HospitalInspections.org

Based on observation, interview and document review the facility failed to ensure expired supplies were removed and not available for use according to facility policy in one of one observations of the Emergency Department.

Findings include:

Facility policy:

The Expired and Out-of-Date Supplies policy read, the purpose of the policy is to ensure supplies with manufacturer expiration dates are monitored and items that are expired are removed from inventory and not utilized. Each department is responsible for monitoring and developing a tracking method for their supplies. Items with a stamped expiration date must be removed from inventory fourteen days prior to the actual expiration date. Each department manager is responsible to designate an employee who will monitor all supplies in possession of the department and promptly return out of date supplies to Materials Management. Materials Management will be responsible for disposal, restocking and inventory updating. All employees will be aware of supply dating and will return any supplies which are expired or out of date.

1. The facility failed to ensure expired supplies were removed from the Emergency Department and were not available for the treatment of patients with emergency medical conditions.

a. On 3/8/22 at 8:45 a.m. observations were conducted in the facility Emergency Department (ED). Observations of ED Room 7 at 9:40 a.m. revealed the following expired supplies:

i. One OB pack (a pre-packaged kit of supplies used for obstetrical procedures such as delivery of an infant) was observed on the bottom shelf of the infant warmer (a device used to provide thermoregulation for newborn infants). The OB pack was stamped with a manufacturer expiration date of 12/14/21. On the front of the OB pack was a list of the supplies contained within, which included bowls, drapes, sponges, scissors, a yankauer (suction) bulb, syringes, umbilical clamps and maternity pads.

ii. Two foley trays (a pre-packaged kit containing supplies needed for insertion of a urinary catheter) were observed in a supply drawer. The foley trays had a manufacturer expiration date of 12/31/21.

iii. One set of pediatric nasal cannula tubing (plastic tubing used to deliver oxygen to a pediatric patient) was observed in a supply cabinet. The tubing had a manufacturer expiration date of 8/18/21.

b. The Emergency Department Nurse Manager (Manager) #1 was present during the observations. Manager #1 stated Room #7 was used mostly for ED patients with orthopedic injuries or obstetrical emergencies. Manager #1 stated supplies in the ortho and OB room were supposed to be checked regularly for expiration dates. She stated expired supplies were to be either removed and used only for training or disposed. She stated an expired OB pack should not be used for patient care.

c. On 3/16/22 at 10:38 a.m. Manager #1 was interviewed. Manager #1 stated staff in the ED were supposed to check for expired materials and supplies in all areas of the ED. She stated this was not performed at established intervals but rather when staff had spare time. She stated there was a form to document checks for expired supplies, however she did not know if all staff in the ED were aware where the form was or how to complete it.

Manager #1 stated supplies needed to be checked for expiration because supplies could break down over time, and if the supply was beyond the expiration date the integrity of the supply could be compromised. She stated if the seal of a medical supply broke down over time there could also be an infection control issue if an expired supply was used.

Manager #1 stated she did not know the last time Room #7 was checked for expired supplies. She stated when she went to find a new OB pack in the facility's central supply area she found three more OB packs with the same expiration date as the expired OB pack observed in the ED.

Based on the manner and degree of the standard-level deficiencies referenced to the Condition, it was determined the Condition of Participation §485.635 Provision of Services was out of compliance.

C-1048 A registered nurse or, where permitted by State law, a physician assistant, must supervise and evaluate the nursing care for each patient, including patients at a SNF level of care in a swing-bed CAH. Based on document review and interview, the facility failed to ensure nursing staff reported abnormal patient assessment findings to the provider according to facility policy. The failure was identified in one of one medical records reviewed for patients who received Medication Assisted Treatment (MAT) induction in the medical surgical unit (Patient #16). Furthermore, the facility failed to monitor the patient per policy to demonstrate patient condition and stabilization efforts in one of one medical records reviewed for post-partum Emergency Department (ED) patients (Patient #12).

C-1049 All drugs, biologicals, and intravenous medications must be administered by or under the supervision of a registered nurse, a doctor of medicine or osteopathy, or, where permitted by State law, a physician assistant, in accordance with written and signed orders, accepted standards of practice, and Federal and State laws. Based on interviews and document review, the facility failed to ensure policies and procedures were followed for the administration of drugs and the transfusion of blood products. Specifically, staff at the facility failed to ensure process were followed for the administration of blood in two of the three records reviewed where patients received a blood transfusion (Patient #12 and Patient #23). Additionally, staff at the facility allowed a provider who did not work at the facility to administer medications to a patient in one of one records where an outside provider was present with a patient. (Patient #12).

Based on document review and interview, the facility failed to ensure nursing staff reported abnormal patient assessment findings to the provider according to facility policy. The failure was identified in one of one medical records reviewed for patients who received Medication Assisted Treatment (MAT) induction in the medical surgical unit (Patient #16). Furthermore, the facility failed to monitor the patient per policy to demonstrate patient condition and stabilization efforts in one of one medical records reviewed for post-partum Emergency Department (ED) patients (Patient #12).

Findings include:

Facility policies:

The Vital Signs: Routine policy read, this document provides the policy for vital signs monitoring for the nursing staff. It is the policy to obtain, assess and record patient vital signs on all patients on the Inpatient Unit. Vital signs will be taken routinely and documented. The RN (Registered Nurse) may obtain all vital signs or specific vital signs more frequently if condition warrants. Providers will be notified of changes in patient condition that may warrant more frequent monitoring. Abnormal vital signs should be reported to the RN and/or provider. Documentation of report to the provider will be documented in the electronic health record.

The Nursing Assessment policy read, any change in the patient's condition requires an immediate reassessment with changes in the plan of care reflecting the change in condition. Status changes or updated information that may not have been seen or given to the physician/ will be called to his/ her attention at the time of assessment.

Managing Maternal Health Emergencies policy read, the purpose is to provide guidelines to assist with the identification and management of potential maternal health emergencies. The medical center provides OB care through the emergency department to patients who may be experiencing maternal health emergencies. The policy defines a maternal hemorrhage as the leading cause of preventable maternal death worldwide and encompasses antepartum, intrapartum, and postpartum bleeding. The Emergency Department (ED) nurse is to provide prompt triage to include blood pressure (BP) evaluation. The nurse should repeat BP readings and report to the provider a BP that exceeds 116/110.

Standards of Practice or Care policy read, fundamental emergency department nursing interventions include vitals signs obtained every 15 minutes x two then every thirty minutes afterwards unless ordered more frequently.

