Madison Parish Hospital

Summary Statement of Deficiencies D0000 A Recertification Survey was conducted September 17, 2024 through September 19, 2024 at Madison Parish Hospital - CLIA ID # 19D0464490. The laboratory was found in compliance with 42 CFR 493 Requirement for Laboratories; however, standard deficiencies were cited. 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 assessment activities for unacceptable educational challenge proficiency testing results for one (1) of two (2) events reviewed in 2024. Findings: 1. Review of the laboratory's "Proficiency Testing" policy revealed "

Summary Statement of Deficiencies D0000 A Complaint survey was performed at Madison Parish Hospital, CLIA ID # 19D0464490, on February 9, 2023 through February 10, 2023. Madison Parish Hospital was found not in compliance with the following CONDITION LEVEL DEFICIENCIES: 42 CFR 493.1100 CONDITION: Facility Administration 42 CFR 493.1217 CONDITION: Immunohematology 42 CFR 493.1441 CONDITION: Laboratories Performing High Complexity Testing, Laboratory Director 42 CFR 493.1459 CONDITION: Laboratories Performing High Complexity Testing, General Supervisor D3000 FACILITY ADMINISTRATION CFR(s): 493.1100 Each laboratory that performs nonwaived testing must meet the applicable requirements under 493.1101 through 493.1105, unless HHS approves a procedure that provides equivalent quality testing as specified in Appendix C of the State Operations Manual (CMS Pub. 7). (a) 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, record review and interview with personnel, the facility failed to ensure that procedures are established to provide quality services to the facility and the patients served by the facility. Findings include: 1. The facility failed to document complete transfusion related investigation for Patient MR#1044441. Refer to D3015. 2. The facility failed to have a procedure to report transfusion reactions to Federal and Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 13 -- State authorities. Refer to D3025 I. 3. The facility failed to establish a procedure to identify and investigate transfusion reactions for all blood products. Refer to D3025 II. 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 policy and patient records, the facility failed to document complete transfusion related investigation for Patient MR#1044441. Findings: 1. Review of the laboratory records revealed Patient MR# 1044441 received five (5) units of Packed Red Blood Cells (PRBCs) from October 25, 2021 through October 28, 2021. 2. Review of written email communication between laboratory staff, nursing staff, laboratory director and ordering physician revealed the fifth (5th) unit of Packed Red Blood Cells (PRBCs) was ordered in error, resulting in patient distress. Concern for circulatory overload was noted by the laboratory director. 3. Review of the laboratory policy revealed circulatory shock and/or circulatory collapse as well as respiratory distress listed as indicators of transfusion reactions. 4. Further review of laboratory records, patient chart review and medical staff meetings revealed no documentation for investigation of transfusion error and patient outcome. 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: I. Based on review of hospital policies and interview with personnel, the facility failed to have a procedure to report transfusion reactions to Federal and State authorities. Findings: 1. Review of the hospital policies regarding transfusion reactions and transfusion servicies, to include "Blood/Blood Components-Transfusion Reactions" and "Blood/Blood Components-Transfusion" revealed no instructions or requirements to notifiy the Food and Drug Administration (FDA), or any state or federal regulatory authority. 2. Further review of patient transfusion records revealed the following patient with negative outcome related to transfusion of blood products: Patient MR# 1044441: patient chart and laboratory records revealed the patient received four (4) units of Packed Red Blood Cells (PRBC) between October 25, 2021 through October 27, 2021 as ordered by physician. Upon patient rounding on October 28, 2021 at 16: 55 pm, an additional unit of PRBCs was ordered by the physician on written chart order. Nursing servicies processed the order through electronic medical record (EMR) to the laboratory. The additional unit was transfused October 28, 2021 at 19:55 pm. Following transfusion, patient observed and documented in respiratory distress and placed on bi-pap. Patient expired on October 31, 2021. 3. In interview with ordering physician, director of nursing and laboratory general supervisor confirmed there was no report to FDA or any other state or federal authority. In interview on February 10, -- 2 of 13 -- 2023 at 1pm, the Director of Nursing stated she was not aware any transfusion reactions or fatalities needed to be reported to the laboratory or any outside agency. II. Based on review of hospital policies and interview with personnel, the facility failed to establish a procedure to identify and investigate transfusion reactions for all blood products. Findings: 1. Review of nursing services policy and annual nursing training revealed the following two (2) different policies for transfusion reaction identification: a) Blood/Blood Components-Transfusion Reactions (adopted 04/18/2019) b) Blood /Blood Components-Transfusion (adopted 01/19/2023) 2. Further review of the identified hospital policies revealed the following: a) Blood/Blood Components- Transfusion Reactions (adopted 04/18/2019): Notification of the physician must take place for the following: Hemolytic - chills, fever, backache, restlessness, anxiety, nausea, vomiting, chest pain, tachycardia, dyspnea, hypotension, cyanosis, hemoglobinuria, hemoglobinuria, oliguria, anuria, juandice, vascular collapse; Allergic - uticaria, puritis, chills, nausea, vomiting, headache, nasal congestion, wheezing, bronchospasm, severe dyspnea, laryngeal edema, circulatory overload; Febrile - fever, chills, flushing, back pain, malaise, tachycardia, headache, confusion, nausea, vomiting; Bacterial - fever, chills, abdominal and extremity pain, vomiting, hypotension, bloody diarrhea; Circulatory Overload - cough, chest pain, dyspnea, distended neck veins, tachycardia, cyanosis, frothy sputum, pleural rales, hemoptysis b) Blood/Blood Components-Transfusion (adopted 01/19/2023): Observe for transfusion reactions up to one (1) hour after infusion of blood/blood component for the following: Rash, Flushed feeling (hot), Chills, Shortness of breath, Headache, Fever, Anxiety, Urticaria, Decreased Blood Pressure, Hematuria, Pharyngeal edema, Wheezing, Pain in lower back and legs, or other reactions. 