Dermatology East, Pllc

Summary Statement of Deficiencies D2000 ENROLLMENT AND TESTING OF SAMPLES CFR(s): 493.801 Each laboratory must enroll in a proficiency testing (PT) program that meets the criteria in subpart I of this part and is approved by HHS. The laboratory must enroll in an approved program or programs for each of the specialties and subspecialties for which it seeks certification. The laboratory must test the samples in the same manner as patients' specimens. For laboratories subject to 42 CFR part 493 published on March 14, 1990 (55 FR 9538) prior to September 1, 1992, the rules of this subpart are effective on September 1, 1992. For all other laboratories, the rules of this subpart are effective January 1, 1994. This CONDITION is not met as evidenced by: Based on direct observation, lack of documentation, review of a patient accessioning log and final patient test report, and staff interview, the laboratory failed to enroll in proficiency testing in 2025 for the dermatophyte culture. The findings include: 1. Laboratory observation on 04/02/25 at 11:15 a.m. revealed a patient culture incubating for dermatophyte detection using Hardy Diagnostics Dermatophyte Testing Medium (DTM). 2. The laboratory failed to provide documentation of enrollment in proficiency testing for the dermatophyte culture. 3. A review of the patient accessioning log for dermatophyte culture revealed the laboratory had performed six dermatophyte cultures since 01/01/25. The last reported patient was on 03/17/25 for patient 060323. 4. The laboratory director confirmed the survey findings during an interview on 04/02/25 at 12:45 p.m. D5291 GENERAL LABORATORY SYSTEMS QUALITY ASSESSMENT CFR(s): 493.1239(a) The laboratory must establish and follow written policies and procedures for an ongoing mechanism to monitor, assess, and, when indicated, correct problems 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 -- identified in the general laboratory systems requirements specified at 493.1231 through 493.1236. This STANDARD is not met as evidenced by: Based on direct observation, review of the laboratory's quality assessment plan for the dermatophyte testing medium (DTM), review of records, and staff interviews, the laboratory failed to follow the DTM quality assessment plan when the laboratory director did not review the required documents in 2024 and 2025. The findings include: 1. Laboratory observation on 04/02/25 at 11:15 a.m. revealed a patient culture incubated for dermatophyte detection. 2. A review of the laboratory's quality assessment portion of the individualized quality control plan revealed the laboratory director would review the temperature records, certificate of quality analysis and dermatophyte testing medium log quarterly. 3. The laboratory's temperature records revealed no documented review from April 2024 through March 2025. The dermatophyte testing medium quality certificates and sterility checks were not reviewed for lot number 626030, received on 04/03/24, lot number 638075, received on 09/12/24, or lot number 648909, received on 01/31/25. 4.The laboratory director confirmed the survey findings during an interview on 04/02/25 at 12:45 p.m. -- 2 of 2 --

Summary Statement of Deficiencies D5435 MAINTENANCE AND FUNCTION CHECKS CFR(s): 493.1254(b)(2) For equipment, instruments, or test systems developed in-house, commercially available and modified by the laboratory, or maintenance and function check protocols are not provided by the manufacturer, the laboratory must: (i) Define a function check protocol that ensures equipment, instrument, and test system performance that is necessary for accurate and reliable test results and test result reporting. (ii) Perform and document the function checks, including background or baseline checks, specified in paragraph (b)(2)(i) of this section. Function checks must be within the laboratory's established limits before patient testing is conducted. This STANDARD is not met as evidenced by: Based on observation of the laboratory, record request, and interview with the laboratory director, the laboratory failed to verify the accuracy of their thermometers in 2020, 2021 and 2022. The findings include: 1. Observation of the laboratory on 09 /08/2022 at 8:30 am revealed storage of dermatophyte testing medium (DTM) in a refrigerator and incubation of DTM cultures in a cabinet. The thermometers that were in use for recording temperatures were not certified. 2. Request for records documenting the accuracy of the laboratory thermometers revealed no records were available. 3. Interview with the lab director on 09/08/2022 at 11 am confirmed the laboratory did not have a process in place to verify the accuracy of thermometers used for monitoring temperatures in the refrigerator where the DTM is stored and patient DTM culture are incubated in 2020, 2021 and 2022. D5893 POSTANALYTIC SYSTEMS QUALITY ASSESSMENT CFR(s): 493.1299(b)(c) (b) The postanalytic systems quality assessment must include a review of the effectiveness of

Summary Statement of Deficiencies D5445 CONTROL PROCEDURES CFR(s): 493.1256(d)(1)(2)(g) Unless CMS Approves a procedure, specified in Appendix C of the State Operations Manual (CMS Pub. 7), that provides equivalent quality testing, the laboratory must-- (d)(1) Perform control procedures as defined in this section unless otherwise specified in the additional specialty and subspecialty requirements at 493.1261 through 493.1278. (d)(2) For each test system, perform control procedures using the number and frequency specified by the manufacturer or established by the laboratory when they meet or exceed the requirements in paragraph (d)(3) of this section. (g) The laboratory must document all control procedures performed. This STANDARD is not met as evidenced by: CITATION NUMBER ONE: Based on observation of the laboratory, review of the dermatophyte test medium (DTM) quality control (QC) manufacturer instructions, the laboratory QC data and interview with the laboratory director, the laboratory failed to follow the DTM QC manufacturer instructions when the patient sample for QC was not confirmed prior to use as the QC, in 2018 and 2019. The findings include: 1) Observation on May 22, 2019 at 8: 46 a.m. of the laboratory revealed DTM media in use for patient testing. 2) Review of the DTM in-house QC manufacturer instructions revealed prior to using a patient sample as QC the patient sample must be a confirmed positive by the following: initial scrapping evaluated microscopically then inoculated media produces a positive results, or a microscopic examination of the culture shows branching hyphae and the patient is cleared of fungal infection. 3) Review of the QC data revealed no confirmation of the patient QC samples as positive using either of the manufacturer two confirmation options. A new patient sample was used as positive QC with no confirmation for each new lot number, in 2018 and 2019. 4) Interview on May 22, 2019 at 11:00 a.m. with the laboratory director confirmed that the patient samples in use as QC were not confirmed positive samples as the manufacturer instructions were not followed for confirmation. CITATION NUMBER TWO: Based 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 -- on review of the Individual Quality Control Plan (IQCP), the quarterly quality assessment (QA) documentation and interview with the laboratory director, the laboratory failed to follow the IQCP when the quarterly reviews were not performed and documented. The findings include: 1) Review of the IQCP revealed quarterly reviews are performed by the laboratory supervisor and documented. 2) Review of the QA documentation revealed no documentation of QA quarterly reviews were available for 2018 and 2019. 3) Interview on May 22, 2019 at 11:45 a.m. with the laboratory director confirmed that the QA quarterly reviews were not performed in 2018 and 2019. -- 2 of 2 --