Interim Self-Inspection: What is it and How to do it ... · Documentation of performance of the...

2014 Continuing Compliance Master SeriesInterim Self-Inspection: What is it and How to do it

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John D. Olson, MD, PhD, FCAPMarch 19, 2014

Today’s Presenter - John D Olson MD PhDToday s Presenter John D. Olson, MD, PhD

Dr. John Olson graduated from the University of Dr. John Olson graduated from the University of Colorado and received his Medical Degree from Georgetown University. Following his residency at the Mayo Clinic he received his PhD degree from the University of Minnesota. He is currently Professor and Vi Ch i f Cli i l Aff i i th D t t f Vice Chair for Clinical Affairs in the Department of Pathology at the University of Texas Health Science Center in San Antonio and is the Director of the Clinical Laboratories for the South Texas Reference Laboratories.

Dr. Olson served on the CAP Coagulation Resource Committee from 1993-2004, serving as its chair 1999-2004. He is currently a member for the Continuous Compliance Committee Dr Olson’s academic Compliance Committee. Dr. Olson s academic career has focused on issues of hemostasis and thrombosis. He also has interest in quality management in the laboratory.

© 2014 College of American Pathologists. All rights reserved. 2

Learning ObjectivesLearning Objectives

A lt f ti i ti i thi ti it ill b bl tAs a result of participating in this activity, you will be able to:o Explain the importance of the interim self-inspectiono Apply best practices to your interim self-inspectionpp y p y po Describe how the interim self-inspection will help prepare

you for an unannounced on-site inspectionDescribe how the interim self inspection will help improve o Describe how the interim self-inspection will help improve laboratory quality and promote continuous compliance with accreditation requirements.


Purpose of the Self-InspectionPurpose of the Self Inspection

• Ongoing compliance with the Standards

• Update laboratory practice to comply with current p y p p ychecklist requirements

• Prepare for the next on-site inspection

• Laboratory improvement and better patient care


GEN 23584: Interim Self-Inspection

Th l b t d t i t i lf i ti

GEN.23584: Interim Self Inspection

• The laboratory conducts an interim self-inspection and documents efforts to correct deficiencies identified during that process.g p


GEN 23584 (Continued)

• NOTE: The interim self-inspection is an important aspect of continuing education and laboratory improvement The use of a

GEN.23584 (Continued)

continuing education and laboratory improvement. The use of a variety of mechanisms for self-inspection (residents, technologists or other inspectors) is strongly endorsed. Self inspection by personnel familiar with, but not directly involved in, the routine operation of the l b t ti t b i t d i b t ti laboratory section to be inspected is a best practice. Documentation of performance of the interim self-inspection with correction of deficiencies is a requirement for maintaining accreditation. The laboratory must document that personnel y presponsible for each laboratory section have reviewed the findings of the interim self-inspection.

• Evidence of Compliance:• Evidence of Compliance:

• Written evidence of self-inspection findings with records of corrective action


Get a Fresh Look at Your OperationsGet a Fresh Look at Your Operations

Use the interim self-inspection to look at your laboratory or have someone else look at your laboratory or have someone else look at your laboratory as if seeing it for the first time.


Let’s Get Organized

Plan for completion before your Self-inspection

Let s Get Organized

p y pVerification Form is due to be returned to the CAP:

1. Identify a Team Leader for your self-inspection process (t-60 days)p ( y )

2. The team leader will identify inspectors to perform the self-inspection (t-45 days)

3 Perform inspection (t 30 to t 15 days)3. Perform inspection (t-30 to t-15 days)4. Team meets to review findings5. Summation Conference (t-7 days)6. Mail self-inspection confirmation to CAP (t-7 to t-1

days)7 Corrective action and documentation (t+30 days)

© 2014 College of American Pathologists. All rights reserved.

