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101 INDUSTRIAL ROAD

HILLSBORO, KS 67063

EMERGENCY SERVICES

Tag No.: C0880

Based on observation, record review, policy review, document review and interview the Critical
Access Hospital (CAH) failed to meet the needs of its inpatients and outpatients by not having available, 1. necessary medications used for life-saving measures; 2. functional life-saving medical equipment; and 3. failed to have blood available for transfusion to meet the needs of patients in emergency situations.

The cumulative effects of this deficient practice resulted in 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).

On 11/02/22 at 2:45 PM, the CAH Chief Executive Officer (CEO) was notified that an IJ existed at C-0890, 485.618 (c) Blood and blood products. The facility provides, either directly or under arrangements the following - (1) Services for the procurement, safe keeping, and transfusion, including the availability of blood products needed for emergencies on 24 hours a day basis.

On 11/04/22 at 2:20 PM, a plan of removal (POR) was received that included the following:

(1) Hillsboro Hospital will:

a. Utilizing [Blood Product entity] Agreement

1. Procure 1 Bag of O-NEG, Per Day, Per stated procedure of [Blood Product entity] until 4 Bags of O-NEG are inventoried, on-site.
2. Order Schedule excludes delivery of standard inventory on weekends.
3. Enter into MOU (memorandum of understanding) with [hospital] and [Blood Product entity]
Note: Responsibility of LAB Manager. Bag #4 will be ordered on Tuesday November 8th and without issue delivered on Wednesday November 9th. First Bag ordered today 11/03/2022. Second Bag ordered 11/04/2022. TWO BAGS C URGENTLY ONSITE.

b. Hillsboro Hospital will create and/or follow approval process for current and currently created policies and procedures:

Blood Administration (NBB-1002 Blood or Blood Product Administration)
Blood Administration Checklist (Blood Administration Checklist - HCH)
Blood Compatibility Testing (NBB-1008 Compatibility Testing)
Urgent Requirement of Blood
Suspected Transfusion Reaction Protocol (NBB-1003 Suspected Transfusion Reaction Protocol)
Training Document
Note: Responsibility Lab Manager, Chief Nursing Officer. Policies have been approved by policy committee and board on 11/03/2022, included.

c. Hillsboro Hospital will create competency education and execute education immediately to nursing staff and providers performing services in Hillsboro Hospital ER

Competency education will be created by 11/4/2022

All Full-Time Staff will complete competency the first shift they report to work after plan approval.
All Non-Full-Time staff will complete competency prior to starting first shift after plan approval.
Note: Responsibility Lab Manager, Chief Nursing Officer. Attached Schedule of training with dates. Dates provided are dates the employee is scheduled to work. We will utilize trained staff on-call if not scheduled, until all staff have been trained. Attached employee schedule with dates currently listed on schedule.

The CEO was notified on 11/04/22 at 5:03 PM the POR was accepted. The POR actions were verified by surveyors on 11/06/22 at 4:00 PM prior to survey exit.


Findings Include:


1. The Critical Access Hospital (CAH) failed to ensure it maintained an adequate supply of medication to reverse the potential life-threatening side effect, malignant hyperthermia (MH) (dangerously high body temperature, rigid muscles or spasms, and a rapid heart rate). (Refer to Tag C-0884)

2. The CAH failed to maintain functional life-saving medical equipment, specifically a ventilator (mechanical breathing machine) for use during an emergency medical situation. (Refer to tag C-0888)

3. The CAH failed to have blood products needed for emergencies on a 24-hour a day basis either directly or under arrangement for the procurement and transfusion of blood. (Refer to tag C-0890)

EQUIPMENT, SUPPLIES, AND MEDICATION

Tag No.: C0884

Based on observation, document review, and interview the Critical Access Hospital (CAH) failed to ensure it maintained an adequate supply of medication to reverse the potential life-threatening side effect, malignant hyperthermia (MH) (dangerously high body temperature, rigid muscles or spasms, and a rapid heart rate) resulting from the use of Succinylcholine (a medication used to provide muscle relaxation while inserting a breathing tube) in emergencies. Failure to maintain a supply of medication to reverse the potential life-threatening side effect of succinylcholine places all patients at risk for harm or death.

