Mid Michigan Pain Management

Summary Statement of Deficiencies 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 observation, record review, and interview with collection staff, the laboratory failed to follow its specimen labeling policy for its qualitative urine toxicology testing for 1 of 1 patient specimen observed. Findings include: 1. The surveyor toured the laboratory on 11/29/23 at 9:24 am and observed a urine specimen on a table collected in a plastic container with a Post-It note placed on the top with patient information and no information indicated on the specimen. 2. A review of the laboratory's specimen collection policy revealed a section titled "Urine Collection" stating, "The container must have a label that will adhere under refrigeration. The label must include the patient's identification and the date and time of specimen collection and the labels must be placed on the container, not on the lid." 3. An interview on 11/29/23 at 9:28 am with the collection staff confirmed the specimen was not labeled. 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. 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 -- This STANDARD is not met as evidenced by: . Based on observation and interview with the Technical Consultant, the laboratory failed to ensure its Medica Easy RA reagent had not been used beyond its expiration dates for 1 onboard reagent observed. Findings include: 1. The surveyor toured the laboratory on 11/29/23 at 9:13 am revealed the onboard reagent for its Medica Easy RA instrument included both deionized water and surfactant. The surfactant had the expiration date of 11/9/2022. 2. An interview on 11/29/23 at 9:16 am with the Technical Consultant confirmed the surfactant reagent had been expired. -- 2 of 2 --

Summary Statement of Deficiencies 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 Technical Consultant (TC), the laboratory failed to ensure the individuals using test results were notified of reporting errors when quality control did not pass for 1 (8/8/20) of 13 dates reviewed. Findings include: 1. A review of quality control records on 8/8/20 revealed quality control testing for Opiates was out of range. 2. A review of patient test reports from 8/8/20 revealed the results for Opiates was crossed out with a single line. The test result was visible and did not indicate why the result had a line through it. 3. An interview on 2 /14/22 at 10:17 am with the TC confirmed documentation of the notification of individuals using the test reports with reporting errors was not 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 --

Summary Statement of Deficiencies D2015 TESTING OF PROFICIENCY TESTING SAMPLES CFR(s): 493.801(b)(5)(6) (5) The laboratory must document the handling, preparation, processing, examination, and each step in the testing and reporting of results for all proficiency testing samples. The laboratory must maintain a copy of all records, including a copy of the proficiency testing program report forms used by the laboratory to record proficiency testing results including the attestation statement provided by the PT program, signed by the analyst and the laboratory director, documenting that proficiency testing samples were tested in the same manner as patient specimens, for a minimum of two years from the date of the proficiency testing event. (6) PT is required for only the test system, assay, or examination used as the primary method for patient testing during the PT event. This STANDARD is not met as evidenced by: . Based on record review and interview with the Technical Consultant (TC), the laboratory failed to 1) maintain the original proficiency testing (PT) program report forms and the instrument printouts for 2 (2nd events for 2018 and 2019) of 2 events reviewed and 2) maintain the signed attestation statement sheet for 1 (2nd event 2018) of 2 events reviewed, and 3) maintain documentation of review of the final graded proficiency testing reports for 1 (2nd event 2018) of 2 events reviewed. Findings include: 1. Record review of the American Association of Bioanalysts (AAB) and the American Proficiency Institute (API) final PT documents revealed the laboratory did not maintain the original proficiency testing program report forms and the instrument printouts as follows: a. AAB - 2nd event 2018 original PT program report forms and the instrument printouts b. API - 2nd event 2019 original PT program report forms and the instrument printouts. 2. Record review of the AAB final PT documents revealed the laboratory did not maintain the signed attestation statement sheet for the 2nd event 2018. 3. Record review of the AAB final PT documents revealed the laboratory did maintain documentation of review of the final PT reports for the 2nd 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 -- event of 2018. 4. During the interview on 1/14/2020 at 10:25 am, the TC confirmed the above findings were not maintained by the laboratory. D2016 SUCCESSFUL PARTICIPATION CFR(s): 493.803(a)(b)(c) (a) Each laboratory performing nonwaived testing must successfully participate in a proficiency testing program approved by CMS, if applicable, as described in subpart I of this part for each specialty, subspecialty, and analyte or test in which the laboratory is certified under CLIA. (b) Except as specified in paragraph (c) of this section, if a laboratory fails to participate successfully in proficiency testing for a given specialty, subspecialty, analyte or test, as defined in this section, or fails to take remedial action when an individual fails gynecologic cytology, CMS imposes sanctions, as specified in subpart R of this part. (c) If a laboratory fails to perform successfully in a CMS- approved proficiency testing program, for the initial unsuccessful performance, CMS may direct the laboratory to undertake training of its personnel or to obtain technical assistance, or both, rather than imposing alternative or principle sanctions except when one or more of the following conditions exists: (1) There is immediate jeopardy to patient health and safety. (2) The laboratory fails to provide CMS or a CMS agent with satisfactory evidence that it has taken steps to correct the problem identified by the unsuccessful proficiency testing performance. (3) The laboratory has a poor compliance history. This CONDITION is not met as evidenced by: . Based on record review of the CMS database, American Association of Bioanalysts (AAB), and the American Proficiency Institute (API), and interview with the Technical Consultant (TC), the laboratory failed to be enrolled in a toxicology proficiency testing (PT) program for 2 (1st event 2018 and 2019) of 4 events in 2 years. Findings include: 1. Record review of the CMS database, the AAB and API proficiency testing program final reports revealed the laboratory was not enrolled in a proficiency testing program for 2 (1st event 2018 and 2019) of 4 events. 