Central Ohio Skin & Cancer, Inc

Summary Statement of Deficiencies D0000 An revisit inspection conducted 03/11/2025 found the Central Ohio Skin & Cancer, Inc. laboratory to be in compliance with 42 CFR Part 493 requirement for laboratories. 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: Item I: Based on record review and an interview with the Medical Assistant, the laboratory failed to follow a written policy and procedure to assess competency of Testing Personnel (TP) #2 as required in the personnel requirements in subpart M. This deficient practice had the potential to affect one out of one TP and the potential to affect 2,783 out of 2,783 patients tested with the high complexity Mohs test system in the subspecialty of Histopathology from 01/01/2024 through 12/31/2024. Findings Include: 1. A review of the laboratory's CMS-209 form, approved and signed by the Lab Director on 02/13/2025, found one individual listed as TP for the Mohs test system in the subspecialty of Histopathology. 2. A review of the laboratory's "Periodic Assessments and Proficiency Testing" policy and procedure found the following statement: "...Competency Assessment...pertaining to testing of mohs micrographic surgery...will be conducted initially upon hiring,...after 6 months, after 12 months and annually thereafter..." 3. A review of the laboratory's competency assessment data for TP #2 found the following: TP #2 2023: 4-26-23 2024: [none] 4. The surveyor requested 2024 competency assessment documentation for TP #2 from the Medical Assistant. An interview with the Medical Assistant, on 02/13/2025 at 1:58 PM, confirmed that the laboratory failed to follow the competency assessment policy for TP #2, performing the Mohs test system and was unable to provide the requested 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 -- documentation on the date of the survey. Item II: Based on record review and an interview with the Medical Assistant, the laboratory failed to follow a written policy and procedure to assess competency of Testing Personnel (TP) #3 and TP #4 as required in the personnel requirements in subpart M. This deficient practice had the potential to affect two out of two TP and had the potential to affect 11,434 out of 11,434 patients tested with the high complexity tissue grossing procedures in the subspecialty of Histopathology from 01/01/2024 through 12/31/2024. Findings Include: 1. A review of the laboratory's CMS-209 form, approved and signed by the Lab Director on 02/13/2025, found two individuals listed as TP for tissue grossing procedures in the subspecialty of Histopathology. 2. A review of the laboratory's "Histopathology Competency Checklist" policy and procedure found the following statement: "...The checklist evaluation will be performed by the laboratory director on an annual basis... In the event of a new added employee...an initial assessment...will occur subsequently...a semi-annual review will be performed in the first year..." 3. A review of the laboratory's competency assessment data for TP #3 and TP #4 found the following: TP #3 2023: 4-26-23 2024: [none] TP #4 2023: 4-26-23 2024: [none] 4. The surveyor requested 2024 competency assessment documentation for TP #3 and TP #4 from the Medical Assistant. An interview with the Medical Assistant, on 02/13 /2025 at 1:58 PM, confirmed that the laboratory failed to follow the competency assessment policy for TP #3 and TP #4 and was unable to provide the requested documentation on the date of the survey. 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 record review and an interview with the Medical Assistant, the laboratory failed to conduct blind test accuracy verification (TAV) activities, at least twice annually, for the high complexity Mohs testing procedures in the subspecialty of Histopathology in the year 2024. This deficient practice had the potential to affect 2,783 out of 2,783 patients tested in the subspecialty of Histopathology from 01/01 /2023 through 12/31/2024. Findings Include: 1. The Surveyor requested the blind TAV policy and procedure from the Medical Assistant. The policy stated the following: "...Twice annually 12 representative cases...will be pulled by a member of the laboratory personnel...The cases will be reviewed blindly by the outside reviewer..." 2. The Surveyor requested the blind TAV results for the Mohs test system for the years 2023 and 2024 from the Medical Assistant. The Medical Assistant confirmed the laboratory did not follow the policy and procedure for blind TAV activities at least twice annually for the high complexity Mohs testing procedures performed in the years 2023 and 2024 and was unable to provide the requested documentation on the date of the inspection. The interview occurred on 02/13/2024 at 12:49 PM. -- 2 of 2 --

Summary Statement of Deficiencies D6106 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1445(e)(14) The laboratory director must ensure that an approved procedure manual is available to all personnel responsible for any aspect of the testing process. This STANDARD is not met as evidenced by: Based on review of the laboratory's policy and procedure manual and an interview with the Laboratory Manager, the current Laboratory Director failed to ensure approved policies and procedures were available to all personnel responsible for any aspect of the testing process. This deficient practice had the potential to affect 2076 out of 11,054 tested under the subspecialty of Histopathology from 09/27/2022 through 03/29/2023. Findings Include: 1. Review of the CMS-116 submitted for a change of Laboratory Director revealed a new Laboratory Director as of 09/27/2022. 2. Review of the laboratory's policy and procedure manual titled, "Mohs Laboratory Procedure Manual," failed to find the current Laboratory Director's approval via signature and date. 3 The inspector requested policies and procedures approved by the current Laboratory Director from the Laboratory Manager. The Laboratory Manager confirmed the policies and procedures were not approved and signed by the current Laboratory Director. The interview occurred on 03/29/2023 at 2:25 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 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 policies and procedures and an interview with the Laboratory Director (LD), the laboratory failed to have a written policy and procedure available to laboratory personnel for all oral pathology testing procedures performed. This deficient practice had the potential to affect all oral pathology specimens tested. Findings Include: 1. Review of the laboratory's policies and procedures, provided on the date of survey, did not find any mention of a policy and procedure for the oral pathology test system. 2. The Surveyor requested the laboratory's written policy and procedure for oral pathology testing from the LD. The LD confirmed the laboratory did not establish oral pathology written policies and procedures, and was unable to provide the requested documentation on the date of survey. The interview occurred on 05/16/2019 at 11:30 AM. 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 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 -- electrical current that adversely affect patient test results and test reports. This STANDARD is not met as evidenced by: Based on direct observation and an interview with the Nurse Manager (NM), the laboratory failed to follow the manufacturer's instructions for the storage temperatures of Thermo-Scientific hematoxylin, reagent alcohol, 100% dehydrant and SurgiPath decalcifier II solutions. This deficient practice had the potential to affect 17,770 patients tested in the subspecialty of oral pathology and histopathology. Findings Include: 1. Direct observation found the following storage requirements listed on each container: Thermo Scientific hematoxylin 15-30 C Thermo Scientific reagent alcohol 15-30 C Thermo Scientific 100% dehydrant 15-30 C SurgiPath decalcifier II 15-30 C C; degrees Celsius 2. The NM confirmed the laboratory did not monitor the storage area for the Thermo-Scientific hematoxylin, reagent alcohol, 100% dehydrant and SurgiPath decalcifier II solutions and did not follow the manufacturers instructions. The interview occurred on 05/14/2019 at 11:00 AM. -- 2 of 2 --