Mid Michigan Pain Specialty, Pc

Summary Statement of Deficiencies D5413 TEST SYSTEMS, EQUIPMENT, INSTRUMENTS, REAGENT CFR(s): 493.1252(b) (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: (b)(1) Water quality. (b)(2) Temperature. (b)(3) Humidity. (b)(4) Protection of equipment and instruments from fluctuations and interruptions in electrical current that adversely affect patient test results and test reports. This STANDARD is not met as evidenced by: Based on observation, record review and interview with Testing Personnel #1 (TP1), the laboratory failed to ensure that reagents on the Indiko Plus Chemistry Analyzer were properly stored for six of six reagent containers. Findings include 1. On 02/04 /2025 at 10:00 am, the surveyor observed six reagent containers (Benzo R1, Benzo R2, Cocaine R1, Cocaine R2, Opiate R1, Opiate R2, Oxy R1, and Oxy R2) loaded on the Indiko Plus analyzer without caps while it was not in operation. 2. A review of the laboratory policy titled " Storage Requirement" for each Assay (DRI Benzodiazepine, DRI Cocaine, DRI Opiate, DRI Oxycodone) revealed, "Store the reagents...with screw caps tightly when not in use." 3. An interview with TP1 on 02/04/2025 at 10:02 am confirmed that the reagents stored on the Indiko Plus Chemistry Analyzer did not have screw caps on containers when not in use. D5415 TEST SYSTEMS, EQUIPMENT, INSTRUMENTS, REAGENT CFR(s): 493.1252(c) (c) Reagents, solutions, culture media, control materials, calibration materials, and other supplies, as appropriate, must be labeled to indicate the following: (c)(1) 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 -- 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: . A. Based on observation, record review and interview with Testing Personnel #1 (TP1), the laboratory failed to ensure reagents on the Indiko Plus Chemistry Analyzer were labeled with expiration dates for 6 of 6 reagent containers. Findings include: 1. On 02/04/2025 at 10:00 AM, the surveyor observed six reagent containers (Benzo R1, Benzo R2, Cocaine R1, Cocaine R2, Opiate R1, Opiate R2, Oxy R1, and Oxy R2) loaded on the Indiko Plus analyzer without labels indicating the expiration dates. 2. A review of the laboratory policy under the section titled "Reagent Handling" for each analyte states the following: a. DRI Benzodiazepine Assay: Page 4 of 9 states: " ... Transfer Reagents A and E into separate and clean reagent containers." "Label the containers with appropriate reagent name, expiration date, lot number..." b. DRI Cocaine Assay: Page 3 of 9 states: "...Reagents A and E come in barcoded containers with lot numbers, expiration date...can be placed directly on the analyzer..." c. DRI Opiate Assay: Page 4 of 11 states: "...Reagents A and E come in barcoded containers with lot numbers, expiration date...can be placed directly on the analyzer..." d. DRI Oxycodone Assay: Page 3 of 9 states: "...Reagents A and E come in barcoded containers with lot numbers, expiration date...can be placed directly on the analyzer..." 3. An interview conducted with TP1 on 02/04/2025 at 10:02 am confirmed that the reagent containers were not labeled with expiration dates. B. Based on record review and interview with Testing Personnel #1 (TP1), the laboratory failed to ensure reagents on the Indiko Plus Chemistry Analyzer were correctly documented in the laboratory's "Reagent Lot Log" for 1 of 4 reagents. Findings include: 1. On 02/04 /2025 at 11:45 am, a request was made to TP1 to print the reagent lot number documentation from Indiko Plus Chemistry Analyzer for 4 reagents currently in use (DRI Benzodiazepine Assay, DRI Cocaine Assay, DRI Opiate Assay, DRI Oxycodone Assay). 2. A record review of laboratory's reagent lot log revealed that the lot number documented for Oxycodone (#75155774) did not match the lot number documented in the instrument (#74580047). 3. An interview conducted with TP1 on 02 /04/2025 at 11:50 am confirmed that the reagent lot numbers were not documented correctly. -- 2 of 2 --

