Altus Lumberton Hospital, Llc

Summary Statement of Deficiencies D0000 The laboratory was found to be in compliance with 42 CFR Part 493, Requirements for Laboratories as a result of a recertification survey completed August 30, 2024. 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 D0000 Noted deficiencies and plans of correction were discussed with the laboratory representative(s) at the exit conference. The facility was found to be in compliance with applicable Conditions of Participation in the CLIA program, and recertification is recommended. . D2087 ROUTINE CHEMISTRY CFR(s): 493.841(a) Failure to attain a score of at least 80 percent of acceptable responses for each analyte in each testing event is unsatisfactory analyte performance for the testing event. This STANDARD is not met as evidenced by: Based on the review of API chemistry Core test events in 2021, and confirmed in an interview found the laboratory failed to attain a score of at least 80% in one of three 2021 Chemistry Core test Events (2021 Chemistry Core 3rd event) for i-STAT blood analyzer using CG4+ cartridges for one of four analytes: pH. The findings were: 1. Review of the API chemistry test events in 2021 revealed the laboratory performed chemistry with CG4+ cartridges for the analytes of Lactate, pCO2, pH, and pO2 on i- STAT blood analyzer. 2. Further review of the API chemistry test events in 2021 revealed the laboratory scored unsatisfactory score of 40% for one of four analytes of pH in one of three chemistry test events: 2021 Chemistry Core 3rd event. 3. Review of 2021 Chemistry Core 3rd event revealed the analyte of pH attained three of five unacceptable responses. IB13 Reported result 2.41 Expected result 7.34-7.43 IB14 Reported result 8.69 Expected result 6.95-7.04 IB15 Reported result 6.70 Expected result 7.09-7.18 4. An interview with the technical consultant on 10/12/22 at 10:45 am in the conference room confirmed the above findings. Key: API=American Proficiency Institute D5439 CALIBRATION AND CALIBRATION VERIFICATION CFR(s): 493.1255(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 3 -- 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 the direct observation of the surveyor, the review of the manufacturer's insert, the laboratory records, patient results, and confirmed in interview found he laboratory failed to perform one of two calibration verification for four of four analytes on the Abbott i-STAT blood analyzers in 2021. The findings were: 1. Direct observation of the surveyor on 10/12/22 at 10:00 am in the lab revealed the laboratory used two i-STAT blood analyzers: SN: 364466 and SN: 365791. 2. Direct observation of the surveyor on 10/12/22 at 10:00 am in the lab revealed the laboratory used CG4+ cartridges on i-STAT blood analyzers. 3. Review of the manufacturer's insert titled i- STAT CG4+ Cartridge (Art: 765788-00 Rev. A Rev. Date: 20-Feb-2020) under p.6 Calibration Verification revealed "Calibration Verification is a procedure intended to verify the accuracy of results over the entire measurement range of a test... However, it may be required by regulatory or accreditation bodies." 4. Review the laboratory's calibration verification records for CG4+ revealed the laboratory had documentation of calibration verification performed on 11/27/2020, and then on 12/24/2021 for i- STAT blood analyzers SN: 364466 and SN: 365791. The laboratory had no documentation of calibration verification for CG4+ of both i-STAT blood analyzers between 5/28/2021 to 12/23/2021. 5. Random review of the laboratory's patient records from 9/2/2021 to 12/15/2021 revealed 51 patient had testing performed with CG4+ cartridges on i-STAT blood analyzers. 9/2/2021 Patient MRN#: 46310 9/4 /2021 Patient MRN#: 46348 9/6/2021 Patient MRN#: 46427 9/7/2021 Patient MRN#: 46338 9/7/2021 Patient MRN#: 46427 9/8/2021 Patient MRN#: 46356 9/8/2021 Patient MRN#: 46485 9/9/2021 Patient MRN#: 46427 9/10/2021 Patient MRN#: 46427 9/11/2021 Patient MRN#: 46554 9/13/2021 Patient MRN#: 46554 9/14/2021 Patient MRN#: 46554 9/15/2021 Patient MRN#: 46642 9/18/2021 Patient MRN#: 46699 9/18/2021 Patient MRN#: 40649 9/20/2021 Patient MRN#: 46714 9/23/2021 Patient MRN#: 45736 9/25/2021 Patient MRN#: 46831 9/26/2021 Patient MRN#: 46858 9/27/2021 Patient MRN#: 46827 9/27/2021 Patient MRN#: 46874 9/28/2021 Patient MRN#: 37137 10/2/2021 Patient MRN#: 46969 10/4/2021 Patient MRN#: 46985 10/4/2021 Patient MRN#: 38160 10/10/2021 Patient MRN#: 46469 10/11/2021 Patient MRN#: 37518 10/11/2021 Patient MRN#: 47126 10/18/2021 Patient MRN#: -- 2 of 3 -- 45681 10/18/2021 Patient MRN#: 44279 10/19/2021 Patient MRN#: 44279 10/21 /2021 Patient MRN#: 47306 10/23/2021 Patient MRN#: 47344 11/20/2021 Patient MRN#: 47828 11/26/2021 Patient MRN#: 47942 12/1/2021 Patient MRN#: 48025 12 /6/2021 Patient MRN#: 48129 12/7/2021 Patient MRN#: 40602 12/7/2021 Patient MRN#: 48138 12/9/2021 Patient MRN#: 33832 12/15/2021 Patient MRN#: 43358 6. An interview with the technical consultant on 10/13/22 at 11:35 am in the conference room confirmed the above findings. -- 3 of 3 --

