Advanced Spine And Pain, Llc

Summary Statement of Deficiencies D5401 PROCEDURE MANUAL CFR(s): 493.1251(a) A written procedures manual for all tests, assays, and examinations performed by the laboratory must be available to, and followed by, laboratory personnel. Textbooks may supplement but not replace the laboratory's written procedures for testing or examining specimens. This STANDARD is not met as evidenced by: Based on surveyor review of the Procedure Manual (PM) and interview with the Techincal Supervisor (TS), the laboratory failed to have a procedure for six month method comparison between two Carolina CL800 analyzers performing Toxicology testing from 2/15/22 to the date of survey. The TS confirmed on 6/25/24 that the laboratory did not have the above mentioned procedure. D5415 TEST SYSTEMS, EQUIPMENT, INSTRUMENTS, REAGENT CFR(s): 493.1252(c) Reagents, solutions, culture media, control materials, calibration materials, and other supplies, as appropriate, must be labeled to indicate the following: (1) Identity and when significant, titer, strength or concentration. (2) Storage requirements. (3) Preparation and expiration dates. (4) Other pertinent information required for proper use. This STANDARD is not met as evidenced by: Based on surveyor observation of Quality Control (QC) material in use, review of Manufacture Package Inserts (MPI) and interview with the Techincal Supervisor (TS), the laboratory failed to put open and expiration dates on QC material for Toxicology tests run on the Carolina CLC800 analyzer at the time of survey. The findings include: 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 -- 1. The expiration date of the QC material shortens once opened. 2. The laboratory did not put open or expiration dates on controls in use run on the Carolina CLC800 analyzer . 3. The TS confirmed on 6/25/24 at 11:45 am the laboratory failed to put open and expiration dates on the control material. D5469 CONTROL PROCEDURES CFR(s): 493.1256(d)(10)(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-- Establish or verify the criteria for acceptability of all control materials. (i) When control materials providing quantitative results are used, statistical parameters (for example, mean and standard deviation) for each batch and lot number of control materials must be defined and available. (ii) The laboratory may use the stated value of a commercially assayed control material provided the stated value is for the methodology and instrumentation employed by the laboratory and is verified by the laboratory. (iii) Statistical parameters for unassayed control materials must be established over time by the laboratory through concurrent testing of control materials having previously determined statistical parameters. (g) The laboratory must document all control procedures performed. This STANDARD is not met as evidenced by: Based on surveyor review of Quality Control (QC) records and interview with Techincal Supervisor (TS), the laboratory failed to verify commercially assayed QC material with each new lot and/or shipment of Toxicology QC used on the Carolina CLC800 analyzer from 12/15/to the date of survey. The findings include: 1. There was no documented evidence that QC material was verified for the following Lot numbers: a) UDT- Multi Drug Lot H2341 A&B b) Lin-ZHI Methadone Lots 2310037 & 2310039 2. The TS confirmed on 6/25/24 at 11:20 am that all assayed QC material was not verified before putting in use. D5779

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 surveyor review of the Proficiency Testing (PT) records and interview with the Techincal Supervisor (TS), the laboratory failed to maintain Attestation Statements (AS) signed by the Laboratory Director for Toxicology tests performed with the College of American Pathologists (CAP) in 2020 and 2021. The findings include: 1. There was no AS for CAP - Toxicology for event UT-B and UT-A 2021. 2 . The TS confirmed on 2/15/22 at 10:15 am that the laboratory did not maintain complete records for PT. 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. 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 -- This STANDARD is not met as evidenced by: Based on surveyor review of the Quality Control (QC) records and interview with the Techincal Supervisor (TS), the laboratory failed to retain all QC records for tests performed on the Carolina CLC/800 from January 5/21/19 to the date of survey. The finding includes: 1. All Toxicology QC that was repeated due to a failed QC run were not retained. 2. The TS confirmed on 2/15/22 at 11:00 am that the all QC records were not retained. D5217 EVALUATION OF PROFICIENCY TESTING PERFORMANCE CFR(s): 493.1236(c)(1) At least twice annually, the laboratory must verify the accuracy of any test or procedure it performs that is not included in subpart I of this part. This STANDARD is not met as evidenced by: Based on surveyor review of the Procedure Manual (PM), Biannual Assessment (BA) records and interview with the Techincal Supervisor (TS), the laboratory failed to verify the accuracy and reliability of Toxicology testing twice a year in the calendar years 2020 and 2021. The finding includes: 1. BA was performed once in 2020 and 2021. 2. The TS confirmed on 2/15/22 at 11:30 am that the laboratory did not verify the accuracy of Toxicology twice a year. 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: Based on surveyor observation of the Calibration (Cal) material and interview with the Techincal Supervisor (TS), the laboratory retained expired Cal for tests performed on the Carolina CLC/800 from 5/31/21 to the date of survey. The findings include: 1. DRI (Trademark) MultiDrug Urine Drugs of Abuse Calibrator 2 Lot # 73955420 expired 5/31/21. 2. DRI (Trademark) MultiDrug Urine Drugs of Abuse Calibrator 1 Lot # 74168821 expired 12/31/21. 3. Approximately 40,000 patients run and reported. 4. The TS confirmed on 2/15/22 at 1:32 pm that the laboratory the laboratory used calibration material after its expiration date. D6091 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1445(e)(4)(iii) The laboratory director must ensure all proficiency testing reports received are reviewed by the appropriate staff to evaluate the laboratory's performance and to identify any problems that require

