Texas Health Presbyterian Hospital Of Plano

Summary Statement of Deficiencies D0000 The laboratory was surveyed in response to complaint TX00479960 for compliance with CMS 42CFR regulations. Complaint TX00479960 was substantiated. CONDITION LEVEL DEFICIENCIES were found to be out of compliance: 493.1101 Condition: Facility Administration 493.1217 Condition: Immunohematology 493.1441 Condition: Laboratories performing high complexity testing; laboratory director 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 review of the laboratory and facility policies, blood product administration training records, patient records, and confirmed in interview, the facility administration failed to meet the requirements specified in 493.1101 through 493.1105 as evidenced by: 1. The facility failed to ensure all transfusion related activities were documented for administration of blood products to be able to identify and promptly investigate transfusion reactions for 3 of 12 patients in 2023 (random review March 4, May 27, and September 18). Refer to D3015. 2. The facility failed to ensure transfusion reaction procedures included defined criteria to promptly identify, investigate and document blood product transfusion reactions and the facility failed to Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 17 -- promptly identify, investigate, and document blood product transfusion reactions for 2 of 12 patients in 2023 (random review March 4, May 27, and September 18). Refer to D3025. 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 facility policies, patient transfusion records, and confirmed in interview, the facility failed to ensure all transfusion related activities were documented for administration of blood products to be able to identify and promptly investigate transfusion reactions for 3 of 12 patients in 2023 (random review March 4, May 27, and September 18). Findings included: 1. Review of the laboratory and facility's policy "Blood Administration" stated: "4.0 Policy Guidelines ... 4.4 Emergency Management for Blood Transfusion Reaction ... 4.4.3 Adult/pediatric signs of possible adverse reaction to blood transfusion include: a. Chills or rigor b. Fever c. Hematuria d. Skin rash/Urticaria e. Pain at infusion site f. Hypotension g. Flank/back pain h. Respiratory distress including dyspnea, tachypnea, pulmonary edema, and or hypoxemia i. Nausea with or without vomiting j. Anaphylaxis k. Cardiac arrest l. Shock m. Jaundice n. Cyanosis o. Seizure p. Headache ... 4.5 Non- Emergent Transfusion of Crossmatched Blood and Blood Products 4.5.1 For an adult or pediatric patient, the following shall be entered in the medical record prior to transfusing any blood or blood products and, if possible, verified by the RN: a. Indication for transfusion b. Pre-Transfusion hemoglobin level c. Pertinent clinical findings 4.5.2 For an adult or pediatric patient, start the infusion at 100 mL per hour, if appropriate for the patient, for the first 15 minutes and observe for adverse reactions. The initial rate may be faster or slower, depending on clinical judgement related to the patient's status and history ... 4.5.4 Procedural Steps (all ages) ... Step 5: Obtain baseline temperature, pulse, respirations, and blood pressure prior to starting the blood products. Step 6: Obtain baseline temperature, pulse, respirations, and blood pressure within 15 minutes of starting the infusion of blood products ... Step 7: At completion of blood products, check temperature, pulse, respirations, and blood pressure. Step 8: Monitor the patient for potential adverse events periodically for 4 to 6 hours after the end of the transfusion to detect febrile or pulmonary reactions after the end of the transfusion." The policy did not define the criteria for "fever", "hypotension", "respiratory distress including dyspnea, tachypnea, pulmonary edema, and or hypoxemia". Refer to D3025. Review of the facility and laboratory policy titled "Suspected Transfusion Reaction Workup" revealed: "8.0 Stepwise Procedure 8.1 In the event of a suspected transfusion reaction, the personnel attending the patient are responsible for Immediately notifying the Blood Bank and the physician. 8.1.1 Urge the nursing unit to maintain intravenous access, as this may be necessary if resuscitation is required. 8.1.2 The Blood Bank initiates a workup whenever the care giver expresses concern that the patient may be having a transfusion reaction. 8.2 The Blood Bank sends a Report of Adverse Reaction to Transfusion Form to the care giver to fill out and send back to the Blood Bank. (A supply of forms is kept in the Blood Bank). 8.3 Transfusion reactions are handled according to classifications. Some of the more important and /or common transfusion reactions are listed. Follow the directions for each type. If any discrepancies are found, proceed to the next highest workup. 8.3. 1 Allergic Reactions: a Cause is usually due to allergens in the unit of blood and -- 2 of 17 -- occurs in approximately 1 in 100 units of blood. Allergic reactions may range from inconsequential (urticarial only) to severe (anaphylaxis). b The typical urticaria reaction is characterized by local erythema (swelling), rash (hives) and/or itching (pruritis), usually without fever (generally defined as "increase in temperature of greater than 1 C or 2F") or other adverse effects. 1) As long as NO FEVER nor symptoms other than hives, itching or local erythema are present, an urticarial only reaction requires no workup by the laboratory and further units of blood may be dispensed for the patient's use. 2) The nurse should obtain the ordering physician's approval before proceeding. c The presence of other symptoms, which may include a mild headache, edema, wheezing and/or dyspnea, necessitates starting with an initial workup. d If the patient has an anaphylactic reaction, an initial and an extended workup by the laboratory is required. 