Pain Clinic Of Michigan

Summary Statement of Deficiencies D0000 A recertification survey was performed on September 9, 2025 by the State of Michigan Licensing and Regulatory Affairs Department. The laboratory was found to be out of compliance with CLIA regulations (42 CFR Part 493, Laboratory Requirements) for the following condition-level deficiencies: 493.1213 Condition: Toxicology. 493.1487 Condition: Laboratories performing high complexity testing; testing personnel. 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: . A. Based on observation and interview with testing personnel #1, the laboratory failed to have an eye wash bottle that had not exceeded its expiration date since 2/26 /22. Findings include: 1. The surveyor observed the laboratory's eye wash bottle on 9/9 /25 at 9:11 am and it expired on 2/26/22. 2. An interview on 9/9/25 at 9:11 am with testing personnel #1 confirmed the eye wash bottle was expired. B. Based on record review, observation, and interview with testing personnel #1, the laboratory failed to follow it's safety procedures to ensure adequate spill kit components were present in the laboratory for three (sorbent powder, a poly apron, and a whisk-on-pan dustpan) of 14 spill kit components. Findings include: 1. A review of the laboratory's "Spill Response Policy" revealed a section titled "Spills and Leaks Procedure" stating, "Spill kits: All laboratories should obtain or create a spill kit, which should contain the following: 5- Universal Pillows 6-Lab Pillows 2- Disposable Bags with Twist Ties 1- Pair of Chemical-Resistant Gloves 1- Whisk-on-Pan Dust Pan 1-Poly Apron 1-Pair of Splash Goggles 1-Carton of Sorbent Powder." 2. The surveyor observed the laboratory's spill kit contents on 9/9/25 at 9:43 am and noted the kit was missing Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 4 -- sorbent powder, a poly apron, and a whisk-on-pan dustpan. 3. An interview on 9/9/25 at 9:43 am with testing personnel #1 confirmed the spill kit was missing sorbent powder, a poly apron, and a whisk-on-pan dustpan. D5022 TOXICOLOGY CFR(s): 493.1213 If the laboratory provides services in the subspecialty of Toxicology, the laboratory must meet the requirements specified in 493.1230 through 493.1256, and 493.1281 through 493.1299. This CONDITION is not met as evidenced by: . Based on observation, record review, and interviews, the laboratory failed to establish policies to ensure positive identification of patient urine specimens from preanalytical aliquoting to specimen storage (refer to D5203) and failed to perform

Summary Statement of Deficiencies D2009 TESTING OF PROFICIENCY TESTING SAMPLES CFR(s): 493.801(b)(1) The individual testing or examining the samples and the laboratory director must attest to the routine integration of the samples into the patient workload using the laboratory's routine methods. This STANDARD is not met as evidenced by: . Based on record review and interview with the Technical Supervisor, the laboratory director and testing personnel failed to attest to the integration of proficiency testing samples into the patient workload for 4 (UT-A 2022, UT-B 2022, UT-C 2022, and UT-B 2023) of 5 proficiency testing events reviewed. Findings include: 1. A review of the laboratory's College of American Pathology proficiency testing events revealed a lack of attestation by the laboratory director and the testing personnel for the following urine toxicology proficiency testing events: a. UT-A 2022 b. UT-B 2022 c. UT-C 2022 d. UT-B 2023 2. An interview on 1/10/24 at 11:58 pm with the Technical Supervisor confirmed the laboratory director and testing personnel had not attested to integration of proficiency testing samples into the patient workload. D3001 FACILITIES CFR(s): 493.1101(a)(1) The laboratory must be constructed, arranged, and maintained to ensure the space, ventilation, and utilities necessary for conducting all phases of the testing process. This STANDARD is not met as evidenced by: . Based on observation, record review and interview with the Technical Supervisor, the laboratory failed ensure appropriate ventilation necessary for performing urine toxicology testing reagent preparation for 2 (January 2022 to January 2024) of 2 years Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 4 -- reviewed. Findings include: 1. The surveyor observed a lack of ventilation hood in the laboratory on 1/10/24 at 9:02 am. 2. A review of the laboratory's "Acetonitrile HPLC Grade" Safety Data Sheet (SDS) revealed a section titled "Precautions for safe handling" stating, " Work under hood. Do not inhale substance/mixture. Avoid generation of vapors/aerosols. Observe label precautions." 3. A review of the laboratory's "iso-Propyl Alcohol HPLC Grade" SDS revealed a section titled "Precautions for safe handling" stating, " Work under hood. Do not inhale substance /mixture. Avoid generation of vapors/aerosols. Observe label precautions." 4. An interview on 1/10/24 at 1:07 pm with the Technical Supervisor confirmed the laboratory did not have a hood to ensure ventilation when working with the above reagents. 