Summary Statement of Deficiencies D3037 RETENTION REQUIREMENTS CFR(s): 493.1105(a)(4) Proficiency testing records. Retain all proficiency testing records for at least 2 years. This STANDARD is not met as evidenced by: Based on surveyor review of Proficiency Testing (PT) records and interview with the Technical Supervisor (TS), the laboratory failed to retain the attestation record for the Chemistry Miscellaneous 2-2018 PT event performed with the American Proficiency Institute. The TS confirmed on 5/21/19 at 1:00 pm that the laboratory failed to retain all PT records. 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 surveyor review of the Competency Assessment (CA) records, review of the personnel files and interview with the Technical Supervisor (TS), the laboratory failed to perform a CA on one of one TS from March 2018 to the date of the survey. The TS confirmed on 5/21/19 at 12:20 pm that a CA was not performed on the TS. D5415 TEST SYSTEMS, EQUIPMENT, INSTRUMENTS, REAGENT CFR(s): 493.1252(c) Reagents, solutions, culture media, control materials, calibration materials, and other 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 -- supplies, as appropriate, must be labeled to indicate the following: (1) Identity and when significant, titer, strength or concentration. (2) Storage requirements. (3) Preparation and expiration dates. (4) Other pertinent information required for proper use. This STANDARD is not met as evidenced by: Based on surveyor observation of the Quality Control (QC) material and interview with the Technical Supervisor (TS), the laboratory failed to put new expiration dates on all controls used for urine Toxicology tests performed on the Carolina CLC/800 analyzers from March 2018 to the date of survey. The TS confirmed on 5/21/19 at 1: 00 pm the laboratory failed to put new expiration dates on the control material. 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 surveyor review of Performance Specification (PS) records and interview with the Technical Supervisor (TS), the laboratory failed to ensure that PS procedures for all urine toxicology tests performed on the Carolina CLC/800 #1 were performed prior to patient testing from March 2018 to the date of survey. The findings include: 1. A review of the PS records revealed accuracy, precision, and linearity were not performed for: a. Benzodiazepines b. Buprenorphine c. Cocaine Metabolite d. Methadone - 2-ethylidene-1,5-dimethyl-3,3-diphenylpyrrolidine (EDDP) e. Opiates f. Oxycodone 2. The TS confirmed on 5/21/19 at 1:15 pm that PS were not performed on the drugs listed above. D5439 CALIBRATION AND CALIBRATION VERIFICATION CFR(s): 493.1255(b) Unless otherwise specified in this subpart, for each applicable test system the laboratory must do the following: Perform and document calibration verification procedure - (b)(1) Following the manufacturer's calibration verification instructions; (b)(2) Using the criteria verified or established by the laboratory under 493.1253(b)(3) -- (b)(2)(i) Including the number, type, and concentration of the materials, as well as acceptable limits for calibration verification; and (b)(2)(ii) Including at least a minimal (or zero) value, a mid-point value, and a maximum value near the upper limit of the range to verify the laboratory's reportable range of test results for the test system; and (b)(3) At least once every 6 months and whenever any of the following occur: (b)(3)(i) A complete change of reagents for a procedure is introduced, unless the laboratory can demonstrate that changing reagent lot numbers does not affect the range used to report patient test results, and control values are not adversely affected by reagent lot number changes. (b)(3)(ii) There is major preventive maintenance or replacement of critical parts that may influence test performance. (b)(3)(iii) Control -- 2 of 5 -- materials reflect an unusual trend or shift, or are outside of the laboratory's acceptable limits, and other means of assessing and correcting unacceptable control values fail to identify and correct the problem. (b)(3)(iv) The laboratory's established schedule for verifying the reportable range for patient test results requires more frequent calibration verification. This STANDARD is not met as evidenced by: Based on lack of Calibration Verification (CV) records and interview with the Technical Supervisor (TS), the laboratory failed to perform and document CV procedures at least once every six months for Toxicology Testing on the Carolina CLC /800 analyzer in the calendar year 2018 and 2019. The TS confirmed on 5/21/19 at 12: 00 pm CV was not performed every six months. D5469 CONTROL PROCEDURES CFR(s): 493.1256(d)(10)(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-- Establish or verify the criteria for acceptability of all control materials. (i) When control materials providing quantitative results are used, statistical parameters (for example, mean and standard deviation) for each batch and lot number of control materials must be defined and available. (ii) The laboratory may use the stated value of a commercially assayed control