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Based on observation, policy review, document review and interview, the Critical Access Hospital (CAH) failed to have either directly or under arrangement, services for the procurement, safekeeping, and transfusion of blood, including the availability of blood products needed for emergencies on a 24-hours a day basis. This deficient practice has the potential to place patients who need blood at risk for serious adverse events up to and including death.

The cumulative effects of this deficient practice resulted an Immediate Jeopardy (IJ) (a situation in which entity noncompliance has placed the health and safety of recipients in its care at risk for serious injury, serious harm, serious impairment, or death) situation.

On 07/14/24 at 3:35 PM, on-site surveyor notified Staff D, Operations Supervisor, that an Immediate Jeopardy (IJ) existed respective to Condition of Participation (CoP) 42 CFR §485.61: Emergency Services.

The hospital submitted a plan of removal (POR) on 07/16/25 at 2:35 PM. On 07/16/24 at 3:18 PM the hospital was notified the written POR was accepted.

The POR included but was not limited to the following:

"Updated Corrective Action Plan for Immediate Jeopardy (IJ) Hamilton County Hospital (HCH)

Date: July 16, 2025

IJ Citation: §485.618(c) Standard: Blood and Blood Products

Patients at Risk: The Immediate Jeopardy finding identified potential risks to all patients presenting to the emergency department who may require emergent blood transfusions.
Immediate Corrective Actions:

1. Blood Product Availability:

Hamilton County Hospital (HCH) currently holds a formal contractual agreement with the [Blood Supplier Company], effective January 1, 2024, ensuring availability of blood products. This agreement is in full effect through December 31, 2026. The [Blood Supplier Company] agreement is attached.

2. Provider Awareness and Confirmation:

As of July 15, 2025, the Hamilton County Hospital Medical Director informed that she was previously aware of the [Blood Supplier Company] blood procurement agreement. The Medical Director supervises the ER. All ER Providers will be educated on the existing agreement, the Emergent Blood Ording Protocol, the Emergency Release of Un-Crossmatched Red Blood Cell policy, and the Blood Transfusion (Emergent Release) policy before their next scheduled shift. We will document the Providers knowledge of this with an email read receipt. Additionally, a discussion will occur at the next Medical Staff meeting to reinforce consistent understanding of decision-making protocols regarding patient transfers versus procurement of blood products through [Blood Supplier Company]. This Medical Staff meeting and discussion will be completed at the next Medical Staff scheduled meeting, but no later than August 31, 2025. The Assistant Administrator will oversee Provider Awareness and Confirmation.

3. Laboratory Testing Agreement:

[Hospital 2] Vice President of Regional Operations has provided an agreement to enter into a laboratory services agreement with HCH to perform necessary transfusion-related testing. This agreement was signed by the Hamilton County Hospital administrator on 7/15/2025 and was sent back to the [Hospital 2] Vice President for countersignature. Once this agreement is finalized, HCH anticipates having the capability to store blood units on site. However, we are requesting satisfaction of corrective action based on the [Blood Supplier Company] agreement for blood products above, not additional step of maintaining blood products on site.

4. Policy Readiness

On July 15, 2025, the Laboratory Policy titled "Emergency Release of Un¿ Crossmatched Red Blood Cell" was reviewed. The Policy was found to be complete and last reviewed by the governing board on 03/25/2025. A copy is attached.

On July 15, 2025, the Nursing Policy and Procedure titled "Blood Transfusion (Emergent Release) was reviewed. The last Revision date was O1/2024. All RN (Registered Nurses) Staff reviewed this policy and signed off on their review through the [Online Learning for Nursing Education] system starting March 2024. This policy was not in one of two Policy Manuals reviewed, but was placed in that one policy book on 07/15/2025. The governing body approved the Nursing Policy Manual on their regular meeting on 07/15/2025. A copy is attached.

All Nursing and Lab staff will be required to complete education in [Online Learning for Nursing Education] on the existing [Blood Supplier Company] agreement, the Emergency Release of Un-Crossmatched Red Blood Cell policy, and the Blood Transfusion (Emergent Release) policy before their next scheduled shift.

