St Helena Parish Hospital

Summary Statement of Deficiencies D0000 Recertification Survey was conducted on July 22, 2024 through July 24, 2024 at St Helena Parish Hospital - CLIA ID # 19D0707957. The laboratory was found in compliance with 42 CFR 493 Requirement for Laboratories; however, standard 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 manufacturers' storage requirements, package inserts, and the laboratory's temperature records; as well as interview with personnel, the laboratory failed to define acceptable room temperature limits within the manufacturers' required ranges for laboratory supplies and reagents for two (2) of three (3) rooms. Findings: 1. Observation by surveyor during the laboratory tour on July 22, 2024 at 10:31 a.m. revealed supplies stored in the laboratory to include, but not limited to, the following: a) Main Lab - MEDTOX Scan - Manufacturer's storage requirements 64 - 77 degrees Fahrenheit or 18 - 25 degrees Celsius - HemosIL Cleaning solution - Manufacturer's storage requirements 15 - 25 degrees Celsius b) Blood Bank - DxH 500 Series cleaner - Manufacturer's storage requirements 2 - 25 degrees Celsius - DxH 500 Series Lyse - Manufacturer's storage requirements 4 - 25 degrees Celsius 2. Further observation revealed the laboratory utilized the following reagents for coagulation testing: - HemosIL SynthASil - HemosIL RecombiPlasTin 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 -- 2G - HemosIL Normal Control 1 - HemosIL Abnormal Control 3 3. Review of the HemosIL package inserts revealed the following preparation requirements: - HemosIL SynthASil - "Each vial of APTT Reagent must be equilibrated at 15 - 25 degrees Celsius for at least 15 minutes and mixed thoroughly before use." - HemosIL RecombiPlasTin - "Allow each vial of RecombiPlasTin 2G Diluent to equilibrate at 15 - 25 degrees Celsius for at least 15 minutes before reconstituting the lyophilized reagent with the diluent...Following reconstitution...Keep the reagent at 15 - 25 degrees Celsius for 15 - 20 minutes and invert to mix before use." - HemosIL Normal Control 1 - "...Make sure of the complete reconstitution of the product. Keep the control at 15 - 25 degrees Celsius for 30 minutes..." - HemosIL Abnormal Control 3 - "...Make sure of the complete reconstitution of the product. Keep the control at 15 - 25 degrees Celsius for 30 minutes..." 4. Review of the laboratory's temperature logs from January 2023 through June 2024 revealed the laboratory defined the room temperature acceptable upper limit for both the Main Lab and Blood Bank as 84.6 degrees Fahrenheit (29.2 degrees Celsius) which exceeded the manufacturers' acceptable upper limits. 5. In interview on July 23, 2024 at 2:45 p.m., the General Supervisor confirmed the laboratory's room temperature upper limit exceeded the manufacturers' acceptable upper limit for the Main Lab and Blood Bank. D5807 TEST REPORT CFR(s): 493.1291(d) Pertinent "reference intervals" or "normal" values, as determined by the laboratory performing the tests, must be available to the authorized person who ordered the tests and, if applicable, the individual responsible for using the test results. This STANDARD is not met as evidenced by: Based on review of the laboratory's validation records, policies, and test menu; as well as interview with personnel, the laboratory failed to ensure the patient final test reports included the laboratory's validated reference range for cell blood count (CBC) testing. Findings: 1. Review of the laboratory's validation study for the DxH 560 revealed validated reference ranges based on gender to include the following analytes: a) Male - Red Blood Cell Count - 4.06 - 5.63 m/uL - Mean Corpuscular Hemoglobin Concentration - 32.5 - 36.3 g/dL b) Female - Red Blood Cell Count - 3.63 - 4.92 m/uL - Lymphocyte number - 1.1 - 3.1 K/uL 2. Review of a random selection of two (2) patient final reports from May 2024 revealed the following reference ranges included on the patient final reports: a) May 15, 2024: Patient 349926 - Male - Red Blood Cell Count - 4.06 - 4.92 m/uL - Mean Corpuscular Hemoglobin Concentration - 32.3 - 36.3 g/dL b) May 6, 2024: Patient 349673 - Female - Red Blood Cell Count - 3.63 - 5.63 m /uL - Lymphocyte number - 1.1 - 3.2 K/uL 3. In interview on July 23, 2024 at 1:52 p. m., the General Supervisor confirmed the reference ranges on the final patient test report for the analytes identified above were incorrect. 4. Review of the laboratory's test menu revealed the laboratory performs 4, 074 tests annually. D6026 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(e)(8) 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)(8) Ensure that reports of test results include pertinent information -- 2 of 3 -- required for interpretation. This STANDARD is not met as evidenced by: Based on record review and interview with personnel, the Laboratory Director failed to ensure final reports for hematology testing included pertinent information. Refer to D5807. 