8.3.2 Febrile Nonhemolytic Reaction a Cause is usually leukocyte or platelet antibodies. b Symptoms may include chills, temperature rise greater than 1 C or 2F, headache, backache, nausea, vomiting and/or hypotension. c An initial workup is required. 8.3.3 Bacterial Contamination Reaction a Cause is pathogenic bacteria in blood product. b Symptoms may include rise in blood pressure, especially diastolic, pounding headache, orthopnea, possible chills and/or fever. c An initial workup is required. 8.3.4 Hemolytic Reaction a. Cause is usually transfused red cells interacting with pre-formed antibodies in the recipient. b. Symptoms may appear within 10-30 minutes of initiation of transfusion and may include pain in lower back or legs, chest constriction with shortness of breath, shock, hemoglobinuria, fever, chills or diffuse bleeding (bleeding at surgical site and/or around IV, central lines, venipuncture sites, or other wounds and can be indicative of DIC). c An initial and extended workup should be performed. 8.3.5 TRALI (Transfusion Related Acute Lung Injury) a TRALI is characterized by acute respiratory distress, bilateral pulmonary edema, and hypoxia in the setting of transfusion of plasma containing blood products. TRALI should be considered when other causes of pulmonary injury (eg, circulatory overload and acute left ventricular dysfunction secondary to cardiac ischemia) have been ruled out. b If TRALI is suspected, notify the Blood Bank Medical Director or pathologist on call to follow up with patient's physician and to determine if further testing is indicated. c Perform an initial, an extended and a TRALI transfusion reaction workup following standard procedure." The policy did not define the criteria for "rise in blood pressure". Refer to D3025. Transfusion reactions were identified by symptoms and patient vital signs taken which were documented by the staff administering the blood products. 2. In a random review, 3 of 12 patients in 2023 (random review March 4, May 27, and September 18) revealed the following incomplete documentation: Patient MRN# 2000154102 was administered PRBC, Unit #W035222355552 on 05/27/2023 at 14:36 hours. Patient temperature, pulse, blood pressure and respirations were not taken and documented at the 15- minute assessment (14:51 hours). At 14:44 hours and 14:57 hours blood pressure and pulse were taken and documented, however, patient temperature and respirations were not taken and documented. Patient temperature, pulse, blood pressure and respirations were not taken and documented at the completion of the transfusion. The transfusion ended at 17:00 hours. The above incomplete documentation could not properly identify transfusion reactions. Patient MRN# 2000164129 was administered PRBC, Unit #W035223636863 on 09/18/2023 at 10:29 hours. Patient temperature, pulse, blood pressure and respirations were not taken and documented at the 15-minute assessment (10:44 hours). At 10:39 hours and 10:54 hours blood pressure and pulse were taken and documented, however, patient temperature and respirations were not taken and documented. Patient temperature, pulse, blood pressure and respirations were not taken and documented at the completion of the transfusion. The transfusion ended at 12:42 hours. The above incomplete documentation could not properly identify transfusion reactions. Patient MRN# 2000160217 was administered PRBC, -- 3 of 17 -- Unit #W091023149508 on 09/17/2023 at 17:31 hours. Patient temperature, pulse, blood pressure and respirations were not taken and documented at the completion of the transfusion. The transfusion ended at 21:50 hours. On 09/18/2023 the patient was administered PRBC, Unit #W035223603997 at 05:47 hours. Patient temperature, pulse, blood pressure and respirations were not taken and documented at the completion of the transfusion. The transfusion ended at 09:09 hours. On 09/18/2023 the patient was administered PRBC, Unit #W035223613451 at 09:26 hours. Patient temperature, pulse, blood pressure and respirations were not taken and documented at the 15-minute assessment (09:41 hours). Patient temperature and respirations were not taken and documented at the completion of the transfusion. The transfusion ended at 12:05 hours. The above incomplete documentation could not properly identify transfusion reactions. 3. During an interview on 12/14/2023 at 1:50 pm, the facility and laboratory representatives, after a review of records confirmed the above findings. Word Key: RN- registered nurse MRN- medical record number PRBC- packed red blood cells 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 the laboratory and facility policies, blood product administration training records, patient records, and confirmed in interview, the facility failed to ensure transfusion reaction procedures included defined criteria to promptly identify, investigate and document blood product transfusion reactions and the facility failed to promptly identify, investigate, and document blood product transfusion reactions for 2 of 12 patients in 2023 (random review March 4, May 27, and September 18). Findings included: 1. Review of the laboratory and facility's policy "Blood Administration" stated: "4.0 Policy Guidelines ... 4.4 Emergency Management for Blood Transfusion Reaction ... 4.4.3 Adult/pediatric signs of possible adverse reaction to blood transfusion include: a. Chills or rigor b. Fever c. Hematuria d. Skin rash/Urticaria e. Pain at infusion site f. Hypotension g. Flank/back pain h. Respiratory distress including dyspnea, tachypnea, pulmonary edema, and or hypoxemia i. Nausea with or without vomiting j. Anaphylaxis k. Cardiac arrest l. Shock m. Jaundice n. Cyanosis o. Seizure p. Headache ... 