1. The facility nursing staff failed to report abnormal assessment findings, specifically vital signs which were not within normal limits, to the provider overseeing the patient's care.

a. Patient #16's medical record was reviewed. Patient #16 was treated on 2/26/22 in the facility's medical surgical unit for MAT induction (initiation of treatment for substance use disorders which utilizes Suboxone, a narcotic medication used to control opioid withdrawal and craving).

The medical record revealed Registered Nurse (RN) #2 assessed Patient #16's vital signs on six occasions between 8:30 a.m. when Patient #16 presented to the unit for treatment, and 3:48 p.m. when Patient #16 was discharged. The medical record included a reference range for normal vital signs. On four of six assessments of Patient #16's vital signs, the patient's diastolic blood pressure was outside of the reference range of 60 to 90 mmHg.

i. At 12:08 p.m. Patient #16's diastolic blood pressure was 54.

ii. At 1:23 p.m. Patient #16's diastolic blood pressure was 59.

iii. At 2:56 p.m. Patient #16's diastolic blood pressure was 51.

iv. At 3:48 p.m. Patient #16's diastolic blood pressure was 52.

The recorded diastolic blood pressure values were all lower than the reference range of 60-90 mmHg indicated in the nursing flowsheets. However, there was no evidence in the medical record RN #2 notified the patient's provider of the abnormal vital sign assessments.

b. On 3/16/22 at 1:31 p.m., Registered Nurse (RN) #2 was interviewed. RN #2 stated she was a nurse on the inpatient medical surgical unit, and she was one of two nurses who cared for patients during induction of MAT. She stated when a patient underwent induction for MAT she assessed the patient regularly throughout the patient's treatment, which included obtaining the patient's vital signs. She stated she obtained vital signs when the patient arrived and also each time she assessed the patient's withdrawal symptoms. She stated it was important to monitor the patient's vital signs during MAT induction because Suboxone was a sedating medication and the patient was in withdrawal, and both could affect the patient's vital signs.

RN #2 stated she checked the patient's blood pressure each time she assessed the patient's vital signs. She stated if a patient's diastolic blood pressure was lower than 70 or 60 she would pay more attention to that patient. She stated if there were changes in the patient's vital signs or the vital signs were not within normal ranges she notified the provider who prescribed the patient's treatment. RN #2 stated if a patient's blood pressure was low she assessed the patient for symptoms, however she stated even if the patient was not symptomatic she would still notify the provider of the vital signs.

RN #2 stated when Patient #16 came in for MAT induction his blood pressures were in the 100's/60's. She stated when Patient #16's diastolic blood pressure went below 60 she did not notify the provider because the patient did not have any other symptoms and she believed the patient's blood pressure was normally low. RN #2 stated because his blood pressure remained consistently low throughout the treatment, she did not believe she needed to notify the provider of his vital signs.

RN #2 stated when a patient's blood pressure was low there was a risk the patient could become lightheaded or dizzy, and if a patient became symptomatic with low blood pressure the patient could need further monitoring in the hospital.

c. On 3/16/22 at 12:01 p.m., Family Nurse Practitioner (FNP) #3 was interviewed. FNP #3 stated she was one of two providers who oversaw the MAT service at the facility. She stated patients were seen for MAT induction on the medical surgical unit as observation status patients, as this allowed a nurse to monitor the patient's response to the treatment.

FNP #3 stated the nurse was to assess the patient throughout the MAT induction, which included evaluating the patient's withdrawal symptoms and their vital signs. She stated nurses contacted her to notify her of any persistent symptoms or abnormal findings so that she could order necessary interventions. FNP #3 stated nursing staff were to report any vital signs which were outside of normal limits to her.

FNP #3 stated she oversaw Patient #16's MAT induction. She stated she was not aware Patient #16's diastolic blood pressure was in the 50's during his treatment. She stated RN #2 contacted her during Patient #16's treatment to notify her the patient had persistent cravings, however RN #2 did not notify her of the patient's low blood pressures.

FNP #3 stated because Patient #16 was a new patient at the facility she did not know if his blood pressure was low at baseline. FNP #3 stated it would have been important for RN #2 to notify her of the patient's blood pressures as the patient may have needed fluids to bring his pressures back up.

FNP #3 stated if a patient's blood pressure was low the risks to the patient included dizziness, fainting, fatigue, blurry vision and confusion.


42693

2. The facility failed to monitor the patient per policy to demonstrate patient condition and stabilization efforts.

a. Review of Patient #12's medical record revealed there was a lack of evidence the patient was monitored and assessed according to facility policy and protocols.

i. On 2/17/22 at 5:36 a.m., Patient #12 arrived at the emergency department. The patient's diagnosis was determined to be postpartum hemorrhage and hemorrhagic shock.

ii. On 2/17/22 at 6:46 a.m., one set of vital signs was documented for the patient's stay. The documented blood pressure was systolic 72. The diastolic BP was not documented. The patient's HR was noted to be 116 BPM.

iii. On 3/15/22 at 3:45 p.m., the facility was asked to ensure all documents were provided in regards to Patient #12's medical record. The facility claimed the Critical Care document had been completed by the nurse, which would be where additional vital signs and assessments were documented, however no evidence was provided.

b. Interviews revealed there was no evidence Patient #12 was monitored and assessed per facility protocol.

i. On 3/14/22 at 5:55 p.m., an interview was conducted with RN #7. RN #7 stated Patient #12 was placed on a monitor and her blood pressure was checked every five minutes. RN #7 acknowledged the chart lacked evidence Patient #12 was monitored throughout her ED care.

ii. On 3/16/22 at 10:28 a.m., an interview was conducted with ED Nurse Manager (Manager) #1. Manager #1 stated the ED monitors can be set to collect vital signs on a patient during certain time frames. Manager #1 stated RNs could also use the critical care form or the computer to chart assessment and vital sign monitoring. Manager #1 stated Patient #12 should have been monitored at least every 10 minutes.

iii. On 3/15/22 at 1:21 p.m., an interview was conducted with Chief Nursing Officer (CNO) #10. CNO #10 stated in the emergency department, patients are placed on monitors and a time frame was set for the vital signs to be obtained by the machine. CNO #10 stated if vital signs were not monitored while the patient was present in the ED it would be problematic since there would not be evidence to demonstrate the patient's condition.

Based on interviews and document review, the facility failed to ensure policies and procedures were followed for the administration of drugs and the transfusion of blood products. Specifically, staff at the facility failed to ensure process were followed for the administration of blood in two of the three records reviewed where patients received a blood transfusion (Patient #12 and Patient #23). Additionally, staff at the facility allowed a provider who did not work at the facility to administer medications to a patient in one of one records where an outside provider was present with a patient. (Patient #12).

