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Based on observation, record review, professional reference review, review of policy and procedure, review of manufacturer's guidelines, and staff interview, the Hospital failed to recognize the safe and appropriate use of roll belt physical restraint (a type of soft canvas restraint applied to a patient's torso/waist) and wrist restraint for 3 of 8 closed patient (Patient #1, #2, and #4) records reviewed. Failure of the Hospital to ensure its usage of roll belt physical restraints complied with manufacturer guidelines violated the rights of Patient #1, #2, and #4 and has the potential to violate the rights of other patients.

Findings include:

The Centers for Medicare and Medicaid Services (CMS) has outlined the standards of practice for the use of restraints. The safety of the patient, staff, or others is the premise for initiating and discontinuing the use of restraint. Restraints may not be used unless it is necessary to ensure the immediately physical safety of the patient, staff, or others. The decision to use a restraint is not directed by diagnosis, but by a comprehensive individual patient assessment. This assessment should include a physical assessment to help staff identify medical problems that might be causing behavior changes in the patient. If the assessment shows the need for an intervention, the hospital must use the least restrictive intervention that will effectively protect the patient from harm. If the need for a restraint intervention is determined, the practitioner must then determine the type of restraint that will meet the patient's needs, after weighing the risks of using a restraint against the risks brought on by the patient's behavior. The restraint chosen must be associated with the least risk and most benefit to the patient. Staff must assess and monitor a patient's condition to ensure patient safety, the continued need for restraint, and to see that a patient is released from restraint at the earliest possible time. Staff must demonstrate through documentation the assessments, interventions, and reasons why the restraint is the least restrictive intervention that protects the patient's safety. The use of restraint for the prevention of falls should not be considered a routine part of a falls prevention program. A history of falling without a current clinical premise for a restraint intervention is inadequate to demonstrate the need for restraint. If a patient displays symptoms of dementia, has unsteady gait, continues to get out of bed, walks or wanders, even at night, the rationale that the patient should be restrained because he/she might fall does not constitute an adequate premise for using a restraint. A request from a patient or family member to apply restraints is not a sufficient premise for the use of a restraint. The Hospital is responsible to provide safe, appropriate care to it's patients.

Review of the printed "Posey Company's 2009 Roll Belt Manufacture Guidelines," provided by the CMS Denver Regional Office prior to the survey, identified indications for use in "Patients assessed to be at risk of injury from a fall. Patients needing freedom to roll from side to side or sit up in bed." The manufacturer's guidelines pertaining to "Contraindications" stated, "DO NOT use on a patient who is or becomes highly combative, agitated, or suicidal. DO NOT use on patients with: ostomy, colostomy, g-tubes; hernias, severe Chronic Obstructive Pulmonary Disease [COPD]; or with post-surgery tubes, incisions, or monitoring lines. These could be disrupted by a restraint."

On 02/18/09, an administrative staff nurse (#2) provided the "2007 Posey Company Self-Releasing Roll Belt Manufacture Guidelines" for review. Review of this information included the same contraindications as mentioned above.

Review of facility policy "Restraints/Seclusion" occurred on 02/17/10. This policy, revised May 2008, stated, "Purpose: To outline the components necessary for safe use of restraints when utilized to protect the patient and or others from injury. Policy: It is Trinity's commitment to limit restraint use to clinically justified situations where there is imminent risk of a patient physically harming him/herself or others. Leaders and patient caregivers strive to create a safe environment where restraint use can be prevented or where alternatives to restraint can be employed. All patient care processes are designed to preserve the patient's dignity, rights and well being. All clinical staff completes the annual 'Restraint Use' competencies. Definitions: 1. Restraint- The direct application of human or mechanical force to a patient, with or without the patient's permission, to restrict his or her freedom of movement. . . . Procedure: A. Restraint use for Medical and Surgical Care (to support physical healing) 1. Assessment. The RN [registered nurse], in collaboration with the charge nurse or supervisor, assesses the need for patient restraint. After assessment, chooses least restrictive restraint method. 2. Restraint order. RN initiates order only if LIP [licensed independent practitioner] is not available. Notify LIP within 12 hours (ASAP [as soon as possible] if significant change in patient condition) to obtain verbal or written order. 3. Patient exam/Order time limit. LIP examines pt. [patient] and writes renewal order within 24 hours of initiation. Renewal order and re-exam required at least every 24 hours. . . . 4. Monitoring of the patient in restraint. At least every 2 hours. Requires observation, direct interaction or examination by a nurse or LIP. 5. Discontinuation of restraint. Restraints are terminated as soon as possible but may later be re-applied within the time-limit of an order if patient behavior warrants. . . . C. Restraint Protocols. Patients who have certain specific conditions may require the use of a restraint during their treatment. The restraint is necessary to prevent significant harm to the patient. 1. Assessment - The RN, in collaboration with the charge nurse, assesses for the following risk of harm to the patient: a. Presence of one or more: central venous line, arterial line, IABP [intra-aortic balloon pump], endotracheal tube, tracheostomy, ICP [intracranial pressure] monitor, ventriculostomy catheter and b. Risk of harm to the patient if item in a. is removed by the patient and c. Presence of one or more: confusion, sedation, agitation, inability to respond to direct requests/directions, direct attempts to remove the device (in a. above). 2. Restraint protocol order. RN uses assessment criteria in #1 above and determines need for restraint. LIP issues a patient-specific order authorizing the use of restraint protocols. 3. Patient exam/Order time limit. RN re-assesses patient every 24 hours and PRN [as needed] for the need to continue the protocol. 4. Patient monitoring. As per medical/surgical restraint section A. above. 5. Discontinuation of protocol. RN will release the restraint and discontinue the protocol when either of the following conditions apply: a. device listed in 1.a. above has been removed, patient is alert, oriented, and able to follow commands; patient is free of agitation, confusion, combative behavior; and less restrictive interventions for maintaining patient free from harm have proven effective. D. Documentation . . . 1. Complete restraint initiation power form. Date/time, reason for restraint and alternatives attempted. 2. Complete restraint monitoring and discontinuation power form . . . Medical/surgical restraint use - every 2 hours. . . . Includes: restraint type and activity (applied, removed, reapplied), skin assessment and positioning, nutrition/hydration/hygiene/elimination, safety, affect/behavior, restraint discontinuation readiness attempts, education to patient/family, if released, time/date and criteria met for release. . . . A clinical note or the power form comment fields may be used to document additional information or assessment, update care plan, update family if involved in plan of care. . . ."

