Palmetto Pain Management, Llc

Summary Statement of Deficiencies D0000 An announced onsite CLIA recertification survey was conducted on July 23, 2025, at the laboratory of Palmetto Pain Management by the South Carolina Department of Public Health (SC DPH) Bureau of Nursing Homes and Medical Services. The Laboratory was found to be out of compliance with Medicare condition 42 CFR Part 493, CLIA Requirements for Laboratories. The following is a list of Condition and Standard level deficiencies cited as a result of the CLIA recertification survey on July 23, 2025. D2016 42 CFR 493.803 Successful Participation in Proficiency Testing. 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 records review, American Proficiency Institute (API) performance summary 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 -- documentation, and staff interview, the labortory failed to successfully participate in a CMS approved proficiency testing (PT) program in 4 out of 4 events reviewed. Findings included: 1. Review of API PT results reveals to following: a. 2023 API Chemistry Miscellaneous 2nd event test pH score = 67% b. 2024 API Chemistry Miscellaneous 1st event test pH score = 33% c. 2024 API Chemistry Miscellaneous 2nd event test pH score = 67% d. 2025 API Chemistry Miscellaneous 1st event test pH score = 33% 2. Review of CLIA standards indicates 2 consecutive PT failures or 2 out of 3 PT failures for a given analyte constitutes "Unsuccessful" participation in PT program. 3. In an interview with General Supervisor (GS1) on July 23, 2025 at 1:45 pm in the laboratory breakroom, the findings were confirmed. D6004 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(a)(b) 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. (a) The laboratory director, if qualified, may perform the duties of the technical consultant, clinical consultant, and testing personnel, or delegate these responsibilities to personnel meeting the qualifications of 493.1409, 493.1415, and 493.1421, respectively. (b) If the laboratory director reapportions performance of his or her responsibilities, he or she remains responsible for ensuring that all duties are properly performed. This STANDARD is not met as evidenced by: Based on records review, API PT performance summaries, and staff interview, the laboratory director failed to ensure the successful participation in an approved PT program in 4 out of 4 events reviewed. Findings included: 1. Review of API PT results reveals to following: a. 2023 API Chemistry Miscellaneous 2nd event test pH score = 67% b. 2024 API Chemistry Miscellaneous 1st event test pH score = 33% c. 2024 API Chemistry Miscellaneous 2nd event test pH score = 67% d. 2025 API Chemistry Miscellaneous 1st event test pH score = 33% 2. Review of CLIA standards indicates 2 consecutive PT failures or 2 out of 3 PT failures for a given analyte constitutes "Unsuccessful" participation in PT program. 3. In an interview with General Supervisor (GS1) on July 23, 2025 at 1:45 pm in the laboratory breakroom, the findings were confirmed. -- 2 of 2 --

Summary Statement of Deficiencies D0000 A Recertification Survey was conducted at Palmetto Pain Management, Columbia, SC on 02/16/2024. The laboratory was found to be out of compliance with CLIA regulations 42CFR Part 493. Standard level deficiencies were cited. D5431 MAINTENANCE AND FUNCTION CHECKS CFR(s): 493.1254(a)(2) For unmodified manufacturer's equipment, instruments, or test systems, the laboratory must perform and document function checks as defined by the manufacturer and with at least the frequency specified by the manufacturer. Function checks must be within the manufacturer's established limits before patient testing is conducted. This STANDARD is not met as evidenced by: Based on the review of the laboratory's Agilent 6460 procedure manual, Maintenance Checklist for Agilent 6460, and staff interview, the laboratory failed to follow the laboratory's policy for documentation of instrument maintenance in 3 of 24 months. I Findings included: 1. Review of the Agilent 6460 procedure manual reveals the instrument manufacturer's maintenance requirement, which includes weekly maintenance. 2. Review of the Maintenance Checklist for Agilent 6460 for 2022 and 2023 revealed 3 of 24 months with no documentation of weekly maintenance. 3. In an interview on 02/16/2024 at 11:20 am in the laboratory conference room, the staff acknowledged no documentation of weekly maintenance for 01/2023, 02/2023, and 03 /2023. II Based on the review of the laboratory's Olympus AU400 e analyzer procedure manual, AU400e Analyzer Maintenace Log, and staff interview, the laboratory failed to follow the laboratory's policy for documentation of instrument maintenance 12 of 12 months in 2022. Findings included: 1. Review of the Olympus AU400e analyzer procedure manual reveals the instrument manufacturer's maintenance requirement, which includes quarterly maintenance. 2. Review of the Olympus AU400e Analyzer Maintenance log for 2022 revealed 12 of 12 months with no documentation of quarterly maintenance. 3. In an interview on 02/16/2024 at 11:25 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 -- am in the laboratory conference room, the staff acknowledged no documentation of quarterly maintenance 12 of 12 months in 2022. -- 2 of 2 --

