The information below comes from the statement of deficiencies compiled by health inspectors and provided to AHCJ by the Centers for Medicare and Medicaid Services. It does not include the steps the hospital plans to take to fix the problem, known as a plan of correction. For that information, you should contact the hospital, your state health department or CMS. Accessing the document may require you to file a Freedom of Information Request. Information on doing so is available here.

SOUTH GEORGIA MEDICAL CENTER 2501 NORTH PATTERSON STREET, PO BOX 1727 VALDOSTA, GA 31602 May 5, 2020
VIOLATION: COMPLIANCE WITH 489.24 Tag No: A2400
Based on review of medical record review, Medical Staff Bylaws, policies and procedures, interviews, an email from the Paramedicine Program Chair of Southern Regional Technical College regarding Paramedic training, facility required Emergency Medical Services (EMS) New Hire Orientation, National EMS Education Standards, personnel files, on-call providers' calendars, and Blood Product Infusion Protocol, effective date / addendum 4/14/2020, it was determined that the facility failed to ensure that the EMS crew were qualified to transfer patients with blood infusing for one (1) of 20 sampled medical records when Patient #1 presented to the Emergency Department (ED) on 3/14/2020.

Findings were:

Cross refer to tag A-2409 as it relates to failure to ensure the transfer of patient #1 was effected through qualified staff/personnel.
VIOLATION: APPROPRIATE TRANSFER Tag No: A2409
**NOTE- TERMS IN BRACKETS HAVE BEEN EDITED TO PROTECT CONFIDENTIALITY**

Based on medical record review, policies and procedures review, Emergency Department Log review, Staff interviews, Emergency Medical Services (EMS) Blood Monitoring Training review, ambulance trip report review, personnel files review, and Blood Product Infusion Protocol review, it was determined that the facility failed to ensure that the transfer was effected through qualified EMS crew personnel who were qualified to transfer patients with blood infusing; and failed to utilize the transportation equipment (blood transfusion pump) during transfer for one (1) of 20 sampled medical records when Patient #1 presented to the Emergency Department (ED).

An off-site complaint investigation was initiated on 4/27/2020 at 9:00 a.m., due to COVID-19 outbreak.

MEDICAL RECORD REVIEW FOR PATIENT #1:

Review of Patient #1's medical record revealed the patient was a 7 -year-old male that was brought to the Emergency Department (ED) by his mother on 3/14/2020 at 10:41 p.m. The ED Central Log and Patient #1's medical record revealed the chief complaint was headache, generalized weakness, vomiting blood twice, and fever. The consent for treatment forms were signed by Patient #1's mother at 10:44 a.m.

At 10:54 p.m. the triage (assessment by a nurse to determine the priority in which patients will be seen based on their chief complaint, signs, and symptoms) nurse noted that Patient #1 ' s mother reported that the patient had surgery to remove his tonsils and adenoids on 2/26/2020 and had been having periods of vomiting since the surgery. In addition, the nurse noted that the mother reported that Patient #1 had been having syncopal (fainting spells) episodes on 3/14/2020. At 10:59 a.m., the triage nurse noted that Patient #1 was a level 2 emergent acuity and that Patient #1 was placed the ED room #3. At 10:56 p.m., the triage nurse documented Patient #1's vital signs as follows: temperature 98.1 (normal 98.6), pulse 126 (normal resting pulse for 7-year-old is 68 - 105), respirations 20 (normal for 6 to [AGE]-year-old is 12 - 24), and oxygen saturation 100% (normal 96 - 100%).

At 11:16 p.m., Physician JJ noted that Patient #1 had experienced multiple syncopal (fainting spells) episodes that day and had vomited blood once that afternoon. The physician noted that Patient #1 was very pale and sleepy but awakened easily and answered questions appropriately. Physician JJ noted that Patient #1 had no past medical history and that all other systems were reviewed and found to be negative. In addition, the physician noted that Patient #1 was alert, active, and in no acute distress. Physician JJ's orders included the following:
--Complete blood count (CBC - checks for increase or decrease in blood cell counts),
--Basic metabolic panel (BMP - evaluates blood sugar level, electrolytes, and kidney function),
--Hepatic panel (evaluates liver function),
--Lipase (evaluates fat breakdown and can signify bowel problems),
--Type and screen (blood test to determine blood comparability prior to blood transfusion);
--Transfuse a unit of red blood cells, and
--Vital signs prior to starting blood, 10 minutes after transfusion is started, every 30 minutes until transfusion is complete, and one (1) hour after transfusion is completed.


