Great Lakes Medical Laboratories Inc

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, record review, and interview with the Technical Supervisor (TS), the laboratory failed to follow its established safety policy for 10 bottles of chemically hazardous materials. Findings include: 1. On 10/13/2025 at 1:30 pm, the surveyor observed flammable reagents stored in a non-flammable cabinet including: a. Three (3) unopened bottles of Dynamic Xylene b. Three (3) unopened bottles of Dynamic 100% Ethyl Alcohol c. Three (3) unopened bottles of Dynamic 95% Ethyl Alcohol d. One (1) bottle of astraldiagnostics Quick III fixative with Methanol 2. A review of the laboratory's policy titled "Safety" revealed that the first paragraph under "Purpose" states: "The Laboratory Department endorses the standard Safety Management Programs and guidelines as recommended by the College of American Pathologists and the Department of Human Services of the State of Michigan." 3. An internet search of the Safety Data Sheets (SDS) for Dynamic Xylene, Dynamic 95% Ethyl Alcohol, Dynamic 100% Ethyl Alcohol, and astraldiagnostics Quick III Fixative (methanol) revealed that all products are classified as highly flammable liquids and vapors. Each requires storage in a locked flammable storage cabinet to ensure proper safety and compliance with flammable material storage requirements. 4. During an interview conducted on 10/13/2025 at 5:00 pm, the TS confirmed that, according to the laboratory's policy and the Safety Data Sheets (SDS) for the reagents, the flammable chemicals were not stored in a flammable safety cabinet as required. D5415 TEST SYSTEMS, EQUIPMENT, INSTRUMENTS, REAGENT CFR(s): 493.1252(c) 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 -- (c) Reagents, solutions, culture media, control materials, calibration materials, and other supplies, as appropriate, must be labeled to indicate the following: (c)(1) Identity and when significant, titer, strength or concentration. (c)(2) Storage requirements. (c)(3) Preparation and expiration dates. (c)(4) Other pertinent information required for proper use. This STANDARD is not met as evidenced by: Based on observation and interview with the Technical Supervisor (TS), the laboratory failed to ensure that 14 reagents were labeled with expiration dates and content identification for Histopathology and Non-GYN Cytology tissue examination. Findings include: 1. On 10/13/2025 at 1:25 pm, during a tour of the laboratory, the surveyor observed 14 reagents that were not labeled with expiration dates and 4 without content identification as follows: a. 13 reagents onboard the VIP Tissue Tek stored in secondary containers were not labeled to reflect expiration dates and 4 were not labeled with contents: 1. Secondary container labeled "10% Formalin 1" without an expiration date. 2. Secondary container labeled "10% Formalin 2" and no expiration date. 3. Secondary container labeled "80% ALC 3" without an expiration date. 4. Secondary container of unknown contents labeled "95% 4" without an expiration date. 5. Secondary container of unknown contents labeled "95% 5" without an expiration date. 6. Secondary container labeled "ALC 100% 6" without an expiration date. 7. Secondary container labeled "ALC 100% 7" without an expiration date. 8. Secondary container labeled "ALC 100% 8" without an expiration date. 9. Secondary container with contents and strength illegible without an expiration date. 10. Secondary container labeled "XXL Xylene 10" without an expiration date. 11. Secondary container labeled "Xylene 15" without an expiration date. 12. Secondary container labeled "100%" with illegible contents 13. Secondary container labeled "Tap H2O 17" without an expiration date. b. A secondary container labeled "Formalin" stored on countertop without an expiration date. 2. A request made on 10 /13/2025 at 1:35 p.m. for the reagent log documenting lot numbers, receipt dates, and expiration dates was not provided prior to survey exit. 3. An interview on 10/13/2025 at 1:45 pm with TS confirmed that reagents were not labeled with expiration dates and content identification. D5417 TEST SYSTEMS, EQUIPMENT, INSTRUMENTS, REAGENT CFR(s): 493.1252(d) (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 Technical Supervisor (TS), the laboratory failed to ensure that two bottles of reagents used for Histopathology tissue examination were not available for use beyond their expiration dates. Findings include: 1. On 10/13/2025 at 1:45 pm, the surveyor observed the following expired reagents: a. 1 bottle 3% Acetic Acidic Solution with an expiration date of 4/12/2025. b. 1 bottle of astraldiagnostics Methanol Quick III fixative with an expiration date 9/15 /2024. 