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2013 C ti i C li M t S i 2013 Continuing Compliance Master Series Pre-analytic Issues and Quality Indicators Susan Thrasher Martin, MD, FCAP October 16, 2013 www.cap.org v. 1.0

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Page 1: LAP QM indicators preanalytic Dr. Thrasher template Oct ... · • Paa e /spec e de ca otient/specimen identification • Test order accuracy • Identification of person drawing

2013 C ti i C li M t S i 2013 Continuing Compliance Master Series Pre-analytic Issues and Quality IndicatorsSusan Thrasher Martin, MD, FCAP

October 16, 2013www.cap.org v. 1.0

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ObjectivesObjectives

• Identify common pre-analytic issues that are pertinent to providing safe, timely and accurate testing.

• Design specific quality assurance indicators that track pre-analytic issues.analytic issues.

• Discuss best practices for addressing potential issues.

© 2013 College of American Pathologists. All rights reserved. 2

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TopicsTopics

Quality assessment is often separated:

•Pre-analytical

•Analytical

•Post-analytical

© 2013 College of American Pathologists. All rights reserved. 3

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Where the story beginsWhere the story begins…..

• Pre-analytical = factors affecting patient testing from the time of the physician ordering the test to the test performance

• Garbage in, garbage out – quality testing starts at the very beginningbeginning

© 2013 College of American Pathologists. All rights reserved. 4

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Importance of Pre analytic and Post analytic PhasesImportance of Pre-analytic and Post-analytic Phases

• Research indicates 68 -87% of laboratory errors occur in the pre-analytic or post-analytic phases of testing *

o Errors are uncovered better through careful study than h t di li d l i t t f when studies relied on complaints or reports of near

accidents*− *Article by Bonini published in Clinical Chemistry 2002;

48:548:5

o Follows that careful study (monitoring)of pre-analytic and post-analytic processes should result in less errors and post analytic processes should result in less errors and better processes

© 2013 College of American Pathologists. All rights reserved. 5

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Pre analytic IndicatorsPre-analytic Indicators

• This session will be dedicated to pre-analytic indicators.

• We will discusso How to develop appropriate indicatorso How to measure the indicators once selectedo How to measure the indicators once selectedo How to provide corrective action when indicators fall

below established thresholds

i i f i i i• We will provide examples of pre-analytic variables in common laboratory scenarios.

© 2013 College of American Pathologists. All rights reserved. 6

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CAP Quality Management RequirementsCAP Quality Management Requirements

• GEN.13806 Documented QM Plan

• GEN.16902 QM Plan implemented as designed and reviewed annually for effectiveness

GEN 20100 QM Pl i l t d i ll f th l b t• GEN.20100 QM Plan implemented in all areas of the laboratory

• GEN.20208 QM System has a program to identify errors, incidents and problems that may interfere with patient carep y p

• GEN.20316 QM Program monitors quality indicators in the pre-analytic, analytic and post-analytic phases of testing

• COM.04000 The laboratory has a documented QM/QC program

© 2013 College of American Pathologists. All rights reserved. 7

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Pre-analytic QM Monitoring - Your LaboratoryPolling Question # 1Polling Question # 1

In your laboratory what is the percentage of time that y y p gyour pre-analytic monitors are in the acceptable range?

© 2013 College of American Pathologists. All rights reserved. 8

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How to Get Started Quality Indicator ProcessHow to Get Started – Quality Indicator Process

• Developing indicators

• Methodology utilized

• Limits or Thresholds

• Presentation of information

• Limitations of the data

• Action Plan or Corrective actions

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Developing Indicators ProcessDeveloping Indicators Process

Objective:

1. What are you trying to measure?

2. Why am I collecting this information?

Be specific.

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Developing Indicators Process (Cont )Developing Indicators Process (Cont.)

Methodology:

1. What data needs to be captured?

2. Who (or what) will capture the data?

3. How often to capture the data?

4. Is it achievable (time, resources, revenue)?

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Developing Indicators Process (Cont )Developing Indicators Process (Cont.)

