CMS Form 209 Laboratory Personnel Report: Filing and Codes

CMS Form 209, the Laboratory Personnel Report, is the document a CLIA-certified lab uses to list every person who performed or supervised non-waived testing over the past two years, along with the CLIA position each one holds and the qualification level they meet. You complete it in-house, the Laboratory Director signs it, and you submit it to your State Agency or CMS Regional Office at initial certification, before each biennial survey, and whenever the Laboratory Director changes.1Centers for Medicare & Medicaid Services. Laboratory Personnel Report (CLIA) Form CMS-209

Which Labs File Form 209

The form applies to any laboratory holding a Certificate of Registration, Certificate of Compliance, or Certificate of Accreditation — the certificates that authorize moderate-complexity or high-complexity testing. Labs holding only a Certificate of Waiver or a Certificate for Provider-Performed Microscopy procedures do not file it.2Centers for Medicare & Medicaid Services. How to Obtain a CLIA Certificate

When to File

Three events trigger a filing. First, initial certification: a new lab applying for a CLIA certificate to perform non-waived testing includes Form 209 in the application package. Second, the biennial survey: State Agency surveyors inspect non-waived labs every two years, and an updated report covering everyone with testing responsibilities during that period must be ready when they arrive.1Centers for Medicare & Medicaid Services. Laboratory Personnel Report (CLIA) Form CMS-209 Third, a change in Laboratory Director: you have 30 days to notify your State Agency or Accreditation Organization, and an updated Form 209 goes with that notice.3Centers for Medicare & Medicaid Services. Laboratory Director Responsibilities

Gather Personnel Records Before You Start

Pull the file for every person who performed or supervised testing during the past two years. Staff limited to specimen processing, clerical work, or waived testing are excluded from the report.1Centers for Medicare & Medicaid Services. Laboratory Personnel Report (CLIA) Form CMS-209

For each qualifying person, you need:

  • Full legal name as it appears on their credentials.
  • The CLIA position held: Laboratory Director, Clinical Consultant, Technical Consultant, Technical Supervisor, General Supervisor, Testing Personnel, Cytotechnologist, or Cytology General Supervisor.
  • The highest qualification level the person meets — moderate complexity (M) or high complexity (H).
  • For Technical Consultants and Technical Supervisors, the numbered specialty from the form’s Specialty List.
  • Supporting documentation: diplomas, transcripts, training certificates, and any state licensure records that back up the qualifications you plan to claim.

Primary Source Verification

A photocopy of a diploma handed in by the employee will not satisfy a surveyor. CMS requires Primary Source Verification, meaning direct confirmation of the degree or certificate with the issuing institution or its authorized agent. That can be a documented phone call with the school, a letter or email confirmation, or a check through a secure database run by the institution.4Centers for Medicare & Medicaid Services. Personnel Policies for Individuals Directing or Performing Non-waived Tests Frequently Asked Questions

If a third-party PSV report confirms the diploma was awarded, you do not need to keep a separate copy of the diploma. If the report does not cover that element, the lab must retain the diploma to demonstrate compliance.4Centers for Medicare & Medicaid Services. Personnel Policies for Individuals Directing or Performing Non-waived Tests Frequently Asked Questions Any qualification element the PSV report does not verify has to be documented some other way, and the Laboratory Director is the one accountable for that.

Foreign Degrees

Staff who earned their degrees outside the United States need a credential equivalency evaluation before their education can be reported. Under 42 CFR 493.2, the evaluation has to be done on a course-by-course basis by a nationally recognized organization.5ECE. Healthcare Compliance Solutions CMS accepts evaluations performed by members of the National Association of Credential Evaluation Services.6NACES. Members Keep the equivalency report with the employee’s other qualification records.