Summary Statement of Deficiencies D2007 TESTING OF PROFICIENCY TESTING SAMPLES CFR(s): 493.801(b)(1) The samples must be examined or tested with the laboratory's regular patient workload by personnel who routinely perform the testing in the laboratory, using the laboratory's routine methods This STANDARD is not met as evidenced by: Review of the CMS 209 Laboratory Personnel Report, the American Proficiency Institute ( API) proficiency testing records, and staff interview found that the laboratory failed to test proficiency testing samples in the same manner as it routinely tested patient samples in five of five events for Chemistry and 4 of 4 events for Hematology in 2020 and 2021. Findings were as follows: 1. Review of the CMS Report 209 Laboratory Personnel report found the laboratory listed 34 testing personnel performing non waived testing. 2. Review of the American proficiency Institute (API) proficiency testing records for Chemistry and Hematology/Coagulation for the 1st testing event of 2020 through the second testing event of 2021 (3 testing events per year) found that testing person three signed the attestation statements for 5 of 5 Chemistry testing events and four of four Hematology testing events . 3. Interview of the technical consultant conducted June 17, 2021 at 10:20 AM confirmed that testing person three performed all proficiency testing events. D5441 CONTROL PROCEDURES CFR(s): 493.1256(a)(b)(c)(g) (a) For each test system, the laboratory is responsible for having control procedures that monitor the accuracy and precision of the complete analytic process. (b) The laboratory must establish the number, type, and frequency of testing control materials using, if applicable, the performance specifications verified or established by the laboratory as specified in 493.1253(b)(3). (c) The control procedures must-- (c)(1) 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 -- Detect immediate errors that occur due to test system failure, adverse environmental conditions, and operator performance. (c)(2) Monitor over time the accuracy and precision of test performance that may be influenced by changes in test system performance and environmental conditions, and variance in operator performance. (g) The laboratory must document all control procedures performed. This STANDARD is not met as evidenced by: Review of quality control records and interview of facility personnel found that the laboratory failed to have a means of evaluating the accuracy and precision of Chemistry and Coagulation test performance over time for quality control materials tested on the Triage meter (Troponin and D dimer) and the i Stat ( Blood gasses and Lactate) . Findings included: 1. Review of laboratory quality control records for the Triage meters in 2021 found no statistical information or graphs available for review that would aid in identifying shifts and trends in quality control performance occurring over time. Quality control material lot numbers used between January and March 2021 for each of the Triage meters were: Meter 00084422 - D dimer Triage Total 5 Control 1 lot C3553AN expiration 2021/03/27- used January 07, 2021 Triage Total 5 Control 2 lot C3577AN expiration 2021/04/22- used January 07, 2021 Triage Total 5 Control 1 lot C3654AN expiration 2021/06/04 - used January 23, 2021 Triage Total 5 Control 2 lot C3668AN expiration 2021/06/30- used January 23, 2021 Triage Total 5 Control 1 lot C3654AN expiration 2021/06/04 - used February 4, 2021 Triage Total 5 Control 2 lot C3668AN expiration 2021/06/30- used February 4, 2021 Triage Total 5 Control 2 lot C3658AN Expiration 2021/08/06 - used February 20, 2010 Triage Total 5 Control 2 lot C3671AN expiration 2021/09/04 - used February 20, 2021 Triage Total 5 Control 1 lot C3654AN expiration 2021/06/04 - used March 4, 2021 Triage Total 5 Control 2 lot C3671AN expiration 2021/09/04 - used March 4, 2021 Triage Total 5 Control 