Findings include:

Facility policies:

The Medication Administration policy read, only a provider with current privileges or an authorized staff member may administer medications. Medication administration will be documented in the patient's eMAR or appropriate flowsheets.

The Emergency Release of Blood Products policy read, the purpose is to provide a procedure for the emergency release of blood. If time doesn't permit the ability to type the patient's blood specimen, group O red blood cells should be used. If the patient is male or a female older than child bearing age, type of positive may be substituted but must have the ABO confirmed before issuing. The statement that a patient is receiving an urgent transfusion prior to testing being completed, must be signed by the medical provider. The patient's historical type will never be used to issue type-specific blood, only a current specimen that has been collected and the blood bank bracelet attached as per policy will be accepted.

The Blood and Blood Component Administration policy read, packed red blood cells, platelets, and fresh frozen plasma will be verified at the patient's bedside prior to the transfusion, by two registered nurses (RN) or a RN and provider. The unit to be transfused will be compared with the Blood Transfusion Tag for a complete match as well as patient identification and patient compatibility for red cells.

The Issuing (Dispensing) Blood and Blood Products policy read, two qualified staff members must compare and check the blood product label, the attached unit tag and the Blood product check out slip matching the following information before product is issued: patient's name, date of birth, blood band bracelet, patient's ABO Rh type, unit #, unit ABO Rh type, unit expiration, etc. The transfusionist and one other individual are responsible for positively identifying the recipient and matching the blood component to the recipient through the use of two acceptable identifiers at the bedside.

The Blood Bank Inventory policy read, the purpose is to provide a policy for the management of the blood bank inventory. The policy read the following is the inventory to be kept for Packed Red Blood Cells (PRBC): two units of O +, two units of A +, and two units of O-.

The Blood Procurement in Emergency Situations read, when an emergency arises, the blood bank technologist will communicate with the caregiver the products available at the facility. The technologist should always stay in contact with the caregiver to communicate the status of the products.

The Indications for Transfusion policy read, in order to use blood, physicians should know what products are available and have knowledge of the properties. As with all drugs known side effects, the physician must weigh the potential danger against the expected benefit before ordering a transfusion. A blood transfusion should never be ordered or given unless the expected benefit exceeds the potential risk.

Processing Requests for Blood components policy read, each request for blood must be processed accurately. The lab is to perform tests on the patient's specimen to determine blood ABO Group (cell and serum), Rho(D) Typing, and Antibody Screening. Do not rely on a historical type. Each new specimen must be retyped.

The Release of Uncross Matched Blood policy read, situations arise in which it is not prudent to wait for the completion of compatibility testing prior to the administration of blood. The medical urgency often justifies the increased risk. When a physician believes the urgency of the situation warrants the release of blood before the completion of testing, the provider must indicate both the urgency and acceptance of the additional risk in writing.

Facility documents:

According to the February Packed Red Blood Cell (PRBC) Inventory Log, on 2/17/22 there were the following PRBC units available: four units of O-, one unit of O+, eight units of A+, and four units of A-.

According to the March PRBC Inventory Log, on 3/6/22 there were the following PRBC units available: two units of O-, six units of O+, four units of A+ and four units of A-.

According to the Fresh Frozen Plasma (FFP) inventory, on 2/17/22 there were a total of 10 units of FFP available.

Resources:

According to The American College of Surgeons (ACS) Trauma Quality Improvement Program (TQIP) Massive Transfusion in Trauma Guidelines, as referenced in the Massive Transfusion Protocol provided by the facility, during a massive transfusion, communication between the ED and the transfusion service is imperative. Uncrossmatched (O Rh negative or O Rh positive RBC) should be available immediately. Group O Rh negative RBC should be reserved for women of child bearing age. For MTP to be effective, universal thawed plasma should be immediately available.

A designated trauma center should have on hand and immediately available for immediate release at least 8 units of universal donors (O + and O-).

1. The facility failed to ensure processes were followed for the administration of blood and blood products.

A. A review of medical records revealed the provider ordered O- blood however a different blood type was administered.

a. Review of Patient #15's record revealed O- blood was ordered however O + blood was administered without the provider's knowledge.

i. According to the EMS run-report, on 2/17/22 at 3:20 a.m., Patient #12 gave birth at home. EMS was called to Patient #12's home due to the newborn baby being in distress.

ii. On 2/17/22 at 5:36 a.m., Patient #12 arrived at the emergency department. The patient's diagnosis was determined to be postpartum hemorrhage and hemorrhagic shock.

iii. The blood transfusion order set was placed at 5:49 a.m. by Provider #8. Two units of O- blood were ordered emergent.

iv. At 5:55 a.m., labs were collected as ordered by the provider to include the type and screen for the administration of blood products.

v. At 6:00 a.m., the first unit of PRBCs was released from the lab as emergent and was provided prior to the patient's blood type resulting (uncrossed).

According to the Blood Bank Card, O+ positive was released. O+ blood administered to the patient was in contrast to the provider's order.

vi. At 6:30 a.m., the first unit of PRBCs was administered, 40 minutes after the order was placed. Additionally, the second unit of PRBCs was released as emergent and uncrossed.

vii. According to the blood bank results the patient's Type and Cross resulted at 6:47 a.m.,17 minutes after the second unit of O+ blood was initiated.

b. Review of Patient #23's record revealed the provider ordered two units of O- blood however one unit of O+ and one unit of A+ was administered without the provider's knowledge.

i. On 3/6/22 at 10:54 p.m., Patient #23 arrived after a motor vehicle crash (MVC). The trauma team was activated.

ii. At 11:45 p.m., the emergency blood transfusion form was completed.

iii. According to the provider's note, he was made aware only two units of O- blood were present. The provider further documented the patient received two units of Fresh Frozen Plasma and two units of O- were administered to the patient.

iv. The provider placed an order for the blood transfusion order set at 12:16 a.m. The provider specified Stat O- blood was to be administered.

v. According to the blood administration record, at 11:51 p.m. one unit of O+ blood was administered. At 23:57 one unit of FFP was administered. At 00:29 one unit of A+ was administered.

There was no evidence in the record the provider was made aware of O + and A + blood being administered rather than the ordered O- blood.

