Chattanooga Skin & Cancer Clinic Cleveland

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 a review of the laboratory's policies and procedures, proficiency testing logs, and staff interviews, the laboratory failed to verify the accuracy of micrographically oriented histographic surgery (MOHS) testing at least twice annually in 2023 and 2024. The findings include: 1. A review of the laboratory's policy titled "Comparison of Test Results" revealed the following statement: - "test systems not enrolled in proficiency testing, split-specimen testing will be implemented to evaluate the correlation of the results." When asked what "split- specimen testing" means for MOHS testing, the Laboratory Consultant explained that the laboratory sends cases to another pathologist or MOHS surgeon to compare test results. 2. A review of the laboratory's "Proficiency Testing" logs revealed the laboratory sent cases for comparison once in 2023 (05/02/2023) and none in 2024. 3. An interview with the laboratory consultant on 12/12/2024 at 1:00 p.m. confirmed that the laboratory has not sent MOHS cases for a comparison of test results since May 2023. 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. 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 -- (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 laboratory observation, review of the manufacturer's instructions for use, lack of documentation, and staff interview, the laboratory failed to monitor ambient temperature and humidity where patient tissue processing occurred in 2023 and 2024 (18 of 18 months reviewed). 1. Observation of the laboratory on 12/12/2024 at 10:00 a. m. revealed a Leica CM 1950 cryostat and Linistat Linear Stainer used for processing patient tissue samples removed during MOHS procedures. 2. A review of the manufacturer's instructions for use revealed the following environmental specifications: - The Leica CM 1950 requires an operating temperature of 18 to 35 degrees Celcius (C) with 20 - 60% relative humidity. - The Linistat Linear Stainer requires 5C to 40C operating temperature with a maximum relative humidity of 80%. 3. No laboratory temperature and humidity monitoring records were available for review from June 2023 to December 2024. 4. An interview with the laboratory consultant on 12/12/2024 at 1:00 p.m. confirmed the laboratory did not monitor laboratory temperature and humidity from June 2023 to December 2024. 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 laboratory observation, a review of patient test records, quality control (QC) records, and staff interviews, the laboratory failed to document daily Hematoxylin and Eosin (H&E) staining QC for one of the four testing days reviewed in 2023 and 2024. The findings include: 1. Observation of the laboratory on 12/12/2024 at 10:00 a.m. revealed a Linistat Linear Stainer using Hematoxylin (Lot: 144470) and Eosin (Lot: 145250) reagents for the staining of patient tissues removed from the micrographically oriented hectographic surgery (MOHS) procedure. 2. A random review of patient test records revealed the laboratory performed H&E staining on tissues obtained during MOHS procedures on 12/27/2022 (ID: 234840), 09/15/2023 (ID:206974), 01/10/2024 (ID:245064), and 11/26/2024 (ID:215539). 3. A review of the daily H&E QC records revealed no documented QC recorded for 09/15/2023. 4. An interview with the laboratory consultant on 12/12/2024 at 1:00 p.m. confirmed that the laboratory did not perform H&E stain QC on 09/15/2023. D6094 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1445(e)(5) The laboratory director must ensure that the quality assessment programs are established and maintained to assure the quality of laboratory services provided and to identify failures in quality as they occur. -- 2 of 3 -- This STANDARD is not met as evidenced by: Based on a review of laboratory policies, lack of records, and staff interviews, the laboratory director failed to ensure the laboratory maintained the quality assessment program in 2022, 2023, and 2024. The findings include: 1. A review of the laboratory's quality assessment policy revealed the following: - "We will perform periodic quality assessment monitoring and review the results with the laboratory director or technical consultant for their approval. The laboratory director or consultant will initial and date our written reviews and actions." - "The records of our quality assessment monitoring are filed in the QA Monitoring section of this manual." - "Signatures below document that the current laboratory director has reviewed and approved this Quality Assessment policy initially and each year." 2. No signatures were present on the quality assessment policy indicating the lab director's review and approval. There were no records in the "QA Monitoring" section of the manual indicating the laboratory conducted periodic quality assessments. 3. An interview with the laboratory consultant on 12/12/2024 at 1:00 p.m. confirmed the laboratory did not maintain the quality assessment program in 2022, 2023, and 2024. -- 3 of 3 --

