L5 Medical Holdings Llc Dba Pain Care Center Of

Summary Statement of Deficiencies D0000 An announced CLIA Recertification on-site survey was conducted at the L5 Medical Holdings on June 29, 2021 by the Virginia Department of Health's Office of Licensure and Certification. The laboratory was surveyed under 42 CFR part 493 CLIA Requirements. The initial contact and entrance interview with laboratory conducted on June 4, 2021 with off-site record review of documentation on June 28, 2021. Specific deficiencies cited are as follows: The laboratory was not in compliance with the following 42 CFR part 493 CLIA Regulations: D6000 - 42 C.F.R. 493-1403 Condition: Moderate Complexity Laboratory Director. 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 the review of policy and procedures (P&P), lack of documentation, and interviews, the laboratory did not have a P&P for performing competency assessments on individuals performing the job duties of technical supervisor (TS), general supervisor (GS), and technical consultant (TC) at the date of the survey on 06/29/21. Refer to D5407. Findings include: 1. Review of the available P&P's revealed lack of documentation of a policy for performing competency assessments on individuals performing the job duties of TS, GS, and TC. The inspector requested to review the P&P for competency assessments. The document was not available for review at the date of survey. 2. An exit interview with TP A on 06/29/21 at approximately 3:00 PM confirmed the findings. A phone interview with the lab director on 06/30/21 at approximately 12:45 PM confirmed the findings. D5407 PROCEDURE MANUAL Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 6 -- 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 review of the laboratory's policy and procedure (P&P) manual, lack of documentation and interviews, the laboratory director failed to review, approve, and sign the P&P at the date of survey on 06/29/21. Findings include: 1. An interview with the testing personnel (TP) A on 06/29/21 at approximately 10:00 AM revealed that the new lab director accepted responsibilities as of 06/30/21. 2. Review of the P&P located in the laboratory binder and presented to the inspector at the date of survey (signed by the previous lab director on 01/13/17) lacked documentation of review and approval by the current laboratory director. Review of the P&P presented to the inspector at approximately 2:45 PM on the date of survey revealed lack of documentation by the current lab director indicating review and approval. In addition, TP A stated that the second P&P was the current P&P in use by laboratory staff. 3. An exit interview with the TP on 06/29/21 at approximately 3:00 PM confirmed the findings. A phone interview with the lab director on 06/30/21 at approximately 12:45 PM confirmed the findings. 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 the review of operator's guide, instrument data, lack of documentation, and interviews, the laboratory failed to follow and document the weekly and monthly maintenance for the Thermo Fisher Indiko Plus Chemistry analyzer from 03/28/19 up to the date of survey on 06/29/21, a total of twenty-six (26) months. Findings include: 1. Review of the operator's guide revealed the following maintenance procedures to be done weekly to include cleaning cuvette waste bin, clean sample racks and reagent disk and clean wash well; and monthly maintenance to include cleaning of the incubator. 2. Review of the available data within the instrument revealed lack of documentation of performance of weekly and monthly maintenance procedures. Additional maintenance documentation was not available for review upon request at the date of survey. 3. An exit interview with TP A on 06/29/21 at approximately 3:00 PM confirmed the findings. A phone interview with the lab director on 06/30/21 at approximately 12:45 PM confirmed the findings. D5787 TEST RECORDS CFR(s): 493.1283(a) The laboratory must maintain an information or record system that includes the following: (a)(1) The positive identification of the specimen. (a)(2) The date and time of specimen receipt into the laboratory. (a)(3) The condition and disposition of specimens that do not meet the laboratory's criteria for specimen acceptability. (a)(4) The records and dates of all specimen testing, including the identity of the personnel -- 2 of 6 -- who performed the test(s). This STANDARD is not met as evidenced by: Based on the review of patient test records, personnel education records, and interviews, the laboratory failed to include the identity of the individual performing the Liquid chromatography/Tandem Mass Spectrometry (LG/MS) for three (3) of 3 patients reviewed at the date of survey on 06/29/21. Findings include: 1. The surveyor selected 3 patient test numbers and performed a patient tracing method at the date of survey. Patient 1- 133175 on 11/06/20, Patient 2- 134466 on 01/11/21 and Patient 3- 138003 on 05/24/21. 