7. Corrective action and documentation (t+30 days)

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Team Leader

• Someone with experience with the inspection

Team Leader

p pprocess

• Has previously been a team leader or member of a p yteam inspecting another laboratory

• Has taken the Team Leader Training offered online gat CAP.org:

http://learning.cap.org/catalog/options/view/ccf50d5a 9a33 438a 8872 469831d6194fcf50d5a-9a33-438a-8872-469831d6194f

• An opportunity to lead a project


Self-Inspection Team MembersSelf Inspection Team Members

• Use supervisory staff, experienced non-supervisory technical staff, residents, fellowstechnical staff, residents, fellows

• Cross discipline lines when practical- Cultivates new team members for future inspections- Provides depth for unannounced on-site inspections- Prepares staff for inspection interviews- Elucidates weaknessesElucidates weaknesses

• Explore exchange with other laboratories in your region

• All team members should take the inspector training at All team members should take the inspector training at CAP.org: http://learning.cap.org/catalog/options/view/d9c451f3-addd-4d09-b24a-5b1f83d27a3e


Initial Team Leader Meeting with Inspectors

1. Assignments and distribution of checklists

Initial Team Leader Meeting with Inspectors

- Have the checklists provided for the inspection- Be clear about the assignments for each team member- Define any focus issuesDefine any focus issues

2. Establish timing- Timing is flexible so set precise goals- Lay out the entire timeline

3. Define communication and “esprit de corps” - New members will have questions. Provide them support- Collegial process, inspector and laboratory are both

learning


Inspection Process

• Focus Issues

Inspection Process

o Prior inspection deficiencies, on site or self-inspection− There is no reason for and there should not be

recurrence of prior deficienciesrecurrence of prior deficiencieso Known issues in your laboratory (products of your event

management program)Many of the events that occur in the laboratory are − Many of the events that occur in the laboratory are related to accreditation requirements

− Check that all events have documented corrective action; verify that you are compliant for accreditationaction; verify that you are compliant for accreditation


Inspection ProcessInspection Process

• Focus Issueso Common problems (deficiencies) found in

inspections of other laboratoriesinspections of other laboratories- We will review some common issues that are

found during inspections generally.g p g y- Data is a compilation of the findings of all CAP

inspections.



• 2012: Common Deficiencieso Among the checklist items, many laboratories

are cited for the same issueso Comparing the current list of common

d fi i i t th f i fi d deficiencies to those of prior years, we find that the most frequently cited deficiencies are similar from one year to the next, and do are similar from one year to the next, and do not necessarily involve new requirements


Inspection ProcessInspection ProcessMost Common Deficiencies in 2012

GEN.55500 Competency Assessment

GEN.20375 Document Control System

GEN.75400 Annual Fire DrillCOM.01700 Proficiency Testing (PT) Evaluation

COM.10000 Complete Procedure Manual

COM 01400 PT Att t ti St t tCOM.01400 PT Attestation Statement

CHM.10100 Procedure Review

POC.06900 Competency Assessment

CHM 13600 AMR V lid tiCHM.13600 AMR Validation

COM.10300 Knowledge of Procedures


0 100 200 300 400 500 600

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Inspection Process

Five Phase II Items Most Often Cited from the All Common

Inspection Process

Checklist:o COM.01100 Laboratory has procedure for grading

challenges intended to be graded, but which were g g ,not

o COM.01500 Alternative Assessmento COM.01600 Proficiency Testing Integration into

Routine Workloado COM.01700 Proficiency Testing & alternative o COM.01700 Proficiency Testing & alternative

assessment: evaluation and corrective actiono COM.10100 Procedure Manual Review had been

annual now at least every two years


annual, now at least every two years

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Polling Question 1

While performing your self inspection, you are asked to review the Proficiency Testing records You find that your

Polling Question 1

review the Proficiency Testing records. You find that your Director has correctly signed every attestation sheet for the past 2 years except for the A mailing of the CGL survey this year year.

What do you do?A Cite a Phase II deficiency for failure to sign the A. Cite a Phase II deficiency for failure to sign the

attestation.B. Issue a recommendation the laboratory has

established practice of signing. C. This is minor, cite yourself for only a Phase I

deficiency.


deficiency.

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Inspection ProcessInspection ProcessMost Cited Discipline Specific Deficiencies in 2012

POC.06900 Competency Assessment

CHM.13600 Validation of Analytic Measurement RangeC 3600 y g

TLC.11425 Delegation of Director Duties

CHM.13800 Method Comparisons

MIC.11020 Quality Control Monthly Review y y

POC.07300 Daily Control Testing

TRM.31450 Method Comparisons

HEM.24000 Reagent Labeling g g

ANP.12087 Cryostat Decontamination

ANP.08216 Formaldehyde Monitoring


0 100 200 300 400 500 600

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Inspection Process

CHM.13600 (Phase II) Validation of the analytical t (AMR) i f d ith t i

Inspection Process

measurement range (AMR) is performed with matrix-appropriate materials which include the low, mid and high range of the AMR, appropriate acceptance criteria

d fi d d th i d t dare defined, and the process is documented.

