Pain Management Institute

Summary Statement of Deficiencies D3000 FACILITY ADMINISTRATION CFR(s): 493.1100 Each laboratory that performs nonwaived testing must meet the applicable requirements under 493.1101 through 493.1105, unless HHS approves a procedure that provides equivalent quality testing as specified in Appendix C of the State Operations Manual (CMS Pub. 7). (a) Reporting of SARS-CoV-2 test results During the Public Health Emergency, as defined in 400.200 of this chapter, each laboratory that performs a test that is intended to detect SARS-CoV-2 or to diagnose a possible case of COVID-19 (hereinafter referred to as a "SARS-CoV-2 test") must report SARS-CoV-2 test results to the Secretary in such form and manner, and at such timing and frequency, as the Secretary may prescribe. This CONDITION is not met as evidenced by: Based on review of the laboratory's application for CLIA Certification (CMS 116); COVID test results; COVID reporting; and interview with personnel from the doctor's office and the technical consultant, the laboratory failed to report its waived rapid COVID-19 Antigen testing to the Illinois Department of Public Health (IDPH). Findings: 1. On April 6, 2021 at 2:00 PM, surveyor review of the laboratory's (CMS 116) revealed that the laboratory performs the following tests: a. Toxicology - Moderate Complexity Testing using the Medica Easy RA analyzer b. Rapid HCG - Waived Test using McKesson Consult Rapid Cassette c. Rapid COVID-19 Antigen using Care Start Rapid Cassette 2. On April 6, 2021 at 4:30 PM, the surveyor requested testing logs for COVID-19 Antigen Tests. The technical consultant told the surveyor that her laboratory was not the personnel performing any of the waived testing. Doctors on the floor above the laboratory performed waived testing under the labs CLIA Certificate. 3. On April 6, 2021 at 5:00 PM, at the request of the surveyor, personnel from the doctor's office made copies of the COVID-19 Antigen testing logs and patients' test reports for the surveyor. The surveyor received the following documentation: a. COVID-19 Antigen testing logs with 61 patients' names from 01/13 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 -- /21 to 03/24/21 where 1 of 61 patients' test results was documented in the log as "POS". b. 7 patients' test reports from 03/24/2021- all reported as 'NEGATIVE"; no Reference Range is documented on the report. c. 21 patients' test reports from 03/31 /2021 - all reported as 'NEGATIVE"; no Reference Range is documented on the report. 4. On April 2021 at 5:00 PM, in an interview with office staff it was revealed that the laboratory reported only positive COVID- 19 test results to IDPH, telling the surveyor that they only had one positive COVID-19 patient test thus far. There were no negative test results reported to IDPH for 7 of 7 patients tested on 03/24/2021 and 21 of 21 patients tested on 03/31/2021. 5.On April 2021 at 5:30 PM, the surveyor asked the technical consultant if she was aware that both positive and negative COVID-19 tests should be reported to IDPH. The technical consultant said she is aware of the requirements for reporting all COVID results to IDPH but did not ensure the doctor's office knows the requirement for reporting all COVID-19 test results to IDPH. D5789 TEST RECORDS CFR(s): 493.1283(b) Records of patient testing including, if applicable, instrument printouts, must be retained. This STANDARD is not met as evidenced by: Based on review of the laboratory's procedures manual; patients' testing logs; patient's test reports; and interview with the technical consultant, the laboratory failed to retain patients' toxicology test records for at least 2 years. Findings: 1. The laboratory's procedures manual contained a page which lists retention requirements of at least 2 years for the following information: a. Requisitions b. Test Records c. Test Reports d. Quality Control Records e. Calibration Records f. Maintenance Records g. Proficiency Test Records 2. On April 6, 2021 at 4:00 PM, the surveyor reviewed the patients' test logs. 3. The surveyor selected a total of 5 patients names from the patients' testing logs and requested the following documents for each patient: a. the patients' test reports b. corresponding Quality Control records for patients' test reports selected. 4. On April 6, 2021 at 4:00 PM, surveyor review of patient's test records revealed, there was no test report for 1 of 5 patients test records selected for review. 6. On April 6, 2021 at 4:30 PM, the technical consultant confirmed the surveyor's findings. 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 observations; review of the laboratory's procedures manual; patients' testing -- 2 of 3 -- logs; patient's test reports; and interview with the technical consultant, the laboratory failed to ensure test results and patient specific data are accurately and reliably sent from the point of data entry to final report destination in a timely manner. Findings: 1. On April 6, 2021 at 4:00 PM, the surveyor observed that the laboratory performs toxicology testing where a physical result is printed and manually entered into patients' Electronic Medical Record (EMR) that is shared with the lab's reference laboratory. 