4.4.4 Process for a suspected or actual blood transfusion reaction Step 1: Stop the blood transfusion immediately and remove blood transfusion tubing Step 2: Keep the vein open with Normal Saline using NEW tubing Step 3: Notify the physician immediately. Call a RRT if needed. Step 4: Follow the hospital and/or Blood Bank procedure for possible blood transfusion workup (usually requires return of blood component containers and tubing to the Blood Bank and a patient blood/urine specimen to be sent to the Lab) Step 5: If the physician suspects Transfusion Related Acute Lung Injury (TRALI), this must be communicated to the Blood Bank so an appropriate work-up may commence. Step 6: Document the reaction in CareConnect One Transfusion fields 4.5 Non-Emergent Transfusion of Crossmatched Blood and Blood Products 4.5.1 For an adult or pediatric patient, the following shall be entered in the medical record prior to transfusing any blood or blood products and, if possible, verified by the RN: a. Indication for transfusion b. Pre- Transfusion hemoglobin level c. Pertinent clinical findings 4.5.2 For an adult or -- 4 of 17 -- pediatric patient, start the infusion at 100 mL per hour, if appropriate for the patient, for the first 15 minutes and observe for adverse reactions. The initial rate may be faster or slower, depending on clinical judgement related to the patient's status and history ... 4.5.4 Procedural Steps (all ages) ... Step 5: Obtain baseline temperature, pulse, respirations, and blood pressure prior to starting the blood products. Step 6: Obtain baseline temperature, pulse, respirations, and blood pressure within 15 minutes of starting the infusion of blood products ... Step 7: At completion of blood products, check temperature, pulse, respirations, and blood pressure. Step 8: Monitor the patient for potential adverse events periodically for 4 to 6 hours after the end of the transfusion to detect febrile or pulmonary reactions after the end of the transfusion." The policy did not state to notify the laboratory of a suspected transfusion reaction. The policy did not define the criteria for "fever", "hypotension", "respiratory distress including dyspnea, tachypnea, pulmonary edema, and or hypoxemia". Review of the facility and laboratory policy titled "Suspected Transfusion Reaction Workup" revealed: "8.0 Stepwise Procedure 8.1 In the event of a suspected transfusion reaction, the personnel attending the patient are responsible for Immediately notifying the Blood Bank and the physician. 8.1.1 Urge the nursing unit to maintain intravenous access, as this may be necessary if resuscitation is required. 8.1.2 The Blood Bank initiates a workup whenever the care giver expresses concern that the patient may be having a transfusion reaction. 8.2 The Blood Bank sends a Report of Adverse Reaction to Transfusion Form to the care giver to fill out and send back to the Blood Bank. (A supply of forms is kept in the Blood Bank). 8.3 Transfusion reactions are handled according to classifications. Some of the more important and /or common transfusion reactions are listed. Follow the directions for each type. If any discrepancies are found, proceed to the next highest workup. 8.3. 1 Allergic Reactions: a Cause is usually due to allergens in the unit of blood and occurs in approximately 1 in 100 units of blood. Allergic reactions may range from inconsequential (urticarial only) to severe (anaphylaxis). b The typical urticaria reaction is characterized by local erythema (swelling), rash (hives) and/or itching (pruritis), usually without fever (generally defined as "increase in temperature of greater than 1 C or 2F") or other adverse effects. 1) As long as NO FEVER nor symptoms other than hives, itching or local erythema are present, an urticarial only reaction requires no workup by the laboratory and further units of blood may be dispensed for the patient's use. 2) The nurse should obtain the ordering physician's approval before proceeding. c The presence of other symptoms, which may include a mild headache, edema, wheezing and/or dyspnea, necessitates starting with an initial workup. d If the patient has an anaphylactic reaction, an initial and an extended workup by the laboratory is required. 8.3.2 Febrile Nonhemolytic Reaction a Cause is usually leukocyte or platelet antibodies. b Symptoms may include chills, temperature rise greater than 1 C or 2F, headache, backache, nausea, vomiting and/or hypotension. c An initial workup is required. 8.3.3 Bacterial Contamination Reaction a Cause is pathogenic bacteria in blood product. b Symptoms may include rise in blood pressure, especially diastolic, pounding headache, orthopnea, possible chills and/or fever. c An initial workup is required. 8.3.4 Hemolytic Reaction a. Cause is usually transfused red cells interacting with pre-formed antibodies in the recipient. b. Symptoms may appear within 10-30 minutes of initiation of transfusion and may include pain in lower back or legs, chest constriction with shortness of breath, shock, hemoglobinuria, fever, chills or diffuse bleeding (bleeding at surgical site and/or around IV, central lines, venipuncture sites, or other wounds and can be indicative of DIC). c An initial and extended workup should be performed. 8.3.5 TRALI (Transfusion Related Acute Lung Injury) a TRALI is characterized by acute respiratory distress, bilateral pulmonary edema, and hypoxia in the setting of transfusion of plasma containing blood products. TRALI should be considered when other causes of pulmonary injury -- 5 of 17 -- (eg, circulatory overload and acute left ventricular dysfunction secondary to cardiac ischemia) have been ruled out. b If TRALI is suspected, notify the Blood Bank Medical Director or pathologist on call to follow up with patient's physician and to determine if further testing is indicated. c Perform an initial, an extended and a TRALI transfusion reaction workup following standard procedure." The policy did not define the criteria for "rise in blood pressure". The above procedures were not consistent with one another. The facility did not ensure transfusion reaction procedures included defined criteria to promptly identify, investigate and document blood product transfusion reactions. 