Christus Central Louisiana Surgical Hospital

Summary Statement of Deficiencies D0000 A Recertification survey was performed on May 20, 2025 through May 21, 2025 at Central Louisiana Surgical Hospital, CLIA ID # 19D0672493. 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 observation, review of the laboratory's policies, and interview with personnel, the laboratory failed to follow their policy for centrifugation of coagulation specimens for one (1) of one (1) centrifuges utilized for centrifugation of coagulation specimens. Findings: 1. Observation by surveyor during the laboratory tour on May 20, 2025 at 8:45 a.m. revealed the laboratory utilized the Hettich EBA 200 centrifuge for centrifugation of coagulation specimens. 2. In interview on May 20, 2025 at 9:10 a. m., the Laboratory Manager stated the laboratory spins samples for coagulation testing at a speed of 6000 RPM for two (2) minutes. 3. Review of the laboratory's policy "Testing Menu and Collection Requirements" revealed the following instructions for centrifugation of coagulation specimens: * Test: Protime/APTT - Specimen Requirements: Blue Top Citrated plasma (Spin at 4250 RPM/2520 G for 15 min) 4. In interview on May 20, 2025 at 4:23 p.m., the Laboratory Manager confirmed the laboratory did not follow their policy for centrifugation of coagulation specimens. D5413 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 5 -- CFR(s): 493.1252(b) (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: (b)(1) Water quality. (b)(2) Temperature. (b)(3) Humidity. (b)(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: I. Based on observation, review of manufacturers' instructions and laboratory temperature records, as well as interview with personnel, the laboratory failed to define acceptable room temperature limits within the manufacturers' required ranges for supplies stored in the frozen section room. Findings: 1. Observation by surveyor during the laboratory tour on May 21, 2025 at 9:53 a.m. revealed the laboratory stored supplies in the frozen section room at room temperature to include, but not limited to, the following: a) CDI's Tissue Marking Dyes Black - Manufacturer's storage requirements 15 to 30 degrees Celsius b) Epredia Cytoseal XYL - Manufacturer's storage requirements 15 to 30 degrees Celsius c) Epredia Eosin-Y - Manufacturer's storage requirements 15 to 30 degrees Celsius 2. Review of the laboratory's May 2025 room temperature records for the frozen room revealed the laboratory defined the acceptable room temperature limits as 18 - 35 degrees Celsius which exceeded the manufacturers' upper temperature limits. 3. In interview on May 21, 2025 at 10:00 a. m., the Laboratory Manager confirmed the laboratory's acceptable room temperature limits for the frozen room exceeded the manufacturers' limits as identified above. II. Based on observation, review of the manufacturers' storage requirements and laboratory temperature records, as well as interview with personnel, the laboratory failed to monitor the room temperature for two (2) of five (5) rooms where laboratory supplies are stored. Findings: 1. Observation by surveyor during the laboratory tour on May 21, 2025 at 9:53 a.m. revealed the following supplies stored in two (2) draw rooms: a) Pre-Admission Testing Draw Room * BD Vacutainer SST Blood Collection Tubes - Manufacturer's storage requirements 4 to 25 degrees Celsius * BD Vacutainer K2E - Manufacturer's storage requirements 4 to 25 degrees Celsius * BD Vacutainer Buffered Sodium Citrate - Manufacturer's storage requirements 4 to 25 degrees Celsius * BD Vacutainer Lithium Heparin - Manufacturer's storage requirements 4 to 25 degrees Celsius * Greiner bio-one vacuette K3E K3EDTA - Manufacturer's storage requirements 4 to 25 degrees Celsius b) Outpatient Lab Draw Room * BD Vacutainer SST Blood Collection Tubes - Manufacturer's storage requirements 4 to 25 degrees Celsius * BD Vacutainer K2E - Manufacturer's storage requirements 4 to 25 degrees Celsius * BD Vacutainer Buffered Sodium Citrate - Manufacturer's storage requirements 4 to 25 degrees Celsius * BD Vacutainer Lithium Heparin - Manufacturer's storage requirements 4 to 25 degrees Celsius * Greiner bio-one vacuette K3E K3EDTA - Manufacturer's storage requirements 4 to 25 degrees Celsius 2. Review of laboratory temperature records revealed no documentation