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 Technical Supervisor, the laboratory failed to establish a competency assessment policy to include Clinical Consultant competency for 2 (January 2022 to January 2024) of 2 years reviewed. Findings include: 1. A review of the laboratory's "Personnel Requirements" policy revealed a lack of process for ensuring Clinical Consultant competency. 2. An interview on 1/10 /24 at 10:07 am with the Technical Supervisor confirmed the laboratory had not established a competency assessment policy to include Clinical Consultant competency. D5215 EVALUATION OF PROFICIENCY TESTING PERFORMANCE CFR(s): 493.1236(b)(2) The laboratory must verify the accuracy of any analyte, specialty or subspecialty assigned a proficiency testing score that does not reflect laboratory test performance (that is, when the proficiency testing program does not obtain the agreement required for scoring as specified in subpart I of this part, or the laboratory receives a zero score for nonparticipation, or late return or results). This STANDARD is not met as evidenced by: . Based on record review and interview with the Technical Supervisor, the laboratory failed to verify the accuracy of analytes not graded by the proficiency testing program for 2 (UT-B 2022 and UT-B 2023) of 5 proficiency testing events reviewed. Findings include: 1. A review of the laboratory's College of American Pathologists' proficiency testing records revealed the laboratory had not reported its results to the proficiency testing program before the deadline for testing events UT-B 2022 and UT-B 2023. 2. The surveyor requested the laboratory's documentation of the verification of accuracy of the UT-B 2022 and UT-B 2023 testing events on 1/10/24 at 11:53 am and it was not made available. 3. An interview on 1/10/24 at 12:27 pm with the Technical Supervisor revealed the laboratory had not documented its verification of accuracy of the UT-B 2022 and UT-B 2023 testing events. -- 2 of 4 -- D5311 SPECIMEN SUBMISSION, HANDLING, AND REFERRAL CFR(s): 493.1242(a) The laboratory must establish and follow written policies and procedures for each of the following, if applicable: (1) Patient preparation. (2) Specimen collection. (3) Specimen labeling, including patient name or unique patient identifier and, when appropriate, specimen source. (4) Specimen storage and preservation. (5) Conditions for specimen transportation. (6) Specimen processing. (7) Specimen acceptability and rejection. (8) Specimen referral. This STANDARD is not met as evidenced by: . Based on record review and interviews, the laboratory failed to establish a written policy for conditions of specimen transportation for 2 (January 2022 to January 2024) of 2 years. Findings include: 1. An interview on 1/10/24 at 9:54 am with the Testing Personnel revealed the specimens received by the laboratory from outside clinics are received by local drop-off. 2. A review of the laboratory's "Specimen Handling and Requisition Procedure" revealed a lack of conditions of specimen transportation via local drop-off. 3. An interview on 1/10/24 at 11:14 am with the Technical Supervisor confirmed the laboratory had not established a policy to include the conditions for specimen transportation via local specimen drop-off. 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. This STANDARD is not met as evidenced by: . Based on record review and interview with the Testing Personnel, the laboratory failed to monitor and document the urine specimen freezer temperatures for 2 (January 2022 to January 2024) of 2 years reviewed. Findings include: 1. A review of the laboratory's temperature monitoring logs revealed a lack of monitoring the freezer holding urine specimens. 2. The surveyor requested the specimen freezer temperature logs on 1/10/24 at 11:28 am and they were not made available. 3. An interview on 1/10 /24 at 11:35 am with the Testing Personnel confirmed the laboratory did not have the urine specimen freezer temperature monitoring documentation available. D6079 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1445(a)(b) The laboratory director is responsible for the overall operation and administration of the laboratory, including the employment of personnel who are competent to perform test procedures, record and report test results promptly, accurately and proficiently, and for assuring compliance with the applicable regulations. (a) The laboratory director, if qualified, may perform the duties of the technical supervisor, clinical consultant, general supervisor, and testing personnel, or delegate these responsibilities -- 3 of 4 -- to personnel meeting the qualifications under 493.1447, 493.1453, 493.1459, and 493.1487 respectively. (b) If the laboratory director reapportions performance of his or her responsibilities, he or she remains responsible for ensuring that all duties are properly performed. This STANDARD is not met as evidenced by: . Based on record review and interview with the Technical Supervisor, the Laboratory Director failed to ensure the laboratory notified the State Agency when a change in laboratory director was made in accordance with 493.51 for 14 (November 2022 to January 2024) of 14 months. Findings include: 1. An interview on 1/10/23 at 9:12 am with the Technical Supervisor revealed the laboratory had changed their laboratory director in November 2022. 