Acadiana Family Practice Lab, Inc

Summary Statement of Deficiencies D0000 A Recertification survey was performed on July 10, 2024 at Acadiana Family Practice Lab, INC, CLIA ID # 19D0688964. The laboratory was found in compliance with 42 CFR 493 Requirements for Laboratories; however, standard level deficiencies were cited. 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 by surveyor, review of manufacturers' storage requirements, and interview with personnel, the laboratory failed to monitor the room temperature of the closet where laboratory supplies were stored. Findings: 1. Observation by surveyor on July 10, 2024 at 1:20 p.m. revealed the laboratory stored the following supplies in a closet that was not monitored for temperature: a) Greiner bio-one Vacuette Tube 3.5 mL 9NC Coagulation sodium citrate 3.2% High Altitude - manufacturer's storage requirements 4 - 25 degrees Celsius b) BD Vacutainer K2 EDTA - manufacturer's storage requirements 4 - 25 degrees Celsius c) Greiner bio-one Vacuette Tube 5 mL CAT Serum Sep Clot Activator - manufacturer's storage requirements 4 - 25 degrees Celsius d) BD Vacutainer C&S Preservative Urine Tube - manufacturer's storage requirements 4 - 25 degrees Celsius 2. In interview on July 10, 2024 at 2:41 p.m., the Laboratory Director confirmed the laboratory did not monitor the temperature of the closet as identified above. Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 4 -- 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 and interview with personnel, the laboratory failed to document the opened expiration date for hematology quality control (QC) materials as required. Findings: 1. Observation by surveyor during the laboratory tour on July 10, 2024 at 1: 20 p.m. revealed the laboratory utilized Boule Con-Diff Tri-Level quality control (QC) materials for hematology testing on the Medtronic analyzer. 2. Further observation revealed the following vials of QC were in use, but the opened expiration date was not documented: - Boule Con-Diff Low: Lot 22405-01, Manufacturer's expiration date 9/23/24, opened date 7/8/24 - Boule Con-Diff Normal: Lot 22405-02, Manufacturer's expiration date 9/23/24, opened date 7/8/24 - Boule Con-Diff High: Lot 22405-03, Manufacturer's expiration date 9/25/24, opened date 7/8/24 3. Review of the Boule Con-Diff Tri-Level package insert revealed "Open vial stability 14 days after opening when returned to refrigerator after each use." 4. In interview on July 10, 2024 at 3:21 p.m., the Laboratory Director confirmed the laboratory did not document the opened expiration date as identified above. D5779

Summary Statement of Deficiencies D0000 A Certification survey was performed on November 29, 2022 at Acadiana Family Practice Lab, INC, CLIA ID # 19D0688964. The laboratory was found in compliance with 42 CFR 493 Requirements for Laboratories; however, standard level deficiencies were cited. D5317 SPECIMEN SUBMISSION, HANDLING, AND REFERRAL CFR(s): 493.1242(d) If the laboratory accepts a referral specimen, written instructions must be available to the laboratory's clients and must include, as appropriate, the information specified in paragraphs (a)(1) through (a)(7) of this section. This STANDARD is not met as evidenced by: Based on review of the laboratory's policies, documents, and interview with personnel, the laboratory failed to ensure complete detailed written instructions for providers to maintain integrity of samples were established. Findings: 1. In interview on November 29, 2022 at 10:40 am, Testing Personnel 1 stated the laboratory receives samples from local home health agencies. 2. Review of the laboratory's policies and documents revealed the laboratory did not have detailed written instructions for providers that included the following: a) Patient preparation. b) Specimen collection. c) Specimen labeling, including patient name or unique patient identifier and, when appropriate, specimen source. d) Specimen storage and preservation. e) Conditions for specimen transportation. f) Specimen processing. g) Specimen acceptability and rejection. h) Specimen referral. 3. In further interview on November 29, 2022 at 10:47 am, Testing Personnel 1 stated the laboratory provides a list of tests offered to providers. Testing Personnel 1 confirmed the document provided did not include detailed written instructions for providers. D5403 PROCEDURE MANUAL CFR(s): 493.1251(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 -- 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 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)

Summary Statement of Deficiencies D0000 A Certification Survey was conducted on June 12, 2018 at Acadiana Family Practice Laboratory, Inc - CLIA ID # 19D0688964. The laboratory was found in compliance with 42 CFR 493 Requirement for Laboratories; however, standard 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 laboratory policy and procedure manual, and interview with personnel, the laboratory failed to establish written policies and procedures to assess employee and, if applicable, consultant competency. Findings: 1. Review of the Laboratory's Policy and Procedure Manual revealed the laboratory did not establish written instructions that include the following six (6) procedures as a minimal requirement for assessing the competency of all personnel involved in any phase of laboratory 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. Further review of the policy and procedure manual revealed the laboratory did not establish detailed written instructions for Clinical Consultant and Technical Consultant competency assessment to include the frequency to be performed. 2. 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 -- Interview with Personnel 3 on June 12, 2018 at 12:15 pm confirmed the laboratory did not have detailed written instructions to assess employee and consultant competency. 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 deteriorated, or are of substandard quality. This STANDARD is not met as evidenced by: Based on observation and interview with personnel, the laboratory failed to ensure supplies have not exceeded their expiration date. Findings: 1. Observation by surveyor during laboratory tour on June 12, 2018 revealed the following expired item: * Drew Scientific Inc Ex-Cal Hematology Calibrator - Lot EX0418-CAL, Exp 05/05/2018 2. In interview on June 12, 2018 at 10:15 am, Personnel 3 stated the calibrators come in the same box as the controls for the Hematology analyzer and that he was unaware that the calibrator was expired. 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 the employment of personnel who are competent to perform test procedures, and record and report test results promptly, accurate, and proficiently and for assuring compliance with the applicable regulations. (e) The laboratory director must-- (e)(3) Ensure that-- (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 observation, and interview with personnel, the Laboratory Director failed to ensure laboratory supplies have not exceeded their expiration date. Refer to D5417. D6030 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(e)(12) The laboratory director is responsible for the overall operation and administration of the laboratory, including the employment of personnel who are competent to perform test procedures, and record and report test results promptly, accurate, and proficiently and for assuring compliance with the applicable regulations. (e) The laboratory director must-- (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 policies and procedures were established for assessing personnel -- 2 of 3 -- competency, and whenever necessary, identify needs for remedial training or continuing education to improve skills. Refer to D5209. -- 3 of 3 --