2. There were no written procedures that describes the laboratory's process for how it ensures all patients test result get entered in the EMR. 3. On April 6, 2021 at 4:00PM the surveyor selected a total of 5 patients names from the patients' testing logs. The surveyor requested the patients' test reports and corresponding Quality Control records for each patient selected. The EMR shows the results of toxicology test results performed by a reference laboratory on July 23, 2019 for 1 of 4 patients reports selected for review. However, there was no record of the toxicology screening test reports entered in the EMR for 1 of 5 patients test records selected for review. 5. Review of the testing logs shows that the patients' specimen for the missing toxicology report was collected on July 16, 2019. 6. On April 6, 2021 at 4:30 PM, the technical consultant confirmed the surveyor's findings. D5891 POSTANALYTIC SYSTEMS QUALITY ASSESSMENT CFR(s): 493.1299(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 postanalytic systems specified in 493.1291. This STANDARD is not met as evidenced by: Based on review of the laboratory's procedures manual; patients test records; and interview with the technical consultant, the laboratory failed to establish and follow written policies and procedures for an ongoing mechanism to monitor, assess, and correct problems identified in the post analytic systems specified in 493.1291. Findings: 1. There were no procedures that described how the laboratory ensures its toxicology screening results are entered in patient's Electronic Medical Records (EMR). 2. On April 6, 2021 at 4:00 PM, review of patient's tests reports revealed that there was no record of test performance for 1 of 5 patients' test results reviewed. See tag D5789 3. On April 6, 2021 at 4:00 PM, review of patient's tests reports revealed that there was no record of test results in the Electronic Medical Record for 1 of 5 patients' test results reviewed. See tag D5801 4. On April 6, 2021 at 4:30 PM, the technical consultant confirmed the surveyor's findings. -- 3 of 3 --

Summary Statement of Deficiencies D3000 FACILITY ADMINISTRATION CFR(s): 493.1100 Each laboratory that performs nonwaived testing must meet the applicable requirements under 493.1101 through 493.1105, unless HHS approves a procedure that provides equivalent quality testing as specified in Appendix C of the State Operations Manual (CMS Pub. 7). (a) Reporting of SARS-CoV-2 test results During the Public Health Emergency, as defined in 400.200 of this chapter, each laboratory that performs a test that is intended to detect SARS-CoV-2 or to diagnose a possible case of COVID-19 (hereinafter referred to as a "SARS-CoV-2 test") must report SARS-CoV-2 test results to the Secretary in such form and manner, and at such timing and frequency, as the Secretary may prescribe. This CONDITION is not met as evidenced by: Based on review of the laboratory's application for CLIA Certification (CMS 116); COVID test results; COVID reporting; and interview with personnel from the doctor's office and the technical consultant, the laboratory failed to report its waived rapid COVID-19 Antigen testing to the Illinois Department of Public Health (IDPH). Findings: 1. On April 6, 2021 at 2:00 PM, surveyor review of the laboratory's (CMS 116) revealed that the laboratory performs the following tests: a. Toxicology - Moderate Complexity Testing using the Medica Easy RA analyzer b. Rapid HCG - Waived Test using McKesson Consult Rapid Cassette c. Rapid COVID-19 Antigen using Care Start Rapid Cassette 2. On April 6, 2021 at 4:30 PM, the surveyor requested testing logs for COVID-19 Antigen Tests. The technical consultant told the surveyor that her laboratory was not the personnel performing any of the waived testing. Doctors on the floor above the laboratory performed waived testing under the labs CLIA Certificate. 3. On April 6, 2021 at 5:00 PM, at the request of the surveyor, personnel from the doctor's office made copies of the COVID-19 Antigen testing logs and patients' test reports for the surveyor. The surveyor received the following documentation: a. COVID-19 Antigen testing logs with 61 patients' names from 01/13 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 -- /21 to 03/24/21 where 1 of 61 patients' test results was documented in the log as "POS". b. 7 patients' test reports from 03/24/2021- all reported as 'NEGATIVE"; no Reference Range is documented on the report. c. 21 patients' test reports from 03/31 /2021 - all reported as 'NEGATIVE"; no Reference Range is documented on the report. 4. On April 2021 at 5:00 PM, in an interview with office staff it was revealed that the laboratory reported only positive COVID- 19 test results to IDPH, telling the surveyor that they only had one positive COVID-19 patient test thus far. There were no negative test results reported to IDPH for 7 of 7 patients tested on 03/24/2021 and 21 of 21 patients tested on 03/31/2021. 