Coastal Pain & Spinal Diagnostics

Summary Statement of Deficiencies D2016 SUCCESSFUL PARTICIPATION CFR(s): 493.803(a)(b)(c) (a) Each laboratory performing nonwaived testing must successfully participate in a proficiency testing program approved by CMS, if applicable, as described in subpart I of this part for each specialty, subspecialty, and analyte or test in which the laboratory is certified under CLIA. (b) Except as specified in paragraph (c) of this section, if a laboratory fails to participate successfully in proficiency testing for a given specialty, subspecialty, analyte or test, as defined in this section, or fails to take remedial action when an individual fails gynecologic cytology, CMS imposes sanctions, as specified in subpart R of this part. (c) If a laboratory fails to perform successfully in a CMS- approved proficiency testing program, for the initial unsuccessful performance, CMS may direct the laboratory to undertake training of its personnel or to obtain technical assistance, or both, rather than imposing alternative or principle sanctions except when one or more of the following conditions exists: (1) There is immediate jeopardy to patient health and safety. (2) The laboratory fails to provide CMS or a CMS agent with satisfactory evidence that it has taken steps to correct the problem identified by the unsuccessful proficiency testing performance. (3) The laboratory has a poor compliance history. This CONDITION is not met as evidenced by: Based on a review of the proficiency testing (PT) results during the laboratory inspection, and an interview with the General Supervisor (GS), it was determined that the laboratory failed to enroll in Toxicology proficiency testing ) for Cycle 1 of 2019 and Cycle 2 of 2020 for PT specimens not processed by the College of American Pathology (CAP) program. The laboratory inspection occurred on 8/20/21 between 1: 30 p.m. and 4:00 p.m. Findings include: 1. The PT process and the associated PT reports were reviewed 2. The laboratory normally participates in the CAP Toxicology testing program for approximately 25 toxicology analytes. Approximately 14 other analytes from their requisition form are split-tested and sent to another CLIA-certified 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 -- laboratory- Integra Lab Solutions in Jupiter, Florida for 2019 and Equaltox in Tustin, CA for 2020. 3. For each patient specimen (approximately 500 per year), the laboratory does a screening test using a Themo Indiko device, and a Sciex chromatograpy/spectroscopy device for specific analyte measurement using LC/MS (liquid chromatography/mass spectroscopy) 4. PT specimen testing is normally done twice per year for both CAP and the specimens sent to the Integra or Equaltox laboratories. 5. Five split specimens are normally sent to Integra and Equaltox. 6. The analytes (identified by the GS) normally sent to Integra or Equaltox are: - Cyclobenzapine - Desipramine - Doxepin - Imipramine - MDEA - Midazolam - Methylphenidate - Naloxone - Norketamine - Nortriptyline - Naltrexone - Sulfentanil - Ventalfaxine - Zolpidem 7. The GS normally receives the data in spreadsheet format and prepares a correlation report to evaluate the PT acceptance 8. The spreadsheet correlation reports were only available for one cycle for 2019 and one for 2020- two PT report cycles are required per CLIA requirements 9. The GS affirmed on 8/20/21 at 2:20 p.m. that PT submissions for split testing for 2019 and 2020 were only done for 1 cycle and that the second cycle was skipped. D6016 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(e)(4)(i) 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)(4)(i) Ensure that the proficiency testing samples are tested as required under Subpart H of this part; This STANDARD is not met as evidenced by: Based on a review of the proficiency testing (PT) results during the laboratory inspection, and an interview with the General Supervisor (GS), it was determined that the laboratory failed to enroll in Toxicology proficiency testing ) for Cycle 1 of 2019 and Cycle 2 of 2020 for PT specimens not processed by the College of American Pathology (CAP) program. 1. The laboratory director did not ensure that the laboratory participated in two PT events annually for the split specimens. 2. See D 2016. 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 a review of the procedure documentation, and an interview with the GS, it was determined that the laboratory director failed to complete competency reports for -- 2 of 3 -- the GS for 2019 and 2020. The laboratory inspection occurred on 8/20/21 between 1: 30 p.m. and 4:00 p.m. Findings include: 1. The GS was asked to produce competency reports for his performance for 2019 and 2020. 2. The GS indicated on 8/20/21 at 2:45 p.m. that the competency reports were not done for 2019 and 2020. -- 3 of 3 --