Findings Include:

Review of the Malignant Hyperthermia Association of the United States (MHAUS) showed, ...All facilities, including ambulatory surgery centers and offices, where MH triggering anesthetics (isoflurane, desflurane, and sevoflurane) and depolarizing muscle relaxants (succinylcholine) are administered, should stock dantrolene as indicated below, along with the other drugs and devices necessary to treat an MH reaction. If none of these agents are ever in use in the facility, then dantrolene need not be kept on hand ...

...To treat an MH episode, an initial dose of dantrolene at 2.5 milligram/kilogram (mg/kg) is recommended, with a suggested upper limit of 10 mg/kg. If a patient of average weight (approximately 70 kg) were to require dantrolene at the upper dosing limit, then at least 700 mg of dantrolene would be needed.

DANTRIUM/REVONTO - stock a minimum of 36-20 mg vials
RYANODEX- stock a minimum of 3 - 250 mg vials

In addition, a review of cases has shown that in a "worse case" scenario of a very large person (i.e., about 100-110 kg or 220 - 250 pounds) having an acute MH incident, as much as 8-10 mg/kg will be needed for treatment; higher doses may be required on rare occasions. This regimen of dantrolene will allow for initial stabilization and treatment while more vials are being acquired to continue treatment, as needed.

Review of a policy titled, "Malignant Hyperthermia", revised 06/02/21, showed the hospital pharmacy should have 36 vials of Dantrolene on hand for emergency situations

Observation on 11/01/22 at 1:15 PM showed the hospital had 19 vials of Succinylcholine 20 milligrams/milliliter (mg/ml) in the hospital's medication/pharmacy room.

Observation on 11/02/22 at 3:15 PM of the medication/pharmacy room showed 18 vials of Dantrolene 20 mg/ml. A second observation on 11/03/22 at 9:30 AM of the ED crash cart showed an additional 6 vials of Dantrolene 20 mg/ml vials for a total of 24 vials of Dantrolene 20 mg/ml.

EMERGENCY AND SUPPLIES

Tag No.: C0888

Based on record review, document review and interview the Critical Access Hospital (CAH) failed to maintain functional life-saving medical equipment, specifically a ventilator (mechanical breathing machine) for use during an emergency medical situation for one of 22 patients (Patient 1) reviewed. The CAH also failed to ensure adequate and/or appropriate education and skill competency for use of a ventilator. This deficient practice has the potential to place any patient at the hospital at risk of harm, injury, up to or including death.

Findings Include:

Review of Patient 1's medical record showed that Patient 1 was admitted 08/12/22 at 1:30 PM with a chief complaint of a dislodged Foley catheter (device used to drain urine from the bladder). Patient 1 was admitted to inpatient status on 08/12/22 at 4:49 PM with a past medical history and diagnosis of renal cell carcinoma, acute on chronic liver injury, rhabdomyolysis (a muscle tissue breakdown) and acute renal failure (sudden onset of kidney failure). Further review of the medical record showed that Patient 1 had a code blue (a condition when the heart and breathing stops) which required life-saving measures including the use of a ventilator.

Review of a progress note for Patient 1, dated 08/13/22 at 2:08 PM, written by, Staff J APRN, showed " ...patent is critically ill and at risk for decompensation ..." Review of a progress note for Patient 1, dated 08/13/22 at 2:39 PM, signed by, Staff J APRN, showed that Patient 1 became unresponsive and CPR (cardiopulmonary resuscitation) was initiated. At 12:00 PM Patient 1 was successfully intubated on the 2nd attempt by on site physician, Staff V, MD (medical doctor). " ... 1400: [Patient 1] remains intubated, unable to connect the ventilator due to missing parts ...1420: [EMS] present for transportation to [a hospital] ..."