5.On April 2021 at 5:30 PM, the surveyor asked the technical consultant if she was aware that both positive and negative COVID-19 tests should be reported to IDPH. The technical consultant said she is aware of the requirements for reporting all COVID results to IDPH but did not ensure the doctor's office knows the requirement for reporting all COVID-19 test results to IDPH. D5789 TEST RECORDS CFR(s): 493.1283(b) Records of patient testing including, if applicable, instrument printouts, must be retained. This STANDARD is not met as evidenced by: Based on review of the laboratory's procedures manual; patients' testing logs; patient's test reports; and interview with the technical consultant, the laboratory failed to retain patients' toxicology test records for at least 2 years. Findings: 1. The laboratory's procedures manual contained a page which lists retention requirements of at least 2 years for the following information: a. Requisitions b. Test Records c. Test Reports d. Quality Control Records e. Calibration Records f. Maintenance Records g. Proficiency Test Records 2. On April 6, 2021 at 4:00 PM, the surveyor reviewed the patients' test logs. 3. The surveyor selected a total of 5 patients names from the patients' testing logs and requested the following documents for each patient: a. the patients' test reports b. corresponding Quality Control records for patients' test reports selected. 4. On April 6, 2021 at 4:00 PM, surveyor review of patient's test records revealed, there was no test report for 1 of 5 patients test records selected for review. 6. On April 6, 2021 at 4:30 PM, the technical consultant confirmed the surveyor's findings. 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 observations; review of the laboratory's procedures manual; patients' testing -- 2 of 3 -- logs; patient's test reports; and interview with the technical consultant, the laboratory failed to ensure test results and patient specific data are accurately and reliably sent from the point of data entry to final report destination in a timely manner. Findings: 1. On April 6, 2021 at 4:00 PM, the surveyor observed that the laboratory performs toxicology testing where a physical result is printed and manually entered into patients' Electronic Medical Record (EMR) that is shared with the lab's reference laboratory. 2. There were no written procedures that describes the laboratory's process for how it ensures all patients test result get entered in the EMR. 3. On April 6, 2021 at 4:00PM the surveyor selected a total of 5 patients names from the patients' testing logs. The surveyor requested the patients' test reports and corresponding Quality Control records for each patient selected. The EMR shows the results of toxicology test results performed by a reference laboratory on July 23, 2019 for 1 of 4 patients reports selected for review. However, there was no record of the toxicology screening test reports entered in the EMR for 1 of 5 patients test records selected for review. 5. Review of the testing logs shows that the patients' specimen for the missing toxicology report was collected on July 16, 2019. 6. On April 6, 2021 at 4:30 PM, the technical consultant confirmed the surveyor's findings. D5891 POSTANALYTIC SYSTEMS QUALITY ASSESSMENT CFR(s): 493.1299(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 postanalytic systems specified in 493.1291. This STANDARD is not met as evidenced by: Based on review of the laboratory's procedures manual; patients test records; and interview with the technical consultant, the laboratory failed to establish and follow written policies and procedures for an ongoing mechanism to monitor, assess, and correct problems identified in the post analytic systems specified in 493.1291. Findings: 1. There were no procedures that described how the laboratory ensures its toxicology screening results are entered in patient's Electronic Medical Records (EMR). 2. On April 6, 2021 at 4:00 PM, review of patient's tests reports revealed that there was no record of test performance for 1 of 5 patients' test results reviewed. See tag D5789 3. On April 6, 2021 at 4:00 PM, review of patient's tests reports revealed that there was no record of test results in the Electronic Medical Record for 1 of 5 patients' test results reviewed. See tag D5801 4. On April 6, 2021 at 4:30 PM, the technical consultant confirmed the surveyor's findings. -- 3 of 3 --

Summary Statement of Deficiencies D5203 SPECIMEN IDENTIFICATION AND INTEGRITY CFR(s): 493.1232 The laboratory must establish and follow written policies and procedures that ensure positive identification and optimum integrity of a patient's specimen from the time of collection or receipt of the specimen through completion of testing and reporting of results. This STANDARD is not met as evidenced by: Based on review of laboratory records, direct observation and interviews with testing personnel (TP) #1 the technical consultant (TC); the laboratory failed to ensure specimen integrity was maintained throughout the testing process by failing to follow the laboratory's specimen storage requirements. Findings Include: 1. Review of the laboratory's policy and procedure manual identified the procedure, "PMI 100 - Laboratory Policy and Procedure Manual", which stated on page 3 under the heading of "Specimen Handling": " - If not analyzed immediately, specimens can be stored refrigerated for up to one week. - After 7 days, all specimens (if kept by facility) should be frozen. Within two months, all frozen samples should be analyzed and then discarded, or sent out for analysis." 2. During tour of the laboratory facility on 2-27- 2019, at 11:00 am, processed specimens were found stored at room temperature in the laboratory. 3. Interview with TP#1, at 11:00 am, confirmed once a specimen has been processed they are stored at room temperature in the laboratory. 