of room temperature monitoring for the draw room. 3. In interview on May 23, 2025 at 9:55 a. m., the Laboratory Manager confirmed the laboratory did not monitor the room temperature of the draw rooms as identified above. D5481 CONTROL PROCEDURES CFR(s): 493.1256(f)(g) -- 2 of 5 -- (f) Results of control materials must meet the laboratorys and, as applicable, the manufacturers test system criteria for acceptability before reporting patient test results. (g) The laboratory must document all control procedures performed. This STANDARD is not met as evidenced by: Based on review of the laboratory's policies and quality control (QC) records as well as interview with personnel, the laboratory failed to ensure quality control mean/range adjustments were documented for Endocrinology testing. Findings: 1. Review of the laboratory's policies revealed the laboratory had a quality control policy which included establishment of means/ranges, but did not include adjusting the established means/ranges to include, but not limited, criteria for adjustments and documentation. 2. Review of the laboratory's quality control form "New QC Ranges" revealed the laboratory established the following ranges for QC BioRad Lot 85380 for Prostate Specific Antigen (PSA), Thyroid Stimulating Hormone (TSH) and Testosterone: a) PSA: Level 1: 0.21 - 0.33 Level 3: 17.66 - 22.18 b) TSH: Level 1: 0.69 - 0.93 Level 3: 28.82 - 37.14 c) Testosterone: Level 1: 92.5 - 130.5 Level 3: 1031.3 - 1183.3 3. Further review of the QC lot establishment records for BioRad Lot 85380 revealed the laboratory put the above ranges into use on September 30, 2024. 4. Review of the laboratory's QC records from January 2025 revealed the following means/ranges for BioRad Lot 85380: a) PSA: Level 1: 0.19 - 0.31 Level 3: 16.94 - 22.46 b) TSH: Level 1: 0.68 - 0.92 Level 3: 30.30 - 38.62 c) Testosterone: Level 1: 85.3 - 123.3 Level 3: 1076 - 1228 5. Further review of the laboratory's January 2025 QC records revealed the ranges for BioRad Lot 85380 were different than the established ranges from September 2024, but the laboratory did not document the reason for the adjusted ranges. 6. In interview on May 21, 2025 at 11:15 a.m., the Laboratory Manager stated he calculates new means/ranges monthly utilizing the QC data points from the month and the laboratory's historical standard deviations (SD). He confirmed the laboratory did not have a policy that included adjustments to the laboratory's established quality control ranges. 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 observation, record review, and interview with personnel, the Laboratory Director failed to ensure the laboratory personnel performed test methods as required. Refer to D5401. D6020 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(e)(5) (e)(5) Ensure that the quality control and quality assessment programs are 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: -- 3 of 5 -- Based on record review and interview with personnel, the Laboratory Director failed to ensure that quality programs were in place to assure quality laboratory testing. Refer to D5481. 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 Consultant failed to provide technical and scientific oversight to the laboratory. Refer to D5401. D6042 TECHNICAL CONSULTANT RESPONSIBILITIES CFR(s): 493.1413(b)(4) (b)(4) Establishing a quality control program appropriate for the testing performed and establishing the parameters for acceptable levels of analytic performance and ensuring that these levels are maintained throughout the entire testing process from the initial receipt of the specimen, through sample analysis and reporting of test results; This STANDARD is not met as evidenced by: Based on record review and interview with personnel, the Technical Consultant failed to ensure the quality control program was maintained to assure the quality of laboratory testing. Refer to D5481. D6087 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1445(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 observation, record review, and interview with personnel, the Laboratory Director failed to ensure the laboratory personnel performed test methods as required. Findings: 1. The laboratory failed to define acceptable room temperature limits within the manufacturers' required ranges for supplies stored in the frozen