Acadia-St Landry Hospital Pathology

Summary Statement of Deficiencies D0000 A Recertification survey was performed on December 9, 2024 through December 12, 2024 at Acadia St. Landry Hospital Pathology, CLIA ID # 19D0461133. 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 observation, review of laboratory policies and lot rollover records, as well as interview with personnel, the laboratory failed to follow their policy for verification of new Prothrombin Time (PT) and Activated Partial Thromboplastin Time (APTT) reagent lots for one (one) of one (1) lot rollovers reviewed. Findings: 1. Observation by surveyor during the laboratory tour on December 9, 2024 at 11:22 a.m. revealed the laboratory utilized a Sysmex CA-600 analyzer for PT and APTT testing. 2. Review of the laboratory's policy "Coagulation Reagents - New Rollover" section "Policy" revealed "The following steps are required for a successful new lot rollover: ...A normal range study for PT and APTT testing." 3. Further review of the laboratory's policy under the section "Specimen" revealed "Specimens obtained from healthy individuals from the population served by the laboratory. Each patient is asked specific questions related to their overall health and medication usage. Their answers are recorded on a Normal Patient Range Study Health Questionnaire (see attached)." 4. Review of the example questionnaire for the "Coagulation Normal Range Study" revealed "All highlighted areas should be completed by the pt." The following highlighted areas were included on the form: - "Sex, age, date - Are you Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 12 -- feeling healthy and well today? - Are you on Birth Control or any Estrogen containing products? - Are you pregnant or have any known immunologic diseases? - Are you on any "blood thinner" medication such as Coumadin? - Are you on Heparin? - Have you recently taken any Direct Thrombin Inhibitors (Aspirin, Etc.)? - Have you recently taken any antibiotics? - Did you review the list of medications given to you prior to having your blood drawn for this Normal Range Study?" 5. Further review of the form revealed the following instructions: "If they are taking any of the drugs on the second sheet, they do not qualify to be drawn." 6. Review of the laboratory's October 2023 lot rollover revealed the laboratory utilized the following four (4) donors that did not meet the normal donor requirements established by the laboratory, but were utilized in the normal range study: a) Donor M3: - Answered "no" to the question "Did you review the list of medications given to you prior to having your blood drawn for this Normal Range Study?" b) Donor M4: - Answered "yes" to the question "Have you recently taken any Direct Thrombin Inhibitors (Aspirin, Etc.)" - Answered "yes" to the question "Did you review the list of medications given to you prior to having your blood drawn for this Normal Range Study?" and "High Blood Pressure Medications" and "Salicylate" was circled on the medication list. c) Donor M6: - Answered "no" to the question "Did you review the list of medications given to you prior to having your blood drawn for this Normal Range Study?" d) Donor F11 - Answered "no" to the question "Did you review the list of medications given to you prior to having your blood drawn for this Normal Range Study?" 7. In interview on December 11, 2024 at 11:27 a.m., the Laboratory Manager confirmed the laboratory utilized donors that did not meet the normal donor requirements as defined in the laboratory's policy. D5403 PROCEDURE MANUAL CFR(s): 493.1251(b) 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 An offsite PT Desk Review was performed on August 1, 2023 at Acadia St Landry Hospital - Laboratory, 19D00461133, was found not in compliance with the following CONDITION LEVEL DEFICIENCIES: 42 CFR 493.803 CONDITION: Successful Participation 42 CFR 493.1441 CONDITION: Laboratory Director, High Complexity D2016 SUCCESSFUL PARTICIPATION CFR(s): 493.803(a)(b)(c) (a) Each laboratory performing nonwaived testing must successfully participate in a proficiency testing program approved by CMS, if applicable, as described in subpart I of this part for each specialty, subspecialty, and analyte or test in which the laboratory is certified under CLIA. (b) Except as specified in paragraph (c) of this section, if a laboratory fails to participate successfully in proficiency testing for a given specialty, subspecialty, analyte or test, as defined in this section, or fails to take remedial action when an individual fails gynecologic cytology, CMS imposes sanctions, as specified in subpart R of this part. (c) If a laboratory fails to perform successfully in a CMS- approved proficiency testing program, for the initial unsuccessful performance, CMS may direct the laboratory to undertake training of its personnel or to obtain technical assistance, or both, rather than imposing alternative or principle sanctions except when one or more of the following conditions exists: (1) There is immediate jeopardy to patient health and safety. (2) The laboratory fails to provide CMS or a CMS agent with satisfactory evidence that it has taken steps to correct the problem identified by the unsuccessful proficiency testing performance. (3) The laboratory has a poor compliance history. This CONDITION is not met as evidenced by: Based on review of laboratory's American Proficiency Institute proficiency testing records, CASPER 153D & 155D report the laboratory failed to successfully perform in two of three consecutive Compatilbilty Testing proficency testing events in 2022- 2023. Findings: 1. The laboratory failed to achieve a satisfactory score of 100% for 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 -- two (2) of three (3) consecutive proficiency testing events in 2022-2023 resulting in an initial unsuccessful performance for Compatibility Testing. Refer to D2181. D2181 COMPATIBILITY TESTING CFR(s): 493.863(e) Failure to achieve an overall testing event score of satisfactory for two consecutive testing events or two out of three consecutive testing events is unsuccessful performance. This STANDARD is not met as evidenced by: Based on review of the laboratory's proficiency testing records from American Proficiency Institute (API) and the CASPER 153D & 155D reports, the laboratory failed to achieve a satisfactory score of 100% for two (2) of three (3) consecutive proficiency testing events in 2022-2023 resulting in an initial unsuccessful performance for Compatibility Testing. Findings: 1. Review of the CASPER 153D & 155D report revealed the laboratory received the following scores of less than 100% for Compatibility Testing for the following two (2) of three (3) consecutive proficiency testing events: a) 2022 event 2 for Compatibility Testing: score of 80% b) 2023 event 1 for Compatibility Testing: score of 80% 2. Review of the laboratory's American Proficiency Institute (API) proficiency testing records revealed the laboratory received the following scores for Compatibility Testing: a) API 2022 Immunology/Immunohematology 2nd event: sample SER-08 (unacceptable) b) API 2023 Immunology/Immunohematology 1std event: sample SER-05 (unacceptable) D6076 LABORATORY DIRECTOR CFR(s): 493.1441 The laboratory must have a director who meets the qualification requirements of 493. 