Limits:

Can I preset levels for:

Acceptable, Concern, Unacceptable, Critical

Presentation:

Graphic or Text

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Developing Indicators Process (Cont )Developing Indicators Process (Cont.)

Interpretation:

1. What does it mean?

2. Does it reflect on your quality?

3. Can I compare it?

4. Can I trend it?

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Developing Indicators Process (Cont )Developing Indicators Process (Cont.)

Limitations:

1. Unintended variables

2. What does it not mean?

Action Plan:

1. What will I do if it indicates acceptable performance?

2. What will I do if it does not?

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Sources for Developing New Pre analytic IndicatorsSources for Developing New Pre-analytic Indicators

• Quality Committee or Team

• Laboratory Director and other staff pathologists

• Bench Technologists

• Physicians and other practitioners

• Nursing and other facility departments

• Patients

• Satisfaction Studies

• Incidents and Complaints

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Mechanisms for Discovery of New Pre analytic IndicatorsMechanisms for Discovery of New Pre-analytic Indicators

• Review the test order and requisition processes

• Follow the patient identification process

• Follow a sample from collection to testing

• Follow a patient from sign in to collection

• Discovered due to an error

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Examples of Common Pre analytic IndicatorsExamples of Common Pre-analytic Indicators

• Patient/specimen identificationa e /spec e de ca o

• Test order accuracy

• Identification of person drawing transfusion Medicine specimens

• Labeling accuracy on cytology slides

Ad f i f ti i l th l i iti• Adequacy of information on surgical pathology requisitions

• Blood culture contamination

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Scenario in which a Pre-analytic Indicator was discovered by review of Test Orders and Requisitionsdiscovered by review of Test Orders and Requisitions

• You overhear the processing staff complaining about incomplete outpatient test requisitions. Discussion reveals that several times a day, they must stop and call the outpatient clinics to obtain information that was not included on the

i iti Th t i i t b th l k f requisition. The most serious issue seems to be the lack of complete patient demographic information (i.e., dates of birth or other identification numbers).

• After verifying that the requisition errors are corrected, you realize there is no process for tracking the number of errors and there is no quantifiable improvement.

• Using the Quality Indicator Process, develop the Pre-analytic indicator for Test Order Requisition Accuracy.

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O t ti t T t R i iti Q lit I di t POutpatient Test Requisition Quality Indicator Process

• Objectives – The objective of the outpatient test requisition pre-analytic monitor is to ensure that test requisitions received from outpatient clinics include all required information 100% of the time.

• Methodology – After identifying which outpatient clinics are responsible, and subsequent retraining of outpatient clinic staff, weekly audits will be conducted by the quality y y q ymanager. The weekly audits will document which outpatient clinics have improved and which outpatient clinics require additional training in assuring completeness of test requisitions.

• QM Graphics – Once data is collected, a bar graph will be created for each month.

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Outpatient Identification Quality Indicator Process (Cont )Outpatient Identification Quality Indicator Process (Cont.)

• Preset Limits – Due to the importance of test orders, the Preset Limits Due to the importance of test orders, the procedure must be followed correctly. Outpatient clinics who do not show immediate improvement will require retraining. The goal is 100% accuracy.g

• Interpretation – The analysis and interpretation of the QM data will be completed on a quarterly basis, signed off by the medical director and be presented at the laboratory’s QM medical director, and be presented at the laboratory s QM meeting. It will also be shared with the staff.

• Limitations of interpretation - Since the outpatient laboratory personnel will know that they are being audited they may be personnel will know that they are being audited, they may be more careful to fully follow the procedure.

• Action Plan – This will be implemented continuously and once the data is interpreted.

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Scenario in which a Pre-analytic Indicator was discovered by f ll i th P ti t Id tifi ti Pfollowing the Patient Identification Process

• You are the quality manager for your laboratory. You are speaking with one of the phlebotomists and notice that another phlebotomist is in the process of identifying a patient. The phlebotomist does not follow the process as required in th d Th hl b t i t t t th ti t’ the procedure. The phlebotomist states the patient’s name and asks if this is his name. The man shakes his head in an affirmative motion and the phlebotomist draws the patient samplesample.