3. Review of all laboratory records from January 2021 through December 2022 as well as chart reviews with nursing staff on February 10, 2023 revealed the following twelve (12) of seventy one (71) patients with indicators of transfusion reactions based on hospital policies with no transfusion workup: a) MR #52707 * Unit Number W069121131481 Transfusion Begin Date/Time 07/26/2021 16:40 pm Transfusion End Date/Time 07/26/2021 19:40 pm Pre-Transfusion Vital Signs documented 16:30 pm Blood Pressure 132/86; Pulse 111; Respirations 20; Temperature 97.7; SAT O2: NO ENTRY; Pain Level 0/10 1 hour Vital Signs documented at 19:30 pm Blood Pressure 126/84; Pulse 109; Respirations 20; Temperature 100.6; SAT O2: NO ENTRY; Pain Level 6/10 The patient had an increase in temperature of 2.9 degrees fahrenheit and pain level of 6/10. The facility did not define specific criteria for temperature and pain level changes. b) MR #52707 * Unit Number W069121131484 Transfusion Begin Date/Time 07/27 /2021 10:25 am Transfusion End Date/Time 07/27/2021 13:45 pm Pre-Transfusion Vital Signs documented at 10:25 am Blood Pressure 138/91; Pulse 90; Respirations 18; Temperature 97.7; O2 SAT 100%; Pain Level 0/10 Post-Transfusion Vital Signs documented at 14:45 pm Blood Pressure 133/94; Pulse 104; Respirations 18; Temperature 100.4; O2 SAT 98%; Pain Level 0/10 The patient had an increase in temperature of 2.4 degrees fahrenheit from the start of the transfusion to the end of the transfusion. The facility did not define specific criteria for temperature changes. c) MR #7882 * Unit Number W036522011990 Transfusion Begin Date/Time 03/14 /2022 16:30 pm Transfusion End Date/Time 03/14/2022 20:15 pm Pre-Transfusion Vital Signs documented at 16:15 pm Blood Pressure 130/72; Pulse 100; Respirations 20; Temperature 97.8; O2 SAT 96%; Pain Level 0/10 15 minute Vital Signs documented at 17:00 pm Blood Pressure 164/67; Pulse 101; Respirations 20; Temperature 97.8; O2 SAT 97%; Pain Level 0/10 The patient had a noted increase in Blood Pressure; however, the facility did not define specific criteria for Blood Pressure changes. 15 minute Vital Signs documented at 17:15 pm Blood Pressure 177 /80; Pulse 116; Respirations 20; Temperature 97.7; O2 SAT 98%; Pain Level 0/10 The patient had a noted increase in Blood Pressure and an increase in pulse from the -- 3 of 13 -- start of the transfusion and previous vital sign check. The facility did not define specific criteria for Blood Pressure and Pulse changes. d) MR #7882 * Unit Number W036522033384 Transfusion Begin Date/Time 03/15/2022 17:30 pm Transfusion End Date/Time 03/15/2022 Pre-Transfusion Vital Signs documented at 17:15 pm Blood Pressure 132/76; Pulse 112; Respirations 20; Temperature 97.3; O2 SAT 97%; Pain Level 0/10 5 minute (after start of Transfusion) Vital Signs documented at 17:20 pm Blood Pressure 153/77; Pulse 115; Respirations 22; Temperature 98.1; O2 SAT 98%; Pain Level: NO ENTRY The patient had an increase in Blood Pressure from the start of the transfusion; however, the facility did not define specific criteria for Blood Pressure changes. e) MR #7882 * Unit Number W036522033384 Transfusion Begin Date/Time 03/15/2022 17:30 pm Transfusion End Date/Time 03/15/2022 20:50 pm Pre-Transfusion Vital Signs documented at 17:15 pm Blood Pressure 132/76; Pulse 112; Respirations 20; Temperature 97.3; O2 SAT 97%; Pain Level 0/10 15 minute Vital Signs documented at 17:45 pm Blood Pressure 156/93; Pulse 113; Respirations 20; Temperature 97.4; O2 SAT 97%; Pain Level 0/10 The patient had an increase in Blood Pressure of 156/93 from the start of the transfusion. The facility did not define specific criteria for Blood Pressure changes. Post-Transfusion Vital Signs documented at 21:50 pm Blood Pressure 107/63; Pulse 117; Respirations 20; Temperature 97.8; O2 SAT 100%; Pain Level 0/10 The patient had a decrease in Blood Pressure from the previous vital sign as well as start of the transfusion. The facility did not define specific criteria for Blood Pressure changes. f) MR #17075 * Unit Number W036522087283 Transfusion Begin Date/Time 10/08/2022 11:15 am Transfusion End Date/Time 10/08/2022 14:05 pm Pre-Transfusion Vital Signs documented at 11: 10 am Blood Pressure 112/56; Pulse 93; Respirations 22; Temperature 98.6; O2 SAT 100%; Pain Level 1/10 1 hour Vital Signs documented at 14:05 pm Blood Pressure 117/63; Pulse 108; Respirations 20; Temperature 100.7; O2 SAT 100%; Pain Level 1 /10 The patient had an increase in temperature of 2.1 degrees fahrenheit and increase pulse from the start of the transfusion. The facility did not define specific criteria for temperature and pulse changes. Post-Transfusion Vital Signs documented at 15:05 pm Blood Pressure 140/52; Pulse 98; Respirations 22; Temperature 102.4; O2 SAT 100%; Pain Level 1/10 The patient had an increase in temperature of 3.8 degrees fahrenheit from the start of the transfusion and increase blood pressure. The facility did not define specific criteria for temperature and Blood Pressure changes. g) MR #54111 * Unit Number W036522048784 Transfusion Begin 07/21/2022 00:48 am Transfusion End 07/21/2022 04:30 am Pre-Transfusion Vital Signs documented at 00: 24 am Blood Pressure 130/77; Pulse 84; Respirations 22; Temperature 97.2; O2 SAT 100%; Pain Level 0/10 15 minute Vital Signs documented at 01:38 am Blood Pressure 120/66; Pulse 61; Respirations 16; Temperature 97.7; O2 SAT 100%; Pain Level 0/10 The patient had a decrease in Blood Pressure of 120/66 from start of transfusion. The facility did not define specific criteria for Blood Pressure changes. 30 minute Vital Signs documented at 02:08 am Blood Pressure 135/69; Pulse 62; Respirations 16; Temperature 97.7; O2 SAT 100%; Pain Level 0/10 The patient had an increase in Blood Pressure of 135/69 and decrease in Respirations of 16 from last documentation of vital signs. The facility did not define specific criteria for Blood Pressure and Respiration changes. 