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.

SAINTS MEDICAL CENTER INC 1 HOSPITAL DRIVE LOWELL, MA Sept. 22, 2011
VIOLATION: PROGRAM SCOPE, PROGRAM DATA Tag No: A0273
**NOTE- TERMS IN BRACKETS HAVE BEEN EDITED TO PROTECT CONFIDENTIALITY**

Based on medical record reviews and staff interviews, the Hospital failed to monitor the effectiveness and safety of services and quality of care for six of nine Patients (#1, #3, #5, #6 #7 and #9) restrained in enclosed beds between April 2011 though September 2011.


Refer to A Tag A 144 and ATag 165.

Findings included:

1) The Director of Critical Care and the Director of Medical Surgical Nursing were interviewed on 09/21/11 and 09/22/11 respectively. Both confirmed that there were inconsistencies in nursing documentation for the use of restraints. The Director of Medical Surgical Nursing counseled the nursing staff involved in Patient #6's elopement from the restraint/enclosed bed on 05/14/11. However, the Director of Medical Surgical Nursing's investigation did not consider Patient #6's earlier success at getting herself/himself out of the enclosed bed, and did not identify measures that could have been taken to ensure the Patient #6's safety.

The Director of Medical Surgical said Patient #6's second elopement, dated 05/19/11, was not investigated nor was it reported to the Hospital's Quality Department because Patient #6 had been discharged on [DATE].

2) The VP of Quality/Interim CNO had no knowledge of Patient #6's two successful elopements from the Hospital during the same admission in May 2011.

3) The Hospital had no policy for the use of restraints within the enclosed bed.
VIOLATION: PATIENT RIGHTS: CARE IN SAFE SETTING Tag No: A0144
**NOTE- TERMS IN BRACKETS HAVE BEEN EDITED TO PROTECT CONFIDENTIALITY**

Based on review of the medical record and interviews, Patient #6 was not provided care in a safe setting, and eloped two times from the Hospital: 5/14/11 and 5/19/11. Patient #6 eloped from an enclosed bed [an enclosure bed is constructed with an over the bed frame with zippered mesh walls and a roof covering all four side of the bed. The bed is used to reduce restraint use, allow free movement within the bed, prevent falls and/or wandering].

Findings included:

Background information: Review of the medical record indicated that Patient #6 was admitted to the Hospital from a supervised group home in the community. Patient #6 had a legal guardian and was not able to make decisions independently. Patient #6's diagnoses included respiratory failure, which required mechanical ventilation, and was admitted on [DATE]. Other diagnoses included seizures, depression and paranoid schizophrenia.

Following discharge from the ICU, Patient #6 was admitted to the Medical Surgical floor and placed in an enclosed bed with an activated bed alarm.

Review of the manufacturer's educational literature indicated that the enclosed bed provided a secure, padded, protected environment. It is used for patients in need of protection from any medical condition which renders the patient at risk of injury when traditional restraints impede treatment, healing or cognitive function. The enclosed bed can protect patients at risk for falls, wandering, seizures or other behaviors that put patients at risk. In addition, the literature indicated that the enclosed bed allowed the patient to have access to his/her body and be able to move freely within the enclosure.

Review of the Hospital's Policy for Restraints indicated that a restraint was defined as a physical or mechanical device which limits movement of the whole or portion of a patient's body. A physical/mechanical device included a Posey vest protectors, limb restraints, enclosed beds and siderails if used to restrict the patient's freedom to leave the bed.

Non-Violent or Non Self-Destructive Restraint is a restraint applied to patients who demonstrate confusion, delirium, and cognitive or physical impairment, that involves the patient grabbing, pulling or tugging at medical devices, lines or tubes and/or is at risk for injury. The patient exhibits a lack of decision-making capacity in which the patient is incapable of understanding the benefits, risks and alternative treatments for which a device, invasive line or tubes were placed.

1) The Hospital did not have an approved policy regarding the use of the enclosed bed which outlined the specific criteria for use, including directives for safe monitoring of the patient while in the enclosed bed.

