Dermatology Associates Lancaster Ltd

Summary Statement of Deficiencies 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 review of the laboratory's procedure manual, lack of documentation, and interviews with the Mohs Laboratory Technologist (LT) and laboratory director (LD), the laboratory failed to ensure a written procedure was available for microscopic histopathology slide examinations performed from 02/17/2023 to the date of the survey.. Findings Include: 1. On the date of survey, 11/12/2024, the laboratory failed to provide a written procedure for microscopic histopathology slide examinations performed from 01/17/2023 to 11/12/2024. 2. The LD and LT confirmed the finding above on 11/12/2024 at 1:00 pm D5413 TEST SYSTEMS, EQUIPMENT, INSTRUMENTS, REAGENT 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. Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 3 -- This STANDARD is not met as evidenced by: Based on record review and interview with the Mohs Laboratory Technologist (LT), the laboratory failed to document the internal cryostat temperature to ensure operating conditions were met for 1 of 1 Leica 1510S Cryostat used to perform MOHS micrographic slide examinations from March 2024 to September 2024. Findings include: 1. On the day of survey, 11/12/2024 at 11:00 am, review of the laboratory temperature logs revealed the laboratory failed to document the internal cryostat temperature of 1 of 1 Leica 1510S cryostat for the following days when MOHS micrographic slide examinations were performed to ensure operating conditions were met: - 03/28/2024 - 09/19/2024 2. The laboratory's Daily Routine procedure stated, "2. Check cryostat temperature and document." 3. The LT confirmed the findings above on 11/12/2024 at 11:00 am. 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 laboratory records and interview with the Mohs Laboratory Technologist (LT), the laboratory failed to document the positive and negative control each day of patient testing for KOH and Mineral Oil (Scabies) examinations performed from January 2024 until day of survey. Findings include: 1. The laboratory Quality Control (QC) Program policy states," Each day that this procedure is performed, a positive and a negative control sample will be analyzed in exactly the same manner as patient samples. The results obtained with control materials will be recorded on a sheet that contains the following information: name of procedure, description and source of positive control, results expected for the positive control, description and source of negative control, results expected for the negative control, date of test, an identifier such as initials indicating who performed the test, results obtained with the positive control, and results obtained with the negative control." 2. On day of survey 11/12/2024 at 9:30 am review of the laboratory's Prep logs for Scabies and KOH revealed the laboratory failed to document a positive and negative control each day of patient testing for the following days from January 2024 to the date of the survey: - 2 out of 17 days KOH examinations were performed: - 04/05 /2024 - 05/20/2024 -1 out of 17 days Mineral Oil (Scabies) examinations were performed: - 06/05/2024 3. The LT confirmed the findings above on 11/05/2024 at 9: 50 am D5601 HISTOPATHOLOGY CFR(s): 493.1273(a)(f) (a) As specified in 493.1256(e)(3), fluorescent and immunohistochemical stains must be checked for positive and negative reactivity each time of use. For all other differential or special stains, a control slide of known reactivity must be stained with each patient slide or group of patient slides. Reactions of the control slide with each special stain must be documented. (f) The laboratory must document all control procedures performed, as specified in this section. -- 2 of 3 -- This STANDARD is not met as evidenced by: Based on review of quality control (QC) records, lack of documentation, and interviews with the Mohs Laboratory Technologist (LT) and Laboratory Director (LD), the laboratory failed to document all control procedures performed for microscopic histopathology examinations from 02/16/2023 to 11/12/2024. Findings include: 1. On the day of survey 11/12/2024 at 11:00 am, the laboratory failed to provide documentation for positive and negative reactivity each time of use for the following 36 of 36 immunohistochemical stains (IHC) used for microscopic histopathology examinations performed from 02/2023 to 11/2024: CD3 CD4 CD8 CD20 CD30 HMB45 CD31 CD34 CD45 CD66 CD138 CEA(Monoclonal) EMA Adipophilin BerEP-4 FLI-1 P16 Smooth Muscle Actin Synaptophysin PMS-2 Melan- A Prame S-100 Sox-10 CK 5/6 CK7 CK 20 ErG Factor XIIIA Kappa Lambda MLH-1 MSH-2 MSH-6 HHV-8 PanKeratin (AE1/AE2) 2. Further review of laboratory's QC records revealed the laboratory failed to document the date and testing personnel that reviewed QC slides for IHC and special stains performed on histopathology specimens from 02/16/2023 to 11/12/2024. 3. The LT and LD confirmed the findings above on 11/12/2024 at 1:00 pm D6051 TECHNICAL CONSULTANT RESPONSIBILITIES CFR(s): 493.1413(b)(8)(v) The procedures for evaluation of the competency of the staff must include, but are not limited to assessment of test performance through testing previously analyzed specimens, internal blind testing samples or external proficiency testing samples. This STANDARD is not met as evidenced by: Based on review of the laboratory's proficiency testing and competency records, and interview with the Mohs Laboratory Technologist (LT), the Technical Supervisor (TS) failed to evaluate assessment of test performance through testing previously analyzed specimens, internal blind testing samples, or external proficiency testing samples for laboratory testing personnel (TP) who performed potassium hydroxide (KOH) and scabies examinations in 2023. Finding include: 1. On day of the survey, 11 /12/2024 at 9:25 am, review of competency assessments revealed the TS failed to evaluate assessment of test performance through testing previously analyzed specimens, internal blind testing samples, or external proficiency testing samples for the following TP that performed KOH and scabies examinations in 2023: - 3 of 11 TP (CMS 209 TP #4, #7, and #8) that performed Scabies examinations in 2023 - 1 of 11 TP (CMS 209 TP #3) that performed KOH examinations in 2023 2. The LT confirmed the findings above on 11/12/2024 at 10:30 am. -- 3 of 3 --