30 minute Vital Signs documented at 02:38 am Blood Pressure 148/76; Pulse 91; Respirations 18; Temperature 97.8; O2 SAT 100%; Pain Level 0/10 The patient had an increase in Blood Pressure of 148/76 and an increase in Pulse of 91 from last documentation of vital signs. The facility did not define specific criteria for Blood Pressure and Pulse changes. 1 hour Vital Signs documented at 03:38 am Blood Pressure 135/75; Pulse 60; Respirations 18; Temperature 97.8; O2 SAT 100%; Pain Level 0/10 The patient had a decrease in Pulse of 60 from last documentation of vital signs. The facility did not define specific criteria for Pulse changes. h) MR #54111 * Unit Number W036522061302 Transfusion Begin 07/21/2022 05:50 am Transfusion -- 4 of 13 -- End 07/21/2022 09:40 am Pre-Transfusion Vital Signs documented at 05:24 am Blood Pressure 163/86; Pulse 94; Respirations 18; Temperature 97.6; O2 SAT 100%; Pain Level 0/10 5 minutes (after start of transfusion) Vital Signs documented at 05:55 am Blood Pressure 138/83; Pulse 89; Respirations 18; Temperature 97.7; O2 SAT 100%; Pain Level 0/10 The patient had a decrease in Blood Pressure and Pulse from the start of the transfusion. The facility did not define specific criteria for Blood Pressure and Pulse changes. 15 minutes Vital Signs documented at 06:10 am Blood Pressure 120 /69; Pulse 73; Respirations 16; Temperature 97.7; O2 SAT 100%; Pain Level 0/10 The patient had a continued decrease in Blood Pressure and Pulse from the start of the transfusion. The facility did not define specific criteria for Blood Pressure and Pulse changes. 1 hour Vital Signs documented at 9:40 am Blood Pressure 112/66; Pulse 95; Respirations 16; Temperature 98.0; O2 SAT 100%; Pain Level 0/10 The patient had a continued decrease in Blood Pressure from the start of the transfusion. The facility did not define specific criteria for Blood Pressure changes. Post-Transfusion Vital Signs documented at 10:40 am Blood Pressure 104/68; Pulse 83; Respirations 17; Temperature 97.9; O2 SAT 100%; Pain Level 0/10 The patient had a continued decrease in Blood Pressure from the start of the transfusion. The facility did not define specific criteria for Blood Pressure changes. i) MR #54111 * Unit Number W036522060578 Transfusion Begin 07/21/2022 16:50 Transfusion End 07/21/2022 20:00 Pre-Transfusion Vital Signs documented at 16:25 pm Blood Pressure 128/78; Pulse 76; Respirations 16; Temperature 98.0; O2 SAT 100%; Pain Level 0/10 15 minute Vital Signs documented at 17:40 pm Blood Pressure 138/77; Pulse 76; Respirations 18; Temperature 97.5; O2 SAT 100%; Pain Level 0/10 30 minute Vital Signs documented at 18:10 pm Blood Pressure 118/68; Pulse 88; Respirations 16; Temperature 98.3; O2 SAT 99%; Pain Level 0/10 The patient had a decrease in Blood Pressure and an increase in Pulse from start of transfusion. The facillity did not define specific criteria for Blood Pressure and Pulse changes. 30 minute Vital Signs documented at 18:40 pm Blood Pressure 110/78; Pulse 85; Respirations 18; Temperature 97.5; O2 SAT 100%; Pain Level 0/10 The patient had a continued decrease in Blood Pressure from start of transfusion. The facillity did not define specific criteria for Blood Pressure changes. 1 hour Vital Signs documented at 19:40 pm Blood Pressure 129/71; Pulse 63; Respirations 16; Temperature 97.7; O2 SAT 100%; Pain Level 0/10 The patient had a decrease in Pulse. The facillity did not define specific criteria for Pulse changes. j) MR# 14112 Unit Number W036522053628 Transfusion Begin 09/26/2022 14:00 pm Transfusion End 09/26 /2022 17:40 pm Pre-Transfusion Vital Signs documented at 13:45 pm Blood Pressure 141/77; Pulse 104; Respirations 20; Temperature 98.2; O2 SAT 96%; Pain Level 0/10 5 minute (after start of transfusion) Vital Signs documented at 14:05 pm Blood Pressure 141/77; Pulse 96; Respirations 20; Temperature 101.8; O2 SAT 96%; Pain Level 0/10 The patient had an increase in temperature of 3.6 degrees fahrenheit . The facility did not define specific criteria for temperature changes. k) MR# 1044113 Unit Number W069121114512 Transfusion Begin 05/07/2021 14:35 pm Transfusion End 05/07/2021 18:15 pm Pre-Transfusion Vital Signs documented at 14:15 pm Blood Pressure 120/60; Pulse 97; Respirations 24; Temperature 97.9; O2 SAT 95%; Pain Level 0/10 15 minute Vital Signs documented at 15:25 pm Blood Pressure 128/60; Pulse 79; Respirations 18; Temperature 98.0; O2 SAT: NO ENTRY; Pain Level: NO ENTRY The patient had a decrease in pulse of 79 from the start of the transfusion. The facility did not define specific criteria for pulse changes. Missing documentation of vital signs from 15:25pm - 19:15pm. Post-Transfusion Vital Signs documented at 19:15 pm Blood Pressure 120/62; Pulse 96; Respirations 30; Temperature 100.3; O2 SAT 85%; Pain Level 0/10 The patient had an increase in temperature of 2.4 degrees fahrenheit and a decrease in O2 Sat of 85% from the start of the transfusion. The facility did not define specific criteria for temperature and O2 SAT changes. l) MR# -- 5 of 13 -- 49786 Unit Number W069121135687 Transfusion Begin 08/28/2021 21:10 pm Transfusion End 08/29/2021 0059 am Pre-Transfusion Vital Signs documented at 21: 04 pm Blood Pressure 128/78; Pulse 84; Respirations 18; Temperature 100.6; O2 SAT: NO ENTRY; Pain Level 0/10 5 minute vital signs documented at 21:15 pm Blood Pressure 118/73; Pulse 83; Respirations 18; Temperature 99.8; O2 SAT: NO ENTRY; Pain Level 0/10 Missing vital sign documentation throughout transfusion. 1 hour Vital Signs documented at 19:40 pm Blood Pressure 130/89; Pulse 106; Respirations 20; Temperature 101.1; SAT O2: NO ENTRY; Pain Level 6/10 The patient had an increase in temperature, increase pulse and increase pain level of 6/10. The facility did not define specific criteria for temperature, pulse or pain changes. 