2) Review of the Restraint Documentation Reassessment, dated 05/13/11 at 8:00 PM, indicated that Patient #6's restraint was the enclosed bed. Review of the Plan of Care indicated that Patient #6 would demonstrate a reduction in fear and anxiety and that
Patient #6 would be free from falls. There was no nursing documentation that described Patient #6's response to the enclosed bed.

3) Review of the Nursing Note, dated 05/14/11 at 7:40 AM, indicated that Patient #6's bed alarm sounded and Patient #6 broke out of the enclosed bed. Patient #6 reported to the nursing staff "it was really hard to undo that zipper". The Nursing Note at 8:00 AM indicated that Patient #6 at first refused to return to the enclosed bed, but reluctantly agreed to return. Patient #6 complained of being hungry and wanted breakfast. The Nursing Note indicated Patient #6 will be offered a meal tray when someone can sit with the patient so the bed can be unzipped.

There was no nursing documentation indicating that a reassessment was conducted to identify increased safety measures required to prevent Patient #6 from getting out of the bed, nor were arrangements made to attend to Patient #6's hunger needs. Refer to A-Tag 0165.

4) Review of the Nursing Note, dated 05/14/11 at 10:30 AM, indicated that Patient #6 was missing from the enclosed bed and not in the room. The hospital gown was found on the floor. At 10:35 AM, Patient #6 was found outside of the Hospital wandering on the street and was returned to the inpatient unit by ambulance.

5) Review of the Restraint Reassessment, dated 05/14/11 at 10:58 AM, indicated that the enclosed bed had been discontinued and Patient #6 could be restrained as needed.

There was no documented physician's order to restrain as needed [which would have been in violation of the regulatory requirements: 482.13 (e) (6) which states that orders for the use of restraint or seclusion must never be written as a standing order or on as needed basis].

6) On 05/19/11 at 1:20 PM, Patient #6 eloped for the second time and went back to the group home where he/she resided. At 2:40 PM, Patient #6 was returned to the Hospital by the Security staff.

On 05/20/11, Patient #6 was discharged to the group home where she/he resided.

7) The Hospital failed to re-evaluate Patient #6's safety and reaction to being placed in the enclosed bed in a timely manner. In addition, the hospital failed to provide 1:1 observation to prevent the two elopement episodes.
VIOLATION: PATIENT RIGHTS: RESTRAINT OR SECLUSION Tag No: A0165
**NOTE- TERMS IN BRACKETS HAVE BEEN EDITED TO PROTECT CONFIDENTIALITY**

Based on review of the medical record and interviews, the nursing staff failed to implement the least restrictive intervention for three of three applicable Patients: Patients #1 in September 2011, Patient #6 in May 2011 and Patient #9 in August 2011, all of whom were restrained in an enclosed bed.

Findings included:


A) Patient #6: Refer to A-Tag 0144 for specific information regarding Patient #6.

B) PATIENT #1:

Review of the Emergency Department (ED) Record, dated 09/07/11 at 11:32 AM, indicated that Patient #1 was transported to the Hospital with complaints of shortness of breath, mental and functional status changes. Patient #1 had dementia. While in the ED, the Nurses Note at 1:30 PM, indicated that Patient #1 became more agitated with the insertion of an indwelling Foley catheter. Review of the Nursing Admission Assessment, dated 09/07/11 at 5:30 PM, indicated that Patient #1 was tugging at the johnny and the Foley catheter and attempting to get out of bed. The Nurses Note indicated there was an attempt to reorient Patient #1.

Review of the Physician Restraint Order Label indicated that a telephone order was obtained on 09/07/11 at 8:45 PM for the application of wrist restraints to facilitate treatment that was necessary to the Plan of Care. However, following the Restraint Order Label, there was a second telephone order which was out of order for the enclosed bed. This entry was written on 09/07/11 at 5:20 PM. There was no clear documentation regarding the need for the enclosed bed. The order for the enclosed bed was written an hour before Patient #1 was placed into the enclosed bed.

