Baylor Scott & White Surgical Hospital

Summary Statement of Deficiencies D0000 The laboratory was found to be in substantial compliance with CLIA regulations 42 CFR Part 493. Standard level deficiencies were cited. 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 facility and laboratory policies, blood transfusion record, and confirmed in interview, the facility failed to have defined criteria to promptly identify, investigate, and report blood and blood product transfusion reactions. Findings included: 1. Review of the facility's policy "Blood Administration Guidelines P&P#: 2.008" (reviewed 08/2022) revealed: "TRANSFUSION REACTION ... Notification of the physician and blood bank/lab must take place for the following types of reactions: TYPE Hemolytic ... SIGNS AND SYMPTOMS Chills, Temperature 2 degrees Fahrenheit above baseline, backache, restlessness, anxiety, nausea, vomiting, chest pain, tachycardia, dyspnea, hypotension, cyanosis, hemoglobinemia, hemoglobinuria, oliguria, anuria, jaundice, vascular collapse. TYPE Allergic ... SIGNS AND SYMPTOMS Urticaria, pruritus, chills, nausea, vomiting, headache, nasal congestion, wheezing. In more severe reactions: bronchospasm, severe dyspnea, laryngeal edema, circulatory collapse. TYPE Febrile ... SIGNS AND SYMPTOMS Temperature 2 degrees Fahrenheit above baseline, chills, flushing, back pain, malaise, tachycardia, headache, confusion, nausea and vomiting [sic] TYPE Bacterial ... SIGNS AND SYMPTOMS Temperature 2 degrees Fahrenheit above baseline, chills, abdominal and extremity pain, vomiting, hypotension, bloody diarrhea. TYPE Circulatory Overload ... SIGNS AND SYMPTOMS Cough, chest pain, dyspnea, Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 4 -- distended neck veins, tachycardia, cyanosis, frothy sputum, pleural rales, and hemoptysis. TYPE Air Emboli ... SIGNS AND SYMPTOMS Sudden shortness of breath; sharp chest pain; anxiety; coughing; decreased blood pressure. TYPE Citrate Toxicity ... SIGNS AND SYMPTOMS Cardiac arrhythmias; nausea/vomiting; hypokalemia; alkalosis; decreased blood pressure" Review of the facility "BLOOD TRANSFUSION RECORD" record revealed: "TRANSFUSION REACTION CRITERIA Heat at infusion site Hemoglobinuria or dark urine Nausea & Vomiting Flank or Back pain Chest Tightness or Pain Fever (1-2 degrees C/apx 2 degrees F rise without any other explanaJion) Hypotension Urticaria (Hives) Itching Wheezing or Coughing Tachycardia Headache Dyspnea Tachypnea Chills" Review of the laboratory policy "TRANSFUSION REACTION FOR CROSS MATCHES POLICY NUMBER: LB 8030" (revised July 2024) revealed: "GUIDE FOR INVESTIGATION OF SUSPECTED ACUTE TRANSFUSION REACTION Signs or Symptoms Reported Rise in temperature > 2 F Hypo/Hypertension or shock (with or without fever)- 20% or greater change from intimal [sic] BP once units are finished Low grade fever and/or chills Urticaria (hives), rash, itching, local erythema (redness) with absence of fever Dyspnea, tachypnea, cyanosis, headache, congestive heart failure, pulmonary edema Respiratory distress, coughing, NO FEVER Respiratory distress, severe hypoxemia, pulmonary edema on chest x-ray. Fever, chills, and hypotension may be present." The facility policy and blood transfusion record were NOT consistent with the laboratory policy for the defined criteria of "hypo/hypertension" change in initial blood pressure of 20% or greater to indicate a possible transfusion reaction. The facility failed to have defined criteria to promptly identify, investigate, and report blood and blood product transfusion reactions. Refer to D5559. 