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Based on medical record review, interviews, and review of hospital policy and procedure, the hospital failed to follow hospital policy, obtain a physician's order for the application of four point soft restraints for Patient Identifier (PI ) # 1, and document the application of the restraints in the medical record on 4/18/2012. This affected one of ten sampled patients.

Findings include:

Medical Record Review Includes:

PI # 1's History and Physical, original date 4/5/2012, updated 4/18/2012, documents the following diagnoses:

1. Shortness of Breath
2. Abnormal Cardiovascular Study
3. Long Term Anticoagulant Use
4. Atrial Fibrillation
5. Hypertension
6. Cardiomyopathy
7. Congestive Heart Failure

History of Present Illness: PI # 1 presents today with shortness of breath which began one to two months ago. The shortness of breath occurs with moderate exertion and is relieved by rest.

Treatment: Arrange left heart catheterization.

On 4/18/2012, PI # 1 was admitted to the hospital for an outpatient heart catheterization.

According to the cardiac catheterization report, dated 4/18/2012, when the 6 French sheath was placed in the right common femoral artery, a leak
(blood) was noted around the sheath. The sheath was changed three more times in an effort to stop/control the bleeding.

Some degree of bleeding was noted after the the last sheath was inserted in the artery. As a result, an angiogram was done. The angiogram revealed that some blood was escaping from the artery at the puncture site and going into the groin area below the inguinal ligament. Pressure was applied to the sheath, homeostasis was achieved, and the coronary angiography was performed.

At the end of the procedure after letting up on pressure to the groin, oozing of blood was still noted around the sheath. According to the physician's documentation, "The needle may have caused a small tear in the arterial wall on passing the length of the artery as the artery felt very calcified on passing the needle initially." The cardiologist, Employee Identifier (EI # 1), documents the situation was discussed with the vascular surgeon and an Angio-Seal device was used to attempt to seal the artery. However, the Angio-Seal failed, and the entire device was retrieved from the patient. Pressure was applied and will be held for 30 minutes to see if this will seal the artery. If not, the patient (PI # 1) may need surgery. The patient is in the holding area of the catheterization lab with pressure being applied to the groin. Currently, there is no evidence of any hematoma.

Interviews

During an interview on 6/6/2012 at 5:15 PM, the ICU Manager, EI # 2, said the patient (PI # 1) was sent to ICU for close monitoring for bleeding because his femoral artery was torn during the heart catheterization.
PI # 1 got out of bed on admission to ICU on 4/18/2012. PI # 1 had no physician orders to get out of bed due to his procedural complication and bleeding.

At or around 7:00 PM (shift change), the RN (EI # 3) assigned to the patient (PI # 1), saw PI # 1 standing at the bedside. The bed alarm was sounding. The RN (EI # 3) entered PI # 1's room and told the patient he could not be out of bed. According to the Manager, the RN assigned to the patient (EI # 3) steadied the patient. This conversation between the primary RN (EI # 3) and PI # 1 was overheard by another ICU RN, EI # 4. The patient (PI # 1) became combative. The charge nurse (EI # 5) and staff RN (EI # 4) went to PI # 1's room to see if assistance was needed.

According to the ICU Manager (EI # 2), PI # 1 was sitting on the side of the bed. The charge nurse, EI # 5, saw blood dripping from the patient's groin /catheter site onto the floor. The charge nurse said we have to get the patient back in bed and the RN's physically put the patient in bed. It took 45 minutes of applied pressure to stop the bleeding at the groin/catheter site.

The Manager stated the on-call cardiologist (EI # 6) was notified. EI # 6 (on-call cardiologist) was on his way to the hospital and he asked the Emergency Room (ER) physician to see the patient. The ER physician came to ICU and evaluated the patient (PI # 1). The patient had to be restrained to prevent further bleeding from the catheterization site. The charge nurse reassigned the patient (PI # 1) to another RN (EI # 4) and the restraints were removed when the patient was calm.

According to the ICU Manager (EI # 2), the cardiologist (EI # 1) who performed the cardiac catheterization saw PI # in ICU after the procedure on 4/18/2012. EI # 1 told the patient he could not get out of bed until the following day because the cardiologist (EI #1) wanted to be present when the patient got out of bed. Around midnight, PI # 1 began saying he needed to get out of bed. The on-call cardiologist (EI # 6) came to ICU. EI # 6 told the patient (PI # 1)that he could get out of bed x 1 to use the bedside commode, but advised PI # 1 he could not get up afterwards.

