Rppc Labs Llc

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 3 (Testing Personnel #1-#3) of 3 testing personnel listed on the CMS-209 form. 1. A review of the laboratory's "RPPC Personnel" policy revealed a section stating, "A formal performance evaluation is conducted at the end of the first six months of employment and each year of employment thereafter." 2. A review of the laboratory's personnel documentation revealed a lack of documentation of competency assessments for personnel hired at the RPPC Labs, LLC laboratory. 3. An interview on 8/18/21 at 11: 49 am with TS2 confirmed the laboratory did not have documentation of competency assessments for testing at RPPC Labs, LLC. D5213 EVALUATION OF PROFICIENCY TESTING PERFORMANCE CFR(s): 493.1236(b)(1) The laboratory must verify the accuracy of any analyte or subspecialty without analytes listed in subpart I of this part that is not evaluated or scored by a CMS- approved proficiency testing program. This STANDARD is not met as evidenced by: . Based on record review and interview with Technical Supervisor #2 (TS2), the laboratory failed to verify the accuracy of toxicology analytes that were not scored by 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 College of American Pathologists proficiency testing program for 1 (UT-C 3rd event in 2020) of 6 events reviewed. Findings include: 1. A review of the laboratory's "PT Exception Code/Ungraded Results" procedure revealed a section stating, "PT Exception Code/Ungraded Results appear in an evaluation to signify the PT for the analyte has not been graded. The laboratory must identify all of the analytes with an Exception Reason Code and investigate the acceptability of performance. If a PT Exception Code/Ungraded Results appears on the evaluation, the following protocol will be followed: 1. The technical supervisor will perform a self-evaluation of all PT Exception Code/Ungraded Results using the evaluation criteria in the participant summary. 2. This self-evaluation will be documented and reviewed by the laboratory staff. 3. The director will review and sign off on the self- evaluation. 4. All documentation will be retained for a period of two years." 2. A review of the laboratory's College of American Pathologists' proficiency testing documentation from the 2020 UT-C event revealed the "11- Unable to to analyze (documentation to be provided by the laboratory)" code, showing the proficiency testing company did not score the laboratory's results. There was a lack of documentation of the laboratory performing the self-evaluation in the participant summary. 3. An interview on 8/18/21 at 1:57 pm with TS2 confirmed the laboratory did not perform the self-evaluation for the UT-C event that was not scored by the proficiency testing provider. 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 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: . A. Based on record review and interview with Technical Supervisor #2 (TS2), the laboratory failed to establish the storage stability of refrigerated or ambient urine specimens prior to testing patients since the testing began using the AB Sciex QTrap 4500 toxicology test system on 3/1/2016. Findings include: 1. A review of the laboratory's establishment of performance specifications "MPX-2 Validation" revealed it did not establish the storage stability for refrigerated or ambient urine samples for toxicology testing using the AB Sciex QTrap 4500 analyzer. 2. An interview on 8/18/21 at 1:45 pm with TS2 confirmed the laboratory did not have documentation of establishing the storage stability of refrigerated urine samples. B. Based on record review and interview with Technical Supervisor #2 (TS2), the laboratory failed to ensure the establishment of performance specifications of the laboratory-developed liquid chromatography mass spectrometry system met the laboratory's acceptance criteria before reporting patient toxicology results for 27 of 52 analytes on the laboratory's test menu. Findings include: 1. A review of the laboratory's test menu revealed the following analytes were tested by the laboratory: a. Alprazolam b. Hydroxyalprazolam c. 7 aminoclonazepam d. Diazepam e. Nordiazepam f. Oxazepam g. Temazepam h. Lorazepam i. Meperidine j. Tapentadol -- 2 of 3 -- k. Methadone l. Fentanyl m. Norphentanyl n. Tramadol o. O-Desmethyltramadol p. Buprenorphine q. Norbuprenorphine r. Codeine s. Norcodeine t. Hydrocodone u. Norhydrocodone v. Dihydrocodeine w. Hydromorphone x. Morphine y. Oxycodone z. Noroxycodone aa. Oxymorphone bb. Naloxone cc. Naltrexone dd. Amobarbital- pentobarbital ee. Butalbital ff. Phenobarbital gg. Secobarbital hh. Carisoprodol ii. Mebrobamate jj. Zolpidem kk. Gabapentin ll. Pregabalin mm. Amphetamine nn. Methylphenidate oo. Ritalinic Acid pp. Phentermine qq. 6-MAM rr. Benzoylecgonine ss. 3,4-Methylenedioxyamphetamine (MDA) tt. 3,4-Methylenedioxy-N- ethylamphetamine (MDEA) uu. 3,4-Methylenedioxymethamphetamine (MDMA) vv. Methamphetamine ww. Tetrahydrocannabinol (THC-COOH) xx. Methylone yy. Methcathinone zz. Methylenedioxypyrovalerone (MDPV) 2. A review of the laboratory's "LIQUID CHROMATOGRAPHY MASS SPECTROMETRY METHOD VALIDATION PLAN" revealed a section stating, "Calculated percent bias should be less than or equal to 20% to be acceptable (sufficient accuracy)." 