• After verifying that this was indeed the correct patient and counseling the phlebotomist, you decide that a new patient identification indicator needs to be employed.

• Using the Quality Indicator Process develop the Pre-analytic Indicator for patient identification.p

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Patient Identification Quality Indicator ProcessPatient Identification Quality Indicator Process

• Objectives – The objective of the patient identification pre-analytic indicator is to ensure that laboratory personnel identifying patients for specimen collection will follow the written procedure 100 % of the time.

• Methodology – At random times throughout the day members of the staff will observe the patient identification process and document whether or not the process was performed p paccording to the procedure and, if not, what parts were performed contrary to the procedure.

• QI Graphic – Once data is collected a bar graph will be QI Graphic Once data is collected, a bar graph will be created for each month.

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Patient Identification Quality Indicator Process (Continued)(Continued)

• Preset Limits – Due to the importance of patient identification, the procedure must be followed correctly 100 % of the time and any deviations will require corrective action.

• Interpretation – The interpretation of the data will be reviewed Interpretation The interpretation of the data will be reviewed each month and analyzed.

• Limitations of interpretation – Since the laboratory personnel will know that there is the potential for their patient will know that there is the potential for their patient identification process to be observed, they may be more careful to fully follow the patient identification procedure.

• Action Plan – This will be implemented continuously and once the data is interpreted.

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Turn Around Times: A common pre-analytic and post-analytic quality indicator that is monitored.Polling Question # 2Polling Question # 2

Scenario:

To improve patient services, the laboratory and nursing department’s quality assurance committees were charged with providing data regarding the time it took for the with providing data regarding the time it took for the laboratory to collect STAT specimens, in order to identify areas that may need improvement. When the quality management reports were generated and the data was assessed by the p g ynursing and laboratory performance improvement staff, the average collection times were significantly different between the two departments. Nursing’s STAT specimen collection averages were noticeably longer than the laboratory’s average times.

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Turn Around Times: a common pre-analytic and post-analytic quality indicator that is monitored.Polling Question # 2 (Continued)Polling Question # 2 (Continued)

Question:

When does the clock start for monitoring STAT specimen collection times?

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Managing Blood Culture Contamination RateManaging Blood Culture Contamination Rate

• As the Microbiology supervisor, it is your task to monitor the blood culture contamination rate. In recent months the rate has been climbing and is now up to 6% for the last two months.

• This is already an existing quality monitor, but obviously the parameters need to be reviewed.

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Blood Culture Contamination – Quality Indicator ProcessProcess

• Objective: Obtain and maintain 3% blood contamination rate for the institution, consistent with the nationally accepted contamination rate

• Methodology: Breakdown the data from the last several Methodology: Breakdown the data from the last several months to look for “hot spots”. First break down the contamination rate by phlebotomist, then break down by floors or unit.

• QI Graphic: use bar graph to show the data

• Preset Limits – goal is 3% blood culture contamination rate

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Blood Culture Contamination Process continuedBlood Culture Contamination – Process continued

• Interpretation: This is an on-going indicator and once the troubleshooting and action plan are complete; the monthly rate will be monitored for improvement and continuity

• Limits of Interpretation: Variables such as different personnel Limits of Interpretation: Variables such as different personnel drawing the blood cultures

• Action plan: once the “hot spots” have been identified, training to include dollars wasted on working up training to include dollars wasted on working up contaminated blood cultures, proper technique to disinfect the drawing site, possibility of limiting the drawing of blood cultures to certain individuals re-training to include necessity cultures to certain individuals, re training to include necessity of observation for those with high contamination rates

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Scenario in which a Pre-analytic Indicator was discovered by following the Patient Sample from collection to testing collection to testing

• You are the quality manager for your laboratory. You are accompanying one of the phlebotomists from the floor back to the lab where the samples he has drawn will be accessioned for testing. The phlebotomist does not follow the

i d i th d S l b t t t process as required in the procedure. Some laboratory tests (e.g., coagulation assays) have specific requirements for blood to anticoagulant ratio and the tech accessioning in the blood notes that 3 out of 5 samples appear to be under filled blood notes that 3 out of 5 samples appear to be under-filled. These limitations may impact the results obtained.

