Center For Interventional Pain & Spine Llc

Summary Statement of Deficiencies D3009 FACILITIES CFR(s): 493.1101(c) The laboratory must be in compliance with applicable Federal, State, and local laboratory requirements. This STANDARD is not met as evidenced by: Based on record review and interview with the laboratory director (LD) and Techinical Supervisor (TS), the LD failed to be present for a reasonable period of each working day in each laboratory for which he was director from 8/26/22 to the day of survey as required by PA state regulations. Findings include: 1.The PA State regulation 5.22 (g) states: "A director shall be present for a reasonable period of each working day in each laboratory for which he is director." 2.The laboratory's policy GEN 105.0 LD Communication states, "The Laboratory Director will be available for laboratory and laboratory personnel, as well as for clients (physicians), once a month or as needed by phone, email, and other communication means. In addition, many laboratory activities are completed through qualified Laboratory Director designees. Laboratory Director will document the director's site visits and communication(s) with the laboratory on the Director's Site Visit and Communication Log. " 3. According to the Laboratory Director Log the LD visited the laboratory 11 of 29 months from 01/2022 to the day of survey. 4. The LD confirmed the findings above on 05/01/2024 at 01:00 pm. 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 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 -- 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 review of temperature records, observation of the laboratory, and interview with the laboratory director (LD) and technical supervisor (TS), the laboratory failed to monitor and document refrigerator temperatures to ensure operating conditions were met for the proper storage of reagents for chemistry testing from 8/11/2022 to the day of survey. Findings Include: 1. On the day of the survey, 05/01/2024 at 12:30 pm, review of 2 of 2 months of laboratory's temperature logs revealed the laboratory failed to monitor and document refrigerator temperature for weekends and holidays from 5/24/2022 to the day of survey. 2. During observation of the laboratory the following reagents were found to be stored in refrigerator in the laboratory. 7 of 7 IMCSzyme- acceptable storage temperature 2-8 degrees Celsius 8 of 8 Rapid Hydrolysis Buffer- acceptable storage temperature 2-30 degrees Celsius 3. The LD and TS confirmed the findings above on 05/01/2024 at 1:00 pm. 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. This STANDARD is not met as evidenced by: Based on lack of documentation and interview with the laboratory director (LD) and technical supervisor (TS), the laboratory failed to evaluate twice a year the relationship between 2 of 2 AB Sciex Triple Quad 4500MD analyzers used for toxicology testing performed from 08/26/2022 to the date of survey. Findings include: 1. On the day of survey, 05/01/2024, the laboratory failed to provide documentation of the biannual comparison studies for the following instruments used for Toxicology testing performed from 08/26/2022 to 05/012024: - AB Sciex Triple Quad 4500 MD SN: CP20101710 v. AB Sciex Triple Quad 4500 SN: BJ23581405 2. The LD and TS confirmed the findings above on 05/01/2024 at 1:00 pm. -- 2 of 2 --

Summary Statement of Deficiencies D6125 TECHNICAL SUPERVISOR RESPONSIBILITIES CFR(s): 493.1451(b)(8)(v) The procedures for evaluation of the competency of the staff must include, but are not limited to assessment of test performance through testing previously analyzed specimens, internal blind testing samples or external proficiency testing samples. This STANDARD is not met as evidenced by: Based on review of the Training and Competency Assessment form records and interview with the Technical Supervisor (TS), General Supervisor (GS), and Laboratory Director (LD), the TS failed to assess test performance through testing previously analyzed specimens, internal blind testing samples or external proficiency testing samples for 1 of 5 Testing Personnel (TP) who performed toxicology screening and confirmatory test from 04/26/2021 to 08/26/2022. Findings include: 1. On the day of inspection, 08/26/2022 at 09:33 AM, a review of competency assessment records revealed that the TS did not perform an assessment on TP #4 on external proficiency testing samples or through internal blind testing samples who performed toxicology screening and confirmatory test from 4/26/2021 through 08/26/2022. 