material provided the stated value is for the methodology and instrumentation employed by the laboratory and is verified by the laboratory. (iii) Statistical parameters for unassayed control materials must be established over time by the laboratory through concurrent testing of control materials having previously determined statistical parameters. (g) The laboratory must document all control procedures performed. This STANDARD is not met as evidenced by: Based on surveyor review of Quality Control (QC) records, Manufacturers Package Inserts (MPI) and interview with Technical Supervisor (TS), the laboratory failed to establish the statistical parameters and verify the QC material before use for urine Toxicology tests from March 2018 to the date of the survey. The findings include: 1. The Buprenorphine QC MPI stated the control material was to be used with the Immunalysis Buprenorphine Urine Enzyme Immunoassay but the laboratory did not use that Immunoassay reagent. 2. A lack of QC documentation revealed a QC range was not established or verified before using the control. 3. The TS confirmed on 5/21 /19 at 12:30 pm that the laboratory did not establish statistical parameters for Buprenorphine QC. D5775 COMPARISON OF TEST RESULTS CFR(s): 493.1281(a)(c) (a) If a laboratory performs the same test using different methodologies or instruments, or performs the same test at multiple testing sites, the laboratory must have a system that twice a year evaluates and defines the relationship between test results using the different methodologies, instruments, or testing sites. (c) The laboratory must document all test result comparison activities. -- 3 of 5 -- This STANDARD is not met as evidenced by: Based on surveyor review of the Laboratory Records and interview with the Technical Supervisor (TS), the laboratory failed to perform and document comparison studies for the two Carolina CLC/800 analyzers twice per year from March 2018 to the date of the survey. The TS confirmed on 5/21/19 at 12:20 pm that the laboratory did not do comparison studies. 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 surveyor review of the Procedure Manual (PM), Quality Control (QC) records and interview with the Technical Supervisor (TS), the laboratory failed to establish a procedure to verify new QC material used in Toxicology screening tests before putting it in use from March 2018 to the date of the survey. The TS confirmed on 5/21/19 at 12:10 pm the laboratory did not have a procedure to verify new QC material. 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 surveyor review of the Final Report (FR) and interview with the Technical Supervisor (TS), the laboratory failed to report Urine Drug confirmation test results accurately from March 2018 to the date of survey. The finding includes: 1. The laboratory performed non Food and Drug Administration cleared tests and there was no statement stating the test had not been cleared or approved by the U.S. Food and Drug Administration" on the FR. 2. The TS confirmed on 5/21/19 at 1:00 pm that Urine Drug confirmation tests were not reported accurately. D6074 TESTING PERSONNEL RESPONSIBILITIES CFR(s): 493.1425(b)(5) Each individual performing moderate complexity testing must be capable of identifying problems that may adversely affect test performance or reporting of test results and either must correct the problems or immediately notify the technical consultant, clinical consultant or director. -- 4 of 5 -- This STANDARD is not met as evidenced by: Based on surveyor review of the Quality Control (QC) records and interview with the Technical Supervisor (TS), the Testing Personal (TP) failed to identify problems that may affect test performance by not reviewing and evaluating trends and/or shifts for tests performed on the two Carolina CLC/800 analyzers from March 2018 to the date of the survey. The TS confirmed on 5/21/19 at 12:45 pm that trends and shifts were not reviewed. D6086 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1445(e)(3)(ii) The laboratory director must ensure that verification procedures used are adequate to determine the accuracy, precision, and other pertinent performance characteristics of the method. This STANDARD is not met as evidenced by: a. Based on surveyor review of the Performance Specification (PS) records and interview with the Technical Supervisor (TS), the Laboratory Director (LD) failed to sign PS records for the two Carolina CLC/800 analyzers from March 2018 to the date of survey. The TS confirmed on 5/21/19 at 1:10 pm that the PS records were not signed. b. Based on surveyor review of the PS records and interview with the TS, the LD failed to ensure that PS were adequate to perform urine Toxicology confirmation tests on the AbSciex Triple Quad 4500 from March 2018 to the date of survey. The findings include: 1. The laboratory failed to perform a sample stability study beyond five days and room temperature. 2. There was no validation performed to establish the expiration date of reagents, working solutions, Internal Standard, controls and calibrators used. 3. The Interference study for Ketamine failed the accuracy and persicion accessment for Quality Control Level 1, 2 and 3. 4. The validation of the hydrolysis control did not include validation of: a. Temperature of the Heat Block b. Time on the Heat Block 5. The TS confirmed on 5/21/19 at 12:30 pm that PS tests were not adequate. D6091 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1445(e)(4)(iii) The laboratory director must ensure all proficiency testing reports received are reviewed by the appropriate staff to evaluate the laboratory's performance and to identify any problems that require