2. When queried on 1/14/2020 at 10:25 am, Testing Personnel #1 (TP1) stated the order for the 2019 API program did not go through. 3. During the interview on 1/14/2020 at 10:25 am, TP1 and the TC confirmed the laboratory was not enrolled in a PT program for the 1st events of 2018 and 2019. D3027 RETENTION REQUIREMENTS CFR(s): 493.1105(a)(1) Test requisitions and authorizations. Retain records of test requisitions and test authorizations, including the patient's chart or medical record if used as the test requisition or authorization, for at least 2 years. This STANDARD is not met as evidenced by: . Based on patient chart review and interview with Testing Personnel #1 (TP1) and the Technical Consultant (TC), the laboratory failed to retain patient written requisitions and/or electronic orders for 7 (January to July 2018) of 7 months of patient testing. Findings include: 1. Patient chart review revealed for 7 (January to July 2018) of 7 months of testing a lack of documentation of the patient's test requisition. 2. When queried on 1/14/2020 at approximately 1:15 pm, TP1 and the TC were unable to locate test requisitions for patient testing for 7 of 7 months in 2018. 3. During the -- 2 of 4 -- interviews on 1/14/2020 at approximately 1:15 pm, TP1 and the TC confirmed there was not a method to track patient test requisitions and/or electronic orders. 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 Testing Personnel #1 (TP1) and the Technical Consultant (TC), the laboratory failed to retain the chemistry Synermed IR 500 patient test results for 7 (January to July 2018) of 7 months reviewed for 2 years. Findings include: 1. Record review of the Synermed IR 500 instrument documents showed the instrument was in use from January to July of 2018. 2. Record review of the Synermed IR 500 documents revealed a lack of documentation of patient final test results for 7 of 7 months reviewed in 2018. 3. During the interview on 1/14/2020 1:15 pm, TP1 and TC confirmed patient final test results were not available on the day of the survey and retained for 2 years. D5421 ESTABLISHMENT AND VERIFICATION OF PERFORMANCE CFR(s): 493.1253(b)(1) Each laboratory that introduces an unmodified, FDA-cleared or approved test system must do the following before reporting patient test results: (1)(i) Demonstrate that it can obtain performance specifications comparable to those established by the manufacturer for the following performance characteristics: (1)(i)(A) Accuracy. (1)(i) (B) Precision. (1)(i)(C) Reportable range of test results for the test system. (1)(ii) Verify that the manufacturer's reference intervals (normal values) are appropriate for the laboratory's patient population. This STANDARD is not met as evidenced by: . Based on record review and interview with the Technical Consultant (TC), the laboratory failed to perform and document method validation for the Medica EasyRa chemistry instrument for 17 (September 2018 to January 2020) of 17 months of patient testing. Findings include: 1. Record review of the Medica EasyRa chemistry instrument revealed there was no documentation to show the new instrument installed in 9/2018 was validated for accuracy, precision, reportable range, and verification of the patient normal ranges for 17 months of operation. 2. When queried on 1/14/2020 at 12:30 pm, the TC stated they had been performed. No documentation was available to the surveyor to show the performance specifications had been performed and documented. 3. During the interview on 1/14/2020 at 12:30 pm, the TC confirmed the performance verification documentation was not available on the day of the survey. D6063 LABORATORY TESTING PERSONNEL CFR(s): 493.1421 The laboratory must have a sufficient number of individuals who meet the qualification requirements of 493.1423, to perform the functions specified in 493. 1425 for the volume and complexity of tests performed. -- 3 of 4 -- This CONDITION is not met as evidenced by: . Based on record review and interview with the Technical Consultant (TC), the laboratory failed to provide the educational requirements for 1 (Testing Personnel #1) of 1 testing personnel performing moderately complex toxicology testing. Refer to D6065. D6065 TESTING PERSONNEL QUALIFICATIONS CFR(s): 493.1423(b)(1)(2)(3)(4)(i) (b) Meet one of the following requirements: (b)(1) Be a doctor of medicine or doctor of osteopathy licensed to practice medicine or osteopathy in the State in which the laboratory is located or have earned a doctoral, master's, or bachelor's degree in a chemical, physical, biological or clinical laboratory science, or medical technology from an accredited institution; or (b)(2) Have earned an associate degree in a chemical, physical or biological science or medical laboratory technology from an accredited institution; or (b)(3) Be a high school graduate or equivalent and have successfully completed an official military medical laboratory procedures course of at least 50 weeks duration and have held the military enlisted occupational specialty of Medical Laboratory Specialist (Laboratory Technician); or (b)(4)(i) Have earned a high school diploma or equivalent; and This STANDARD is not met as evidenced by: . Based on record review and interview with the Technical Consultant (TC), the laboratory failed to ensure all testing personnel met the educational requirements at 493.1423 for 1 (Testing Personnel #1) of 1 testing personnel. Findings include: 1. Record review of testing personnel credentials revealed a lack of documentation of the equivalency evaluation for a foreign academic credentials for Testing Personnel #1 performing moderately complex toxicology testing. 2. During the interview on 1/14 /2020 at 9:40 am, the TC confirmed the above findings. 3. The laboratory was given 7 additional days to supply the necessary educational documents. The documents were not received. -- 4 of 4 --