2. Technical Supervisor (TS), General Supervisor (GS), and Laboratory Director (LD) confirmed the above findings on 08/26/2022 at 11:48 AM. 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 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 review of the competency assessment records and policy & interview with the Laboratory Director, Technical Supervisor, and General Supervisor, the Technical Supervisor failed to establish written policies and procedures to assess competency for 1 of 1 Technical Supervisor, and 1of 1 General Supervisor from (09/12/2018) through the date of the survey (06/12/2020). Findings: 1. At the time of the survey, the Laboratory could not provide written policies and procedures to assess the Technical Supervisor & General Supervisor competency assessment. 2. A review of the competency assessment records revealed there was no documentation of supervisor competency assessment from (09/12/2018) through the date of the survey (06/10 /2020). 3. From (09/12/2018) through the date of the survey (06/10/2020), 40,927 toxicology specimens were run. 4. During the survey (11:00 06/10/2020), the General Supervisor confirmed, the above findings. 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 D3011 FACILITIES CFR(s): 493.1101(d) Safety procedures must be established, accessible, and observed to ensure protection from physical, chemical, biochemical, and electrical hazards, and biohazardous materials. This STANDARD is not met as evidenced by: Based on the review of the Chemical Inventory Communication Policy, observation of the laboratory and interview with the laboratory Director (LD), Technical Supervisor (TS) and General Supervisor, the Laboratory failed to have adequate Personnel Protective Equipment (PPE) procedures for handling quality controls and calibrators prepared in the laboratory. Findings include: 1. The Chemical Inventory Communication Policy, SAF 104.0, under PPE sections states "It is the responsibility of management to provide a safe working environment and to provide equipment to ensure the personal safety to all employees. While this statement holds true, it is the responsibility of staff to ensure PPE equipment is maintained in sufficient quantities, obtained if needed, and located in an area accessible to all employees in time of need." 2. On the day of survey, 09/12/2018, the SAF 104.0 Chemical Inventory Communication Policy lacked specifics in PPE needed to be used in the laboratory when working with specimen and during preparation of quality material produced in the laboratory. 3. The LD and TS confirmed the findings above on 09/12/2018 around 12:24 pm. 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 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 -- 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 Sciex LCMS/MS record review and interview with the Laboratory Director (LD) and the Technical Supervisor (TS), the laboratory failed to verify the performance specification of the Lower Limit of Quantification (LLOQ) and Upper Limit of Quantification (ULOQ) cutoff values for the Sciex LCMS/MS used for confirmatory toxicology tests before reporting patient results from 7/23/2018 to 9/12 /2018. Findings include: 1. On the day of survey, 09/12/2018, the Laboratory could not provide the surveyor with validation documentation for the LLOQ and ULOQ cutoff values used for the Sciex LCMS/MS confirmation toxicology tests. 2. From 7 /23/2018 to 09/12/2018, 1475 patient Toxicology Confirmatory tests were analyzed. 3. The LD and TS confirmed the findings above on 09/12/2018 around 10:30 am. * LCMS/MS = Liquid Chromatography Mass Spectrometry 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 upon Sciex LCMS/MS record review and interview with the Laboratory Director (LD) and the Technical Supervisor (TS), the laboratory failed to establish, verify and document the acceptability of all control materials (3 of 3) prepared in house for the Sciex LCMS/MS from July 23, 2018 to September 12, 2018. Findings include: 1. On the day of survey, 09/12/2018, the laboratory could not provide documentation of documented criteria for acceptability and show statistical parameters performed on 3 of 3 unassayed quality control materials prepared in the laboratory. 2. From 7/23/2018 to 09/12/2018, 1475 patient Toxicology Confirmation tests were analyzed. 3. The LD and TS confirmed the findings above on 09/12/2018 around 12:00 pm. -- 2 of 2 --