4. In interview with Director of Nursing on February 10, 2023 at time of chart reviews revealed nursing services uses their own transfusion reaction policy (Blood Transfusion Record) and notifies the physician when a sign or symptom of transfusion reaction is identified. The Director of Nursing further stated that ordering physician would determine whether to treat the patient, for example with Tylenol, Benadryl, or pause the transfusion, but the laboratory was not notified or involved. She further stated she was not aware the laboratory should be notified. The Director of Nursing confirmed the transfusion policy does not specify the changes in vital signs that would indicate transfusion reactions, it is at the discretion of the nursing and physicians treating the patients. D5026 IMMUNOHEMATOLOGY CFR(s): 493.1217 If the laboratory provides services in the specialty of Immunohematology, the laboratory must meet the requirements specified in 493.1230 through 493.1256, 493. 1271, and 493.1281 through 493.1299. This CONDITION is not met as evidenced by: Based on observation by surveyors, review of laboratory policy, patient records, and interview with personnel, the laboratory failed to provide quality services for the specialty of Immunohematology. Findings: 1. The laboratory failed to have a system in place to identify problems that occurred as a result of breakdown in communication between the laboratory and nursing personnel responsible for transfusion services within the hospital. Refer to D5207. 2. The laboratory failed to ensure that transfusion reactions according to the laboratory policy were investigated for twelve (12) of seventy one (71) blood products issued in the facility from January 2021 through December 2022. Refer to D5559 I. 3. The laboratory failed to make recommendations to the medical staff regarding improvements in transfusion procedures. Refer to D5559 II. 4. The laboratory's quality assessment monitors failed to correct issues identified with the analytic system. Refer to D5793. D5207 COMMUNICATIONS CFR(s): 493.1234 The laboratory must have a system in place to identify and document problems that occur as a result of a breakdown in communication between the laboratory and an authorized person who orders or receives test results. This STANDARD is not met as evidenced by: Based on review of laboratory and hospital policies, patient records, documentation -- 6 of 13 -- provided by the laboratory and interview with laboratory and hospital personnel, the laboratory failed to have a system in place to identify problems that occurred as a result of breakdown in communication between the laboratory and nursing personnel responsible for transfusion services within the hospital. Findings: 1. Review of the "Blood Transfusion Records" policy provided by nursing services, implemented on April 15, 2021, revealed the following as the only instruction to nursing personnel monitoring patients during transfusion regarding communication with the laboratory: "Procedure: Observation of adverse effects during administration with appropriate actions if such effects should occur (i.e., stopping of administration, notification of physician and the Blood Bank). A transfusion reaction record shall be completed." 2. In interview on February 9, 2023 at 11:28 am, the Director of Nursing stated nursing would only notify the laboratory if the ordering physician initiated a transfusion reaction. 3. Review of the laboratory "Blood Bank Transfusion Criteria Policy" revealed "At MPH, if a patient experiences signs and/or symptoms during a transfusion of blood or blood products that are unrelated to their present illnesses, a transfusion reaction workup is initiated by the nursing services utilizing the "Nursing Services Transfusion Reaction Form". The laboratory is notified by the nursing services or physician to perform the laboratory portion of the workup using the "Lab Transfusion Reaction Form". Most suspected transfusion reaction workups are intiated by the nursing services with communication with the attending physician. Laboratory personnel may initiate a transfusion reaction workup if indicated by suspected hemolysis within the unit or subsequent lab test results, including possible infection or sepsis." 4. In inteview on February 9, 2023 at 10:30 am, the laboratory general supervisors confirmed there were no specific processes in place for nursing services and laboratory communication during transfusion of blood products. 5. Review of patient transfusion records from January 2021 through December 2022 revealed the following patient with identified negative outcome due to communication breakdown between ordering physician, nursing services, and the laboratory: Patient MR #1044441 6. Further review of Patient MR #1044441 chart and laboratory records revealed the patient received four (4) units of Packed Red Blood Cells (PRBCS) between October 25, 2021 through October 27, 2021 as ordered by physician. Upon Patient rounding on October 28, 2021 at 16:55 pm an additional - fifth (5) unit of PRBC was ordered by physician. Nursing services processed order to laboratory. The additional unit was transfused October 28, 2021 at 19:55 pm. Following transfusion, patient observed and documented in respiratory distress and placed on bi-pap. 7. Review of laboratory email correspondance between the laboratory director and general supervisor on November 1, 2021 at 11:22 am provided to surveyors revealed the laboratory phlebotomist upon morning blood collection on Friday, October 29, 2021 noticed Patient MR# 1044441 had difficulty breathing, wheezing, and flushed face. The phlebotomist reported patient condition to the nursing station along with notification to laboratory general supervisor. 8. Further review of laboratory email correspondance between the laboratory director and general supervisor on November 1, 2021 at 1:35 pm revealed general supervisor received a phone call from the attending physician concerning Patient MR# 1044441. The attending physician questioned why the laboratory director was notified about Patient MR# 1044441 condition. General supervisor informed the attending physician that Patient MR# 1044441 received five (5) units of PRBCs and that the patient was placed on bi-pap following transfusions. The general supervisor informed the attending physician that this was something that the laboratory reports to the laboratory director. The attending physician said that the patient only received three (3) units of PRBCs and that he did not order five (5) units. General supervisor referred the attending physician to speak with the nursing staff responsible for processing transfusion orders. 