Advanced Dermatology And Cosmetic Surgery

CLIA Laboratory Citation Details

2
Total Citations
5
Total Deficiencyies
4
Unique D-Tags
CMS Certification Number 10D2142152
Address 11474 Sw Village Parkway, Port Saint Lucie, FL, 34987
City Port Saint Lucie
State FL
Zip Code34987
Phone(772) 318-4945

Citation History (2 surveys)

Survey - November 29, 2023

Survey Type: Standard

Survey Event ID: UKND11

Deficiency Tags: D0000 D5217

Summary:

Summary Statement of Deficiencies D0000 Recertification survey was conducted on 11/29/2023. Advanced Dermatology and Cosmetic Surgery clinical laboratory was not in compliance with 42 CFR Part 493, requirements for clinical laboratories. D5217 EVALUATION OF PROFICIENCY TESTING PERFORMANCE CFR(s): 493.1236(c)(1) At least twice annually, the laboratory must verify the accuracy of any test or procedure it performs that is not included in subpart I of this part. This STANDARD is not met as evidenced by: Based on record review and interview, the laboratory failed to perform biannual Mohs micrographic surgery (MOHS) Histopathology accuracy peer review verification for 1 out of 2 for 2022. Findings included: Review of MOHS Histopathology & Proficiency Testing Policy effective date of 11/23/2022 read, "Peer review proficiency testing for all MOHS surgeons and histopathologist will be performed bi-annually. Proficiency testing is to be sent out and returned by June 30th and December 31st each year." Review of MOHS Proficiency documents revealed MOHS proficiency peer review was done on 12/15/2022. No written documentation of other MOHS proficiency peer review in 2022 documents. On 11/29/2023 at 2:43 PM, the Office Manager confirmed there was no documentation of a second accuracy peer review verification for MOHS in 2022. Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 1 --

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Survey - March 9, 2022

Survey Type: Standard

Survey Event ID: 0UVM11

Deficiency Tags: D5403 D0000 D5805

Summary:

Summary Statement of Deficiencies D0000 An initial certification survey was conducted on March 9, 2022. Advanced Dermatology and Cosmetic Surgery clinical laboratory was not in compliance with 42 CFR 493, requirements for clinical laboratories. D5403 PROCEDURE MANUAL CFR(s): 493.1251(b) The procedure manual must include the following when applicable to the test procedure: (1) Requirements for patient preparation; specimen collection, labeling, storage, preservation, transportation, processing, and referral; and criteria for specimen acceptability and rejection as described in 493.1242. (2) Microscopic examination, including the detection of inadequately prepared slides. (3) Step-by-step performance of the procedure, including test calculations and interpretation of results. (4) Preparation of slides, solutions, calibrators, controls, reagents, stains, and other materials used in testing. (5) Calibration and calibration verification procedures. (6) The reportable range for test results for the test system as established or verified in 493.1253. (7) Control procedures. (8)

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