Marietta Dermatology Associates Pa

Summary Statement of Deficiencies D0000 A recertification survey was performed on February 14, 2024. The facility was found to be NOT in compliance with all applicable CLIA requirements for specialties /subspecialties for 42 CFR. D5209 PERSONNEL COMPETENCY ASSESSMENT POLICIES CFR(s): 493.1235 As specified in the personnel requirements in subpart M, the laboratory must establish and follow written policies and procedures to assess employee and, if applicable, consultant competency. This STANDARD is not met as evidenced by: Based on laboratory policy and procedure manual (SOP) review and interview with the clinical supervisor, the laboratory failed to establish and follow a policy and procedure to assess testing personnel (TP) competency containing the 6 required components. Findings include: 1. SOP review revealed a policy and procedure (P&P) failed to assess TP competency for Potassium Hydroxide (KOH) preparations. The P&P addressed the direct observation (DO) of TP performing the test. 2. The P&P lacked the following required components: - monitor recording and reporting of results - review immediate test results,worksheets, quality control (QC), proficiency testing (PT) and preventative maintenance (PM) - DO of instrument maintenance/ function checks - Assessment of test performance thru testing previously analyzed specimens, internal blind testing samples or external PT - Assessment of problem solving 3. An interview with the clinical supervisor, in the downstairs lab #2, at 10:24 a.m., confirmed the aforementioned findings. 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 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 -- procedure it performs that is not included in subpart I of this part. This STANDARD is not met as evidenced by: Based on testing personnel (TP) document review and interviews with the clinical supervisor and the lab director (LD), the laboratory failed to verify at least twice annually the accuracy of any test or procedure performed. Findings include: 1. TP document review revealed there were no twice annually peer reviews performed on Staff #2 thru #9; #16 & #17 (CMS 209) for the Potassium Hydroxide (KOH) testing in 2022, 2023, or 2024 thus far. 2. Interviews with the clinical supervisor and LD, in the conference room,on 02/14/24, at 12:05 PM,confirmed the lack of KOH TP peer reviews for the aforementioned dates. D5417 TEST SYSTEMS, EQUIPMENT, INSTRUMENTS, REAGENT CFR(s): 493.1252(d) Reagents, solutions, culture media, control materials, calibration materials, and other supplies must not be used when they have exceeded their expiration date, have deteriorated, or are of substandard quality. This STANDARD is not met as evidenced by: Based on observation and testing personnel (TP) interview, the laboratory failed to ensure reagents and solutions not be used after expiration date. Findings include: 1. Observation during the laboratory tour on 02/14/2024 at 11:20 a.m. revealed Marking Tissue Dye Green Lot #21245 expired 09/30/2023 and Marking Tissue Dye Black Lot#21250 expired 09/30/23. Observation during the same tour at 1:20 p.m. on 02/14 /2024 revealed there was no replacement dyes available at the time of survey. 2. Interview with TP #14 (CMS 209) in the MOHS laboratory #1 on 02/14/2024 at 11:20 a.m. confirmed the dyes in use had expired and there was no replacement available at the time of survey. -- 2 of 2 --

Summary Statement of Deficiencies D0000 A Clinical Laboratory Improvement Amendments (CLIA) recertification survey was completed on May 12, 2022. The laboratory was not in compliance with applicable CLIA requirements found at 42 CFR 493.1 through 42 CFR 493.1780. The following deficiencies were cited: 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 Testing Personnel (TP) document review and staff interview, the laboratory failed to verify at least twice annually, the accuracy of testing performed for Moh's. Findings include: 1. TP document review revealed there were no twice annual peer reviews performed on the Clinical Consultant's (CMS 209) for Moh's testing in 2020 and 2021 for Moh's lab #1. 2. TP document review revealed there were no twice annual peer review performed on the Clinical Consultant's (CMS 209) for Moh's testing in 2022 thus far for Moh's lab #2. 3. During an interview with TP#5 (CMS 209) in the Moh's#1 laboratory on May 12, 2022 at 11:00 AM, it was confirmed the lack of peer review was performed for Moh's testing. D6079 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1445(a)(b) The laboratory director is responsible for the overall operation and administration of the laboratory, including the employment of personnel who are competent to perform test procedures, record and report test results promptly, accurately and proficiently, and for assuring compliance with the applicable regulations. (a) The laboratory director, if qualified, may perform the duties of the technical supervisor, clinical 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 -- consultant, general supervisor, and testing personnel, or delegate these responsibilities to personnel meeting the qualifications under 493.1447, 493.1453, 493.1459, and 493.1487 respectively. (b) If the laboratory director reapportions performance of his or her responsibilities, he or she remains responsible for ensuring that all duties are properly performed. This STANDARD is not met as evidenced by: Based on laboratory competency document review and staff interview with the Moh's Technician, the Laboratory Director(LD) failed to perform annual competency on all testing personnel (TP). The Findings include: 1. Laboratory competency review revealed the LD failed to perform an annual competency for the Clinical Consultant (CC) and testing personnel (TP). 2. During an interview with the Moh's Technician TP#5(CMS 209) on May 12, 2022 at 11:00 AM, in the Mohs Laboratory #1, confirmed the LD failed to perform annual competencies on all required personnel. -- 2 of 2 --

