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Based on a review of the medical record, interviews with facility staff and the complainant, review of policies and procedures, and a review of the facility's Complaint and Grievance Log, it was determined that the facility's staff failed to properly monitor one of 4 sampled patients (P) (P#1) per protocol while receiving a blood transfusion at the facility. Specifically, the facility staff failed to obtain P#1's vital signs within the first 15 minutes of the blood being transfused, per a physician's order.

A review of Patient (P) #1 medical record revealed that P#1 arrived at the facility's emergency department (ED) by car on 3/18/22 at 10:19 a.m. P#1 complained of shortness of breath that had lasted for five days. P#1 past medical history included Chronic Obstructive Pulmonary Disease (COPD) (lung diseases that make it hard to breathe and get worse over time), and iron deficiency anemia (a condition in which blood lacks adequate healthy red blood cells. Red blood cells carry oxygen to the body's tissues).

On 3/18/22 at 1:21 p.m., P#1 was admitted to the facility's inpatient unit for treatment of iron deficiency anemia. A review of the facility's consent for the blood transfusion procedure consent revealed that P#1 signed the consent for blood transfusion.

On 3/19/22 at 8:24 a.m., MD GG ordered a transfusion of red blood cells for P#1. Further review of the physician orders revealed that MD GG ordered that P#1's vital signs should be obtained within the first 15 minutes of each unit of blood being transfused, each hour during the infusion; and at the end of the infusion.

A review of the flowsheet revealed that on 3/19/22 at 9:16 a.m., RN CC documented transfusing 300 milliliters (ml) of blood to P#1 through her right forearm at a rate of 120 ml per (/) hour (hr.). A continued review of the flowsheet revealed that P#1's vital signs were obtained at 9:05 a.m., prior to the administration of blood. A detailed review failed to reveal a vital sign within the first 15 minutes of the blood being transfused. Further review of the flowsheet revealed that the next vital sign was obtained at 9:40 a.m. P#1's blood pressure at 9:40 a.m. was 214/97 (high), pulse rate was 86, and temperature 98.2 F.

A review of the progress note revealed that on 3/19/22 at 9:41 a.m., RN CC documented notification to MD GG about P#1's elevated blood pressure during transfusion. MD GG said it was okay to continue the blood transfusion.

A review of the flowsheet revealed that the facility's staff were actively assessing P#1's pain every hour from 3/18/22 at 10:29 a.m. through 3/19/22 at 10:31 a.m. RN CC documented that P#1 had no pain.

A review of the discharge summary revealed that P#1 was discharged from the facility on 3/19/22 at 4:53 p.m. P#1 discharge condition was stable. P#1 hemoglobin level was 7.8, and hematocrit was 25. Her blood pressure was 176/95 at the time of discharge.

An interview with Clinical Manager (CM) FF was conducted on 6/7/22 at 9:47 a.m. CM FF stated she recalled responding to a grievance submitted by P#1 about P#1's stay at the hospital. CM FF said P#1 felt she was not appropriately monitored during her blood transfusion. P#1 said Registered Nurse (RN) CC started the blood transfusion and left the room. P#1 said she was experiencing pain and adverse reactions and stated she spoke to MD GG about the concerns; however, MD GG cleared her to leave. CM FF explained that P#1 said she felt she should not have been discharged. CM FF said that P#1's chart was reviewed, and she apologized to P#1 because RN CC should have monitored P#1 per facility protocol. CM FF said the protocol was to have a patient's vital signs taken within 30 minutes of a blood transfusion and to stay with the patient for the first 15 minutes. CM FF said RN CC stepped out of P#1's room in the first 15 minutes based on the vital signs. CM FF said she reached out to RN CC to ask her about the incidence, but RN CC did not recall P#1. CM FF said RN CC was educated regarding the facility's expectations during blood transfusion and was provided with the appropriate policies. CM FF stated there was also concern about P#1's elevated blood pressure during blood transfusion, which RN CC brought to the attention of MD GG. MD GG completed the transfusion under his guardians.