Position Codes and Specialty Numbers

Page two of the form carries two reference tables you will use constantly. The position codes are:1Centers for Medicare & Medicaid Services. Laboratory Personnel Report (CLIA) Form CMS-209

  • LD — Laboratory Director
  • CC — Clinical Consultant
  • TC — Technical Consultant (moderate complexity)
  • TS — Technical Supervisor (high complexity)
  • GS — General Supervisor (high complexity)
  • TP — Testing Personnel
  • CT/GS — Cytology General Supervisor
  • CT — Cytotechnologist

Which of those positions appear on your report depends on the work the lab does. Moderate-complexity labs list LD, CC, TC, and TP. High-complexity labs list LD, CC, TS, GS, and TP. Cytology labs list LD, CC, TS, CT/GS, and CT.1Centers for Medicare & Medicaid Services. Laboratory Personnel Report (CLIA) Form CMS-209

The Specialty List is numbered 1 through 17 and covers areas such as Bacteriology, Mycology, Chemistry, Hematology, Immunohematology, Histopathology, and Clinical Cytogenetics. You enter those numbers only in the TC or TS columns to show which specialty the Technical Consultant or Technical Supervisor oversees. When one person covers more than one specialty, give each specialty its own line.

Completing the Form

Download Form CMS-209 from the CMS forms library.7Centers for Medicare & Medicaid Services. CMS 209 – Laboratory Personnel Report (CLIA) It is a two-page PDF.

Header

Fill in the lab’s CLIA identification number, legal name, full street address, and telephone number at the top of page one. Verify the CLIA number against your certificate. A single wrong digit can attach the report to the wrong facility or get it kicked back.

Personnel Table

Each row of the table represents one person in one CLIA position. Enter the full name, check the column matching the position code, and mark (M) or (H) in the qualification column to show the highest level the individual qualifies for.1Centers for Medicare & Medicaid Services. Laboratory Personnel Report (CLIA) Form CMS-209

A few points that catch people out:

  • Only one person may be listed as Laboratory Director.
  • Someone who holds more than one CLIA position gets a separate line for each. A physician serving as both LD and CC appears on two lines.
  • For TC and TS entries, put the specialty number from page two in the column rather than a checkmark. A TC covering Chemistry and Hematology gets two lines, one for each specialty.
  • The two-year lookback includes people who no longer work at the lab, as long as they had testing responsibilities during that window.

Signature

The Laboratory Director signs and dates the certification at the bottom, attesting that every person listed qualifies for the position shown under 42 CFR Part 493, Subpart M. The form carries a warning under 18 U.S.C. § 1001 that knowingly submitting false information can bring a fine of up to $10,000, up to five years in prison, or both.1Centers for Medicare & Medicaid Services. Laboratory Personnel Report (CLIA) Form CMS-209

Where to Send It

The signed form goes to the State Agency or CMS Regional Office with jurisdiction over your lab. Submission method varies. Some states accept fax or secure email; others still want mailed hard copies. Call your State Agency to confirm before you send. CMS has moved toward a paperless system for certificate issuance and fee payments, but personnel reports and director-change notices still go through the State Agency rather than a national portal.8Centers for Medicare & Medicaid Services. Clinical Laboratory Improvement Amendments (CLIA)

Keep an exact copy in the lab’s records. Surveyors cross-check the submitted report against on-site personnel files, and having the same version in front of you makes any question easier to close out.

What Surveyors Do With It

At the biennial survey, the State Agency surveyor treats your Form 209 as a roadmap. They compare each claimed qualification against the documentation in the employee’s personnel file: diplomas, transcripts, PSV records, and foreign credential evaluations where applicable. A claim that lacks adequate documentation draws a deficiency citation, and the lab is asked to produce the missing evidence or submit a plan of correction.

Unresolved deficiencies escalate. Under 42 CFR Part 493, Subpart R, CMS can impose a directed plan of correction, mandatory state on-site monitoring, civil money penalties, or suspension and revocation of the CLIA certificate.9eCFR. 42 CFR 493.1806 – Available Sanctions: All Laboratories A personnel gap left unaddressed can end with the lab losing its authority to perform non-waived testing. Answering surveyor requests quickly is the cheapest way to keep a paperwork problem from turning into a certificate problem.