1443 of this subpart and provides overall management and direction in accordance with 493.1445 of this subpart. This CONDITION is not met as evidenced by: Based on record review and interview with personnel, the Laboratory Director failed to provide overall management and direction for the laboratory. Refer to D6089 D6089 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1445(e)(4)(i) The laboratory director must ensure the proficiency testing samples are tested as required under subpart H of this part. This STANDARD is not met as evidenced by: Based on record review, the laboratory director failed to ensure that proficiency testing scores achieved satisfactory performance as required. Findings: 1. The the laboratory failed to achieve a satisfactory score of 100% for two (2) of three (3) consecutive proficiency testing events in 2022-2023 resulting in an initial unsuccessful performance for Compatibility Testing. Refer to D2181. -- 2 of 2 --

Summary Statement of Deficiencies D0000 A Recertification survey was performed on February 14, 2023 through February 17, 2023 at Acadia St. Landry Hospital Pathology, CLIA ID # 19D0461133. The laboratory was found in compliance with 42 CFR 493 Requirements for Laboratories; however, standard level deficiencies were cited. D2006 TESTING OF PROFICIENCY TESTING SAMPLES CFR(s): 493.801(b) The laboratory must examine or test, as applicable, the proficiency testing samples it receives from the proficiency testing program in the same manner as it tests patient specimens. This testing must be conducted in conformance with paragraph (b)(4) of this section. If the laboratory's patient specimen testing procedures would normally require reflex, distributive, or confirmatory testing at another laboratory, the laboratory should test the proficiency testing sample as it would a patient specimen up until the point it would refer a patient specimen to a second laboratory for any form of further testing. This STANDARD is not met as evidenced by: Based on review of the laboratory's policies, quality control records, patient test logs, and interview with personnel, the laboratory failed to ensure one (1) of five (5) proficiency testing samples for D-dimer were tested in the same manner as patient samples in September 2022. Findings: 1. Review of the laboratory's "Proficiency Testing Policy and Procedure" revealed "Laboratory routine procedures are followed for PT sample testing, however keeping the PT provider instructions as a priority." 2. Review of the laboratory's September 2022 quality control records and patient test logs for D-dimer revealed the laboratory did not perform two (2) levels of quality control prior to proficiency testing as they would for patient testing for the following date and sample: September 13, 2022: "CPSI SURVEY 11" 3. In interview on February 16, 2023 at 9:29 am, the Compliance Personnel confirmed the identified proficiency testing sample did not have quality controls performed. Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 21 -- 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 policies, proficiency testing records, and interview with personnel, the laboratory failed to ensure attestation statements were signed by testing personnel as required for four (4) of five (5) proficiency testing (PT) events reviewed. Findings: 1. Review of the laboratory's "Proficiency Testing Policy and Procedure" under the "Handling of Survey" section revealed "The assigned testing personnel will also be required to sign and date the attestation statement." 2. Review of the laboratory's 2021 and 2022 American Proficiency Institute (API) proficiency testing records revealed the laboratory's testing personnel did not sign the attestation statements for the following four (4) events: a) 2021 Chemistry Miscellaneous 2nd event b) 2021 Chemistry Core 3rd event c) 2022 Immunology/Immunohematology 1st event: specific samples testing by personnel was not indicated d) 2022 Hematology /Coagulation 2nd event 3. In interview on February 15, 2023 at 11:31 am, General Supervisor 1 confirmed the laboratory did not have complete or signed attestation statements for the identified events. D3015 REQUIREMENTS FOR TRANSFUSION SERVICES CFR(s): 493.1103 A facility that provides transfusion services must meet all of the requirements of this section and document all transfusion-related activities. This STANDARD is not met as evidenced by: Based on review of laboratory and hospital policies and procedures and patient records, as well as interview with laboratory and nursing personnel, the laboratory failed to ensure complete transfusion-related activities were documented as required by the hospital and laboratory for three (3) of three (3) patients reviewed. Findings: 1. Review of the hospital policy "Blood and Blood Components Administration Policy" and the laboratory policy "Blood Administration Policy" under section "Procurement of blood or blood product" revealed both laboratory personnel and the nurse receiving the unit from the laboratory are required to sign the "Blood Administration Signout Form." 2. Further review of hospital policy "Blood and Blood Components Administration Policy" and the laboratory policy "Blood Administration Policy" revealed the following: *Document pre-vitals (no more than 15 minutes prior to transfusion). *Enter volume transfused. *Document end vitals. *For Inpatients, resume routine vital sign checks as ordered and continued monitoring for delayed blood transfusion reactions. Document in Evident 30 minutes to 1 hour after the end -- 2 of 21 -- of the transfusion in order to monitor for delayed transfusion reaction. *For Outpatients being discharged, monitor patient another hour after completion of transfusion and recheck vital signs at this time and document in Evident 30 minutes to 1 hour after the end of the transfusion in order to monitor for delayed transfusion reaction. *Summary of Documentation of Vital Signs/Assessments: DOCUMENTATION IN Electronic Health Record: 1. Document Vital Signs 15 minutes prior to transfusing patient. 