errors occurring in these phases

Discuss actions to avoid these errors

Reflect how detection/avoidance of these errors fit into a Quality Management Plan

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Institute of Medicine

2000: “To Err Is Human”

2001: “Crossing the Quality Chasm”

2015: Improving Diagnosis In Healthcare

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Fig 1 Most common causes of death in the United States, 2013

Martin A Makary, and Michael Daniel BMJ

2016;353:bmj.i2139

©2016 by British Medical Journal Publishing Group

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Phase most prone to error due to complexity and multiple manual steps

46 – 68% total laboratory errors are pre-analytic

Estimated 25% pre-analytical errors result in unnecessary investigation or improper patient care

Appropriate training and quality management activities can lead to improvement

Availability of utilization tools can reduce ordering errors

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Errors can be fatal e.g. incorrect patient specimen used for cross-match in blood bank

1.12 % blood bank specimens in 122 laboratories misidentified

Estimated patient/specimen misidentifications as bad as 3% as “good” as 1/1000

CAP Q-Probe 2010 http://www.pathologyinformatics.com/sites/default/files/2012Powerpoints/23AllerWed.pdf

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Complete, detailed PROCEDURE MANUAL covering pre-analytic phase is critical

TEST CATALOG should contain specimen type, transport and storage requirements and also be available at point of ordering and point of specimen collection

Phlebotomists and non-laboratorians involved in specimen acquisition must be familiar with (and follow) contents

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TEST REQUEST FORMAT

May be paper requisition or Computerized Physician Order Entry (CPOE)

If paper requisition, must be current version

If CPOE, system security essential

CLERICAL ERRORS in test ordering occur e.g. order placed on incorrect patient, inadvertent ordering of incorrect test.

Miscommunication of verbal order in office setting

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TEST REQUEST

Patient name, age/date of birth, MRN, and gender

Specimen source e.g. wound, throat etc.

Other relevant patient preparation information

If drug levels, names of drug and time last administered

If culture, current antibiotic(s) in use

If urine, clean catch, catheterized or aliquot of 24 hour collection

If Pap Test, LMP

Fasting/non-fasting

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6

Bar coded specimen container label is ideal

Label specimen container – NOT lid Patient name and second identifier

Date and time of collection

Identifier of collector

Beware re-labeling

Label all aliquots with two identifiers

Destroy all unused labels

Label applied at time of collection in presence of patient Container should NEVER EVER EVER be pre-labeled!

Clinical Laboratory News April 2014 40.4

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Patient or specimen misidentification during the pre-analytic phase of testing will follow through the entire testing process potentially culminating in results being reported on incorrect patient!

Clinical Laboratory News April 2014 40:4

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Appropriate collection tools/devices/containers especially with waived testing

Order of draw

Adequate specimen volume

Fluid contamination

Hemolysis of specimen due to collection technique

Clotting of specimen due to inappropriate mixing

Date and time of specimen collection

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If possible, avoid sites with IV fluid infusion Use other arm

If must use IV site, draw below IV after IV off 2 minutes and tourniquet between IV and site of draw and discard first specimen drawn

Document if arm with IV has been used and appropriate procedures followed

Avoid mastectomy sites due to lymphostasis

Avoid edematous areas due to accumulation of fluid with potential for dilution of specimen

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8

Avoid small bore needles (butterfly)

Avoid traumatic venipuncture

Avoid prolonged tourniquet application

Avoid vigorous shaking of tube after collection

With storage or transportation avoid freezing blood and excessive heat

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After collection of blood invert tubes as directed in package insert/procedure to distribute anticoagulant in tube

Generally gentle inversion 7 – 10 times allows adequate mixing of anticoagulant and blood

Ideally analyzers should have clot detection ability

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Specimen unsuitable if inadequate specimen identification

Written specimen rejection guidelines are essential

Rejection guidelines must be enforced

SST should be centrifuged one time

Quality management evaluations should include assessment of specimen integrity

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Documented program to ensure each employee maintains satisfactory level of competence

Performed annually

Direct observation of performance

Monitoring of patient identification

Monitoring of specimen container and labeling

Review of specimen accessioning

Evaluation of problem solving skills

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Always follow Universal Precautions – patients very cognizant of this

