Neuro Pain Consultants

Summary Statement of Deficiencies D5429 MAINTENANCE AND FUNCTION CHECKS CFR(s): 493.1254(a)(1) For unmodified manufacturer's equipment, instruments, or test systems, the laboratory must perform and document maintenance as defined by the manufacturer and with at least the frequency specified by the manufacturer. This STANDARD is not met as evidenced by: . Based on observation, lack of documentation, and interview with the Operations Manager (OM), the laboratory failed to perform and document the thermometer calibration checks as required by the manufacturer before the expiration for 6 (Thomas Scientific) of 6 thermometers in use. Findings include: 1. During a tour of the laboratory on 3/30/2023 at 9:17 am, the surveyor observed thermometers in the Maxx Cold refrigerators and the Berg freezers were in use past their expiration dates as follows: a. Maxx Cold refrigerators 1. S/N 170553844 expired 7/31/2019. 2. S/N 170553860 expired 7/31/2019. 3. S/N 170553863 expired 7/31/2019. b. Berg freezers 1. S/n 160217920 expired 2/19/2018. 2. S/N 160623490 expired 7/26/2018. 2. S/N 150113016 expired 2/18/2017. 2. A review of the "Daily Temperature Checks" procedure in the "Maintenance Manual" revealed there is no maintenance procedure for the frequency of the thermometer calibrations and/or replacement prior to the expiration date noted on the thermometer. 3. A record reviewed revealed a lack of documentation for the calibration of the thermometers and/or replacement by the expiration dates noted on the thermometers. 4. A interview on 3/30/2023 at 9:20 am, the OM confirmed the thermometers were not calibrated and/or replaced before their expiration. 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 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 Technical Supervisor #2 (TS2), the laboratory failed to follow its policy to assess employee competency for 1 (Testing Personnel #2) of 3 testing personnel listed on the CMS-209 form. 1. A review of the laboratory's "Neuro Pain Consultants Personnel" policy revealed a section stating, "Verify that a formal employee performance appraisal is conducted at the end of the first six months of employment and each year of employment thereafter." 2. A review of Testing Personnel #2's personnel documentation revealed a lack of documentation of competency assessments since the personnel was hired at the Neuro Pain Consultants laboratory on 10/26/20. 3. An interview on 8/17/21 at 1:55 pm with TS2 confirmed Testing Personnel #2 did not have documentation of competency assessments for testing at Neuro Pain Consultants since their hire date of 10/26/20. D5423 ESTABLISHMENT AND VERIFICATION OF PERFORMANCE CFR(s): 493.1253(b)(2) Each laboratory that modifies an FDA-cleared or approved test system, or introduces a test system not subject to FDA clearance or approval (including methods developed in-house and standardized methods such as text book procedures), or uses a test system in which performance specifications are not provided by the manufacturer must, before reporting patient test results, establish for each test system the performance specifications for the following performance characteristics, as 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 -- applicable: (2)(i) Accuracy. (2)(ii) Precision. (2)(iii) Analytical sensitivity. (2)(iv) Analytical specificity to include interfering substances. (2)(v) Reportable range of test results for the test system. (2)(vi) Reference intervals (normal values). (2)(vii) Any other performance characteristic required for test performance. This STANDARD is not met as evidenced by: . Based on record review and interview with Technical Supervisor #2 (TS2), the laboratory failed to establish the storage stability of refrigerated urine specimens prior to testing patients since the test system was approved on 4/25/18. Findings include: 1. A review of the laboratory's "Neuro Pain Consultants LC-MS/MS Initial Sample Processing and Storage" policy revealed a section stating, "Sample may be stored at room temperature for 5 days for testing and up to ten days refrigerated. Or it will be rejected by lab for testing. Doctor will be notified." 2. A review of the laboratory's establishment of performance specifications "MXP5 Validation" revealed it did not establish the storage stability for refrigerated urine samples. 3. An interview on 8/17 /21 at 2:14 pm with TS2 confirmed the laboratory did not have documentation of establishing the storage stability of refrigerated urine samples. -- 2 of 2 --

