Jackson Clinic Pa, The

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 laboratory observation, a review of the laboratory procedure manual, testing personnel records, patient test records, and staff interview, the laboratory failed to have a procedure for training and competency assessment for personnel who performed provider microscopy (PPMP) testing in 2025 and 2026. The findings include: 1. Laboratory observation of the general dermatology area on 09/02/26 at approximately 8:10 a.m. revealed a microscope used for provider-performed patient testing for fungal elements and scabies. 2. A review of the procedure manual for the PPMP procedures revealed no policy for personnel training and competency assessment. 3. A review of the PPMP testing personnel (TP) records revealed the following: 2025 annual competency assessment was not performed for PPMP TP2 or PPMP TP3. PPMP TP1 did not have documentation of training on the laboratory's procedures for performing potassium hydroxide fungal examination or scabies examination, or an initial demonstration of accuracy prior to patient testing. Competency assessments performed in August 2026 for PPMP TP1 and PPMP TP3 did not include direct observation of patient testing, monitoring the recording and reporting of test results, or review of intermediate test results or worksheets, quality control (QC) records, and proficiency testing (PT) results. The annual competency assessment performed in March 2026 for PPMP TP2 did not include direct observation of patient testing, monitoring the recording and reporting of test results, or review of intermediate test results or worksheets, quality control (QC) records, and proficiency testing (PT) results, or evaluation of problem-solving skills. 4. A review of patient test records revealed the first patient was reported by PPMP TP1 on 09/03 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 -- /25 (patient PPMP 1), with a total of approximately 40 patients reported by PPMP TP1 before the first competency assessment was performed on 08/31/26. 5. Technical consultant one confirmed the survey findings during an interview on 09/02/26 at approximately 12:30 p.m. D5417 TEST SYSTEMS, EQUIPMENT, INSTRUMENTS, REAGENT CFR(s): 493.1252(d) (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 laboratory observation, a review of the laboratory's histology reagent log, the Mohs surgical accession log, and staff interview, the laboratory failed to ensure that stains were not used past their expiration dates in 2025 and 2026, with approximately 203 patient tissues processed using expired stains. The findings include: 1. Laboratory observation on 09/02/26 at approximately 8:20 a.m. revealed equipment and stains used for processing tissue removed during Mohs surgical procedures. During observation, processing personnel stated that toluidine blue was used to stain tissue positive for basal cell carcinoma, and hematoxylin and eosin were used to stain tissue positive for squamous cell carcinoma. 2. A review of the laboratory's reagent log revealed the following: Toluidine blue, lot number 226307, expiration date of 09/25/25, opened on 09/10/25, and used until 01/28/26. Hematoxylin, lot number 195241, expiration date 10/31/25, opened on 09/10/25 and used until 01/28/26. Eosin, lot number 195251, expiration date 10/31/25, opened on 09 /10/25, and used until 01/28/26. 3. A review of the Mohs accessioning log revealed the following: Approximately 126 Mohs surgical tissues positive for basal cell carcinoma were stained with expired toluidine blue between 09/26/25 and 01/28/26. Approximately 77 Mohs surgical tissues positive for squamous cell carcinoma were stained with expired hematoxylin and eosin between 11/01/25 and 01/28/26. 4. The laboratory director confirmed the survey findings during an interview on 09/02/26 at approximately 12:15 p.m. -- 2 of 2 --

