Interventional Pain Management Services

Summary Statement of Deficiencies D5449 CONTROL PROCEDURES CFR(s): 493.1256(d)(3)(ii)(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-- At least once a day patient specimens are assayed or examined perform the following for-- Each qualitative procedure, include a negative and positive control material; (g) The laboratory must document all control procedures performed. This STANDARD is not met as evidenced by: Based on review of laboratory procedures, review of the Carolina urine drug screen quality control (QC) from September 2023 to date March 18, 2024, review of patient results and interview with the technical supervisor (TS), the laboratory failed to perform a negative and a positive control material for 2 of 28 patient testing days. Findings: 1. Review of the laboratory procedure "Quality Control Acceptability" states "Patient test results will not be reported if quality control results are not within acceptable limits." 2. Review of the Carolina urine drug screen QC from September 2023 to date March 18, 2024 showed no acceptable QC on December 28, 2023 or on January 25, 2024 for the following analytes: benzodiazepine (BZO), delta-9- tetrahydrocannabinol (THC), opiates (OPI), alcohol (EOTH) and urine creatinine. 3. Review of patient results showed the laboratory reported 102 patient test results on December 28, 2023 and 104 patient test results on January 25, 2024 while QC was not performed. 4. Interview with the technical supervisor on March 18, 2024 at 1:30 PM confirmed the laboratory failed to perform a negative and a positive control material each day of patient testing. 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 D2003 ENROLLMENT CFR(s): 493.801(a)(2)(ii) For those tests performed by the laboratory that are not included in subpart I of this part, a laboratory must establish and maintain the accuracy of its testing procedures, in accordance with 493.1236(c)(1) This STANDARD is not met as evidenced by: Based on review of laboratory procedures, review of proficiency records for 2020, 2021 and to date June 21, 2022, review of patient reports and interview with the technical supervisor (TS), the laboratory failed to establish a means to verify the accuracy of 5 of 5 non-regulated analytes for urine drug screen testing twice a year. Findings: 1. Review of laboratory procedure"Quality Management Plan" states, "All testing performed by the laboratory is monitored by proficiency testing." 2. Review of proficiency records for 2020, 2021 and to date June 21, 2022, showed the laboratory failed to enroll to prove accuracy on the non-regulated analytes in urine drug screen testing which include creatinine, alcohol, benzodiazepine, opiate and tetrahydrocannabinol (THC) since patient testing started in March 2020. 3. Review of patient results confirmed the laboratory reports out the 5 non-regulated analytes of urine drug screen testing which are creatinine, alcohol, benzodiazepine, opiate and THC. 4. Interview with the TS on June 21, 2022 at 1:00 PM confirmed the laboratory failed to establish a means to verify the accuracy of 5 of 5 non-regulated analytes for urine drug screen testing twice a year. 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. Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 7 -- This STANDARD is not met as evidenced by: Based on review of College of American Pathologists proficiency testing (PT) for 2020, 2021, 2022 and interview with the technical supervisor (TS), the laboratory failed to ensure the individual testing or examining the samples and the laboratory director attested to the routine integration of the samples into the patient workload using the laboratory's routine methods for four of four PT events. Findings: 1. Review of 2020 PT showed no attestion for event DMPM-B. 2. Review of 2021 PT showed no attestion for DMPM-A and DMPM-B. 3. Review of 2022 PT showed no attestion for DMPM-A. 4. Interview with the TS on June 21, 2022 at 1:00 PM confirmed the laboratory failed to ensure the individual testing or examining the samples and the laboratory director attested to the routine integration of the samples into the patient workload using the laboratory's routine methods. 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 review of College of American Pathologists proficiency testing (PT) for 2020, 2021, 2022 and interview with the technical supervisor (TS), the laboratory failed maintain a copy of all instrumentation data printouts for four of four PT events. Findings: 1. Review of 2020 PT showed no instrument data printouts for event DMPM-B. 2. Review of 2021 PT showed no instrument data printouts for events DMPM-A and DMPM-B. 3. Review of 2022 PT showed no instrument data printouts for event DMPM-A. 4. Interview with the TS on June 21, 2022 at 1:00 PM confirmed the laboratory failed maintain a copy of all instrumentation data printouts. D5400 ANALYTIC SYSTEMS CFR(s): 493.1250 Each laboratory that performs nonwaived testing must meet the applicable analytic systems requirements in 493.1251 through 493.1283, 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 analytic systems and correct identified problems as specified in 493.1289 for each specialty and subspecialty of testing performed. This CONDITION is not met as evidenced by: Based on review of procedures, observation of freezer, review of manufacturer's -- 2 of 7 -- instructions, observation of internal standards and calibrators, review of pipette function checks and biosafety cabinet, review of Carolina quality control (QC) records, and interviews, the laboratory failed to meet the condition of analytic systems. The laboratory failed to follow procedure for storage of urine specimens (Refer to D5401); the laboratory failed to follow manufacturer's instructions for acceptable storage temperature for Cerilliant urine drug testing internal standards stored in freezer #3 (Refer to D5413); the laboratory failed to ensure the laboratory's internal standards and calibrators were not used when they had exceeded their expiration date (Refer to D5417); the laboratory failed to perform and document function checks for one Eppendorf 1000 pipette, and the laboratory biosafety cabinet (Refer to D5435); and the laboratory failed to establish criteria for acceptability of control materials providing quantitative results (Refer to D5469). 