Do not collect from legs and feet

Do not leave tourniquet on for >1-2 min

Vein selection

Disinfect collection area with alcohol sponge and allow alcohol to air dry

Number of failed attempts before obtaining assistance

Remove tourniquet before removing needle

Appropriate discarding of used equipment

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Observe universal precautions

Use ring or middle finger

Make the puncture on the side of the fingertip pad

Automatic lancing devices can assure adequate, consistent depth of puncture

Gentle finger massage can be helpful

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Labeling can be difficult but is essential

Computer generated label with two identifiers potentially can be attached

Tube can be placed into a larger labeled tube with two identifiers

Remember: Properly dispose of used lancets into puncture resistant sharps container

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Heel stick is a minimally invasive and easily accessible way of obtaining capillary blood samples for various laboratory tests, especially newborn screens, bilirubin and glucose levels.

Improved laboratory technologies require smaller sample volumes

Heel lancing devices minimize trauma

Heel stick sampling can also help preserve venous access for future intravenous (IV) lines

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Specimen transportation

Accessioning of specimen

Clotting completion

Centrifugation

Labeling of aliquots

Storage of specimen and aliquots

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Compare ID: requisition/bar code/sample

Be aware and alert if original tube re-labeled or aliquot obtained

Be aware and alert to avoid clerical errors with manual systems Accurate transfer of patient identification to logs, into

IT systems, etc.

Accurate transfer of test order

Ideally use bar codes to avoid ID errors

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Include in procedure length of time and RCFs for centrifugation

Post centrifugation check all identification labels

Perform regular cleaning and maintenance of centrifuges

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Follow procedures for storage time and temperature(s)

Procedure should specify length of time specimen suitable for storage

Procedure may indicate different temperatures for different lengths of storage i.e. room temperature x hours, refrigerated y days and frozen z days

Different analytes in specimen might have different storage temperatures and lengths of storage

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Ideally on-line, interfaced ordering/reporting

Availability of Reference Laboratory Manual

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Information on test availability

Decision support tools for test selection

Specimen collection guidelines

Specimen container/preservatives

Specimen handling and temporary storage

Specimen packaging transportation

Test interpretative information

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Provide written instructions for collection of at home self-collected specimens

Instructions must include timing requirements Particularly applies to 24 hour urine collections

Also needed for semen analysis

Appropriate preservatives included in specimen container and provide patient sheet containing any warnings

Appropriately label specimen container

Use of wall charts for on-site patient collected urine a must

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Pre-Analytic errors constitute approximately 65% total laboratory errors

Pre-Analytic phase of testing has most steps, and involves many people and has most variations in work environment from the bedside to potentially the reference laboratory

Pre-Analytic errors are avoidable!

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Phlebotomist and healthcare professional education

Training and Competency assessment

Use of error reducing technology

Clear written procedures readily available

Adherence to procedures – this is not the place for creativity

Specific, enforced laboratory specimen rejection criteria

Robust quality management system

http://www.mlo-online.com May 2014

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Result reporting including reporting unacceptable specimens

Critical value reporting

Error correction

Data Interpretation

Reference laboratory reports

Turn Around Time both POS and reference lab tests

Patient access to test results

Record retention

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Name and second identifier of patient

Name of laboratory where performed Name, address and CLIA ID number

Name of performed test

Specimen type or source where appropriate

Date/time of specimen collection

Date(s) of testing and reporting

Test result and appropriate unit of measure

Reference range of the test

Other pertinent information for interpretation

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Result report must include the name of the ordering clinician

May include others to whom result transmitted

Must be assure ordering clinician receives result

Readily accomplished with electronic reporting

Can be problematic with non-interfaced reference laboratory results and process must be in place to assure delivery

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When specimen is unacceptable, condition of specimen and action taken by the laboratory must be indicated on the result report

Should be documented for all tests whether performed in house or at reference laboratory

Helpful to keep a log on unacceptable specimens for quality management review

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Abnormal values that are life threatening

Values require rapid response from care giver

Development of critical values requires close collaboration of clinicians and laboratory

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Critical value reporting procedure is essential

Procedure should include names of critical tests, reportable critical values and protocol to be followed in notifying clinician of critical value

Notification may be telephone or electronic or both

Record should include who was notified, when notification occurred and who made the notification

Laboratory should utilize a read back procedure if verbal notification used

REMEMBER: Clinician involvement in alert policy development is essential!