2. Review of blood product administration training records titled: "Blood Transfusion, Acute Reactions" revealed: "Acute Hemolytic Transfusion Reaction (AHTR) ... AHTR Symptoms AHTR Symptoms can start within five to fifteen minutes - and up to 24 hours - after the start of a transfusion. The first are a rise in body temperature and a fast heart rate. Other symptoms may include: Chills Trouble breathing Chest or back pain Bleeding Anxiety Low blood pressure ... Febrile Non-Hemolytic Transfusion Reaction (FNHTR) ... FNHTR Symptoms Symptoms occur during or shortly after the transfusion may include: Fever (1-2C) above baseline Shaking/chills General sick feeling ... Allergic Reactions ... Allergic Reaction Symptoms Symptoms occur during the transfusion or up to one hour after and may include: Hives Itchy skin Wheezing /trouble breathing Angioedema ... Anaphylaxis ... Anaphylaxis Symptoms Additional symptoms may include: Tightness in the throat and chest Trouble breathing Stomach cramps, nausea, vomiting or diarrhea Rapid heart rate and low blood pressure Not responding to a person's touch or speech ... Transfusion-Related Acute Lung Injury (TRALI) ... TRALI Symptoms Symptoms develop within six hours from the end of the transfusion and may include: Trouble breathing Cyanosis and low oxygen levels Fluid in the lungs Infection in the lungs Other signs that may look like an infection include: Fever (1-2C above baseline) Fast heart rate Very low body temperature Blood pressure that is not stable ... Transfusion-Associated Circulatory Overload (TACO) ... TACO Symptoms Symptoms that start within two to six hours and include: Abnormal breathing, fast rate High blood pressure Rapid heart rate Swelling of feet, ankles, legs, or hands ... Transfusion-Transmitted Infection (TTI) ... TTI Symptoms Symptoms of TTI begin right after starting the transfusion and may include the following: Severe chills and high fever High heart and breathing rates A quick drop in blood pressure Confusion Nausea and vomiting ... Reporting Transfusion Adverse Reactions ... Reporting Transfusion Reactions Policies for reporting transfusion reactions should include the following: Report the reaction right away to the treating provider. Document the rection in the person's medical record. Report the reaction to management and the quality assurance and performance improvement (QAPI) program as an adverse event." The blood product administration training record failed to indicate to report transfusion reactions to the laboratory. 3. During an interview on 12/14/2023 at 1:25 pm in the conference room, a registered nurse stated nurses transfusing patients have a "yes" or "no" prompt in the transfusion record that asks the transfusionist if the patient experienced any transfusion reactions. He further stated that hypotension was typically related to systolic blood pressure not diastolic. 4. A random review of blood and blood component transfusion patient records from March 4, May 27, and September 18, 2023, revealed the following 2 of 12 patient transfusions with signs/symptoms of a transfusion reaction: 09/18/2023 Patient MRN: 2000164129 Packed Red Cell Unit Number: W035223636863 Transfusion started: 10:29 hours Baseline Assessment at 10:20 hours BP: 103/60 Temp: 100.7 Pulse: 118 Resp: 18 During Transfusion Assessment at 10:39 hours BP: 115/67 Temp: not performed/no documentation Pulse: 118 Resp: not performed/no documentation 15-minute Assessment at 10:44 hours BP: not performed/no documentation Temp: not performed/no documentation Pulse: not performed/no -- 6 of 17 -- documentation Resp: not performed/no documentation During Transfusion Assessment at 10:54 hours BP: 155/65 Temp: not performed/no documentation Pulse: 116 Resp: not performed/no documentation During Transfusion Assessment at 12:18 hours BP: 125/78 Temp: 101.6 Pulse: 117 Resp: 18 Transfusion completion 12:42 hours Post Transfusion Assessment at 12:42 hours BP: not performed/no documentation Temp: not performed/no documentation Pulse: not performed/no documentation Resp: not performed/no documentation Post Transfusion Assessment at 14:27 hours BP: 117/81 Temp: 103.1 Pulse: 119 Resp: 18 Post Transfusion Assessment at 14:40 hours BP: 113/75 Temp: not performed/no documentation Pulse: 131 Resp: not performed/no documentation Post Transfusion Assessment at 14:55 hours BP: 106/67 Temp: not performed/no documentation Pulse: 120 Resp: not performed/no documentation Post Transfusion Assessment at 15:10 hours BP: 95/62 Temp: not performed/no documentation Pulse: 116 Resp: not performed/no documentation Post Transfusion Assessment at 16:03 hours BP: not performed/no documentation Temp: 101.6 Pulse: not performed/no documentation Resp: not performed/no documentation Post Transfusion Assessment at 16:10 hours BP: 102/58 Temp: not performed/no documentation Pulse: 118 Resp: not performed/no documentation Post Transfusion Assessment at 16:25 hours BP: 100/60 Temp: not performed/no documentation Pulse: 111 Resp: 18 Post Transfusion Assessment at 17: 16 hours BP: not performed/no documentation Temp: 101 Pulse: not performed/no documentation Resp: not performed/no documentation Post Transfusion Assessment at 20:15 hours BP: 116/78 Temp: 104.2 Pulse: 133 Resp: 20 The patient had a temperature increase of 2.4 degrees Fahrenheit from baseline at 14:27 hours and an increase of 3.5 degrees Fahrenheit from baseline at 20:15 hours. Per facility policy, a temperature increase of 2 degrees Fahrenheit was a sign of a transfusion reaction. NO documentation of prompt identification or investigation of a transfusion reaction was provided. Patient MRN: 2000160217 09/17/2023 Packed Red Cell Unit Number: W091023149508 Transfusion started: 17:31 hours Baseline Assessment at 17:25 hours BP: 100/67 Temp: 97.5 Pulse: 98 Resp: 20 15-minute