section room. Refer to D5413 I. 2. The laboratory failed to monitor the room temperature for two (2) of five (5) rooms where laboratory supplies are stored. Refer to D5413 II. D6144 GENERAL SUPERVISOR RESPONSIBILITIES CFR(s): 493.1463 The general supervisor is responsible for day-to-day supervision or oversight of the laboratory operation and personnel performing testing and reporting test results. -- 4 of 5 -- This STANDARD is not met as evidenced by: Based on observation, record review, and interview with personnel, the General Supervisors failed to provide day-to-day supervision to testing personnel to ensure accurate and reliable test performance of laboratory testing. Findings: 1. The laboratory failed to define acceptable room temperature limits within the manufacturers' required ranges for supplies stored in the frozen section room. Refer to D5413 I. 2. The laboratory failed to monitor the room temperature for two (2) of five (5) rooms where laboratory supplies are stored. Refer to D5413 II. -- 5 of 5 --

Summary Statement of Deficiencies D0000 A Certification survey was performed on July 25, 2023 through July 26, 2023 at Central Louisiana Surgical Hospital, CLIA ID # 19D0672493. 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 signed the attestation forms for one (1) of four (4) proficiency testing events reviewed. Findings: 1. Review of the laboratory's American Proficiency Institute (API) proficiency testing records revealed the laboratory director did not sign the following document for one (1) of four (4) proficiency testing events reviewed in 2022 and 2023: a. 2022 Immunology/Immunohematology 2nd event: Laboratory Director/designee no signature on attestation 3. In interview on July 25, 2023 at 12:55 pm, General Supervisor 1 confirmed the identified attestation statement was not signed by the laboratory director. 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 -- D5429 MAINTENANCE AND FUNCTION CHECKS CFR(s): 493.1254(a)(1) For unmodified manufacturer's equipment, instruments, or test systems, the laboratory must perform and document maintenance as defined by the manufacturer and with at least the frequency specified by the manufacturer. This STANDARD is not met as evidenced by: I. Based on observation by surveyor, review of maintenance records and interview with personnel, the laboratory failed to ensure the weekly maintenance on the Sysmex CA-600 analyzer was performed as required by the manufacturer for two (2) of eighty (80) weeks reviewed. Findings: 1. Observation by surveyor during the laboratory tour on July 25, 2023 at 11:07 am revealed the laboratory utilizes a Sysmex CA-600 analyzer for coagulation testing. 2. Review of the laboratory's CA 620 maintenance records for 2022 and 2023 revealed the laboratory performs the following weekly tasks: a) Clean CA620 Interior/Exterior 3. Further review of the CA 620 maintenance records revealed the laboratory did not perform weekly maintenance for the following two (2) of eighty (80) weeks reviewed: a) June 10, 2022 b) June 2, 2023 4. In interview on July 26, 2023 at 1:15 pm, General Supervisor 1 confirmed the weekly maintenance identified was not performed. II. Based on observation by surveyor, review of maintenance records and interview with personnel, the laboratory failed to ensure the semi-annual maintenance on the TOSOH AIA 360 analyzer was performed as required by the manufacturer for 2022 and 2023. Findings: 1. Observation by surveyor during the laboratory tour on July 25, 2023 at 11:07 am revealed the laboratory utilizes the TOSOH AIA 360 analyzer for the following tests: Prostate Specific Antigen (PSA), Thyroid Stimulating Hormone (TSH), Testosterone (TEST), Intact Parathyroid Hormone 2. Review of the laboratory's TOSOH AIA 360 maintenance records revealed the laboratory performs the following semi-annual maintenance: a) Decontaminate diluent wash tubing lines b) Replace filter diluent and wash bottle 3. Further review of the TOSOH maintenance records from 2022 and 2023 revealed the laboratory did not perform the following maintenance semi- annually: a) April 2022 b) March 2023 4. In interview on July26, 2023 at 1:15pm, General Supervisor stated that service representatives perform the semi-annual maintenance when they are onsite for preventive maintenace (PM) but he could not find the documentation that states from the manufacturer. General Supervisor 1 confirmed the above identified maintenance was not peformed. D6018 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(e)(4)(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)(4)(iii) Ensure that all proficiency testing reports received are reviewed by the appropriate staff to evaluate the laboratory's performance and to identify any problems that require