4. On survey date 2- 27-2019, at 1:00 pm, the TC confirmed the laboratory was not following the specimen handling procedure as outlined in the laboratory policy and procedure manual. 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) 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 -- 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 review of laboratory records and interview with the technical consultant (TC); the laboratory's specimen handling procedure failed to meet the specimen acceptability requirements set by the manufacturer for urine toxicology testing on the Medica EasyRA analyzer. Findings Include: 1. Review of the laboratory's policy and procedure manual identified the procedure, "PMI 100 - Laboratory Policy and Procedure Manual", which stated on page 3 under the heading of "Specimen Handling": "- If not analyzed immediately, specimens can be stored refrigerated for up to one week." 2. Review of the manufacturer's reagent inserts for MEDICA Amphetamine-qualitative (AMP), Barbiturate-qualitative (BAR), Opiate-qualitative (OPI), Oxycodone Enzyme Immunoassay (OXY), and Benzodiazepine enzyme immunoassay (BZO) all state the following: "if the sample cannot be analyzed immediately, it may be stored refrigerated for up to 3 days." 3. On survey date 2-27- 2019, at 1:00 pm, the TC confirmed the laboratory's policy for specimen acceptability is not in line with the manufacturer's specimen acceptability criteria. 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 laboratory must document all control procedures performed. This STANDARD is not met as evidenced by: Based on review of laboratory records and interview with the technical consultant (TC); the laboratory failed to follow the laboratory's quality control procedure for 2 of 5 patient test dates reviewed. Findings Include: 1. Review of the laboratory's policy and procedure manual identified the procedure, "PMI 100 - Laboratory Policy and Procedure Manual", which stated on page 5 under the heading of "Quality Control Frequency Requirements": "A minimum of two levels of quality controls will be run with a batch. The negative control will have an expected value below the assay cut- off. The expected value of the positive control will be above the cut-off. Minimum frequency of control testing will be: - Each day of patient testing - After each calibration - After major or preventative maintenance - When troubleshooting QC or instrument issues - When patient results are questionable" 2. Review of quality control records for 2 of 5 patient testing dates found the Medica EasyRA was re-calibrated after quality control (QC) failures but 2 levels of quality control materials were not re- ran as outlined in the laboratory procedure. Test Date QC Analyte Failure Failed Control 2-14-2019 Oxycodone UDT A-2 (Positive) 2-21-2019 Barbiturate UDT B-2 (Positive) 3. Review of the patient testing log identified 14 patients tested on the two dates (2-14-2019 and 2-21-2019) when 2 levels of quality control were not ran after -- 2 of 3 -- calibration, as indicated in the laboratory's policy and procedure manual. 4. On survey date 2-27-2019, at 1:00 pm, the TC confirmed the laboratory failed to follow the laboratory's quality control procedure. D5805 TEST REPORT CFR(s): 493.1291(c) The test report must indicate the following: (c)(1) For positive patient identification, either the patient's name and identification number, or a unique patient identifier and identification number. (c)(2) The name and address of the laboratory location where the test was performed. (c)(3) The test report date. (c)(4) The test performed. (c)(5) Specimen source, when appropriate. (c)(6) The test result and, if applicable, the units of measurement or interpretation, or both. (c)(7) Any information regarding the condition and disposition of specimens that do not meet the laboratory's criteria for acceptability. This STANDARD is not met as evidenced by: Based on review of laboratory records and interview with the technical consultant (TC); the laboratory failed to include interpretation information for urine toxicology testing performed on the Medica EasyRA analyzer for 5 of 5 patient test reports reviewed. Findings Include: 1. Review of the reagent inserts for the analytes tested on the Medica EasyRA analyzer all indicated the following: Amphetamine-qualitative (AMP), Barbiturate qualitative (BAR), Opiate-qualitative (OPI), Oxycodone Enzyme Immunoassay (OXY), and Benzodiazepine enzyme immunoassay (BZO) "The assay provides only a preliminary analytical result. A more specific alternative chemical method must be used in order to obtain a confirmed analytical result. Gas Chromatography/mass spectrometry (GC/MS) or Liquid Chromatography/mass spectrometry (LC/MS) are the preferred confirmatory methods. Clinical consideration and professional judgement should be exercised to any drug of abuse test result, particularly when the preliminary test result is positive." 2. Review of 5 of 5 patient test reports found the reports failed to provide the above interpretation information. Test Date Patient Identification 11-21-2018 P1 12-20-2018 P2 01-21-2019 P3 02-14- 2019 P4 02-21-2019 P5 3. On survey date 2-27-2019, at 1:00 pm, the TC confirmed the laboratory failed to include the manufacturer's interpretation information on the patient test reports for urine toxicology testing performed on the Medica EasyRA analyzer. -- 3 of 3 --