Assessment at 17:47 hours BP: 111/73 Temp: 97.2 Pulse: 99 Resp: 18 During Transfusion Assessment at 18:36 hours BP: 114/78 Temp: 98 Pulse: 104 Resp: 18 During Transfusion Assessment at 19:52 hours BP: 115/79 Temp: 97.2 Pulse: 104 Resp: 17 During Transfusion Assessment at 21:23 hours BP: 120/78 Temp: not performed/no documentation Pulse: 106 Resp: 20 During Transfusion Assessment at 21:27 hours BP: 117/75 Temp: 97.8 Pulse: 107 Resp: 20 During Transfusion Assessment at 21:43 hours BP: 118/75 Temp: 98.6 Pulse: 104 Resp: 20 Transfusion completion 21:50 hours Post Transfusion Assessment at 21:50 hours BP: not performed/no documentation Temp: not performed/no documentation Pulse: not performed/no documentation Resp: not performed/no documentation Post Transfusion Assessment at 23:27 hours BP: 112/77 Temp: 98.3 Pulse: 114 Resp: 17 Post Transfusion Assessment at 02:27 hours BP: 118/81 Temp: 97.4 Pulse: 121 Resp: 20 Progress note by an RN electronically signed at 02:54 hours stated: "Sent message to hospitalist regarding patient heart rate increasing in 120s. Her blood pressure is stable at 118/81, but heart rate is increasing. She got PRBCs one unit during day shift. Just ordered a stat CBC to see what her H&H is" [sic] Post Transfusion Assessment at 04:32 hours BP: 115/72 Temp: 96.8 Pulse: 120 Resp: 20 09/18/2023 Packed Red Cell Unit Number: W035223603997 Transfusion started: 05:47 hours Baseline Assessment at 05:39 hours BP: 118/76 Temp: 96.5 Pulse: 115 Resp: 20 During Transfusion Assessment at 05:55 hours BP: 124/78 Temp: 96.5 Pulse: 111 Resp: 18 15-minute Assessment at 06:04 hours BP: 118/74 Temp: 96.5 Pulse: 113 Resp: 18 During Transfusion Assessment at 07:00 hours BP: 128/88 Temp: not performed/no documentation Pulse: 118 Resp: 18 During Transfusion Assessment at 07:47 hours BP: 138/90 Temp: 99 Pulse: 122 Resp: 17 During Transfusion Assessment at 08:49 -- 7 of 17 -- hours BP: 142/94 Temp: not performed/no documentation Pulse: 121 Resp: 18 Transfusion completion 09:09 hours Post Transfusion Assessment at 09:09 hours BP: not performed/no documentation Temp: not performed/no documentation Pulse: not performed/no documentation Resp: not performed/no documentation Packed Red Cell Unit Number: W035223613451 Transfusion started: 09:26 hours Baseline Assessment at 09:22 hours BP: 137/86 Temp: 97 Pulse: 94 Resp: 18 During Transfusion Assessment at 09:37 hours BP: 140/85 Temp: 97.5 Pulse: 100 Resp: 18 Progress Note documented by RN at 9:37 hours (electronically signed at 10:24 hours): "Patient vomited. oral [sic] suction done. Maintained HOB 60 degree. Cleaned patient. Vital signs documented. Notified charge nurse and primary doctor." 15-minute Assessment at 09:41 hours BP: not performed/no documentation Temp: not performed/no documentation Pulse: not performed/no documentation Resp: not performed/no documentation During Transfusion Assessment at 09:52 hours BP: 138/85 Temp: 97.5 Pulse: 101 Resp: 18 During Transfusion Assessment at 10:23 hours BP: 138/68 Temp: 97.5 Pulse: 102 Resp: 18 During Transfusion Assessment at 10:53 hours BP: 138/86 Temp: 98.1 Pulse: 101 Resp: 18 During Transfusion Assessment at 11:47 hours BP: 132/91 Temp: 98.6 Pulse: 101 Resp: 17 Transfusion completion 12:05 hours Post Transfusion Assessment at 12:04 hours BP: 143/86 Temp: not performed/no documentation Pulse: 105 Resp: not performed/no documentation Progress Note by provider electronically signed at 12:30 hours stated: "Remains unresponsive but had an episode of emesis earlier today." Physician Notified note sent by RN at 13:57 hours stated: "patient heart rate is high 115 now" Physician Notified note sent by RN at 14: 03 hours stated: "patient vomited just now, i [sic] stopped feed. i [sic] just want to let you kno [sic]" Post Transfusion Assessment at 15:47 hours BP: 102/75 Temp: 98.6 Pulse: 108 Resp: 17 Post Transfusion Assessment at 17:00 hours BP: not performed /no documentation Temp: not performed/no documentation Pulse: not performed/no documentation Resp: 19 Care Plan Note by RN at 17:50 hours stated: "1 bag of PRBC transfused Heart rate increased to 115 bpm, notify doctor, no new order received CBC rechecked after post transfusion Vomited noted x1 CBC checked this after noon [sic] Low SpO2 noted, started oxygen and called respiratory therapist. Continue to monitor" Post Transfusion Assessment at 18:20 hours BP: 106/48 Temp: not performed/no documentation Pulse: not performed/no documentation Resp: not performed/no documentation Progress Note by RN at 18:20 hours (electronically signed at 19:34 hours) stated: "SpO2 showing 85-88%. Started 2 L oxygen. Notified charge nurse. 18:20 PM called RRT 18:26 pm notified Dr [XX] about RRT. Got order for STAT ABG and lasix [sic] 20 mg iv x once 18;42 [sic] PM - ABG result notified MD 18:46 pm - breathing very hard and non rebreather [sic] mask connected 18:47 pm - BP 106/48 MM OF HG now. Doctor want [sic] to hold lasix [sic] for now." Progress Note by RN #2 at 19:33 hours (electronically signed at 19:37 hours) stated: "RRT called at 1820 because there was no O2 sat. Patient had BP and pulse, breathing heavily but the O2 sat would not register. RRT team arrived and we did stat ABG. MD [XX] notified about ABG results. I discussed with DR. [XX] this case and updated her. [XX] was also notified re RRT." Progress Note by provider at 20:55 hours (electronically signed 09/19/2023 at 07:79 hours) stated: "Earlier this evening, RRT was called by dayshift nursing staff. They spoke with Dr. [XX], dayshift hospitalist. HR was elevated, and pt was requiring increased supplemental oxygen. Remained unresponsive, unchanged from prior mental status. Dose of Lasix was ordered by dayshift hospitalist. Repeat CBC showed increased hgb up to 9.4. At that time, pt's O2 sats were down to 85% on 2L NC, so NRB mask placed. BP was 106/68 ... In meantime, RRT was announced overhead due to BP of 78/44 ...In meantime, HR dropped to the 30s and pt's