Baton Rouge Clinic Industriplex

Summary Statement of Deficiencies D0000 A Recertification survey was performed at Baton Rouge Clinic Industriplex, INC, CLIA ID 19D2055846, on February 25, 2025. The laboratory was found in compliance with 42 CFR 493 Requirements for Laboratories; however, standard level deficiencies were cited. D5401 PROCEDURE MANUAL CFR(s): 493.1251(a) (a) A written procedures manual for all tests, assays, and examinations performed by the laboratory must be available to, and followed by, laboratory personnel. Textbooks may supplement but not replace the laboratory's written procedures for testing or examining specimens. This STANDARD is not met as evidenced by: Based on review of the laboratory's policy and procedure manual and interview with personnel, the laboratory failed to establish a complete policy and procedure manual. Findings: 1. Review of the laboratory's policy and procedure manual revealed the laboratory did not have a written quality control procedure for visual inspections of blood culture bottles and media. 2. In interview on February 25, 2025 at 2:00 pm, Technical Consultant 3 confirmed the laboratory did not have a written procedure for visual inspections of blood culture bottles and media. D5421 ESTABLISHMENT AND VERIFICATION OF PERFORMANCE CFR(s): 493.1253(b)(1) (b) Each laboratory that introduces an unmodified, FDA-cleared or approved test system must do the following before reporting patient test results: (b)(1)(i) Demonstrate that it can obtain performance specifications comparable to those established by the manufacturer for the following performance characteristics: (b)(1)(i) (A) Accuracy. (b)(1)(i)(B) Precision. (b)(1)(i)(C) Reportable range of test results for Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 5 -- the test system. (b)(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 observation by surveyor, review of the laboratory's performance specification studies, and interview with personnel, the laboratory failed to have complete precision and reference range studies for Complete Blood Count (CBC) testing. Findings: 1. Observation by surveyor during the laboratory tour on February 25, 2025 at 10:01 am revealed the laboratory utilizes a Sysmex XN-330 for CBC testing. 2. Review of the laboratory's "Method Performance Verification/Validation" form for the Sysmex XN 330, in use September 19, 2023, revealed the following: a) "Precision-must demonstrate within run, (simple precision), between run, and operator variance. Within run: manufacturer will run a single specimen in replicate 10; minimum 10 runs for intra-assay precision." b) "Reference ranges: minimum of 10 samples will be tested to span the analytical range of testing, if able to obtain 10 'normal' pediatric samples. Acceptance Criteria/Acceptable Failure Rate: Will utilize current reference ranges or published data to verify reference intervals. If able to obtain 10 normal patients.. No more than one outlier. If no more than one outlier, the reference interval is verified. Correction Action for Failures: If unable to obtain enough normal pediatric samples, reference intervals will be verified by obtaining an acceptable method comparison which allows the RI to transfer to the instrument since there has been no change in patient demographic." 3. Review of the laboratory's performance specification studies revealed the laboratory did not include the following: Precision: raw data for within-run studies and documentation of operator variance Reference range: Clinical reference or studies to support the reference range in use 4. In interview on February 25, 2025 at 1:55 pm, Technical Consultant 3, confirmed the laboratory did not include the identified items with their performance specification studies. D5477 CONTROL PROCEDURES CFR(s): 493.1256(e)(4)(g) (e)(4) Before, or concurrent with the initial use-- (e)(4)(i) Check each batch of media for sterility if sterility is required for testing; (e)(4)(ii) Check each batch of media for its ability to support growth and, as appropriate, select or inhibit specific organisms or produce a biochemical response; and (e)(4)(iii) Document the physical characteristics of the media when compromised and report any deterioration in the media to the manufacturer. This STANDARD is not met as evidenced by: Based on observation by surveyor, review of the laboratory's policies, manufacturers' package inserts, and interview with personnel, the laboratory failed to document the visual inspection of media and blood culture bottles per manufacturers' requirements. Findings: 1. Observation by surveyor during the laboratory tour on February 25, 2025 at 10:01 am revealed the laboratory utilizes the following media and blood culture bottles for collection only: BD BBL TSA II 5% sheep blood media BD BBL COL CN /MAC II media BacT/ALERT FN Plus BacT/ALERT FA Plus BacT/ALERT PF Plus 2. Review of the BD BBL media package insert revealed "Examine plates as described under 'Product Deterioration.' Do not use plates if they show evidence of microbial contamination, discoloration, drying, cracking, or other signs of deterioration." 3. Review of the BacT/ALERT blood culture bottles package insert -- 2 of 5 -- revealed to perform an examination of bottles for evidence of damage or deterioration (discoloration). "Do not use a bottle which contains medium exhibiting turbidity, a yellow sensor, or excess gas pressure, these are signs of possible contamination." 4. Review of the laboratory's policies revealed the laboratory did not have a policy related to visual inspections of media and blood culture bottles. 