9. In interview on February 10, 2023 at 2:02 pm with the ordering physician confirmed that Patient MR# -- 7 of 13 -- 1044441 was transfused with more units of PRBCs than intended and the breakdown between laboratory and nursing contributed to this error. Ordering physician further stated nursing should have known his order was meant for the fourth unit of PRBCs, not for an additional fifth unit of PRBC. 10. Interview with laboratory general supervisors and director of nursing confirmed no changes to processes or communication had been implemented after the incident with Patient MR# 1044441. D5559 IMMUNOHEMATOLOGY CFR(s): 493.1271(e)(f) (e) Investigation of transfusion reactions. (e)(1) According to its established procedures, the laboratory that performs compatibility testing, or issues blood or blood products, must promptly investigate all transfusion reactions occurring in facilities for which it has investigational responsibility and make recommendations to the medical staff regarding improvements in transfusion procedures. (e)(2) The laboratory must document, as applicable, that all necessary remedial actions are taken to prevent recurrences of transfusion reactions and that all policies and procedures are reviewed to assure they are adequate to ensure the safety of individuals being transfused. (f) Documentation. The laboratory must document all control procedures performed, as specified in this section. This STANDARD is not met as evidenced by: I. Based on review of laboratory policy and blood bank records, patient transfusion records as well as interview with personnel, the laboratory failed to ensure that transfusion reactions according to the laboratory policy were investigated for twelve (12) of seventy one (71) blood products issued in the facility from January 2021 through December 2022. Findings: 1. Review of the laboratory blood bank records revealed the zero (0) transfusion reaction workups were initiated in 2021 and 2022. 2. Review of the laboratory policy "Evaluation of a Suspected Acute Transfusion Reaction" revealed the following indicators determined by the laboratory as indicators of transfusion reaction: a) Fever with or without body chills (2 degrees fahrenheit increase in body temperature) b) Shaking chills (rigors) with or without fever c) Pain at infusion siteor in chest, abdomen, or flanks d) Blood pressure changes, usually acute, either hypertension or hypotension e) Respiratory distress including dyspnea, tachypnea, wheezing, or hypoxemia f) Skin changes including uticaria, puritis (itching), flushing or localized edema (angioedemia) g) Nausea with or without vomiting h) Darkened urine or jaundice i) Bleeding or other manisfestations of a consumptive coagulopathy 3. Review of all laboratory records as well as chart reviews with nursing staff on February 10, 2023 revealed the following twelve (12) of seventy one (71) patients with indicators of transfusion reactions: a) MR #52707 * Unit Number W069121131481 Transfusion Begin Date/Time 07/26/2021 16:40 pm Transfusion End Date/Time 07/26/2021 19:40 pm Pre-Transfusion Vital Signs documented 16:30 pm Blood Pressure 132/86; Pulse 111; Respirations 20; Temperature 97.7; SAT O2: NO ENTRY; Pain Level 0/10 1 hour Vital Signs documented at 19:30 pm Blood Pressure 126/84; Pulse 109; Respirations 20; Temperature 100.6; SAT O2: NO ENTRY; Pain Level 6/10 The patient had an increase in temperature of 2.9 degrees fahrenheit and increase pain level of 6/10. The facility did not define specific criteria for pain level changes. b) MR #52707 * Unit Number W069121131484 Transfusion Begin Date/Time 07/27/2021 10:25 am Transfusion End Date/Time 07/27/2021 13:45 pm Pre-Transfusion Vital Signs documented at 10:25 am Blood Pressure 138/91; Pulse 90; Respirations 18; Temperature 97.7; O2 SAT 100%; Pain Level 0/10 Post-Transfusion Vital Signs -- 8 of 13 -- documented at 14:45 pm Blood Pressure 133/94; Pulse 104; Respirations 18; Temperature 100.4; O2 SAT 98%; Pain Level 0/10 The patient had an increase in temperature of 2.4 degrees fahrenheit from the start of the transfusion to the end of the transfusion. c) MR #7882 * Unit Number W036522011990 Transfusion Begin Date /Time 03/14/2022 16:30 pm Transfusion End Date/Time 03/14/2022 20:15 pm Pre- Transfusion Vital Signs documented at 16:15 pm Blood Pressure 130/72; Pulse 100; Respirations 20; Temperature 97.8; O2 SAT 96%; Pain Level 0/10 15 minute Vital Signs documented at 17:00 pm Blood Pressure 164/67; Pulse 101; Respirations 20; Temperature 97.8; O2 SAT 97%; Pain Level 0/10 The patient had an increase in Blood Pressure of 164/67. The facility did not define specific criteria for Blood Pressure changes. 15 minute Vital Signs documented at 17:15 pm Blood Pressure 177 /80; Pulse 116; Respirations 20; Temperature 97.7; O2 SAT 98%; Pain Level 0/10 The patient had an increase in Blood Pressure and an increase in Pulse from the start of the transfusion. The facility did not define specific criteria for Blood Pressure and Pulse changes. d) MR #7882 * Unit Number W036522033384 Transfusion Begin Date /Time 03/15/2022 17:30 pm Transfusion End Date/Time 03/15/2022 Pre-Transfusion Vital Signs documented at 17:15 pm Blood Pressure 132/76; Pulse 112; Respirations 20; Temperature 97.3; O2 SAT 97%; Pain Level 0/10 5 minute (after start of Transfusion) Vital Signs documented at 17:20 pm Blood Pressure 153/77; Pulse 115; Respirations 22; Temperature 98.1; O2 SAT 98%; Pain Level: NO ENTRY The patient had an increase in Blood Pressure from the start of the transfusion. The facility did not define specific criteria for Blood Pressure changes. e) MR #7882 * Unit Number W036522033384 Transfusion Begin Date/Time 03/15/2022 17:30 pm Transfusion End Date/Time 03/15/2022 20:50 pm Pre-Transfusion Vital Signs documented at 17:15 pm Blood Pressure 132/76; Pulse 112; Respirations 20; Temperature 97.3; O2 SAT 97%; Pain Level 0/10 15 minute Vital Signs documented at 17:45 pm Blood Pressure 156/93; Pulse 113; Respirations 20; Temperature 97.4; O2 SAT 97%; Pain Level 0/10 Post-Transfusion Vital Signs documented at 21:50 pm Blood Pressure 107/63; Pulse 117; Respirations 20; Temperature 97.8; O2 SAT 100%; Pain Level 0/10 The patient had both an increase and decrease in Blood Pressure from the start of the transfusion. The facility did not define specific criteria for Blood Pressure changes. f) MR #17075 * Unit Number W036522087283 Transfusion Begin Date/Time 10/08/2022 11:15 am Transfusion End Date/Time 10/08 /2022 14:05 pm Pre-Transfusion Vital Signs documented at 11:10 am Blood Pressure 112/56; Pulse 93; Respirations 22; Temperature 98.6; O2 SAT 100%; Pain Level 1/10 1 hour Vital Signs documented at 14:05 pm Blood Pressure 117/63; Pulse 108; Respirations 20; Temperature 100.7; O2 SAT 100%; Pain Level 1/10 The patient had an increase in temperature of 2.1 degrees fahrenheit and increase pulse from the start of the transfusion. The facility did not define specific criteria for pulse changes. Post- Transfusion Vital Signs documented at 15:05 pm Blood Pressure 140/52; Pulse 98; Respirations 22; Temperature 102.4; O2 SAT 100%; Pain Level 1/10 The patient had an increase in temperature of 3.8 degrees fahrenheit and increase Blood Pressure from the start of the transfusion. The facility did not define specific criteria Blood Pressure changes. g) MR #54111 * Unit Number W036522048784 Transfusion Begin 07/21 /2022 00:48 am Transfusion End 07/21/2022 04:30 am Pre-Transfusion Vital Signs documented at 00:24 am Blood Pressure 130/77; Pulse 84; Respirations 22; Temperature 97.2; O2 SAT 100%; Pain Level 0/10 15 minute Vital Signs documented at 01:38 am Blood Pressure 120/66; Pulse 61; Respirations 16; Temperature 97.7; O2 SAT 100%; Pain Level 0/10 30 minute Vital Signs documented at 02:08 am Blood Pressure 135/69; Pulse 62; Respirations 16; Temperature 97.7; O2 SAT 100%; Pain Level 0/10 30 minute Vital Signs documented at 02:38 am Blood Pressure 148/76; Pulse 91; Respirations 18; Temperature 97.8; O2 SAT 100%; Pain Level 0/10 1 hour Vital Signs documented at 03:38 am Blood Pressure 135/75; Pulse 60; Respirations -- 9 of 13 -- 18; Temperature 97.8; O2 SAT 100%; Pain Level 0/10 The patient had changes in Blood Pressure, Pulse, and respiration throughout transfusion. The facility did not define specific criteria for Blood Pressure, Pulse or respiration changes. h) MR #54111 * Unit Number W036522061302 Transfusion Begin 07/21/2022 05:50 am Transfusion End 07/21/2022 09:40 am Pre-Transfusion Vital Signs documented at 05: 24 am Blood Pressure 163/86; Pulse 94; Respirations 18; Temperature 97.6; O2 SAT 100%; Pain Level 0/10 5 minutes (after start of transfusion) Vital Signs documented at 05:55 am Blood Pressure 138/83; Pulse 89; Respirations 18; Temperature 97.7; O2 SAT 100%; Pain Level 0/10 15 minutes Vital Signs documented at 06:10 am Blood Pressure 120/69; Pulse 73; Respirations 16; Temperature 97.7; O2 SAT 100%; Pain Level 0/10 1 hour Vital Signs documented at 9:40 am Blood Pressure 112/66; Pulse 95; Respirations 16; Temperature 98.0; O2 SAT 100%; Pain Level 0/10 Post- Transfusion Vital Signs documented at 10:40 am Blood Pressure 104/68; Pulse 83; Respirations 17; Temperature 97.9; O2 SAT 100%; Pain Level 0/10 The patient had a decrease in Blood Pressure from the start of the transfusion, and changes in pulse throughout the transfusion. The facility did not define specific criteria for Blood Pressure or pulse changes. i) MR #54111 * Unit Number W036522060578 Transfusion Begin 07/21/2022 16:50 Transfusion End 07/21/2022 20:00 Pre- Transfusion Vital Signs documented at 16:25 pm Blood Pressure 128/78; Pulse 76; Respirations 16; Temperature 98.0; O2 SAT 100%; Pain Level 0/10 15 minute Vital Signs documented at 17:40 pm Blood Pressure 138/77; Pulse 76; Respirations 18; Temperature 97.5; O2 SAT 100%; Pain Level 0/10 30 minute Vital Signs documented at 18:10 pm Blood Pressure 118/68; Pulse 88; Respirations 16; Temperature 98.3; O2 SAT 99%; Pain Level 0/10 30 minute Vital Signs documented at 18:40 pm Blood Pressure 110/78; Pulse 85; Respirations 18; Temperature 97.5; O2 SAT 100%; Pain Level 0/10 The patient had a decrease in Blood Pressure from start of transfusion. The facillity did not define specific criteria for Blood Pressure changes. 1 hour Vital Signs documented at 19:40 pm Blood Pressure 129/71; Pulse 63; Respirations 16; Temperature 97.7; O2 SAT 100%; Pain Level 0/10 The patient had a decrease in Pulse from start of transfusion. The facillity did not define specific criteria for Pulse changes. j) MR# 14112 Unit Number W036522053628 Transfusion Begin 09/26/2022 14:00 pm Transfusion End 09/26/2022 17:40 pm Pre-Transfusion Vital Signs documented at 13:45 pm Blood Pressure 141/77; Pulse 104; Respirations 20; Temperature 98.2; O2 SAT 96%; Pain Level 0/10 5 minute (after start of transfusion) Vital Signs documented at 14:05 pm Blood Pressure 141/77; Pulse 96; Respirations 20; Temperature 101.8; O2 SAT 96%; Pain Level 0/10 The patient had an increase in temperature of 3.6 degrees fahrenheit. k) MR# 1044113 Unit Number W069121114512 Transfusion Begin 05/07/2021 14:35 pm Transfusion End 05/07 /2021 18:15 pm Pre-Transfusion Vital Signs documented at 14:15 pm Blood Pressure 120/60; Pulse 97; Respirations 24; Temperature 97.9; O2 SAT 95%; Pain Level 0/10 15 minute Vital Signs documented at 15:25 pm Blood Pressure 128/60; Pulse 79; Respirations 18; Temperature 98.0; O2 SAT: NO ENTRY; Pain Level: NO ENTRY The patient had a decrease in pulse from the start of the transfusion. The facility did not define specific criteria for pulse changes. Post-Transfusion Vital Signs documented at 19:15 pm Blood Pressure 120/62; Pulse 96; Respirations 30; Temperature 100.3; O2 SAT 85%; Pain Level 0/10 The patient had an increase in temperature of 2.4 degrees fahrenheit and a decrease in O2 Sat from the start of the transfusion. The facility did not define specific criteria O2 SAT changes. l) MR# 49786 Unit Number W069121135687 Transfusion Begin 08/28/2021 21:10 pm Transfusion End 08/29/2021 0059 am Pre-Transfusion Vital Signs documented at 21: 04 pm Blood Pressure 128/78; Pulse 84; Respirations 18; Temperature 100.6; O2 SAT: NO ENTRY; Pain Level 0/10 5 minute vital signs documented at 21:15 pm Blood Pressure 118/73; Pulse 83; Respirations 18; Temperature 99.8; O2 SAT: NO -- 10 of 13 -- ENTRY; Pain Level 0/10 1 hour Vital Signs documented at 19:40 pm Blood Pressure 130/89; Pulse 106; Respirations 20; Temperature 101.1; SAT O2: NO ENTRY; Pain Level 6/10 The patient had changes in Blood Pressure throughout the transfusion, and increase of pulse, respiration and pain level. The facility did not define specific criteria for Blood Pressure, pulse, respiration or pain level changes. 