RR was down to just a few times per minute. I told RT to bag mask pt, and I spoke with the ICU NP, [XX] who agreed to accept pt to ICU for further care since pt was limited DNR (no intubation, but ok for chest compressions). -- 8 of 17 -- We were in the process of moving pt to ICU when pt's breathing completely stopped and she went into asystole on monitor with no palpable pulse. Code Blue was called and Limited CPR was started as per code status on chart, and pt remained in systole whole time with no dopplerable pulse. Continued CPR for 10 minutes with no resumption of breathing. ICU NP spoke with ICU attending on call, Dr [XX], who agreed that it was reasonable to call the code at that point ... Code called/time of death: 8:48pm." The patient had a temperature increase of 2.5 degrees Fahrenheit from baseline at 07:47 hours during the first transfusion on 09/18/2023. Per facility policy, a temperature increase of 2 degrees Fahrenheit was a sign of a transfusion reaction. During the second transfusion at 9:37 hours the patient vomited and after the transfusion was complete the patient vomited at 13:57 hours. Per facility policy, vomiting was a sign of a transfusion reaction. NO documentation of prompt identification or investigation of a transfusion reaction was provided. THE FACILITY FAILED TO ENSURE TRANSFUSION REACTIONS WERE PROMPTLY IDENTIFIED, INVESTIGATED AND DOCUMENTED FOR ALL BLOOD PRODUCTS. 5. According to Blood Utilization Committee records, the laboratory had a volume of 379 units of PRBCs transfused for September 2023. Further review of records revealed 0 suspected transfusion reactions were evaluated in September 2023. This was a 0% transfusion reaction rate. 6. During an interview on 12/14/2023 at 11:25 am, the Blood Bank Medical Director stated that the facility did not have a lot of transfusion reaction workups and there statistically speaking there should be more. During the exit interview on 12/14/2023 at 4:30 pm, laboratory and facility representatives confirmed the above findings. Word Key: RN- registered nurse temp- temperature BP- blood pressure Resp- respiration MRN- medical record number HOB- head of bed PRBC- packed red blood cell CBC - complete blood count H&H - hemoglobin and hematocrit bpm - beats per minute SpO2 - oxygen saturation RRT- rapid response team ABG - arterial blood gas iv- intravenous MM OF HG - millimeters of mercury sat- saturation HR - heart rate pt - patient hgb - hemoglobin NRB- non-rebreather RR- respiratory rate RT - respiratory therapy ICU - intensive care unit NP - nurse practitioner DNR - do not resuscitate 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 review of the laboratory and facility policies, patient records, laboratory records, and confirmed in interview, the laboratory failed to meet the requirements for the specialty of immunohematology as evidenced by: 1. The laboratory failed to ensure transfusion reaction procedures included defined criteria to promptly identify, investigate and document blood product transfusion reactions and the laboratory failed to promptly identify, investigate, and document blood product transfusion reactions for 2 of 12 patients in 2023 (random review March 4, May 27, and September 18). Refer to D5559, I. 2. The laboratory failed to ensure all transfusion related activities were documented for administration of blood products to be able to identify and promptly investigate transfusion reactions for 3 of 12 patients in 2023 (random review March 4, May 27, and September 18). Refer to D5559, II. D5559 IMMUNOHEMATOLOGY -- 9 of 17 -- 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 the laboratory and facility policies, patient records, laboratory records, and confirmed in interview, the laboratory failed to ensure transfusion reaction procedures included defined criteria to promptly identify, investigate and document blood product transfusion reactions and the laboratory failed to promptly identify, investigate and document blood product transfusion reactions for 2 of 12 patients in 2023 (random review March 4, May 27, and September 18). Findings included: 1. Review of the laboratory and facility's policy "Blood Administration" stated: "4.0 Policy Guidelines ... 4.4 Emergency Management for Blood Transfusion Reaction ... 4.4.3 Adult/pediatric signs of possible adverse reaction to blood transfusion include: a. Chills or rigor b. Fever c. Hematuria d. Skin rash/Urticaria e. Pain at infusion site f. Hypotension g. Flank/back pain h. Respiratory distress including dyspnea, tachypnea, pulmonary edema, and or hypoxemia i. Nausea with or without vomiting j. Anaphylaxis k. Cardiac arrest l. Shock m. Jaundice n. Cyanosis o. Seizure p. Headache ... 4.4.4 Process for a suspected or actual blood transfusion reaction Step 1: Stop the blood transfusion immediately and remove blood transfusion tubing Step 2: Keep the vein open with Normal Saline using NEW tubing Step 3: Notify the physician immediately. Call a RRT if needed. Step 4: Follow the hospital and/or Blood Bank procedure for possible blood transfusion workup (usually requires return of blood component containers and tubing to the Blood Bank and a patient blood/urine specimen to be sent to the Lab) Step 5: If the physician suspects Transfusion Related Acute Lung Injury (TRALI), this must be communicated to the Blood Bank so an appropriate work-up may commence. Step 6: Document the reaction in CareConnect One Transfusion fields 4.5 Non-Emergent Transfusion of Crossmatched Blood and Blood Products 4.5.1 For an adult or pediatric patient, the following shall be entered in the medical record prior to transfusing any blood or blood products and, if possible, verified by the RN: a. Indication for transfusion b. Pre- Transfusion hemoglobin level c. Pertinent clinical findings 4.5.2 For an adult or pediatric patient, start the infusion at 100 mL per hour, if appropriate for the patient, for the first 15 minutes and observe for adverse reactions. The initial rate may be faster or slower, depending on clinical judgement related to the patient's status and history ... 