During an interview on 11/09/22 at 1:45 PM, Staff D, CNO, stated that staff education and skills training is her responsibility as the CNO. When asked to supply evidence of staff training and skills checklist for using a ventilator she was unable to provide attestation of training or skills competencies for nurses and/or providers. Staff D stated that biomed takes care of equipment maintenance but is unsure if this a contracted service or a hospital employee. When surveyors requested policies regarding mechanical ventilation the facility was unable to provide a written policy.

During an interview on 11/08/22 at 12:00 PM, Staff V, MD, stated that during the incident with Patient 1, the ventilator parts were not missing but stated they were not the correct parts resulting in the inability to use the ventilator.

BLOOD AND BLOOD PRODUCTS

Tag No.: C0890

Based on policy review, document review, record review and interview the Critical Access Hospital (CAH) failed to have blood products needed for emergencies on a 24-hour a day basis either directly or under arrangement for the procurement and transfusion of blood.

The cumulative effects of this deficient practice resulted in 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).


Findings Include:


Review of the facility policy titled, "Emergency Department Service Standards," revised 02/2021, showed, " ...4. Blood and Blood Products a. [the Hospital] provides, either directly or under arrangement, the following: i. services for the procurement, safe keeping and transfusion of blood, including the availability of blood products needed for emergencies on a 24-hours a day basis. ii. Availability of blood products means the blood and blood products are accessible to [the Hospital] staff in time to effectively treat emergency patients at [the Hospital] ..."


During an interview on 11/01/22 at 12:33 PM, Staff D, Chief Nursing Officer, (CNO), stated that facility has no blood products available, and the facility policy is out of date. Staff D stated that patients who need a blood transfusion would be transferred out and that there are no agreements with any other suppliers to obtain blood products.


Review of Patient 13's medical record on 11/01/22 showed that Patient 13 presented to the Emergency Department on 06/15/22 at 11:08 PM with alcohol intoxication, self-harm ideation, and lacerations to her right arm. Staff G, Physician Assistant, documented "arterial bleed from mid dorsal forearm. 220 mmHg with a blood pressure cuff and direct pressure doesn't stop bleeding." Review of the vitals monitoring showed two documented blood pressures. At 11:23 PM the blood pressure (BP) was 88/56 (low BP < 90/60) and at 11:43 PM the blood pressure was 117/71. Further review of the medical record failed to show any additional vital signs and failed to show evidence of laboratory testing to determine the level of Patient 13's Hemoglobin (Hgb) (a protein in red blood cells that carries oxygen throughout the body). Patient 13 was transferred ALS (advanced life support) ground transport to Hospital 4 (H4) on 06/16/22 at 12:20 AM.


During an interview on 11/02/22 at 11:45 AM, Staff A, Chief Executive Officer, (CEO), stated that the hospital provided blood and/or blood products prior to the change of ownership in approximately 2019. After the change of ownership, the hospital stopped providing blood or blood products. Staff A stated that reinstating the ability to provide blood and blood products has been "in the works for some time." Staff A was not sure if the facility had any contracts for the procurement of blood or blood products, but it would be checked into. At 12:15 PM, Staff A, provided an agreement between the CAH and the [Blood Product supplier] dated 01/20/21 for the procurement of blood or blood products. Staff A stated that this agreement was in place as part of their future plan to provide blood or blood products but had not been utilized to date.


Review of a document on 11/02/22 at 1:09 PM, titled, "[Blood Product supplier] BLOOD SERVICES AGREEMENT," dated, 01/20/21 showed a hand written notation by Staff A, "11/02/22 12:18 talked to [Blood Product supplier senior sales director]-12:44 ask for 1 hr (hour) & 1 hr travel 2 hrs for (stat order) of blood, comes out of Wichita ..." Staff A informed surveyors that per conversation with The [Blood Product supplier], the procurement of blood would require a two hour minimum for a STAT(immediately) order of blood.

