Lackawanna Valley Dermatology Assoc

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, the laboratory failed to monitor and document room temperature and humidity to ensure operating conditions were met for 1 of 1 McKesson Lumeon series microscope used to perform mycology and parasitology microscopic slide examinations from 11/13 /2023 to the day of survey. Findings include: 1. The manufacturer's operating environment specifications for the McKesson Lumeon series microscope are 5-35 degrees Celsius (ambient temperature) and maximum 80% relative humidity. 2. On the day of the survey, 04/07/2025, the laboratory failed to provide documentation of the monitoring of room temperature and humidity to ensure operating conditions were met for the 1 of 1 McKesson Lumeon series microscope (s/n 20200090) used to perform DTM fungal cultures (dermatophyte screening), potassium hydroxide (KOH) and ectoparasite (scabies) microscopic examinations from 11/13/2023 to 04/07/2025. 3. The laboratory performed 71 dermatophyte screenings, 234 KOH and 79 scabies microscopic examinations from 11/13/2023 to 04/07/2025. 4. The Clinical Coordinator confirmed the above findings on 04/07/2025 at 1:26 pm. 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 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 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 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 competency assessment records and interview with the medical assistant/ clinical coordinator and testing personnel (TP) #9, the laboratory failed to establish a complete competency assessment procedure to assess the competency of TP at 6 months and 12 months during the first year of employment and perform competency assessment on TP analyzing Mohs microscopic examinations from 2019 to the day of survey. Findings Include: 1. On the day of survey, 10/20/2021, the laboratory could not provide a written procedure that states to assess TP for competency at 6 months and 12 months during the first year of employment. 2. The laboratory could not provide the following records. - TP #5 - Potassium hydroxide (KOH) and Scabies 6 month and 12 month competency. - TP #8 - KOH and Scabies 6 month and 12 month competency. - TP #4 - Mohs competency annual competency for 2019, 2020 and 2021. - TP #9 - Mohs competency annual competency for 2019, 2020 and 2021. 3. The medical assistant/ clinical coordinator and TP #9 confirmed the findings above on 10/20/2021 around 10:00 am. 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. Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 4 -- This STANDARD is not met as evidenced by: Based on review of peer review records and interview with the medical assistant/ clinical coordinator and testing personnel (TP) #9, the laboratory failed to ensure 1 of 2 high complexity TP performed verification of accuracy for Mohs microscopic examinations in 2020. Findings Include: 1. On the day of survey, 10/20/2021, the laboratory could not provide verification of accuracy or peer review records for 1 of 2 high complexity TP (TP #2) for Mohs microscopic examinations performed in 2020. 2. The medical assistant/ clinical coordinator and TP #9 confirmed the finding above on 10/20/2021 around 12:00 pm. D5449 CONTROL PROCEDURES CFR(s): 493.1256(d)(3)(ii)(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-- At least once a day patient specimens are assayed or examined perform the following for-- Each qualitative procedure, include a negative and positive control material; (g) The laboratory must document all control procedures performed. This STANDARD is not met as evidenced by: Based on review of quality control records and interview with Medical Assistant/ Clinical Coordinator and testing personnel (TP) #9, the laboratory failed to perform document quality control (QC) each day of patient testing for potassium hydroxide (KOH) and Scabies microscopic examinations analyzed in 2019, 2020 and 2021. Findings include: 1. On the day of survey, 10/20/2021, review of KOH and scabies QC records revealed, each physician analyzing KOH and scabies microscopic examination were not documenting QC each day of patient testing on the following days: - 2019: 10/31. - 2020: 1/23, 6/12, 7/21, 10/27 and 10/28. - 2021: 1/21, 1/28, 3 /16, 3/22, 5/10, 5/13, 5/26, 6/14, 6/24, and 6/30. 2. The Medical Assistant/ Clinical Coordinator and TP #9 confirmed the findings above on 10/20/2021 around 09:40 am. *** Repeat deficiency from 3/19/2019 inspection. D5473 CONTROL PROCEDURES CFR(s): 493.1256(e)(2)(g) (e) For reagent, media, and supply checks, the laboratory must do the following: (e) (2) Each day of use (unless otherwise specified in this subpart), test staining materials for intended reactivity to ensure predictable staining characteristics. Control materials for both positive and negative reactivity must be included, as appropriate. (g) The laboratory must document all control procedures performed. This STANDARD is not met as evidenced by: Based on review of Hematoxylin and Eosin (H&E) quality control (QC) records and interview with the medical assistant/ clinical coordinator and testing personnel (TP) #9, the laboratory failed to document H&E QC stain acceptability each day of patient testing for Mohs micrographic examinations from 10/20/2019 to the day of survey. Findings include: 1. On the day of survey, 10/20/2021, review of the H&E stain QC log revealed, daily H&E QC records did not state if QC intended reactivity was acceptable and QC was not performed and documented by the physician analyzing the Mohs microscopic examination from 10/20/2019 to 10/20/2021. 2. The medical -- 2 of 4 -- assistant/ clinical coordinator and TP #9 confirmed the finding above on 10/20/2021 around 11:35 am. 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 medical assistant/ clinical coordinator and testing personnel (TP) #9, 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 2019 to the date of survey. Findings Include: 1. On the day of survey, 10/20/2021, 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 10/20 /2019 to 10/20/2021. 2. In 2019 (10/20/2021 to 12/31/2021): 45 DTM tests were examined. 3. In 2020: 192 DTM tests were examined. 4. In 2021 (01/01/2021 to 10/20 /2021): 146 DTM tests were examined. 5. The medical assistant/ clinical coordinator and TP #9 confirmed the finding above on 10/20/2021 around 10:45 am. D6018 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(e)(4)(iii) 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, and record and report test results promptly, accurate, and proficiently and for assuring compliance with the applicable regulations. (e) The laboratory director must-- (e)(4)(iii) Ensure that all proficiency testing reports received are reviewed by the appropriate staff to evaluate the laboratory's performance and to identify any problems that require

Summary Statement of Deficiencies 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 review of Mohs proficiency testing procedure, review of Mohs proficiency records and interview with the Clinical coordinator and Testing personnel (TP) #10, the laboratory failed perform at least twice annually the accuracy for Mohs slide reading from 08/24/2017 to the date of survey. Findings Include: 1. The laboratory's Proficiency Testing Procedure states "every 6 months, there will be 5 random cases pulled and reviewed..). 2. On the day of survey, 03/19/2019, review of Mohs peer review records revealed, the laboratory did not perform Mohs proficiency at least twice annually in 2017, 2018 and 2019. 3. TP # 10 confirmed the findings above on 03 /19/2019 around 11:15 am. D5293 GENERAL LABORATORY SYSTEMS QUALITY ASSESSMENT CFR(s): 493.1239(b)(c) (b) The general laboratory systems quality assessment must include a review of the effectiveness of