At 6:00 PM, the Nurses Note indicated Patient #1 was with family members and remained restless and pulling at the Foley catheter.

At 6:30 PM, the Nursing Note indicated Patient #1 was placed into an enclosed bed for safety. Patient #1 continued to pull off the johnny and cardiac monitor leads.

Review of the Medication Administration Record (MAR) indicated on that on 09/07/11 at 7:00 PM, the antipsychotic medication, Haldol - two milligrams, was administered by intramuscular injection for agitation.

Review of the Nursing Note, dated 09/07/11 at 7:00 PM, indicated that Patient #1 was placed into bilateral soft limb restraints and remained in the enclosed bed.

The Nursing Note dated 09/07/11 at 10 PM, indicated that Patient #1 was repositioned in the enclosed bed and the wrist restraints remained in place.

The manufacturer's literature for the enclosed bed indicated that patients have the capability to reposition themselves in the enclosed bed and would not require staff assistance for repositioning. However, Patient #1 was placed in additional restraints, bilateral wrist restraints, which was contrary to the recommendations for safe use.

Registered Nurse (RN) #1 was interviewed in person on 09/21/11 at 2 PM. RN #1 said Patient #1 threw his/her legs over the siderails and a enclosed bed was ordered. RN #1 said a bed alarm was initially placed on the bed. RN #1 said pleading with Patient #1 to stay in bed by family and staff was ineffective. RN #1 said Patient #1 tugged at the medical equipment and bilateral wrist restraints were applied so that Patient #1 was no longer able to tug at the medical devices. RN #1 said the enclosed bed was given to patients identified as a fall risk.

However, Nurse #1 did not document a comprehensive assessment for the use of bilateral wrist restraints, nor was there a Falls Assessment documented by RN #1 prior to Patient #1 being issued the enclosed bed.

Review of the Restraint Reassessment, dated 09/08/11 at 12 AM by RN #2 (five hours after application of the wrist restraints), indicated that the alternatives to the continuation of the wrist restraints and the enclosed bed, were documented as assessed by the registered nurse. The alternatives included reorientation, distraction, medication review, and family (option for sitter services) were considered. Patient #1 remained in restraint. RN #2 also documented in a Nursing Note that Patient #1 was restless in the enclosed bed.

RN #2 was interviewed on 09/21/11 at 3:44 PM. RN #2 said Patient #1 was agitated and pulling off of the oxygen mask. RN #2 said Patient #1 remained in restraints until a family member arrived on 09/08/11 between 7 AM and 7:30 AM, so that the wrist restraints could be removed. RN #2 said the (wrist) restraints were off during the day and the zippered netting on one side of the bed was lifted.

However, RN #2 did not document that the wrist restraints were removed while a family member was present on 09/08/11 between 7 AM and 7:30 AM nor was there documentation by RN #2 that any of the restraints were removed from Patient #1.

Review of the Nursing Note, dated 09/08/11 at 5 PM, indicated that Patient #1's condition had declined. The Patient was to receive care and comfort measures only. However, RN #2 did not document the removal of the restraints until 8:15 PM. Patient #1 continued to decline and later expired on [DATE] at 6:08 AM.


PATIENT # 9:

Review of the medical record indicated Patient #9 was admitted with diagnoses including mental status changes during August 2011, end-stage liver disease, possible sepsis and mental illness.

Review of the Restraint Orders indicated an enclosed bed was ordered on [DATE] at 12:30 PM.

Review of the Nursing Notes dated 08/03/11 at 2 PM, indicated that Patient #9 was agitated, confused and pulled out an indwelling Foley catheter. Patient #9 was medicated with Haldol without effect. The Nursing Notes indicated bilateral wrist restraint were applied.

Review of the physician's order sheet indicated there was no order for the bilateral wrist restraints written by the physician assuming the care of Patient #9 on the intermediate care unit.

Review of the Nursing Notes, dated 08/03/11 at 5:30 PM, indicated multiple family members arrived and were concerned about the use of the enclosed bed. Nursing staff failed to document their response to Patient #9's family about the Patient being placed in the enclosed bed.