RECORDS SYSTEM

Tag No.: C1104

Based on record review, policy review, document review and interview the Critical Access Hospital (CAH) failed to ensure the emergency department (ED) staff accurately and completely documented test results and evaluations in the medical records for 9 of 22 patient (Patient 2, 3, 7, 8, 9, 13, 15, 16, and 17) ED records reviewed and failed to obtain a physician order, provide and document ongoing monitoring of a patient while in restraints, and failed to document reassessment evaluations for continued use of restraint for 1 of 22 patients (Patient 20) reviewed. The CAH's failure to accurately and completely document test results, evaluations and the use of restraints has the potential to place patients at risk for unidentified medical needs resulting in deterioration of an emergency medical condition (EMC) up to and including death.


Findings Include:


Review of a policy titled, "Chest Pain," revised 12/2019, showed," ... guidelines: 1. All patients presenting with chest pain should be treated as a medical emergency ...3. Follow chest pain protocol per provider. 4. Assess ABC's and obtain full set of vitals and document ...6. Apply cardiac monitor and obtain EKG ...Nursing: 1. EKG STAT (within 10 minutes of arrival) ...3. Continuous cardiac monitoring with telemetry ...5. Monitor vital signs every 10-15 minutes ..."


Review of a policy titled, "Vital signs/ Blood glucose," revised 02/2021, showed " ...Policy: vital signs will be obtained and documented upon arrival, before discharge and as necessary due to patient condition. Procedure: vital signs in the ER include temperature, pulse rate, respiratory rate, blood pressure, height, weight, pain assessment and pulse oximetry ...3. Patients initially triaged with ESI (Emergency Severity Index) of 3: a. stable patients should have vital signs checked and documented at least every 1 hour. ...8. Vital signs should be obtained and documented within 15 minutes of discharge on all ER patients regardless of condition."


Review of a policy title, "Restraints", revised 12/2019, showed " ...to protect the patients' health and safety, protect patients from harming themselves, other patients, or staff, and limit the use of restraints to clinically appropriate and adequately justified situations ... physician orders: ...b. restraints orders can be written by the patients attending physician. c. the restraint order will be followed with consultation by the patients treating physician as soon as possible if the restraint is not ordered by the patients treating physician ...e. the order needs to specify i. the behavior requiring the restraint. ii. the type of restraint to be used ...v. the frequency of monitoring and assessment if different from hospital policy. ...the physician will see and evaluate the need for restraint or seclusion within 1 hour of initiation of the restraint ... iii. if a patient is in 3-, 4-, or 5-point restraints all of the following must be in place: 1.) an order 1:1 observation must be obtained 2.) the 1:1 may be completed by RN/LPN/CNA/RT/PT. 3.) behavioral assessments must be performed every 15 minutes and documented on "The Restraint Flowsheet". 4.) Vital signs must be documented every 4 hours, and nursing care (limb release/ROM, circulation, mobility, sensation, circulation, skin integrity, and care delivery) (food and fluids, oral care, toileting, and patient education) must be offered/done/checked every 2 hours and PRN and documented on The Restraint Flowsheet. The nurse must validate that the care and documentation are being performed by signing and initializing The Restraint Flowsheet. iv. a nurse's note will be written every shift to document restraint use, alternatives tried, attempts to reduce or remove restraints and patients response to these interventions ... When a restraint is or has been discontinued, a new order will be obtained for re-application of the restraint ...


