Louisiana Gastroenterology Associates, Llc

Summary Statement of Deficiencies D0000 A Recertification survey was conducted on January 23, 2024 at Louisiana Gastroenterology Associates, LLC, CLIA ID # 19D0982971. 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, review of the laboratory's temperature records, and interview with personnel, the laboratory failed to define acceptable room temperature limits within the manufacturer's required range for supplies stored in the laboratory. Findings: 1. Observation by surveyor during the laboratory tour on January 23, 2024 at 10:45 a.m. revealed the following reagents stored in the laboratory: - Histology Connections - HC Ascertain Bluing Buffer, RTU - manufacturer's storage requirements 15-30 degrees Celsius - Histology Connections - HC Ascertain Clarifying 2 Reagent (RTU) - manufacturer's storage requirements 15-30 degrees Celsius - Histology Connections - Differential Rapid Blood Stain, Solution A - manufacturer's storage requirements 15-30 degrees Celsius - Histology Connections - Differential Rapid Blood Stain, Solution B - manufacturer's storage requirements 15- 30 degrees Celsius - Histology Connections - Schiff Stain Solution, McManus - manufacturer's storage requirements 15-30 degrees Celsius - Histology Connections - 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 -- Periodic Acid Solution, 1.0% w/v - manufacturer's storage requirements 15-30 degrees Celsius - Histology Connections - Alcian Blue Stain Solution, 1% w/v, pH 2.5 - manufacturer's storage requirements 15-30 degrees Celsius 2. Review of the laboratory's temperature records revealed the laboratory defined the acceptable limits for room temperature as 55-80 degrees Fahrenheit which the surveyor calculated to equal 12.8 - 26.7 degrees Celsius. 3. In interview on January 23, 2024 at 12:36 p.m., the Laboratory Director confirmed the laboratory's acceptable room temperature limits exceeded the manufacturer's acceptable limits for room temperature. 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 manufacturer's package inserts, and interview with personnel, the laboratory failed to establish and label expiration dates for marking dyes. Findings: 1. Observation by surveyor during the laboratory tour on January 23, 2024 at 10:45 a.m. revealed the following open and in use marking dyes in their original primary containers: - TMD Tissue Marking Dye - Cat #TMD7 (blue), quantity: one (1) bottle - TMD Tissue Marking Dye - Cat #TMD7 (green), quantity: one (1) bottle - TMD Tissue Marking Dye - Cat #TMD7 (black), quantity: one (1) bottle - TMD Tissue Marking Dye - Cat #TMD7 (red), quantity: one (1) bottle 2. Further observation revealed the marking dye bottles identified above did not have expiration dates marked on each container. 3. Review of the manufacturer's package inserts for the marking dyes revealed the manufacturer did not define an expiration date for the dyes. 4. In interview on January 23, 2024 at 11:00 a.m., the Laboratory Director confirmed the laboratory did not establish an expiration date for the marking dyes identified above or label them with an expiration date. D5433 MAINTENANCE AND FUNCTION CHECKS CFR(s): 493.1254(b)(1) For equipment, instruments, or test systems developed in-house, commercially available and modified by the laboratory, or maintenance and function check protocols are not provided by the manufacturer, the laboratory must establish a maintenance protocol that ensures equipment, instrument, and test system performance that is necessary for accurate and reliable test results and test result reporting. The laboratory must perform and document the maintenance activities specified in paragraph (b)(1)(i) of this section. This STANDARD is not met as evidenced by: Based on observation, review of maintenance records, and interview with personnel, the laboratory failed to perform and document maintenance on the microtome as required by the laboratory for twenty (20) of twenty (20) months reviewed. Findings: 1. Observation by surveyor during the laboratory tour on January 23, 2024 at 10:45 a. m. revealed the laboratory utilized two (2) microtomes: a) Shandon Finesse ME + b) -- 2 of 3 -- Leica RM2235 2. Review of the laboratory's maintenance logs revealed the following: "Microtome oiled on: ______________________**Per manufacturer's manual microtome should be oiled monthly**" 3. Further review of the laboratory's maintenance logs from May 2022 through December 2023 revealed the laboratory did not document oiling the microtome each month from May 2022 through December 2023. 4. In interviews on January 23, 2024 at 12:36 p.m., Testing Personnel 1 stated that the microtome maintenance is performed on the first of every month but was not documented. The Laboratory Director confirmed the maintenance identified above was not documented from May 2022 through December 2023. 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 observation, record review, and interview with personnel, the Laboratory Director failed to ensure laboratory personnel performed test methods as required. Findings: 1. The laboratory failed to define acceptable room temperature limits within the manufacturer's required range for supplies stored in the laboratory. Refer to D5413. 2. The laboratory failed to establish and label marking dyes in primary containers with expiration dates for proper use. Refer to D5415. D6095 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1445(e)(6) The laboratory director must ensure the establishment and maintenance of acceptable levels of analytical performance for each test system. This STANDARD is not met as evidenced by: Based on observation, review of maintenance logs, and interview with personnel, the Laboratory Director failed to ensure maintenance procedures were performed to ensure acceptable levels of test performance. Refer to D5433. -- 3 of 3 --