Summary Statement of Deficiencies D0000 A Certification Survey was performed at Christus Central La Surgical Hospital - CLIA # 19D0672493 on November 15, 2021 through November 16, 2021. Christus Central La Surgical Hospital was found not in compliance with the following CONDITION LEVEL DEFICIENCIES: 42 CFR 493.1250 CONDITION: Analytic systems 42 CFR 493.1403 CONDITION: Laboratories Performing Moderate Complexity Testing; Laboratory Director 42 CFR 493.1409 CONDITION: Laboratories Performing Moderate Complexity Testing; Technical Consultant 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: ***Repeat deficiency from survey on May 21, 2019*** I. Based on review of the laboratory's policy and procedure manual and interview with personnel, the laboratory failed to ensure the personnel competency policy included the frequency of performance for the Technical Consultant and General Supervisor. Findings: 1. Review of the laboratory's policy "Competency" revealed the laboratory did not include the frequency of performance for assessment of duties for the Technical Consultant and General Supervisor. 2. In interview on November 15, 2021 at 1:29 pm, General Supervisor 1 confirmed the policy did not include the frequency of assessment for the Technical Consultant and General Supervisor. II. Based on review of the laboratory's policy and procedure manual, CMS 209 form, Employee Competency Assessment form, and personnel records as well as interview with personnel, the laboratory failed to follow their established competency assessment policy for one (1) of five (5) testing personnel reviewed. Findings: 1. Review of the laboratory's "Competency" policy revealed "Employee competency will be assessed at 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 -- initial hire, at 6 months of employment, 1 year of employment, and annually thereafter". 2. Review of the laboratory's CMS 209 form (Laboratory Personnel Report) revealed that Personnel 2 serves as Technical Consultant, General Supervisor and Testing Personnel. 3. Review of the laboratory's Employee Competency Assessment form for Personnel 2 from 2019, 2020, and 2021 revealed the laboratory did not perform a competency assessment for the duties of Testing Personnel. 4. In interview on November 15, 2021 at 1:29 pm, General Supervisor 1 stated that he was unsure who should perform the testing personnel competency assessment since he also serves as General Supervisor and Technical Consultant. General Supervisor confirmed that a competency assessment for his duties of testing personnel was not performed for the identified years. D5400 ANALYTIC SYSTEMS CFR(s): 493.1250 Each laboratory that performs nonwaived testing must meet the applicable analytic systems requirements in 493.1251 through 493.1283, unless HHS approves a procedure, specified in Appendix C of the State Operations Manual (CMS Pub.7), that provides equivalent quality testing. The laboratory must monitor and evaluate the overall quality of the analytic systems and correct identified problems as specified in 493.1289 for each specialty and subspecialty of testing performed. This CONDITION is not met as evidenced by: Based on observation by surveyor, review of laboratory records, and interview with personnel, the laboratory failed to ensure the quality of testing within the analytic systems. Findings: 1. The laboratory failed to ensure the policy and procedure manual contained complete policies and procedures. Refer to D5403. 2. The laboratory failed to ensure patient samples for Arterial Blood Gas testing are analyzed within fifteen (15) minutes according to the manufacturer for one (1) of thirteen (13) patient reviewed from August 2020 through October 2021. Refer to D5411. 3. The laboratory failed to ensure supplies did not exceed their expiration date. Refer to D5417. 4. The laboratory failed to take