Summary Statement of Deficiencies 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 review of the laboratory proficiency testing records, reports, and interview with the laboratory personnel, it was determined that the laboratory failed to verify the accuracy of any test or procedure it performs, at lease twice annually. The findings included: a. The laboratory used Thermo Indiko Plus instrument to perform urine drugs screen and report 17 analyte. b. The laboratory failed to verify and ensure the accuracy of the testing procedures at least twice annually. c. The laboratory personnel affirmed (3/12/2019 @11:34 AM) that the laboratory failed to verify and ensure the accuracy of the testing procedures for its urine drugs screen testing systems by Thermo Indiko Plus instrument. d. The laboratory used AB Sciex LC/MS/MS to perform drug confirmation plus providing drug concentrations in urine, when detected by screen or directly perform urine drugs testing. e. The laboratory used LC/MS/MS to report 44 drug analyte for its patient samples. f. In order to verify and ensure the accuracy of the LC/MS/MS systems, the laboratory elected to enroll DMPM (Drug Monitoring for Pain Management) with CAP (College of American Pathologists) PT (Proficiency Testing) program, which did not cover all 44 drugs this laboratory offers in its laboratory report. g. The laboratory used split samples and sent out to a CLIA certified laboratory as an alternative method to verify and ensure the accuracy of the drugs not covered by CAP's DMPM program. h. The laboratory failed to evaluate the complete test results from the outside CLIA laboratory, but only the analyte not covered by CAP's DMPM. D5413 TEST SYSTEMS, EQUIPMENT, INSTRUMENTS, REAGENT CFR(s): 493.1252(b) Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 4 -- 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 observations of the laboratory temperature charts and interview with the laboratory personnel, it was determined that the laboratory failed to familiarize the features of the digital thermometers and monitored and documented appropriately the storage devices. The findings included: a. The laboratory used refrigerators and/or freezers to store their laboratory reagents, supplies, and patient samples. b. The laboratory used digital thermometers to monitor the temperatures of the storage devices. c. The digital thermometer features "current", "Min", and "Max" temperature displays, "Alarm" and etc. When the current temperature outside of the acceptable /optimal temperature ranges for storage matters, the alarm shall be on. d. The laboratory established acceptable/optimal temperature for its refrigerator is between 2 to 8 degree Celsius (oC). e. At the time of survey (3/12/2019 @ 9:50 AM), a 1.87 oC was observed on a digital thermometer in its LC/MS/MS room, which is outside of its laboratory established acceptable storage temperature between 2 to 8 oC. f. No alarm sound was noticed at that time. g. Further interviewed and observed with the testing personnel, a "Min" temperature of 0.74 oC and "Max" temperature of 18.33 oC were noted on that digital thermometer, which indicated that at some time passed, the refrigerator temperature conditions were outside of the acceptable/optimal temperature range for storage purposes, low at 0.74 oC and high at 18.33 oC, outside. h. No action taken or documented for failure to maintain the storage temperature within the acceptable/optimal range. i. The laboratory personnel affirmed (3/12/2019 @9:50 AM) that the laboratory failed to monitor the digital thermometer closely, and to ensure and maintain the storage temperature within the acceptable range, and no action taken to correct the failures. D5467 CONTROL PROCEDURES CFR(s): 493.1256(d)(9)(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-- When using calibration material as a control material, use calibration material from a different lot number than that used to establish a cut-off value or to calibrate the test system. (g) The laboratory must document all control procedures performed. This STANDARD is not met as evidenced by: Based on observations of the facility, and review of the laboratory calibrator and quality control preparation records, and interview with the laboratory personnel, it was determined that the laboratory failed to use a different lot numbers to prepare in house working calibrators and quality control materials that used to establish a cut-off value or to calibrate the test system.. The findings included: a. The laboratory purchased certified commercial stock drug materials from Cerillian and prepared its working calibrators and quality controls in house. b. When using calibrator material as -- 2 of 4 -- control material, the laboratory must use calibrator material from a different lot number that used to established a cut off value or to calibrator test system. c. The laboratory personnel affirmed (3/12/2019 @ 12:55 PM) that the laboratory used the same lot number of the stock drug materials to prepare calibrators as well as control materials. 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