Summary Statement of Deficiencies 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: During an onsite recertification survey on 06/26/2019, based on laboratory procedure manual review, chemistry analyzer operator's manual review, lack of documentation, and testing personnel interview, it was determined that the laboratory failed to document and monitor room humidity readings for 3 of 3 years reviwed (2017, 2018, and 2019). Findings include: 1. The laboratory procedure manual stated a required room humidity range of 40 to 80% would be documented daily. 2. The operator's manual for the AU400 chemistry analyzer stated that the instrument should be operated at an ambient humidity of 40 to 80% humidity. 3. Documentation of acceptable humidity readings and of humidity being routinely monitored was unavailable for review on the day of the survey for the years 2017, 2018, and 2019. 4. Testing personnel confirmed during an onsite interview on 06/26/2019 at 2:00pm that the laboratory had failed to ensure that acceptable humidity ranges were monitored and documented for the laboratory. D5429 MAINTENANCE AND FUNCTION CHECKS CFR(s): 493.1254(a)(1) For unmodified manufacturer's equipment, instruments, or test systems, the laboratory 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 -- 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: During an onsite recertification on 06/26/2019, based on instrument operator manual review, instrument maintenance record review and testing personnel interview, it was determined that the laboratory failed to document quarterly maintenance on the chemistry instrument for three of three years reviewed (2017, 2018, and 2019). Findings include: 1. Review of the AU400 chemistry analyzer operator's manual revealed that all operators should routinely perform scheduled maintenance to ensure optimum performance of the instrument including a quarterly cleaning of the air filters and replacement of the wash solution. 2. Review of the AU400 chemistry analyzer maintenance logs on 06/26/2019 at 2:00pm revealed that quarterly maintenance had not been documented for three of three years reviewed (2017, 2018, and 2019). 3. Testing personnel confirmed during an onsite interview on 06/26/2019 at 2:30pm that the quarterly maintenance had not been performed for the reviewed years. D5777 COMPARISON OF TEST RESULTS CFR(s): 493.1281(b)(c) (b) The laboratory must have a system to identify and assess patient test results that appear inconsistent with the following relevant criteria, when available: (b)(1) Patient age. (b)(2) Sex. (b)(3) Diagnosis or pertinent clinical data. (b)(4) Distribution of patient test results. (b)(5) Relationship with other test parameters. (c) The laboratory must document all test result comparison activities. This STANDARD is not met as evidenced by: During an onsite recertification survey on 06/26/2019, based on the laboratory procedure manual, lack of documentation and testing personnel interview, the laboratory failed to ensure that documentation of urine drug test result comparison procedures was performed for 3 of 3 years reviewed (2017, 2018, and 2019). Findings include: 1. The laboratoy procedure manual stated that the records of 10 patients who had urine drug testing laboratory procedures requested would be selected and reviewed by the laboratory quarterly to ensure the following criteria were consistent: (1) patient age, (2) sex, (3) diagnosis or pertinent clinical data,(4) distribution of patient test results, (5) relationship with other test parameters. 2. Documentation of a quarterly patient record review for CBC testing was unavailable for review on the day of the survey for the years 2017, 2018, and 2019. 3. Testing personnel confirmed during an onsite interview on 06/26/2019 at 2:00pm that the laboratory had failed to ensure that a urine drug test result comparison was performed as required. -- 2 of 2 --