2. Stay with patient for the first 15min after starting the transfusion and document a set of Vital signs. 3. Continue to monitor the patient throughout the transfusion. 4. Document vitals at 1 hour, 2 hour, 3 hour and upon completion of the transfusion. 5. Patients, are monitored and vitals are to be taken and documented 60 min after the transfusion and prior to discharge for a possible delayed transfusion reaction. 3. Review of three (3) patient charts revealed missing transfusion related documentation: a) Patient A transfused December 13, 2021. -Blood checked out of lab at 1711. *Laboratory personnel did not sign the Blood Administration Unit Signout Form. *Nursing did not document vital signs at the completion of the transfusion and 1 hour after completion of the transfusion. b) Patient B transfused November 26, 2022. -Blood checked out of lab at 0630. *Nursing personnel did not document "Time Blood Hung" in the chart. *Nursing personnel did not document "Amount of Blood Transfused" in the chart. c) Patient B transfused January 12, 2023. -Blood checked out of lab at 1532. *Nursing personnel did not document "Time Stopped" in the chart. *Nursing personnel did not document "Amount of Blood Transfused" in the chart. *Nursing did not document vital signs 1 hour after completion of the transfusion. d) Patient B transfused January 12, 2023. - Blood checked out of lab at 2253. *Nursing did not document vital signs 1 hour after completion of the transfusion. e) Patient C transfused August 11, 2022. -Blood checked out of lab at 1452. *Nursing documented pre-transfusion vital signs greater than 15 minutes before the transfusion was started. Nursing documented patient vital signs at 1415. Nursing hung the blood at 1500. *Nursing did not document vital signs 1 hour after completion of the transfusion. 4. In interview on February 16, 2023 at 3: 42 PM, the Director of Nursing confirmed that the missing information identified above was not documented in the patient charts. D3031 RETENTION REQUIREMENTS CFR(s): 493.1105(a)(3) Analytic systems records. Retain quality control and patient test records (including instrument printouts, if applicable) and records documenting all analytic systems activities specified in 493.1252 through 493.1289 for at least 2 years. This STANDARD is not met as evidenced by: Based on observation, review of quality control, and interview with laboratory personnel, the laboratory failed to retain quality control records for at least two (2) years. Findings: 1. Observation by surveyors during laboratory tour on February 14, 2023 revealed the laboratory utilizes the Siemens Dimension EXL instrument. 2. Review of chemistry quality control records for the current lot in use at the time of the survey revealed the laboratory did not have records for establishing their acceptable range for MMB Level 1 and Level 3, Troponin Level 1, and BNP Level 1 and Level 3. 3. In interview on February 16, 2023 at 9:03 AM, General Supervisor 1 stated he was unable to find the quality control new lot establishment data for the analytes and levels identified above. D5209 PERSONNEL COMPETENCY ASSESSMENT POLICIES -- 3 of 21 -- 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 CMS 209 (Laboratory Personnel Form) form, policies, personnel records, and interview with personnel, the laboratory failed to ensure procedures to assess competency for one (1) of two (2) Technical Consultants and General Supervisors reviewed were followed. Findings: 1. Review of the laboratory's CMS 209 form revealed two (2) personnel serve as Technical Consultant and General Supervisor. 2. Review of the laboratory's "Competency Policy" revealed "Documented competency assessment is required for the personnel listed as Technical Consultant/Clinical Consultant on the 209 form. This competency will be performed annually. Documented competency assessment is required for the personnel listed as General Supervisor on the 209 Form This competency will be performed annually. 3. Review of personnel records for Technical Consultant/General Supervisor 2 revealed the laboratory did not have documentation of a 2022 competency assessment for his duties as Technical Consultant and General Supervisor. 4. In interview on February 14, 2023 at 1:26 pm, General Supervisor 1 confirmed the Laboratory Director did not perform competency assessments for the duties of Technical Consultant and General Supervisor for Technical Consultant/General Supervisor 2. D5221 EVALUATION OF PROFICIENCY TESTING PERFORMANCE CFR(s): 493.1236(d) All proficiency testing evaluation and verification activities must be documented. This STANDARD is not met as evidenced by: Based on review of the laboratory's policies, proficiency testing records, and interview with personnel, the laboratory failed to perform complete assessments for three (3) of five (5) proficiency testing (PT) events reviewed. Findings: 1. Review of the laboratory's "Proficiency Testing Policy and Procedure" under the "Survey Result Evaluation" section revealed "The Laboratory Manager is to perform the survey result evaluation review upon receipt of the result evaluation which includes