Summary Statement of Deficiencies D5601 HISTOPATHOLOGY CFR(s): 493.1273(a)(f) (a) As specified in 493.1256(e)(3), fluorescent and immunohistochemical stains must be checked for positive and negative reactivity each time of use. For all other differential or special stains, a control slide of known reactivity must be stained with each patient slide or group of patient slides. Reactions of the control slide with each special stain must be documented. (f) The laboratory must document all control procedures performed, as specified in this section. This STANDARD is not met as evidenced by: Based on review of quality control (QC) records and interview with the Mohs Laboratory Technologist (LT), the laboratory did not document Hematoxylin and Eosin (H & E) stain QC monitoring activities for intended reactivity and review of QC documents by the pathologist every day of patient testing from 02/10/2021 to the day of survey. Findings include: 1. On the day of survey 02/15/2023 at 09:50 a.m., the laboratory could not provide QC documentation for staining characteristics for the H&E stain performed and review of QC documents by the pathologist every day of patient testing from 02/10/2021 to 02/15/2023. 2. The LT confirmed the finding above on 02/15/2023 around 10:30 am. D6120 TECHNICAL SUPERVISOR RESPONSIBILITIES CFR(s): 493.1451(b)(7)(8) (7) The technical supervisor is responsible for identifying training needs and assuring that each individual performing tests receives regular in-service training and education appropriate for the type and complexity of the laboratory services performed; (8) Evaluating the competency of all testing personnel and assuring that the staff maintain their competency to perform test procedures and report test results promptly, accurately and proficiently. 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 review of the laboratory competency assessment records and interview with the Mohs Laboratory Technologist (LT), the laboratory failed to assess the competency of 1 of 2 testing personnel (TP) who performed the Mohs microscopic examinations from 02/10/2021 to the day of survey. Findings include: 1. On the day of survey, 02/15/2023 at 08:41 am, the laboratory could not provide the annual competency assessment documentation for 2021 and 2022 for TP#2 (CMS 209 TP#2) who performed the Mohs microscopic examinations. 2. The LT confirmed the finding above on 02/15/2023 around 10:30 am. D6125 TECHNICAL SUPERVISOR RESPONSIBILITIES CFR(s): 493.1451(b)(8)(v) The procedures for evaluation of the competency of the staff must include, but are not limited to assessment of test performance through testing previously analyzed specimens, internal blind testing samples or external proficiency testing samples. This STANDARD is not met as evidenced by: Based on review of the proficiency testing records and interview with the Mohs Laboratory Technologist (LT), the Technical Supervisor (TS) failed to assess test performance examination through testing previously analyzed specimens or internal blind testing samples for 1 of 1 TP (CMS 209 TP#10) performing grossing examinations from 02/10/2021 to the day of survey. Findings include: 1. On the day of survey, 02/15/2023 at 09:25 am, the laboratory could not provide the documentation to assess test performance examination through testing previously analyzed specimens or internal blind testing samples for 2021 and 2022 for TP#10 (CMS 209 TP#10) who performed the grossing examinations. 2. The LT confirmed the finding above on 02/15/2023 around 10:30 am. -- 2 of 2 --

Summary Statement of Deficiencies D5409 PROCEDURE MANUAL CFR(s): 493.1251(e) The laboratory must maintain a copy of each procedure with the dates of initial use and discontinuance as described in 493.1105(a)(2). This STANDARD is not met as evidenced by: Based on review of laboratory competency policy, personnel competency assessment records and interview with the Laboratory Director (LD), Compliance Officer (CO) and Testing personnel (TP) #10, the laboratory failed to follow their written competency assessment policy to assess testing personnel and consultant yearly competency assessment for 2 of 10 TP in 2017. Findings Include: 1. Point #3 of the Laboratory's Competency Policy states, "Competency will be asses 6 months after initial competency then one year there after" and point # 4 states, "Supervisory performance will also assess for Technical consultant and general supervisory as part of competency. 2. On the day of survey, 08/30/2018, while reviewing personnel competency assessment records, it was discovered that the TP # 10 (Mohs grossing technologist) competency was not assessed and TP# 2 (on CLIA 209 hold positions of, Clinical Consultant, Technical consultant, and general supervisor) was not assessed for their regulatory responsibilities in 2017. 3. The LD and CO confirmed the findings above on 8/30/2018 around 9:45 am. D5415 TEST SYSTEMS, EQUIPMENT, INSTRUMENTS, REAGENT CFR(s): 493.1252(c) Reagents, solutions, culture media, control materials, calibration materials, and other supplies, as appropriate, must be labeled to indicate the following: (1) Identity and when significant, titer, strength or concentration. (2) Storage requirements. (3) Preparation and expiration dates. (4) Other pertinent information required for proper use. 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 tour of the MOHS laboratory, observation of Tissue Marking Dye bottles, interview with the Laboratory Director (LD), Compliance Officer (CO) and Testing Personnel #10, the laboratory failed to label 5 of 5 bottles and aliquots of Davidson Tissue Marking Dyes with open and expiration dates. Findings Include: 1. On the day of survey, 08/30/2018, while on tour of the MOHS laboratory, it was discovered that the laboratory does not write the open and expiration date of Davidson Tissue Marking Dyes in use. 5 of 5 bottles were found on site. 4. The LD and CO confirmed the findings above on 08/30/2018 around 10:00 am. -- 2 of 2 --