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 by surveyors, record review, and interview with personnel, the Technical Consultant failed to provide technical and scientific oversight to the laboratory. Refer to D5413. D6151 GENERAL SUPERVISOR RESPONSIBILITIES CFR(s): 493.1463(b)(3)(4) (3) The director or technical supervisor may delegate to the general supervisor the responsiblity for providing orientation to all testing personnel; and (4) Annually evaluating and documenting the performance of all testing personnel. This STANDARD is not met as evidenced by: Based on review of laboratory policies and personnel records and interview with personnel, the General Supervisor failed to perform an annual competency assessment for one (1) of six (6) testing personnel reviewed. Findings: 1. Review of the laboratory policy "Performance Evaluations and Competency Assessments" revealed "All new laboratory testing personnel shall have an evaluation/competency assessment at initial hire/6 months, one year, and then annually thereafter from the original date of hire." 2. Review of personnel records revealed Testing Personnel 4 was hired April 2023 and had a semi-annual competency performed in October 2023. 3. Further review of personnel records for Testing Personnel 4 revealed an annual competency was not performed when due in April 2024. 4. In interview on July 23, 2024 at 9:30 a.m., the General Supervisor confirmed the annual competency for Testing Personnel 4 was not performed one year after the hire date. -- 3 of 3 --

Summary Statement of Deficiencies D0000 A Certification survey was performed on October 25, 2022 through October 27, 2022 at St. Helena Parish Hospital, CLIA ID # 19D0707957. 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 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 policies and interview with personnel, the laboratory failed to have a complete policy and procedure manual. Findings: 1. Review of the laboratory's policies and procedures revealed the laboratory did not include the following: a) "Therapeutic Phlebotomy Weight Scale" including procedure for quarterly checks and

Summary Statement of Deficiencies D0000 A Recertification survey was performed on April 12, 2021 through April 15, 2021 at St. Helena Parish Hospital, CLIA ID # 19D0707957. The laboratory was found in compliance with 42 CFR 493 Requirements for Laboratories; however, standard level deficiencies were cited. D2015 TESTING OF PROFICIENCY TESTING SAMPLES CFR(s): 493.801(b)(5)(6) (5) The laboratory must document the handling, preparation, processing, examination, and each step in the testing and reporting of results for all proficiency testing samples. The laboratory must maintain a copy of all records, including a copy of the proficiency testing program report forms used by the laboratory to record proficiency testing results including the attestation statement provided by the PT program, signed by the analyst and the laboratory director, documenting that proficiency testing samples were tested in the same manner as patient specimens, for a minimum of two years from the date of the proficiency testing event. (6) PT is required for only the test system, assay, or examination used as the primary method for patient testing during the PT event. 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 ensure the Laboratory Director and/or qualified designee signed the attestation forms for three (3) of six (6) proficiency testing (PT) events reviewed. Findings: 1. Review of the laboratory's American Proficiency Institute (API) PT records for 2019 and 2020 revealed the Laboratory Director and/or qualified designee did not sign the attestation statements for the following three (3) events: a) 2020: Hematology 3rd Event b) 2020: Immunology/Immunohematology 2nd Event; Laboratory Director did not sign c) 2019: Chemistry-Core 2nd Event 2. In Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 9 -- interview on April 12, 2021 at 3:06 pm, the Technical Consultant 2 confirmed the Laboratory Director did not sign the attestation statements for the identified PT events. D3021 REQUIREMENTS FOR TRANSFUSION SERVICES CFR(s): 493.1103(c)(1) Blood and blood products storage and distribution. If a facility stores or maintains blood or blood products for transfusion outside of a monitored refrigerator, the facility must ensure the storage conditions, including temperature, are appropriate to prevent deterioration of the blood or blood product. This STANDARD is not met as evidenced by: Based on review of the laboratory's blood bank refrigerator temperature logs and interview with personnel, the laboratory failed to record the refrigerator temperature and checks for one (1) of thirty one (31) days in August 2020. Findings: 1. Review of the laboratory's blood bank refrigerator temperature logs for 2020 and 2019 revealed the laboratory did not document the refrigerator's "Rec. Chart" temperature, digital temperature, wall temperature, inside temperature, and alarm/battery checks for August 19, 2020. 