2. During an interview on 12/18/2024 at 11:47 a.m., the Laboratory Manager after a review of records confirmed the facility failed to have defined criteria to promptly identify, investigate, and report blood and blood product transfusion reactions. Word Key: C - Celsius apx- approximately F- Fahrenheit 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 the laboratory policy, blood transfusion records, patient records, blood transfusion audit records, and confirmed in interview, the facility failed to promptly identify, investigate and document blood product transfusion reactions for two of five units transfused in 2024 (random review September through December). Findings included: 1. Review of the laboratory policy "TRANSFUSION REACTION FOR CROSS MATCHES POLICY NUMBER: LB 8030" (revised July 2024) revealed: "GUIDE FOR INVESTIGATION OF SUSPECTED ACUTE TRANSFUSION REACTION Signs or Symptoms Reported Rise in temperature > 2 F -- 2 of 4 -- Hypo/Hypertension or shock (with or without fever)- 20% or greater change from intimal [sic] BP once units are finished Low grade fever and/or chills Urticaria (hives), rash, itching, local erythema (redness) with absence of fever Dyspnea, tachypnea, cyanosis, headache, congestive heart failure, pulmonary edema Respiratory distress, coughing, NO FEVER Respiratory distress, severe hypoxemia, pulmonary edema on chest x-ray. Fever, chills, and hypotension may be present." Review of the laboratory's "BLOOD TRANSFUSION RECORD" that was issued with each unit of blood product stated: "Transfusion Started Date Time Record vital signs at the time intervals indicated. Pre-transf Time Temp Pulse Resp BP Reaction? Signed 15 Min Time Temp Pulse Resp BP Reaction? Signed 30 Min Time Temp Pulse Resp BP Reaction? Signed 1 Hour Time Temp Pulse Resp BP Reaction? Signed 2 Hour Time Temp Pulse Resp BP Reaction? Signed 3 Hour Time Temp Pulse Resp BP Reaction? Signed 4 Hour Time Temp Pulse Resp BP Reaction? Signed 1 Hr Post Time Temp Pulse Resp BP Reaction? Signed Continue vital signs on nurse's notes if necessary. TRANSFUSION REACTION CRITERIA Heat at infusion site Hemoglobinuria or dark urine Nausea & Vomiting Flank or Back pain Chest Tightness or Pain Fever (1-2 degrees C/apx 2 degrees F rise without any other explanaJion) Hypotension Urticaria (Hives) Itching Wheezing or Coughing Tachycardia Headache Dyspnea Tachypnea Chills Transfusion Reaction: Yes No Date /Time Transfusion complete: By: Whole Unit Transfused: Yes No If No Then Amount Discarded: mls" The transfusion record was NOT consistent with the laboratory policy. Refer to D3025. 2. A random review of blood transfusion patient records from September 2024 through December 2024 revealed the following two of five transfusions with signs/symptoms of a possible transfusion reaction based on the criteria established by the laboratory: 12/13/2024 Patient FIN: HSP1000708681 PRBC Unit Number: W046824008380 Transfusion started: 1000 Pre-transf Time: 1000 Temp: 37.0 Pulse: 85 Resp: 16 BP: 115/49 Reaction?: No Signed: [XX] 15 Min Time: 1015 Temp: 37.0 Pulse: 89 Resp: 16 BP: 119/61 Reaction?: No Signed: [XX] 30 Min Time: 1030 Temp: 37.0 Pulse: 81 Resp: 16 BP: 113/59 Reaction?: No Signed: [XX] 1 Hour Time: 1100 Temp: 37.0 Pulse: 81 Resp: 16 BP: 109/61 Reaction?: No Signed: [XX] 2 Hour Time: 1200 Temp: 37.1 Pulse: 86 Resp: 16 BP: 115/56 Reaction?: No Signed: [XX] 3 Hour Time: 1300 Temp: 37.1 Pulse: 88 Resp: 16 BP: 113/61 Reaction?: No Signed: [XX] 4 Hour "completed" 1 Hr Post "started next unit /consecutive" Signed [XX] The patient had a diastolic blood pressure increase greater than 20% at the conclusion of the transfusion (61 mmHg) from baseline (49 mmHg). Per facility policy, an increase in blood pressure of 20% or greater was a sign of a transfusion reaction. NO documentation of prompt identification or investigation of a transfusion reaction was provided. 12/13/2024 Patient FIN: HSP1000708681 PRBC Unit Number: W046824009753 (second transfused unit) Transfusion started: 1330 Pre-transf Time: 1330 Temp: 36.9 Pulse: 88 Resp: 16 BP: 116/59 Reaction?: No Signed: [XX] 15 Min Time: 1345 Temp: 37.1 Pulse: 87 Resp: 16 BP: 104/45 Reaction?: No Signed: [XX] 30 Min Time: 1400 Temp: 37.0 Pulse: 84 Resp: 16 BP: 125/59 Reaction?: No Signed: [XX] 1 Hour Time: 1500 Temp: 37.0 Pulse: 73 Resp: 16 BP: 113/56 Reaction?: No Signed: [XX] 2 Hour Time: 1600 Temp: 37.1 Pulse: 84 Resp: 16 BP: 113/57 Reaction?: No Signed: [XX] 3 Hour Time: end 1610 Temp: [blank] Pulse: [blank] Resp: [blank] BP: 103/57 Reaction?: No Signed: [XX] 1 Hr Post Time: 1700 Temp: 37.0 Pulse: 92 Resp: 16 BP: 128/71 Reaction?: No Signed: [XX] The patient had a diastolic blood pressure increase greater than 20% at one hour post transfusion (71 mmHg) from baseline (59 mmHg). Per facility policy, an increase in blood pressure of 20% or greater was a sign of a transfusion reaction. NO documentation of prompt identification or investigation of a transfusion reaction was provided. THE LABOROTRY FAILED TO ENSURE TRANSFUSION REACTIONS WERE PROMPTLY IDENTIFIED, INVESTIGATED AND -- 3 of 4 -- DOCUMENTED FOR ALL BLOOD PRODUCTS. 