• After requesting that the samples be redrawn, and counseling the phlebotomist, you decide that a new patient identification indicator needs to be employed.

• Using the Quality Indicator Process develop the Pre-analytic g y p yIndicator for rejection of under-filled samples for coagulation testing.

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Specimen Quality: Quality Indicator Process Specimen Quality: Quality Indicator Process

• Objectives – The objective of the appropriate fill level pre-analytic indicator is to ensure that coagulation testing is accurate and to monitor that phlebotomists will follow the written procedure 100 % of the time.

• Methodology – There will be a specimen rejection log in place to track the reasons that specimens are rejected prior to testing. Document whether or not the process was g pperformed according to the procedure and if not, what parts were performed contrary to the procedure.

• QI Graphic – Once data is collected a bar graph will be QI Graphic Once data is collected, a bar graph will be created for each month.

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Specimen Quality: Quality Indicator Process (Continued)(Continued)

• Preset Limits – Due to the importance of proper blood to anticoagulant ratio as it pertains to coagulation testing, the procedure must be followed correctly 100 % of the time and any deviations will require corrective action or documentation

f t ti i tof extenuating circumstances.

• Interpretation – The interpretation of the data will be reviewed and analyzed each month data is collected.y

• Limitations of interpretation – Since the laboratory personnel will know that there is the potential for their sample technique and process to be observed they may be more careful to fully and process to be observed, they may be more careful to fully follow the procedure.

• Action Plan – This will be implemented continuously and once the data is interpretedthe data is interpreted.

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Pre-analytic indicator scenario: Patient Tube Labeling Process Process

• As the phlebotomy supervisor you go to the floors and observe the phlebotomists as they draw blood. You are observing a phlebotomist getting ready to go into the patient’s room and notice that the phlebotomist is pre-labeling the tubes with the

ti t’ l b l d i iti li th ll B f th patient’s labels and initialing them as well. Before the phlebotomist enters the room you approach the individual explaining what they are doing is dangerous and against policypolicy.

• After reprinting the labels, the phlebotomist enters the room, draws the patient and labels and initials the tubes correctly.

• Using the Quality Indicator Process develop the Pre-analytic Indicator for patient tube labeling.

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Patient Tube Labeling: Quality Indicator ProcessPatient Tube Labeling: Quality Indicator Process

• Objectives – The objective of the patient tube labeling pre-analytic indicator is to ensure phlebotomists label the tubes at the patient’s bedside 100 % of the time.

• Methodology – At random times, the phlebotomy supervisor or Methodology At random times, the phlebotomy supervisor or manager will observe the tube labeling process and document whether the process was performed according to the procedure and if not, what parts were not performed or p p pwere contrary to the procedure.

• QI Graphic – Once data is collected, a bar graph will be created for each monthcreated for each month.

• Preset limits – Due to the importance of correct tube labeling, the procedure must be followed correctly 100 % of the time and any deviations will require corrective actionand any deviations will require corrective action.

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Patient Tube Labeling: Quality Indicator Process (Continued)(Continued)

• Interpretation – The interpretation of the data will be reviewed and analyzed each month data is collected.

• Limitation of interpretation – Since the phlebotomists will be aware that they will be observed at various times, they may aware that they will be observed at various times, they may be more careful to follow the patient tube labeling process.

• Action plan – This will be implemented continuously and once the data is interpretedthe data is interpreted.

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Scenario in which a Pre-analytic Indicator was discovered by following a Patient from Sign in to CollectionCollection

• You are the quality manager for your laboratory. You are auditing the outpatient laboratory specimen collection process as part of the laboratory’s continuous CAP inspection readiness assessment. You decide to follow the pre-analytic

f t ti t i i t hl b t i t ll ti process from outpatient sign in to phlebotomist collection. You observe that the staff member at the laboratory’s outpatient sign in desk, who is required to generate and attach the barcode labels to the outpatient test order is attach the barcode labels to the outpatient test order, is leaving the barcode labels for two different outpatients on the Zebra printer. She then quickly separates the barcode labels and attaches them to the respective outpatient order forms and attaches them to the respective outpatient order forms. The outpatient phlebotomist then picks up the order form with the attached barcode labels. Following the laboratory’s

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Scenario in which a Pre-analytic Indicator was discovered by following a Patient from Sign in to Collection (Continued)Collection (Continued)

HIPAA guidelines, the phlebotomist then calls outpatient #3 and accompanies her into the outpatient draw area. The phlebotomist verifies the outpatient’s identity by asking her to identify herself. The phlebotomist checks the order form and it i th Th hl b t i t th d th bl d is the same name. The phlebotomist then draws the blood, and attempts to attach the appropriate barcode labels. The barcode labels are for another patient.