2. In interview with personnel on April 14, 2021 at 3:58 pm, the Technical Consultant 2 confirmed the laboratory did not document the temperatures and alarm/ battery checks for August 19, 2020. 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 personnel records, and interview with personnel, the laboratory failed to ensure written policies and procedures to assess competency for one (1) of two (2) Technical Consultants and General Supervisors were followed. Findings: 1. Review of personnel records revealed no documentation of an annual competency assessment, per laboratory policy, for 2020 for Technical Consultant 1, who also serves as a General Supervisor, for her duties as Technical Consultant and General Supervisor. 2. In interview on April 12, 2021 at 2:15 pm, the Technical Consultant 2 confirmed the laboratory did not have documentation of performance of a competency assessment by the Laboratory Director for Technical Consultant 1 for 2020 for her duties as Technical Consultant and General Supervisor. 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 applicable: (1) 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 referral. -- 2 of 9 -- This STANDARD is not met as evidenced by: Based on observation by surveyor, review of patient test logs, manufacturer's package inserts, and interview with personnel, the laboratory failed to ensure patient samples for Lactic Acid testing were separated within fifteen (15) minutes of receipt per manufacturer requirements for three (3) of thirty four (34) patients reviewed. Findings: 1. Observation by surveyor during the laboratory tour on April 12, 2021 at 10:30 am revealed the laboratory utilizes the Vitros 5600 for Lactic Acid testing. 2. Review of the Ortho Vitros package insert under the "Special Precautions" section revealed "Centrifuge specimens and remove the plasma from the cellular material within 15 minutes of collection." 3. Review of patient test logs for Lactic Acid from October 2020 through March 2021 revealed the following three (3) patients: a) October 25, 2020: Patient 312063, collected 10:10 am, received 10:37 am b) February 21, 2021: Patient 315019, collected 3:10 am, received 3:35 am c) March 23, 2021: Patient 315814, collected 14:25, received 15:49 4. In interview on April 15, 2021 at 11:00 am the Technical Consultant 2 confirmed the identified patient samples were not separated per manufacturer requirements. 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 policies and procedures and interview with personnel, the laboratory failed to have a complete policy and procedure manual. Findings: 1. Review of the laboratory's policies and procedures revealed the laboratory did not include the following: a) Reporting of SARS COV-2 test results to state public health agency, to include but not limited to frequency and who is responsible b) Blood Culture Collection Kits: to include current manufacturer of kits for blood culture collection bottles 2. In interview on April 14, 2021 at 9:10 am, the Technical Consultant 2 confirmed the identified policies were not included. 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 specifications for each test system as determined under 493.1253. This STANDARD is not met as evidenced by: I. Based on observation by surveyor, review of the manufacturer's instrument manual, quality control records, test menu, and interview with personnel, the laboratory failed to follow manufacturer's instructions for flags appearing on the Ortho Vitros analyzer for one (1) of eleven (11) patients reviewed for Lactate Dehydrogenase (LDH). Findings: 1. Observation by surveyor during the laboratory tour on April 12, 2021 at -- 3 of 9 -- 10:30 am revealed the laboratory utilizes the Ortho Vitros 5600 for LDH testing. 2. Review of the manufacturer's instrument manual revealed the following codes and actions: a) "Incubator Temperature (IT): The incubator temperature is outside of specifications. Actions: Once the analyzer displays 'READY' repeat the test." 3. Review the laboratory's quality control records for LDH testing from October 2020 through February 2021 revealed the following instrument flags and patients reported: a) January 5, 2021: Level 1: flag "IT": Patient 313725 4. In interview on April 13, 2021 at 3:26 pm, Testing Personnel 6 stated the temperature may have been out when QC was run. Testing Personnel 6 stated for the identified flag the laboratory does not repeat the the quality control. 