B. Interviews revealed staff and the provider attending to Patient #12 were unaware she had received O + blood instead of O- which was ordered by the provider.

a. On 3/15/22 at 11:07 a.m., an interview was conducted with ED Provider (Provider) #8. Provider #8 confirmed he had ordered O- blood for Patient #12. During the interview, it was noted to Provider #8 the patient received O+ blood. Provider #8 stated he was not aware the patient received O+ blood. Provider #8 stated he had notified the lab prior to the patient's arrival they would need emergent O- blood.

b. On 3/14/22 at 5:55 p.m., an interview was conducted with RN #7. RN #7 stated two units of blood were ordered and the first unit of O negative blood was administered immediately through a rapid infuser. RN #7 stated he was unaware O+ blood was administered instead of O-.

c. On 3/15/22 at 10:09 a.m., an interview was conducted with Travel Medical Technologist (Tech) #9. Tech #9 worked in the lab and the blood bank at the facility. Patient #12 was discussed with Tech #9. Tech #9 stated the tech who was on the prior shift released the first unit of blood for the patient. Tech #9 stated the ED called for the second unit of blood at the same time she received a specimen on the patient. Tech #9 stated the process was to do a type and screen on the patient unless it was an emergent situation and there wasn't enough time, then the tech would release O- blood. Tech #9 stated in regards to Patient #12, the night tech had stated to her the patient was O +.

d. On 3/16/22 at 10:28 a.m., an interview was conducted with ED Nurse Manager (Manager) #1. Manager #1 stated in an emergent situation O + or O- blood should be administered. If the situation was truly emergent and there wasn't time to do a type and screen, O- should be administered because it was the universal blood donor type (could be administered to any patient regardless of their blood type). Manager #1 stated she was previously not aware Patient #12 received O+ blood even though O- blood was ordered by the provider.

e. On 3/16/22 at 6:13 p.m., an interview was conducted with Lab Manager (Manager) #11. Manager #11 stated when a request for emergent blood was placed, the lab technician would check to see if the patient had a prior type and screen. Manager #11 stated this was the standard process because the most compatible blood product should be administered to the patient. Manager #11 stated the Provider can request a certain type of blood, however the blood bank will administer what they determine was the best type for the patient regardless of the provider's order. Manager #11 stated for Patient #12, he had typed the Patient's blood prior to the blood orders being placed.

Review of medical records revealed a lack of evidence to indicate the patient's blood type and screen was completed prior to the order for blood being placed.

Manager #11 stated there was not a policy which stated the lab technician could determine or release the type of emergent blood rather than to follow the doctor's order. Manager #11 stated he notifies the provider on what blood type the patient is receiving.

According to the previous interview with Provider #8, he was unaware Patient #12 received O+ blood until the interview was conducted.

f. On 3/15/22 at 1:21 p.m., an interview was conducted with Chief Nursing Officer (CNO) #10. CNO #10 stated the facility did not have a hypovolemic shock protocol and the provider would initiate the massive transfusion protocol if the provider chose to. CNO #10 stated emergent transfusions were ordered by the provider and then the provider signed for the release of the emergent blood. CNO #10 explained the RN caring for the patient was responsible to ensure the correct blood is administered to the patient. CNO #10 stated she was not previously aware the patient received O+ blood although the provider ordered O- blood.

2. The facility failed to ensure a provider or staff member of the facility administered medication to a patient.

a. Review of Patient #12's medical record revealed it was unclear whether the patient received a dose of Cytotec (a medication administered in order to prevent postpartum hemorrhage) ordered by the provider.

i. According to the Medication Administration record, Registered Nurse (RN) #7 documented on 2/17/22 at 6:51 a.m., Cytotec was not given because the medication was not in the pyxis (medication dispensing machine).

ii. According to the ED Provider (Provider) #8's note, signed 2/17/22 at 6:56 a.m., 100 mcg of Cytotec was given to Patient #15.

b. Interviews revealed Patient #15 did receive the Cytotec medication and the medication was administered by a provider who was not employed nor had credentialed privileges at the facility.

i. On 3/14/22 at 5:55 p.m., an interview was conducted with RN #7. RN #7 stated he retrieved the Cytotec from the pyxis and handed it to the midwife, who had arrived with the patient, for her to administer. RN #7 stated he charted the medication as not given since he was unsure what to chart due to the fact he had not administered the medication.

ii. On 3/16/22 at 10:28 a.m., an interview was conducted with ED Nurse Manager (Manager) #1. ED Manager #1 stated the facility did not have midwife providers on staff.

iii. On 3/15/22 at 1:21 p.m., an interview was conducted with Chief Nursing Officer (CNO) #10. CNO #10 stated once Patient #15 arrived at the facility, she was under the care of the ED provider and no longer under the care of the midwife who arrived with the patient. CNO #10 stated the facility did not have midwife providers on staff.

The medication administered by the midwife was in contrast to interviews and policies at the facility which read only a provider or staff employed by the facility may administer medications.

Based on observations, interviews and document reviews, the facility failed to ensure methods to prevent and control the transmission of infections were implemented. Specifically, the facility failed to ensure equipment was covered during transport per national guidelines to prevent contamination in one of one observations of equipment transport.

Findings include:

Facility policy:

The Reprocessing Flexible Fiberoptic Endoscopes policy read, transport the endoscope using both hands or on a clean plastic tray.

Reference:

The Storage and Transport of Flexible Endoscopes guidance read, endoscopes that have been reprocessed must be properly transported back to reuse by placing the device into a clean, labeled container. This step of clean transport is important to prevent a patient-ready endoscope from being inadvertently recontaminated. By completing this cycle of proper endoscope storage and transport, the risk of unsafe endoscopes being delivered back to the procedure room for reuse is reduced.

1. The facility failed to ensure endoscopes (A medical device used to look inside a body cavity or organ) were covered during transport after they had been processed (cleaned and disinfected) to prevent contamination.

a. On 3/9/22 at 10:41 a.m., an observation was conducted of a clean endoscope being transported to the procedure room. Surgical technician (ST) #5 handed an endoscope which had been processed to ST #4. ST #4 took the endoscope and left the processing room with the scope uncovered and walked through the entrance of the preoperative (pre-op)/ post anesthesia care unit (PACU) area and into the procedure room. This was the same entrance staff, patients and visitors used.

b. During the observation, ST #4 was interviewed. ST #4 stated the normal process was for the person who cleaned and processed the endoscope to transport it to the procedure room. ST #4 stated it was the process at the facility to transport endoscopes uncovered after they had been processed.

c. During the observation, ST #5 was interviewed. ST #5 stated both he and the regular staff who processed the endoscopes did not cover them while transporting to the procedure room. ST #5 stated he had never been educated to cover the endoscope for transport nor had he seen national guidance to do so.

d. On 3/9/22 at 10:45 a.m., director of surgical services (director) #6 was interviewed. Director #6 stated the facility did not cover clean endoscopes when transporting them to the procedure area.

