Ochsner Clinic Foundation Infectious Disease

Summary Statement of Deficiencies D0000 A Recertification Survey was conducted on March 28, 2023 at Ochsner Clinic Foundation/Infectious Disease Research Lab-CLIA ID # 19D0966877. The laboratory was found in compliance with 42 CFR 493 Requirement for Laboratories; however, standard level deficiencies were cited. D5291 GENERAL LABORATORY SYSTEMS QUALITY ASSESSMENT CFR(s): 493.1239(a) The laboratory must establish and follow written policies and procedures for an ongoing mechanism to monitor, assess, and, when indicated, correct problems identified in the general laboratory systems requirements specified at 493.1231 through 493.1236. 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 maintain a complete policy for proficiency testing. Findings: 1. Review of the laboratory's "Quality Control" policy under the section "Proficiency testing program" revealed the laboratory did not include review of scores from the proficiency testing provider to include but not limited to scores that are ungraded and/or educational, as well as, documentation of review. 2. Review of proficiency testing events from the College of American Pathologists revealed no documentation of review for educational and/or not graded results for the following: D-B 2021 D-C 2021 D-A 2022 D-B 2022 D-C 2022 3. In interview on March 28, 2023 at 10:12 AM, Testing Personnel 1 stated that for ungraded/educational results, they read the report but do not document anything. D6094 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1445(e)(5) The laboratory director must ensure that the quality assessment programs are 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 -- established and maintained to assure the quality of laboratory services provided and to identify failures in quality as they occur. This STANDARD is not met as evidenced by: Based on record review and interview with personnel, the Laboratory Director failed to ensure that a quality assessment (QA) program was maintained to assure the quality of laboratory services provided. Refer to D5291. D6107 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1445(e)(15) The laboratory director must specify, in writing, the responsibilities and duties of each consultant and each supervisor, as well as each person engaged in the performance of the preanalytic, analytic, and postanalytic phases of testing, that identifies which examinations and procedures each individual is authorized to perform, whether supervision is required for specimen processing, test performance or result reporting and whether supervisory or director review is required prior to reporting patient test results. This STANDARD is not met as evidenced by: Based on record review and interview with personnel, the Laboratory Director failed to provide written job responsibilities for all laboratory personnel. Findings: 1. Review of the laboratory's documents and personnel records revealed the laboratory did not have written job responsibilities/descriptions for the following: Laboratory Director Clinical Consultant 2. In interview on March 28, 2023 at 11:58 am, Testing Personnel 1 confirmed the laboratory did not have written job descriptions that included the Laboratory Director and Clinical Consultant. -- 2 of 2 --

Summary Statement of Deficiencies D0000 A Certification Survey was performed on January 23, 2019 at Ochsner Clinic Foundation Infectious Diseases, CLIA ID # 19D0966877. 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 record review and interview with personnel, the laboratory failed to establish complete 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 include the following six (6) procedures as a minimal requirement for assessing the competency of all personnel performing 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. In interview on January 23, 2019, Personnel 2 confirmed the laboratory's current competency procedure did not include the identified six (6) procedures. D5417 TEST SYSTEMS, EQUIPMENT, INSTRUMENTS, REAGENT 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 -- 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 reagents have not exceeded their expiration date. Findings: 1. Observation by surveyor during the laboratory tour on January 23, 2019 revealed the following expired items located in the walk-in refrigerator: a) RapID Spot Indole Reagent, Lot # 874467, Expiration date: 2018-06-23, Quantity: one (1) box b) RapID Nitrate B Reagent, Lot # 859895, Expiration date: 2018-05-11, Quantity: one (1) box c) RapID Nitrate A Reagent, Lot # 844505, Expiration date: 2018-04-28, Quantity: one (1) box 2. In interview on January 23, 2019 at 1:15 pm, Personnel 2 stated the identified reagents were old and newer reagents were in front. D6087 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1445(e)(3)(iii) The laboratory director must ensure that 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 laboratory personnel performed testing as required for accurate and reliable results. Refer to D5417. D6103 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1445(e)(13) The laboratory director must 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 competency, and whenever necessary, identify needs for remedial training or continuing education to improve skills. Refer to D5209. D6112 TECHNICAL SUPERVISOR RESPONSIBILITIES CFR(s): 493.1451 The technical supervisor is responsible for the technical and scientific oversight of the laboratory. The technical supervisor is not required to be on site at all times testing is performed; however, he or she must be available to the laboratory on an as needed -- 2 of 3 -- basis to provide supervision as specified in (a) of this section. This STANDARD is not met as evidenced by: Based on observation and interview with personnel, the Technical Supervisor failed to provide technical and scientific oversight for the laboratory. Refer to D5417. -- 3 of 3 --