11/16/2018

CLIA Documentation in the Mohs Lab Daniel H. Gong, MS, MSO, C-PM

Daniel H. Gong, MS, MSO, C-PM Management Services Officer No Disclosure of Relevant Relationships with Industry Clinical Service/Laboratory Manager

UC Davis Dermatology, Mohs Laboratories 2018 Fundamentals of Mohs Surgery UC Davis Dermatopathology Service San Diego, CA

Duplicate CLIA Documentation in the Mohs Lab What is CLIA?

X What is CLIA? Types of CLIA labs X Clinical Laboratory Improvement Amendments (Established in X CLIA Documentation in the Mohs Lab or 1988 by the Federal Government) X Lab Manual- QC Program, Lab Classifications, and Lab Procedures X CLIA Regulations: X QC Monitors: Temperature, Equipment (Cryostat, Stainer, Refrigerator, Eyewash Station, Fume Hood, Autoclave, Microscope), 1) Establish/follow written polices and procedures Service Reports, Reagent and Stain and Corrective Action 2) Take corrective actions, as necessary

X Proficiency Testing Requirements 3) Review effectiveness of the assessments and corrective actions taken X Preparing for a CLIA Inspection 4) Revise policies and procedures, as necessary X Guidelines for Counting Tests 5) Communication with staff on assessments X Quality Assessment Process 6) Document all assessment activities

Types of CLIA DistributeLabs Lab Procedure Manual

1) Waived – simple tests that do not require additional quality assessment (see current list of waived tests) http://www.cms.gov/Regulations-and- X The Lab Manual reflects the current practices of the Guidance/Legislation/CLIA/Downloads/waivetbl.pdf laboratory. 2) Moderate Complexity – most automated tests that do not meet the waiver criteria (e.g., KOH exams, fungal cultures, and staining procedures) X New procedures and all changes to the Manual must be 3) High ComplexityNot – non-automated tests ( e.g., histopathology, Mohs Surgery) approved, signed and dated by the Laboratory Director X The Lab Director will also review, sign, and date each lab manual annually Do

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Lab Procedure Manual 1) Quality Control Program

X General Policy – QC program ensures testing/results are accurate and in compliance. 1) Quality Control Programs X Training – Employees trained in QA and QC procedures

X Documentation – Results of QC analyses will be documented. 2) Laboratory Classification X Maintenance Checks – Equipment maintained according to protocols.

X Corrective Actions – All corrective actions must be documented. 3) Laboratory Procedures

Duplicate Temperature Monitors Equipment Monitors

X Cryostat QCor X Monitor Daily Room Temperature X Stainer QC

X Refrigerator QC X Changes in Room Temperature must be documented X Eyewash Station QC

X Check humidity in the Laboratory X Fume Hood or Extractor QC

X Autoclave QC X Warmer temperatures requires the Cryostat to work harder X Microscope QC

Cryostat DistributeQC Stainer QC Not

Do Specify acceptable ranges

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Refrigerator QC Eyewash Station

Specify what you are testing

Duplicate Fume Hood or Extractor QC orAutoclave QC

MicroscopeDistribute QC Slide QC/Daily QA Not Do

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Service Repair Forms Service Reports

X Yearly Preventative Maintenance (PM) Reports

X Equipment Repairs

X Service Reports should specify Model/Serial #

X Follow up on any PM report recommendations

X Ask about equipment recalls

Duplicate Reagent and Supplies Reagent Log

orOr Lot # The laboratory must define proper storage of reagents and specimens

All reagents should have the following on the labels: -identity, titer, concentration, storage requirements, received and open date, initials

The laboratory must maintain an inventory to track reagents using a running balance system.

Corrective Action Form Corrective ActionsDistribute

X Written policies and procedures for corrective action must be available and followed as necessary to maintain operations to ensure accurate and reliable test results.