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Pose a greater challenge than critical values

Malpractice data supports this

Australian study found failure to review laboratory tests on day of hospital discharge in 50% of cases and 14% of results not reviewed were abnormal

Emergency Department data reveals failure to follow up in a proportion of patients a problem present with both paper and electronic reports

Arch.Int.Med 2012;172:1-2

BMJ Qual Safe 2011;20:194-9

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After report released either laboratory recognizes an erroneous result has been transmitted or the laboratory is notified that a reported result is incorrect

Essential to have written policies and procedures How to correct error

Who to notify of error

Label erroneous report as such and revised report as such

Documentation of who was notified, by whom and date and time of notification of correction

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Tools must be available to enable test interpretation e.g. on-line interpretative handbook

For some tests interpretation should be provided as part of the report

Remember: Radiologists and Surgical Pathologists provide interpretations … Why not the clinical laboratory?

Interpretative comments serve to avoid miscommunication and patient care errors

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Testing results should be reported on reference laboratory reporting form

Ideal is an interfaced electronic report

Some reports may require cut and paste or scan

Name and address of reference laboratory must appear on the test report form

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System in place to assure all referred tests are resulted and reported

Especially problematic if no electronic interface between EMR and reference lab or if interface present but report directed to “unusual” location

Interface with reference laboratory should be periodically validated

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Policy that reference laboratory report cannot be altered by receiving laboratory

If telephone notification by reference laboratory of an error, do not change original report

Note may be appended to original report and appropriate individuals notified

Obtain a copy of the corrected report from the reference laboratory and distribute per error correction procedure

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“Doc, I found this fantastic test on the internet and ordered it, can you please explain the results to me?”

“Doc, I found this test on the internet, would you please collect my blood and order it for me? …… What! You want me to pay for it up front! Well certainly my insurance will pay for it, after all it IS an internet test!!!”

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Laboratory results must be reported in a reasonable, generally predictable turn around time

If performed in house, attempt to report out all results the same day or store samples as per procedure

If performed in reference laboratory, monitor performance of TAT to ascertain appropriateness

Monitoring should be incorporated into QA plan

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If a large practice, set goals for turn around for commonly ordered analytes particularly those where patients will be waiting for results

Periodically measure actual results to goal

May measure

order to report time

collection to report time

patient arrival at practice to report time

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Improper data entry

Erroneous validation of analytic data

Failure in reporting

Critical values not reported timely manner

Lab Medicine February/March 2012 43:2:41-43

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Available results not reviewed

Delayed review of results – in box

Lack of interpretative information leading to incorrect interpretation of result

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Upon request, patient or patient representative must have access to completed test results

Procedures must be in place for receiving, processing and responding to test result requests

Results must be provided within 30 days

If not available at 30 days lab must notify patient in writing of reason for delay

Results must be provided in format requested and if not available a readable hard copy may be issued

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If lab does not perform any covered transactions electronically (e.g. billing, preauthorization) they are exempt

This will be a rare facility

If a licensed health care professional has determined that access is reasonably likely to endanger the life or physical safety of an individual or another person, request may be denied by laboratory

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Procedure for direct patient access to results must include a defined authentication process to verify the identity of the patient or their personal representative

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Instrument printouts that contain patient results must be retained for two years

Laboratory does not have to produce a printout just because instrument has this function, especially true if instrument interfaced into an electronic system

An original or exact duplicate of patient test reports (either paper or electronic) from both in-house testing and reference laboratories must be maintained for at least two years (see chart)

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DOCUMENT MININUM TIMEFRAME COMMENTS

Requisitions 2 years

Test procedures 2 years beyond date of

discontinuance

QC records 2 years

IQCP Records 2 years beyond date

that IQCP was discontinued

Include all components of plan and QA activities

EQC qualifying studies 2 years beyond date

that EQC was discontinued

Discontinued 12/2015 Maintain records 2 years

Patient test records 2 years Includes instrument

printouts

Maintenance and Calibration Records

2 years

Performance Verification As long as test system

is in use + 2 years

Blood Bank records 10 years

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Risk of inappropriate follow up clinical investigation reported as high as 25 - 30% for erroneous laboratory reports Additional laboratory testing