5. Emergent Blood Ordering Protocol:

In the event of an emergent need for blood products, staff shall immediately follow this protocol:

1. Immediately notify the ER Provider, who will determine the need for emergent blood.

2. If the ER Provider determines emergent blood procurement is appropriate and that transfer is not the best immediate clinical option, the ER or Lab staff will: i. Immediately call the [Blood Supplier Company] Customer Service Center (available 24/7) at [phone number]. ii. Provide patient details, the specific type and quantity of blood required, and confirm urgency. iii. Coordinate directly with [Blood Supplier Company] regarding delivery details, estimated time of arrival, and receipt logistics.

3. Staff will document all steps taken, including the[Blood Supplier Company] contact name, time called, estimated arrival time, and confirmation of blood product receipt in the patient's medical record.

Protocol will be placed in the red folder located in ER nurses' station used for blood products administration information. The protocol will also be uploaded to [Online Learning for Nursing Education] and used for initial and annual nursing training. The deadline for placement in red folder and upload to Relias is end of business 7/16/2025. All Nursing and Lab staff will be educated on the Emergent Blood Ording Protocol before their next scheduled shift. Director of nursing will be responsible for compliance with protocol training as above.

Monitoring and Sustainability:

The Director of Nursing will conduct weekly audits beginning within one week of the Medical Staff discussion referenced above, and will continue until the greater of 90 days or until 100% of ER Providers demonstrate awareness of the choices for blood products administration for four subsequent reporting periods, whichever is greater. The audit question will be: "what are the options for emergent blood products administration on an emergent basis at the [Above Named Hospital]?" The correct response should be include the [Blood Supplier Company] service and transferring patients to a referral center for blood products administration.

Audit findings will be documented and presented monthly to the hospital's Quality Assurance Committee.

Additional corrective actions or clarifications will be promptly implemented if deficiencies are identified.

Conclusion:

With these immediate corrective actions, HCH believes the IJ finding related to §485.618(c) has been promptly and effectively addressed. We also believe we will soon be able to provide the additional service of on-site blood products for emergent administration ..."

The hospital's plan of removal was validated by the on-site surveyor prior to survey exit on 07/16/25 at 4:05 PM.

Findings Include:

The Critical Access Hospital (CAH) failed to ensure it, either directly or under arrangements, services for the procurement, safekeeping, and transfusion of blood, including the availability of blood products needed for emergencies on a 24-hours a day basis. (Refer to tag C0890)

Based on observation, policy review, document review and interview, the Critical Access Hospital (CAH) failed to ensure that blood was available directly or by arrangement for procurement and transfusion in an emergency situation for any patients. This deficient practice has the potential to place patients who need blood at risk for serious adverse events up to and including death.

Findings Include:

Review of hospital policy titled, "Blood Component Transfusion," dated 03/25/19, showed, " ...[Above Named Hospital] will attempt to do the best of our ability, to obtain the blood required to meet the needs of our patients. Blood is available through the Blood Bank in the Laboratory Services Department ..."

Review of hospital policy titled, "Emergency Release of Un-Cross-matched Red Blood Cell," dated 10/26/23, showed, " ...To release uncross-matched Packed Red Blood Cells by the request of the Physician for emergency transfusions of patients who are acutely bleeding prior to the beginning or completion of required laboratory tests ..."

During observation on 07/14/25 at 10:45 AM, the lab failed to show 4 units of O negative packed red blood cells.

During an interview on 07/14/25 at 10:50 AM, Staff A, Lab Manager, stated that there is no blood on-site and the last time blood products were used was in 2021.

During an interview on 07/14/25 at 10:59 AM, Staff B, Administrator, stated that the facility has not had blood products for 4 years.

During an interview on 07/14/25 at 11:00 AM, Staff C, Director of Nursing, stated that currently the hospital has no arrangements with another hospital to access blood products or provide a supply of O-negative blood on-site.

During an interview on 07/16/25 at 1:34 PM, Staff P, Doctor of Medicine (MD), stated that the hospital does not have blood products and would have to transfer patient to higher level of care.