2. A review of the laboratory's records and the CMS database revealed the laboratory failed notify the State Agency when the laboratory changed its laboratory director in compliance with 493.51, which states: "Laboratories issued a certificate of compliance must meet the following conditions: (a) Notify HHS or its designee within 30 days of any change in-- (1) Ownership; (2) Name; (3) Location; (4) Director; or (5) Technical supervisor (laboratories performing high complexity only). (b) Notify HHS no later than 6 months after performing any test or examination within a specialty or subspecialty area that is not included on the laboratory ' s certificate of compliance, so that compliance with requirements can be determined. (c) Notify HHS no later than 6 months after any deletions or changes in test methodologies for any test or examination included in a specialty or subspecialty, or both, for which the laboratory has been issued a certificate of compliance." D6094 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1445(e)(5) The laboratory director must ensure that the quality assessment programs are established and maintained to assure the quality of laboratory services provided and to identify failures in quality as they occur. This STANDARD is not met as evidenced by: . Based on record review and interview with the Technical Supervisor, the Laboratory Director failed to ensure the quality assessment program was maintained for 2 (January 2022 to January 2024) of 2 years. Findings include: 1. A review of the laboratory's "Quality Assessment Plan" revealed a section stating, "Reviews will be conducted quarterly by the supervisor" and "The file containing completed quality assurance reports will be reviewed at least 2 times a year to verify that reviews are performed as scheduled and there are not recurrent problems requiring attention." 2. A review of the laboratory's quality assessment documentation revealed a lack of quality assessments performed quarterly between January 2022 and January 2024. 3. The surveyor requested documentation of the quarterly quality assessment reviews on 10: 53 am and they were not made available. 4. An interview on 1/10/24 at 11:46 am with the Technical Supervisor confirmed the laboratory had not performed quality assessments at least quarterly according to their quality assessment program. -- 4 of 4 --

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 record review and interview with the Technical Supervisor (TS), the laboratory failed to verify the accuracy of its quantitative toxicology testing at least twice annually for 2 (January 2020 to January 2022) of 2 years reviewed. Findings include: 1. A review of the laboratory's verification of accuracy data revealed it tests the following toxicology analytes: a. 6-Monoacetylmorphine b. 7-Aminoclonazepam c. alpha-hydroxyalprazolam d. alprazolam e. amphetamine f. benzoylecgonine g. buprenorphine h. bupropion i. butalbital j. carisoprodol k. clonazepam l. codeine m. cyclobenzaprine n. desipramine o. diazepam p. doxepin q. duloxetine r. EDDP s. ETS t. fentanyl u. fluoxetine v. gabapentin w. hydrocodone x. hydromorphone y. imipramine z. ketamine aa. lorazepam bb. MDMA cc. meperidine dd. meprobamate ee. methadone ff. methamphetamine gg. midazolam hh. mitragynine ii. morphine jj. naloxone kk. naltrexone ll. N-desmethyl-Tapentadol mm. norbuprenorphine nn. norcodeine oo. nordiazepam pp. norfentanyl qq. norhydrocodone rr. normeperidine ss. noroxycodone tt. nortriptyline uu. O-Desmethyltramadol vv. oxazepam ww. oxycodone xx. oxymorphone yy. PCP zz. phenobarbital aaa. pregabalin bbb. ritalinic acid ccc. secobarbital ddd. sertraline eee. tapentadol fff. temazepam ggg. thc-cooh hhh. tramadol iii. venlafaxine jjj. zolpidem 2. A review of the laboratory's verification of accuracy records revealed the laboratory performed testing once in March 2021 and once in March 2020. 3. The surveyor requested the second verification of accuracy testing events for 2020 and 2021 on 1/18/22 at 10:52 am and they were not made available. 4. An interview on 1/18/22 at 10:52 am with the TS confirmed the laboratory did not perform verification of accuracy testing for the analytes listed above at least twice annually in 2020 and 2021. 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 -- 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, record review and interview with the Technical Supervisor (TS), the laboratory failed to label reagents with the concentration and expiration date for 4 of 5 solutions observed. Findings include: 1. The surveyor observed the following reagents during a tour of the laboratory on 1/18/22 at 8:59 am: a. One bottle with "Water" and "12/2/21" and no expiration date listed. b. One bottle with "MeOH" and "1/12/22" and no expiration date listed. c. One bottle with "MPA" and "Prep: 1/3 /22" and no concentration or expiration date listed. d. One bottle with "B" and "Prep: 1 /13/22" and no concentration or expiration date listed. 