Summary Statement of Deficiencies D5431 MAINTENANCE AND FUNCTION CHECKS CFR(s): 493.1254(a)(2) 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 observation, lack of documentation, and interview with the Technical Consultant (TC), the laboratory failed to perform and document the traceable thermometer calibration checks as required by the manufacturer before the expiration for 1 (traceable Thomas Scientific) of 1 thermometers in use in the laboratory Frigidaire refrigerator. Findings include: 1. During a tour of the laboratory on 1/03 /2023 at 9:11 am, the surveyor observed a traceable thermometer in the Frigidaire refrigerator in use past the expiration date of 4/30/2020. 2. A lack of documentation upon review of the laboratory records revealed the thermometer was not calibrated and /or replaced by the expiration of 4/30/2020. 3. A interview on 1/03/2023 at 9:14 am, the TC confirmed the traceable thermometer was not calibrated and/or replaced. D5445 CONTROL PROCEDURES CFR(s): 493.1256(d)(1)(2)(g) Unless CMS Approves a procedure, specified in Appendix C of the State Operations Manual (CMS Pub. 7), that provides equivalent quality testing, the laboratory must-- (d)(1) Perform control procedures as defined in this section unless otherwise specified in the additional specialty and subspecialty requirements at 493.1261 through 493.1278. (d)(2) For each test system, perform control procedures using the number and frequency specified by the manufacturer or established by the laboratory when they meet or exceed the requirements in paragraph (d)(3) of this section. (g) 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 must document all control procedures performed. This STANDARD is not met as evidenced by: . Based on record review and interview with the Technical Consultant (TC), the laboratory failed to perform quality control (QC) testing each day of patient testing for 2 (oxycodone and opiates) of 4 drugs for the patient testing dates reviewed. Findings include: 1. A review of patient test records from 7/28/2021 to 12/15/2022 revealed a lack of quality control results for 2 of the 4 drugs tested (51 patients tested) as following: a. 12/02/2021 - no QC for oxycodone b. 12/02/2021 - no QC for opiates 2. An interview on 1/03/2023 at 11:20 am, the TC confirmed the laboratory did not have quality control documentation available for all the drugs reported out on 12/02/2021. -- 2 of 2 --

Summary Statement of Deficiencies D3037 RETENTION REQUIREMENTS CFR(s): 493.1105(a)(4) Proficiency testing records. Retain all proficiency testing records for at least 2 years. This STANDARD is not met as evidenced by: . Based on record review and interview with the Technical Consultant (TC), the laboratory failed to retain proficiency testing records for at least 2 years for 2 (2019 events 2 and 3) of 6 events reviewed. Findings include: 1. A review of the laboratory's American Proficiency Institute proficiency testing documentation revealed the following testing events were not available: a. Toxicology 2019 Event 2 b. Toxicology 2019 Event 3 2. A review of the laboratory's "Proficiency Testing and Employee Competency" policy revealed a section stating, "All proficiency results and

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 Testing Personnel #1 (TP1), the laboratory failed to follow written policies and procedures for an ongoing mechanism to monitor, assess, and correct problems as specified for the laboratory systems for 10 (August 2018 to June 2019) of 10 months reviewed. Findings include: 1. "Mid-Michigan Pain Specialty General Policies and Procedures" review revealed in section 3.2.2 Pre-Analytic Phase on page 17 stated: "five requisitions, chosen at random, are reviewed for name and address of person/facility ordering the tests, patient identification (first, last, and unique identifier), specimen source, date and time of collection, and tests ordered." 2. Quality assurance review revealed lack of documentation to show the test requisitions had been reviewed for 10 months. 3. During the interview on June 11, 2019 at approximately 12:00 pm, TP1 acknowledged chart review of patient test requisitions were not been performed and documented. D5301 TEST REQUEST CFR(s): 493.1241(a) The laboratory must have a written or electronic request for patient testing from an authorized person. 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 -- This STANDARD is not met as evidenced by: . Based on patient chart review, procedure review, and interview with Testing Personnel #1 (TP1), the laboratory failed to have a written request for patient testing from an authorized person for drug screen testing for 10 (patients #1-#10) of 10 patient charts reviewed. Findings include: 1. A patient chart review conducted on 10 (patients #1-#10) chosen patient charts revealed the laboratory did not have a written request or standing order for routine drug screen testing. 2. A review of the "Authorization for Ordering Tests" procedure revealed a section stating, "The laboratory will perform testing when receiving a written request from a licensed healthcare provider." 2. An interview on 6/11/19 at 11:29 am with TP1 confirmed no written request for patient testing from a authorized person had been documented in the patient charts. 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 patient chart audit and interview with Testing Personnel #1 (TP1), the laboratory failed to ensure test results were sent to the patient chart in a timely manner for 1 (patient #9) of 10 patient charts audited. Findings include: 1. A patient chart audit revealed Patient #9, tested on 4/16/19, did not have final results in their chart. 2. An interview on 6/11/19 at 11:29 am with TP1 confirmed the patient did not have results in their chart from 4/16/19. D6091 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1445(e)(4)(iii) The laboratory director must ensure all proficiency testing reports received are reviewed by the appropriate staff to evaluate the laboratory's performance and to identify any problems that require