4. In interview with Director of Nursing on February 10, 2023 at time of chart reviews revealed nursing services uses their own transfusion reaction policy (Blood Transfusion Record) and notifies the physician when a sign or symptom of transfusion reaction is identified. The Director of Nursing further stated that ordering physician would determine whether to treat the patient, for example with Tylenol, Benadryl, or pause the transfusion, but the laboratory was not notified or involved. She further stated she was not aware the laboratory should be notified. 5. In interview with General Supervisor 1&2 on February 9, 2023 revealed the laboratory reviews all blood products transfused, but the laboratory does not access nursing charts for full transfusion records. II. Based on review of laboratory and nursing policies as well as interview with personnel, the laboratory failed to make recommendations to the medical staff regarding improvements in transfusion procedures. Findings: 1. Review of three (3) different hospital procedures (Evaluation of a Suspected Acute Transfusion Reaction, Blood/Blood Components - Transfusion Reactions, Blood /Blood Components - Transfusion) revealed separate parameters for identification of indicators of transfusion reactions. 2. Review of email communications between laboratory staff and director of nursing revealed notification of different policies on November 9, 2022 by email. 3. In interview on February 10, 2023 the laboratory general supervisors and director of nursing confirmed there were different policies throughout the facility, expectations for identification of transfusion reactions, and how to communicate these indicators between laboratory and transfusion servicies. D5793 ANALYTIC SYSTEMS QUALITY ASSESSMENT CFR(s): 493.1289(b)(c) (b) The analytic systems quality assessment must include a review of the effectiveness of

Summary Statement of Deficiencies D0000 A Recertification survey was performed on November 14, 2022 through November 17, 2022 at Madison Parish Hospital, CLIA # 19D0464490. Madison Parish Hospital 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 155D report and interview with personnel, the laboratory failed to successfully perform in Compatilbilty Testing proficency testing events in 2021. 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 -- Findings: 1. The laboratory failed to achieve a satisfactory score of 100% for two (2) of five (5) proficiency testing events in 2021 and 2022 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), the CASPER 155D report, and interview with personnel, the laboratory failed to achieve a satisfactory score of 100% for two (2) of five (5) proficiency testing events in 2021 and 2022 resulting in an initial unsuccessful performance for Compatibility Testing. Findings: 1. Review of the CASPER 155D report revealed the laboratory received the following scores of less than 100% for Compatibility Testing for the following two (2) of five (5) consecutive testing events: a) 2021 event 2 for Compatibility Testing: score of 80% b) 2021 event 3 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 in 2021: a) API 2021 Immunology/Immunohematology 2nd event: score of 80% for sample SER-10 (unacceptable) b) API 2021 Immunology/Immunohematology 3rd event: score of 80% for sample SER-12 (unacceptable) 3. In interview on November 15, 2022 at 1115 am, Technical Consultant 2 confirmed the laboratory proficiency testing events were unsuccessful and that remedial actions for the two (2) events in 2021 were already performed. D5559 IMMUNOHEMATOLOGY CFR(s): 493.1271(e)(f) (e) Investigation of transfusion reactions. (e)(1) According to its established procedures, the laboratory that performs compatibility testing, or issues blood or blood products, must promptly investigate all transfusion reactions occurring in facilities for which it has investigational responsibility and make recommendations to the medical staff regarding improvements in transfusion procedures. (e)(2) The laboratory must document, as applicable, that all necessary remedial actions are taken to prevent recurrences of transfusion reactions and that all policies and procedures are reviewed to assure they are adequate to ensure the safety of individuals being transfused. (f) Documentation. The laboratory must document all control procedures performed, as specified in this section. This STANDARD is not met as evidenced by: Based on review of policies, quality control records, patient transfusion logs and interview with personnel, the laboratory failed to document quality control for blood bank testing prior to patient testing. Findings: 1. Review of the laboratory's Blood Bank quality control (QC) policy revealed the laboratory performs QC each day of blood bank testing which covers a twenty-four (24) hour period. 2. Review of the laboratory's blood bank QC records and patient transfusion logs from July 2021 -- 2 of 3 -- through October 2022 revealed the laboratory did not perform QC for the following: a) American Proficiency Testing (API) proficiency testing event performed on August 6, 2022 at 20:00 pm - Last documented QC performed August 5, 2022 18:30 pm 3. In interview on November 15, 2022 at 11:50 am, General Supervisor 1 stated that the quality assurance (QA) checks performed for the month of August 2022 obviously missed that QC was not documented. General Supervisor 1 confirmed the laboratory did not have documentation of QC for the sample identified. 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 review of laboratory proficiency testing records and interview with personnel, the laboratory failed to provide overall management and direction. Findings: 1. The Laboratory Director failed to ensure the laboratory performed