Summary Statement of Deficiencies D0000 A Clinical Laboratory Improvement Amendments (CLIA) recertification survey was completed on January 30, 2018. The laboratory was not in compliance with applicable CLIA requirements found at 42 CFR 493.1 through 42 CFR 493.1780. The following deficiencies were cited: D5401 PROCEDURE MANUAL CFR(s): 493.1251(a) A written procedures manual for all tests, assays, and examinations performed by the laboratory must be available to, and followed by, laboratory personnel. Textbooks may supplement but not replace the laboratory's written procedures for testing or examining specimens. This STANDARD is not met as evidenced by: Based on policy and procedure manual (SOP) review, the laboratory failed to establish a written procedure for all tests, assays, and examinations performed by the laboratory. Findings include: 1. The laboratory failed to establish a written procedure for a sterility check of the mycology media. 2. The laboratory failed to establish a written procedure for quality control (QC) of the mycology media. 3. An interview with the laboratory quality supervisor on 1/30/18 at approximately 130 p.m. in lab#12 confirmed the laboratory SOP did not contain a procedure for mycology media sterility check or QC. D5429 MAINTENANCE AND FUNCTION CHECKS CFR(s): 493.1254(a)(1) For unmodified manufacturer's equipment, instruments, or test systems, the laboratory must perform and document maintenance as defined by the manufacturer and with at least the frequency specified by the manufacturer. 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 -- This STANDARD is not met as evidenced by: Based on observation and interview with the lead histotechnologist, the lab failed to calibrate/certify the vent (fume) hood, microscope, and timers per the procedure manual (SOP). Findings include: 1. Observation during the lab tour revealed the Airventronix hood located in the Histology lab has not been certified since installation. 2. Observation during the lab tour revealed the Premiere microscope #1206545 located in the Histology lab has not been serviced since 09/19/14. 3. Observation during the lab tour revealed the timers (S/N 150317607, 150317602, 122304384, 122097541) located in the Histology lab have not been certified since purchase. Timers expired 04/20/17, 06/01/14, 02/24/14 respectively. 2. Interview with lead histotechnologist on 1/30/18 in the histology lab at approximately 1:45 PM, confirmed the aforementioned equipment had not been calibrated as outlined in the SOP. D5477 CONTROL PROCEDURES CFR(s): 493.1256(e)(4)(g) (e) For reagent, media, and supply checks, the laboratory must do the following: (e) (4) Before, or concurrent with the initial use-- (e)(4)(i) Check each batch of media for sterility if sterility is required for testing; (e)(4)(ii) Check each batch of media for its ability to support growth and, as appropriate, select or inhibit specific organisms or produce a biochemical response; and (e)(4)(iii) Document the physical characteristics of the media when compromised and report any deterioration in the media to the manufacturer. (g) The laboratory must document all control procedures performed. This STANDARD is not met as evidenced by: Based on quality control (QC) document review and staff interview, the laboratory failed to check each batch of media for its ability to support growth and, as appropriate, select or inhibit specific organisms, and to check each batch for sterility. Findings include: 1. QC document review revealed the laboratory failed to perform a sterility check for each batch of media for 2017, and 2018 thus far. 2. QC document review revealed the laboratory failed to check each batch of media for its ability to support growth. or, as appropriate, inhibit growth for each batch of media for 2017 and 2018 thus far. 2. An interview with the laboratory quality supervisor in lab #12 room on 1/30/18 at approximately 1:30 p.m. confirmed a sterility check for each batch of media had not been performed nor a check for each batch of media to support or, as appropriate, inhibit growth for 2017 and 2018 thus far. -- 2 of 2 --