Summary Statement of Deficiencies D5411 TEST SYSTEMS, EQUIPMENT, INSTRUMENTS, REAGENT CFR(s): 493.1252(a) Test systems must be selected by the laboratory. The testing must be performed following the manufacturer's instructions and in a manner that provides test results within the laboratory's stated performance specifications for each test system as determined under 493.1253. This STANDARD is not met as evidenced by: =================================== Based on observation of Xylene, Bluing Reagent and Histoprep chemicals during survey 8/13/18, lack of documentation of receipt dates, lot numbers, open dates and expiration dates and upon interview with the MOH's technician, determined the laboratory failed to document receipt dates, lot numbers, open dates and expiration dates of chemicals used since 2017. The findings include: 1. Observation during survey 8/13/18 at approximately 9: 30 a.m. of Xylene, Bluing Reagent and Histoprep chemicals used in processing MOH's specimens. 2. Lack of documentation of receipt dates, lot numbers, open dates and expiration dates for chemicals used in MOH's processing since 2017. 3. Interview at approximately 9:30 a.m. August 13, 2018 with MOH's technician confirmed the laboratory failed to document receipt dates, lot numbers, open dates and expiration dates for chemicals used in processing MOH's specimens since 2017. ==================================== 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. 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 observation of outdated KOH (Potassium Hydroxide) and Tzanck testing solution 8/13/18 during on-site survey, log books and patient charts with documentation of 2018 KOH and Tzanck testing and interview with the MOH's technician and one of three MOH's Dermatologists, the laboratory used KOH and Tzanck Testing Solution when they had exceeded their expiration dates. The findings include: 1. Observation 8/13/18 at approximately 9:15 a.m. of KOH solution with January 2018 expiration date and Tzanck Solution with April 2018 expiration date. 2. Log books and 2 patient charts with documentation of KOH and Tzanck testing results for 2018. 2. Interview at approximately 9:30 a.m. August 13, 2018 with the MOH's technician and 1 of 3 MOH's Dermatologists, confirmed KOH and Tzanck analysis had been performed on patients using outdated testing solution in 2018. ==================================== D5433 MAINTENANCE AND FUNCTION CHECKS CFR(s): 493.1254(b)(1) For equipment, instruments, or test systems developed in-house, commercially available and modified by the laboratory, or maintenance and function check protocols are not provided by the manufacturer, the laboratory must establish a maintenance protocol that ensures equipment, instrument, and test system performance that is necessary for accurate and reliable test results and test result reporting. The laboratory must perform and document the maintenance activities specified in paragraph (b)(1)(i) of this section. This STANDARD is not met as evidenced by: ================================== Based on laboratory's maintenance policy for the cryostat, lack of preventive maintenance documentation for cryostat and interview with the MOH's technician, determined the laboratory failed to have preventive maintenance done on cryostat annually since 2016. The findings include: 1. The Laboratory's maintenance policy for the cryostat states that PM (preventative maintenance) is to be performed annually. 3. Lack of Cryostat PM documentation since installation in 2016. 4. Interview with the MOH's technician at approximately 11: 30 a.m. August 13, 2018 confirmed there were no PM's performed on the cryostat since installation in 2016. =================================== D6007 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(e)(1) 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)(1) Ensure that testing systems developed and used for each of the tests performed in the laboratory provide quality laboratory services for all aspects of test performance, which includes the preanalytic, analytic, and postanalytic phases of testing; This STANDARD is not met as evidenced by: -- 2 of 3 -- =================================== Based on review of the laboratory procedure manual.which lacked procedure for microscopic examination and reporting of Tzanck smears to include personnel competency and interview with MOH's technician and one of three dermatologists, the laboratory director failed to ensure procedure for performing Tzanck smears and competency performance of testing personnel since 2017. The findings include: 1. Review of the laboratory procedure manual revealed no procedure for the microscopic examination and reporting of Tzanck smears including personnel competency. 2. Interview on August 13, 2018 at approximately 11:30 a.m. with MOH's technician and one of three dermatologists, confirmed the laboratory performed and reported microscopic examination and reporting of Tzanck smears without an approved procedure in place to include personnel competency since 2017. ==================================== -- 3 of 3 --