Northern Louisiana Medical Center

Summary Statement of Deficiencies D0000 A Recertification survey was conducted at Northern Louisiana Medical Center -CLIA ID # 19D0696771 on July 21, 2025 through July 24, 2025. The laboratory was found in compliance with 42 CFR 493 Requirement for Laboratories; however, standard level deficiencies were cited. D5403 PROCEDURE MANUAL CFR(s): 493.1251(b) (b) The procedure manual must include the following when applicable to the test procedure: (b)(1) Requirements for patient preparation; specimen collection, labeling, storage, preservation, transportation, processing, and referral; and criteria for specimen acceptability and rejection as described in 493.1242. (b)(2) Microscopic examination, including the detection of inadequately prepared slides. (b)(3) Step-by- step performance of the procedure, including test calculations and interpretation of results. (b)(4) Preparation of slides, solutions, calibrators, controls, reagents, stains, and other materials used in testing. (b)(5) Calibration and calibration verification procedures. (b)(6) The reportable range for test results for the test system as established or verified in 493.1253. (b)(7) Control procedures. (b)(8)

Summary Statement of Deficiencies D0000 An Initial survey was performed at Northern Louisiana Medical Center, CLIA ID 19D0696771 on November 14, 2023 through November 17, 2023. Northern Louisiana Medical Center was found not in compliance with the following CONDITION LEVEL DEFICIENCIES: 42 CFR 493.1250 CONDITION: Analytic systems 42 CFR 493.1403 CONDITION: Laboratories performing moderate complexity testing; Laboratory Director D3037 RETENTION REQUIREMENTS CFR(s): 493.1105(a)(4) Proficiency testing records. Retain all proficiency testing records for at least 2 years. This STANDARD is not met as evidenced by: Based on review of the laboratory's proficiency testing records and interview with personnel, the laboratory failed to retain proficiency testing records for at least two (2) years for one (1) of five (5) Critical Care Blood Gas with Chemistry events reviewed in 2022 and 2023. Findings: 1. Review of the laboratory's College of American Pathologists (CAP) proficiency testing records from 2022 and 2023 revealed the laboratory did not retain the original evaluation documents to include evaluation and comparative method statistics for results submitted for Arterial Blood Gas (ABG) testing for the following one (1) of five (5) testing events reviewed: a) AQ-C 2022 Critical Care Blood Gas w/ Chemistry (pH, pCO2, pO2) 3. In interview on November 15, 2023 at 12:56 pm, Testing Personnel 1 for the respiratory department stated the evaluation forms are printed from the computer and the wrong form was attached to the records for this event. Testing Personnel 1 from respiratory confirmed the laboratory did not have documentation for the identified proficiency testing event. D5400 ANALYTIC SYSTEMS CFR(s): 493.1250 Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 16 -- Each laboratory that performs nonwaived testing must meet the applicable analytic systems requirements in 493.1251 through 493.1283, unless HHS approves a procedure, specified in Appendix C of the State Operations Manual (CMS Pub.7), that provides equivalent quality testing. The laboratory must monitor and evaluate the overall quality of the analytic systems and correct identified problems as specified in 493.1289 for each specialty and subspecialty of testing performed. This CONDITION is not met as evidenced by: Based on observation by surveyors, review of laboratory policies and records as well as interview with personnel, the laboratory failed to ensure the quality of testing within the analytic systems. Findings: 1. The laboratory failed to perform platelet poor plasma studies monthly as required by laboratory policy for 2022 and 2023. Refer to D5403. 2. The laboratory failed to analyze Ammonia patient samples within thirty (30) minutes of centrifugation as required by the manufacturer for twenty four (24) of forty eight (48) patients reviewed. Refer to D5411 I. 3. The laboratory failed to ensure patient samples for D Dimer testing are analyzed within four (4) hours of collection as required by the manufacturer for three (3) of one hundred eighty seven (187) patients reviewed from August 2023 through November 2023. Refer to D5411 II. 4. The laboratory failed to ensure patient samples for Activated Partial Thromboplastin Time (APTT) testing are analyzed within four (4) hours of collection as required by the manufacturer for one (1) of one hundred forty seven (147) patients reviewed from July 2023 and November 2023. Refer to D5411 III. 5. The laboratory failed to ensure supplies did not exceed their expiration dates. Refer to D5417. 6. The laboratory failed to ensure verification of performance studies for Activated Clotting Time (ACT) on the i-Stat analyzer were complete. Refer to D5421. 7. The laboratory failed to have in house data to support the reduction of frequency of quality control for Activated Clotting Time (ACT) testing. Refer to D5445. 8. The laboratory failed to perform two (2) levels of quality controls (QC) prior to patient testing for D Dimer for one (1) of ninety two (92) days reviewed. Refer to D5447. 9. The laboratory failed to perform external reactive, weakly reactive, and non reactive quality controls for Rapid Plasma Reagent (RPR) each batch of patient testing for eight (8) of one hundred two (102) patients reviewed. Refer to D5449. 10. The laboratory failed to ensure the high /low temperature alarm spike was visible on the blood bank freezer circular chart in 2023. Refer to D5555. 11. The laboratory failed to perform