Review of the CBC revealed Patient #1's hemoglobin (HGB - protein in red blood cells that carries oxygen throughout the body) was 3.5 low/ abnormal (normal for children 5 to [AGE] years old is 11.5 to 14.5) and hematocrit low/ abnormal (HCT - measures the percentage of red blood cells in the blood) was 10.5 (normal 33 - 43%).

At 11:23 p.m., Registered Nurse (RN) FF noted that she placed a #20-gauge intravenous (IV - inserted into a vein) catheter in Patient #1' s left antecubital (elbow bend). RN FF noted that Patient #1 was oriented and that his skin was pale. At 11:29 p.m., registration was documented as being completed. At 11:30 p.m. Patient #1's pulse was noted to be 110 and oxygen saturation was 100%.

On 3/15/2020 at 12:15 a.m., Patient #1's pulse was 128, respirations were 20, and oxygen saturation was 100%. At 12:21 a.m. Patient #1 ' s mother signed the consent for blood administration form and RN AA signed the form at 12:22 a.m. At 12:23 a.m., RN FF noted that Physician JJ was on the phone with the accepting physician. At 12:31 RN FF noted that Patient #1 was accepted by the accepting facility and Physician JJ noted that Patient #1 ' s disposition was set to transfer to the accepting facility. At 12:45 a.m., RN AA noted that he hung one (1) unit of packed red blood cells. RN FF noted that a second #20-gauge IV site was placed in Patient #1 ' s right antecubital and that Patient #1's temperature was 98.4, pulse was 137, respirations were 26, blood pressure was 88/48 (normal for 7-year-old 110/74), and oxygen saturation was 100%. At 12:58 a.m., the patient's pulse was 116, respirations were 20, blood pressure was 111/64, and oxygen saturation was 100%. At 1:00 a.m., Patient #1's temperature was 98.6, pulse was 116, and oxygen saturation was 100%. At 1:08 a.m., the patient's temperature was 98.6, pulse 116, respirations were 20, blood pressure was 111/64, and oxygen saturation was 100%.

Physician JJ documented that nurses' notes, vital signs, and lab tests were reviewed. Physician JJ also noted that one (1) unit of blood transfusing in the ED. Spoke with a physician at the receiving facility who has agreed to accept Patient #1. Physician JJ noted that Patient #1 was hemodynamically (related to the flow of blood to body organs and tissue) stable.

Physician JJ noted that Patient #1's diagnosis was upper GI (gastrointestinal - tube from the mouth to the stomach, stomach, and first part of the small intestines) bleed. Review of the Physician Certification Statement for Non-Emergency Ambulance Services revealed Patient #1 was to be transferred to the receiving facility ' s pediatric ED by ambulance. Physician JJ noted that Patient #1 ' s condition included anemia with the first unit of blood transfusion in progress and syncope. Physician JJ noted that IV medications / fluids were required, that special handling / isolation was required, and that cardiac (heart) / hemodynamic monitoring was required enroute to the receiving facility. This form was signed by RN EE on 3/15/2020. Section 1. Physician Assessment and Certification noted that Patient #1 presented or developed an Emergency Medical Condition, and at the time of transfer was not in a stable condition. The receiving physician was listed, and the Risks was noted to include deterioration of condition, motor vehicle accident, and death, the benefits was noted to be further specialized care. Estimated transport time was 2 to 3 hours. Based on the risks and benefits, Physician JJ checked the form indicated that the medical benefits reasonably expected from treatment at the receiving facility outweighed the risks of transfer. Physician JJ signed this form on 3/15/2020 at 12:35 a.m. The consent for transfer was signed by Patient #1 ' s parent and witnessed by RN FF at 1:08 a.m. The Acceptance Information form included the following: names of the receiving hospital and accepting physician, mode of transport was noted to be by ambulance. Departure from the ED was noted to be 1:15 a.m. on 3/15/2020. Summary of Patient #1 ' s condition was documented as temperature 98.6, pulse 116, respirations 20, blood pressure 111/64, oxygen saturation 100%. Right antecubital 20 gauge IV and red blood cells infusing at 120 milliliters per hour to the left 20 gauge antecubital IV. Patient #1 was noted to be alert and oriented to person, place, time, and situation, and lethargic (drowsy). The nurse noted that Patient #1 ' s skin was warm and dry, and that respirations were even and nonlabored. In addition, RN FF noted that essential portions of Patient #1 ' s medical record were given to the ambulance crew and a member of the ambulance crew signed receipt of Patient #1 ' s medical record. RN FF noted that Patient #1 left the ED in stable condition. At 2:03 a.m., a nurse noted that report was called to an RN at the receiving facility. The nurse noted that Patient #1 departed the ED in stable condition on a stretcher for transfer to the receiving facility by Emergency Medical Services (EMS).