Inappropriate treatment

Unneeded imaging studies

More invasive testing

Additional unnecessary consultations

Financial and emotional toll on patient

Litigation American Journal of Clinical Pathology: 2000;113:9-11

Clin Chemistry 1997;43:1348-51

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A Quality System routinely monitoring all phases of laboratory work is essential for optimal patient care

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1

John Daly, MD COLA Chief Medical Officer

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At the end of this presentation you should be able to

Define Quality Assessment

Understand the role, structure and components of an acceptable Quality Assessment plans

Understand use of root cause analysis in QA

Understand how to develop a “culture of quality” in your laboratory

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A pro-active, ongoing, system-wide review process that audits and monitors all aspects of the laboratory’s technical and non-technical functions to ensure they are all being performed properly

Examines general lab, analytic and pre and post analytic laboratory activities

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Essential to certify quality of patient care the laboratory is providing and to ensure patient safety

In addition to patients, also assesses and ensures quality in laboratory interactions with: Physicians and other clinicians

Outside laboratories

Other non-laboratory departments

Required by CLIA 88

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Detect and identify existing and potential problems

Investigate and evaluate the root cause of problems

After identifying the root cause develop and implements a plan to: Correct any errors discovered,

Prevent the problem from happening again

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Results of QA audits and ensuing actions must be communicated to all stakeholders

Lab Director

Laboratory staff (administrative & technical)

Those responsible for ordering labs and retrieving or utilizing results

Conduct follow-up audits to ensure corrective actions were completed and are effective (no additional occurrences)

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Organize Quality Assessment audits around activities that make up the path of workflow Pre-Analytic (lab orders, specimen collection and

identification)

Analytic (QC, equipment maintenance and performance of lab tests)

Post Analytic (reporting test results, specimen storage)

Also include critical activities that are necessary to support the path of workflow General laboratory processes (employee training and

competency, IT validation)

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Check lists alone are not adequate

Checklists serve are useful as a guide tracking tasks performed at regular intervals

Instrument maintenance (daily, weekly, monthly)

Instrument Calibration/Calibration Verification

Instrument start up and shut down procedures

Quality Audits are Essential

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Audits are detailed data driven evaluations of the activity being reviewed

Trace the activity from start to finish

Evaluate content of procedures and records generated by the activity

Identify performance metrics/expectations for the activity and determine if they are being met

Document extent and outcome of the audit (time period reviewed, how many examples of activity reviewed, level of performance achieved based on the review)

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Activity to be reviewed (What)

Method of review (How - describe and quantitate where possible)

Time period included in sample (When)

Sample size & selection (How many? Which ones?)

Expected performance measures (Quantitate where possible)

Minimum acceptable score (Quantitate)

Date audit performed

Results of audit, resolution of problem, follow-up

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Expected Performance - Confirmed

Expected Performance - Not Attained

Celebrate

Any improvement opportunities noted?

Comparison to prior audits ( or )

Any results or cases worthy of additional investigation?

Lab Director review & approval

Comparison to prior audits ( or )

Any changes to process, people, equipment in targeted timeframe?

Root cause analysis

Action plan

Lab Director review & approval

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Create a problem statement that describes the failure identified in the audit (What)

Ask questions to thoroughly understand the context of the problem

Who? When? Where? How?

Use Cause and effect, fault tree analysis or “5 why’s” to explore potential causes of the failure.

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A simple way to solve a problem without a large detailed investigation requiring many resources By repeatedly asking “Why” – you peel away layers

of issues and symptoms to try and uncover the underlying cause.

There are multiple possible answers to each why question. Each should be explored with a series of subsequent “whys?”

Caution: Before developing an action plan – gather evidence to confirm the cause, so resources aren’t wasted fixing things that did not cause the failure.