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 review of procedures, observation of freezer and interview with the technical supervisor (TS), the laboratory failed to follow procedure for storage of urine specimens. Findings: 1. Review of "IPMS Urine Drug Testing Method by LC- MS/MS" procedure states "Once the urine has been ran for the LCMS the aliquot is taken, each specimen should be frozen and kept for 6 months thereafter". 2. Observation of urine freezer showed no urine specimens from January 2022 to April 2022. 3. Interview with the TS on June 21, 2022 at 1:00 PM confirmed the laboratory failed to follow procedure for storage of urine specimens. D5413 TEST SYSTEMS, EQUIPMENT, INSTRUMENTS, REAGENT CFR(s): 493.1252(b) The laboratory must define criteria for those conditions that are essential for proper storage of reagents and specimens, accurate and reliable test system operation, and test result reporting. The criteria must be consistent with the manufacturer's instructions, if provided. These conditions must be monitored and documented and, if applicable, include the following: (1) Water quality. (2) Temperature. (3) Humidity. (4) Protection of equipment and instruments from fluctuations and interruptions in electrical current that adversely affect patient test results and test reports. This STANDARD is not met as evidenced by: Based on observation of freezer #3, review of package insert for Cerilliant urine drug testing internal standards, review of laboratory temperature logs from April 2021 to date June 21, 2022 and interview with the technical supervisor (TS), the laboratory failed to follow manufacturer's instructions for acceptable storage temperature for Cerilliant urine drug testing internal standards stored in freezer #3 for 21 of 149 testing days. Findings: 1. Observation of freezer # 3 showed Cerilliant urine drug testing internal standards labeled "currently in use". 2. Review of package insert for Cerilliant urine drug testing internal standards states, "Long term stability has been -- 3 of 7 -- assessed for Freezer storage (-10 degrees Celsius to -25 degrees Celsius) conditions. 3. Review of laboratory temperature logs from April 2021 to date June 21, 2022 showed freezer #3 with the an acceptable temperature range of -10 degrees Celsius to -25 degrees Celsius. The laboratory failed to meet the acceptable temperature range for 21 of 149 testing days. 4. Interview with the TS on June 21, 2022 at 1:00 PM confirmed the laboratory failed to follow manufacturer's instructions for acceptable storage temperature for Cerilliant urine drug testing internal standards stored in freezer #3. 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 observation of the laboratory freezer, and interview with the technical supervisor (TS), the laboratory failed to ensure the laboratory's internal standards and calibrators were not used when they had exceeded their expiration date. Findings: 1. Observation of the laboratory freezer showed Cerilliant chemistry internal standards and calibrators still in use: MDMA lot #FE02211702 exp: 04/2022 benzoylegonine D3 lot #FE03291703 exp: 05/2022 nordiazepam lot #FE12231502 exp: 01/2021 hydrocodone lot # FE04291601 exp: 05/2021 methanol lot #FN07251703 exp: 10 /2021 pregabalin lot #FE05041703 exp: 06/2021 nicotine lot #FN05131604 exp: 05 /2021 methamphetamine lot #FE1214602 exp: 03/2022 meprobamate lot #FE06151605 exp: 07/2021 MDMA lot #FE06241606 exp: 07/2021 MDA lot #FE03161701 exp: 04/2022 benzoylegonine D3 lot #FE01061604 exp: 01/2021 amphetamine lot #FE04061701 exp: 06/2021 EDDP perchlorate lot #FN06281604 exp: 07/2021 methadone lot #FE12071601 exp: 01/2022 cyclobenzaprine lot #FN02031705 exp: 02/2022 oxycodone lot #FE01181701 exp: 03/2022 noroxycodone hci lot #FE02091701 exp: 03/2022 temazapam DT lot #FE11301602 exp: 01/2022 6 acetylmorphine lot #FE02161701 exp: 03/2022 THC lot #FE07211503 exp: 09/2020 2. Interview with the TS on June 21, 2022 at 1:00 PM confirmed the laboratory failed to ensure the laboratory's internal standards and calibrators were not used when they had exceeded their expiration date. D5435 MAINTENANCE AND FUNCTION CHECKS CFR(s): 493.1254(b)(2) For equipment, instruments, or test systems developed in-house, commercially available and modified by the laboratory, or maintenance and function check protocols are not provided by the manufacturer, the laboratory must: (i) Define a function check protocol that ensures equipment, instrument, and test system performance that is necessary for accurate and reliable test results and test result reporting. (ii) Perform and document the function checks, including background or baseline checks, specified in paragraph (b)(2)(i) of this section. Function checks must be within the laboratory's established limits before patient testing is conducted. This STANDARD is not met as evidenced by: Based on the lack of maintenance documentation and interview with the technical -- 4 of 7 -- supervisor (TS), the laboratory failed to perform and document function checks for one Eppendorf 1000 pipette, and the laboratory biosafety cabinet for 2020, 2021, and to date June 21, 2022. Findings: 1. Lack of maintenance documentation showed the laboratory failed to perform and document the function checks for one Eppendorf 1000 pipette in use for patient testing, and for the laboratory biosafety cabinet. 