Common reasons for citations:Did t lid t 6 tho Did not revalidate every 6 months

o Did not include materials than span the assay rangeo Did not include all applicable analytes in the o Did not include all applicable analytes in the

validation process (e.g. blood gases, BNP, and TNI)o New issue in Hemostasis that is generating questions


Inspection ProcessTLC.11425 (Phase II) If the laboratory director has delegated some functions to others documentation

Inspection Process

delegated some functions to others, documentation specifies the individuals and the specific activities so authorized.

Common reasons for citations:o No documentationo Duties or individuals not includedo Delegated activities that must not be delegated

such as new procedure or policy reviewo Letter/memo needs to be specific regarding the

duties that are being delegated


duties that are being delegated

20

Inspection Process

CHM.13800 (Phase II) If the laboratory uses more th i t t/ th d t t t f i

Inspection Process

than one instrument/method to test for a given analyte, the instruments/methods are checked against each other at least twice a year for g ycorrelation of results.

Common reasons for citations:o Not performed twice per yearo Not including all the appropriate

iinstruments/methodso No established criteria for acceptability

Al TRM 31450 (Ph II)


o Also TRM.31450 (Phase II)

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Inspection Process

MIC 11020 (Phase II) Quality control data are

Inspection Process

MIC.11020 (Phase II) Quality control data are reviewed and assessed at least monthly by the laboratory director or designee.

Common reasons for citation:o No documentationo Not completed monthlyo Not performed by a documented designeeo Also POC.07300 Managing controls for POCT


Inspection Process

ANP.23410 (Phase II) There is a documented

Inspection Process

procedure for the routine decontamination of the cryostat at defined intervals, and decontamination records are evident.records are evident.

Common reasons for citations:o Lack of documentationo Lack of documentationo Laboratories sometimes use uv or fog, but do not physically

wipe the cryostat downL b t i ’t i th t t d il d o Laboratories aren’t using the cryostat daily and are unsure of the frequency of decontamination

o Laboratories have a difficult time decontaminating once


per week due to high volumes and only one cryostat available.

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Inspection ProcessANP.08216 (Phase II) Formaldehyde and xylene vapor concentrations are maintained below the f i i i i i

Inspection Process

following maxima, expressed as parts per million, in all areas of the Anatomic Pathology Department where formaldehyde or xylene are used.

Common Reasons for Citations:• Laboratories sometimes don’t do both the 15 minute and the 8 Laboratories sometimes don t do both the 15 minute and the 8

hour monitoring

• Laboratories have small quantities of these chemicals and believe that the requirement does not apply to thembelieve that the requirement does not apply to them.

• Do not repeat the monitor when changes have taken place in the laboratory that could potentially increase exposure such as

h i d ti i t l


changes in production, equipment, personnel

24

Polling Question 2

While performing your self inspection you find a procedure was l t i d d i d 18 th i l Y l b t ’

Polling Question 2

last reviewed and signed 18 months previously. Your laboratory’s quality plan states that procedures are reviewed annually.

What do you do?yA. Current CAP regulations require review every 24 months so

this is compliant.B. The laboratory’s policy states the review is to be every 12 . e abo a o y s po cy s a es e e e s o be e e y

months. This is a Phase II deficiency. C. The laboratory’s policy states the review is to be every 12

months. Write a recommendation to update the policy.


Inspection Process

Encourage inspectors to:

Inspection Process

g po Spend time in the laboratory!o Interview non-supervisory staff (bench techs,

hl b t i t d t l)phlebotomists, order entry personnel)− Structure the interim self-inspection to be

as similar to the on-site inspection as as similar to the on site inspection as possible:

− Interview non-supervisory personnel during th lf i ti d k the self inspection -- does everyone know the policies as well as the supervisors?


Inspection Process

Testing Readiness

Inspection Process

Testing Readinesso“If your supervisor were not here on the day of

the inspection, how would you respond if you p y p ywere asked by the inspector…”

−…for a certain procedure or practice?−…where PT policies are located?−…where the Chemical Hygiene plan is housed?− where the maintenance records are kept?…where the maintenance records are kept?−…etc.