The ambulance trip reported revealed Patient #1 was to be an emergent transfer to the receiving facility. The primary impression was documented as bleeding, hemorrhage controlled or uncontrolled. The trip report noted that the ambulance attendants arrived at the transferring facility on 3/15/2020 at 1:04 a.m. Paramedic GG noted that Patient #1 was lethargic but would open his eyes and answer questions appropriately. The trip report indicated the ambulance departed the transferring facility at 1:24 a.m. Documentation revealed Patient #1 was lethargic (drowsy). Level of care was noted to be Advanced Life Support and the chief complaint was listed as a recent tonsillectomy possible bleed, with onset noted to be 3/14/2020 at 6:00 p.m. At 1:33 a.m. documentation revealed the physical examination of Patient #1 was normal. Paramedic GG noted that Patient #1 had no known allergies and that no medications were reported as being administered. Vital signs were documented at 1:22 a.m., 1:37 a.m., 1:52 a.m., 2:09 a.m., 2:20 a.m., and 2:37 a.m. Patient #1 ' s pulse ranged from 123-128, respirations ranged from 16-24), blood pressure ranged from 106-132/55-64, and oxygen saturation ranged from 97-100%. The Glasgow Coma Scale (evaluates eye opening, verbal response, and motor response to determine a patient's responsiveness) was evaluated with each set of vital signs and Patient #1 remained within normal limits during transport. Paramedic GG noted that Patient #1 received almost one (1) unit of blood during transport, but that at 1:50 a.m. she noticed that the blood was not dripping. Paramedic GG noted that she flushed the IV site and that the IV was patent. Paramedic GG noted that the blood bag was filling up with saline and the normal saline bag was filling with blood. She noted that the transferring hospital was contacted, and an RN instructed her (Paramedic GG) to put the blood on a pump. Paramedic GG noted that once the blood was put on a pump the pump was indicating that there was an occlusion above the pump. Paramedic GG further noted that the RN was unsure what the problem was and informed her (Paramedic GG) that the blood should have been completely infused by 2:00 a.m. At 2:55 a.m., Paramedic GG noted that upon arrival to the receiving facility Patient #1 was transferred to a stretcher and report given to the receiving nurse. The trip report was signed by Paramedic GG and Emergency Medical Technician (EMT) HH.


POLICIES:

--Emergency Medical Treatment and Patient Transfer Policy, policy number 2.002 (HPP 105), adopted 6/1991, last revised 3/28/2019 was reviewed. The policy revealed in part, "
TRANSFER OF INDIVIDUAL WITH EMERGENCY MEDICAL CONDITION
No individual will be Transferred unless:
a) Medical treatment which minimizes the risks to the individual's health and in the case of a woman in Labor, the health of the unborn child, within the Dedicated Emergency Department's Capacity is provided; ...c) The Transfer is effected through qualified personnel and transportation equipment, as required, including medically appropriate life-support capabilities;

--Intravenous Infusion, policy number PEDS-008, adopted 3/26/1987, last revised 11/1/2019, revealed the purpose of this policy is to serve as a resource for intravenous infusion of the pediatric The policy noted that Pediatric staff establishes intravenous infusion to restore blood volume, to supply fluid in treatment or prevention of dehydration, and/or administration of medication, as ordered.
Documentation was required to include the following: date, time, site, size and type of needle or catheter, number of attempts, solutions and additives, flow rate, and IV pump.

