Derm Institute Of West Michigan, Plc The

Summary Statement of Deficiencies D3011 FACILITIES CFR(s): 493.1101(d) Safety procedures must be established, accessible, and observed to ensure protection from physical, chemical, biochemical, and electrical hazards, and biohazardous materials. This STANDARD is not met as evidenced by: . Based on observation and interview with Testing Personnel #2, the laboratory failed to ensure protection from chemical and biohazardous materials for one (Testing Personnel #2) of 5 testing personnel listed on Form CMS-209. Findings include: 1. The surveyor observed an open cup of coffee in the pathology laboratory on a desk between the processor and the tissue flotation bath on 10/7/24 at 9:05 am. 2. An interview on 10/7/24 at 9:08 am with Testing Personnel #2 confirmed the open cup of coffee was present in the pathology laboratory. 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 Chief Finance Officer, the laboratory failed to ensure its reagents and materials were not used when they had exceeded expiration dates for two (toluene and yellow tissue marking dye) bottles observed. Findings include: 1. The surveyor observed the following reagents and materials in the Mohs dermatopathology laboratory on 10/7/24 at 9:26 am: a. OpticMount Toluene 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 -- with the open date of 1/19/23 and the expiration date of 7/31/24. b. Mercedes Scientific Yellow Tissue Marking Dye with the expiration date of 9/30/24. 2. An interview on 10/7/24 at 9:27 am with the Chief Finance Officer confirmed the reagents and materials listed above had exceeded expiration dates. ***This is a repeated deficiency from the 12/19/22 recertification survey*** 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 record review and interview with the Chief Finance Officer and the Practice Manager, the laboratory failed to perform and document maintenance for the cryostat and automated stainer used in histopathology testing for 16 of 24 months reviewed. Findings include: 1. A review of the laboratory's "Daily Routine" procedure revealed a section stating, "Place Cryo-embedder, disks, and brushes in cryostat to allow for proper cooling. Place a new disposable blade in blade holder of cryostat. Change stain set up with new reagents according to stain maintenance procedure" and "Clean cryostat according to maintenance log and document in Mohs Log Folder at the end of the day." 2. A review of the laboratory's "Laboratory Maintenance" policy revealed a section stating, "The defrost cycle will be set for 11:30 pm each evening. Staining set up will be changed according to the Stain Maintenance Procedure." 3. A review of the laboratory's "Daily Temperature/Maintenance Log" revealed a lack of documentation of cryostat and stainer maintenance for the following months: a. January 2023 b. February 2023 c. April 2023 d. May 2023 e. July 2023 f. August 2023 g. September 2023 h. October 2023 i. December 2023 j. February 2024 k. April 2024 l. May 2024 m. June 2024 n. July 2024 o. August 2024 p. September 2024 4. An interview on 10/7/24 at 11:21 am with the Chief Finance Officer and the Practice Manager confirmed documentation of cryostat and autostainer maintenance for the months listed above were not present. -- 2 of 2 --

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, record review, and interview with the Chief Financial Officer (CFO) and the histotechnician, the laboratory failed to ensure reagents and tissue marking dyes used in histopathology testing did not exceed their expiration dates for 4 (blue, black, red, and yellow) of 4 marking dyes and 3 (Scott's Tap Water Substitute, Eosin Y stain Solution 1%, and Hematoxylin Stain Solution, Gill III) of 5 Hematoxylin & Eosin (H&E) staining reagents observed. Findings include: 1. During a tour of the laboratory on 12/19/2022 at 9:19 am, the surveyor observed 4 of 4 tissue marking dyes in the laboratory that had exceeded their expiration dates as follows: a. Tissue Marking Dyes 1. blue - lot 109673 expired 11/30/2022 2. black - lot 107324 expired 9/30/2022 b. Mercedes Scientific 1. red - lot 110105 expired 9/30/2022 c. Cancer Diagnostics 1. yellow - lot 20217 expired 8/31/2022 2. During a tour of the flammable cabinet on 12/19/2022 at 10:00 am, the surveyor observed 3 of 5 H&E staining reagents that had exceeded their expiration dates as follows: a. Scott's Tap Water Substitute 1. lot 2012125 (2 bottles) - expired on 5/05/2021 b. Eosin Y Stain Solution 1% 1. lot 2011812 - expired 4/30/2022 2. lot 2006626 - expired 3/13/2022 c. Hematoxylin Stain Solution, Gill III 1. lot 2008323 - expired 3/26/2022 3. An interview on 12/19/2022 at 9:25 and 10:00 am, the CFO and histotechnician confirmed the tissue marking dyes and the H&E staining reagents listed above had exceeded their expiration