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Errors in written procedure/Failure to document changes in procedure

Failure to follow written procedure

Clerical errors

Failing to take action or taking the wrong action

Lack of training or knowledge

Equipment not maintained, calibrated, or available, or functioning properly

Communication failures

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Two levels: Correcting any identified errors

Addressing issues identified in root cause analysis to prevent future occurrences

Laboratory Director must be involved and sign off

Once approved – Implement plan

Once implemented – repeat audit after set timeframe following corrective implementation

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If follow up audit reveals problem not resolved:

Verify planned changes actually implemented

Confirm audit only included samples after planned changes were actually implemented

Compare to prior audit, is performance improving or declining?

Conduct another root cause analysis

Compare findings to prior root cause

Possible that the true cause was not correctly identified

Develop new action plan & implement

Re-audit again

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Goal of QA audits is to improve quality by:

Ensuring laboratory processes meet customer/regulatory expectations and requirements

Improve efficiency of laboratory processes

QA is about PROCESS NOT PERSONNEL!

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What is always “going wrong”?

What problems are indicated in the problem log?

What are the complaints?

What issues lead to repetitive work?

What frustrates staff/clinicians?

What doesn’t work properly?

Are there discrepancies between written procedures and how the work is actually performed?

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Schedule Audits as part of a QA calendar

Determine known recurring processes in your lab: Start with those having highest risk or impact on

patient or employee safety

Some activities may be scheduled based on customer or regulatory requirements, e.g. Monthly review of QC,

PT review each trimester,

Annual review of procedures

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JANUARY QC

IT SYSTEM HIPAA compliance

IQCP Annual Review

FEBRUARY QC

SPEC COLLECTION/ IDENTIFICATION

Verification of correct INR and PT reference

range

MARCH QC

EQUIPMENT MAINTENANCE &

CALIBRATION Specimen integrity of received specimens

APRIL QC PT

COMPLAINTS

MAY QC

TEST REPORTS for Completeness

REFERENCE LAB (TAT, ISSUES)

JUNE QC

PERSONNEL TRAINING AND COMPETENCY

Alert value reporting

JULY QC

Written request all tests

All necessary information on test

requests

AUGUST QC PT

SAFETY AUDIT

SEPTEMBER QC

EQUIPMENT MAINTENANCE &

CALIBRATION

OCTOBER QC

COMPLAINTS New analytes with

complete verification and ordering of PT

NOVEMBER QC

POLICIES & PROCEDURES -Complete

-Signed -Followed

DECEMBER QC PT

RECORD RETENTION & DISPOSAL

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Problem Statement:

Complaint received indicating that ALT results reported by chemistry analyzer were a factor of 10 higher than results reported by a national reference laboratory

Lab had been doing QA and QC, how could this happen?

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Checklist is used to evaluate reporting results twice a year.

Yes or No questions

No problems identified

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Patient involved had testing performed Aug 15. Results auto-verified

Chemistry analyzer directly interfaced to electronic medical record

Tests repeated Aug 20 at reference laboratory with disparate results

Specimen no longer retained in lab 1– can’t retest

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Improper specimen?

Specimen mix-up?

Calibration or QC issues for test?

Problem with reagents?

Transmission of results?

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Jan 2 New Chemistry analyzer/EMR interfaced

EMR rep performed validation of data transfer between instrument and EMR (Jan 2-5)

Instrument calibrated/maintained appropriately

QC is acceptable

Aug 3 update to EMR installed with no verification of data transfer across interface

Aug 25 complaint received

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New Problem Statement:

When results transmitted from the analyzer across the interface the first digit of ALT result was being repeated (e.g. 21 became 221). No similar problem with other analytes

Concerns:

When did this start?

Is this only occurring with ALT?

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Lack of validation of data transmission following system upgrade August 3

Why? No Procedure

Why? Lack of staff experience

Why? Allowed vendor to do initial validation

Why? No additional charge by vendor – good for limited laboratory budget

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Identify patients affected and notify physicians of problem

Develop procedure for validating data transfer and identify conditions requiring validation

Train staff in interface validation

Perform validation and confirm acceptable results

Offer patients complimentary retesting

Design and implement routine QA audit

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While investigating the complaint to determine if analyzer now producing accurate results, identified that PT order had not been updated to include new Chemistry analytes added to menu when analyzer was installed in January

Despite having completed QA Checklists, this PT oversight had not been detected

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Simple yes/no checklist will not identify issues, causes, and help formulate corrective actions

QA must be an in-depth audit that analyzes day to day performance

Thorough & timely complaint investigations are valuable QA tools

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Purpose

The purpose of our Quality Assessment plan is to monitor our processes and procedures to ensure the accuracy of our laboratory testing results; evaluate our policies and protocols to improve their efficiency; and to assess our methods, technologies and communications to confirm we continue to provide quality services to all customers, internal and external.

