Adult & Pediatric Dermatology Specialists, Pc

Summary Statement of Deficiencies 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 record review and staff interview, the laboratory failed to establish competency assessment policy and procedures to assess competency for the regulatory responsibilities of the general supervisor (GS), technical supervisor (TS), technical consultant (TC) and clinical consultant (CC). Findings include: 1. Record review on 09 /10/2024 of the laboratory's 'Personnel Training/ Employee Proficiency Evaluations/ Monthly Meetings' binder revealed lack of documentation of competency assessment for the regulatory positions of GS, TS, TC and CC. 2. Record review on 09/10/2024 of the laboratory's policies and procedure revealed lack of documentation of an established competency assessment policy and procedures to assess competency for the regulatory responsibilities of the GS, TS, TC and CC. 3. Staff interview on 09/10 /2024 at 11:00 AM with testing personnel #1 confirmed the above findings. 4. The laboratory performs 413 tests annually in the subspecialty of mycology and 5,963 tests annually in the subspeciality histopathology. 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: 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 -- Based on record review and staff interview the laboratory failed to follow their established policies and procedures to ensure that proficiency testing (PT) samples were performed twice annually in the subspecialty of histopathology. Findings Include: 1. Record review on 09/10/2024 of the laboratory's 'Monthly Quality Assurance/ Monthly Patient Quality Assurance/ Quality Control-Proficiency' binder revealed lack of documentation of PT samples being sent out for microscopic review /evaluations for 2023. 2. Record review on 09/10/2024 of the laboratory's 'Proficiency Testing: Mohs Micrographic Surgery Skin Specimen' procedure revealed 'Semi annually, the tech will send two cases containing the original slides and send it out for a microscopic examination by a Board Certified Dermatopathologist or Mohs surgeon'. 3. Staff interview on 09/10/2024 at 11:30AM with the testing personnel #1 confirmed the above findings. 4. The laboratory performs 5,963 samples annually in the subspecialty of histopathology. D5779

Summary Statement of Deficiencies D5407 PROCEDURE MANUAL CFR(s): 493.1251(d) Procedures and changes in procedures must be approved, signed, and dated by the current laboratory director before use. This STANDARD is not met as evidenced by: Based on record review and staff interview, the laboratory failed to ensure changes to the fungal culture procedure were updated, approved and signed by the laboratory director in the subspecialty of mycology prior to patient testing. Findings include: 1. Record review on 3/29/2022 of the laboratory's 'Obtaining/entering/reading /documenting results overview' procedure revealed: a. The procedure for 'taking /obtaining a fungal culture' was to inoculate the fungal culture media Sabouraud Dextrose Agar. b. After 2 weeks the provider does a visual reading of the Sabouraud Dextrose agar vial and results a positive or negative culture. c. Approval date of the procedure was 7/31/2018. 2. Surveyor observation on 3/29/2022 at 12:00 PM of the laboratory's inoculated fungal culture media revealed Remel Dermatube Dermatophyte Test Medium (DTM), Lot #: 367893 exp 9/22/2022 in use. 3. Record review on 3/29/2022 of the Remel DTM manufacturer product insert revealed to examine the media at regular intervals for a red color development. 4. Record review on 3/29/2022 of the laboratory's 'Form 21: Laboratory Test Requisition and Report Log' revealed: a. 2 shipments of Sabouraud Dextrose Agar with date received 6/20/18 and 1/24/2019. b. 4 shipments of DTM with date received 1/17/2020, 9/4/2020, 10/21 /2021 and 2/16/2022 (Lot #367893). 5. Staff interview with the laboratory director (LD) on 3/29/2022 at 12:10 PM confirmed the above findings. The LD disclosed he /she was aware the laboratory switched to DTM at some point and a positive result on DTM is the color change to red but did not update the procedure. 6 The laboratory performs 277 fungal cultures annually in the subspecialty of mycology. D5413 TEST SYSTEMS, EQUIPMENT, INSTRUMENTS, REAGENT 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 -- 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 record review and staff interview, the laboratory failed to follow manufacturer instructions to monitor and document temperatures for proper testing performance of fungal cultures in the subspecialty of mycology. Findings include: 1. Surveyor observation on 3/29/2022 at 12:00 PM of the laboratory's inoculated fungal culture media revealed Remel Dermatube Dermatophyte Test Medium (DTM), Lot #: 367893 exp 9/22/2022 were in use and stored at room temperature. 2. Record review on 3/29/2022 of the Remel DTM product insert revealed to incubate DTM in ambient air at 25-30 degrees Celsius for up to 14 days. 3. Record review on 3/29/2022 of laboratory maintenance records revealed the lack of documentation of room temperature readings where inoculated DTM are stored during the 14 day testing period. 4. Staff interview with the laboratory director on 3/29/2022 at 12:10 PM confirmed the above findings. 5. The laboratory performs 277 fungal cultures annually in the subspecialty of mycology. -- 2 of 2 --

Summary Statement of Deficiencies D6053 TECHNICAL CONSULTANT RESPONSIBILITIES CFR(s): 493.1413(b)(9) The technical consultant is responsible for evaluating and documenting the performance of individuals responsible for moderate complexity testing at least semiannually during the first year the individual tests patient specimens. This STANDARD is not met as evidenced by: Based on record review and staff interview, the laboratory failed to assess and document new testing personnel competency to perform fungal cultures in the subspecialty of mycology twice in the first year of performing patient testing. Findings include: 1. Record review of the CMS Laboratory Personnel Report 209 form on 7/24/18 revealed 1 new testing personnel was hired since the last survey. 2. Record review of the testing personnel competency records on 7/24/18 revealed the semiannual assessment for 1 of 1 new testing personnel was not available. 3. Record review of the laboratory's procedure manual on 7/24/18 revealed the lab did not have a policy in place to train and perform semiannual competency in the first year and annual thereafter for new testing personnel. 4. Staff interview with the laboratory director on 7/24/18 at 11:00 AM confirmed the above findings. 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 --