dates. D5431 MAINTENANCE AND FUNCTION CHECKS CFR(s): 493.1254(a)(2) 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 -- For unmodified manufacturer's equipment, instruments, or test systems, the laboratory must perform and document function checks as defined by the manufacturer and with at least the frequency specified by the manufacturer. Function checks must be within the manufacturer's established limits before patient testing is conducted. This STANDARD is not met as evidenced by: . Based on lack of documentation and interview with the Chief Financial Officer (CFO), the laboratory failed to perform and document the function checks as required for the room temperature in the laboratory for 17 (August 2021 to December 2022) of 17 months of operation of the cryostat in the laboratory. Findings include: 1. A record review on 12/19/2022 at 11:34 am revealed a lack of documentation of the room temperature for 17 (August 2021 to December 2022) of 17 months of operation of the cryostat instrument in the laboratory. 2. When queried on 12/19/2022 at 11:34 am, the CFO was not able to provide the surveyor the documentation to show the room temperature had been performed and documented. 3. An interview on 12/19/2022 at 11:34 am, the CFO confirmed the laboratory failed to perform and document the room temperature function checks for the proper operation of the cryostat instrument. 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 record review and interview with the Chief Financial Officer (CFO), the laboratory director failed to ensure the final Mohs' map showed that the stage of testing was clear and/or negative of positive margins for 9 ( M21-056, M21-073, M21- 091, M21-132, M21-165, M22-016, M22-069, M22-118, and EM22-092) of 11 Mohs' maps reviewed. Findings include: 1. A record review for 9 of 11 final Mohs' maps in the patient's electronic medical record (EMR) revealed the final Mohs' map lacked the documentation to show that the stage of testing was clear and/or negative of positive margins to show the testing was complete as follows: a. M21-056 tested on 5/24/2021 b. M21-073 tested on 6/14/2021 c. M21-091 tested on 8/30/2021 d. M21-132 tested on 10/25/2021 e. M21-165 tested on 12/06/2021 f. M22-016 tested on 2/14/2022 g. M22-069 tested on 4/11/2022 h. M22-118 tested pm 6/13/2022 i. EM22-092 tested on 10/24/2022 2. When queried on 12/19/2022 at 10:15 am, the CFO was unable to provide the surveyor documentation to show the margins on the Mohs' map were negative. 3. An interview on 12/19/2022 at 10:15 am, the CFO confirmed the final Mohs' map do not show that the tumor margins were clear and/or negative. D5793 ANALYTIC SYSTEMS QUALITY ASSESSMENT CFR(s): 493.1289(b)(c) (b) The analytic systems quality assessment must include a review of the effectiveness of

Summary Statement of Deficiencies 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 record review and interview with the Practice Manager (PM), the laboratory failed to 1) record the specimen time of receipt into the laboratory for the Mohs' tissue specimens for 3 (#1, #3, and #4) of 5 final Mohs' maps reviewed and 2) the identity of the Mohs' surgeon was not recorded on the Mohs' map for 5 (#1 - #5) of 5 final Mohs' maps reviewed. Findings include: 1. A record review for 3 (#1, #3, and #4) of 5 final Mohs' maps reviewed in the patients electronic medical record (EMR) system revealed the laboratory did not record the specimen time of receipt into the laboratory for the Mohs' tissue specimen on the Mohs' map as follows: a. specimen #1 - no time recorded on the Mohs' map for section II b. specimen #3 - no time recorded on the Mohs' map for section I and II c. specimen #4 - no time recorded on the Mohs' map for section I and II 2. A record review for 5 (#1 - #5) of 5 Mohs' maps reviewed revealed the identity of the Mohs' surgeon was not recorded on the Mohs' map. 3. An interview on 5/10/2021 at 11:00 am, the PM confirmed the above listed were not documented on the final Mohs' map. D5805 TEST REPORT CFR(s): 493.1291(c) The test report must indicate the following: (c)(1) For positive patient identification, 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 -- either the patient's name and identification number, or a unique patient identifier and identification number. (c)(2) The name and address of the laboratory location where the test was performed. (c)(3) The test report date. (c)(4) The test performed. (c)(5) Specimen source, when appropriate. (c)(6) The test result and, if applicable, the units of measurement or interpretation, or both. (c)(7) Any information regarding the condition and disposition of specimens that do not meet the laboratory's criteria for acceptability. This STANDARD is not met as evidenced by: . Based on record review and interview with the Practice Manager (PM), the