An interview took place with the Medical Doctor (MD) AA on 6/7/22 at 10:10 a.m. in the conference room. MD AA stated that he was notified about P#1's grievances which included some nursing frequencies of vital sign checks, which CM FF addressed. He stated there were also some physician issues, which were also discussed with P#1. MD AA said he called P#1, and P#1 was concerned that she was discharged too soon from the facility and had issues with pain during a blood transfusion. MD AA said he read the complaint and that P#1 wanted compensation. MD AA explained that he reviewed P#1's chart and that the blood transfusion was done according to protocol. The transfusion met the standard of care. MD AA said P#1 came with hemoglobin of 4.8g/dl, received three units of blood, and she had an adequate physiologic response. P#1's hemoglobin level was 7.8 g/dl at the time of discharge. MD AA said it is acceptable to push blood one bag/hr. P#1 received each unit of blood within 4 hours. MD AA said P#1 was eager to go home, and there was a discussion about keeping her at the hospital for another day, but she refused and wanted to leave. MD AA said P#1 had a past medical history of COPD and was already wheezing upon admission. MD AA said P#1's was treated for the COPD exacerbation and was transitioned to an oral steroid. MD AA said there was no documentation or evidence that P#1 experienced a transfusion reaction or had a volume overload. MD AA said P#1 was clinically stable and deemed fit to be discharged.

During a telephone interview on 6/7/22 at 10:31 a.m. with RN CC, RN CC stated that she had been an RN for two years. RN CC said that the protocol to administer blood was to:

1. verify the order
2. check for all consents required
3. call the blood bank to ensure the type/screen was done
4. obtain the blood
5. verify the blood with another RN
6. obtain the patient's vital signs
7. administer the blood

RN CC stated that an RN must be present in the room for the first 15 minutes and obtain a set of vital signs; if no reaction was noted, vital signs were to be checked every hour during the transfusion. RN CC stated that if a patient had an elevated blood pressure or pain during the transfusion, RN CC would stop the transfusion and notify the MD. RN CC said that anything that happened during the transfusion was worth reporting to the MD because it may be a sign of a reaction. RN CC stated that she received a follow-up email detailing a conversation about blood administration and education with RN FF following the incident/grievance that P#1 made with the facility. RN CC stated she did not remember P#1 or the incident.

A telephone interview was conducted with RN BB on 6/7/22 at 10:45 a.m. RN BB stated that she had been an RN for a little over one year. RN BB said that the protocol to administer blood was to verify a type/screen was completed, check the hemoglobin/hematocrit levels, and confirm that an order was placed by an MD for blood administration. RN BB stated she would notify the blood bank, obtain the blood, obtain a set of vital signs, check the blood with another RN, and then administer the blood. RN BB stated that an RN must stay with the patient for the first 15 minutes to monitor for adverse reactions. RN BB said that if no reactions were noted, follow-up vital signs could be performed every hour during the transfusion. RN BB stated that pumps were programmed according to the order of the medication. If the pump alerted early, RN BB would restart and continue the pump following the same order to ensure that the patient received the full dosage of the medication.

A telephone interview was conducted with Care Partner (CP) EE on 6/7/22 at 12:04 p.m. CP EE stated she had worked at the facility for 14 years. CP EE said she recalled that P#1 received a blood transfusion. CP EE was asked to obtain a set of vital signs, but CPE could not recall the timeframe. CP EE stated she reported the vital signs to RN CC. CP EE stated that P#1 was upset but only complained about the previous shift (night) and did not give specifics. CP EE said she did not ask P#1 for details on why she was upset. CP EE stated she recalled RN CC being in the room at times throughout the blood transfusion and taking vital signs but does not recall the specific times.

