Warren Skin Care Center

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 the lack of Biannual Assessment (BA) records and interview with the Testing Personnel (TP), the laboratory failed to verify the accuracy of Histopathology testing in the calendar years 2022 and 2023. The TP confirmed on 3/5/24 at 11:30 am that the laboratory did not perform BA for Histopathology. D5415 TEST SYSTEMS, EQUIPMENT, INSTRUMENTS, REAGENT CFR(s): 493.1252(c) Reagents, solutions, culture media, control materials, calibration materials, and other supplies, as appropriate, must be labeled to indicate the following: (1) Identity and when significant, titer, strength or concentration. (2) Storage requirements. (3) Preparation and expiration dates. (4) Other pertinent information required for proper use. This STANDARD is not met as evidenced by: Based on surveyor observation of the Staining Station and interview with the Testing Personnel (TP), the laboratory failed to label the identity of all staining jars used for Histopathology testing from 1/17/19 to the date of the survey. The TP confirmed on 3 /5/24 at 10:35 am that all staining jars were not labeled. Note: This was previously cited. 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 D3003 FACILITIES CFR(s): 493.1101(a)(2) The laboratory must be constructed, arranged, and maintained to ensure contamination of patient specimens, equipment, instruments, reagents, materials, and supplies is minimized. This STANDARD is not met as evidenced by: Based on surveyor observation of the Staining Station (SS) where Mohs testing was performed and interview with the Testing Personnel (TP), the laboratory failed to minimize contamination of reagents, from 1/17/19 to the date of the survey. The findings include: 1. Observation of the SS revealed the laboratory did not maintain the SS to prevent contamination of reagents. 2. The TP confirmed on 10/27/21 at 10:10 am the SS was not maintained to minimize contamination. D5403 PROCEDURE MANUAL CFR(s): 493.1251(b) The procedure manual must include the following when applicable to the test procedure: (1) Requirements for patient preparation; specimen collection, labeling, storage, preservation, transportation, processing, and referral; and criteria for specimen acceptability and rejection as described in 493.1242. (2) Microscopic examination, including the detection of inadequately prepared slides. (3) Step-by-step performance of the procedure, including test calculations and interpretation of results. (4) Preparation of slides, solutions, calibrators, controls, reagents, stains, and other materials used in testing. (5) Calibration and calibration verification procedures. (6) The reportable range for test results for the test system as established or verified in 493.1253. (7) Control procedures. (8)

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: a. Based on surveyor review of the Procedure Manual (PM), Leica Operators Manual (LO) and interview with the Testing Personnel (TP), the laboratory failed to have the correct temperature range for the Leica Cryostat in the PM from 2/3/17 to the date of survey. The TP confirmed on 1/17/19 at 1:45 pm the laboratory did not follow the LO. b. Based on surveyor review of the Procedure Manual (PM) and interview with the Testing Personnel (TP), the laboratory failed to follow their Microscope Use Protocol (MP) procedure from 2/3/17 to the date of the survey. The finding includes: 1. The MP stated: "Microscope stage and ocular pieces are to cleaned every day" but there was no documented record microscope was cleaned daily. 2. The TP confirmed on 1 /17/19 at 2:00 pm that the PM was not followed. 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. 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 -- This STANDARD is not met as evidenced by: Based on surveyor review of the Procedure Manual (PM), Temperature Log (TL) and interview with Testing Personnel (TP), the laboratory failed to monitor and document Room Temperature (RT) and Humidity where Histopathology tests were performed from 2/13/17 to the date of survey. The TP confirmed on 1/17/19 at 1:20 pm that the laboratory did not document RT and Humidity. D5787 TEST RECORDS CFR(s): 493.1283(a) The laboratory must maintain an information or record system that includes the following: (a)(1) The positive identification of the specimen. (a)(2) The date and time of specimen receipt into the laboratory. (a)(3) The condition and disposition of specimens that do not meet the laboratory's criteria for specimen acceptability. (a)(4) The records and dates of all specimen testing, including the identity of the personnel who performed the test(s). This STANDARD is not met as evidenced by: Based on surveyor review of the Mohs Log (ML) and interview with the Testing Personnel (TP), the laboratory failed to maintain an accurate ML for Mohs test from 2 /13/17 to the date of survey. The findings include: 1. Review of ML revealed: a. The repair column did not have a repair listed. b. The "# of slide" column did not have a slide count. c. The Stage column was not completed. d. The "Cryostat Temp" did not have temperature recorded, but had the number of slides recorded. 2. The TP confirmed on 1/17/19 at 2:30 pm that the laboratory did not maintain an accurate ML. -- 2 of 2 --