Dermatology Specialists Of Shelby

Summary Statement of Deficiencies 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 and interview with the Assistant Office Manager, the laboratory failed to ensure its Frozen Embedding Media had not exceeded its expiration dates for 4 of 14 total bottles observed. Findings include: 1. The surveyor observed the 14 bottles of laboratory's POLARSTAT Frozen Embedding Media on 2/5 /24 at 11:32 pm the following had exceeded expiration dates: a. 1 bottle with the lot number 118028 and the expiration date 1/31/23. b. 3 bottles with the lot number 123390 and the expiration date 5/31/23. 2. An interview on 2/5/24 at 11:38 am with the Assistant Office Manager confirmed the Frozen Embedding Media had exceeded expiration dates for the bottles listed above. 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 D5801 TEST REPORT CFR(s): 493.1291(a) The laboratory must have an adequate manual or electronic system(s) in place to ensure test results and other patient-specific data are accurately and reliably sent from the point of data entry (whether interfaced or entered manually) to final report destination, in a timely manner. This includes the following: (a)(1) Results reported from calculated data. (a)(2) Results and patient-specific data electronically reported to network or interfaced systems. (a)(3) Manually transcribed or electronically transmitted results and patient-specific information reported directly or upon receipt from outside referral laboratories, satellite or point-of-care testing locations. This STANDARD is not met as evidenced by: . Based on document review and interview with the Office Manager (OM), the laboratory failed to establish a system to ensure the transcribed Mohs' surgery site was accurately reported for 2 of 9 Mohs' cases and 1 of 5 frozen section cases reviewed. Findings include: 1. Record review revealed for 2 of 9 Mohs' cases and 1 of 5 frozen section cases, the surgical site on the pre-op biopsy report, the Mohs' map, Mohs' log, and the final report in the electronic medical record (EMR) system are not consistent as follows: Mohs' a. MS-2022-059 - performed on 3/09/2022 i. Pre-op biopsy report - base of left thumb ii. Mohs' map, Mohs' log, and EMR report - 1st webspace left hand b. MS-2022-124 performed on 5/25/2022 i. Pre-op biopsy report and the Mohs' map - superior mid forehead ii. Mohs' log and EMR report - superior midline forehead Frozen section a. MS-2022-09 - performed on 5/11/2022 i. Pre-op biopsy report and EMR report - posterior mid-parietal scalp ii. Mohs' map and Mohs' log - posterior scalp 2. An interview on 6/01/2022 at 11:10 and 11:23 am, the OM confirmed the locations on the pre-op biopsy report, Mohs' map, Mohs' log, and the final EMR report were not consistent with the original biopsy site. 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 D5429 MAINTENANCE AND FUNCTION CHECKS CFR(s): 493.1254(a)(1) For unmodified manufacturer's equipment, instruments, or test systems, the laboratory must perform and document maintenance as defined by the manufacturer and with at least the frequency specified by the manufacturer. This STANDARD is not met as evidenced by: . Based on record review and interview, the laboratory failed to perform and document the monthly maintenance for the histology microscope for 17 (2017 and January - May 2018) of 24 months reviewed. Findings include: 1. On May 8, 2018 at 10:15 AM, record review of the microscope maintenance log revealed the laboratory did not perform and document 17 (2017 and January - May 2018) of 24 months the monthly cleaning of the microscope. 2. During the interview on May 8, 2018 at 10:15 AM, the office manager confirmed the monthly maintenance was not documented. 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 record review and interview, the laboratory failed to follow written policies and procedures for an ongoing mechanism to monitor, assess, and correct problems in the analytic laboratory systems for two (2016 and 2017) of two years reviewed. 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 -- Findings include: 1. On May 8, 2018 at 11:00 AM, record review of the twice a year "Quality Assurance Checklist" revealed there was no documentation for two (2016 and 2017) of two years. 2. When queried on May 8, 2018 at 11:00 AM, the office manager was unable to provide the surveyor with the documentation requested. 3. During the interview on May 8, 2018 at 11:00 AM, the office manager confirmed the "Quality Assurance Checklist" was not performed and documented in 2016 and 2017. -- 2 of 2 --