• After reattaching the correct barcode labels to outpatient #3’s order form, and counseling both the staff member generating the barcode label and the outpatient phlebotomist, you determine that a new outpatient identification pre-analytic monitor needs to be implemented.

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O t ti t Id tifi ti Q lit I di t POutpatient Identification: Quality Indicator Process

• Objectives – The objective of the outpatient identification pre-analytic monitor is to ensure that outpatient laboratory personnel generating the barcode labels and identifying the outpatients for specimen collection will follow the written

d 100% f th tiprocedure 100% of the time.

• Methodology – After the mandatory retraining of all outpatient laboratory personnel has been completed, weekly p y p p yaudits will be conducted by the quality manager. The weekly audits will document whether or not the staff members generating the barcode label and the outpatient phlebotomists are performing their processes according to the procedure.

• QM Graphics – Once data is collected, a bar graph will be p , g pcreated for each month.

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Outpatient Identification: Quality Indicator Process (Continued)(Continued)

• Preset Limits – Due to the importance of patient identification, the procedure must be followed correctly 100% of the time and any deviations will require retraining and a coaching note.

• Interpretation – The analysis and interpretation of the QM data will be completed on a quarterly basis, signed off by the medical director, and be presented at the laboratory’s QM p ymeeting.

• Action Plan – After having a mandatory staff in-service, this indicator will be continuously monitored for compliance indicator will be continuously monitored for compliance. Failure to comply will result in additional training and a written reprimand in the staff member’s personnel record.

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Examples of Less Common Pre analytic IndicatorsExamples of Less Common Pre-analytic Indicators

• Hemolysis in critical patients (e.g., patient coming in through the ED that will undergo cardiac catheterization, etc., and now results for that patient need to be redrawn causing a delay in critical treatment). Goal is <3%. This was a large i iti ti t thi ti l i tit tiinitiative at this particular institution.

• Logging blood cultures as collected in emergency department by the phlebotomist so nursing may administer antibiotics after blood culture collection

• Urine Culture Contamination

S i ti• Specimen preparations

• Proper specimen transportation

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Examples of Less Common Pre-analytic Indicators (Continued)(Continued)

• Physician written order with every specimen

• Cost/benefit assessment for laboratory test menu

• Specimen quantity

• Number of samples with inadequate sample-anticoagulant ratio (%)

• Number of samples damaged in transport (%)• Number of samples damaged in transport (%)

• Number of requests with erroneous identification of physician (%)

• Number of samples lost/not received (%)

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Examples of Less Common Pre-analytic Indicators (Continued)(Continued)

• Collection of TDM peak/trough at incorrect times or lack of times given for the collection of these specimenstimes given for the collection of these specimens

• Cytology specimen inadequacy

• Whole blood glucose SOP followed in terms of repeats, lab Whole blood glucose SOP followed in terms of repeats, lab draws, critical value notification

• Instructions to the patientFasting / Non fastingo Fasting / Non fasting

o 24 hour collection (urine instructions)/ first morning void/ random specimenC h di th i t ti b th ti t o Comprehending the instructions by the patient

• Patient consent appropriately collected

Test utilization by clinician for best patient care• Test utilization by clinician for best patient care

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Pathology Patient Identification Pathology Patient Identification

A private pathology laboratory has a group of 5 pathologists who practice among 3 different sites. A biopsy specimen has a manual requisition. The physician marks the type of specimen and site that it is obtained from based on the

li i l Th i d i iti i d i clinical exam. The specimen and requisition are received in the laboratory, accessioned, and the demographic data is entered into the LIS. Computerized labels are generated for the slides and the cassettes are manually labeled Formalinthe slides and the cassettes are manually labeled. Formalin-fixed paraffin-embedded tissue is cut, fixed, and stained for microscopic examination. Each step of the way the specimen is identified with two unique handwritten patient identifiers is identified with two unique handwritten patient identifiers and is accompanied by the requisition for additional notes. Once the slides are stained, the computerized labels are affixed to the slides for review.