--Blood and Blood Components: Administration, Consent and Refusal, policy number 2.036, adopted 7/1986, last revised 10/2/2019, revealed the purpose of this policy is to establish guidelines for the appropriate administration, consent or refusal of blood and blood components.
This policy defined a qualified transfusionist as personnel such as RNs, Advanced Nurse Practitioners, Providers, Physician Assistants or Anesthetists who is qualified to administer blood, blood components or derivatives.
PROCEDURE
I. General Provisions
A. Facility personnel cross-match and verify blood and blood components prior to administration for transfusion safety.
B. In accordance with the procedures described in this Policy, qualified transfusionists provide appropriate monitoring during blood and/or blood component transfusions and interventions for transfusion reactions.
II. Qualified Transfusionists
A. Qualified transfusionists who are expected to administer and/or monitor blood and/or blood component transfusions receive training during orientation and annually thereafter.
IV. Patient Consent
Consent to administration of blood or blood components is addressed within the electronic healthcare record. A prior consent for blood or blood component administration will be valid for a period of thirty (30) days from the date of admission or for the period of time the person is confined at the facility for that purpose, whichever is greater. During downtime, refer to the " Consent for Administration of Blood or Blood Components " form, located on the Intranet, under Forms on Demand.
B. Administration and Monitoring
2. A qualified transfusionist initiates the blood or blood component transfusion.
a. All routine non-emergent transfusions should be started at 120 mL/hour for ten (10) minutes, unless otherwise ordered by the provider. The rate may then be increased to provider order.
3. The qualified transfusionist who initiated the transfusion will monitor the patient ' s vital signs and observe the patient for signs and symptoms of a transfusion reaction (see Policy Section VIII) during the initial ten (10) minutes of the administration process.
4. If there is no indication of a transfusion reaction during the initial ten (10) minutes, then another qualified staff member may monitor the patient during the remainder of the transfusion.
5. The qualified transfusionist who initiated the transfusion records the patient ' s vital signs and other observations after the initial ten (10) minutes.
6. Thereafter, a qualified transfusionist records the patient ' s vital signs and other observations every thirty (30) minutes until the transfusion is completed or stopped.


INTERVIEWS:

During a telephone interview on 4/27/2020 at 9:00 a.m., RN AA explained that he does not remember the name of Patient #1 or how old the child was, but that he thinks the child was about seven (7) to nine (9) years old. He said he does not remember anything other than that the patient was not his primary patient. RN AA said that the patient was transferred to the receiving hospital by a Paramedic and an EMT. RN AA said the ambulance attendants said they had training in blood administration, but in his opinion the ambulance attendants did not seem to know how to trouble shoot blood infusion problems. RN AA said that he was fired, and that the facility refused to let him complete a written report of the event for the Risk Management Department. In addition, RN AA said that the hospital reported to the company he works for that he was let go because he made a medication error, was hard to work with, and had a negative attitude. RN AA stated he had worked at the facility for two (2) years and never received a written or verbal reprimand. RN AA confirmed that he has been an RN for five (5) years and has received EMTALA training at least once a year.

On 04/27/2020 at 9:30 a.m. the Chief Executive Officer (CEO) BB was informed that a possible EMTALA / Immediate Jeopardy (IJ) complaint was to be investigated. At 10:40 a.m., the 1541A, CMS Data form, and a list of items needed for the investigation were emailed to the CEO and his Administrative Assistant.

During a telephone interview on 4/27/2020 at 11:10 a.m., Chief Nursing Officer (CNO) CC reported that the travel RN involved with transferring Patient #1 was terminated. The CNO said that he suspects the travel RN is responsible for filing this complaint. The CNO went on to say that the travel RN filed a complaint with The Joint Commission and the facility is getting ready to file a response. In addition, the CNO said the travel RN had posted multiple inappropriate post on social media. The CNO provided Patient #1's name and said the patient was seven (7) years old. The CNO said that Patient #1 was vomiting blood upon arrival to the ED. The CNO confirmed that the hospital owns the ambulance service and that the transport team had received training on monitoring blood. The CNO brought in ED Director DD and the list of required facility documents was reviewed with the CNO and the ED Director.