5. Review of the laboratory's test menu reveals the laboratory performs thirty two (32) LDH tests annually. II. Based on observation by surveyor, review of the manufacturer's package insert, laboratory records, and interview with personnel, the laboratory failed to document visual inspection of blood culture bottles prior to use per manufacturer requirements. Findings: 1. Observation by surveyor during the laboratory tour on April 12, 2021 at 10:30 am revealed the laboratory utilizes the BioMerieux Adult and Pediatric Blood Culture Collection kits that contain BacT/ALERT FA Plus Aerobic, Anaerobic ad PF Plus Pediatric bottles. 2. Review of the manufacturer's package insert revealed "Inspect each blood culture bottle before use to ensure integrity of bottle and sensor on bottom of bottle is intact. The sensor is normally a uniform grayish-green color and a yellow color would indicate contamination of the broth. Discard any bottle found to be damaged or with a sensor that is yellow." 3. Review of the laboratory's records revealed the laboratory does not document visual inspections of the blood culture bottles prior to use. 4. In interview on April 13, 2021 at 3:00 pm the Technical Consultant 2 confirmed the laboratory does not document visual inspections of the blood culture bottles received in the collection kits prior to use. 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 by surveyor, review of the laboratory's policies, and interview by personnel, the laboratory failed to ensure supplies had not exceeded their expiration dates. Findings: 1. Observation by surveyor during laboratory tour on April 12, 2021 at 10:30 am revealed the following expired supplies: a) BACT/ALERT FN Plus blood culture collection bottles, Lot 0004055286, Expiration date: 2021-02-20, Quantity: ten (10) bottles b) Remel Microtest M4RT Transport tubes, Lot 422133, Expiration date: 2020-04-15, Quantity: one (1) tube; Lot 474803, Expiration date: 2020-07-28, Quantity: one (1) tube; Lot 504639, Expiration date: 2020-09-24, Quantity: three (3) tubes; Lot 496250, Expiration date: 2020-09-03, Quantity: four (4) tubes; Lot 474061, Expiration date: 2020-07-27, Quantity: one (1) tube 2. Review of the laboratory's "Inventory/Inspection of Reagents, Calibrators, Solutions, Controls, Other Supplies, Etc" policy revealed "The Laboratory shall conduct a MONTHLY inventory/inspection of reagents, calibrators, solutions, controls, other supplies, etc to ensure that they are not expired." 3. In interview on April 14, 2021 at 11:28 am, Testing Personnel 4 confirmed the identified items were expired. D5447 CONTROL PROCEDURES -- 4 of 9 -- CFR(s): 493.1256(d)(3)(i)(g) Unless CMS Approves a procedure, specified in Appendix C of the State Operations Manual (CMS Pub. 7), that provides equivalent quality testing, the laboratory must-- At least once a day patient specimens are assayed or examined perform the following for-- Each quantitative procedure, include two control materials of different concentrations; (g) The laboratory must document all control procedures performed. This STANDARD is not met as evidenced by: Based on observation by surveyor, review of the laboratory's quality control (QC) records, policies, patient test logs, test menu, and interview with personnel, the laboratory failed to perform two (2) levels of controls prior to patient testing for Alcohol testing for one (1) of 182 days reviewed. Findings: 1. Observation by surveyor during the laboratory tour on April 12, 2021 at 10:30 am revealed the laboratory utilizes the Vitros 5600 for Alcohol testing. 2. Review of the laboratory's "Quality Control Program (Overview)" policy revealed "Patient testing will not occur until all levels of known control material have been analyzed according to procedural guidelines are within the established acceptable range. Control specimens are to be run in the same manner as patient specimens to verify that the entire test system is working properly." 3. Review of the laboratory's quality control records for alcohol testing and patient logs from October 2020 through March 2021 revealed the laboratory did not perform two (2) levels of QC prior to patient testing for the following patient: November 6, 2020: Patient 312412 4. In interview on April 13, 2021 at 4:47 pm, the Technical Consultant 2 stated she was unable to find documentation of QC performance for the identified date. 5. Review of the laboratory's test menu reveals the laboratory performs 119 alcohol tests annually. D5793 ANALYTIC SYSTEMS QUALITY ASSESSMENT CFR(s): 493.1289(b)(c) (b) The analytic systems quality assessment must include a review of the effectiveness of

