Associated Dermatologists Pc

Summary Statement of Deficiencies D5413 TEST SYSTEMS, EQUIPMENT, INSTRUMENTS, REAGENT CFR(s): 493.1252(b) The laboratory must define criteria for those conditions that are essential for proper storage of reagents and specimens, accurate and reliable test system operation, and test result reporting. The criteria must be consistent with the manufacturer's instructions, if provided. These conditions must be monitored and documented and, if applicable, include the following: (1) Water quality. (2) Temperature. (3) Humidity. (4) Protection of equipment and instruments from fluctuations and interruptions in electrical current that adversely affect patient test results and test reports. This STANDARD is not met as evidenced by: Based on lack of humidity records for review from 2023 and 2024, review of the manufacturer's specifications for the Leica CM1850 Cryostat and interview with the facility personnel, the laboratory failed to monitor and document the ambient humidity of the room where the cryostat is utilized. Findings include: 1. The laboratory utilizes the Leica CM1850 Cryostat in conjunction with Mohs testing under the subspecialty of Histopathology with an annual test volume of 500. 2. The manufacturer's specifications for the Leica CM1850 Cryostat reviewed during the survey listed an operating relative humidity range of 0%-60%. 3. The laboratory failed to provide documention demonstrating the ambient humidity of the room where the cryostat is utilized was monitored and recorded on each day of patient testing from 2023 through 2024 (through the survey date of 11/20/2024). 4. The facility personnel interviewed on 11/20/2024 at 8:50 AM confirmed the laboratory failed to monitor and document the ambient humidity as indicated above. 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 --

Summary Statement of Deficiencies D5203 SPECIMEN IDENTIFICATION AND INTEGRITY CFR(s): 493.1232 The laboratory must establish and follow written policies and procedures that ensure positive identification and optimum integrity of a patient's specimen from the time of collection or receipt of the specimen through completion of testing and reporting of results. This STANDARD is not met as evidenced by: Based on review of frozen biopsy test reports, review of patient slides and interview with the facility personnel, the laboratory failed to ensure positive identification of the patient's dermatopathology specimens. Findings include: 1. The laboratory performs dermatopathology testing under the sub-specialty of histopathology, with an approximate annual test volume of 300. It is the practice of the laboratory to indicate the frozen biopsy test results on the Mohs map. 2. Review of the frozen biopsy slide for patient C.B. from 8/14/20 revealed the slide was labeled with the Mohs accession number, "20-147" and the site was listed as "R Central Eyebrow". The correct site of the frozen biopsy was "L Nasal Ala", as indicated in the test result listed on the Mohs map. 3. The facility personnel interviewed during the survey conducted on 10/15/20 stated that it is the practice of the laboratory to label frozen biopsy slides with the patient name, date of service and specimen location. No accession number is assigned to the frozen biopsy cases. 4. The facility personnel confirmed that the frozen biopsy slide from the patient indicated above was erroneously labeled with the Mohs accession number and the incorrect specimen location. 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, Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 2 -- 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)