2. Review of the AB Sciex 4000 Quadrupole mass spectrometer instrument results did not provide the identity of the individual performing and reviewing patient test data, daily calibrations and quality control results. During the review of instrument data, TP A demonstrated that the instrument was able to include the identity of the individuals performing daily testing procedures. The function had not been enabled prior to the date of survey. 3. Review of the Labtrak Laboratory Information System (LIS) results for the above-mentioned patients' revealed TP B initials as indicating review and accepting results. In an interview with TP A and B at the date of survey at approximately 12:00, TP A stated that TP B was just reviewing other patient data and that their initials populated because TP B was logged into the Labrack LIS. Review of TP B education records revealed TP B is not qualified to perform high complexity testing. 4. An exit interview with TP A on 06/29/21 at approximately 3:00 PM confirmed the findings. A phone interview with the lab director on 06/30/21 at approximately 12:45 PM confirmed the findings. D5791 ANALYTIC SYSTEMS QUALITY ASSESSMENT CFR(s): 493.1289(a)(c) (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 analytic systems specified in 493.1251 through 493.1283. (c) The laboratory must document all analytic systems assessment activities. This STANDARD is not met as evidenced by: Based on the review of policy and procedures (P&P), available quality assurance (QA) documents, lack of documentation and interviews, the laboratory failed to demonstrate a QA mechanism to identify and address analytic issues in the sub- specialty of toxicology from 03/28/19 up to 06/01/20, a total of fourteen (14) months at the date of survey on 06/29/21. Findings include: 1. Review of the P&P located in the laboratory binder and presented to the inspector at the date of survey (signed by the previous lab director on 01/13/17) revealed the following statement: "Quality Management General Policy- the general laboratory systems are monitored on a monthly basis utilizing the "Monthly Quality Assessment Checklists". Each month's review is maintained in a monthly folder and stored for two years in the laboratory. When issues are identified we evaluate and determine

Summary Statement of Deficiencies D0000 An announced CLIA Recertification survey was conducted at the L5 Medical Holdings on March 28, 2019 by the Virginia Department of Health's Office of Licensure and Certification. The laboratory was surveyed under 42 CFR part 493 CLIA Requirements. Specific deficiencies cited are as follows: 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. This STANDARD is not met as evidenced by: A. Based on the tour of the laboratory, manufacturer package inserts (PI), and an interview with the technical consultant, the laboratory failed to ensure that the calibration materials for the DRI THC, CEDIA Buprenorphine, and Immunalysis Oxydocdone analytes were within the stated manufacturer expiration date ranges at the date of survey on March 28, 2019. Findings include: 1. Tour of the laboratory and review of the PI's revealed the following calibration materials (located in the lab refrigerator) and expiration dates for the DRI THC, CEDIA Buprenorphine, and Immunalysis Oxydocdone analytes: DRI THC 50 (lot number 72862307) and 100 ng /mL (lot number 72862304) exp date 01/30/2019, Immunalysis Oxydocdone 100 mg /mL (lot number E32733) exp date 02/28/2019, CEDIA Buprenorphine Negative (lot number 72630057) open vial exp date 60 days (opened 10/4/2018), CEDIA Buprenorphine 5 ng/mL (lot number 72630061) open vial exp date 60 days (opened 10 /4/2018), CEDIA Buprenorphine 20 ng/mL (lot number 72630064) open vial exp date 60 days (opened 10/4/2018), CEDIA Buprenorphine 50 ng/mL (lot number 72630068) open vial exp date 60 days (opened 10/4/2018) and, CEDIA Buprenorphine 75 ng/mL (lot number 72630071) open vial exp date 60 days (opened 10/4/2018). 