4.5.4 Procedural Steps (all ages) ... Step 5: Obtain baseline temperature, pulse, respirations, and blood pressure prior to starting the blood products. Step 6: Obtain baseline temperature, pulse, respirations, and blood pressure within 15 minutes of starting the infusion of blood products ... Step 7: At completion of blood products, check temperature, pulse, respirations, and blood pressure. Step 8: Monitor the patient for potential adverse events periodically for 4 to 6 hours after the end of the transfusion to detect febrile or pulmonary reactions after the end of the transfusion." The policy did not state to notify the laboratory of a suspected transfusion reaction. -- 10 of 17 -- The policy did not define the criteria for "fever", "hypotension", "respiratory distress including dyspnea, tachypnea, pulmonary edema, and or hypoxemia". Review of the facility and laboratory policy titled "Suspected Transfusion Reaction Workup" revealed: "8.0 Stepwise Procedure 8.1 In the event of a suspected transfusion reaction, the personnel attending the patient are responsible for Immediately notifying the Blood Bank and the physician. 8.1.1 Urge the nursing unit to maintain intravenous access, as this may be necessary if resuscitation is required. 8.1.2 The Blood Bank initiates a workup whenever the care giver expresses concern that the patient may be having a transfusion reaction. 8.2 The Blood Bank sends a Report of Adverse Reaction to Transfusion Form to the care giver to fill out and send back to the Blood Bank. (A supply of forms is kept in the Blood Bank). 8.3 Transfusion reactions are handled according to classifications. Some of the more important and /or common transfusion reactions are listed. Follow the directions for each type. If any discrepancies are found, proceed to the next highest workup. 8.3. 1 Allergic Reactions: a Cause is usually due to allergens in the unit of blood and occurs in approximately 1 in 100 units of blood. Allergic reactions may range from inconsequential (urticarial only) to severe (anaphylaxis). b The typical urticaria reaction is characterized by local erythema (swelling), rash (hives) and/or itching (pruritis), usually without fever (generally defined as "increase in temperature of greater than 1 C or 2F") or other adverse effects. 1) As long as NO FEVER nor symptoms other than hives, itching or local erythema are present, an urticarial only reaction requires no workup by the laboratory and further units of blood may be dispensed for the patient's use. 2) The nurse should obtain the ordering physician's approval before proceeding. c The presence of other symptoms, which may include a mild headache, edema, wheezing and/or dyspnea, necessitates starting with an initial workup. d If the patient has an anaphylactic reaction, an initial and an extended workup by the laboratory is required. 8.3.2 Febrile Nonhemolytic Reaction a Cause is usually leukocyte or platelet antibodies. b Symptoms may include chills, temperature rise greater than 1 C or 2F, headache, backache, nausea, vomiting and/or hypotension. c An initial workup is required. 8.3.3 Bacterial Contamination Reaction a Cause is pathogenic bacteria in blood product. b Symptoms may include rise in blood pressure, especially diastolic, pounding headache, orthopnea, possible chills and/or fever. c An initial workup is required. 8.3.4 Hemolytic Reaction a. Cause is usually transfused red cells interacting with pre-formed antibodies in the recipient. b. Symptoms may appear within 10-30 minutes of initiation of transfusion and may include pain in lower back or legs, chest constriction with shortness of breath, shock, hemoglobinuria, fever, chills or diffuse bleeding (bleeding at surgical site and/or around IV, central lines, venipuncture sites, or other wounds and can be indicative of DIC). c An initial and extended workup should be performed. 8.3.5 TRALI (Transfusion Related Acute Lung Injury) a TRALI is characterized by acute respiratory distress, bilateral pulmonary edema, and hypoxia in the setting of transfusion of plasma containing blood products. TRALI should be considered when other causes of pulmonary injury (eg, circulatory overload and acute left ventricular dysfunction secondary to cardiac ischemia) have been ruled out. b If TRALI is suspected, notify the Blood Bank Medical Director or pathologist on call to follow up with patient's physician and to determine if further testing is indicated. c Perform an initial, an extended and a TRALI transfusion reaction workup following standard procedure." The policy did not define the criteria for "rise in blood pressure". The above procedures were not consistent with one another. The laboratory did not ensure transfusion reaction procedures included defined criteria to promptly identify, investigate and document blood product transfusion reactions. 2. During an interview on 12/14/2023 at 1:25 pm in the conference room, a registered nurse stated nurses transfusing patients have a "yes" or "no" prompt in the transfusion record that asks the transfusionist if the patient -- 11 of 17 -- experienced any transfusion reactions. He further stated that hypotension was typically related to systolic blood pressure not diastolic. 