Summary Statement of Deficiencies D0000 A Certification Survey was conducted on June 18, 2018 through June 21, 2018 at St Helena Parish Hospital - CLIA ID # 19D0707957. The laboratory was found in compliance with 42 CFR 493 Requirement for Laboratories; however, standard deficiencies were cited. D5791 ANALYTIC SYSTEMS QUALITY ASSESSMENT CFR(s): 493.1289(a)(c) (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 analytic systems specified in 493.1251 through 493.1283. (c) The laboratory must document all analytic systems assessment activities. This STANDARD is not met as evidenced by: I. Based on record review and interview with personnel, the laboratory's Quality Assurance monitors failed to identify and correct quality issues for Blood Bank refrigerator temperature checks. Findings: 1. Review of the laboratory's Quality Assurance Protocol policy revealed under "Refrigerator/Temperature Checks" that "Refrigerator/Temperature checks are to be performed daily in the laboratory. This is to ensure proper storage and performance of reagents, controls, instrumentation, supplies, etc." 2. Further review of the laboratory's Quality Assurance Protocol policy revealed under "Thresholds for Evaluation" that "If the Daily Refrigerator /Temperature checks are not met, the workload, organization of workload, and techniques employed by the General Supervisor and/or other personnel responsible for processing and testing as well as the competency of lab staff/tech performing testing will be reviewed to identify problems that contribute to their inability to meet established criteria." 3. Review of the Quality and Appropriateness Review for Laboratory Blood Bank Temp Charts form revealed the following criteria: a. Are blood bank/temp charts changed every 7 days weekly? b. Are laboratory personnel documenting date/time and initials when putting charts on and off? c. Are laboratory 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 -- personnel documenting directly on Revco/blood bank temp charts and discrepancies /fluctuations in temperature? 4. Review of the Blood Bank refrigerator circular charts revealed the following fluctuations in temperature with no documentation: a. Week of January 23, 2017 through January 30, 2017 showed a spike in temperature on Wednesday, January 25, 2017 b. Week of April 30, 2018 through May 7, 2018 showed a spike in temperature on Sunday, May 6, 2018 5. Review of the Quality and Appropriateness Review for Laboratory Blood Bank Temp Charts form for January 2017 and May 2018 revealed that Quality Assurance (QA) was checked for those months with no issues documented. 6. In interview on June 20, 2018 at 1:06 pm, Personnel 2 stated that Personnel 4 changes the circular charts and inspects them. Personnel 2 stated she had no explanation for the changes in temperature. Personnel 2 confirmed that the QA monitors established by the laboratory did not identify the above issues. II. Based on record review and interview with personnel, the laboratory's Quality Assurance (QA) monitors failed to identify and correct quality issues for the Blood Bank Temperature/Humidity checks. Findings: 1. Review of the laboratory's Quality Assurance Protocol policy revealed under "Refrigerator /Temperature Checks" that "Refrigerator/Temperature checks are to be performed daily in the laboratory. This is to ensure proper storage and performance of reagents, controls, instrumentation, supplies, etc." 2. Review of the laboratory's Blood Bank Temperature/Humidity Log Sheet revealed the following three (3) days in February 2017 with unacceptable temperatures recorded: a. On February 24, 2017 - temperature recorded as -70.0 degrees b. On February 25, 2017 - temperature recorded as -69.9 degrees c. On February 26, 2017 - temperature recorded as -67.9 degrees 3. Review of the laboratory's Quality and Appropriateness Review form for February 2017 revealed the QA monitor for Temp/Humidity in lab was checked with no issues documented. 4. In interview on June 21, 2018, Personnel 2 confirmed the QA monitors established did not identify the above issues. D6021 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(e)(5) 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)(5) Ensure that quality assessment programs are established and maintained to assure the quality of laboratory services provided. This STANDARD is not met as evidenced by: Based on observation, record review and interview with laboratory personnel, the Laboratory Director failed to ensure that a quality assessment (QA) program was established and maintained to assure the quality of laboratory services provided. Refer to D5791. -- 2 of 2 --