Summary Statement of Deficiencies D5291 GENERAL LABORATORY SYSTEMS QUALITY ASSESSMENT CFR(s): 493.1239(a) The laboratory must establish and follow written policies and procedures for an ongoing mechanism to monitor, assess, and, when indicated, correct problems identified in the general laboratory systems requirements specified at 493.1231 through 493.1236. This STANDARD is not met as evidenced by: Based on review of the laboratory procedure manual, review of the laboratory's alternative proficiency testing (PT) assessment records, and staff interview, the laboratory failed to follow the quality assessment policy for laboratory director review and evaluation of alternative proficiency testing results for three of three events reviewed from 2023 and 2024. The findings include: 1. A review of the laboratory procedure manual, under the section for Proficiency Testing, revealed the following statements: "Purpose. To evaluate the diagnostic abilities of the Mohs surgeon and the quality of the slides produced by the histotechnologist." "The results of proficiency testing are reviewed by the Laboratory Director. Any errors encountered will be addressed to determine any pre-analytical, analytical or post-analytical errors that may be contributing." 2. A review of the laboratory's alternative PT records showed that the laboratory director did not document review and evaluation of the alternative PT assessment for the following PT periods: 04/01/23 through 06/30/23, 07/01/23 through 12/31/23, and 01/01/24 through 06/30/24. 3. The laboratory director confirmed the survey findings during an interview on 07/29/24 at 11:15 a.m. 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 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 -- 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 observation of the chemical storage area, review of the manufacturer instructions for use, lack of documentation, and staff interview, the laboratory failed to monitor the temperature of the area where chemicals were stored in 2023 and 2024. The findings include: 1. The surveyor observed the area where tissue processing chemicals and stains were stored on 07/29/24 at 8:15 a.m. Chemicals and stains observed were 100% Reagent Alcohol, Xylene substitute, Vintage Bluing, 95% Plus Alcohol, Eosin-Y vintage, Hematoxylin Vintage, and Toluidine Blue Stain. A thermometer was noted during in the storage area. 2. A review of the instructions for the Xylene Substitute, 100% Alcohol and 95% Alcohol revealed the following statements: 'Storage: Store in a dry, cool, and well-ventilated place. Keep container closed when not in use. Store locked up. Keep/store away from direct sunlight, extremely high or low temperatures, and incompatible materials." 3. The laboratory did not document temperatures for the chemical/stain storage area. 4. During an interview on 07/29/24 at 8:15 a.m., the lead histotech stated that she checked the temperatures in the storage area, but did not document the temperature readings. This confirmed the survey findings. -- 2 of 2 --

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 observation of the laboratory, review of patient records, document request and staff interview, the laboratory failed to verify the accuracy of its' histopathology procedures twice a year in 2022 and 2023 with approximately 200 patient Mohs cases performed since testing began on 10/10/22. The findings include: 1. Observation of the laboratory on 02/13/23 at 8:30 am revealed equipment and stains in use for preparing tissue removed during Mohs surgery for histopathology procedures. 2. Review of patient records revealed the first Mohs case was performed on 10/10/22 (Patient case number JC22-001), with approximately 200 patient Mohs cases performed since testing began. 3. Request on 02/13/23 at 11am for verification of accuracy records for the laboratory's histopathology procedures revealed no records were available from 2022 or 2023. 4. Interview with the lab director on 02/13/23 at 12: 15 pm confirmed the laboratory failed to verify the accuracy of its' histopathology procedures twice a year in 2022 and 2023 with the first patient tested on 10/10/22. D5391 PREANALYTIC SYSTEMS QUALITY ASSESSMENT CFR(s): 493.1249(a) The laboratory must establish and follow written policies and procedures for an ongoing mechanism to monitor, assess, and when indicated, correct problems identified in the preanalytic systems specified at 493.1241 through 493.1242. 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 4 -- Based on review of the laboratory procedure manual, the Mohs procedure manual, patient Mohs cases, document request, and staff interview the laboratory failed to follow its' own policy for monitoring of preanalytic systems in 2022 and 2023. The findings include: 1. Review of the laboratory procedure manual in section D. Laboratory Systems Quality Assessment revealed the following statement: "Purpose: To monitor, assess, and when indicated, correct problems identified in the preanalytic, analytic and post-analytic systems." 2. Review of the laboratory Mohs procedure manual revealed the following: Surgical case number: "The next available case number in the logbook is assigned to that patient. Numbers are assigned as such "JC" followed by the 2-digit year, followed by the serially numbered accession number for that patient. Numbers re-set each calendar year at 0001." The accession number is noted on chuck pad, on Tefla pad, on each frozen section slide, each patient photo and in the Mohs case log book. "Correct identification of test specimens throughout the entire Mohs surgical procedure is of utmost importance and must be the primary focus of the Mohs histotechnologist." Slide labeling: Line 1-surgery accession/case# and lesion designation number Line 2-patient last name, first name (first slide of each patient) then initials on each slide thereafter Lower right corner-stage #/tissue piece # 3. Review of random patient cases revealed that the labeling system was not followed for four of four patients: JC22-001 (1st patient performed 10/10/22)-1st slide did not include first name. The Mohs accessioning log did include complete labeling to include the "JC" designation or the year. JC22-100 (performed 12/12/22)-1st slide did not include first name. The Mohs accessioning log did include complete labeling to include the "JC" designation or the year. JC23-032 (performed 01/19/23)-1st slide did not include first name. The Mohs accessioning log did include complete labeling to include the "JC" designation or the year. JC23-074 (performed 02/09/23)-1 slide did not include first name. The Mohs accessioning log did include complete labeling to include the "JC" designation or the year. Further review of the accessioning log revealed the laboratory's procedure for accessioning had not been followed since the first patient case performed on 10/10/22 until the date of the survey on 02/13/23. 4. Request on 02/13/23 at 11:00 am for quality assessment documentation and