Summary Statement of Deficiencies D0000 A Recertification Survey was performed on April 26, 2021 through April 29, 2021 at Madison Parish Hospital, CLIA ID # 19D0464490. 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 record review and interview with personnel, the laboratory failed to document quarterly alarm check on the circular chart as required by laboratory policy. Findings: 1. Review of the laboratory's policy for "Blood Bank Refrigeration Alarm Check" revealed "Ensure a spike is registered on the chart, write on chart: 'Manual Alarm Check,' date, time, and tech initials". 2. Review of the laboratory's "Manual Alarm Check Worksheet" for 2020 revealed the laboratory performed an alarm check on July 2, 2020; however, the laboratory did not document information required by policy on the circular chart to include: a) "Manual Alarm Check" b) Date and Time c) Tech initials 3. In interview on April 28, 2021 at 1:30 pm, Personnel 3 confirmed the manual alarm check was not documented on the circular chart for the above date. 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 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 -- 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 utilize acceptable donors as required by the manufacturer to verify reference interval and establish normal Prothrombin Time (PT) mean. Findings: 1. Observation by surveyor during the laboratory tour on April 26, 2021 at 9:16 am revealed the laboratory utilized the Stago STA Compact Max analyzer for Prothrombin Time (PT) and International Normalized Ratio (INR) testing. 2. Review of the CLSI 28-A3 recommendations for donor requirements revealed the following requirements for donor testing: a) Minimum of 120 donors b) Use well screened samples c) No medications (CLSI states "including oral contraceptives and estrogen") d) Healthy (CLSI states "Donors should have no pathological conditions or include inpatient or pre surgery patients") e) Should include samples that are representative of your patient population (CLSI states "The donors used should span the adult age range within a fairly even distribution of males and females") f) CLSI also includes that samples should be collected over a period of time and include variability ao age of reagents. 3. Review of the laboratory's policy "Verification or Establishing Assay Reference Ranges" revealed the laboratory did not have written, detailed instructions for establishing a normal donor population. 4. Review of the laboratory's "Selection of Individuals for Reference Range Studies" revealed the following questionnaire: a) Do you consider yourself to be healthy? b) Have you recently been ill? When? c) Details of recent illness... d) Are you taking any prescribed or over the counter medications, including aspirin? Please list all medications... e) Do you have a medical condition that requires on going treatment by a physician? If yes, please describe... f) Have you recently exercised? 5. Further review of the laboratory's "Selection of Individuals for Reference Range Studies" revealed the laboratory did not include the following criteria: a) Not taking any aspirin related products b) Not taking any oral contraceptives or estrogen 6. Review of the laboratory's donor questionnaires revealed the laboratory utilized the following donors who did not meet the acceptable criteria: a) PID 49995: documented taking oral contraceptives b) PID 48531: documented taking aspirin related products 7. In interview on April 28, 2021 at 3:35 pm, Personnel 3 stated she was unaware that the above donors listed medications that were unacceptable. 8. Review of the Task 1 & 3 form provided to surveyor revealed the laboratory performs 722 PT/INR 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 direct observation by surveyor, record review, and interview with personnel, the Laboratory Director failed to ensure laboratory personnel performed testing as required. Findings: 1. The laboratory failed to document quarterly alarm check on the -- 2 of 3 -- circular chart as required by laboratory policy. Refer to D5401. 2. The laboratory failed to utilize acceptable donors as required by the manufacturer to verify reference interval and establish normal Prothrombin Time (PT) mean. 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 by surveyor, record review, and interview with personnel, the Technical Consultant failed to provide technical and scientific oversight to the laboratory. Findings: 1. The laboratory failed to document quarterly alarm check on the circular chart as required by laboratory policy. Refer to D5401. 2. The laboratory failed to utilize acceptable donors as required by the manufacturer to verify reference interval and establish normal Prothrombin Time (PT) mean. Refer to D5411. -- 3 of 3 --

Summary Statement of Deficiencies D0000 A CERTIFICATION SURVEY was performed at Madison Parish Hospital - CLIA # 19D0464490 on July 23, 2018 through July 27, 2018. The laboratory was found in compliance with 42 CFR 493 Requirements for Laboratories; however, standard level deficiencies were cited. D3033 RETENTION REQUIREMENTS CFR(s): 493.1105(a)(3)(i) In addition, the laboratory must retain records of test system performance specifications that the laboratory establishes or verifies under 493.1253 for the period of time the laboratory uses the test system but no less than 2 years. This STANDARD is not met as evidenced by: Based on record review and interview with personnel, the laboratory failed to retain the in-house data to support the precision studies for the STA Compact Max Stago analyzer for Coagulation testing. Findings: 1. Review of performance study records for the STA Compact Max Stago Coagulation analyzer revealed the laboratory performed studies for accuracy, precision, reference range and reportable range; However, the laboratory failed to retain the in-house data to support day-to-day precision and operator variance studies from October 30, 2017 through November 1, 2017. 2. In interview on July 25, 2018 at 3:47 pm, Personnel 3 confirmed the laboratory did not retain the supporting data for complete precision studies. D5447 CONTROL PROCEDURES CFR(s): 493.1256(d)(3)(i)(g) Unless CMS Approves a procedure, specified in Appendix C of the State Operations Manual (CMS Pub. 7), that provides equivalent quality testing, the laboratory must-- At least once a day patient specimens are assayed or examined perform the following for-- Each quantitative procedure, include two control materials of different 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 -- concentrations; (g) The laboratory must document all control procedures performed. This STANDARD is not met as evidenced by: **REPEAT DEFICIENCY** Based on observation, record review, and interview with personnel, the laboratory failed to perform