During a telephone interview on 4/27/2020 at 11:45 a.m., the ED Director DD explained that the ED has 44 beds which includes 4 trauma beds, 4 rapid medical screening / fast track beds, and 36 general ED beds. She explained that the medical screening examination (MSE) is performed by physicians or mid-level providers (nurse practitioners or physician assistants) under the supervision of a physician. The ED Director confirmed that the hospital's EMTs and Paramedics receive training on monitoring blood as part of their annual competency testing.

A second telephone interview was conducted with ED Director DD on 4/28/2020 at 10:40 a.m. ED Director DD confirmed that Patient #1 is the only patient transferred with blood infusing and that the ED has not transferred any pregnant patients to other acute care facilities within the past six (6) months. ED Director DD also confirmed that Patient #1 was transferred because the facility does not have a Pediatric Intensive Care Unit or staff qualified to care for critical pediatric patients. ED Director DD said she did not know why the blood products were not infused prior to Patient #1 being transferred. The ED's Quality Data was reviewed with the ED Director who reported that the ED uses a score card and tracks several things, for instance: psychiatric patients for completion of medical records, random chart review, completion of the suicide screening, EMTALA paperwork, time to greet, and length of stay. She stated that in less than two (2) years the ED has decreased the left without being seen (LWBS) patients from 9-14% to 1%. The ED Director said the ED now has a provider in triage to help expedite care. When questioned as to why Patient #1's blood was not put on a pump prior to transfer, the ED Director stated she did not know. The ED Director said that it is facility policy to put blood on a pump and that RN AA was terminated for several issues which included behavior issues, refusal to give a statement, sending Patient #1 out without placing the blood on a pump, and for sending a second unit of blood with the ambulance attendants. She went on to explain that the second unit of blood had to be wasted because Paramedic GG could not administer blood and that the wasted unit of blood could have been used for another patient.

During a telephone interview on 4/28/2020 at 11:20 a.m., Director of EMS LL explained that paramedics receive training and have annual competency testing which includes intravenous (IV - administered into a vein) pumps. He confirmed that the pumps used in the ED are the same ones used on the ambulance. He stated Paramedic GG is a field trainer and has lots of experience with the IV pumps used on the ambulance. The Director of EMS explained that paramedics in Georgia are trained to monitor and maintain blood once it is hung but that it is out of their scope of practice to initiate blood.

During a telephone interview on 4/29/2020 at 9:30 a.m., Physician JJ stated he remembers Patient #1. Physician JJ said that he completed his residency in 2012 and has practiced as a physician since then. He stated he has been at the facility since 2017. Physician JJ explained that Patient #1 was brought to the ED by his mother due to experiencing a syncopal episode (fainting) earlier that day. Physician JJ said Patient #1 had surgery to remove his tonsils about two (2) weeks prior to coming to the ED and his mother reported he had been having intermittent (sporadic) vomiting. Physician JJ said that the mother reported that Patient #1 vomited prior to coming to the ED and she noticed some blood in the vomit. Physician JJ said that initially Patient #1 was alert and talking with his mother, he was Hispanic and was noticeably pale. Physician JJ said he was concerned that the patient was anemic (low blood count) and that the anemia was causing the syncope. Physician JJ confirmed that he ordered labs which revealed the patient's Hgb was 3.5, and a unit of blood to be administered. Physician JJ explained that he did not call any of the on-call specialists because the facility does not have any pediatric surgeons or intensivist and that this patient's care was out-side the scope of the facility's pediatric department. Physician JJ confirmed that he contacted the receiving facility and that Patient #1 was accepted by the receiving facility and the receiving physician. Physician JJ said Patient #1 left the ED with blood infusing and that he was never notified that there was a problem with the infusion enroute to the receiving facility. Physician JJ said he thought it was safe for Patient #1 to go by ground ambulance because the trip would not take long and that a helicopter would have taken almost as long because it would have to take off and land at this facility and at the receiving facility. Physician JJ said he has not received word as to how Patient #1 is doing. Physician JJ confirmed that he has received EMTALA training.