2. A review of the laboratory's policy revealed a section titled "Laboratory Reagents and Glassware" stating, "Reagents shall adhere to the following standards: a. All reagents prepared by the laboratory will be marked with initials of preparer, preparation and expiration date. b. All reagents purchased from a commercial vendor will be marked with date of receipt and initials of receiver. c. All reagents will be marked with date opened. d. All reagents will be marked with expiration date. e. All reagents will be stored in accordance with manufacturer's specifications." 3. An interview on 1/18/22 at 9:10 am with the TS confirmed the reagent bottles listed above were not labeled with concentration and expiration dates. ***This is a repeated deficiency from the 3/16/20 initial certification 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 observation, record review, and interview with the Technical Supervisor (TS), the laboratory failed to ensure centrifuge and fume hood function checks were performed for 2 (January 2020 to January 2022) of 2 years reviewed. Findings include: 1. The surveyor observed a VWR centrifuge and a fume hood in the laboratory during a tour on 1/18/22 at 8:59 am. 2. A review of the laboratory's "PERFORMANCE CHECK POLICY FOR INSTUMENTS OF MEASURE" revealed a section titled "Centrifuges, Pippettes, Balances, Hoods" stating, "All centrifuges, Pippettes, Balances and hoods are to be assessed for performance on a yearly basis. This laboratory issues Vitec Calibration as its performance check vendor." 3. The surveyor requested documentation of the performance assessed annually for the fume -- 2 of 3 -- hood and the centrifuge on 1/18/22 at 10:57 am and it was not made available. 4. An interview on 1/18/22 at 10:57 am with the TS confirmed the laboratory did not perform function checks for the centrifuge and fume hood. D6092 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1445(e)(4)(iv) The laboratory director must ensure an approved

Summary Statement of Deficiencies D5301 TEST REQUEST CFR(s): 493.1241(a) The laboratory must have a written or electronic request for patient testing from an authorized person. This STANDARD is not met as evidenced by: . Based on record review and interview with the Technical Supervisor (TS), the laboratory failed to have a electronic test request for patient testing for 9 (patients #1- #9) of 9 patient results reviewed. Findings include: 1. Record review of patient test requests revealed patients #1-#9 did not have orders indicated on the electronic test request for the following tests that were performed and resulted: Zolpidem and Ethyl Sulfate (ETS). 2. During the interview on 3/16/2020 at approximately 2:20 pm, the TS confirmed the laboratory did not have an electronic test request for all the tests reported out on the final test reports. 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, record review, and interview with the Technical Supervisor (TS) and Testing Personnel (TP) #1, the laboratory failed to label the toxicology reagents located in the refrigerator and on the toxicology analyzer for 9 (July 2019 to 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 -- March 2020) of 9 months of operation with the open date and content with the concentration of the reagent. Findings include: 1. During a tour of the laboratory on 3 /16/2020 at 9:10 am, the surveyor observed reagents in use in the refrigerator and located on the AB Sciex Triple Quad 4500 toxicology analyzer that did not have documentation of the open date and content with the concentration of the reagent as follows: a. refrigerator - no open dates 1. Internal Standard 2. IMCSzyne >50 ku/ml 3. IMCS Rapid Hydrolysis Buffer b. AB Sciex Triple Quad 4500 analyzer - no content with the concentration of reagent 1. Phase A 2. Phase B 3. Needle Wash 2. Review of the laboratory's established procedure manual revealed a procedure "Quality Assurance Plan" that stated in Section III "Laboratory Reagents and Glassware" the following that was not followed: "A. Reagents 3. Reagents shall adhere to the following standards: a. All reagents prepared by the laboratory will be marked with initials of preparer, preparation and expiration date. b. All reagents purchased from a commercial vendor will be marked with date of receipt and initials of receiver. c. All reagents will be marked with date opened. d. All reagents will be marked with expiration date. e. All reagents will be stored in accordance with manufacturer's specifications. f. All reagents will be labeled to indicate content and if appropriate, concentration or titer. g. Reagents shelf life will be observed and will not be used after their expiration date, have deteriorated or are of substandard quality." 3. During the interview on 3/16/2020 at 9:10 am, TS and TP1 confirmed the policy was not followed and the reagents listed above were not labeled properly. -- 2 of 2 --