Inspection Process

• An Example: What’s the problem?

Inspection Process

p

• GEN.41067 (Phase II)

“D th L b t

p

• No written policy.

N d t ti • “Does the Laboratory director review the format of the report on

• No documentation that this is occurring.

pa bi-annual basis?”

• I look at report formats every day!


Inspection Process

The Lesson: • “If you didn’t

Inspection Process

• Provide documentation that th ti it i b i

• If you didn t write it down, it did ’t the activity is being

performed.didn’t happen……”

• Failure to document equals non-equals noncompliance.


Inspection ProcessInspection ProcessFamous Last Words“Oh yes, we do all of that all of the time!”Dr. I. M. Complacent,p

Medical DirectorMediocre Laboratories, USA

Wh i f ili i t l d ti it When you are in a familiar environment, same place and activity, day after day, you can overlook details, forget best practices and become complacent.

Consistency is also an issue. Do all of the staff perform the same procedures the same way.


Inspection Process

Safety

Inspection Process

yo Safety procedures and policies posted readily

available to all employees?o Documentation of safety training to new

employees.During the Interim Self Inspection interview o During the Interim Self-Inspection, interview personnel regarding contents of the safety manual.−Choose several items to ask non-supervisory

staff.


Inspection Process

Competency AssessmentD i th fi t f ti t t ti

Inspection Process

o During the first year of patient testing, competency assessment must be performed every six months.

o Competency must be reassessed at least annually.

o Confirm all six elements are included for each o Confirm all six elements are included for each test system (if applicable).

o Managing Competency for POCT is a problem i i tit tiin many institutions.

o PPMP now requires competency with the same detail as others who perform testing.


p g

32

Inspection Process

Point of Care Testing

Inspection Process

go Inspection of POCT requires the use of the POCT

checklist and all applicable portions of the L b t G l h kli tLaboratory General checklist.

o For accreditation, all analytes being measured under the program/site are included in the live under the program/site are included in the live CAP inspection.

o POCT is often overlooked in the self-inspection. o Not in the Laboratory, but the Laboratory

provides oversight. Be sure all elements are compliant


compliant.

33

Inspection Process

(GEN.20375) Elements of Document Control System

Inspection Process

• Policies, procedures and processes (P/P/P) current

• Personnel have read the relevant documentsPersonnel have read the relevant documents

• P/P/P have been authorized by the director

• P/P/P reviewed annually by the director or designee• P/P/P reviewed annually by the director or designee

• Discontinued P/P/P are archived and quarantined a in separate file

• Are all required elements present? Are Documents current?


Polling Question 3Your laboratory has a new director. She started as the director just a month ago. As you review the procedures, o note that onl one ne major re ision has occ rred

Polling Question 3

you note that only one new major revision has occurred that she has signed. All other procedures have been signed by the prior director.

What do you do?A. The new director must only sign the new procedures from

her start date, not prior procedures.B. Cite a Phase II deficiency. The new director is required to

approve and sign ALL procedures.C. The director must sign all procedures but is allowed a g p

“reasonable time” to complete the task.


Inspection Process

Team Leader Assessment of the Laboratory Director

Inspection Process

and Quality Checklist

• Evaluate the qualifications of the Laboratory Director.

• Assess the effectiveness with which that individual implements and supports the Standards of the Laboratory Accreditation Program.

C d t th i t i it h l id d th • Conduct the interview, it can help provide depth for the on-site inspection.


Inspection Process

Team Leader Assessment of the Laboratory Director and Q lit Ch kli t

Inspection Process

Quality Checklist

• Review documents:o QM plan -- include review of specific monitors, o QM plan include review of specific monitors,

corrective actions.o Organizational chart -- does it represent operations?

H th b h i th L b t Di t ? • Has there been a change in the Laboratory Director? o COM.10400: If there is a change in laboratory

directorship, the new laboratory director reviews and approves (over a reasonable period of time) that approves (over a reasonable period of time) that laboratory procedures are current. −Create your own goals, write them down and

document that you are progressing.


docu e a you a e p og ess g.