Summary Statement of Deficiencies D0000 A Certification Survey was performed at Acadia St. Landry Hospital -CLIA # 19D0461133 on June 21, 2021 through June 24, 2021. Acadia St. Landry Hospital was found not in compliance with the following CONDITION LEVEL DEFICIENCIES: 42 CFR 400.200 CONDITION: Reporting of SARS-COV-2 Test Results 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 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: I. Based on observation by surveyor, review of manufacturer's instructions, test menu, and interview with personnel, the laboratory failed to include "Fact Sheets" to providers or patients for Emergency Use Authorization (EUA) SARS COV-2 testing. Findings: 1. Observation by surveyor during laboratory tour on June 22, 2021 at 10:33 am revealed the laboratory utilizes the CareStart COVID-19 Antigen tests for SARS COV-2 testing. 2. Review of the manufacturer's instructions for use under the "Conditions of Authorization of the Laboratory" section revealed "Authorized laboratories using your product must include with test result reports, all authorized Fact Sheets. Under exigent circumstances, other appropriate methods for disseminating these Fact Sheets may be used, which may include mass media." 3. In interview on June 22, 2021 at 12:57 pm, the Technical Consultant stated fact sheets are not given to patients or providers. 4. Review of the laboratory's test menu revealed the laboratory performs 275 SARS COV-2 tests annually. II. Based on review of Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 20 -- manufacturer's instructions, patient final test reports, test menu, and interview with personnel, the laboratory failed to include the Food and Drug Administration (FDA) Emergency Use Authorization statement on SARS COV-2 patient final reports. Findings: 1. Review of the manufacturer's instructions for the CareStart revealed the following statement: "This product has not been FDA cleared or approved, but has been authorized by FDA under an Emergency Use Authorization (EUA) for use by laboratories certified under the CLIA that meet the requirements to perform moderate, high or waived complexity tests." 2. Review of random selection of patient final reports for SARS COV-2 revealed the laboratory did not include the identified Emergency Use Authorization statement on patient final reports. 3. In interview on June 22, 20121 at 1:23 pm, the Technical Consultant confirmed the laboratory's patient final reports for SARS COV-2 did not include the identified statement. 4. Review of the laboratory's test menu revealed the laboratory performs 275 SARS COV-2 tests annually. D1002 REPORTING OF SARS-CoV-2 TEST RESULTS During the Public Health Emergency, as defined in 400.200 of this chapter, each laboratory that performs a test that is intended to detect SARS-CoV-2 or to diagnose a possible case of COVID-19 (hereinafter referred to as a "SARS-CoV-2 test") must report SARS-CoV-2 test results to the Secretary in such form and manner, and at such timing and frequency, as the Secretary may prescribe. This CONDITION is not met as evidenced by: Based on observation by surveyor, review of the laboratory's COVID reports and interview with personnel, the laboratory failed to report ninety one (91) COVID patient test results to the state as required. Findings: 1. Observation by surveyor during laboratory tour on June 22, 2021 at 10:33 am, the laboratory utilizes the CareStart COVID-19 Antigen tests for SARS COV-2 testing. 2. In interview on June 22, 2021 at 12:07 pm, the Technical Consultant stated the laboratory does not report any COVID-19 results to the state. 3. In further interview on June 22, 2021 at 12:57 pm, the Technical Consultant stated the laboratory began testing COVID samples in- house on February 13, 2021. 4. Review of the laboratory's "CARESTART COVID-19 ANTIGEN" patient logs for May 2021 and June 2021 revealed the laboratory did not report positive or negative results for the following patients: Patient 10076920 Patient 10077141 Patient 10077258 Patient 10077422 Total of thirty three (33) patients tested in May 2021 and June 2021. 4. In interview on June 24, 2021 at 8:55 am, the Technical Consultant stated as of June 24, 2021 the laboratory tested ninety one (91) COVID-19 samples. D3025 REQUIREMENTS FOR TRANSFUSION SERVICES CFR(s): 493.1103(d) Investigation of transfusion reactions. The facility must have procedures for preventing transfusion reactions and when necessary, promptly identify, investigate, and report blood and blood product transfusion reactions to the laboratory and, as appropriate, to Federal and State authorities. This STANDARD is not met as evidenced by: Based on review of nursing administration policies, laboratory policies, and interview with personnel, the laboratory failed to define specific criteria for suspected -- 2 of 20 -- transfusion reactions. Findings: 1. Review of the laboratory's "Transfusion Reaction" procedure revealed "The nurse will monitor for common signs and symptoms of a transfusion reaction: Hemolytic or incompatibility reaction-most sever, Bacterial contamination, Allergic Reaction, Febrile, non-hemolytic reaction (temperature elevation of 2 degrees F). Common signs and symptoms: abnormal bleeding, chest /back pain, chills, coughing, cyanosis, dyspnea, facial flushing, fever (a temperature elevation of 2 degrees F is considered a reportable symptom of a suspected reaction), headache, heat at infusion site, hemoglobinuria, hypotension, itching, myalgia, nausea, oliguria/anuria, pulmonary edema, rales, rash, uneasy feelings, urticaria (hives) , wheezing." 2. Review of the nursing department's "Adverse Transfusion Reactions" policy, revealed the following signs and symptoms of a possible transfusion reaction: "localized urticarial (hives), pruitis, rash, dyspnea, wheezing, tachypnea, cyanosis, blood pressure changes greater than or equal to 20 mm/HG in 2 consecutive readings, tachycardia, nausea, vomiting, cramping, rigors, temperature changes great [sic] than or equal to 2 degrees Fahrenheit in 2 consecutive readings, flank pain, unexplained bleeding, hemoglobinuria, chills, oliguria." 3. Review of the nursing department's "Blood and Blood Product Administration" policy (revised "5 /2017") under step "12." revealed the following: a) "If a patient's temperature increases or decreases by 2 degrees Fahrenheit in two consecutive readings, stop blood, notify MD, and initiate Management of Possible Transfusion Reaction" b) "If the patient's blood pressure decreases by 50 mm/Hg in two consecutive readings and is NOT symptomatic, observe the patient and recheck the BP in 10 minutes. If the BP still has a 50 mm/Hg difference, stop blood and notify MD. Document any BP change explanation (ie. up to bathroom)." 4. Review of the nursing department's "Blood Administration Record" under the "Initiate Blood Transfusion Reaction Protocol and Report for the Following Positive Findings:" section revealed the following: "Was there a Temperature increase by 2 F? Was there a B/P increase or decrease of 20 mm /Hg in 2 consecutive readings?" 