5. In interview on February 25, 2025 at 2:00 pm, Technical Consultant 3 stated the laboratory receives media and blood culture bottles from the main clinic. Technical Consultant 3 confirmed the laboratory does not document visual inspections of the media and blood culture bottles received. D6013 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(e)(3)(ii) (e)(3)(ii) Verification procedures used are adequate to determine the accuracy, precision, and other pertinent performance characteristics of the method; and This STANDARD is not met as evidenced by: Based on observation, record review, and interview with personnel, the Laboratory Director failed to ensure that complete verification procedures were performed. Refer to D5421. D6014 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(e)(3)(iii) (e)(3)(iii) Laboratory personnel are performing the test methods as required for accurate and reliable results; This STANDARD is not met as evidenced by: Based on record review and interview with personnel, the Laboratory Director failed to ensure the laboratory personnel performed test methods as required. Refer to D5477. D6030 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(e)(12) (e)(12) Ensure that policies and procedures are established for monitoring individuals who conduct preanalytical, analytical, and postanalytical phases of testing to assure that they are competent and maintain their competency to process specimens, perform test procedures and report test results promptly and proficiently, and whenever necessary, identify needs for remedial training or continuing education to improve skills; This STANDARD is not met as evidenced by: Based on record review and interview with personnel, the Laboratory Director failed to ensure complete policies and procedures for assessing personnel competency were maintained. Refer to D6051. D6031 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(e)(13) -- 3 of 5 -- (e)(13) Ensure that an approved procedure manual is available to all personnel responsible for any aspect of the testing process; and This STANDARD is not met as evidenced by: Based on record review and interview with personnel, the Laboratory Director failed to ensure that an approved procedure manual was available to all personnel. Refer to D5401. D6036 TECHNICAL CONSULTANT RESPONSIBILITIES CFR(s): 493.1413 The technical consultant is responsible for the technical and scientific oversight of the laboratory. The technical consultant is not required to be onsite at all times testing is performed; however, he or she must be available to the laboratory on an as needed basis to provide consultation, as specified in paragraph (a) of this section. This STANDARD is not met as evidenced by: Based on observation by surveyor, record review, and interview with personnel, the Technical Consultants failed to provide technical and scientific oversight to the laboratory. Refer to D5477. D6040 TECHNICAL CONSULTANT RESPONSIBILITIES CFR(s): 493.1413(b)(2) (b)(2) Verification of the test procedures performed and the establishment of the laboratorys test performance characteristics, including the precision and accuracy of each test and test system; This STANDARD is not met as evidenced by: Based on observation by surveyor, review of the laboratory's performance verification studies, and interview with personnel, the Technical Consultants failed to ensure performance specification verification studies were complete. Refer to D5421. D6051 TECHNICAL CONSULTANT RESPONSIBILITIES CFR(s): 493.1413(b)(8)(v) (b)(8)(v) Assessment of test performance through testing previously analyzed specimens, internal blind testing samples or external proficiency testing samples; and This STANDARD is not met as evidenced by: Based on review of the laboratory's personnel competency records, proficiency testing records, and interview with personnel, the Technical Consultants failed to ensure the assessment of test performance through previously analyzed, internal blind samples, or external proficiency testing samples for three (3) of five (5) testing personnel was performed annually in 2023 and 2024. Findings: 1. Review of the laboratory's personnel competency records and proficiency testing records for 2023 and 2024 revealed the following personnel did not have the assessment of test performance through previously analyzed specimens, internal blind testing samples or external proficiency testing samples performed: 2023: Testing Personnel 4 2024: Testing -- 4 of 5 -- Personnel 2 and Testing Personnel 3 2. In interview on February 25, 2025 at 2:00 pm , Technical Consultant 1 confirmed the identified three (3) personnel did not have an assessment of test performance through previously analyzed specimens, internal blind testing samples or external proficiency testing samples performed. -- 5 of 5 --

Summary Statement of Deficiencies D0000 A Recertification survey was performed on May 23, 2023 at Baton Rouge Clinic Industriplex, CLIA ID # 19D2055846. The laboratory was found in compliance with 42 CFR 493 Requirements for Laboratories; however, standard level deficiencies were cited. 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 laboratory's policy and procedure manual as well as interview with personnel, the laboratory failed to establish written policies and procedures to assess competency for testing personnel. Findings: 1. Review of the laboratory's policy and procedure manual revealed the laboratory did not have a competency assessment policy for testing personnel to include but not limited to frequency of performance and the following six (6) procedures as a minimal requirement for assessing the competency of all personnel performing moderate complexity testing: a) Direct observations of routine patient test performance, including patient preparation, if applicable, specimen handling, processing and testing. b) Monitoring the recording and reporting or test results. c) Review of intermediate test results or worksheets, quality control records, proficiency testing results, and preventative maintenance records. d) Direct observation of performance of instrument maintenance and function checks. e) Assessment of test performance through testing previously analyzed specimens, internal blind testing samples or external proficiency testing samples. f) Assessment of problem solving skills. 