Premier Diagnostics

Summary Statement of Deficiencies D3009 FACILITIES CFR(s): 493.1101(c) The laboratory must be in compliance with applicable Federal, State, and local laboratory requirements. This STANDARD is not met as evidenced by: . A. Based on observation, record review, and interview with the Laboratory Supervisor (LS), the laboratory failed to operate as a separate and distinct laboratory to comply with 493.55 for two (January 2023 to January 2025) of two years reviewed. Findings include: 1. On March 10, 2025, at 9:45 am, a tour of the laboratory's testing area was performed. The surveyor observed the laboratory testing area was equipped with instruments and supplies for processing histopathology patient slides to include: a. Tissue Tek | VIP Tissue Processor b. Tissue Tek | Tissue Processor c. Tissue Tek | SCA Automated Coverslipper d. Lecia | Tissue Autostainer e. Lecia Microtome f. Tissue Tek TEC | Tissue Embedder h. Paraffin Wax Bath i. Microscope g. Refrigerator 2. A review of the laboratory's (Laboratory A, Premier Diagnostics) procedure manual revealed a lack of policies pertaining to specimen processing as well as the use and maintenance of the equipment listed above. 3. An interview with LS on 03/10/2025 at 3:00 pm revealed that specimen processing was performed by another CLIA certified laboratory (Laboratory C) operating in the same physical location as Laboratory A. Furthermore, LS stated procedures for specimen processing were outlined in Laboratory C's procedure manual. LS further stated patient slides processed at Laboratory C were forwarded to this laboratory (Laboratory A) for review and confirmed that the tour conducted earlier at 9:45 am was of the testing area belonging to Laboratory C. 4. A review of Laboratory C's address in Aspen Web revealed its operating address as 1349 S. Rochester Road, Suite 210, Rochester Hills, MI 48307 and its hours of laboratory testing as Monday through Friday from 10:00 am to 6:00 pm. 5. A review of the CMS 116 completed by Laboratory A, signed and 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 -- dated 03/02/2025 by the laboratory director revealed its operating address as 1349 S. Rochester Road, Suite 210, Rochester Hills, MI 48307 and its hours of laboratory testing as Monday through Friday from 10:00 am to 7:00 pm. B. Based record review and interview with the Laboratory Supervisor (LS), the laboratory failed operate as a separate and distinct laboratory to comply with 493.55 for two (January 2023 to January 2025) of two years reviewed. Findings include: 1. A record review of Laboratory A's microscope maintenance logs revealed that there was single set of data recorded. The log listed dates temperatures were recorded, however, there was no distinction pertaining to which laboratory documented the temperatures. 2. An interview with the LS on 03/10/2025 at 3:00 pm revealed that Laboratory A and Laboratory B, two separately certified CLIA laboratories with the same physical location and testing personnel, shared maintenance data records. LS further stated Laboratory A's days of operation and Laboratory B's days of operation did not overlap. 3. A review of Laboratory B's address in Aspen Web revealed its operating address as 1349 S. Rochester Road, Suite 210, Rochester Hills, MI 48307 and its hours of laboratory testing as Monday, Tuesday, Thursday from 10:00 am to 6:30 pm. 4. A review of the CMS 116 completed by Laboratory A, signed and dated 03/02 /2025 by the laboratory director revealed its operating address as 1349 S. Rochester Road, Suite 210, Rochester Hills, MI 48307 and its hours of laboratory testing as Monday through Friday from 10:00 am to 7:00 pm. 5. Further record review of the microscope maintenance logs revealed temperatures were not separate and distinctly documented on the following dates patient testing occurred: a. 01/08/2023 b. 04/14 /2023 c. 11/06/2023 d. 03/04/2024 e. 07/01/2024 f. 12/30/2024 g. 01/25/2025 h. 04/04 /2023 i. 05/01/2023 j. 11/12/2024 k. 01/16/2024 l. 01/07/2024 6. An interview on 03 /10/2025 at 3:00 pm with the LS confirmed that temperatures were not documented separately and distinctly for Laboratory A. 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: . Based on record review and interview with the Laboratory Supervisor (LS), the laboratory failed to establish competency assessment policies for testing personnel for 2 (January 2023 to January 2025) of 2 years reviewed. Findings include: 1. A review of the laboratory's policies and procedures revealed a lack of a personnel competency assessment policy. 2. An interview 03/10/2025 at 11:56 am with the LS confirmed that the policies for personnel competency assessment had not been established for the laboratory. -- 2 of 2 --

Summary Statement of Deficiencies D5601 HISTOPATHOLOGY CFR(s): 493.1273(a)(f) (a) As specified in 493.1256(e)(3), fluorescent and immunohistochemical stains must be checked for positive and negative reactivity each time of use. For all other differential or special stains, a control slide of known reactivity must be stained with each patient slide or group of patient slides. Reactions of the control slide with each special stain must be documented. (f) The laboratory must document all control procedures performed, as specified in this section. This STANDARD is not met as evidenced by: . Based on record review and interview with the Office Manager (OM), the laboratory failed to ensure the Hematoxylin and Eosin (H & E) for 1 (#8) of 13 and the immunohistochemical stain, Warthin for 1 (#13) of 13 patient charts reviewed were documented for positive and negative reactivity each day of patient testing. Findings include: 1. A review of the laboratory's "H & E Quality Log" revealed the lack of documentation of the positive and negative reactivity for the H & E stain for 1 (#8) of 13 patient charts reviewed on 9/09/2020. 2. A record review of the special stains logs revealed the log was put into use in 4/2021. 3. A record review revealed for 1 (#13) of 13 patient charts reviewed a lack of documentation of the positive and negative reactivity for the Warthin stain for patient #13 report date on 7/07/2021. 4. A interview on 7/19/2021 at 11:15 AM and 11:30 AM, the OM confirmed a lack of documentation for the positive and negative reactivity for the H & E and immunohistochemical Warthin stain. 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 D5291 GENERAL LABORATORY SYSTEMS QUALITY ASSESSMENT CFR(s): 493.1239(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 general laboratory systems requirements specified at 493.1231 through 493.1236. This STANDARD is not met as evidenced by: . Based on procedure review, lack of documentation, and interview with the office manager, the laboratory failed to follow written policies and procedures for an ongoing mechanism to monitor, assess, and correct problems as specified in 493.1231 through 493.1236 in the general laboratory systems for 15 (April 2018 to June 2019) of 24 months. Findings include: 1. "General Systems Quality Checks" procedure section D, "Records Review", "random audits will be made of all records to ensure daily compliance". 2. "Patient Chart Audit" review logs state to perform monthly. No documentation was found to show the monthly patient chart audits were performed from April 2018 to the date of the survey. 3. During the interview on June 24, 2019 at approximately 12:15 pm, the office manager confirmed the patient chart audits were not performed and documented. 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 --