5. Review of the nursing department's " Blood Transfusion Documentation Review/Check-List" revealed the following: a)" Increase of temperature by 2 degrees F" b) "BP increase or decrease of 20 mm/Hg in 2 consecutive readings" 6. Further review of the "Nursing" department procedures and forms for transfusion reactions revealed the clinical symptoms for suspected transfusion reactions did not match the laboratory's criteria. 7. In interview on June 24, 2021 at 3:30 pm, the Director of Nursing stated the laboratory's previous Laboratory Director approved the transfusion reactions policies and forms. The Director of Nursing further stated the nursing department's "Adverse Transfusion Reaction" policy is no longer in use. The Director of Nursing stated she was unsure of why the change in blood pressure differed in the policies. The Director of Nursing confirmed the nursing department's criteria for transfusion reactions did not match the laboratory's criteria. 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 policy and interview with personnel, the laboratory failed to ensure the personnel competency assessment policy included frequency of performance for the Technical Consultant and General Supervisor. -- 3 of 20 -- Findings: 1. Review of the "Laboratory Competency" policy revealed the laboratory did not include frequency of performance of assessment of duties for the Technical Consultant and General Supervisor. 2. In interview on June 23, 2021 at 11:50 am, the Technical Consultant confirmed the policy did not include frequency of performance of competency assessment by the Laboratory Director for his duties as Technical Consultant and General Supervisor . 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 collection instructions and interview with personnel, the laboratory failed to establish detailed written instructions for providers regarding specimen transport. Findings: 1. Review of the collection instructions (requisition and "Tube Colors" form) revealed the laboratory did not include the following instructions for providers: a) Specimen storage and preservation b) Conditions for specimen transportation. 2. In interview on June 23, 2021 at 11:22 am, Testing Personnel 1 confirmed the laboratory's instructions to providers did not include written instructions for specimen storage and transport. 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, record review, and interview with personnel, the laboratory failed to ensure the quality of testing within the analytic systems. Findings: 1. The laboratory failed to establish a complete policy and procedure manual. Refer to D5401 I. 2. The laboratory failed to perform the platelet poor plasma studies annually per policy for one (1) of two (2) years reviewed. Refer to D5401 II. 3. The laboratory failed to ensure the policy and procedure manual contained complete policies and procedures. Refer to D5403. 4. The laboratory failed to ensure policies and procedures were updated to current instrumentation. Refer to D5407. 5. The laboratory failed to document the appropriate expiration date of the saline utilized for blood bank testing as required. Refer to D5415. 6. The laboratory failed to have complete reference range studies for D-dimer. Refer to D5421 I. 7. The laboratory failed to have complete reference range studies for Hemoglobin A1C (HGB A1C). Refer to D5421 II. 8. The laboratory failed to perform positive and negative controls for Acetone testing for one (1) of five (5) months reviewed. Refer to D5449. 9. The laboratory failed to utilize control material relative to the specific drug of abuse cut-off values per manufacturer requirements for urine drug screen (UDS) testing. Refer to D5479. 10. The laboratory -- 4 of 20 -- failed to perform two (2) levels of controls every eight (8) hours of patient testing for Coagulation testing for two (2) of 151 days reviewed. Refer to D5545. 11. The laboratory failed to ensure the pathologist (Laboratory Director) reviewed blood products released for emergency release for one (1) of one (1) patients reviewed. Refer to D5553. 12. The laboratory failed to perform quarterly blood bank refrigerator alarm checks for two (2) of nine (9) quarters reviewed. Refer to D5555 I. 13. The laboratory failed to monitor the blood bank refrigerator's temperature for the storage of blood products for two (2) of four (4) weeks in January 2020. Refer to D5555 II. 14. The laboratory failed to take

Summary Statement of Deficiencies D0000 A CERTIFICATION SURVEY was performed at Acadia St Landry Hospital - Pathology - CLIA # 19D0461133 on December 3, 2018 through December 7, 2018. The laboratory was found in compliance with 42 CFR 493 Requirements for Laboratories; however, standard level deficiencies were cited. 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. This STANDARD is not met as evidenced by: Based on observation, record review, and interview with personnel, the laboratory failed to ensure patient samples for Routine Chemistry, General Immunology, and Endocrinology testing are processed according to Becton Dickinson Vacutainer Blood Collection System package instructions. Findings: 1. Observation by surveyor during the laboratory tour on December 3, 2018 revealed the laboratory utilized the Becton Dickinson (BD) Vacutainer Blood Collection Tubes for the collection of patient samples. 2. In interview on December 4, 2018 at 11:03 am, the laboratory assistant stated she receives the patient samples whether by collection or from an outside facility and then processes the physician's orders. The laboratory assistant further stated the collection time and the time spun are documented on the "ASLH SPIN DOWN LOG" along with a patient label which has the specific tests ordered. 3. Observation by surveyor revealed the laboratory received a yellow BD Vacutainer Serum Separator Blood Collection tube with the time collected documented on the "ASLH SPIN DOWN LOG" as 10:45 am and the time spun as 11:07 am with sample Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 7 -- being tested for a Basic Metabolic Panel ( Basic Metabolic Panel includes Sodium, Potassium, Chloride, Carbon Dioxide, Glucose, Blood Urea Nitrogen, Creatinine, and Calcium) 4. Review of the BD Diagnostics-Preanalytical Systems package insert revealed "The minimum recommended clotting time for BD Vacutainer Serum Separator Tubes for patients without anticoagulant is 30 minutes". 5. In interview on December 4, 2018 at 11:19 am, Personnel 2 stated the laboratory does not document whether a serum or plasma specimen is received for patient testing. 