Interventional Spine Specialists Of Florida Llc

Summary Statement of Deficiencies D0000 A recertification survey conducted on 05/03/2023 found the ANESTHESIA PAIN CARE CONSULTANTS LLC clinical laboratory not in compliance with 42 CFR Part 493, Requirements for Laboratories. D2009 TESTING OF PROFICIENCY TESTING SAMPLES CFR(s): 493.801(b)(1) The individual testing or examining the samples and the laboratory director must attest to the routine integration of the samples into the patient workload using the laboratory's routine methods. This STANDARD is not met as evidenced by: Based on record review and staff interview, the laboratory director (LD) failed to sign two out of six events reviewed for Urine Toxicology specialty. Findings included: - Review of College of American Pathologists (CAP) Attestation statement noted "The laboratory director or designee and the testing personnel must sign on the result form. " -Review of CAP proficiency testing (PT) records for years 2021 (second and third event), 2022 (first, second and third event) and 2023 (first event) revealed that the LD failed to sign attestation for the 1st event of 2022 and 2023 in the specialty of Urine Toxicology. During an interview on 05/03/2023 at 12:25 PM, the Technical Supervisor confirmed that the LD failed to sign the attestation for the events of reference. 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 D0000 A recertification survey conducted on 06/02/2021 found that the ANESTHESIA PAIN CARE CONSULTANTS INC clinical laboratory was not in compliance with 42 CFR Part 493, Requirements for Laboratories. The following condition was cited: - D5200 General Laboratory Systems. D5200 GENERAL LABORATORY SYSTEMS CFR(s): 493.1230 Each laboratory that performs nonwaived testing must meet the applicable general laboratory systems requirements in 493.1231 through 493.1236, unless HHS approves a procedure, specified in Appendix C of the State Operations Manual (CMS Pub. 7), that provides equivalent quality testing. The laboratory must monitor and evaluate the overall quality of the general laboratory systems and correct identified problems specified in 493.1239 for each specialty and subspecialty of testing performed. This CONDITION is not met as evidenced by: Based on record review and staff interview, the laboratory did not meet the condition for General Laboratory Systems. Findings include: -The laboratory failed to do at least twice a year accuracy verification for 10 out of 63 analytes tested in urine toxicology. Refer to D5217. 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: 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 -- Based on record review and staff interview, the laboratory failed to do competency evaluation for technical supervisor (TS) for 2 out of 3 years reviewed. Findings include: -Review of CMS 209 Laboratory Personnel Report dated and signed by the Laboratory Director (LD) on 05/12/2021 revealed that there was 1 TS. -Review of personnel records revealed that the laboratory failed to have documentation of competency assessment for TS for 2019 and 2020. During an interview on 06/02/2021 at 10:30 am, with TS, she confirmed that the laboratory failed to have competency assessment for her on 2019 and 2020. 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 record review and technical supervisor (TS) interview, the laboratory failed to provide documentation to verify the accuracy for 10 out of 63 analytes tested in urine toxicology from 2019 to 2021, at least twice annually. This is a repeated deficiency. Findings include: -Review of College of American Pathologists (CAP) proficiency testing (PT) records showed that the analytes Ethyl Sulfate (EtS), Norhydrocodone, Ritalinic Acid, Tapentadol, Midazolam, Naloxone, Naltrexone, N Desmethyltapentadol, Mitragynine and Secobarbital were not included in the list of CAP urine toxicology analytes tested in their PT. -Review of PT policy signed by the laboratory director on 3/20/2020, revealed that the policy failed to list the requirement of at least twice a year accuracy verification for analytes evaluated with a split sample study. -The laboratory provided documentation of one split sample testing for 2019, 2020 and 2021. The laboratory failed to do twice a year verification for the analytes Ethyl Sulfate (EtS), Norhydrocodone, Ritalinic Acid, Tapentadol, Midazolam, Naloxone, Naltrexone, N Desmethyltapentadol, Mitragynine and Secobarbital. During an interview on 6/2/2021 at 12:00 pm with TS, she explained that she understood that the requirement for the verification of accuracy was to do one per year, she confirmed that the laboratory failed to do twice a year verification for the analytes listed above. 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 record review and staff interview, the laboratory Quality Assessment (QA) plan failed to ensure the laboratory performed at least twice a year accuracy verification for 10 out of 63 analytes for 2 out of 2 years reviewed. Findings include: - Review of

Summary Statement of Deficiencies D0000 A recertification survey was conducted on August 1, 2019. Anesthesia Pain Care Consultants Inc was found not in compliance with 42 CFR 493, requirements for clinical laboratories. 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 record review and interview, the laboratory did not have the required signatures on all of the documentation, and failed to maintain all of the proficiency testing records. Findings: The laboratory uses the College of American Pathologist (CAP) to verify the accuracy of urine toxicology analytes. Review of the laboratory's proficiency testing records with CAP showed that the laboratory director or designee failed to sign the performance evaluation for the 2017; 2nd and 3rd events. CAP records also showed that the laboratory director or designee and the testing personnel also failed to sign the attestation for the 2017 3rd event. The laboratory also was unable to provide documentation showing the instrument test results for 2017; 3rd 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 -- event, and 2018 ; 2nd and 3rd events. During an interview on 8/1/19 at 10:28 AM, the Technical Consultant acknowledged that the forms were not signed and that she was unable to located the instrument test results. 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 record review and interview, the laboratory failed to provide documentation to verify the accuracy of the testing methods for 6 out of 49 analytes tested in urine toxicology from 8/1/17 to 12/31/18; at least twice annually. Findings: Review of the College of American Pathologist (CAP) records showed that the analytes ETS (Ethyl Sulfate), Norhydrocodone, Secobarbital, and Tapentadol were not include in the list of CAP urine toxicology analytes tested in their proficiency testing (PT). CAP list of analytes also did not include Gabapentin and Pregabalin before the 2018 3rd PT event. The laboratory was unable to provide documentation that showed the PT was performed at least twice annually for the above mentioned analytes from 8/1/17 to 12 /31/18. During an interview on 8/1/19 at 1:44 PM, the Technical Consultant acknowledged she did not know where the PT for ETS, Norhydrocodone, Secobarbital, Tapentadol, Gabapentin and Pregabalin where located. 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 record review and interview, the laboratory failed to provide documentation of quality control lot to lot comparison from 8/1/17 to 3/6/19 for toxicology. Findings: Review of the quality control logs showed that there were no lot to lot comparisons from 8/1/17 to 3/6/19 for the Shimadzu AB Sciex Triple Quad 4500MD toxicology analyzer. During an interview on 8/1/19 at 1:00 PM, the Testing Personnel acknowledged that she didn't know where the documentation of the toxicology lot to lot comparisons where located. -- 2 of 2 --