Summary Statement of Deficiencies D0000 A Recertification survey was conducted at Central Louisiana Surgical Hospital-CLIA ID # 19D0672493 on May 22, 2019 through May 23, 2019. The laboratory was found in compliance with 42 CFR 493 Requirement for Laboratories; however, standard deficiencies were cited. D1001 CERTIFICATE OF WAIVER TESTS CFR(s): 493.15(e) Laboratories eligible for a certificate of waiver must-- (1) Follow manufacturers' instructions for performing the test; and (2) Meet the requirements in subpart B, Certificate of Waiver, of this part. This STANDARD is not met as evidenced by: Based on observation, record review and interview with personnel, the laboratory failed to follow the manufacturer's requirements for testing of samples in waived chemistry testing. Findings: 1. Observation by the surveyor on May 21, 2019 during the laboratory tour revealed the laboratory utilized the Abbott i-Stat analzer and the Abbott i-Stat G3+ cartridge for a Basic Metabolic Panel (BMP) testing to include the following tests: Calcium (CA), Blood Urea Nitrogen (BUN), Creatinine (CREA), Glucose (GLUC), Sodium (NA), Potassium (K), Chloride (CL), and Carbon Dioxide (CO2) 2. Review of the Abbott i-Stat operator's manual revealed under "Venous Specimens" to "Test Sample collected without anticoagulant immediately. Test sample for pH, pCO2, and ionized calcium within 10 minutes of sample draw. If not tested immediately, remix the sample before testing and discard the first two drops of blood from a syringe before testing. For other cartridge tests, test sample within 30 minutes of collection". 3. Review of patient records from February 10, 2019 through February 16, 2019 revealed the laboratory did not test patient samples for BMP testing within thirty (30) minutes as required by the manufacturer for the following thirteen (13) of fifty eight (58) patients reviewed: On February 11, 2019, Patient 310034 was collected at 11:00 am and resulted at 11:38 am (which is 8 minutes over the 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 -- manufacturer's requirement of 30 minutes) On February 11, 2019, Patient 310764 was collected at 14:08 pm and resulted at 14:50 pm (which is 12 minutes over the manufacturer's requirement of 30 minutes) On February 11, 2019, Patient 310783 was collected at 15:14 pm and resulted at 15:52 pm (which is 8 minutes over the manufacturer's requirement of 30 minutes) On February 12, 2019, Patient 310401 was collected at 06:00 am and resulted at 06:52 am (which is 22 minutes over the manufacturer's requirement of 30 minutes) On February 12, 2019, Patient 310559 was collected at 05:45 am and resulted at 06:33 am (which is 18 minutes over the manufacturer's requirement of 30 minutes) On February 12, 2019, Patient 310068 was collected at 07:30 am and resulted at 08:11 am (which is 11 minutes over the manufacturer's requirement of 30 minutes) On February 12, 2019, Patient 310061 was collected at 11:00 am and resulted at 11:45 am (which is 15 minutes over the manufacturer's requirement of 30 minutes) On February 13, 2019, Patient 311059 was collected at 11:15 am and resulted at 11:50 am (which is 5 minutes over the manufacturer's requirement of 30 minutes) On February 13, 2019, Patient 311136 was collected at 15:36 pm and resulted at 16:18 pm (which is 12 minutes over the manufacturer's requirement of 30 minutes) On February 14, 2019, Patient 310465 was collected at 05:55 am and resulted at 06:40 am (which is 15 minutes over the manufacturer's requirement of 30 minutes) On February 14, 2019, Patient 311231 was collected at 10:56 am and resulted at 11:37 am (which is 11 minutes over the manufacturer's requirement of 30 minutes) On February 14, 2019, Patient 311305 was collected at 12:43 pm and resulted at 13:26 pm (which is 13 minutes over the manufacturer's requirement of 30 minutes) On February 15, 2019, Patient 310465 was collected at 06:20 am and resulted at 06:56 am (which is 6 minutes over the manufacturer's requirement of 30 minutes) 4. In interview on May 22, 2019 at 04:25 pm, the General Supervisor confirmed the laboratory did not test the above patients within the thirty (30) minutes according to the manufacturer. 