Director #6 was able to provide national guidance which read, the clean endoscope should be transported in a clean labeled container to prevent contamination of the endoscope.

On 3/9/22 at 12:00 p.m. a follow up interview was conducted with director #6. Director #6 stated she read the guidance she provided to surveyors and she agreed the endoscopes should be covered during transport once processed. She stated the guidance revealed it was a risk to patients since it was possible to inadvertently recontaminate the endoscope. Director #6 stated the facility's current process was created by the previous director and would need to be revised.

e. On 3/16/22 at 9:28 a.m., infection preventionist (IP) #15 was interviewed. IP #15 stated it was important to follow policies and national guidelines since they were evidence based. IP #15 stated there was a risk of endoscopes being contaminated in transport if they were not covered.

f. Review of the facility's endoscope transport policy revealed it was in contrast to the national guidance Director #6 provided.

Based on the manner and degree of the standard-level deficiency referenced to the Condition, it was determined the Condition of Participation §485.641 Quality Assessment and Performance Improvement Programs was out of compliance.

C-1311 QAPI Program Design and scope. The CAH's QAPI program must: Address outcome indicators related to improved health outcomes and the prevention and reduction of medical errors, adverse events, CAH acquired conditions, and transitions of care, including readmissions. Based on interview and document review, the facility failed to ensure the Quality Assessment and Performance Improvement (QAPI) program reviewed and investigated patient safety events to identify causative factors and implement measures to prevent reoccurrence. The failure was identified in one of two patient safety events reviewed which occurred in the Emergency Department (ED). (Cross Reference 1048, 1049)

Based on interviews and document review, the facility failed to ensure the Quality Assessment and Performance Improvement (QAPI) program reviewed and investigated patient safety events to identify causative factors and implement measures to prevent reoccurrence. The failure was identified in one of two patient safety events reviewed which occurred in the Emergency Department (ED). (Cross Reference 1048, 1049)

Findings include:

Facility policies:

The Occurrence Reporting, Response, Investigation and Resolution policy read, an occurrence is any event or situation that is not consistent with facility policy, procedure or differs from established operations. Occurrences that must be reported include: any deviation from the normal routine of the hospital which could adversely affect the quality of patient care, safety or satisfaction; any medical outcome that is less than what would normally be expected; any unexpected patient death; life-threatening transfusion errors or reactions.

Investigation: the completed electronic occurrence report is reviewed by the compliance coordinator and forwarded to the appropriate party to complete an investigation. Root Cause Analysis will be utilized when appropriate. The investigator will ensure the information is correctly and thoroughly documented. Information will be shared with other hospital staff, committees, CEO, the Board and others as appropriate. Any serious injury or occurrence with serious risk potential will be reported to the hospital's malpractice insurance carrier by the Chief Administrative Director. Occurrence reports will be reviewed within the organization for the purpose of improving system processes.

The QAPI Program read, senior leadership ensures the QAPI program is sufficiently broad in scope and authority to properly identify and correct areas of needed improvement. The Quality Council receives and analyzes QAPI data/ reports from the members of the council to ensure the QAPI process is ongoing and effective, and provides an opportunity for other hospital committees and departments to share problems identified and seek guidance on possible corrective actions. QAPI staff collect, analyze and share information to improve patient outcomes and organizational performance; participate in root cause analysis, sentinel event review, and near miss analysis. Hospital department managers identify quality and performance problems and oversee the implementation of improvement activities in their respective departments.

Identification of areas for improvement may result from continuous monitoring of current practices. Departments establish key indicators of performance. Some examples of key performance indicators might be errors in medication delivery, unexpected patient outcomes and adverse event reports. Ongoing monitoring and benchmarking performance helps to focus improvement efforts.

The Investigation of Transfusion Reactions policy read, this document describes the procedure for investigation of possible transfusion reactions. The investigation of transfusion reactions is initiated by the laboratory and facilitated by the Quality and Performance Improvement Manager. If a suspected transfusion reaction is reported on a patient, follow the procedure on the "Investigation of Transfusion Reaction" form.

The Evaluation and Response to a Blood Transfusion Reaction policy read, this document provides the policy regarding response to a suspected transfusion reaction. Transfusion reaction is any unfavorable event in the recipient resulting from a transfusion. Any adverse symptoms or physical signs occurring during transfusion of blood or its components should be considered potentially part of a life-threatening reaction, and investigation with appropriate therapy started as soon as possible.

The Blood Procurement in Emergency Situations read, when an emergency arises, the blood bank technologist will communicate with the caregiver the products available at the facility. The technologist should always stay in contact with the caregiver to communicate the status of the products.

The Indications for Transfusion policy read, in order to use blood, physicians should know what products are available and have knowledge of the properties. As with all drugs known side effects, the physician must weigh the potential danger against the expected benefit before ordering a transfusion. A blood transfusion should never be ordered or given unless the expected benefit exceeds the potential risk.

Managing Maternal Health Emergencies policy read, the purpose is to provide guidelines to assist with the identification and management of potential maternal health emergencies. The medical center provides OB care through the emergency department to patients who may be experiencing maternal health emergencies. The policy defines a maternal hemorrhage as the leading cause of preventable maternal death worldwide and encompasses antepartum, intrapartum, and postpartum bleeding. The emergency department physician is to provide a medical screening exam (MSE) and stabilize/provide treatment of any emergencies such as maternal hemorrhage. The provider should provide treatment within one hour of diagnosis and utilizes the maternal order set to standardize care and improve outcomes. The Emergency Department (ED) nurse is to provide prompt triage to include blood pressure (BP) evaluation. The nurse should repeat BP readings and report to the provider a BP that exceeds 116/110.

The Massive Transfusion Protocol (MTP) policy read, the purpose was to establish a mechanism for the efficient procurement of blood products from the blood bank for patients identified with or at risk for hemorrhagic shock/hypovolemic shock. The protocol should be considered with the physician's primary assessment indicates the patient will require eight units of Packed Red Blood Cells (PRBC's) in 24 hours and with any two or more triggers to include a systolic blood pressure (SBP) less than 90; penetrating injury with heart rate (HR) greater than 120; INR (a test used to calculate prothrombin time. Prothrombin is a protein made by the liver to for coagulation) greater than 1.5; and Lactate greater than 4.

The steps of the massive transfusion protocol included 1. Tranexamic acid (a medication to assist with clotting) should be administered at the beginning of the protocol or within 3 hours of the injury. 2. The blood bank is to thaw 1 unit of Fresh Frozen Plasma (FFP) for every PRBC unit administered. 3. The protocol must be signed by the ordering physician or have verbal orders placed in the chart. 4. Emergency blood release must be signed by the ordering physician. 5. Check with the physician every 30 minutes to ensure the MTP is still in place and notify the blood bank once the MTP is stopped

The Medication Administration policy read, only a provider with current privileges or an authorized staff member may administer medications. Medication administration will be documented in the patient's eMAR or appropriate flowsheets.