3. Review of the laboratory's blood transfusion audit records revealed the following: Transfusion records were audited to ensure the following fields were completed by the transfusionist and laboratory: "Blood Issue and Handling: Issued according to procedure Visual inspection of unit Properly handled during transport Chart Check: Consent on Chart Transfusion order on Chart Copy in PowerChart Identification Check: Patient wearing armband Clerical check by 2 authorized staff Blood Transfusion Record Completely filled out by BB tech Two RN signatures Pre-transfusion vitals Unit started within 30 mins 15, 30, 1hr vitals 1hr post transfusion vitals Completed within 4 hrs Transfusion Reaction During an interview on 12/18/2024 at 11:47 a.m., the Laboratory Manager stated that all transfusion records were audited daily by the laboratory staff. She said the audits were performed to ensure all listed fields above were completed by the transfusionist and laboratory. She further stated that vitals recorded throughout the transfusion were reviewed during the audit. 4. Review of the laboratory audits for the blood transfusion records for the blood products transfused on 12/13/2024 (Patient FIN: HSP1000708681, PRBC Unit Number: W046824008380 and PRBC Unit Number: W046824009753) revealed under the question for transfusion reaction "No" was checked off for both audits. THE LABORATORY BLOOD TRANSFUSION AUDITS FAILED TO ENSURE TRANSFUSION REACTIONS WERE PROMPTLY IDENTIFIED, INVESTIGATED AND DOCUMENTED FOR ALL BLOOD PRODUCTS. 5. During an interview on 12/18/2024 at 11:47 a.m., the Laboratory Manager, after a review of records, confirmed the findings. Word Key: Pre-trasf- pre-transfusion Min- minute Temp- temperature Resp- respiration BP- blood pressure Hr- hour PRBC- packed red blood cell D5805 TEST REPORT CFR(s): 493.1291(c) The test report must indicate the following: (c)(1) For positive patient identification, either the patient's name and identification number, or a unique patient identifier and identification number. (c)(2) The name and address of the laboratory location where the test was performed. (c)(3) The test report date. (c)(4) The test performed. (c)(5) Specimen source, when appropriate. (c)(6) The test result and, if applicable, the units of measurement or interpretation, or both. (c)(7) Any information regarding the condition and disposition of specimens that do not meet the laboratory's criteria for acceptability. This STANDARD is not met as evidenced by: Based on review of patient records and confirmed in interview, the laboratory failed to include the testing facility name and address where the test was performed on the final reports for one of one patient in 2023 (random review) and two of two patients in 2024 (random review). Findings included: 1. Review of patient records from 2023 and 2024 (random sampling) revealed the following three final reports which did not include the testing facility name and address where frozen sections were performed: 01 /11/2023 Accession #: RS-23-11 01/10/2024 Accession #: RS-24-48 07/10/2024 Accession #: RS-24-1103 2. During an interview at 1:45 p.m., the Laboratory Manager, after a review of records, confirmed the above findings. -- 4 of 4 --

Summary Statement of Deficiencies D0000 Noted deficiencies and plans of correction were discussed with the laboratory representative at the entrance and exit conferences. The facility representative was given an opportunity to provide evidence of compliance with the noted deficiencies, and no such evidence was provided prior to survey exit. The facility was found to be in compliance with applicable Conditions of Participation in the CLIA program, and recertification is recommended. Note: The CMS-2567 (Statement of Deficiencies) is an official, legal document. All information must remain unchanged except for entering the