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Based on the manner and degree of the standard-level deficiency referenced to the Condition, it was determined the Condition of Participation §489.20 Policies and Procedures Which Address AntiDumping Provisions was out of compliance.

C-2407- (1) General. Subject to the provisions of paragraph (d)(2) of this section, if any individual (whether or not eligible for Medicare benefits) comes to a hospital and the hospital determines that the individual has an emergency medical condition, the hospital must provide either- (i) within the capabilities of the staff and facilities available at the hospital, for further medical examination and treatment as required to stabilize the medical condition. (ii) For for transfer of the individual to another medical facility in accordance with paragraph (e) of this section. Based on interviews and document review, the facility failed to exhaust all capabilities in order to stabilize a patient diagnosed with a postpartum hemorrhage in one of one postpartum hemorrhage medical records reviewed. (Patient #15).

Based on interviews and document review, the facility failed to exhaust all capabilities in order to stabilize a patient diagnosed with a postpartum hemorrhage in one of one postpartum hemorrhage medical records reviewed. (Patient #15).

Findings include:

Facility policies:

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 Emergent Release of Blood Products policy read, the purpose is to provide a procedure for the emergency release of blood. 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 Emergency Resuscitation and Initial Stabilization policy read, documentation will be completed by the provider and RN staff.

The Emergency Medical Treatment and Labor Act policy read, patients who are determined to have an emergency medical condition shall be provided with stabilizing treatment, as required by EMTALA, and shall be transferred or discharged as necessary in accordance with this policy. The ED physician on duty shall be responsible for the general care of all patients presenting themselves to the ED. This responsibility remains with the ED physician until the patient is transferred or discharged. All persons with an emergency medical condition or in labor shall receive further examination and treatment, within the capabilities of the staff and facilities available at the hospital to stabilize the patient unless the patient refuses treatment or is transferred in accordance with the provisions of this policy. The hospital shall transfer a patient in accordance with the requirements of this policy (including the required physician certifications) when the hospital has exhausted all of its capabilities in attempting to remove the patient's emergency medical condition.

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.

The Issuing Blood and Blood Products policy read, the patient shall be observed for potential adverse events during the transfusion.

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.

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.

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 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.

Facility documents:

According to the EMS Tranexamic Acid (TXA) protocol, TXA is an antifibrinolytic that works by preventing blood clots from breaking down too quickly which in turn helps to reduce excessive bleeding.

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.

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 initiate the Massive Transfusion Protocol (MTP) devised to stabilize a patient in hemorrhagic/hypovolemic shock who met the triggers for the protocol to be activated.

A. Review of Patient #15's medical record revealed she met two triggers for MTP to be initiated.

a. According to the EMS run-report, on 2/17/22 at 3:20 a.m., Patient #15 gave birth at home.

i. EMS was called to Patient #15's home due to the newborn baby being in distress.

ii. While EMS was on scene for the newborn, the EMS team assessed Patient #15 as well. At 4:08 a.m. an IV was inserted into the patient and 500 mL normal saline was administered. At 4:14 a.m., Patient #15's blood pressure (BP) was 78/57 and her Heart Rate (HR) was 60.

iii. At 4:23 a.m. EMS team communicated with the Facility's ED Provider (Provider) #8 regarding the patient's situation.

iv. At 4:30 a.m. the patient's BP was 73/40 with a HR of 46. Atropine (a medication used to treat low heart rate) was administered per recommendation from the ED provider.

v. At 4:33 a.m., per EMS assessment, the patient was still bleeding. Due to the birth occurring in the birth water tank, EMS was unable to determine how much blood the patient had lost.

vi. At 4:38 a.m., the Patient's BP was 49/28 with a HR of 43. EMS team administered 10 mcg of epinephrine. Epinephrine was administered two more times in the time frame from when EMS administered the first dose and when the patient arrived to the emergency department.

vii. At 5:21 am the Patient's BP was 89/69 and HR of 176, prior to arrival at the ED.

b. On 2/17/22 at 5:36 a.m., Patient #15 arrived at the emergency department. The patient's diagnosis was determined to be postpartum hemorrhage and hemorrhagic shock. Review of the provider orders indicated the MTP was not initiated or ordered.

According to the MTP policy, if a patient will require eight units of PRBCs in 24 hours, the protocol should be considered. Additionally, if the patient meets two or more triggers such as a high lactate (a test conducted to determine if someone has lactic acidosis which is a condition when there is too much acid in the body) and low systolic blood pressure, the protocol should be considered.

i. Upon arrival and throughout the patient's ED course, her systolic blood pressure (BP) was less than 90 and the patient's heart rate was tachycardic at 173 bpm. Additionally, the patient's lactate resulted as 9.9. There was no evidence in the record as to what time the lactate resulted. These results were triggers for the MTP policy to be activated.

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

i. 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.

ii. 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.

iii. 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.

iv. At 6:56 a.m., Patient #15 was transferred to another facility. The EMS report showed the patient's BP was 61/39 with a HR of 146. Prior to the patient's departure, the second unit of blood was administered and transfused en route to the accepting facility.