Standards of Practice or Care policy read, fundamental emergency department nursing interventions include vitals signs obtained every 15 minutes x two then every thirty minutes afterwards unless ordered more frequently.

The Emergency Resuscitation and Initial Stabilization policy read, documentation will be completed by the provider and RN staff.

Facility documents:

According to the February PRBC Inventory Log, on 2/17/22 there were the following PRBC units: four units of O-, one unit of O+, eight units of A+, and four units of A-.

According to the Fresh Frozen Plasma (FFP) inventory, on 2/17/22 there were a total of 10 units of FFP available.

References:

The Transfusion Reaction Form: Instructions for Transfusion Reactions document read, if a hemolytic transfusion reaction is suspected, perform a clerical check of the patient's identification band, unit label and this Transfusion Report. Section 2 read, clerical checks to be performed: clerical check of ALL blood components transfused in the last 24 hours. Initial the following when the check is complete: worksheets, logs and product labels. Submit this completed form with all specimens to the lab.

1. The facility's QAPI program failed to implement performance improvement activities in response to a patient safety event which involved a patient who was treated in the facility's ED. The patient was transferred to another facility and subsequently died. The facility's QAPI program did not investigate the safety event in order to identify potential quality problems and implement action to prevent reoccurrence.

A. Patient #12

Medical record review and interviews revealed facility staff did not adhere to facility policies and protocols in order to stabilize a patient diagnosed with postpartum hemorrhage; did not administer blood products according to facility policy and provider's order; did not monitor a patient in the ED according to facility policy; and did not administer medications according to facility policy.

1. Patient #12's medical record was reviewed. According to the Emergency Medical Services (EMS) report, Patient #12 gave birth at home on 2/17/22 at 3:20 a.m. The EMS report read Patient #12 experienced indeterminate blood loss and hypotension following the birth. Patient #12 arrived at the facility's ED at 5:36 a.m. and her diagnosis was determined to be postpartum hemorrhage and hemorrhagic shock.

2. According to the medical record, Patient #12 met two triggers for the facility's Massive Transfusion Protocol (MTP, a protocol devised to stabilize a patient in hemorrhagic/hypovolemic shock), as her systolic blood pressure was below 90 throughout the course of her treatment in the ED and her lactate was greater than 4. According to the MTP protocol, if a patient met two or more triggers for MTP or if a patient was expected to require eight units of PRBCs (packed red blood cells) in a 24 hour period the MTP should be considered.

There was no evidence in Patient #12's medical record the MTP was ordered or initiated.

a. Interviews revealed Patient #12's presentation qualified for the MTP to be activated, however due to gaps in the process and communication the MTP was not initiated.

i. On 3/14/22 at 5:55 p.m., an interview was conducted with Registered Nurse (RN) #7. RN #7 stated he cared for Patient #12 in the ED. RN #7 stated during Patient #12's treatment in the ED there was no conversation with the provider about initiating the MTP.

ii. On 3/15/22 at 10:09 a.m., an interview was conducted with Travel Medical Technologist (Tech) #9. Tech #9 worked in the lab and the blood bank at the facility. Patient #12 was discussed with Tech #9. Tech #9 stated fresh frozen plasma (FFP), was not ordered by the provider and was not provided to Patient #12. According to the MTP, administration of FFP was the second step for a massive transfusion.

iii. On 3/15/22 at 11:07 a.m., an interview was conducted with Provider #8. Provider #8 stated he cared for Patient #12. Provider #8 stated the patient was in need of a large amount of blood products that the facility did not have. Provider #8 stated he did not use the maternal hemorrhage order set available at the facility and did not activate the MTP due to the lack of resources at the facility.

This was in contrast to the blood bank inventory for 2/17/22, which revealed the facility had the following onsite: four units of O-, four units of O +, eight units of A +, and four units of A-. According to the Fresh Frozen Plasma (FFP) inventory, on 2/17/22 there were a total of 10 units of FFP available.

Provider #8 stated when he ordered the emergent blood he was not made aware of the inventory available at the facility. This was in contrast to facility policy which read, when an emergency arises, the blood bank technologist will communicate with the caregiver the products available at the facility.

3. Review of Patient #12's medical record revealed O+ blood was administered to the patient without the provider's knowledge. Provider #8 placed the blood transfusion order set at 5:49 a.m. Two units of O- blood were ordered. However, according to the medical record and the Blood Bank Card O+ blood was released and administered to Patient #12 at 6:30 a.m. and again prior to the patient's departure from the ED at 6:56 a.m. This was in contrast to the provider's order for O- blood. (Cross Reference 1049)

a. Interviews revealed staff and the provider attending to Patient #12 were unaware she received O+ blood instead of O- which was ordered by the provider.

i. On 3/14/22 at 5:55 p.m., an interview was conducted with RN #7. RN #7 stated two units of blood were ordered and the first unit of O- blood was administered immediately through a rapid infuser. RN #7 stated he was unaware O+ blood was administered instead of O-.

ii. On 3/15/22 at 11:07 a.m., an interview was conducted with ED Provider (Provider) #8. Provider #8 confirmed he had ordered O- blood for Patient #15. During the interview, it was noted to Provider #8 the patient received O+ blood. Provider #8 stated he was not aware the patient received O+ blood. Provider #8 stated he had notified the lab prior to the patient's arrival they would need emergent O- blood.

iii. On 3/15/22 at 1:21 p.m., an interview was conducted with Chief Nursing Director (CNO) #10. CNO #10 stated emergent transfusions were ordered by the provider and then the provider signed for the release of the emergent blood. CNO #10 explained the RN caring for the patient was responsible to ensure the correct blood is administered to the patient. CNO #10 stated she was not previously aware the patient received O+ blood although the provider ordered O- blood.

iv. On 3/16/22 at 10:28 a.m., an interview was conducted with ED Nurse Manager (Manager) #1. Manager #1 stated she was previously not aware Patient #15 received O+ blood even though O- blood was ordered by the provider.

v. On 3/16/22 at 6:13 p.m., an interview was conducted with Lab Manager (Manager) #11. Manager #11 stated the Provider could request a certain type of blood, however the blood bank administered what they determined was the best type for the patient regardless of the provider's order. Manager #11 stated for Patient #12, he had typed the patient's blood prior to the blood orders being placed. However, review of medical records revealed a lack of evidence to indicate the patient's blood type and screen was completed prior to the order for blood being placed.