2. An interview with TS on 10/13/2025 at 1:45 pm confirmed the reagents were expired. -- 2 of 3 -- D5431 MAINTENANCE AND FUNCTION CHECKS CFR(s): 493.1254(a)(2) (a)(2) Function checks as defined by the manufacturer and with at least the frequency specified by the manufacturer. Function checks must be within the manufacturers established limits before patient testing is conducted. (b) 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 do the following: This STANDARD is not met as evidenced by: . Based on observation and interview with the Technical Supervisor (TS), the laboratory failed to perform and document maintenance for the laboratory hood for 26 (August 2023 through October 2025) of 26 months reviewed. Findings include: 1. On 10/13/2025 at 1:50 pm, the surveyor observed the laboratory hood and noted that no maintenance or certification stickers were affixed to the equipment. 2. The surveyor requested maintenance records for the laboratory hood; however, no documentation was provided for review. 3. On 10/13/2025 at 5:00 pm an interview conducted with the TS confirmed that service or certification had not been performed on the laboratory hood. -- 3 of 3 --

Summary Statement of Deficiencies D3031 RETENTION REQUIREMENTS CFR(s): 493.1105(a)(3) Analytic systems records. Retain quality control and patient test records (including instrument printouts, if applicable) and records documenting all analytic systems activities specified in 493.1252 through 493.1289 for at least 2 years. This STANDARD is not met as evidenced by: . Based on record review and interview with the Laboratory Director, the laboratory failed to retain temperature monitoring records for at least 2 years for 12 (January - December 2022) of 19 months reviewed. Findings include: 1. A review of the laboratory's temperature monitoring records revealed a lack of records between January - December in 2022. 2. When queried on 7/13/2023 at 12:43 pm, the Laboratory Director was not able to provide the surveyor the documents requested. 3. An interview on 7/13/2023 at 12:43 pm, the Laboratory Director confirmed the laboratory did not retain temperature monitoring records from January - December in 2022. 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 observation and interview with the Laboratory Director (LD), the 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 -- laboratory failed to ensure staining reagents used in histopathology testing's pour-off tubes were labeled with the concentration, preparation, and expiration dates for 4 (Schiff Stain Solution, Iron, Gomori Prussian Blue Stain, and MassonTrichrome, and Aniline Blue Stain) of 4 staining kits observed in the laboratory. Findings include: 1. The surveyor observed the following pour-off tubes in the laboratory that did not include the preparation and expiration dates for the special stains on 7/13/2023 at 8:23 am during a tour of the laboratory: a. Schiff Stain Solution - pour off tube labeled with only the name. b. Iron, Gomori Prussian Blue Stain Kit - pour off tubes labeled with L41 and Red. c. Masson Trichome - pour off tubes labeled with Bouin fluid, Weigert Iron Hematox, Biebrich Scarlet Acid, and Phos, Phos Acid. d. Aniline Blue Stain Kit - pour off tubes labeled with Aniline Blue 2. The surveyor observed the labeling on the Acetic Acid pour-off tube for the Aniline Blue staining did not contain the concentration, preparation, and expiration date on 7/13/2023 at 8:23 am during a tour of the laboratory. 3. An interview on 7/13/2023 at 8:23 am the Laboratory Director confirmed the reagents listed above did not have all the required elements on the pour- off tubes. -- 2 of 2 --

Summary Statement of Deficiencies 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 interviews with the Technical Supervisor (TS), the laboratory failed to establish and perform maintenance for the Nikon microscope used in histopathology and cytopathology testing for 2 (January 2020 to January 2022) of 2 years reviewed. Findings include: 1. A review of the laboratory's records revealed a lack of documentation of maintenance for the Nikon microscope and a policy for how often maintenance is to be performed. 2. An interview on 1/14/22 at 3:57 pm with the TS revealed the laboratory's policy is to have the microscope serviced annually. 3. The surveyor requested the policy and the documentation of microscope maintenance performed annually on 1/14/22 at 3:57 pm and the documents were not made available. 4. An interview on 1/14/22 at 4:14 pm with the TS confirmed the laboratory did not have a policy or documentation of annual microscope maintenance. 