During an interview on 6/7/2012 at 10:50 AM, the RN (EI # 4), said she was assigned to the patient in the room next to PI # 1 on 4/18/2012. The RN reports she heard PI # 1's voice and it sounded "agitated." This RN (EI # 4) asked EI # 3, the RN assigned to PI # 1, if everything was okay. EI # 3 said yes. EI # 4 walked away, but returned to PI # 1's room when she heard the patient and the RN's raised voices. The patient (PI # 1) was cussing at EI # 3. The Charge Nurse (EI # 5) and EI # 4 entered PI # 1's room. The Charge Nurse noticed PI # 1 was bleeding from the groin. Blood was on the floor and "all over the bed." According to the RN (EI # 4), PI # 1's blood loss was serious. We needed to get the patient (PI # 1) back in bed and apply pressure to the catheter site to prevent further blood loss.

EI # 4 reported the patient (PI # 1) was fighting while staff was explaining the need to get back in bed and apply pressure to the catheter insertion site. EI # 4 stated a "puddle" of blood was on the floor. The RN said staff did not realized the amount of blood loss by PI # 1 until staff began getting
PI # back into bed. EI # 4 said pressure was applied to the site and the cardiologist on call was notified. In the interim, the ER physician saw the patient (PI # 1). According to the EN (EI # 4), the patient (PI # 1) required restraint because he was "thrashing around" and would not remain still to prevent further blood loss while staff was applying manual pressure to the catheter site.

The RN (EI # 4) was asked if an order for a restraint was obtained. The RN said no because the decision to use restraints was quick to prevent further bleeding. The RN said PI # 1, "Sort of calmed down" and the restraint was removed.

During an interview on 6/7/2012 at 10:50 AM, the ICU RN (E # 3), said he walked in PI # 1's room on 4/18/2012 as PI # 1 was trying to get out of bed. The RN (EI #) said he was aware PI # 1 had a heart catheterization earlier in the day and could not be out of bed. The RN told PI # 1 that he could not get up, but the patient tried to stand. The RN said he tried to tell PI # 1 that he (RN) needed to check the catheter site, but PI # 1 became belligerent. The RN said he told PI # 1 to wait because he (RN / EI # 3) needed to assess the patient. However, PI #1 started getting up from the bed.

According to the RN (EI # 3), the patient (PI # 1) said he was going to get up, "regardless." PI # 1 said he had been up earlier in the day. The charge nurse (EI # 5) and a ICU staff RN (EI # 4) came to PI # 1's room when they heard PI # 1 screaming. According to the RN (EI # 3), the patient (PI # 1) was kicking and swinging. PI # 1 said he had to get up to "pee."
PI # 1 stated he was going to shoot the RN (EI # 3). The charge nurse (EI # 5) saw blood dripping from PI # 1's groin (heart catheterization site) onto the floor. The RN said staff had to hold PI # 1 to keep the affected leg still in order to prevent further bleeding. According to the RN (EI # 3), it took several people to prevent PI # 1 from hurting himself or anybody else.

EI # 3 (RN) said pressure was held at the catheter site for at least 45 minutes and the soft restraints were on for about an hour (7:15 PM to 8:15 PM). When PI # 1's family visited, the soft restraints were removed at the family's request. The RN (EI # 3) stated he felt he did what was right for the patient (PI # 1) to keep him (PI # 1) from bleeding to death.

Hospital Policy and Procedure

Restraint or Seclusion of Patients, Effective 1/5/92, Revised 8/11:

" 2. Authorization and Restraint Orders:...
B. If a registered nurse initiates use of restraint, a physician provides a verbal or written order within 12 hours of initiation of the restraint, unless the restraint is based on a unanticipated change in the patient's condition, then the registered nurse immediately notifies the physician."

4. Documentation/Monitoring:
A. Each episode of restrain is documented. Documentation should include information about:
- circumstances that led to their use...
- the rationale for the type of physical intervention selected, including the body parts restrained as appropriate...
- written orders for use..."

A review of the physician orders revealed no written order was documented for the application of restraint of PI # 1 on 4/18/2012.
There is no documentation in the nursing notes about the restraints.

This citation is written as a result of the investigation of Complaint Number AL00026746.