Review of a policy titled, "Refusal of treatment/AMA, leaving without being seen, elopement," revised 03/2022 showed, ..." G. Documentation in the Emergency Record should include (but is not limited to): a. Date and time the patient indicated desire to refuse treatment, diagnostic study or intent to leave and the reason given (unless patient eloped, and reason was unknown). b. Date and time provider was notified. c. Any attempts made at explaining consequences or risks involved that may result from this action. d. Date and time of discharge (if applicable) or when it was found the patient had eloped and the person with whom patient left the facility (if known). e. Whether or not the patient signed the Informed Consent to Refuse form identifying they are aware of the consequences and potential results of their actions. f. Patient's apparent or last known condition and any assessment that was completed, including any observational assessment, at the time of the dismissal or elopement. g. In addition to the above emergency record documentation, an incident report should be completed in the event of treatment refusal, refusal of diagnostic studies, leaving without medical advice or leaving without being seen by a provider.


Patient 2

Review of Patient 2's medical record showed Patient 2 presented to the ED on 05/21/22 at 7:00 PM with a chief complaint of vomiting, headache, and body aches and transferred to a higher level of care at 10:30 PM due to the inability to obtain vascular access. Record review showed vital signs were obtained on admission and prior to transfer.

The medical record failed to show evidence of hourly vital signs at 8:00 PM and 9:00 PM as required per facility policy for a patient with an Emergency Severity Index (ESI) of 3.


Patient 3

Review of Patient 3's medical record showed Patient 3 presented to the ED on 07/19/22 at 4:40 AM with a chief complaint of chest pain and transferred to a higher level of care at 5:40 AM with a ST elevation Myocardial Infarction (STEMI) heart attack.

The medical record failed to show documented evidence that patient was monitored with telemetry (continuous cardiac monitoring) as required by facility policy.


Patient 7

Review of Patient 7's medical record showed Patient 7 presented to the ED on 09/07/22 at 12:32 AM with chief complaint of high blood sugar and after a medical screening exam (MSE) laboratory results indicated an elevated Troponin (laboratory test indicating heart attack) and Patient 7 transferred to a higher level of care at 3:32 AM.

The medical record failed to show vital signs were obtained within 15 minutes of discharge as required by facility policy.


Patient 8

Review of Patient 8's medical record showed Patient 8 presented to the ED on 09/23/22 at 3:15 PM with a chief complaint of nausea and vomiting and transferred to a higher level of care at 8:39 PM after MSE indicated acute appendicitis.

The medical record failed to show documentation of hourly vital signs at 4:25 PM, 5:25 PM, 6:50 PM and 7:50 PM as required by facility policy for a patient with an Emergency Severity Index (ESI) of 3.


Patient 9

Review of Patient 9's medical record showed Patient 9 presented to the ED on 10/07/22 at 11:30 AM with a chief complaint of worsening COVID 19 symptoms and decreased urine output and discharged at 4:21 PM.

The medical record failed to show documentation of hourly vital signs at 2:45 PM and 3:45 PM as required by facility policy for a patient with an Emergency Severity Index (ESI) of 3.


Patient 13

Review of Patient 13's medical record showed patient presented to the ED on 06/15/22 at 11:28 PM with a chief complaint of right arm laceration and transferred to a higher level of care on 06/16/22 at 12:15 AM after MSE indicated a right forearm laceration arterial bleed.

The medical record failed to show vital signs were obtained within 15 minutes of discharge as required by facility policy.


Patient 15

Review of Patient 15's medical record showed Patient 15 presented to the ED on 05/12/22 at 12:00 PM with a chief complaint of chest pain, headache, and shortness of air and discharged home at 3:15 PM after MSE ruled out EMC.

The medical record failed to show documented evidence that patient was monitored with telemetry (continuous cardiac monitoring). The record showed an Electrocardiography (EKG) (an electrical recording of the hearts activity) was completed at 12:18 PM, 18 minutes after arrival, and not within 10 minutes as required by policy.

During an interview on 11/06/22 at 2:59 PM Staff J, APRN, verified that the time stamp for the EKG (patient with chest pain) was not obtained within 10 minutes as required by facility policy.