B. Interviews revealed Patient #15's presentation qualified for the MTP to be activated, however there were gaps in the process and communication.

a. On 3/15/22 at 11:07 a.m., an interview was conducted with Provider #8. Patient #15 was discussed with Provider #8. Provider #8 stated he was the ED provider present and cared for Patient #8. 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 the day of Patient #15's ED visit, 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 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.

b. On 3/14/22 at 5:55 p.m., an interview was conducted with Registered Nurse (RN) #7. RN #7 stated he remembered caring for Patient #15 in the ED. RN #7 explained when Patient #15 arrived, he immediately inserted another IV in the patient. RN #7 stated two units of blood were ordered and the first unit of O- blood was administered within the first ten minutes of the patient's arrival through a rapid infuser. RN #7 additionally stated there was not a conversation from the Provider on administering FFP or initiating the MTP.

This was in contrast to Patient #15's medical record which revealed the first unit of PRBCs was administered at 6:30 a.m., approximately one hour after Patient #15 arrived at the ED.

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 #15 was discussed with Tech #9. Tech #9 stated FFP was not ordered by the provider and was not provided to Patient #15.

Tech #9 stated FFP contains clotting factors. She explained if the provider wanted to administer FFP to a patient, the provider must request FFP to be released. On average, FFP takes a minimum of 20 minutes to thaw.

According to the MTP policy, one unit of FFP for each unit of blood was to be thawed and prepared for administration.

d. On 3/16/22 at 10:28 a.m., an interview was conducted with ED Nurse Manager (Manager) #1. Manager #1 stated the ED provider determined whether the MTP should be used. 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. Manager #1 stated FFP supplies clotting factors to the body which whole blood may be missing. Manager #1 stated FFP could take about 30 minutes to thaw. Manager #1 stated it was up to the doctor whether FFP was to be administered to the patient.

e. 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 the provider signed for the release of emergent blood. CNO #10 stated most of the time type O- blood was given if the patient's blood type was unknown and the need was emergent.

CNO #10 explained although the MTP was a protocol at the facility, providers did not have to use order sets or protocols. She further explained the protocols and order sets were built to make processes easier for providers.

2. The facility failed to administer blood products to patients in order to provide stabilizing treatment according to facility policy and the provider's order.

A. Review of Patient #15's medical record revealed O+ blood was administered to the patient without the provider's knowledge.

a. On 2/17/22 at 5:36 a.m., Patient #15 arrived at the emergency department.

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

ii. 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.

iii. At 6:00 a.m., the first unit of PRBCs was released as emergent and uncrossed. According to the Blood Bank Card, O+ blood was released. O+ blood administered to the patient was in contrast to the provider's order, which was for O- blood.

iv. 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.

v. 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. Similar findings of patients receiving a different type of blood than what was ordered was revealed in a medical record review of Patient #2.

a. On 3/6/22 at 10:54 p.m., Patient #2 arrived at the emergency department after a motor vehicle crash (MVC). The patient sustained multiple injuries from the crash, including a gaping scalp injury.

b. According to the Trauma and Critical Care Nursing Record, at 11:53 p.m. the first unit of blood was administered to the patient. The unit administered was documented as O+. However, the physician's order documented O- to be administered. In addition, the physician's Medical Decision Making documentation noted the patient received O- blood.

C. Interviews revealed staff and the provider attending to Patient #15 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 #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.

b. On 3/14/22 at 5:55 p.m., an interview was conducted with RN #7 regarding Patient #15's ED visit. RN #7 stated two units of blood were ordered and the first unit of O- blood was administered immediately through a rapid infuser. After reviewing the medical record, 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 #15 was discussed with Tech #9. Tech #9 stated the tech who was on the prior night shift released the first unit of blood for the patient. Tech #9 stated the ED called for the second unit of emergent blood at the same time Tech #9 received a specimen from the patient to test for the patient's blood type. 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 #15, the night tech had stated to her the patient's blood type was O+; however, this was not documented in the medical record.

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 #15 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 #15, he had typed the patient's blood prior to the blood orders being placed. However, review of the medical record 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 normally notified the provider on what blood type the patient is receiving.

This was in contrast to the previous interview with Provider #8, when he stated he was unaware Patient #15 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 was administered to the patient. CNO #10 stated she was not previously aware the patient received O+ blood although the provider ordered O- blood.

3. The facility failed to monitor Patient #15 per policy to ensure the condition and stabilization of the patient.

A. Review of Patient #15's medical record revealed there was a lack of evidence the patient was monitored and assessed according to facility policy and protocols.

a. On 2/17/22 at 5:36 a.m., Patient #15 arrived at the emergency department. The patient's diagnosis was determined to be postpartum hemorrhage and hemorrhagic shock.

b. On 2/17/22 at 6:46 a.m., one set of vital signs was documented for the patient's entire length of 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 was no further documentation noted on any subsequent vital signs being taken during Patient #15's stay in the ED.

c. On 3/15/22 at 3:45 p.m., the facility was asked to ensure all documents were provided in regards to Patient #15'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 of any additional vital signs.

B. Interviews revealed there was no evidence Patient #15 was monitored and assessed per facility protocol.

a. On 3/14/22 at 5:55 p.m., an interview was conducted with RN #7. RN #7 stated Patient #15 was placed on a monitor and her blood pressure was checked every five minutes. RN #7 acknowledged the chart lacked evidence Patient #15 was monitored throughout her ED care.

b. 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 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 #15 should have been monitored at least every 10 minutes and documented in the medical record.

c. 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 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.