**Please be aware, due to the limited availability of survey dates and times, schedule changes cannot be readily accommodated and may defer renewal of your CLIA certification, and result in claim reimbursement delays/denials.**

The following forms must be completed accurately in their entirety by a representative of your facility and submitted to the surveyor before or at the time of survey. Incomplete forms cannot be processed and will be returned for immediate correction.

CMS-116; CLIA Application for Certification

• This form must be completed in its entirety with current and accurate information, including current specialties and test volumes. Failure to complete this form correctly will result in issuance delays of your new CLIA certificate and/or issuance of the CLIA certificate with incorrect information. Your laboratory will be liable for all costs associated with generating a new CLIA certificate if incorrect and/or inaccurate information was indicated on the CMS 116 form. 

CMS-209; Laboratory Personnel Report

• Carefully read the instructions page provided with the form prior to completion. Use one line (row) per position held. Employees holding multiple positions should use multiple lines (rows) to represent each role. Laboratory Director (LD), Clinical Consultant (CC), General Supervisor (GS), Testing Personnel (TP), Cytology General Supervisor (CT/GS), and Cytotechnologist (CT) roles should be represented in the corresponding column by a check mark (). Technical Consultant (TC) and Technical Supervisor (TS) roles should be represented by the number that corresponds to their specialty area. Use the Specialty List provided on the instruction page to find the correct specialty number to enter in the corresponding column for TC and TS roles. 
• All employees must be paid directly by the owner of the CLIA registered organization to meet the exception detailed in NYS PHL § 579. Please have redacted copies of the previous year’s W-2 forms for all laboratory personnel listed on the CMS-209 form available for review. The facility name and address, Employer Identification Number (EIN), and employee name need to be viewable on the W-2 forms. A paystub will be required for recent or newly hired testing personnel who do not have a previous year’s W-2 form available. 1099 employees are not acceptable.  

DOH-5793; Disclosure of Ownership and Interest Statement
•    Please complete this form with current information. Failure to provide accurate information may result in issuance delays of your next CLIA certification.  

CLIA On-Site Survey Basic Format: 

1. Surveyor Arrival and Introductions.
2. Tour of Facility and Laboratory.
3. Application form completion, document and record review. 
4. Discussion of Findings (including how to reconcile deficiencies and citations, if applicable).
5. Exit Interview.

For the on-site survey, please have the following records for the past two years available for review: 

1. Laboratory policies and Standard Operating Procedure (SOP) manuals including all specimen collection and labeling protocols, test menu, Quality Control (QC), calibration records, Quality Assurance (QA), Individualized Quality Control Plan (IQCP) if applicable, reporting patient results, and remedial action procedures.
2. CMS-approved Proficiency Testing (PT) program testing records, if applicable. Twice-year verification documents are required for any analytes for which PT is unavailable.
3. Patient specimen laboratory analyzer validation records. Validation records for any new or replacement laboratory testing instruments and/or analyzers. Documentation must be provided for any test procedures that have been added or deleted since the last survey.  
4. Records of QA/QC, including calibration, and any relevant remedial corrective action performance, if applicable.  
5. Equipment and instrument preventative maintenance and service records (e.g. chemistry, toxicology, hematology, endocrinology, urinalysis, and bacteriology analyzers, centrifuges, temperature monitoring equipment, biosafety cabinets, microscopes, etc.) must be provided.  
6. Thermometer calibration records and temperature, humidity monitoring records.
7. Staff education, training, and competency assessment records. Annual competency assessment records for clinical consultant(s), technical consultant(s) of moderate complexity testing, technical supervisor(s) of high complexity testing, and general supervisor(s) of high complexity testing, and testing personnel must be provided. Initial training, six-month, and annual competency assessment records for testing personnel must be provided. Job descriptions for laboratory director, clinical consultant(s), technical consultant(s) for moderate complexity testing, testing supervisor(s) for high complexity testing, general supervisor(s) for high complexity testing, and testing personnel must be provided.
8. Patient records and test reports for review.

Please be advised, interfering or obstructing the survey process will not be tolerated and may consequently result in penalties, including but not limited to termination of your CLIA certification