2. An interview with the technical consultant at approximately 4:15 PM 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 -- confirmed that the calibration materials specified above were expired at the date of survey. B. Based on the tour of the laboratory, manufacturer package inserts (PI), patient testing data, and an interview with the technical consultant, the laboratory failed to ensure the DRI THC and CEDIA Buprenorphine calibration materials were not used beyond the stated manufacturer expiration dates when performing calibration procedures on January 20, 2019 and February 28, 2019. The laboratory tested three hundred and forty-nine (349) patients with the DRI THC assay and nine hundred and seventy-six (976) patients with the CEDIA Buprenorphine assay from January 20, 2019 and up to the date of survey on March 28, 2019. Findings include: 1. Tour of the laboratory and review of PI's revealed that the following calibration materials (located in the lab refrigerator) and expiration dates for the DRI THC and CEDIA Buprenorphine: DRI THC 50 (lot number 72862307) and 100 ng/mL (lot number 72862304) exp date 01/30/2019, CEDIA Buprenorphine Negative (lot number 72630057) open vial exp date 60 days (opened 10/4/2018), CEDIA Buprenorphine 5 ng/mL (lot number 72630061) open vial exp date 60 days (opened 10/4/2018), CEDIA Buprenorphine 20 ng/mL (lot number 72630064) open vial exp date 60 days (opened 10/4/2018), CEDIA Buprenorphine 50 ng/mL (lot number 72630068) open vial exp date 60 days (opened 10/4/2018) and, CEDIA Buprenorphine 75 ng/mL (lot number 72630071) open vial exp date 60 days (opened 10/4/2018). The laboratory utilized the above-specified calibration materials to perform calibration procedures on January 20, 2019 and February 28, 2019. 2. Review of the patient testing data revealed 349 patients assayed with the DRI THC test and 976 patients assayed with the CEDIA Buprenorphine test from January 20, 2019 and up to the date of survey on March 28, 2019. 3. An interview with the technical consultant at approximately 4:15 PM confirmed that the findings. D6029 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(e)(11) 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, and record and report test results promptly, accurate, and proficiently and for assuring compliance with the applicable regulations. (e) The laboratory director must-- (e)(11) Ensure that prior to testing patients' specimens, all personnel have the appropriate education and experience, receive the appropriate training for the type and complexity of the services offered, and have demonstrated that they can perform all testing operations reliably to provide and report accurate results. This STANDARD is not met as evidenced by: Based on the review of the Laboratory Personnel Report Form (CLIA) (CMS-209 Form), policy and procedures (P&P), lack of documentation, and an interview with the testing personnel, the laboratory director failed to ensure that testing personnel (TP) A had documented training and competency assessment for the new Thermo Scientific Indiko Plus analyzer prior to testing patients on January 20, 2019. Findings include: 1. Review of CLIA CMS- 209 form revealed TP A performed patient testing (see attached testing personnel code sheet). 2. Review of TP A records revealed a lack of documentation of training and competency assessment for the new Thermo Scientific Indiko Plus analyzer installed on January 17, 2019. Patient testing began on January 20, 2019. 3. Review of the Personnel Competency Assessment P&P (signed by the lab director on 01/13/2017) revealed the following statements: "To ensure all laboratories testing personnel meet the qualifications as determined by CLIA. These regular assessments will also ensure personnel understand their testing responsibilities -- 2 of 3 -- and insure they have appropriate training and comprehension to perform testing procedures in an accurate and reliable manner. Training checklist- one form for each analyzer/test the tech is performing." The inspector requested to review the training checklist and competency assessment for the new chemistry analzyer. The documentation was not available for review. 4. An interview with TP A at approximately 4: 15 PM confirmed the lack of training documentation and competency assessment for the new analyzer installed on January 17, 2019. -- 3 of 3 --