Patient 16

Review of Patient 16's medical record showed Patient 16 presented to the ED on 05/21/22 at 12:31 PM with a chief complaint of a fall with a head injury and transferred to a higher level of care at 3:22 PM with a subdural hemorrhage.

The medical record failed to show documented evidence of hourly vital signs at 2:30 PM as required by facility policy for a patient with an Emergency Severity Index (ESI) of 3.


Patient 17

Review of Patient 17's medical record showed Patient 17 presented to the ED on 05/21/22 at 9:15 PM with a chief complaint of a possible seizure and left Against Medical Advice (AMA) at 10:06 PM.

The medical record showed that the patient left AMA after MSE was completed and prior to testing to rule out EMC.

The medical record failed to show evidence that facility followed policy by not completing an AMA form, not notifying supervising physician or completing occurrence report per facility policy.


Patient 20

Review of Patient 20's medical record showed Patient 20 presented to the emergency department on 10/18/22 at 9:32 PM with altered mental status, acute alcohol intoxication and cocaine abuse. Further review of the medical record showed, " ...2150 (9:50 PM): Pt (patient) becomes agitated and aggressive towards staff attempting to kick, bite, and hit staff. Pt placed in 4 pt restraints with assist x 2 RN, [Staff K, APRN] and 2 EMS (emergency medical services) ...2200-2300 (10:00 -11:00 PM): Restraints in place. Pt checked on. Pt skin warm dry intact, and no decrease in circulation noted. Checked Q 15 m. 2300 (11:00 PM): restraints removed as pt is current cooperative and resting with eyes closed. 2300-0500 (11:00 PM- 5:00 AM): Pt checked Q 1 h and continues to be resting in bed with eyes closed. 0530 (5:30 AM): pt (patient) rips out own IV and becomes violent towards staff. With assist X 4 police officers 3 staff members restraints replaced. [Staff K, APRN] notified. 0700 (7:00 AM): report given to [Staff S, RN] who resumes care at this time. 0700 (7:00 AM) PT resting with eyes closed restraints checked. 0700-0800(7:00-8:00 AM) restraints and pt (patient) checked every 15 minutes. Pt (patient) resting with eyes closed. 0800 (8:00 AM) pt (patient) awake and requesting bathroom. Placed on bedpan. 0805 (8:05 AM) restraints removed ..."

Review of Patient 20's ER record showed an order dated 10/18/22 at 11:24 PM, "use hard restraints for patient safety x 2 hours. Location of restraints: 4 point-ext." signed by Staff K, APRN. The order failed to specify the following as required per policy: the behavior requiring the restraint; the extremity or body part being restrained; and the frequency of monitoring and assessment. Further review of the record showed that Staff K, APRN, failed to document a consultation with the supervising physician for the need of restraints. Review of the record showed that Patient 20 was placed in restraints at 9:50 PM to 11:00 PM (1 hour and 10 minutes.)

The medical record failed to show evidence that a face-to-face assessment was completed by the supervising physician within 1 hour of restraint initiation as required per facility policy. Further review of the orders failed to show that Staff K, APRN, entered an order for 1:1 observation as required per facility policy.

The facility failed to provide documentation of behavioral assessments every 15 minutes, vital signs every 4 hours, and nursing care every 2 hours on the "Restraint Flowsheet" as required per policy for a patient in 4-point restraints.

Patient 20's restraints were removed at 11:00 PM and replaced at 5:30 AM to 8:05 AM (2 hours 35 minutes) on 10/18/22. Review of the ER orders failed to show the facility obtained or enter a new order for re-application of the restraint as required per policy and failed to show evidence of a consultation with the supervising physician prior to re-application of restraints.

The medical record failed to show documentation of patient assessments and nursing care provided on the "Restraint Flowsheet".

The record failed to show any documentation from 11:00 PM to 5:30 AM of patient status, nursing care or vital signs.