Summary Statement of Deficiencies D0000 AN INITIAL CERTIFICATION SURVEY was performed at Gastroenterology Clinic of Acadiana - CLIA # 19D0982971 on April 19, 2018. Gastroenterology Clinic of Acadiana was found not in compliance with the following CONDITION LEVEL DEFICIENCIES: 42 CFR 493.1487 CONDITION: Testing Personnel performing high complexity testing. D5205 COMPLAINT INVESTIGATIONS CFR(s): 493.1233 The laboratory must have a system in place to ensure that it documents all complaints and problems reported to the laboratory. The laboratory must conduct investigations of complaints, when appropriate. This STANDARD is not met as evidenced by: Based on record review and interview with laboratory personnel the laboratory failed to have a system in place to ensure that it documents all complaints and problems reported to the laboratory. Findings: 1. Review of the Laboratory's Policy and Procedure Manual revealed the laboratory failed to have written policies and procedure for addressing complaints and problems reported to the laboratory. The policy should include a detailed procedure on how to address, document and handle complaints or problems reported to the laboratory. 2. Interview with the Laboratory Director on April 19, 2018 confirmed the laboratory failed to have a complete policy and procedure manual. D5207 COMMUNICATIONS CFR(s): 493.1234 The laboratory must have a system in place to identify and document problems that occur as a result of a breakdown in communication between the laboratory and an authorized person who orders or receives test results. 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 -- This STANDARD is not met as evidenced by: Based on record review and interview with laboratory personnel the laboratory failed to have a system in place to ensure that it documents problems associated with a breakdown in communication between the laboratory and authorized persons. Findings: 1. Review of the Laboratory's Policy and Procedure Manual revealed the laboratory failed to have written policies and procedure to identify and document problems that occur as a result of a breakdown in communication between the laboratory and an authorized person who orders or receives test results. 2. Interview with the Laboratory Director on April 19, 2018 confirmed the laboratory failed to have a complete policy and procedure manual. 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 and follow written policies and procedures to assess testing personnel competency. Findings: 1. Review of the Laboratory's Policy and Procedure Manual revealed the laboratory failed to establish written policies and procedures 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. Interview with the Laboratory Director on April 19, 2018 confirmed the laboratory failed to have a detailed written policy and procedure that included the six (6) mandated items for personnel competency. D5401 PROCEDURE MANUAL CFR(s): 493.1251(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 ensure the laboratory policy and procedure manual contained complete policies and procedures. Findings: 1. Review of the laboratory -- 2 of 4 -- policy and procedure manual revealed the laboratory failed to have policies and procedures for: Test Requisitions: what mandated information needs to be on the test requisition: a) The name and address or other suitable identifiers of the authorized person requesting the test and, if appropriate, the individual responsible for using the test results, or the name and address of the laboratory submitting the specimen, including, as applicable, a contact person to enable the reporting of imminently life threatening laboratory results or panic or alert values. b) The patient's name or unique patient identifier. c) The sex and age or date of birth of the patient. d) The test(s) to be performed. e) The source of the specimen, when appropriate. f) The date and, if appropriate, time of specimen collection. g) Any additional information relevant and necessary for a specific test to ensure accurate and timely testing and reporting of results, including interpretation, if applicable. Description of the course of action to take if a test system becomes inoperable. Record Retention policies 2. Interview with the Laboratory Director on April 19, 2018 confirmed the policy and procedure manual was incomplete D6106 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1445(e)(14) The laboratory director must ensure that an approved procedure manual is available to all personnel responsible for any aspect of the testing process. This STANDARD is not met as evidenced by: Based on record review, and interview with laboratory personnel, the Laboratory Director failed to ensure that a complete approved policy and procedure manual is available to all personnel responsible for any aspect of the testing process. Refer to D5205, D5207, D5209 and D5401. D6168 TESTING PERSONNEL CFR(s): 493.1487 The laboratory has a sufficient number of individuals who meet the qualification requirements of 493.1489 of this subpart to perform the functions specified in 493. 1495 of this subpart for the volume and complexity of testing performed. This CONDITION is not met as evidenced by: Based on record review and interview with laboratory personnel, the laboratory failed to ensure testing personnel met the qualifications of education and licensure to perform high complexity testing. Findings: 1. The laboratory failed to have a current license issued by the State of Louisiana (R. S. 37:131 - 1329 "Louisiana Clinical Laboratory Personnel Law"), that would allow testing personnel to perform high complexity testing for one (1) of one (1) testing persons performing high complexity testing. Refer to D6170. 2. Interview with the Laboratory Director and Testing Personnel confirmed the above findings. D6170 TESTING PERSONNEL QUALIFICATIONS CFR(s): 493.1489(a) Each individual performing high complexity testing must possess a current license issued by the State in which the laboratory is located, if such licensing is required. -- 3 of 4 -- This STANDARD is not met as evidenced by: Based on record review and interview with laboratory personnel, the laboratory failed to have a current license issued by the State of Louisiana (R. S. 37:131 - 1329 "Louisiana Clinical Laboratory Personnel Law"), that would allow testing personnel to perform high complexity testing for one (1) of one (1) testing persons performing high complexity testing. Findings: 1. Review of the Laboratory's Test Menu revealed testing personnel performed gross examination of tissue which is categorized as high complexity. 2. Review of Testing Personnel records revealed no documentation of a State License to perform gross examinations. 3. Interviews with the Laboratory Director and Testing Personnel on April 19, 2018 revealed they were unaware that individual performing gross examinations needed to have a State License from the Louisiana State Board of Medical Examiners (LSBME). Both the Laboratory Director and Testing Personnel confirmed that the Testing Personnel did not have a State License for performing gross examinations. -- 4 of 4 --