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Goals

Improve overall quality and efficiency of services

Evaluate effectiveness of policies, processes and procedures

Identify, evaluate and resolve problems in a timely manner

Ensure accurate, reliable and prompt performance of laboratory testing and result reporting

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Webinar for Clinical Laboratories - April 2016 33

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Processes that affect more than one phase of testing

Patient confidentiality

Complaint investigations

Problem log entry investigations

Communications within and outside laboratory

Personnel training and competency assessment

Proficiency testing performance

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Are the Personnel Policies and Procedures complete including all requirements for education, licensure, continuing education, training and competency?

Is each employee file complete and up to date with all required documents?

When performance problems are observed are training records evaluated to insure proper training and is retraining given when needed?

Is there evidence of adequate training of all personnel in new or changed procedures of instruments?

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Is there evidence of annual safety training?

Are the competency assessments performed at proper intervals, 6 months for new employees and annually for all others?

Do the competency assessments cover the 6 CLIA required elements to document competency?

Has there been significant employee turnover? If so, why?

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40 year old male hired as Laboratory Manager/Technical Supervisor in laboratory of 100 bed community hospital

Resume presented to hospital HR showed graduate of an out of state university with a degree in medical technology

Resume showed progressive responsibility from bench technologist through shift supervisor to laboratory manager/general supervisor at prior jobs although last job only held 3 months

Reason given for only 3 months was “family needs”

But reference from the prior employer was acceptable and did not indicate reason of only 3 month employment

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After a short period of employment a laboratory technologist approached hospital administration with concerns about knowledge base of new Laboratory Manager

Particularly issues noted with a deficit in blood bank comprehension

At first administration dismissed concerns as employee dissatisfaction with new manager

Then a second employee presented complaints about depth of knowledge in laboratory practice of blood bank, chemistry and quality control

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CEO of institution had received some complaints from nursing and medical staff on behavior of the new manager

CEO called the laboratory manager in for a “chat”

Discussion focused particularly on prior education and experience

When the interview ended CEO asked the Director of HR to show him the evidence of college graduation with medical technology degree

“Ah…….ah…….ah…….”

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HR had failed to validate credentials so following CEO interview they proceeded to call the university from which he indicated graduation

When called, university had no record of the individual ever having attended

Said individual called in by HR for another “chat”

A copy of diploma from the university was requested to be brought in the next day

The Laboratory Manager disappeared into the ethers never to be heard from again!

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Are Personnel Policies and Procedures, signed annually, and contain all requirements for education, licensure, continuing education, training and re-training if needed and competency?

Are all these documents present in the personnel file of each laboratory employee?

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Metric Employee 1 Employee 2 Employee 3 #/%

Complete

Education

Licensure

Initial

Training

Training

New

Procedures

Re-training

Competency

up to date

Competency

6 elements

Annual

Safety

Training

Continuing

Education

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Test ordering

Specimen collection, submission, and referral

Patient identification and preparation

Specimen collection and labeling

Specimen transportation

Specimen processing

Specimen storage and preservation

Specimen referral

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Quality System Under Review: Test Request

Frequency of Review: Annual

Method of Review: Randomly check 10 test records in medical record

Minimum Acceptable Score: 100 per cent

Date of review: ____Time period covered:____

Reviewer__________

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# Correct # Incorrect

% Correct

Ordering person name and contact information

10 0 100%

Patient identification 10 0 100%

Patient Age, Sex, DOB 10 0 100%

Test(s) ordered and source

10 0 100%

LMP for PAP smears 2 1 66%

Time of collection 5 5 50%

Pertinent Patient Information

4 1 80%

66% had LMP accompanying Pap Smear

Only 50% of requests reviewed had time of collection indicated

Pertinent patient information is at 80% compliance

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Hard stop placed in IT system for LMP