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 ensure written policies and procedures to address competency for Technical Consultant and General Supervisor were complete. Findings: 1. Review of the laboratory's CMS-209 form (Laboratory Personnel Report) revealed the following personnel positions: a) Personnel 2 serves as the Technical Consultant and General Supervisor b) Personnel 3 serves as the General Supervisor 2. Review of the laboratory's policy and procedure manual revealed the laboratory did not include competency assessment criteria or frequency for personnel serving as Technical Consultant and General Supervisor. 3. Review of personnel records for Personnel 2 revealed the laboratory did not perform a competency assessment for the duties of Technical Consultant and General Supervisor. 4. Review of personnel records for Personnel 3 revealed the laboratory did not perform a competency assessment for the duties of General Supervisor. 5. In interview on May 22, 2019 at 10:55 am, Personnel 2 confirmed the laboratory did not have a policy for competency assessment and did not perform competency assessments for the duties of Technical Consultant and General Supervisor. -- 2 of 5 -- 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, record review and interview with personnel, the laboratory failed to ensure patient samples for Arterial Blood Gas testing are analyzed within ten (10) minutes according to the manufacturer for seven (7) of fifteen (15) patients reviewed. Findings: 1. Observation by surveyor during the laboratory tour on May 21, 2019 revealed the laboratory was performing Arterial Blood Gas (ABG) testing on the Abbott i-Stat Clinical analyzer. 2. Review of the Abbott i-STAT operator's manual under "Arterial Specimens" revealed "Test sample collected without anticoagulant immediately. For pH, blood gases and ionized calcium, test within 10 minutes of collection". 3. Review of patient records from January 1, 2018 through May 22, 2019 revealed the laboratory did not perform patient samples for ABG testing within ten (10) minutes according to manufacturer for seven (7) of fifteen (15) patients reviewed: Patient 265100 - Collected January 18, 2018 at 11:38 am then resulted January 18, 2018 at 11:53 am - five (5) minutes over the manufacturer's requirement of ten (10) minutes Patient 276536 - Collected April 25, 2018 at 14:15 pm then resulted April 25, 2018 at 15:07 pm - forty two (42) minutes over the manufacturer's requirement of ten (10) minutes Patient 276536 - Collected April 25, 2018 at 14:55 pm then resulted April 25, 2018 at 15:14 pm - nine (9) minutes over the manufacturer's requirement of ten (10) minutes Patient 276536 - Collected April 25, 2018 at 14:40 pm then resulted April 25, 2018 at 15:10 pm - twenty (20) minutes over the manufacturer's requirement of ten (10) minutes Patient 276536 - Collected April 25, 2018 at 14:50 pm then resulted April 25, 2018 at 15:12 pm - twelve (12) minutes over the manufacturer's requirement of ten (10) minutes Patient 305474 - Collected December 31, 2018 at 16: 20 pm then resulted December 31, 2018 at 16:46 pm - sixteen (16) minutes over the manufacturer's requirement of ten (10) minutes Patient 307692 - Collected January 17, 2019 at 18:50 pm then resulted January 18, 2019 at 07:54 am - twelve (12) hours and fifty four (54) minutes over the manufacturer's requirement of ten (10) minutes 4. In interview on May 22, 2019, the General Supervisor confirmed the above patients were not analyzed within ten (10) minutes according to the manufacturer's requirements. 5. Review of the Task 1 & # form provided to surveyor revealed the laboratory performs four (4) ABG tests annually. II. Based on observation, record review, and interview with personnel, the laboratory failed to ensure donors for Mean Prothrombin Time studies met the laboratory's requirements of normal donors. Findings: 1. Observation by surveyor during laboratory tour on May 21, 2019 revealed the laboratory utilizes the Siemens Sysmex CA-600 analyzer for Prothrombin Time (PT) and International Normalized Ratio (INR) testing. 2. Review of the laboratory's donor questionnaires from February 13, 2018 through February 28, 2018 revealed the laboratory documented responses from twenty (20) donors for the following questions: a) Are you currently pregnant? b) Do you currently have any bruising as a result of recent trauma? c) Have you taken any of the following in the last 24 hours: (check all that apply) Coumadin/Warfarin Heparin or similar anticoagulant Plavix Aspirin or any medications containing aspirin Antibiotics Vitamin K d) Any diagnosed clotting disorder (Hemophilia, von Willebrand's, etc) or factor deficiency? 