Summary Statement of Deficiencies D0000 An Offsite revisit survey was conducted at Northern Louisiana Medical Center - CLIA ID # 19D0696771 on 5, 2019. The laboratory was found in compliance with 42 CFR 493 Requirement for Laboratories. No deficie were cited. ________________________________________________________________________________________ A Validation survey was conducted at Northern Louisiana Medical Center -CLIA ID # 19D0696771 on May through May 17, 2019. The laboratory was found in compliance with 42 CFR 493 Requirement for Laborator however, standard deficiencies were cited. D5311 SPECIMEN SUBMISSION, HANDLING, AND REFERRAL CFR(s): 493.1242(a) The laboratory must establish and follow written policies and procedures for each of the following, if applica Patient preparation. (2) Specimen collection. (3) Specimen labeling, including patient name or unique patient identifier and, when appropriate, specimen source. (4) Specimen storage and preservation. (5) Conditions for specimen transportation. (6) Specimen processing. (7) Specimen acceptability and rejection. (8) Specimen ref This STANDARD is not met as evidenced by: Based on observation, record review and interview with personnel, the laboratory failed to ensure patient sam Lactic Acid testing are separated within 15 minutes according to the manufacturer for six (6) of fifty-two (52 reviewed. Findings: 1. Observation by the surveyor on May 14, 2019 revealed the laboratory was performing Acid testing on the Siemens Dimension EXL-LM Chemistry Analyzer. 2. Review of the Siemens Dimension Acid package insert revealed "Blood is best collected without stasis in a container of sodium fluoride/potassiu oxalate, followed by immediate chilling of the specimen and separation of the cells within 15 minutes. Keep on ice and analyze promptly." 3. Review of patient records for Lactic Acid from March 1, 2019 through Marc 2019 revealed the laboratory did not receive the following six (6) of fifty-two (52) patients within 15 minutes to separate as required by the manufacturer: On March 2, 2019 Patient Number 8630166 was collected at 14: and received at 14:18 pm - exceeding the fifteen (15) minutes required by the manufacturer by three (3) minu March 3, 2019 Patient Number 8630254 was collected at 19:45 pm and received at 20:05 pm - exceeding the 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 -- (15) minutes required by the manufacturer by five (5) minutes. On March 3, 2019 Patient Number 8630264 w collected at 22:00 pm and received at 22:18 pm - exceeding the fifteen (15) minutes required by the manufac three (3) minutes. On March 7, 2019 Patient Number 8630498 was collected at 17:36 pm and received at 17:5 exceeding the fifteen (15) minutes required by the manufacturer by four (4) minutes. On March 8, 2019 Patie Number 8631041 was collected at 18:05 pm and received at 18:48 pm - exceeding the fifteen (15) minutes re the manufacturer by twenty eight (28) minutes. On March 8, 2019 Patient Number 8631054 was collected at and received at 21:49 pm - exceeding the fifteen (15) minutes required by the manufacturer by four (4) minut interview on May 16, 2019 at 1:41 pm, Technical Consultant 1 confirmed the laboratory separates the Lactic patient samples after receiving them and the above patient samples were not received within the fifteen (15) m required by the manufacturer. 5. Review of the Task 1 & 3 form provided to surveyor revealed the laboratory performs 2,412 Lactic Acid tests annually. D5411 TEST SYSTEMS, EQUIPMENT, INSTRUMENTS, REAGENT CFR(s): 493.1252(a) Test systems must be selected by the laboratory. The testing must be performed following the manufacturer's instructions and in a manner that provides test results within the laboratory's stated performance specification each test system as determined under 493.1253. This STANDARD is not met as evidenced by: Based on observation, record review and interview with personnel, the laboratory failed to ensure the donor questionnaires for Mean Prothrombin Time studies corresponds with the raw data on the instrument tapes. Fi 1. Observation by surveyor during laboratory tour on May 15, 2019 revealed the laboratory utilizes the Sysm 600 analyzer for Prothrombin Time (PT) and International Normalized Ratio (INR) testing. 2. Review of the laboratory's policy and procedure manual revealed the laboratory did not have detailed , written instructions f identification of the donor questionnaire and the corresponding raw data. 3. Review of the Normal Mean Prot Time study (NMPT) revealed the laboratory did have twenty (20) donor questionnaires; however, the laborat not identify each questionnaire to correspond with the raw data provided for the NMPT study. 