Emphasized to phlebotomy importance of time of collection

Hard stop placed in IT system for time of specimen collection

Re-monitor pertinent patient information in 6 months

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Review Number

Examined Findings Acceptable

Y/N

QC timing appropriate

Corrective action taken appropriately

Patient report only with correct QC

QC review week/month

Shifts/trends evaluated

Maintenance appropriate

Materials all in date QC/Reagents/ Calibrators

REVIEW NUMBER

EXAMINED FINDINGS ACCEPTABLE

Y/N

Reagents/QC properly stored and labeled

Appropriate Temperature and Humidity Maintained

Calibration/Cal Ver performed per procedure, with major maintenance, Complete change of reagents, unresolved qc

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Quality Control Monthly Check List Instrument_______Analyte_______

QC performed at appropriate intervals

Corrective action taken when needed

Patients reported only when QC acceptable

Evidence of QC having weekly review

Shifts and Trends identified

Timely maintenance performed

QC materials and reagents in date

QC materials and reagents properly stored and labeled

Temperature monitored and corrective action taken when indicated

Calibration/Calibration Verification performed with maintenance, complete change of reagents and unresolved QC issues

Procedure Manual complete and signed

New analytes appropriately verified and PT ordered

Any analytes with recurring problems requiring frequent unscheduled calibration

With change of QC lots are new values verified and entered into instrument

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Focus on appropriateness of corrective action i.e. controls not being run repeatedly until “in”

Focus on service calls

Increased frequency

Resolution of problem

Performance of calibration/calibration verification and QC at end of service call before patient testing resumes

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Have a summary sheet

Findings and evaluation

Results acceptable or not acceptable

If not acceptable results of root cause analysis

Solution(s) to be implemented

Date of follow up review

Attach all work sheets

Obtain Laboratory Director’s Signature

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Accuracy and completeness of test reports

Accuracy of IT transmission of data

Report turn-around-time

Error correction policy implementation

Receipt of reference laboratory results

Clinician notification of alert/panic values

Patient access to reports

Implementation of record retention policies

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Are IT training recorded in personnel files

Are levels of security/data access in place

Are procedures in place to ensure accurate manual entry of results into IT system

What errors attributable to IT have been reported in past year

Are calculations being performed by IT

Are the calculations verified at least annually

If instruments are interfaced is the interface validated annually

Is appropriate back up in place

Can data be readily retrieved for at least two years

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Procedure should be in place to ensure that manually entered data is entered correctly. Easy way to do this is require it be entered two times

Validating interface once a year easily accomplished by running all analytes that cross the interface on single samples (e.g. heme and chemistry) and then compare the results on the instrument with the results that are in the IT system

At time interface is validated, computer generated calculations can be compared with simultaneously performed manual calculations on the same data

Have a summary sheet

Findings and evaluation

Results acceptable or not acceptable

If not acceptable, results of root cause analysis

Solution(s) to be implemented

Date of follow up review

Attach all work sheets

Obtain Laboratory Director’s Signature

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Turn around time and satisfaction of clinicians

Procedure to ensure all results from reference lab are received and reported in manner that ensures clinician awareness of results

Complaints concerning quality of referred testing

Review for accuracy interfaced referred results and results entered manually into IT system - again could use double entry for manual results

Complaint log can be helpful to uncover issues of TAT or quality in reference laboratory

63

Conformity of state and federal requirements for records retention

Include all documentation from pre-analytic, analytic and post-analytic phases of testing

PT records

Medical waste records

Chemical waste records

Personnel records including training, competency and safety

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33

Goal of QA audits improvement of quality, laboratory efficiency and performance

Goal of QA is not to place blame on individuals

For each process to be evaluated determine performance targets and actions to be undertaken if targets are not achieved

Effective QA is a “no blame” process

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CONTINUOUS IMPROVEMENT!

CONTINUOUS IMPROVEMENT!

CONTINUOUS IMPROVEMENT!

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CONTINUOUS IMPROVEMENT!

..CONTINUOUS IMPROVEMENT!

…CONTINUOUS IMPROVEMENT!

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