3. Review of the laboratory's donor questionnaires revealed the -- 3 of 5 -- laboratory did not include the following criteria: a) Not on any oral contraceptives 4. Further review of the laboratory's donor questionnaires revealed the laboratory utilized the followng three (3) of twenty (20) donors taking aspirin/aspirin products and/or plavix: a) Sample ID 06 - Aspirin and plavix b) Sample ID 11 - Aspirin c) Sample ID 15 - Aspirin 5. In interview on May21, 2019 at 3:15 pm, the Laboratory Manager stated he was aware that three (3) donors were taking Aspirin, Aspirin products, and/or Plavix but since the donors results were within normal range, the donors were used for the study. The Laboratory Manager further stated he was unaware birth control for women should be added to the questionnaire. 6. In further interview on May 21, 2019, the Laboratory Director confirmed the laboratory utilized donors taking aspirin, aspirin products, and/or plavix for the study. 7. Review of the laboratory's Task 1 and 3 forms revealed the laboratory performs 719 PT/INR tests annually. 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 blood collection supplies and calibration materials have not exceeded their expiration date. Findings: 1. Observation by surveyor during laboratory tour on May 21, 2019 revealed the following expired items: a) Located on a phlebotomy tray in the laboratory * BD Vacutainer Lithium Heparin 4.0 mL blood collection tubes, Lot #7130538, Expiration date: 2018-09-30, Quantity: four (4) tubes * BD Vacutainer SST 5.0 mL blood collection tubes, Lot #7285755, Expiration date: 2018-10-31, Quantity: five (5) tubes * BD Vacutainer SST 5.0 mL blood collection tubes, Lot #7164938, Expiration date: 2018-05-31, Quantity: one (1) tube * Greiner Bio-One Vacuette K3EDTA 3.0 mL blood collection tubes, Lot #B180134K, Expiration date: 2019-04-19, Quantity: two (2) b) Located in Kenmore Refrigerator * i-Stat Tri- Control 1-5 - Calibration Verification: Level 4, Lot 321100, Expiration date: 2019-04- 30 * i-Stat Tri-Control 1-5 - Calibration Verification: Level 5, Lot 311100, Expiration date: 2019-04-30 2. In interview on May 21, 2019 at 10:55 am, the Laboratory Supervisor stated he was unaware of the expired supplies located on the phlebotomy tray which was used for the early morning lab draws. The Laboratory Supervisor further stated he was unaware the Calibration Verification supplies were expired. 3. In further interview on May 21, 2019, the Laboratory Supervisor confirmed the identified supplies were expired and in place for patient testing. 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. -- 4 of 5 -- 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 testing as required. Findings: 1. The laboratory failed to follow the manufacturer's requirements for testing of samples in waived chemistry testing. Refer to D1001. 2. The laboratory failed to ensure patient samples for Arterial Blood Gas testing are analyzed within ten (10) minutes according to the manufacturer for seven (7) of fifteen (15) patients reviewed. Refer to D5411 I. 3. The laboratory failed to ensure donors for Mean Prothrombin Time studies met the laboratory's requirements of normal donors. Refer to D5411 II. 4. The laboratory failed to ensure blood collection supplies and calibration materials 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 competency. Refer to D5209. 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, record review and interview with laboratory personnel, the Technical Consultant failed to provide technical and scientific oversight of the laboratory. Findings: 1. The laboratory failed to follow the manufacturer's requirements for testing of samples in waived chemistry testing. Refer to D1001. 2. The laboratory failed to ensure patient samples for Arterial Blood Gas testing are analyzed within ten (10) minutes according to the manufacturer for seven (7) of fifteen (15) patients reviewed. Refer to D5411 I. 3. The laboratory failed to ensure donors for Mean Prothrombin Time studies met the laboratory's requirements of normal donors. Refer to D5411 II. 4. The laboratory failed to ensure blood collection supplies and calibration materials have not exceeded their expiration date. Refer to D5417. -- 5 of 5 --