Summary Statement of Deficiencies 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 procedure manual review and interview, the laboratory failed to ensure written competency policies were established that contained the requirements from subpart M for the testing personnel performing the highly complex chemistry and toxicology testing. Findings include: 1. On April 23, 2018 at approximately 9:30 AM, review of the testing personnel files in the "Mid Michigan Pain Management Personal Files" notebook revealed testing personnel #1 as listed on the CMS-209 was evaluated initially by a checklist. 2. On April 23, 2018 at 11:50 AM, procedure manual review revealed the laboratory did not establish a written competency policy that included the six requirements from subpart M for the high complex chemistry and toxicology testing that included the following: a. Direct observations of routine patient test performance, patient preparation, specimen handling, processing, and testing. b. Monitoring the recording and reporting of patient test results. c. Review of test results, worksheets, quality control records, proficiency testing results, and preventive maintenance. d. Direct observation of performance of instrument maintenance and function checks. e. Assessment of test performance through testing previously analyzed samples. f. Assessment of problem solving skills. 3. During the interview on April 23, 2018 at 11:50 AM, testing personnel #1 confirmed the laboratory did not establish a competency policy that contained the requirements from Subpart M. D5301 TEST REQUEST CFR(s): 493.1241(a) 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 -- 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, the laboratory failed to have a written request or standing order for patient testing from an authorized person for the routine chemistry and toxicology testing for nine (#1 - #9) of nine patient charts audited. Findings include: 1. On April 23 2018 at 12:15 PM, record review revealed for nine (#1-#9) of nine patient charts audited the laboratory did not have a written request or standing order for the routine chemistry and toxicology testing by an authorized person. 2. During the interview on April 23, 2018 at 12:15 PM, testing personnel #1 as listed on the CMS-209 confirmed a written request or standing order by an authorized person was not available on the day of the survey. D5305 TEST REQUEST CFR(s): 493.1241(c) The laboratory must ensure the test requisition solicits the following information: (1) The name and address or other suitable identifiers of the authorized person requesting the test and, if appropriate, the individual responsible for using the test results, or the name and address of the laboratory submitting the specimen, including, as applicable, a contact person to enable the reporting of imminently life threatening laboratory results or panic or alert values. (2) The patient's name or unique patient identifier. (3) The sex and age or date of birth of the patient. (4) The test(s) to be performed. (5) The source of the specimen, when appropriate. (6) The date and, if appropriate, time of specimen collection. (7) For Pap smears, the patient's last menstrual period, and indication of whether the patient had a previous abnormal report, treatment, or biopsy. (8) Any additional information relevant and necessary for a specific test to ensure accurate and timely testing and reporting of results, including interpretation, if applicable. This STANDARD is not met as evidenced by: . Based on test requisition review and interview, the laboratory failed to provide the name and address of the testing facility for nine (#1-#9) of nine patient charts audited. Findings include: 1. On April 23, 2018 at 12:15 PM, test requisition review revealed the name and address of the testing facility was not included on the requisition for nine (#1-#9) of nine patient charts audited. 2. During the interview on April 23 2018 at 12:15 PM, testing personnel #1 as listed on the CMS-209 confirmed the test requisition did not contain all the laboratory specific information. D5407 PROCEDURE MANUAL CFR(s): 493.1251(d) Procedures and changes in procedures must be approved, signed, and dated by the current laboratory director before use. This STANDARD is not met as evidenced by: . Based on procedure manual review and interview, the laboratory director failed to approve, sign, and date five of five Enzyme Immunoassay and one of one validity policies and procedures before they were put into use. Findings include: 1. On April -- 2 of 3 -- 23, 2018 at 11:47 AM, procedure manual review revealed there was no documentation to show for five of five Enzyme Immunoassay and one of one validity testing policies and procedures had been approved, signed, and dated before they were put into use as follows: a. Enzyme Immunoassay 1. IR 500 Benzodiazepine Enzyme Immunoassay 2. IR 500 Cocaine Metabolite Enzyme Immunoassay 3. IR 500 Opiate Enzyme Immunoassay 4. IR 500 Oxycodone Enzyme Immunoassay 5. IR 500 Cannabinoids (cTHC) 50 Enzyme Immunoassay b. Validity testing 1. IR 500 Urine Creatinine Validity Test 2. During the interview on April 23, 2018 at 11:47 AM, testing personnel #1 as listed on the CMS-209 confirmed the policies and procedures were not signed before being put into use. -- 3 of 3 --