6. Review of the laboratory's ASLH SPIN DOWN LOG for eight (8) days revealed the following fifty five (55) of ninety seven (97) patients with no documentation of specimen type received: October 2, 2018 a) Patient 5: Time Collected 07:38 - Time Spun 07:41 for Comprehensive Metabolic Panel testing (clotting time of three (3) minutes which is twenty seven (27) minutes less than the recommended clotting time) b) Patient 7: Time Collected 08:00 - Time spun 08:10 for Prostate Specific Ag (Clotting time of ten (10) minutes which is twenty (20) minutes less than the recommended clotting time) c) Patient 8: Time Collected 08:15 - Time Spun 08:20 for Basic Metabolic Panel (Clotting time of five (5) minutes which is twenty five (25) minutes less than the recommended clotting time) d) Patient 9: Time Collected 08:58 - Time Spun 09:00 for Lipid Panel (Clotting time of two (2) minutes which is twenty eight (28) minutes less than the recommended clotting time) e) Patient 15: Time Collected 11:47 - Time Spun 12:10 for Basic Metabolic Panel (Clotting time of twenty three (23) minutes which is seven (7) minutes less than the recommended clotting time) f) Patient 16: Time Collected 14:10 - Time Spun 14:16 for Thyroid Panel (Clotting time of six (6) minutes which is twenty four(24) minutes less than the recommended clotting time) October 29, 2018 g) Patient 18: Time Collected 13:32 - Time Spun 13:42 for Prealbumin (Clotting time of ten (10) minutes which is twenty (20) minutes less than the recommended clotting time) h) Patient 21: Time Collected 19:00 - Time Spun 19: 05 for Basic Metabolic Panel (Clotting time of five (5) minutes which is twenty five (25) minutes less than the recommended clotting time) October 30, 2018 i) Patient 22: Time Collected 03:30 - Time Spun 03:35 for Vancomycin (Clotting time of five (5) minutes which is twenty five (25) minutes less than the recommended clotting time) j) Patient 28: Time Collected 05:30 - Time Spun 05:36 for Prealbumin (Clotting time of six (6) minutes which is twenty four (24) minutes less than the recommended clotting time) k) Patient 29: Time Collected 05:29 - Time Spun 05:36 for Prealbumin (Clotting time of seven (7) minutes which is twenty three (23) minutes less than the recommended clotting time) l) Patient 30: Time Collected 07:00 - Time Spun 07:07 for Comprehensive Metabolic Panel (Clotting time of seven (7) minutes which is twenty three (23) minutes less than the recommended clotting time) m) Patient 31: Time Collected 07:33 - Time Spun 07:34 for Comprehensive Metabolic Panel (Clotting time of one (1) minute which is twenty nine (29) minutes less than the recommended clotting time) n) Patient 33: Time Collected 08:15 - Time Spun 08:15 for Prostate Specific Ag (Clotting time of zero (0) minutes which is thirty (30) minutes less than the recommended clotting time) November 19, 2018 o) Patient 36: Time Collected 10:20 - Time Spun 10:33 for Lipid Panel (Clotting time of thirteen (13) minutes which is seventeen (17) minutes less than the recommended clotting time) p) Patient 37: Time Collected 10:25 - Time Spun 10:33 for Thyroid Panel (Clotting time of eight (8) minutes which is twenty two (22) minutes less than the recommended clotting time) q) Patient 38: Time Collected 10:30 - Time Spun 10:33 for Thyroid Panel (Clotting time of three (3) minutes which is twenty seven (27) minutes less than the recommended clotting time) r) Patient 39: Time Collected 10:40 - Time Spun 10:44 for Thyroid Stimulating Hormone (Clotting time of four (4) minutes which is twenty six (26) minutes less than the recommended clotting time) s) Patient 43: Time Collected 11:45 - Time Spun 11:50 for Thyroid Stimulating Hormone (Clotting time of five (5) minutes which is twenty five (25) minutes less -- 2 of 7 -- than the recommended clotting time) t) Patient 45: Time Collected 11:50 - Time Spun 11:55 for Comprehensive Metabolic Panel (Clotting time of five (5) minutes which is twenty five (25) minutes less than the recommended clotting time) u) Patient 46: Time Collected 10:35 - Time Spun 11:00 for Basic Metabolic Panel (Clotting time of twenty five (25) minutes which is five (5) minutes less than the recommended clotting time) v) Patient 47: Time Collected 10:40 - Time Spun 11:00 for C-Reactive Protein (Clotting time of twenty (20) minutes which is ten (10) minutes less than the recommended clotting time) w) Patient 48: Time Collected 12:05 - Time Spun 12:10 for Basic Metabolic Panel (Clotting time of five (5) minutes which is twenty five (25) minutes less than the recommended clotting time) x) Patient 50: Time Collected 13:10 - Time Spun 13:19 for Basic Metabolic Panel (Clotting time of nine (9) minutes which is twenty one (21) minutes less than the recommended clotting time) y) Patient 51: Time Collected 13:02 - Time Spun 13:15 for Thyroid Panel (Clotting time of thirteen (13) minutes which is seventeen (17) minutes less than the recommended clotting time) z) Patient 52: Time Collected 16:10 - Time Spun 16:15 for Comprehensive Metabolic Panel (Clotting time of five (5) minutes which is twenty five (25) minutes less than the recommended clotting time) aa) Patient 53: Time Collected 18:50 - Time Spun 18:52 for Cardiac Enzymes (Clotting time of two (2) minutes which is twenty eight (28) minutes less than the recommended clotting time) bb) Patient 56: Time Collected 12:40 - Time Spun 12:44 for T3 Free (Clotting time of four (4) minutes which is twenty six (26) minutes less than the recommended clotting time) cc) Patient 59: Time Collected 14:00 - Time Spun 14:21 for Comprehensive Metabolic Panel (Clotting time of twenty one (21) minutes which is nine (9) minutes less than the recommended clotting time) dd) Patient 60: Time Collected 14:40 - Time Spun 14:45 for Basic Metabolic Panel (Clotting time of five (5) minutes which is twenty five (25) minutes less than the recommended clotting time) ee) Patient 61: Time Collected 14:40 - Time Spun 14:45 for Comprehensive Metabolic Panel (Clotting time of five (5) minutes which is twenty five (25) minutes less than the recommended clotting time) ff) Patient 62: Time Collected 20:10 - Time Spun 20:15 for Cardiac Enzymes (Clotting time of five (5) minutes which is twenty five (25) minutes less than the recommended clotting time) gg) Patient 61: Time Collected 14: 40 - Time Spun 14:45 for Comprehensive Metabolic Panel (Clotting time of five (5) minutes which is twenty five (25) minutes less than the recommended clotting time) November 2, 2018 hh) Patient 65: Time Collected 