Manager #11 stated there was no policy which stated the lab technician could determine or release a type of emergency blood which differed to the provider's order. Manager #11 stated he notified the provider of the blood type the patient was to receive. However, according to the previous interview with Provider #8, he was unaware Patient #12 received O+ blood until the interview was conducted.

4. Review of Patient #12's medical record revealed there was a lack of evidence the patient was monitored and assessed according to facility policy and protocols. On 2/17/22 at 6:46 a.m., one set of vital signs was documented for the patient's stay. The documented blood pressure was systolic 72. The diastolic BP was not documented. The patient's HR was noted to be 116 BPM. There were no additional vital signs documented for Patient #12's ED course. (Cross Reference 1048)

a. On 3/15/22 at 3:45 p.m., the facility was asked to ensure all documents were provided in regards to Patient #12's medical record. The facility claimed the Critical Care document had been completed by the nurse, where additional vital signs and assessments were documented, however no evidence was provided of any additional vital signs.

b. Interviews revealed there was no evidence Patient #12 was monitored and assessed according to facility protocol.

i. On 3/14/22 at 5:55 p.m., an interview was conducted with RN #7. RN #7 stated Patient #12 was placed on a monitor and her blood pressure was checked every five minutes. However RN #7 acknowledged the chart lacked evidence Patient #12 was monitored throughout her ED care.

ii. On 3/16/22 at 10:28 a.m., an interview was conducted with Manager #1. Manager #1 stated the ED monitors could be set to collect vital signs on a patient during certain time frames. Manager #1 stated RNs could also use the critical care form or the computer to chart assessment and vital sign monitoring. Manager #1 stated Patient #12 should have been monitored at least every 10 minutes and documented in the medical record.

iii. On 3/15/22 at 1:21 p.m., an interview was conducted with Chief Nursing Director (CNO) #10. CNO #10 stated in the emergency department, patients were placed on monitors and a time frame was set for the vital signs to be obtained by the machine. CNO #10 stated if vital signs were not monitored while the patient was present in the ED it would be problematic since there would not be evidence to demonstrate the patient's condition. CNO #10 stated she would have expected to see the vital signs documented in Patient #15's chart either in the electronic eMAR or on the critical care paper treatment sheet.

5. Review of Patient #12's medical record revealed an individual who was not a provider or staff member of the facility administered medication to the patient. According to the medical record, RN #7 documented Cytotec (a medication administered in order to prevent postpartum hemorrhage) was not given because the medication was not in the facility Pyxis. However, Provider #8 documented Cytotec was given to Patient #12. (Cross Reference 1049)

a. Interviews revealed Patient #15 did receive Cytotec and the medication was administered by a provider who was not employed nor had credentialed privileges at the facility.

i. On 3/14/22 at 5:55 p.m., an interview was conducted with RN #7. RN #7 stated he retrieved the Cytotec from the Pyxis and handed it to Patient #12's midwife, who had arrived with the patient, for her to administer. RN #7 stated he charted the medication as not given because he was unsure what to document due to the fact he had not administered the medication.

ii. On 3/16/22 at 10:28 a.m., an interview was conducted with Manager #1. Manager #1 stated the facility did not have midwife providers on staff.

iii. On 3/15/22 at 1:21 p.m., an interview was conducted with CNO #10. CNO #10 stated once Patient #12 arrived at the facility she was under the care of the ED provider and no longer under the care of the midwife who arrived with the patient. CNO #10 stated the facility did not have midwife providers on staff.

The medication administered by the midwife was in contrast to facility policy, which read only a provider or staff employed by the facility was to administer medications.

B. Patient Safety Event Report

Review of a patient safety event associated with Patient #12's medical record revealed the event was not investigated and preventive measures were not implemented according to facility policy.

1. A patient safety event report was entered for 2/17/22 at 2:50 p.m. The event report read, the event occurred to Patient #12 in the ED. According to the report, Patient #12 died at an outside hospital. Patient #12 gave birth at home and was subsequently brought by EMS to the facility's ED. Both Patient #12 and her newborn baby were in critical condition and were transferred to an outside hospital. The event read, Patient #12 became unstable en route to the accepting hospital.

Included in the event report were assigned follow-up actions. The follow-up actions included: the event was sent to peer review on 2/21/22; the event was reported to the facility's malpractice insurance carrier on 2/21/22; and the facility's medical records office was requested to provide copies of Patient #12's medical records to law enforcement on 2/23/22. In addition, the EMS service requested a quality assurance review of the patient records associated with the event. However, there was no evidence in the follow-up actions the event was investigated or the patient's medical record reviewed to ensure the care provided to Patient #12 in the facility's ED was in alignment with facility policies and protocols.

This was in contrast to facility policy, which read: occurrences including any medical outcome which was less than what would normally be expected was to be reviewed by the compliance coordinator and forwarded to appropriate parties to complete an investigation; the investigation was to be thoroughly documented and shared with other hospital entities as appropriate; and occurrence reports were to be reviewed within the organization to improve system processes. According to the QAPI program, QAPI staff were responsible to analyze information to improve patient outcomes, and department managers were to identify quality problems and implement improvement activities in their respective departments.

C. Leadership Interviews

Interviews with facility leadership revealed department managers, to include nursing and laboratory managers, did not review and investigate the patient safety event which involved Patient #12. The facility therefore did not identify deficiencies regarding patient monitoring, medication administration and blood transfusion protocols and did not implement corrective actions to prevent reoccurrence.

1. On 3/15/22 at 2:30 p.m., the ED Nursing Manager (Manager) #1 was interviewed. Manager #1 stated as part of the ED's integration with the facility QAPI program, she was responsible to review charts and ensure if areas were identified which required improvement then actions were taking to maximize patient care. She stated she typically reviewed the medical records for patients who were transferred out of the ED, trauma cases or patient safety event reports which were referred to her for follow-up.

Manager #1 stated when a patient safety event report was entered it was reviewed by the compliance director, and if she needed to investigate the event she was assigned to do so in the reporting system. She stated when she was referred to investigate an event she reviewed the medical record, specifically the nursing documentation and physician notes. She stated she also would speak with the nursing staff and physician involved in the event, and also discussed events with other departments as needed to address the issue identified in the event. She stated she documented her actions in the reporting system once complete.

Manager #1 stated the expected timeframe to review and complete follow-up actions for a patient safety event was within one month. She stated potential follow-up actions for events included policy changes, coaching with staff and analyzing events for possible trends. Manager #1 stated the importance of reviewing patient safety events was to ensure patients received safe care and to identify any needed process improvements or lapses in facility protocols.