A telephone interview was conducted with MD GG on 6/7/22 at 12:18 p.m. MD GG stated he vaguely remembered P#1 when reviewing the discharge summary on P#1's medical record. MD GG said he recalled that P#1 received a transfusion of a few units of blood during her visit. P#1 had issues with COPD. P#1 was extremely eager to leave. MD GG said she talked to P#1 about staying, but P#1 insisted she wanted to go home. MD GG said P#1 had a chronic uncontrolled high blood pressure. There was no concern about volume overload during the blood transfusion. MD GG said he examined P#1 the morning of discharge, re-examined her before leaving, and P#1 was comfortable. MD GG said he was unaware of P#1 complaining of pain, and P#1 was stable for discharge.

During a telephone interview with the complainant on 6/7/22 at 12:33 p.m., the complainant stated that she was swollen in both legs for weeks after discharge and eventually had to go to another facility's ED for two days. The complainant stated that she received an x-ray to rule out heart failure and blood clots in the ED, and the results of that were negative (normal). The complainant stated that she was sent home from the ED with instructions to continue taking home blood pressure medications, prescribed steroids, wearing compression socks, and recommendations to elevate her legs. The complainant stated that when she took her iron pills (home medication), she felt pain in her buttocks which was a similar feeling to when she received the intravenous iron treatment from the facility. However, the pain was greater during the infusion as she received a higher amount. The complainant stated that RN CC was not in the room for the first 15 minutes when the transfusion started, and it was not until 44 minutes later that staff was present. The complainant stated that CP EE did obtain vital signs, and the complainant acknowledged that the blood pressure might be high due to being upset and in pain. The complainant stated that she informed MD GG of the event during discharge. The complainant stated that MD GG discussed the option to keep the complainant another night. However, the complainant stated that she had to leave unless the facility could arrange transportation. The complainant stated that she expressed pain to the RN CC and MD GG. The complainant said that she requested pain medication during her stay, and it was administered.

A review of the facility's procedure titled "Administration of Blood and Blood Components Procedures," an attachment to Policy #7093966, revealed that the purpose of the document was to provide instructions for administering blood and blood components by approved licensed staff members of the facility. Further review revealed that prior to the administration of blood products, there must be a written or verbal order by a licensed practitioner, and it was the responsibility of the clinician initiating the transfusion to assure that this order was present. The order must state the amount and type of blood product to be administered and any special considerations that pertained to the patient. In addition, orders for any intravenous fluids and pre-medication must be included in the order by the licensed practitioner. Continued review revealed that the clinician must ensure that consent for treatment was in the medical record, the hospital-approved Blood Bank Armband was on the patient, ensured that a Type and Screen was performed and that pre-transfusion vital signs were taken and documented. The policy also revealed that just prior to administration, an identification of blood and blood components required a two-person identification between the transfusionist and another licensed staff member. After a transfusion is started, the patient should remain under direct observation by the transfusionist for the first 15 minutes to monitor for signs of reactions following a completion and documentation of the following vital signs: temperature, blood pressure, pulse, respiration rate, and oxygen saturation. Further review revealed that additional vital signs were to be obtained every hour during the transfusion with a 15-minute leeway and the last post-transfusion vital sign was to be no longer than 60 minutes after the end of the transfusion. Documentation of the administration would include the transfusion record sheet and flow sheet of vital signs. If a reaction was suspected, the transfusionist should immediately stop the transfusion, disconnect any IV tubing from the patient, notify the ordering physician and the blood bank, perform a complete clerical recheck of the blood product, and complete a post-transfusion reaction form. Signs and symptoms of a transfusion reaction may include but are not limited to blood pressure changes (greater than 30 mm in systolic), chest pain, back pain, pain at the infusion site, muscle pain, and bronchospasms.

A review of the Complaint and Grievance Log from 3/1/22 through 5/31/22 revealed that the facility received a grievance from P#1 on 4/18/22. Further review of the log indicated that P#1 contacted the facility regarding her stay at the hospital. P#1 stated she received three blood transfusions consecutively without her nurse doing periodic checks. In addition, P #1 stated she went 30 minutes or more without a nurse entering her room. P#1 said after her discharge, she continued to experience pain, and after seeking medical attention, she was informed the pain was due to premature discharge.