Summary Statement of Deficiencies D2000 ENROLLMENT AND TESTING OF SAMPLES CFR(s): 493.801 Each laboratory must enroll in a proficiency testing (PT) program that meets the criteria in subpart I of this part and is approved by HHS. The laboratory must enroll in an approved program or programs for each of the specialties and subspecialties for which it seeks certification. The laboratory must test the samples in the same manner as patients' specimens. For laboratories subject to 42 CFR part 493 published on March 14, 1990 (55 FR 9538) prior to September 1, 1992, the rules of this subpart are effective on September 1, 1992. For all other laboratories, the rules of this subpart are effective January 1, 1994. This CONDITION is not met as evidenced by: . Based on record review and interview, the laboratory submitted proficiency testing samples to another facility for testing. Proficiency testing specimens were submitted to 23D2119597 Clinical Connect Laboratories, LLC (CCL) for toxicology testing for 1 (UT-B ) of 2 events in 2018. Neuro Pain Consultants PC laboratory reported CCL results for 1 (UT-B) of 2 final proficiency testing results to the PT provider College of American Pathologist (CAP) as their own in 2018. The laboratory engaged in inter- laboratory communication with other laboratories prior to the proficiency testing (PT) submission date for 2 (UT- A and UT-C) of 3 testing events in 2019. Refer to D2011 and D2013. . D2011 TESTING OF PROFICIENCY TESTING SAMPLES CFR(s): 493.801(b)(3) Laboratories that perform tests on proficiency testing samples must not engage in any inter-laboratory communications pertaining to the results of proficiency testing sample (s) until after the date by which the laboratory must report proficiency testing results 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 -- to the program for the testing event in which the samples were sent. Laboratories with multiple testing sites or separate locations must not participate in any communications or discussions across sites/locations concerning proficiency testing sample results until after the date by which the laboratory must report proficiency testing results to the program. This STANDARD is not met as evidenced by: . Based on record review and interview with the Laboratory Manager (LM) and the Laboratory Consultant (LC), the laboratory engaged in inter-laboratory communication with other laboratories prior to the proficiency testing (PT) submission date for 2 (UT- A and UT-C) of 3 testing events in 2019. Findings include: 1. Review of the laboratory's procedure "Proficiency Testing" signed and implemented on 4/1/2019 by the Laboratory Director states, "Results are not allowed to be discussed with other labs prior to sending the results to CAP (College of American Pathologists)." 2. Record review of the PT documents revealed for each laboratory Testing Personnel #1 (TP1) was listed on the proficiency testing attestation sheets and ran all the specimens for each the testing events for each laboratory listed below: a. 23D2113189 RPPC Labs, LLC -UT-A and UT-C in 2019 b. 23D1057542 Neuro Pain Consultants - UT-A and UT-C in 2019 c. 23D2119597 Clinical Connect Laboratory, LLC - UT-A, UT-B, and UT-C in 2019 d. 23D2144369 Synchronized Lab Services, LLC - UT-B and UT-C in 2019 3. During the interview on 1/28/2020 at approximately 12:30 p.m., LM and LC confirmed that TP1 performed the same proficiency testing at multiple labs in 2019. D2013 TESTING OF PROFICIENCY TESTING SAMPLES CFR(s): 493.801(b)(4) The laboratory must not send proficiency testing samples or portions of proficiency testing samples to another laboratory for any analysis for which it is certified to perform in its own laboratory. Any laboratory that CMS determines intentionally referred a proficiency testing sample to another laboratory for analysis may have its certification revoked for at least one year. If CMS determines that a proficiency testing sample was referred to another laboratory for analysis, but the requested testing was limited to reflex, distributive, or confirmatory testing that, if the sample were a patient specimen, would have been in full conformance with written, legally accurate and adequate standard operating procedures for the laboratory's testing of patient specimens, and if the proficiency testing referral is not a repeat proficiency testing referral, CMS will consider the referral to be improper and subject to alternative sanctions in accordance with 493.1804(c), but not intentional. Any laboratory that receives a proficiency testing sample from another laboratory for testing must notify CMS of the receipt of that