3. A random review of blood and blood component transfusion patient records from March 4, May 27, and September 18, 2023, revealed the following 2 of 12 patient transfusions with signs /symptoms of a transfusion reaction: 09/18/2023 Patient MRN: 2000164129 Packed Red Cell Unit Number: W035223636863 Transfusion started: 10:29 hours Baseline Assessment at 10:20 hours BP: 103/60 Temp: 100.7 Pulse: 118 Resp: 18 During Transfusion Assessment at 10:39 hours BP: 115/67 Temp: not performed/no documentation Pulse: 118 Resp: not performed/no documentation 15-minute Assessment at 10:44 hours BP: not performed/no documentation Temp: not performed /no documentation Pulse: not performed/no documentation Resp: not performed/no documentation During Transfusion Assessment at 10:54 hours BP: 155/65 Temp: not performed/no documentation Pulse: 116 Resp: not performed/no documentation During Transfusion Assessment at 12:18 hours BP: 125/78 Temp: 101.6 Pulse: 117 Resp: 18 Transfusion completion 12:42 hours Post Transfusion Assessment at 12:42 hours BP: not performed/no documentation Temp: not performed/no documentation Pulse: not performed/no documentation Resp: not performed/no documentation Post Transfusion Assessment at 14:27 hours BP: 117/81 Temp: 103.1 Pulse: 119 Resp: 18 Post Transfusion Assessment at 14:40 hours BP: 113/75 Temp: not performed/no documentation Pulse: 131 Resp: not performed/no documentation Post Transfusion Assessment at 14:55 hours BP: 106/67 Temp: not performed/no documentation Pulse: 120 Resp: not performed/no documentation Post Transfusion Assessment at 15:10 hours BP: 95/62 Temp: not performed/no documentation Pulse: 116 Resp: not performed/no documentation Post Transfusion Assessment at 16:03 hours BP: not performed/no documentation Temp: 101.6 Pulse: not performed/no documentation Resp: not performed/no documentation Post Transfusion Assessment at 16:10 hours BP: 102/58 Temp: not performed/no documentation Pulse: 118 Resp: not performed /no documentation Post Transfusion Assessment at 16:25 hours BP: 100/60 Temp: not performed/no documentation Pulse: 111 Resp: 18 Post Transfusion Assessment at 17: 16 hours BP: not performed/no documentation Temp: 101 Pulse: not performed/no documentation Resp: not performed/no documentation Post Transfusion Assessment at 20:15 hours BP: 116/78 Temp: 104.2 Pulse: 133 Resp: 20 The patient had a temperature increase of 2.4 degrees Fahrenheit from baseline at 14:27 hours and an increase of 3.5 degrees Fahrenheit from baseline at 20:15 hours. Per laboratory policy, a temperature increase of 2 degrees Fahrenheit was a sign of a transfusion reaction. NO documentation of prompt identification or investigation of a transfusion reaction was provided. Patient MRN: 2000160217 09/17/2023 Packed Red Cell Unit Number: W091023149508 Transfusion started: 17:31 hours Baseline Assessment at 17:25 hours BP: 100/67 Temp: 97.5 Pulse: 98 Resp: 20 15-minute Assessment at 17:47 hours BP: 111/73 Temp: 97.2 Pulse: 99 Resp: 18 During Transfusion Assessment at 18:36 hours BP: 114/78 Temp: 98 Pulse: 104 Resp: 18 During Transfusion Assessment at 19:52 hours BP: 115/79 Temp: 97.2 Pulse: 104 Resp: 17 During Transfusion Assessment at 21:23 hours BP: 120/78 Temp: not performed/no documentation Pulse: 106 Resp: 20 During Transfusion Assessment at 21:27 hours BP: 117/75 Temp: 97.8 Pulse: 107 Resp: 20 During Transfusion Assessment at 21:43 hours BP: 118/75 Temp: 98.6 Pulse: 104 Resp: 20 Transfusion completion 21:50 hours Post Transfusion Assessment at 21:50 hours BP: not performed/no documentation Temp: not performed/no documentation Pulse: not performed/no documentation Resp: not performed/no documentation Post Transfusion Assessment at 23:27 hours BP: 112/77 Temp: 98.3 Pulse: 114 Resp: 17 Post Transfusion Assessment at 02:27 hours BP: 118/81 Temp: 97.4 Pulse: 121 Resp: 20 Progress note by an RN electronically signed at 02:54 hours stated: "Sent message to hospitalist regarding patient heart rate increasing in 120s. Her blood pressure is stable at 118/81, -- 12 of 17 -- but heart rate is increasing. She got PRBCs one unit during day shift. Just ordered a stat CBC to see what her H&H is" [sic] Post Transfusion Assessment at 04:32 hours BP: 115/72 Temp: 96.8 Pulse: 120 Resp: 20 09/18/2023 Packed Red Cell Unit Number: W035223603997 Transfusion started: 05:47 hours Baseline Assessment at 05:39 hours BP: 118/76 Temp: 96.5 Pulse: 115 Resp: 20 During Transfusion Assessment at 05:55 hours BP: 124/78 Temp: 96.5 Pulse: 111 Resp: 18 15-minute Assessment at 06:04 hours BP: 118/74 Temp: 96.5 Pulse: 113 Resp: 18 During Transfusion Assessment at 07:00 hours BP: 128/88 Temp: not performed/no documentation Pulse: 118 Resp: 18 During Transfusion Assessment at 07:47 hours BP: 138/90 Temp: 99 Pulse: 122 Resp: 17 During Transfusion Assessment at 08:49 hours BP: 142/94 Temp: not performed/no documentation Pulse: 121 Resp: 18 Transfusion completion 09:09 hours Post Transfusion Assessment at 09:09 hours BP: not performed/no documentation Temp: not performed/no documentation Pulse: not performed/no documentation Resp: not performed/no documentation Packed Red Cell Unit Number: W035223613451 Transfusion started: 09:26 hours Baseline Assessment at 09:22 hours BP: 137/86 Temp: 97 Pulse: 94 Resp: 18 During Transfusion Assessment at 09:37 hours BP: 140/85 Temp: 97.5 Pulse: 100 Resp: 18 Progress Note documented by RN at 9:37 hours (electronically signed at 10:24 hours): "Patient vomited. oral [sic] suction done. Maintained HOB 60 degree. Cleaned patient. Vital signs documented. Notified charge nurse and primary doctor." 15-minute Assessment at 09:41 hours BP: not performed/no documentation Temp: not performed/no documentation Pulse: not performed/no documentation Resp: not performed/no documentation During Transfusion Assessment at 09:52 hours BP: 138/85 Temp: 97.5 Pulse: 101 Resp: 18 During Transfusion Assessment at 10:23 hours BP: 138/68 Temp: 97.5 Pulse: 102 Resp: 18 During Transfusion Assessment at 10:53 hours BP: 138/86 Temp: 98.1 Pulse: 101 Resp: 18 During Transfusion Assessment at 11:47 hours BP: 132/91 Temp: 98.6 Pulse: 101 Resp: 17 Transfusion completion 12:05 hours Post Transfusion Assessment at 12:04 hours BP: 143/86 Temp: not performed/no documentation Pulse: 105 Resp: not performed/no documentation Progress Note by provider electronically signed at 12:30 hours stated: "Remains unresponsive but had an episode of emesis earlier today." Physician Notified note sent by RN at