3. In interview 15, 2019 at 02:48 pm, the General Supervisor confirmed the laboratory did not have a system in place to iden which normal donor questionnaire corresponds to the raw data provided for the study. 4. Review of the Task forms provided to surveyors revealed the laboratory performs 3,114 PT/INR tests annually. D5429 MAINTENANCE AND FUNCTION CHECKS CFR(s): 493.1254(a)(1) For unmodified manufacturer's equipment, instruments, or test systems, the laboratory must perform and doc maintenance as defined by the manufacturer and with at least the frequency specified by the manufacturer. This STANDARD is not met as evidenced by: I. Based on observation, record review and interview with personnel, the laboratory failed to document month instrument maintenance as defined by the manufacturer for the Siemens Dimension EXL-LM Chemistry anal Findings: 1. Observation by surveyor during the laboratory tour on May 14, 2019 revealed the laboratory util Siemens Dimension EXL-LM analyzer for Electrolye (IMT) testing. 2. Review of instrument manual for the Dimension EXL revealed the following monthly maintenance required by the manufacturer: a) Monthly Clea Check Drain on IMT Port Replace IMT Pump Tubing Clean IMT System* Replace/Clean Air Filters Stylette Wash Probes Replace HM Pump Heads^ Clean R2 Drain Clean R3 Drain** 3. Review of the maintenance lo January 2018 through April 2019 revealed the laboratory did not document the monthly maintenance to Clean System* for the following two (2) of sixteen (16) months reviewed: a) March 2018 b) December 2018 4. In i on May 14, 2019 at 01:38 pm, the Chemistry General Supervisor stated the IMT clean is done monthly or eve (30) days so it sometimes does not fall when the other monthly maintenance is performed. The General Supe confirmed there was not any documentation to show that maintenance was performed. II. Based on observatio -- 2 of 3 -- record review, and interview with personnel, the laboratory failed to document the Heater Temperatures for t Autostainer XL as required. Findings: 1. Observation by surveyor during the laboratory tour on May 16, 2019 revealed the laboratory utilizes the Leica Autostainer XL for staining of slides in the Pathology department. 2 of the package insert for the Leica Autostainer XL revealed the acceptable range for the the Heater Temperat to 65 degrees celsius. 3. Review of the Leica Stainer Quality Control Chart revealed the laboratory is to check heater temperature daily. 4. Further review of the Leica Stainer Quality Control Chart revealed the laboratory document the heater temperature with an actual temperature reading for the following two (2) of six (6) mont reviewed: a) Janury 2019 b) April 2019 5. In interview on May 16, 2019 at 11:34 am, Pathology personnel co the heater temperatures for the Leica Autostainer XL was not documented as required by laboratory policy. D6014 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(e)(3)(iii) The laboratory director is responsible for the overall operation and administration of the laboratory, including employment of personnel who are competent to perform test procedures, and record and report test results pro accurate, and proficiently and for assuring compliance with the applicable regulations. (e) The laboratory dire must-- (e)(3) Ensure that-- (e)(3)(iii) Laboratory personnel are performing the test methods as required for ac and reliable results. This STANDARD is not met as evidenced by: Based on observation, record review, and interview with personnel, the Laboratory Director failed to ensure laboratory personnel performed testing as required. Findings: 1. The laboratory failed to ensure patient sampl Lactic Acid testing are separated within 15 minutes according to the manufacturer for six (6) of fifty-two (52 reviewed. Refer to D5311. 2. The laboratory failed to ensure the donor questionnaires for Mean Prothrombin studies corresponds with the raw data on the instrument tapes. Refer to D5411. 3. The laboratory failed to doc monthly instrument maintenance as defined by the manufacturer for the Siemens Dimension EXL-LM Chem analyzer. Refer to D5429. 4. The laboratory failed to document the Heater Temperatures for the Leica Autost as required. Refer to D5429 II. D6036 TECHNICAL CONSULTANT RESPONSIBILITIES CFR(s): 493.1413 The technical consultant is responsible for the technical and scientific oversight of the laboratory. This STANDARD is not met as evidenced by: Based on observation, record review, and interview with personnel, the Technical Consultants failed to provi technical and scientific oversight to the laboratory. Findings: 1. The laboratory failed to ensure patient sample Lactic Acid testing are separated within 15 minutes according to the manufacturer for six (6) of fifty-two (52 reviewed. Refer to D5311. 2. The laboratory failed to ensure the donor questionnaires for Mean Prothrombin studies corresponds with the raw data on the instrument tapes. Refer to D5411. 3. The laboratory failed to doc monthly instrument maintenance as defined by the manufacturer for the Siemens Dimension EXL-LM Chem analyzer. Refer to D5429 I. 4. The laboratory failed to document the Heater Temperatures for the Leica Auto XL as required. Refer to D5429 II. -- 3 of 3 --