Mid-South Dermatology, 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 review of the laboratory procedure manual, testing personnel competency assessments, lack of documentation and staff interview, the laboratory failed to have a competency assessment procedure that included all six criteria as required in subpart M, and failed to follow the established policy when competency assessment was not performed for Mohs surgeon number two in 2022, 2023 or 2023. The findings include: 1. Review of the laboratory's quality assessment policy for testing personnel competency assessment revealed the following statement: "If the laboratory has employees, the Laboratory Director will use personal observation to perform an ongoing evaluation of all employees of the laboratory to ensure competence in job performance." The policy did not include all six elements as required in Subpart M. The six required elements are: direct observation of routine patient test performance; monitoring the recording and reporting of test results; review of intermediate test results or worksheets, quality control records, proficiency testing results and preventative maintenance records; direct observation of performance of instrument maintenance and function checks; assessment of test performance through previously analyzed specimens, internal blind testing samples or external proficiency testing samples; and assessment of problem-solving skills. 2. Review of the 2022, 2023 and 2024 competency assessments performed for the tissue grosser revealed the competencies were performed without including all six required elements. 3. No documented competency was performed for Mohs surgeon #2 in 2022, 2023 or 2024. 4. During interview on 02/22/24 at 11:50 am, the office manager confirmed the survey 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 4 -- D5221 EVALUATION OF PROFICIENCY TESTING PERFORMANCE CFR(s): 493.1236(d) All proficiency testing evaluation and verification activities must be documented. This STANDARD is not met as evidenced by: Based on review of the laboratory's verification of accuracy documents and staff interview, the laboratory failed to document review of the twice-a-year verification of accuracy performed in 2022, 2023, and 2024. The findings include: 1. Review of the laboratory's twice-a-year verification of accuracy, performed by split case review with an outside laboratory, revealed no documented review of the findings. Dates of performance were 12/23/22, 6/20/23, and 12/20/23. 2. Interview on 02/22/24 at 11:50 am with the office manager confirmed there was no documented review of the verification of accuracy performed in 2022, 2023 and 2024. D5311 SPECIMEN SUBMISSION, HANDLING, AND REFERRAL CFR(s): 493.1242(a) The laboratory must establish and follow written policies and procedures for each of the following, if applicable: (1) Patient preparation. (2) Specimen collection. (3) Specimen labeling, including patient name or unique patient identifier and, when appropriate, specimen source. (4) Specimen storage and preservation. (5) Conditions for specimen transportation. (6) Specimen processing. (7) Specimen acceptability and rejection. (8) Specimen referral. This STANDARD is not met as evidenced by: Based on review of the laboratory procedure manual, Mohs surgical case slides, and staff interview, the laboratory failed to follow the policy for labeling of slides for three of three cases (eight of eight slides) reviewed from 2022, 2023, and 2024. 1. Review of the laboratory policy for labeling patient histopathology slides revealed the labeling would include patient name, chart number, site location, the date done, and "label slides with numbers (1. 2, 3, etc.)." 2. Review of slides for Mohs cases revealed slides for three of three cases (eight of eight slides) were not labeled according to laboratory policy (patient chart #50923-performed on 10/10/22, patient chart number #76858-performed on 08/17/23, and patient chart #314801-performed on 01/29/24). The slides were missing the patient chart numbers. 3. During interview on 02/22/24 at 11:50 am, the office manager confirmed the survey findings. 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. This STANDARD is not met as evidenced by: -- 2 of 4 -- Based on observation of the laboratory areas, the laboratory's environmental records, and staff interview, the laboratory failed to define acceptable ranges for room temperature and humidity in the technical component laboratory and Mohs laboratory in 2022, 2023, and 2024. The findings include: 1. Observation of the laboratory areas on 02/22/24 at 8:30 am revealed the following equipment used for processing dermatology tissue in preparation for microscopic examination: a. In the technical component laboratory-ThermoScientific Shandon Linistain automated stainer, Thermo Scientific Excelsior tissue processor, Thermo Scientific Shandon Histocentre 3 tissue embedding station, Pemiere Lighted Tissue Bath, Thermo Scientific Microm HM355S. b. In the Mohs laboratory - QS 12 Advantik Croystat, Thermo Shandon Cryostat, and Thermo Shandon Linistat stainer. 2. The laboratory's environmental records for 2022, 2023, and 2024 for the technical component laboratory and the Mohs laboratory did not define acceptable ranges for either room temperature or room humidity. 