05:30 - Time Spun 05:38 for Prealbumin (Clotting time of eight (8) minutes which is twenty two (22) minutes less than the recommended clotting time) ii) Patient 66: Time Collected 05:00 - Time Spun 05:38 for Basic Metabolic Panel (Clotting time of eight (8) minutes which is twenty two (22) minutes less than the recommended clotting time) jj) Patient 67: Time Collected 05:25 - Time Spun 05:38 for Basic Metabolic Panel (Clotting time of thirteen (13) minutes which is seventeen (17) minutes less than the recommended clotting time) kk) Patient 73: Time Collected 05:20 - Time Spun 05:38 for Basic Metabolic Panel (Clotting time of eighteen (18) minutes which is twelve (12) minutes less than the recommended clotting time) November 14, 2018 ll) Patient 74: Time Collected 08:34 - Time Spun 08:44 for Comprehensive Metabolic Panel (Clotting time of ten (10) minutes which is twenty (20) minutes less than the recommended clotting time) mm) Patient 75: Time Collected 08:05 - Time Spun 08:10 for Digoxin Level (Clotting time of five (5) minutes which is twenty five (25) minutes less than the recommended clotting time) nn) Patient 76: Time Collected 10:30 - Time Spun 10: 38 for Lipid Panel (Clotting time of eight (8) minutes which is twenty two (22) minutes less than the recommended clotting time) oo) Patient 78: Time Collected 12: 00 - Time Spun 12:15 for Basic Metabolic Panel (Clotting time of fifteen (15) minutes which is fifteen (15) minutes less than the recommended clotting time) pp) Patient 79: Time Collected 14:20 - Time Spun 14:22 for T3 Free (Clotting time of two (2) -- 3 of 7 -- minutes which is twenty eight (28) minutes less than the recommended clotting time) November 15, 2018 qq) Patient 83: Time Collected 06:15 - Time Spun 06:30 for Comprehensive Metabolic Panel (Clotting time of fifteen (15) minutes which is fifteen (15) minutes less than the recommended clotting time) rr) Patient 86: Time Collected 07:17 - Time Spun 07:20 for Comprehensive Metabolic Panel (Clotting time of three (3) minutes which is twenty seven (27) minutes less than the recommended clotting time) ss) Patient 87: Time Collected 08:40 - Time Spun 08:45 for Free T4 (Clotting time of five (5) minutes which is twenty five (25) minutes less than the recommended clotting time) tt) Patient 88: Time Collected 09:25 - Time Spun 09:30 for Comprehensive Metabolic Panel (Clotting time of five (5) minutes which is twenty five (25) minutes less than the recommended clotting time) uu) Patient 89: Time Collected 09:50 - Time Spun 09:58 for Prostate Specific Ag (Clotting time of eight (8) minutes which is twenty two (22) minutes less than the recommended clotting time) vv) Patient 90: Time Collected 09:55 - Time Spun 09:58 for Thryoid Panel (Clotting time of three (3) minutes which is twenty seven (27) minutes less than the recommended clotting time) ww) Patient 91: Time Collected 10: 55 - Time Spun 10:58 for Comprehensive Metabolic Panel (Clotting time of three (3) minutes which is twenty seven (27) minutes less than the recommended clotting time) December 4, 2018 xx) Patient 92: Time Collected 09:20 - Time Spun 09:25 for Vitamin D 25 OH (Clotting time of five (5) minutes which is twenty five (25) minutes less than the recommended clotting time) yy) Patient 93: Time Collected 09:58 - Time Spun 10:00 for Lipid Panel (Clotting time of two (2) minutes which is twenty eight (28) minutes less than the recommended clotting time) zz) Patient 94: Time Collected 10:20 - Time Spun 10:25 for Phosphorus Serum (Clotting time of five (5) minutes which is twenty five (25) minutes less than the recommended clotting time) aaa) Patient 95: Time Collected 10:45 - Time Spun 11:07 for Basic Metabolic Panel (Clotting time of twenty two (22) minutes which is eight (8) minutes less than the recommended clotting time) bbb) Patient 96: Time Collected 10:50 - Time Spun 11: 00 for Lipid Panel (Clotting time of ten (10) minutes which is twenty (20) minutes less than the recommended clotting time) ccc) Patient 97: Time Collected 11:23 - Time Spun 11:30 for Comprehensive Metabolic Panel (Clotting time of seven (7) minutes which is twenty three (23) minutes less than the recommended clotting time) 7. In interview on December 4, 2018 at 11:19 am, Personnel 2 confirmed the laboratory could not verify the above patients were processed according to the manufacturer's instructions. 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 record review and interview with personnel, the laboratory failed to have a detailed, written policy and procedure for addressing flags on Complete Blood Count reports. Findings: 1. Review of the laboratory's policy and procedure manual revealed the laboratory did not have a policy for detailing the actions to be taken for Complete Blood Counts (CBC) with suspect, definitive and system flags reflecting that of the manufacturer requirements. 2. In interview on December 6, 2018 at 3:50 pm, Personnel 2 stated the laboratory follows the Sysmex XS-1000i Automated -- 4 of 7 -- Hematology Analyzer Quick Guide which contains the manufacturer's instructions for flag criteria. 3. Review of the Sysmex XS-1000i Quick Guide revealed the manufacturer's instructions for the following: WBC FLAGS a) Flag:WBC ABN Scattergram; Cause: WBC Abnormal Scattergram; Possible Action: Perform Manual Differential b) Flag: Neutropenia; Cause: Low neutrophil count; Possible Action: Review manual smear c) Flag: Neutrophilia; Cause: High neutrophil count; Possible Action: Review manual smear d) Flag: Lymphopenia; Cause: Low lymphocyte count; Possible Action: Review manual smear e) Flag: Lymphocytosis; Cause: High lymphocyte count; Possible Action: Review manual smear f) Flag: Monocytosis; Cause: High monocyte count; Possible Action: Review manual smear g) Flag: Eosinophilia; Cause: High eosinphil count; Possible Action: Review manual smear h) Flag: Basophila; Cause: High basophil count; Possible Action: Review manual smear i) Flag: Leukocytopenia; Cause: Low leukocyte (WBC) count; Possible Action: Review manual smear j) Flag: Leukocytosis; Cause: High leukocyte (WBC) count; Possible Action: Review manual smear k) Flag: Basts?; Cause: Presence of blasts possible; Possible Action: Perform manual differential m) Flag: Immature Gran?; Cause: Presence of immature granulocytes possible; Possible Action: Perform manual differential n) Flag: Left Shift?; Cause: Presence of "band" granulocytes possible; Possible Action: Perform manual differential o) Flag: Abn Lympho/Blasts?; Cause: Presence of atypical lymphoctes and/or blast possible; Possible Action: Perform manual differential p) Flag: NRBC?; Cause: Presence of nucleated RBC's possible; Possible Action: Verify presence on slide, correct WBC count if necessary q) Flag: Atypical Lymphocyte; Cause: Presence of atypical lymphocytes possible; Possible Action: Perform manual differential RBC FLAGS a) Flag: RBC ABN Distribution; Cause: Interfering particles in RBC histogram, i.e. Schistocytes, large platelets, platelet clumps, RBC clumps; Possible Action: Verify presence on slide. If RBC or platelet clumps present recollect sample if possible. b) Flag: Dimorphic population; Cause: Two different RBC sizes present in sample; Possible Action: Verify RBC morphology c) Flag: Anisocytosis; Cause: RDW CV and/or out of defined range. Multiple sizes of RBCs in sample; Possible Action: Verify RBC morphology d) Flag: Microcytosis; Cause: MCV lower limit range exceeded. Presence of small RBCs; Possible Action: Verify RBC morphology e) Flag: Hypochromia; Cause: MCHC lower limits exceeded; Possible Action: Verify RBC morphology f) Flag: Anemia; Cause: Hemoglobin lower limit exceeded; Possible Action: Verify RBC morphology g) Flag: Erythrocytosis; Cause: RBC upper limit exceeded; Possible Action: Verify RBC morphology h) Flag: RBC Agglutination?; Cause: Possible RBC or Platelet Clumps; Possible Action: Verify RBC morphology. Recollect sample if present. i) Flag: Turbidity/HGB Interference?; Cause: MCHC >36.5; Possible Action: Check sample for interfering substances, i.e. lipemia, icterus, cold agglutinin, and clotted sample. j) Flag: Iron Deficiency?; Cause: Sample Characteristic of iron deficiency anemia; Possible Action: Verify RBC morphology k) Flag: HGB Defect?; Cause: Sample characteristic of hemoglobin defect; Possible Action: Verify RBC morphology m) Flag: Fragments?; Cause: Presence of fragmented RBC's or large, Clumped platelets possible; Possible Action: Verify RBC morphology. If clumped platelets are present, recollect sample if possible. PLT FLAGS a) Flag: PLT Abn. Distribution; Cause: Presence of interfering particles in PLT histogram, i.e. Clumped platelets, fragmented RBC's or microcytic RBC's; Possible Action: Verify presence on slide. If RBC or platelet clumps present recollect sample if possible. Perform PLT estimate to confirm count. b) Flag: Thrombocytopenia; Cause: Low platelet count; Possible Action: Verify on slide. c) Flag: Thrombocytosis; Cause: High platelet count; Possible Action: Verify on slide d) Flag: PLT Clumps?; Cause: Presence of platelet clumps possible, specifically in Diff scattergrams; Possible Action: Verify on slide. Recollect sample if present. e) Flag: PLT Clumps (S)?; Cause: Presence of platelet -- 5 of 7 -- clumps possible, specifically in platelet histogram; Possible Action: Verify on slide. Recollect if present. 3. Review of the laboratory's records for March 2018 revealed the laboratory did not address the flags on Complete Blood Count reports for the following seven (7) of three hundred thirty three (333) patients reviewed: a) Patient 98: Flag - PLT Clumps? b) Patient 99: Flag - Monocytosis; Leukocytopenia c) Patient 100: Flag - Monocytosis d) Patient 101: Flag - HGB Defect? e) Patient 102: Flag - Microcytosis; Iron Deficiency? f) Patient 103: Flag - Iron Deficiency?; PLT Abn Distribution g) Patient 104: Flag - Left Shift? 4. Interview with Personnel 2 on December 6, 2018 confirmed the laboratory did not have a policy for CBC flags. Personnel 2 further confirmed the above patients were not addressed for flags. 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: Based on observation, record review and interview with personnel, the laboratory failed to reconstitute STA-Liatest Control and STA-Coag Control as required by the manufacturer. Findings: 1. Observation by surveyor on December 3, 2018 revealed the laboratory utilized a Stago Satellite analyzer for Coagulation testing with STA- Liatest Control for D-Dimer testing and STA-Coag Control for Prothrombin Time (PT) and Activated Partial Thromboplastin (APTT) testing. 2. Review of the STA- Liatest Control and the STA-Coag Control package inserts under Reagent Preparation and Storage revealed "Reconstitute each vial of Reagent 1 or 2 with exactly 1 ml of distilled water". 3. Observation by surveyor on December 5, 2018 at 08:00 am revealed Personnel 9 utilized water from a specimen cup labeled with Millipore DI H2O when making Quality Control for coagulation. 4. In interview on December 5, 2018 at 08:06 am, Personnel 9 stated the laboratory utilizes the Millipore water to reconstitute the coagulation controls for PT, APTT, and D-Dimer testing. 5. In interview on December 6, 2018 at 08:38 am, Personnel 10 confirmed the laboratory routinely reconstitutes controls with 1ml of deionized water, not distilled water. 6. Review of the laboratory's Task 1 and 3 forms revealed the laboratory performs 1,058 Prothrombin Time (PT), 173 Partial Thromboplastin Time (PTT), and 48 D-Dimer tests annually. 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, record review, and interview with personnel, the Laboratory -- 6 of 7 -- Director failed to ensure laboratory personnel performed testing as required. Findings: 1. The laboratory failed to ensure patient samples for Routine Chemistry, General Immunology, and Endocrinology testing are processed according to Becton Dickinson Vacutainer Blood Collection System package instructions. Refer to D5311. 2. The laboratory failed to have a detailed, written policy and procedure for addressing flags on Complete Blood Count reports. Refer to D5401. 3. The laboratory failed to reconstitute STA-Liatest Control and STA-Coag Control as required by the manufacturer. Refer to D5411. 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 personnel, the Technical Consultant failed to provide technical and scientific oversight for the laboratory. Findings: 1. The laboratory failed to ensure patient samples for Routine Chemistry, General Immunology, and Endocrinology testing are processed according to Becton Dickinson Vacutainer Blood Collection System package instructions. Refer to D5311. 2. The laboratory failed to have a detailed, written policy and procedure for addressing flags on Complete Blood Count reports. Refer to D5401. 3. The laboratory failed to reconstitute STA-Liatest Control and STA-Coag Control as required by the manufacturer. Refer to D5411. -- 7 of 7 --