37


Quality Management

• Your event management program drives much of g p gyour quality management

• Thoughtful selection of indicatorsg

• Corrective actions documented

Di t ’ i l t i d l t d • Director’s involvement in development and management of Quality



Review of Proficiency Testing

• Variant Proficiency Testing performance report

• “Drill down” troublesome analytes

• Alternative Assessment

• Do not share or refer Proficiency Testing results!


Inspection Process

Patient Safety Policy

Inspection Process

y y

• Rigorous adherence to patient identification proceduresp

• Reporting of life threatening conditions/ critical values

• Strategies for preventing medical errors

Institutional approach• Institutional approach


Inspection Process

H dli f C l i t

Inspection Process

Handling of Complaints

• Honestly review the culture of your laboratory.

• Do a policy and procedure exist?

• Do the policy and procedure match actual Do the policy and procedure match actual practice?


Team Meeting at Completion of InspectionTeam Meeting at Completion of Inspection

• Review all deficiencies identified during the inspectioninspectiono Common issues may ariseo Discuss any issues about which an inspector may y p y

be uncertain

• Organize the summation conferenceO g


Summation Conference

• Hold a formal summation conference

Summation Conference

• Invite the leadership of the organizationo Hospital Administration, Director of Organization, p g

Qualityo Your opportunity to shine

• Identify the strengths and quality of the laboratory

• Review the opportunities for improvement that have been identifiedo All inspectors or just the team leader


• Open and Close on a positive note

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PaperworkPaperwork

• Send to the CAP:o Self-inspection Verification Form o Self inspection Verification Form

−Signed by Director


Corrective Actions

• Plan corrective action for all cited deficiencies

Corrective Actions

• Collect documentation that the corrective action has addressed the problemp

• Complete these tasks within ? days, fix the time frame

• File the information for review by the next on-site inspection team

• In 6 months, pull the file and document that the corrective actions have been successful


Inspector Summation Report: Five Crucial Questions

At your on-site inspection, the inspection team leader ith it t i l di th f ll i l t

Inspector Summation Report: Five Crucial Questions

with write a report including the following elements. Consider these same elements as you conclude the self-inspection process:

1. Does the laboratory meet the standards?

2. Is the Director qualified?2. Is the Director qualified?

3. If no, is there a qualified supervisor for each section?

4. Is administration satisfied?

5 Is the medical staff satisfied?


5. Is the medical staff satisfied?

46

What Inspectors Will Focus on About Your Self-Inspection

I t h b i t t d t i th

Inspection

• Inspectors have been instructed to review the results of the interim self-inspectiono Request list of cited deficiencies and scrutinize o Request list of cited deficiencies and scrutinize

documentation of corrective action

• Probing questions will be asked about the self-Probing questions will be asked about the selfinspectiono How seriously did the laboratory take the

process?o Were genuine concerns detected and

corrected?


corrected?

47

Summary of Best Practices

• Involve multiple staff members in the self-inspection

Summary of Best Practices

p p• Make this a formal event for your laboratory• Look at your laboratory as if you are seeing it for the y y y g

first time• Ask questions of the bench technologists and other

t ffstaff• Hold a summation conference encouraging all who

are able to attendare able to attend• Document corrective action for all deficiencies

cited


The Interim Self-Inspection – The Bottom Line

The laboratory is required to perform the interim self-

The Interim Self Inspection The Bottom Line

y q pinspection, but don’t do the inspection because it is required, do it because it will help you maintain and improve the quality of your laboratory Sustaining improve the quality of your laboratory. Sustaining continuous compliance with the accreditation standards is a challenge for Laboratories regardless of i d l it d i b t lit size and complexity and requires a robust quality

program. The inspection process is an important integral part of that program and, when performed g p p g pwell, helps the continuous improvement of the Laboratory.


Acknowledgements/Thank You

• Thanks to Dr. Renee Ellerbroek and Dr. Earle Collum

Acknowledgements/Thank You

• Thanks to Continuous Compliance Committee members, Accreditation Education Committee members, Suzan Mraibie, Jean Ball, Rodney Stewart and other CAP staff for assistance in preparing this presentationpresentation.

• Thank you to our participants for their time.

Keep in mind the tool kit is available with the link your site coordinator has received


Questions


Technical AssistanceTechnical Assistance

http://www.cap.org

Email: [email protected] g

800 323 4040 t 6065800-323-4040, ext. 6065


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