3. A review of the laboratory's accuracy study revealed the following analytes did not meet the laboratory's accuracy criteria of less than or equal to 20% bias: a. 6-MAM b. Amphetamine c. Codeine d. Hydromorphone e. Norbuprenorphine f. Methamphetamine g. Hydroalprazolam h. Lorazepam i. MDA j. MDEA k. MDMA l. Meperidine m. Meprobamate n. Norbuprenorphine o. Nordiazepam p. Oxymorphone q. Tramadol r. Diazepam s. Methylone t. MDPV u. Norcodeine v. Norhydrocodone w. Noroxymorphone x. Noroxycodone y. Butabarbital z. O-desmethyltramasol aa. Ritalinic acid 4. An interview on 8/18/21 at 1:57 pm with TS2 and the Laboratory Manager confirmed the analytes listed above did not meet the laboratory's accuracy criteria. -- 3 of 3 --

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 RPPC Labs, LLC laboratory referred proficiency testing samples to 23D2119597 Clinical Connect Laboratories, LLC (CCL) for toxicology testing. The laboratory reported CCL proficiency testing results to the College of American Pathologist proficiency testing program as their own. Refer to D2013. The laboratory engaged in inter-laboratory communication with other laboratories prior to the proficiency testing submission date. Refer to D2011. 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 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 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 program. This STANDARD is not met as evidenced by: . Based on record review and interview with the Laboratory Manager and the Laboratory Consultant, the laboratory engaged in inter-laboratory communication with other laboratories prior to the proficiency testing submission date for 2 (UT- A and UT-C 2019) of 3 testing events. Findings include: 1. A review of the laboratory's procedure "Proficiency Testing" signed by the Laboratory Director on 4/4/2018 states, "Results are not allowed to be discussed with other labs prior to sending the results to CAP (College of American Pathologists)." 2. A record review of the proficiency testing documents for each laboratory revealed Testing Personnel #1 (TP1) was listed on the proficiency testing attestation sheets and ran all the specimens for the testing events for each laboratory listed below: a. 23D2144369 Synchronized Lab Services, LLC - UT-B 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. 23D2113189 RPPC Labs, LLC - UT-A and UT-C in 2019 3. An interview on 1/27/2020 at approximately 3:37 pm, the Laboratory Manager and the Laboratory Consultant confirmed TP1, listed on the CMS 209 form for all laboratories listed above, was performing all proficiency testing specimens for all laboratories. 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 and the Laboratory Consultant, the laboratory referred proficiency testing samples to 23D2119597 Clinical Connect Laboratory, LLC (CCL) and submitted the CCL results to the College of American Pathologists' (CAP) proficiency testing program for 1 (UT- B 2018) of 5 urine toxicology testing events reviewed. Findings include: 1. A record review of the laboratory's "Proficiency Testing" procedure approved by the Laboratory Director on 4/4/2018 revealed the following section stating, "CAP specimens are not to be sent to outside labs for results." 2. A review of the timeline of when each laboratory was referring patient specimens to Clinical Connect Laboratory, LLC, provided by the Laboratory Manager on 1/28/2020 at approximately 12:49 pm, revealed the following information about the RPPC laboratory: a. 1/1/2018- 7/8/2018 -- 2 of 3 -- testing was performed in Royal Oak at RPPC b. 7/9/2018- 11/4/2018 testing was performed in Troy and referenced to CCL c. 11/5/2018- 6/30/2019 testing was performed in Royal Oak at RPPC d. 7/1/2019- 10/2/2019 testing was performed in Royal Oak, but was referenced to CCL e. Since 10/2/2019, testing has been performed in Royal Oak at RPPC 3. A 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 8/18/2018 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 "RPPC" 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 results from CAP for the UT-B 2018 testing event results directly correlated with the reports generated with the "Clinical Connect Laboratory" logo and information for the specimens listed above. 4. A 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 (Neuro Pain Consultants), 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 Laboratory Manager and the Laboratory Consultant confirmed proficiency testing results were submitted to CAP during the time when laboratory testing was referenced to CCL between 7/9/2018 and 11/4/2018. -- 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 enter test requistions accurately. 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 the toxicology reagents with the preparation and/or Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 5 -- expiration date. Refer to D5415. 4. The laboratory failed to document the