2. Interview with the TS on June 21, 2022 at 1:00 PM confirmed, the laboratory failed to perform and document function checks for one Eppendorf 1000 pipette, and the laboratory biosafety cabinet for 2020, 2021, and to date June 21, 2022. 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 review of Carolina quality control (QC) records, the lack of documentation for the parameters of acceptable QC and interview with the technical supervisor (TS), the laboratory failed to establish criteria for acceptability of control materials providing quantitative results. Findings: 1. Review of the Carolina QC records showed the laboratory did not establish and define statistical parameter criteria (mean and standard deviations) for acceptability of quantitative QC results reported on the chemistry analyzer for the analytes: creatinine, alcohol, benzodiazepine, opiate and THC. 2. Interview with the TS on June 21, 2022 at 1:00 PM confirmed the laboratory failed to establish criteria for acceptability of control materials providing quantitative results. D6076 LABORATORY DIRECTOR CFR(s): 493.1441 The laboratory must have a director who meets the qualification requirements of 493. 1443 of this subpart and provides overall management and direction in accordance with 493.1445 of this subpart. This CONDITION is not met as evidenced by: Based on review of Carolina verification procedures, proficiency testing, procedures, and interviews, the laboratory director failed to provide overall management and direction of the laboratory. The laboratory director failed to verify normal values for creatinine are appropriate for the laboratory's patient population (Refer to D6086); the laboratory director failed to ensure an approved

Summary Statement of Deficiencies D5437 CALIBRATION AND CALIBRATION VERIFICATION CFR(s): 493.1255(a) Unless otherwise specified in this subpart, for each applicable test system the laboratory must perform and document calibration procedures-- (1) Following the manufacturer's test system instructions, using calibration materials provided or specified, and with at least the frequency recommended by the manufacturer; (2) Using the criteria verified or established by the laboratory as specified in 493.1253(b) (3)-- (2)(i) Using calibration materials appropriate for the test system and, if possible, traceable to a reference method or reference material of known value; and (2)(ii) Including the number, type, and concentration of calibration materials, as well as acceptable limits for and the frequency of calibration; and (3) Whenever calibration verification fails to meet the laboratory's acceptable limits for calibration verification. This STANDARD is not met as evidenced by: Based on review of the laboratory's established criteria for toxicology calibration, calibration records for March 2018 and interview with testing personnel #1, calibration data failed to meet acceptable criteria for five of ten drugs performed on the LCMS toxicology analyzer. Findings: 1. The Data Review Process procedure (TOX001) states," Review the cal curve ensuring all cals and controls are within twenty percent of the target values; the R2 (R squared calibration curve) value for each drug is greater than .990 and that all blanks and negative controls are negative." 2. Review of calibration records showed, the R2 calibration values for five drugs were less than the laboratory's established criteria for acceptability. The following R2 calibration curves did not meet the criteria of greater than .990. a.) Fentanyl .979 b.) Benzoylecgonine .975 c.) MDPV .987 d) Methadone .970 e.) THC .984 3. Interview with testing personnel #1 on March 6, 2018 at 11:30 AM confirmed, the calibration curves for the five drugs did not meet the laboratory's established criteria for calibration acceptability. 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 -- 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 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 review of chemistry calibration verification and interview with testing personnel #2 the laboratory failed to perform calibration verification in 2017 on 20 of 20 analytes. Findings: 1. Review of chemistry calibration verification showed no calibration that included a minimal, midpoint and maximum value for 2017 for hemoglobin A1C, albumin, alkaline phosphatase, ALT, AST, BUN, calcium, cholesterol, CO2, creatinine, chloride, direct bilirubin, glucose, HDL, potassium, sodium, phosphate, total bilirubin, total protein and triglycerides. 2. Interview with testing personnel #2 on March 6, 2018 at 12:30 PM confirmed the laboratory failed to perform calibration verification in 2017. D6102 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1445(e)(12) The laboratory director must 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: Review of personnel training records for 2016, 2017 and interview with the laboratory director, the director failed to ensure testing personnel had appropriate training for high complexity testing prior to testing and reporting patient results. Findings: 1. Review of training documentation for 2016, 2017 revealed the director failed to have initial training for 1 of 2 testing personnel who started employment September 2016. -- 2 of 3 -- 2. Interview with the laboratory director on March 6, 2018 at 12:30 PM confirmed, the director failed to ensure each testing person had appropriate training for high complexity testing before testing patient specimens. -- 3 of 3 --