1 lot C3659AN expiration 2021/08/27 - used March 18, 2021 x2 Triage Total 5 Control 2 lot C3668AN expiration 2021/06/30- used March 18, 2021 x2 Meter 00084422 CKMB and Troponin Triage Total 5 Control 1 lot C3553AN expiration 2021/03/27- used January 12, 2021 Triage Total 5 Control 2 lot C3577AN expiration 2021/04/22- used January 12, 2021 Triage Total 5 Control 1 lot C3654AN expiration 2021/06/04 - used January 21, 2021 Triage Total 5 Control 2 lot C3577AN expiration 2021/04/22- used January 21, 2021 Triage Total 5 Control 1 lot C3654AN expiration 2021/06/04 - used January 27, 2021 Triage Total 5 Control 2 lot C3668AN expiration 2021/06/30- used January 27, 2021 Triage Total 5 Control 1 lot C3654AN expiration 2021/06/04 - used February 4, 2021 Triage Total 5 Control 2 lot C3668AN expiration 2021/06/30- used February 4, 2021 Triage Total 5 Control 2 lot C3658AN Expiration 2021/08/06 - used February 20, 2010 Triage Total 5 Control 2 lot C3671AN expiration 2021/09/04 - used February 20, 2021 Triage Total 5 Control 1 lot C3654AN expiration 2021/06/04 - used February 24, 2021 Triage Total 5 Control 2 lot C3670AN expiration 2021/08/21- used February 24, 2021 Triage Total 5 Control 1 lot C3659AN expiration 2021/08/27 - used March 18, 2021 x2 Triage Total 5 Control 2 lot C3668AN expiration 2021/06/30- used March 18, 2021 x2 Triage Total 5 Control 1 lot C3659AN expiration 2021/08/27 - used March 24, 2021 Triage Total 5 Control 2 lot C3668AN expiration 2021/06/30- used March 24, 2021 Meter 00081982 - D dimer Triage Total 5 Control 1 lot C3553AN expiration 2021/03/27- used January 07, 2021 Triage Total 5 Control 2 lot C3577AN expiration 2021/04/22- used January 07, 2021 Triage Total 5 Control 1 lot C3654AN expiration 2021/06/04 - used January 23, 2021 Triage Total 5 Control 2 lot C3668AN expiration 2021/06/30- used January 23, 2021 Triage Total 5 Control 1 lot C3654AN expiration 2021/06/04 - used February 4, 2021 Triage Total 5 Control 2 lot C3668AN expiration 2021/06/30- used February 4, 2021 Triage Total 5 Control 2 lot C3658AN Expiration 2021/08/06 - -- 2 of 3 -- used February 20, 2010 Triage Total 5 Control 2 lot C3671AN expiration 2021/09/04 - used February 20, 2021 Triage Total 5 Control 1 lot C3654AN expiration 2021/06 /04 - used March 4, 2021 Triage Total 5 Control 2 lot C3671AN expiration 2021/09 /04 - used March 4, 2021 Triage Total 5 Control 1 lot C3659AN expiration 2021/08 /27 - used March 18, 2021 x2 Triage Total 5 Control 2 lot C3668AN expiration 2021 /06/30- used March 18, 2021 x2 Meter 00081982 CKMB and Troponin Triage Total 5 Control 1 lot C3553AN expiration 2021/03/27- used January 12, 2021 Triage Total 5 Control 2 lot C3577AN expiration 2021/04/22- used January 12, 2021 Triage Total 5 Control 1 lot C3654AN expiration 2021/06/04 - used January 21, 2021 Triage Total 5 Control 2 lot C3668AN expiration 2021/06/30- used January 21, 2021 Triage Total 5 Control 1 lot C3654AN expiration 2021/06/04 - used January 27, 2021 Triage Total 5 Control 2 lot C3668AN expiration 2021/06/30- used January 27, 2021 Triage Total 5 Control 1 lot C3654AN expiration 2021/06/04 - used February 4, 2021 Triage Total 5 Control 2 lot C3668AN expiration 2021/06/30- used February 4, 2021 Triage Total 5 Control 2 lot C3658AN Expiration 2021/08/06 - used February 20, 2010 Triage Total 5 Control 2 lot C3671AN expiration 2021/09/04 - used February 20, 2021 Triage Total 5 Control 1 lot C3654AN expiration 2021/06/04 - used February 24, 2021 Triage Total 5 Control 2 lot C3670AN expiration 2021/08/21- used February 24, 2021 Triage Total 5 Control 1 lot C3658AN expiration 2021/08/06 - used March 18, 2021 Triage Total 5 Control 2 lot C3668AN expiration 2021/06/30- used March 18, 2021 Triage Total 5 Control 1 lot C3659AN expiration 2021/08/27 - used March 24, 2021 Triage Total 5 Control 2 lot C3668AN expiration 2021/06/30- used March 24, 2021 3. The laboratory was asked to provide documentation of monitoring its quality control results over time to detect shifts, trends and the overall performance. Levy Jennings graphs were provided for CKMB quality control materials tested on the Triage meter between January and May, 2021. No other documents were provided 4. Interview with the Technical Consultant conducted on June 17, 2021 at 1:02 PM confirmed that she did not have a means to evaluate and assess the performance of quality control materials over time. She stated that she just got started on this this year and was looking for a good graph to use. -- 3 of 3 --