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 D5637 CYTOLOGY CFR(s): 493.1274(d)(1)(ii) (d) Workload limits. The laboratory must establish and follow written policies and procedures that ensure the following: (d)(1)(ii) Each individual's workload limit is reassessed at least every 6 months and adjusted when necessary. This STANDARD is not met as evidenced by: . Based on procedure review, record review, and interview with the Laboratory Director (LD), the laboratory failed to follow written policies and procedures to ensure workload limit for the Laboratory Director was reassessed at least every six months and adjusted when necessary for 2 (December 2107 to December 2019) of 2 years. Findings include: 1. "Policy for monitoring workload limit every 6 months" states,"Any time that a slide examination total number exceeds the limit will be investigated and the reason for that identified." 2. Record review revealed for 2 of 2 years 14 of 113 days of slide examination, the number of slides examined exceeded the number allowed for the 24 hour period and no investigation was performed and the reason for the overage was not identified as follows: a. 1/30/18 33 slides examined - 25 allowed b. 3/1/18 27 slides examined - 25 allowed c. 3/29/18 20 slides examined - 19 allowed d. 5/1/18 20 slides examined - 19 allowed e. 7/17/18 33 slides examined - 31 allowed f. 7/24/18 33 slides examined - 31 allowed g. 7/31/18 32 slides examined - 31 allowed g. 8/2/18 36 slides examined - 31 allowed h. 9/13/18 15 slides examined - 13 allowed i. 9/20/18 15 slides examined - 13 allowed j. 1/22/19 26 slides examined - 25 allowed k. 4/16/19 26 slides examined - 25 allowed l. 6/1/19 19 slides examined - 18 allowed m. 9/26/19 26 slides examined - 25 allowed 3. During an interview on 12 /10/19 at approximately 1:50 pm, the LD confirmed the 6 month slide monitoring did not include documentation of the investigation and the reason for the slide review overage. ***Repeat Deficiency from 7/18/17 and 1/4/18*** D5645 CYTOLOGY 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 -- CFR(s): 493.1274(d)(3) (d) Workload limits. The laboratory must establish and follow written policies and procedures that ensure the following: (d)(3) The laboratory must maintain records of the total number of slides examined by each individual during each 24-hour period and the number of hours spent examining slides in the 24-hour period irrespective of the site or laboratory. This STANDARD is not met as evidenced by: . Based on procedure review, record review, and interview with the Laboratory Director (LD), the laboratory failed to follow their procedure for documentation of Non-GYN workload limits for 2 (December 2017 to December 2019) of 2 years. Findings include: 1. Review of the procedure "Policy for weekly Non-Gyn Cytology workload limits" revealed the laboratory did not follow the policy to "ensure that number of non-GYN slide examination does not exceed 100 conventional or cytospin (Liquid based) slides in 24 hours period." 2. Record review revealed lack of documentation for the weekly workload limits for 2 (December 2018 to December 2019) of 2 years. 3. Record review revealed the laboratory started using a log on 1/4 /18 that included each day of testing, "# slides examined, # of hours, and allowed # of slides to examine" to be examined for Non-GYN cytology slides workload limit. The log did not include "conventional and cytospin" documentation which accounts for the "100 conventional or cytospin (Liquid based) slides in 24 hours period." 4. During the interview on 12/10/19 at approximately 1:30 pm, the LD confirmed the weekly Cytology workload limits were not being performed and documented as stated in the policy. ***Repeat Deficiency from 7/18/17, 1/4/18, and 1/23/18 surveys*** D5821 TEST REPORT CFR(s): 493.1291(k) When errors in the reported patient test results are detected, the laboratory must do the following: (k)(1) Promptly notify the authorized person ordering the test and, if applicable, the individual using the test results of reporting errors. (k)(2) Issue corrected reports promptly to the authorized person ordering the test and, if applicable, the individual using the test results. (k)(3) Maintain duplicates of the original report, as well as the corrected report. This STANDARD is not met as evidenced by: . Based on record review and interview with the Laboratory Director (LD), the laboratory failed to detect incorrect patient first names for 2 (GA18-188 and GC19- 210) of 23 patient charts audited. Findings include: 1. Record review for 2 of 23 patient charts audited revealed the spelling of the patient's first name was spelled incorrectly from the spelling on the sample requisition as follows: a. Histology /surgical specimen - GS18-188 b. Cytology specimen - GC19-210 2. During the interview on December 10, 2019 at approximately 1:30 pm, the LD confirmed the spelling of the patient's first name on the final reports were spelled incorrectly. -- 2 of 2 --

Summary Statement of Deficiencies No Tags No deficiency details available. 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 --