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Pathology Patient Identification (Continued)Pathology Patient Identification (Continued)

Slides are reviewed and results are documented by the pathologists directly into the LIS The final patient result is pathologists directly into the LIS. The final patient result is entered manually and sent electronically to the process technologist for final validation of all patient information and release to the electronic medical record. Since patient release to the electronic medical record. Since patient demographics are entered from a manual requisition, the result is tied to the patient at this point in data entry.

A mix up was made when entering patient demographics A mix-up was made when entering patient demographics from the manual requisition into the LIS and assigning the accession numbers resulting in the two patient results being switched One result was malignant and the other benign switched. One result was malignant and the other benign. The patient diagnosed with cancer was seen by the physician and ready for treatment.

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Pathology Patient Identification (Continued)Pathology Patient Identification (Continued)

The benign result was sent to the physician as non-cancerous, and this was truly the patient with a malignant diagnosis.

The error was identified when further testing was ordered for the malignant result. At this time the physician had already the malignant result. At this time the physician had already made a call to the wrong patient and informed him of the positive cancer test and requested further work in preparation for surgery. The actual patient with the cancer was not g y ptreated at this time because of the missed diagnosis.

The errors occurred when the sample identification was not verified at each step of the process against the original verified at each step of the process against the original requisition and LIS.

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Pathology Patient Identification: Quality Indicator ProcessProcess

• Objective: Correct patient identification 100% of the time throughout all phases of testing

• Methodology: Log sheet developed for verification process or a chart audit could be performed since it follows all a chart audit could be performed since it follows all components from order to report in LISo Receipt of the specimeno Checked written identifiers against original informationo Checked written identifiers against original informationo Checked labels generated by computer in the labo Result entry verification with the manual requisition

Release of final report in the patient’s EMR only after o Release of final report in the patient’s EMR only after secondary signature.

o Date & time with signature of auditing person

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Pathology Patient Identification: Quality Indicator ProcessProcess

• QI Graphic: Once the data is collected, it can be illustrated using bar graphs.

• Preset Limits: Due to the importance of the correct patient identification throughout all phases of testing, correct patient identification throughout all phases of testing, correct patient identification must be done 100% of the time.

• Action Plan: If this monitor falls below the 100% compliance threshold additional accessioner staff training will occur and threshold additional accessioner staff training will occur and further non-compliance may result in disciplinary action.

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Scenario in which a Pre-analytic Indicator was discovered by a Molecular Supervisordiscovered by a Molecular Supervisor

• A new technologist was performing infectious disease testing i th l l l b t f l b b h it l in the molecular laboratory of a large suburban hospital. Approximately five hours after setting up an FDA cleared/approved target amplification method for Chlamydia trachomatis/Neisseria gonorrhoeae (CT/NG) the Chlamydia trachomatis/Neisseria gonorrhoeae (CT/NG), the technologist reviewed the instrument printout. Suddenly, she noticed an unusually large number of positive CT/NG patient results at the end of her run Upon further review she verified results at the end of her run. Upon further review, she verified that both the positive and negative controls were positive for CT/NG. Immediately, and prior to reporting out any patient results, she showed the printout to the molecular supervisor. p pThe supervisor suspects that the large number of positive patient results were caused by sample contamination.

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Scenario in which a Pre-analytic Indicator was discovered by a Molecular Supervisordiscovered by a Molecular Supervisor

• The supervisor determines to stay late and repeat the run. Upon completion of the repeat run, both the positive and negative controls are positive for CT/NG. However, there is only one positive patient for CT/NG, all the rest of the patients

th ti Th i t th ti t on the run are negative. The supervisor enters the patient results into the computer and heads home. While driving home, the supervisor determines the need to implement a new pre analytic indicator into the molecular laboratory to new pre-analytic indicator into the molecular laboratory to prevent sample contamination issues in the future.