sample regardless of whether the referral was made for reflex or confirmatory testing, or any other reason. This STANDARD is not met as evidenced by: . Based on record review and interview with the Laboratory Manager (LM) and the Laboratory Consultant (LC), the laboratory referred proficiency testing samples to 23D2119597 Clinical Connect Laboratory, LLC (CCL) and returned the results performed at CCL to the College of American Pathologists' (CAP) proficiency testing (PT) program for 1 (UT-B 2018) of 5 urine toxicology testing events reviewed. Findings include: 1. Record review of the laboratory's "Proficiency Testing" procedure signed and implemented on 4/1/2019 states, "CAP (College of American -- 2 of 3 -- Pathologists) specimens are not to be sent to outside labs for results." 2. Record review of a timeline presented to the surveyors on 1/28/20 at approximately 12:35 pm, revealed the following information about 23D1057542 Neuro Pain Consultants PC (NPC) specimen testing as follows: a. 1/1/2018-7/1/2018 testing was performed in Royal Oak at NPC b. 7/2/2018-11/5/2018 testing was performed in Troy and referenced to CCL c. 11/5/2018-6/30/2019 testing was performed in Royal Oak at NPC d. 7/1/2019-10/2/2019 testing was performed Royal Oak and referenced to CCL e. 10/3/2019-current testing was performed in Royal Oak at NPC 3. Record review of the laboratory's CAP proficiency testing records for the 2018 UT-B testing event revealed the following: a. An attestation form signed by the Laboratory Director and the previously employed testing personnel. b. Reports generated on 8/19/2018 with the "Clinical Connect Laboratory" logo at the top left, "1307- A100 Allen Drive, Troy, MI 48083" and "CLIA# 23D2119597" in the top right of the reports. Reports included "Neuro Pain Clinic" under the "Physician" area of the report for the following proficiency testing samples reported: i. UT-06 CAP ii. UT- 07 CAP iii. UT- 08 CAP iv. UT-09 CAP v. UT-10 CAP c. Final reported results from CAP event UT- B 2018 directly correlated with the generated reports with the "Clinical Connect Laboratory" logo and information for the specimens listed above. 4. Record review of an email sent on 3/29/2019 by the Laboratory Consultant to the Laboratory Manager, the previously employed testing personnel, and other laboratory staff from the six laboratories, revealed the following statement "Clinical Connect Lab- UT-B PT was run at the CCL lab as it should be, and results were reported to CAP. At this time, CCL was located in Troy in the B3 complex. CLIA was notified of the change of address and it is documented. Therefore, CCL did not violate any PT policy. NPC, RPPC, Synchronized, LabTox-At this time, these, four labs were not running any specimens. All of their work was being referenced to CCL per agreement. CAP should have been notified that no results will be sent in for the UT-B because patients were not being run. However, what happened was that (previously employed testing personnel) took the CAP samples, ran them at CCL and reported out the results." 5. An interview on 1/28/2020 at approximately 1:05 pm with the LM and LC confirmed proficiency testing results were submitted to CAP during the time frame when laboratory testing was referenced to CCL between 7/2/2018 and 11/5/2018. -- 3 of 3 --

Summary Statement of Deficiencies 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 and interview, the laboratory failed to properly ventilate one of three instruments observed. Findings include: 1. During the tour of the laboratory on March 29, 2018 from approximately 10:00 AM to 12:00 PM, the surveyor observed a missing piece of vent hose connecting the 4500 analyzer to the ventilation system. 2. During the tour of the laboratory on March 29, 2018 from approximately 10:00 AM to 12:00 PM, technical supervisor #1 confirmed that the 4500 analyzer was not connected to the ventilation system and was venting directly into the room. 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 record review and interview, the laboratory failed to meet the requirements for the specialty in Toxicology as specified in 493.1230 through 493.1256, and 493.1281 through 493.1299. Findings include: 1. The laboratory failed to order tests correctly. Refer to D5309. 2. The laboratory failed to monitor and document the room temperature and humidity readings. Refer to D5413. 3. The laboratory failed to label 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 -- the toxicology reagents with the preparation and/or expiration date. Refer to D5415. 4. The laboratory failed to document the