3. During an interview on 02/22/24 at 11:50 am, the office manager confirmed the laboratory failed to define acceptable ranges for room temperature and humidity in the technical component laboratory and the Mohs laboratory in 2022, 2023, and 2024. D5417 TEST SYSTEMS, EQUIPMENT, INSTRUMENTS, REAGENT CFR(s): 493.1252(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 observation of the laboratory and staff interview, the laboratory failed to ensure marking dyes and eosin stain used for inking and staining tissue had not expired on the date of the survey (02/22/24). The findings include: 1. Observation of the laboratory areas on 02/22/24 at 8:30 am revealed equipment, reagents, stains, and dyes used for performing grossing, inking, staining, and processing of tissue to prepare slides for diagnostic interpretation. In the technical component laboratory area expired marking dyes were observed: orange marking dye (Lot 1142550) expired on 01/31/23, and green marking dye (Lot 114352) expired on 12/31/22. In the Mohs laboratory area, the following expired reagents/stains were observed: the eosin stain expired on 01/15/23 (Lot 2101123), the green marking dye expired on 09/30/23 (Lot 131529), the orange marking dye expired on 08/31/23(Lot 128166). 2. The office manager confirmed the survey findings during interview on 02/22/24 at 11:50 am. 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 observation of the laboratory, lack of records, review of Mohs surgical cases, lack of documentation, and staff interview, the laboratory failed to retain -- 3 of 4 -- records of reagent/stain lot numbers used and failed to document hematoxylin and eosin stain quality in 2022, 2023, and 2024. The findings include: 1. Observation of the Mohs laboratory area on 02/22/24 at 8:30 am revealed equipment and reagents used in preparing tissue removed during Mohs surgical procedure for microscopic analysis, including hematoxylin and eosin stains. 2. No records of the reagent and stain lot numbers used in 2022, 2023, and 2024, dates put into use, or stain quality assessment when reagent lots changed were available on the date of the survey. 3. Review of Mohs surgical cases revealed no documentation of the daily hematoxylin and eosin stain quality for three of three dates selected (patient chart #50923- performed on 10/10/22, patient chart number #76858-performed on 08/17/23, and patient chart #314801-performed on 01/29/24). 4. During an interview on 02/22/24 at 11:50 am, the office manager confirmed the laboratory failed to retain records of reagent lot numbers, expiration dates, and dates put into use, stain quality when lot numbers changed, and failed to document daily hematoxylin and eosin stain quality assessment in 2022, 2023, and 2024. D5791 ANALYTIC SYSTEMS QUALITY ASSESSMENT CFR(s): 493.1289(a)(c) (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 analytic systems specified in 493.1251 through 493.1283. (c) The laboratory must document all analytic systems assessment activities. This STANDARD is not met as evidenced by: Based on review of the laboratory's quality assessment plan, review of documented

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 the twice per year comparison for accuracy records and interview with the practice manager, the laboratory failed to compare for accuracy the fungal element slides and scabies slides twice per year in 2018. The findings include: 1) Review of the twice per year comparison for accuracy records revealed the fungal elements slides and scabies slides were compared for accuracy on 11-5-18 and no other date. 2) Interview on February 26, 2018 at 11:45 a.m. with the practice manager confirmed the fungal element slides and scabies slides comparison for accuracy were not performed twice per year in 2018. 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 observation, review of potassium hydroxide (KOH) procedure, patient number one final report and interview with the lead nurse, the laboratory failed to follow the KOH procedure and interview with the lead nurse, the laboratory failed to follow the KOH quality control (QC) procedure in 2017 and 2018. The 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 2 -- include: 1) Observation of the laboratory on February 26, 2018 at 10:30 a.m. revealed a bottle of KOH solution in use for patient testing. The solution in the KOH bottle appeared cloudy with floating black blobs. 2) Review of the KOH procedure revealed the following: "QC procedure: 10% KOH will be examined annually for contamination. This will be done by placing one drop of KOH solution on a microscope slide, coverslip and examine at 40x for the presence of yeast and scabietic elements. ..." 3) Review of patient number one final report revealed on January 29, 2019 a KOH was performed and reported. 4) Interview on February 26, 2019 at 11:30 a.m. with the lead nurse confirmed the KOH solution was cloudy with black blobs. The KOH solution was not examined for contamination in 2017 and 2018. D5791 ANALYTIC SYSTEMS QUALITY ASSESSMENT CFR(s): 493.1289(a)(c) (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 analytic systems specified in 493.1251 through 493.1283. (c) The laboratory must document all analytic systems assessment activities. This STANDARD is not met as evidenced by: Based on review of the 2017 and 2018 histology maintenance records, the laboratory quality assessment (QA) plan and interview with the laboratory director, the laboratory failed to review the 2017, 2018 and 2019 equipment maintenance records, temperature logs, and reagent solution records. The findings include: 1) Review of the 2017 and 2018 equipment maintenance records, temperature logs, reagent solution records revealed the laboratory director did not review the histology records for quality assessment. 2) Review of the laboratory QA plan revealed, "The Laboratory Director or designee, reviews all quality control charts and logs on an as needed basis". 3) Interview on February 26, 2019 at 12:45 p.m. with the laboratory director confirmed the histology equipment maintenance records, temperature logs, and reagent solution records were not reviewed in 2017 and 2018. -- 2 of 2 --