Manager #1 stated she believed all patient safety events which occurred in the ED were referred to her to review. Manager #1 then reviewed the patient safety event report which involved Patient #12. She stated she did not remember seeing the event report and it was not referred to her for further review. She stated she had reviewed the chart after discussing the patient's case with the Chief Nursing Director (CNO) #10, however their discussion only related to responsibility to complete the birth certification for Patient #12's newborn infant.

Manager #1 stated when she reviewed the chart she looked at the interventions provided to Patient #12, the blood given, the initial triage and the vital signs. She stated she would have liked to see more documentation of the patient's vital signs and this was discussed at a staff meeting. Manager #1 stated she spoke with RN #7 after the event but the discussion was a general check-in and did not relate specifically to lack of vital signs documentation.

Manager #1 stated she did not notice anything unusual in regards to the blood transfusion Patient #12 received. She stated she heard Patient #12 had a possible transfusion reaction in the ambulance en route to the receiving hospital, however she did not know if there was a process to investigate potential transfusion reactions. She stated she did not identify other discrepancies or concerns in the patient's medical record.

Manager #1's interview was in contrast to review of Patient #12's medical record and interviews, which revealed O+ blood was administered to the patient rather than the O- blood ordered by the provider; vital sign assessment and monitoring was not performed and documented according to facility policy; and medication was administered by an individual who was not a provider or staff member of the facility.

i. A second interview with Manager #1 was conducted on 3/16/22 at 10:28 a.m. Manager #1 stated she was mistaken when she described her review of Patient #12's medical record. She stated she may have looked at the record for the patient's initial complaint and disposition, however she did not look at the interventions and vital signs documentation as she described in her previous interview. She stated if she had reviewed the medical record as she described she would have identified there was significant lack of documentation for the patient's vital signs, which she was not aware of prior to the survey. Manager #1 stated she also was not aware of the discrepancy between the blood type order by the provider and the type administered to Patient #12.

Manager #1 stated her brief review of Patient #12's medical record was not performed as part of an investigation for the patient safety event report, because she was never assigned to review the event report.

Manager #1 stated it was important to review medical records to ensure the care provided to the patient was appropriate.

2. On 3/16/22 at 9:34 a.m., the Director of Clinical Value (Director) #12 and the Quality and Performance Improvement Manager (Manager) #13 were interviewed. Director #12 stated when a patient safety event report was entered she and Manager #13 reviewed the report and then assigned the report to other department leaders to review. She stated if a report was entered regarding the ED or the inpatient unit it was assigned to Manager #1 to investigate the event and document findings. She stated the event remained open in the reporting system until the assigned person documented their follow-up, and then she and Manager #13 did a final review to ensure the event was adequately reviewed and addressed.

Director #12 stated the expected timeframe for event reports to be reviewed and investigated was within 20 days of the report entry. Manager #13 stated if a Root Cause Analysis (RCA) was warranted the goal was to conduct the RCA within a few days of the event. He stated an RCA was performed if an event was part of a trend or there was a potentially serious patient outcome, and the goal was to identify contributing factors in order to prevent the event from happening again.

Director #12 and Manager #13 reviewed the patient safety event reporting involving Patient #12. Director #12 stated the event was entered by the facility's Chief Administrative Director when the facility became aware Patient #12 died after she was transferred from the ED. She stated the event was referred for physician peer review because any patient death was automatically sent to peer review. Director #12 stated the peer review was completed 3/15/22, the day prior to the interview, and because peer review was privileged she did not know of any findings from the peer review. Manager #13 stated the QAPI program was usually informed of any non-provider issues identified through a peer review, such as nursing issues or interventions which were not available; however, he and Director #12 stated they were not informed of any non-provider issues identified through the peer review for Patient #12.

Director #12 stated Manager #1 and CNO #10 were not assigned to investigate the patient safety event involving Patient #12, because at the time the event report was entered there were no concerns or questions related to patient care. She stated prior to the survey the QAPI program had not been informed of any concerns related to Patient #12's care.

Manager #13 stated he assumed Manager #1 and CNO #10 had reviewed Patient #12's medical record because the patient had died. He stated because Manager #1 and CNO #10 were notified of the patient safety event report and the patient's death, it was normal practice for them to review the record and identify any concerns. However, Director #12 stated neither Manager #1 nor CNO #10 had communicated any concerns to the QAPI program, nor did they enter any documentation of an investigation in response to the event.

This was in conflict to Manager #1's interview. Manager #1 stated she did not review the entirety of Patient #12's medical record to ensure the care and interventions were appropriate because she was not assigned to investigate the patient safety event.

Director #12 stated after the request was made on 3/15/22 to ensure the entirety of Patient #12's medical record was provided, the facility became aware the record lacked documentation of the ED nurse's monitoring and assessments. Director #12 and Manager #13 stated they did not know why the nursing documentation was not present in the medical record.

Director #12 stated if a patient had a reaction to a blood transfusion, the transfusion reaction was reviewed by the lab. She was not aware whether a transfusion reaction was investigated for Patient #12.

3. On 3/16/22 at 6:13 p.m., the Lab Manager (Manager) #11 was interviewed. Manager #11 stated he was not aware of any suspected transfusion reaction involving Patient #12. He stated when he was notified of a suspected blood transfusion reaction there was a form to complete which was provided to the pathologist and laboratory medical director for review. He stated it was important to track transfusion reactions because most reactions were due to clerical errors. Manager #11 stated the lab should have been informed of a possible transfusion reaction for Patient #12 so that a workup could be completed, however he stated nobody informed him of a suspected reaction.

i. An interview was conducted on 3/14/22 at 3:54 p.m. with Paramedic #14, who cared for Patient #12 during her transfer from the facility's ED. Paramedic #14 stated Patient #12 had a suspected transfusion reaction after she received blood in the ED. He stated he communicated the possible transfusion reaction to Provider #8 and subsequently gave Benadryl (an antihistamine used to treat allergic reactions) and Ativan (a sedative used to relieve anxiety) to treat symptoms of the reaction.

ii. Review of Patient #12's medical record revealed a suspected transfusion reaction was documented in the EMS report for the patient's transfer from the ED. Furthermore, Provider #8 documented in a note he received communication from EMS regarding concerns for a possible blood transfusion.

iii. The interviews and medical record were in contrast to facility policy, which read when a suspected transfusion reaction was reported the laboratory was to initiate an investigation and clerical check of the transfusion reaction and the Quality and Performance Improvement Manager was to facilitate the investigation.