Lackawanna Valley Dermatology Assoc Ltd

Summary Statement of Deficiencies D5413 TEST SYSTEMS, EQUIPMENT, INSTRUMENTS, REAGENT CFR(s): 493.1252(b) (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: (b)(1) Water quality. (b)(2) Temperature. (b)(3) Humidity. (b)(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 documentation and interview with the Clinical Coordinator (CC), the laboratory failed to monitor and document room humidity to ensure operating conditions were met for 1 of 1 Leica DM1000 microscope used to perform mycology and parasitology slide examinations and 2 of 2 Avantik cryostat (QS11/ QS12) for histopathology (Mohs) microscopic slide from 02/15/2025 to the day of survey. Findings include: 1. The manufacturer's operating environment specifications for Lecia DM1000 microscope are 5-35 degrees Celsius (ambient temperature) and maximum 80% relative humidity and for the Advantik cryostat are 5-35 degrees Celsius (ambient temperature) and maximum 60% relative humidity. 2. On the day of the survey, 09/11/2025, the laboratory failed to provide documentation of the monitoring of room humidity to ensure operating conditions were met to perform microbiology and histopathology ( Mohs) microscopic examinations from 02/15/2024 to 09/11/2025 for the following instruments: - 1 of 1 Lecia DM1000 microscope - 2 of 2 Avantik cryostat (QS11/QS12) 3. The laboratory performed 266 microbiology and 1075 histopathology slide examinations in 2024 (CMS 116, estimated annual volume, dated 09/10/2025). 4. The CC confirmed the above findings on 09/11/2025 at 09: 30am. 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 -- D5805 TEST REPORT CFR(s): 493.1291(c) (c) The test report must indicate the following: (c)(1) For positive patient identification, either the patient's name and identification number, or a unique patient identifier and identification number. (c)(2) The name and address of the laboratory location where the test was performed. (c)(3) The test report date. (c)(4) The test performed. (c)(5) Specimen source, when appropriate. (c)(6) The test result and, if applicable, the units of measurement or interpretation, or both. (c)(7) Any information regarding the condition and disposition of specimens that do not meet the laboratory's criteria for acceptability. This STANDARD is not met as evidenced by: Based on review of patient test reports (Preoperative notes and Mohs Maps) and interview with the Clinical Coordinator (CC) and Histotech (HT), the laboratory failed to include the address of the location where MOHS microscopic slide examinations (histopathology) were performed on 2 of 2 patient test reports reviewed from 02/15 /2024 to the date of the survey. Findings include: 1. On 09/11/2025 at 09:45 am, review of 2 of 2 patient test reports (Preoperative notes and Mohs maps) revealed the laboratory failed to ensure the addition of the address of the laboratory where MOHS microscopic slides were examined from 02/15/2024 until 09/11/2025. 2. The laboratory performed 1075 microscopic slide examinations (histopathology) in 2024 (CMS 116, estimated annual volume, dated 09/10/2025). 3. The CC and HT confirmed the above findings on 09/11/2025 at 09:45 am. -- 2 of 2 --

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 lack of documentation and interview with the Clinical Coordinator, the laboratory failed to establish a written policy to assess the competency of 3 of 4 clinical consultants (CC) and 7 of 9 Testing Personnel (TP) for their responsibilities in 2022 and 2023. Findings Include: 1.On the day of the survey, 02/15/2024 at 10:17 am, the laboratory could not provide a competency assessment policy to assess the competency of the following personnel for 2022 and 2023: - 3 of 4 CC (CMS 209 personnel #2, #3, #4) for their supervisory responsibilities. - 7 of 9 TP (CMS 209 personnel #2, #3, #4, #5, #6, #7, #8) who performed potassium hydroxide (KOH), Dermatophyte screen and Scabies microscopic examinations. 2. The Clinical Coordinator confirmed the findings above on 02/15/2024 at 11:18 am. *Repeat deficiency 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 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 -- 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)

Summary Statement of Deficiencies D3037 RETENTION REQUIREMENTS CFR(s): 493.1105(a)(4) Proficiency testing records. Retain all proficiency testing records for at least 2 years. This STANDARD is not met as evidenced by: Based on the lack of the American Proficiency Institute (API) proficiency testing (PT) records for Mycology and interview with the Clinical Coordinator, the Laboratory failed to provide 4 of 6 API PT attestation statement documents from 2020 and 2021. Findings include: 1. On the day of survey, 1/6/2022 at 11:50 a.m., the Clinical Coordinator could not provide the the following: - 2020: Attestation statement: Event #1 and Event #3. - 2021: Attestation statement: Event #2 and Event #3. 2. The Clinical Coordinator confirmed the finding above on 1/6/2022 at 12:00 p.m. 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 review of the laboratory's procedures and interview with Clinical Coordinator, the laboratory failed to have a policy to assess the competency of 3 of 4 laboratory personnel who performed the Clinical Consultant (CC) roles and 5 of 6 Testing Personnel (TP) who performed potassium hydroxide (KOH), Dermatophyte Screen, and Scabies from 01/06/2020 to the date of survey. Findings include: 1. On the day of survey, 01/06/2022 at 10:20 a.m., the Clinical Coordinator could not provide a competency assessment policy to assess the competency of the following 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 -- personnel from 01/06/2020 to the date of survey: - 3 of 4 CC (on CMS 209, listed as personnel #2 , #3 and #4) - 5 of 6 TP (on CMS 209, listed as personnel #2, #3, #4, #5, and #6) 2. The laboratory could not provide competency assements for 3 of 4 CC. 3. The laboratory could not provide separate competency assesments for each analyte for 5 of 6 TP who performed KOH, Dermatophyte Screen, and Scabies for 2020 and 2021 . 4. The Clinical Coordinator confirmed the findings above on 01/06/2022 around 12: 00 p.m. 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. This STANDARD is not met as evidenced by: Based on observation of the laboratory and interview with Clinical Coordinator, the laboratory failed to calibrate 1 of 1 room temperature thermometer where Dermatophyte Test Medium (DTM) is incubated and 1 of 1 digital Thermofisher refrigerator thermometer where DTM is store from 01/06/2020 to the day of survey. Findings include: 1. On the day of survey, 01/06/2022 at 12:00 p.m., while touring the laboratory the surveyor observed the following thermometers were due for calibration: - 1 of 1 Fisher Scientific Traceable refrigerator thermometer was due for calibration on December 04, 2017. - 1 of 1 Big digit Hyro-thermometer Extech instrument for room temperature thermometer was not calibrated from 01/06/2020 to the day of survey. 2. The Clinical Coordinator confirmed the findings above on 01/06/2022 at 12: 30 pm 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 lack of quality control records and interview with the clinical coordinator, the laboratory failed to check and document each batch or shipment of Acuderm Inc. Acu (DTM) media for sterility, its ability to support growth, select or inhibit specific organisms or produce a biochemical response, from 01/06/2020 to the date of survey. Findings Include: 1. On the day of survey, 01/06/2022, the laboratory could not provide end user QC performed on the Acuderm Inc. Acu (DTM) media for sterility, its ability to support growth, select or inhibit specific organisms or produce a biochemical response from 1/06/2020 to 01/06/2022. 2. In 2020: 35 DTM tests were examined. 3. In 2021: 79 DTM tests were examined. 4. The clinical coordinator confirmed the finding above on 01/06/2022 around 12:30 pm. -- 2 of 2 --