laboratory failed to ensure the name and address of the laboratory where the Mohs' tissue microscopic examinations were performed was on the final Mohs' map for 5 (#1 - #5) of 5 patient Mohs' maps reviewed. Findings include: 1. A record review for 5 (#1 - #5) of 5 patient Mohs' maps reviewed revealed the name and address of the laboratory performing the Mohs' tissue microscopic examinations was not recorded on the Mohs' map. 2. An interview on 5/10/2021 at 11:00 am, the PM confirmed the Mohs' map did not list the name and address of the laboratory performing the Mohs' microscopic tissue examination. D6076 LABORATORY DIRECTOR CFR(s): 493.1441 The laboratory must have a director who meets the qualification requirements of 493. 1443 of this subpart and provides overall management and direction in accordance with 493.1445 of this subpart. This CONDITION is not met as evidenced by: . Based on record review and interview with the Practice Manager, the laboratory failed to employ a qualified Laboratory Director that met the qualification requirements of 493.1443 of this subpart. Findings include: 1. The laboratory failed to employ a Laboratory Director that met the qualification requirements for high complexity testing. Refer to D6078. D6078 LABORATORY DIRECTOR QUALIFICATIONS CFR(s): 493.1443 The laboratory director must be qualified to manage and direct the laboratory personnel and performance of high complexity tests and must be eligible to be an operator of a laboratory within the requirements of subpart R. (a) The laboratory director must possess a current license as a laboratory director issued by the State in which the laboratory is located, if such licensing is required; and (b) The laboratory director must-- (b)(1)(i) Be a doctor of medicine or doctor of osteopathy licensed to practice medicine or osteopathy in the State in which the laboratory is located; and (b) (1)(ii) Be certified in anatomic or clinical pathology, or both, by the American Board of Pathology or the American Osteopathic Board of Pathology or possess qualifications that are equivalent to those required for such certification; or (b)(2) Be a doctor of medicine, a doctor of osteopathy or doctor of podiatric medicine licensed to practice medicine, osteopathy or podiatry in the State in which the laboratory is located; and (b)(2)(i) Have at least one year of laboratory training during medical residency (for example, physicians certified either in hematology or hematology and medical oncology by the American Board of Internal Medicine); or (b)(2)(ii) Have at -- 2 of 3 -- least 2 years of experience directing or supervising high complexity testing; or (b)(3) Hold an earned doctoral degree in a chemical, physical, biological or clinical laboratory science from an accredited institution and-- (b)(3)(i) Be certified and continue to be certified by a board approved by HHS; or (b)(3)(ii) Before February 24, 2003, must have served or be serving as director of a laboratory performing high complexity testing and must have at least-- (b)(3)(ii)(A) Two years of laboratory training or experience, or both; and (b)(3)(ii)(B) Two years of laboratory experience directing or supervising high complexity testing. (b)(4) Be serving as a laboratory director and must have previously qualified or could have qualified as a laboratory director under regulations at 42 CFR 493.1415, published March 14, 1990 at 55 FR 9538, on or before February 28, 1992; or (b)(5) On or before February 28, 1992, be qualified under State law to direct a laboratory in the State in which the laboratory is located; or (b)(6) For the subspecialty of oral pathology, be certified by the American Board of Oral Pathology, American Board of Pathology, the American Osteopathic Board of Pathology, or possess qualifications that are equivalent to those required for certification. This STANDARD is not met as evidenced by: . Based on record review and interview with the Practice Manager (PM), the laboratory failed to employ a laboratory director that met the qualification requirements for high complexity testing for 5 (January to May 2021) of 5 months the laboratory has been performing Mohs' surgery. Findings include: 1. A record review of Laboratory Director's personnel record revealed a lack of documentation of the following: a. Board certification in anatomic or clinical pathology; or b. Documentation of at least one year of laboratory training during medical residency; or c. Documentation of at least 2 years of experience directing or supervising high complexity testing. 2. A interview on 5/10/2021 at 11:20 am, the PM was unable to provide the surveyor documentation to qualify the Laboratory Director for high complexity testing. 3. The laboratory was provided 7 days after the survey to supply documentation and it was not made available. -- 3 of 3 --