During a telephone interview on 4/29/2020 at 10::00 a.m., RN FF stated she remembers Patient #1. She explained that she has been an RN for 18 months and has worked at the facility for five (5) years. RN FF said that prior to becoming an RN she was a Licensed Practical Nurse. RN FF said that she and RN AA were working in trauma on 3/14/2020 when Patient #1 arrived and that she was the patient's primary nurse with assistance from RN AA. RN FF said Patient #1 was placed in a trauma room and that all four (4) trauma bays can be seen from the nursing station down the hall. RN FF said Patient #1 had a low Hgb and Physician JJ ordered a unit of blood to be administered. RN FF said she checked the blood with RN AA and then RN AA hung the blood and monitored the patient. RN FF explained that she was not in the room when Patient #1 was loaded onto the ambulance stretcher and that she is not sure if the blood was infusing appropriately. RN FF confirmed that she received a call from Paramedic GG and was informed that the IV pump was alarming that there was an upstream occlusion (above the pump). RN FF said she is not sure Paramedic GG knew what to do so I tried to help trouble shoot by asking if the tubing was clamped or if the patient's arm was bent which could occlude the flow. RN FF said she is not sure how much blood was infused. RN FF confirmed that she did not inform Physician JJ that there was a problem with the blood infusion. RN FF said that the facility routinely transfers patients with blood infusing. She went on to explain that when a helicopter comes to transport a patient there is an RN with the team and they often transfer patients receiving blood. RN FF said she does not think the ground ambulance crew transfers patients with blood infusing very often but that the ambulance crew has transported patients receiving blood in the past. RN FF explained that it is not in a paramedic's scope of practice to initiate blood but that a paramedic can monitor the blood but if they stop it, they cannot restart the infusion. RN FF confirmed that she receives EMTALA training annually.

During a telephone interview on 4/29/2020 at 10: 30 a.m., EMT HH explained that he is an EMTI, he went on to explain that an EMTI is an EMT intermediate and who has received additional training and is right below an Advanced EMT. EMT HH confirmed that he remembers Patient #1. EMT HH said he has been an EMT for 27 years and has worked at the facility for 5 years. EMT HH explained that he and Paramedic GG received a call to pick-up Patient #1 and transport the patient to the receiving facility. EMT HH stated they received Patient #1 from a nurse, but he does not remember which nurse, that blood was infusing but that he does not recall if the blood was on an IV pump. EMT HH confirmed that he has received IV pump training but that it is not in an EMT's scope of practice to initiate or monitor blood. EMT HH confirmed that he was driving the ambulance and could not hear what was going on in the back with the patient. EMT HH said he receives EMTALA training once a year.

During a telephone interview on 4/29/2020 at 10:45 a.m., RN EE stated she remembers Patient #1. She said she has been an RN since 2006 and has worked at the facility since 2008. RN EE explained that on 3/14/2020 she was the ED Charge Nurse. RN EE said she was notified by Physician JJ that Patient #1 needed to be transferred and that she called the receiving hospital. RN EE said Physician JJ spoke with the accepting physician and then informed her (RN EE) that Patient #1 was accepted. RN EE explained that she asked Physician JJ if Patient #1 needed to be flown or could go by ground transportation. RN EE said Physician JJ informed her that Patient #1 could go by ground transport and that she then notified the EMS that a pediatric patient with blood infusing needed to be transferred to the receiving facility. RN EE said she was made aware that there might have been a problem with the blood transfusion when she received a call from the receiving facility. RN EE explained that she was informed that the receiving facility found tubing with blood and saline in the tubing that had been discarded in the receiving facility's trash. RN EE said she gave the caller the EMS Captain's phone number. RN EE said that a little later the EMS Captain came and spoke with her and Physician JJ and confirmed that he (EMS Captain) had spoken to the receiving facility. RN EE confirmed that she receives EMTALA training yearly.