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Sample Contamination Polling question #3Sample Contamination - Polling question #3

Did the supervisor take the appropriate action?p pp p

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Sample Contamination Prevention: Quality Indicator ProcessProcess

• Objectives - The objective of the pre-analytic indicator is to t th i t d ti f i DNA t i ti i t prevent the introduction of genomic DNA contamination into

any corresponding patient samples while performing CT/NG testing in the molecular laboratory. Sample contamination causes erroneous results that typically affect a limited number causes erroneous results that typically affect a limited number of samples in a run. The prevention of contamination with the true target can be addressed only through robust technologist training In addition molecular procedures must be written in training. In addition, molecular procedures must be written in great detail and be strictly followed in a uniform manner by all technologists.

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Sample Contamination Prevention: Quality Indicator ProcessProcess

• Methodology - After the mandatory retraining of all molecular technologists has been completed the supervisor will conduct technologists has been completed, the supervisor will conduct weekly audits to detect any habits that could lead to the cross-contamination of patient samples. During the audit, the supervisor will ensure that the technologists are following the supervisor will ensure that the technologists are following the laboratory procedures in a uniform manner. The weekly audits will document whether or not the molecular technologists are performing the procedures in a uniform manner. In addition, p g pthe supervisor will monitor positivity rate statistics on a weekly basis rather than a monthly basis. The weekly statistics will document that the positivity rates are within the laboratory’s established threshold.

• QM Graphics - Once the data is collected, a bar graph will be created for each week.

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Sample Contamination Prevention: Quality Indicator ProcessProcess

• Preset limits – Due to the importance of this pre-analytic monitor, the procedure must be followed correctly 100% of the time and any deviations will require retraining and a coaching note. In addition, the positivity rate statistics must remain

ithi th t bli h d th h ldwithin the established threshold.

• Interpretation – The analysis and interpretation of the QM data will be completed on a quarterly basis, signed off by the p q y g ymedical director, and be presented at the laboratory’s QM meeting.

• Action Plan – Retrain the technologists and monitor the Action Plan Retrain the technologists and monitor the positivity rates weekly. Conduct weekly procedure audits and all those deviating from the procedure will be retrained and further non-compliance will result in a written reprimand.p p

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Different Methods to Measure Quality IndicatorsDifferent Methods to Measure Quality Indicators

• Percentage of the threshold – e.g., 95% or greater of critical values must be documented properly

• > or < the threshold value - e.g., the physician office laboratories must have less than one contaminated urine laboratories must have less than one contaminated urine specimen per day or corrective action is initiated.

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Methods for Providing Corrective Action for QM IndicatorsIndicators

• Root Cause Analysis

• Stepwise form based process

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Practical Uses of Pre analytic Quality IndicatorsPractical Uses of Pre-analytic Quality Indicators

• May indicate that the process is functioning properly

• May demonstrate that improvement is needed

• May indicate additional resources are needed

• May identify an unexpected problem

• May provide evidence that there is not a problem when others believe there isothers believe there is

• May be used to build physician confidence in the laboratory by providing analytics that demonstrate the quality of the laboratory’s work

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Summary and November WebinarSummary and November Webinar

Topics Discussed

• Ways to develop new pre-analytic indicators

• Common and uncommon pre-analytic indicators

• Reviewed scenarios utilizing pre-analytic indicators

• Discussed how to measure and set threshold for quality indicatorsindicators

• Corrective action strategies

Post-analytic Webinar – November 20thPost analytic Webinar November 20

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Thank youThank you

• Thank you to our presentero Dr. Susan Thrasher Martin

• Thank you to our panel memberso Jean Hoodo Jean Hoodo Rodney Stewarto Arlene Clancy

Joan Roseo Joan Roseo Carolyn Gandyo Trudy Dardeno Sujata Patelo Sujata Patelo Marian Briggso Denise Driscoll

• Thank you to our participants for their time.

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QuestionsQuestions

Questions?

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