2. In interview on May 23, 2023 at 2:30 p.m., Technical Consultant 3 confirmed the laboratory did not have a competency assessment policy. Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 8 -- 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: Based on observation, review of temperature records, and interview with laboratory personnel, the laboratory failed to perform daily monitoring of the room temperature in the phlebotomy room where blood collection supplies are stored. Findings: 1. Observation by surveyors during the laboratory tour on May 23, 2023 at 10:16 a.m. revealed blood collection supplies stored in the phlebotomy room. 2. Review of temperature records for the phlebotomy room revealed the room temperature was monitored weekly and not daily as required by the manufacturer. 3. In interview on May 23, 2023 at 2 p.m., Technical Consultant 3 confirmed the room temperature was not monitored daily for the phlebotomy room. D5415 TEST SYSTEMS, EQUIPMENT, INSTRUMENTS, REAGENT CFR(s): 493.1252(c) Reagents, solutions, culture media, control materials, calibration materials, and other supplies, as appropriate, must be labeled to indicate the following: (1) Identity and when significant, titer, strength or concentration. (2) Storage requirements. (3) Preparation and expiration dates. (4) Other pertinent information required for proper use. This STANDARD is not met as evidenced by: Based on observation, review of the laboratory's policy and procedure manual and quality control records, as well as interview with laboratory personnel, the laboratory failed to document when new lots of Hematology quality control material were put into use for two (2) of two (2) lots reviewed. Findings: 1. Observation by surveyors during the laboratory tour on May 23, 2023 at 10:16 a.m. revealed the laboratory utilized Coulter 4C Plus Cell Control for Hematology quality control testing on the Beckman Coulter AcT analyzer. 2. Review of quality control records for the following lots of Coulter 4C Plus Cell Control revealed the laboratory did not document the date the laboratory put the new quality control lots into use: -Lot 067900, 077900, 087900 expiration date August 29, 2022 -Lot 068600, 078600, 088600 expiration date December 2, 2022 3. In interview on May 23, 2023 at 11:33 a.m., Testing Personnel 1 confirmed the in use dates of the quality control lots identified above was not documented. D5417 TEST SYSTEMS, EQUIPMENT, INSTRUMENTS, REAGENT CFR(s): 493.1252(d) Reagents, solutions, culture media, control materials, calibration materials, and other supplies must not be used when they have exceeded their expiration date, have -- 2 of 8 -- deteriorated, or are of substandard quality. This STANDARD is not met as evidenced by: Based on observation and interview with laboratory personnel, the laboratory failed to ensure that test kits were not used beyond their expiration dates. Findings: 1. Observation by surveyors during the laboratory tour on May 23, 2023 at 10:16 a.m. revealed one (1) expired test kit: - Quidel Sofia Influenza A + B FIA, Lot 706820, Expiration date: May 8, 2023 2. In interview on May 23, 2023 at 10:37 a.m., Testing Personnel 1 confirmed the item identified above was expired. D5779

Summary Statement of Deficiencies D0000 A Recertification survey was conducted at Baton Rouge Clinic - Industriplex-CLIA ID # 19D2055846 on March 19, 2019. The laboratory was found in compliance with 42 CFR 493 Requirement for Laboratories; however, standard deficiencies were cited. D3031 RETENTION REQUIREMENTS CFR(s): 493.1105(a)(3) Analytic systems records. Retain quality control and patient test records (including instrument printouts, if applicable) and records documenting all analytic systems activities specified in 493.1252 through 493.1289 for at least 2 years. This STANDARD is not met as evidenced by: Based on record review and interview with personnel, the laboratory failed to retain raw data for calibration for at least two (2) years for Hematology testing. Findings: 1. Record review of the laboratory's policy detailed the laboratory is to perform calibration every 6 months. 2. Review of the laboratory's calibration records revealed the laboratory performed a calibration for Complete Blood Count on the ACT Diff 2 on December 19, 2018; however, the raw data and calibration information was not available, only the summary report. 3. In interview on March 19, 2019 at 10:22 am, Personnel 2 confirmed the data to support the second annual calibration for 2018 was not in the calibration binder. D5403 PROCEDURE MANUAL CFR(s): 493.1251(b) The procedure manual must include the following when applicable to the test procedure: (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. (2) Microscopic examination, including the detection of inadequately prepared slides. (3) Step-by-step Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 5 -- performance of the procedure, including test calculations and interpretation of results. (4) Preparation of slides, solutions, calibrators, controls, reagents, stains, and other materials used in testing. (5) Calibration and calibration verification procedures. (6) The reportable range for test results for the test system as established or verified in 493.1253. (7) Control procedures. (8)