During a telephone interview on 4/29/2020 at 11:00 a.m., Paramedic GG stated she remembers Patient #1. Paramedic GG said she was an EMT for 1 year, has been a Paramedic 6 years, and has worked at the facility for 6 years. She explained that on 3/14/2020 she and her partner EMT HH received notice that there was a 7-year-old patient in the ED with a low Hgb that needed to be transferred to a higher level of care facility. Paramedic GG stated that Patient #1 had blood hanging, that the blood was on a warmer, but was not placed on a pump. Paramedic GG explained that it is not in the scope of practice for paramedics to initiate blood but that paramedics can maintain and monitor blood. Paramedic GG said she received Patient #1 from RN FF and RN AA and was given a brief report about the hanging blood. Paramedic GG said she informed the nurses that she had a pump on the ambulance and was informed by the male nurse (RN AA) that it would be alright as long as the blood is flowing. Paramedic GG said that about halfway into the trip she noticed that the blood was not flowing. She confirmed that the blood was not on a pump at this time and that she tried to flush the IV site to ensure that the site had not infiltrated. Paramedic GG said she then called the ED and spoke with RN FF and RN AA for recommendations as to what to do. Paramedic GG said the nurses recommended that the blood be placed on the pump and when that didn't work, they recommended discontinuing the blood. Paramedic GG said she never spoke with Physician JJ. Paramedic GG said Patient #1's vital signs remained stable during transport. Paramedic GG said that when they arrived at the receiving facility, she placed the blood and tubing in a red biohazard bag and discarded it at the receiving facility. Paramedic GG confirmed that this was the first time she had transported a patient receiving blood. She stated that she had felt comfortable monitoring the blood when they left the ED. Paramedic GG confirmed that once the blood started to backflow into the saline bag and the saline began to fill the blood bag, she noticed that the saline tubing was not clamped. She said she was not sure if the saline tubing was clamped when they left the ED. Paramedic GG said that a new Blood Protocol for EMS was sent out by their Medical Director around 4/20/2020 and that the new protocol requires blood products to be on a pump during transport. Paramedic GG confirmed that she receives EMTALA training annually during the Annual Review Workshop.

A conference call (which was requested by the facility) was conducted on 4/29/2020 at 11:30 a.m. with the Assistant Chief of EMS NN, Manager of Accreditation and Regulatory Compliance MM, Director of EMS LL, ED Director DD, Director of Quality Improvement and Patient Safety OO, Risk Manager PP, and the Chief Nursing Officer CC. The Manager of Accreditation and Regulatory Compliance explained that the call was to ensure that the Paramedic's competency in regards to monitoring blood infusions was clear. The Assistant Chief of EMS explained that paramedics are taught how to monitor blood during their formal school training. She went on to say that what is taught in school falls under pharmacology and that the facility's paramedics are also evaluated for competency during the paramedics' skills validation. In addition, the Assistant Chief of EMS stated the skills validation includes monitoring after the blood has been hung and assessing for any blood transfusion complications such as allergic reactions or circulatory overload, and that if there is an issue the paramedic is to discontinue the blood. The Assistant Chief of EMS further explained that trouble shooting tubing problems is part of the paramedics' skills validation that paramedics do and part of the National EMS Education Standards which the facility mimics for in-house training. When informed that Paramedic GG's last competency/evaluation was 8/8/18, the Assistant Chief of EMS explained that paramedics are only required to have competency/evaluations every three (3) years.

During a telephone interview on 4/29/2020 at 12:10 p.m., the Manager of Accreditation and Regulatory Compliance MM confirmed that a second unit of blood was sent with Patient #1. She stated that even though Paramedic GG informed RN AA that she could not hang the second unit RN AA had insisted the blood go with Patient #1 replying that maybe the receiving facility could hang the second unit.


EMS BLOOD MONITORING TRAINING:

Facility documentation of EMS blood monitoring training included the following:
--On 4/29/2020 an email was received from the Manager of Accreditation and Regulatory Compliance MM. This email had been forwarded from the Director of EMS LL who had received it from the Program Chair, Paramedicine of Southern Regional Technical College. The Program Chair provided the following information:
This is to confirm that we do cover the maintenance of blood products initiated prior to transport. This includes:
1. Replacement therapy options (whole blood, packed red blood cells, platelets, etc...).
2. Signs and symptoms of local as well as systemic reactions.
3. Common steps for safety (although Paramedics aren't involved with these steps):
--product identification by two (2) approved healthcare providers,
--confirming patient blood type,
--patient name and identification number has to be compared to the blood slip,
--expiration times,
--administration times.
4. IV catheter gauge desired.
5. Filters and tubing.
6. The Georgia Scope of Practice is always discussed:
Paramedics may maintain a blood/blood product infusion started at the sending facility. This does NOT include the initiation of an additional unit of blood or blood product.
Students are told to follow their local protocol and ask questions as needed for clarification on institutional procedures or any "patient specific" concerns that may present.
It is