X All laboratories must document all corrective actions takenNot Do

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2) Laboratory Classification 3) Laboratory Procedures

X Waived Testing – www.cms.hhs.gov/clia X Provider Performed Microscopy (PPM) – e.g, KOH preparations Histopathology in Mohs Surgery is High Complexity

X Moderate and High Complexity Testing – Mohs Histopathology X Principle of Test

X CLIA Certificates: Waiver, PPM Procedures, Registration, Compliance, and X Specimen Collection, Rejection, and Handling Accreditation X Materials, Equipment, and Reagents Used X Application for Certification (CMS-116) X Test Procedure – Sectioning Specimens, H and E Staining www.cms.hhs.gov/forms/cms116 of frozen sections

X Quality Control Analyses – Daily and Random Case Reviews

X Results – Mohs Map and Final Histopathology Report

Duplicate Proficiency Testing/Grossing Preparing for a CLIA Requirements Inspection CLIA inspections are performed every two years for moderate or high X High Complexity Labs (e.g., Mohs Lab): Proficiency complexityor lab. testing is a way to verify your lab tests through an Common Deficiencies: external source. Send your cases to a local Incomplete written policies/procedure manuals colleague (minimum twice a year). 1) No formal quality assessment program 2) Maintaining Equipment X Grossing Educational Requirements: Bachelor’s in 3) Expired Reagents medical technology, CLS, Chem/Phy/Biological Science. 4) Lack of proficiency testing Associate degree in lab science or medical laboratory education and training equivalent to associate degree: 5) Provide documents in organized manner ahead of time 60 semester hrs – 24 sem hrs of mlt or 24 sem hrs of 6) Poor storage of reagents science courses (6hrs each of biology/chemistry and 12 hrs chem/bio or medical lab technology, or any combination

Quality Assessment Guidelines for CountingDistribute Tests Process

1) Assessment Process – What does it include?

For histopathology, each block is counted as one test. 2) Frequency of the Review

Laboratories that perform special stain on histology slides; the test volume 3) Corrective Action Process is determined by adding the number of special stains to total number specimen.Not For Mohs, each stage counts as one test. Do

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Assessment Process Encompasses Frequency of Review

1) All Technical and non-technical functions

2) All locations/sites where testing is performed 1) Establish a schedule or plan for ongoing monitoring

3) Interactions with and responsibilities to patients, 2) The frequency of monitoring will depend on the problem and corrective physicians, other laboratories, and non-laboratory action taken areas or departments of a facility 3) Use the deficiencies and recommendations cited during CLIA surveys for areas to monitor

Duplicate Common Deficiencies in CLIA Corrective Action Process Inspections

1) Identification of the problem X Clearly definedor temperature ranges

2) Resolution of the problem X Acceptable temperature ranges

3) New polices that will prevent recurrence X Regular review of temperatures and noted actions when temperature is out of range. 4) Communication of written polices and the action taken to prevent future problems X QC for stains

5) Monitor corrective actions X How often are you changing your stains

6) Include personnel and staff in the review process

7) Document! Document! Document!

ConclusionDistribute References

CLIA Survey Documentation Focus: CLIA Regulations/Laws http://www.ecfr.gov/cgi-bin/text- 1) Procedure manual idx?SID=1248e3189da5e5f936e55315402bc38b&node=pt42.5.493&rgn=div5

2) Personnel Records (e.g., training and experience, competency assessment) http://www.gpo.gov/fdsys/pkg/USCODE-2011-title42/pdf/USCODE-2011- 3) QC records (e.g., calibration records, instrument title42-chap6A-subchapII-partF-subpart2-sec263a.pdf maintenance American Academy of Dermatology Clinical Laboratory Improvement 4) QualityNot Assessment Plan and Documentation Amendments (CLIA) for Dermatology

Interpretative guidelines for CLIA surveys: https://www.cms.gov/Regulations-and- Do Guidance/Legislation/CLIA/Interpretive_Guidelines_for_Laboratories.html

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