Gulf Coast Interventional Spine & Joint Specialist

Summary Statement of Deficiencies D5413 TEST SYSTEMS, EQUIPMENT, INSTRUMENTS, REAGENT CFR(s): 493.1252(b) (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: (b)(1) Water quality. (b)(2) Temperature. (b)(3) Humidity. (b)(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 reviews of the freezer temperature records, the Quidel Triage Drug Screen Quality Control (QC) package inserts and an interview with Laboratory Director (LD), the laboratory failed to ensure QC materials were stored within the manufacturer's acceptable limits. Freezer temperatures were warmer than the acceptable ranges from the date of the last survey, 06-08-2023to the date of the current survey, 12-16-2025. The findings include: 1. A review of the temperature records revealed the freezer temperature where the QC materials were stored from 2023-2025 was warmer than the manufacturer's acceptable limits of at least minus 20 degrees Celsius. 2. A review of the Quidel Triage Drug Screen QC package insert for storage and handling requirements revealed, "Store frozen at minus 20 degrees Celsius or colder..." 3. During the exit conference on March 28th, 2023, at 1:30 PM, LD confirmed the above findings. D5415 TEST SYSTEMS, EQUIPMENT, INSTRUMENTS, REAGENT CFR(s): 493.1252(c) (c) Reagents, solutions, culture media, control materials, calibration materials, and 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 -- other supplies, as appropriate, must be labeled to indicate the following: (c)(1) Identity and when significant, titer, strength or concentration. (c)(2) Storage requirements. (c)(3) Preparation and expiration dates. (c)(4) Other pertinent information required for proper use. This STANDARD is not met as evidenced by: Based on observations during the laboratory tour, a review of the manufacturer's guidelines for optimum use of the Quidel Triage test devices and an interview with the Laboratory Director (LD), the laboratory staff failed to record the new expiration for Triage Urine Drug Screen (UDS) test devices after they were transferred from the refrigerator to room temperature storage. The surveyor noted one of the 25 test devices had been utilized for testing The findings include: 1. During the laboratory tour on 12-16-2025 at approximately 8:22 AM, the surveyor observed an opened box of room temperature UDS test devices without any dates written on the box or on the individual pouch. The testing personnel failed to record the new expiration date for test devices transferred from refrigerator to room temperature storage. 2. A review of the manufacturer's guidelines on the Top 10 Tips for the Quidel Triage UDS test devices revealed the following, "Once removed from refrigeration, the pouched Test Device is stable up at room temperature for up to 14 days ..." 3. LD confirmed the above findings during the exit conference on 12-16-2025 at 1:30 PM. -- 2 of 2 --

Summary Statement of Deficiencies D6053 TECHNICAL CONSULTANT RESPONSIBILITIES CFR(s): 493.1413(b)(9) The technical consultant is responsible for evaluating and documenting the performance of individuals responsible for moderate complexity testing at least semiannually during the first year the individual tests patient specimens. This STANDARD is not met as evidenced by: Based on a review of Personnel records and an interview with the Laboratory Director, the Technical Consultant failed to evaluate competency of Testing Personnel at least semiannually within the first year of patient testing. This was noted for three out of three Testing Personnel that have been qualified as of the last survey date (4/28 /2023). The findings include: 1. A review of Personnel records revealed the following: a) Testing Personnel #1 - Initial Training 10/14/2021, Six Month Competency Assessment 4/4/2022, Annual Competency Assessment 4/5/2023. No evidence of the Annual Competency Assessment due in October 2022. b) Testing Personnel #2 - Initial Training 5/3/2021, Six Month Competency Assessment 10/5/2021, Annual Competency Assesment 10/6/2022. No evidence of the Annual Competency Assessment due in May 2022. c) Testing Personnel #3 - Initial Training 4/22/2021, Six Month Competency Assessment 12/5/2021, Annual Competency Assessment 10/6 /2022. No evidence of the Annual Competency Assessment due in April 2022. 2. During an interview on 6/8/2023 at 11:00 AM, the Laboratory Director 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 D2010 TESTING OF PROFICIENCY TESTING SAMPLES CFR(s): 493.801(b)(2) The laboratory must test samples the same number of times that it routinely tests patient samples. This STANDARD is not met as evidenced by: Based on a review of proficiency testing (PT) records and an interview with Testing Personnel (TP) #1, the surveyor determined the laboratory failed to ensure testing on PT samples was performed the same number of times as patient specimens. This was noted on four of four surveys reviewed. The findings include: 1. A review of 2017 - 2019 API (American Proficiency Institute) PT records revealed all Urine Drug Screen samples on four surveys (2017-Event #2, 2018-Events #1 and #2, and 2019-Event #1) were run on both Triage Meters (Serial #'s 73450 and 81607); tests were run by the same testing personnel on both analyzer on the same day (before the submission cutoff). 2. In an interview on 10/30/2019 at 10:30 AM, when asked how many times patient urine samples are routinely run, TP #1 stated "Once", and explained the process. The surveyor then asked if patient tests are run on one Triage, and then immediately retested on the second Triage. TP #1 stated, "No, we don't do that". The surveyor then reviewed the PT records with TP #1, and explained PT samples must be tested the same number of times as patient samples. Thus, the above noted findings were confirmed. SURVEYOR ID #32558 Licensure and Certification Surveyor 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 --