- Review of Patient #1's closed medical record occurred 02/17/10. The record identified the Hospital admitted this 90 year old 02/06/10 with diagnoses of chronic obstructive pulmonary disease (COPD) and bilateral pneumonia. Record review indicated a history of Alzheimer's dementia among many other chronic conditions.

Patient #1's history and physical report, dated 02/06/10, stated, ". . .The patient has significant respiratory failure with tachypnea and accessory muscle use on admission . . . ." The patient does have significant sundowning so we will use roll belts as well as use Temazepam [a hypnotic medication used to promote sleep] to help with sedation at night. . . ."

Review of physician orders, dated 02/06/10 at 5:53 p.m., identified an order for Temazepam daily at bedtime, and at 6:21 p.m. an order for a roll belt restraint (a type of soft canvas restraint applied to a patient's torso/waist and ties to the bed).

The nursing interactive flowsheet and assessment form, dated 02/066/10 at 6:30 p.m., identified Patient #1's behavior/mental status as calm, appropriate, cooperative, confused, and obeys simple commands. These forms also indicated Patient #1 as at high risk for falls and showed family at patient's bedside.

Patient #1's medication administration form showed the patient received Temazepam on 02/06/10 at 9:02 p.m. Review of restraint form, nursing interactive flowsheet, and assessment form, dated 02/07/10, identified a roll belt restraint applied at 12:20 a.m. due to cognitive impairment that interferes with medical care and interference with medical devices, tubes, dressings, ect. The forms/flowsheets showed reality orientation as an alternative attempted before staff applied the restraint. These forms indicated Patient #1 behavior/mental status as agitated, restless, uncooperative, and confused. Patient #1's assessment forms from 02/06/09 to 02/07/09 showed labored breathing at times with use of accessory muscles and an (IV) intravenous line and oxygen placed. Review of a nurse note written 02.07/10 stated, ". . . family wishes to keep roll belt on . . . ."

Patient #1's record lacked documentation of an appropriate basis and rationale to use the roll belt restraint. The record lacked appropriate alternatives attempted or rationale for not using alternatives, patient response, and less restrictive interventions tried before staff used restraints.

During interview on the morning of 02/18/10, an administrative nursing staff member (#3) stated the patient's diagnosis of sundowner's syndrome and its symptoms was the reason for the restraint of Patient #1.

The Hospital staff failed to consider the roll belt restraint as a safety risk to Patient #1 due to his diagnosis of COPD. The Hospital staff failed to consider management of patient behavior and family requests as inappropriate reasons for restraint usage.

- Review of Patient #2's closed medical record occurred 02/17/10. The record identified the Hospital admitted this 98 year old 12/19/09 with diagnoses of acute congestive heart failure (CHF) and acute lower extremity cellulitis. Record review indicated a history of ileostomy among many other chronic conditions.

Patient #2's nursing interactive flowsheet and assessment form, dated 12/25/09 at 3:55 p.m., stated "At 1520 hrs [hours] pt. [patient] was found by staff trying to exit the bed and stand. Staff responded and pt. slowly lowered to the floor. Assessment done and no injuries noted/vitals good". The next entry, dated 12/25/09 at 4:08 p.m., stated "Notified [name of physician] and house supervisor of fall. Orders received for restraints. Restraints initiated. . . ."

Patient #2's restraint forms and nursing interactive flowsheets, dated 12/25/09 at 3:50 p.m., showed roll belt restraint placed per physician's orders due to cognitive impairment that interferes with medical care. The forms/flowsheets showed reality orientation as alternatives attempted before staff applied restraints and indicated Patient #2's behavior/mental status as calm and disoriented. These forms also indicated Patient #2 is at high risk for falls.

Patient #2's record lacked documentation of an appropriate basis and rationale to use the roll belt restraint. The record lacked documentation of appropriate alternatives attempted or rationale for not using alternatives, patient response, and less restrictive interventions tried before staff used restraints.

During interview on the morning of 02/18/10 an administrative nursing staff member (#3) stated a history of falls, a high fall risk score and a fall during hospital stay were the reasons for the restraint of Patient #2.

The Hospital staff failed to consider the roll belt restraint as a safety risk to Patient #2 due to his ileostomy. The Hospital staff failed to consider prevention of falls would be an inappropriate reason for restraint usage.

- Review of Patient #4's closed medical record occurred 02/18/10. The record identified the Hospital admitted this 87 year old 10/27/09 with diagnoses of altered mental status, septicemia, urinary tract infection (UTI), dehydration, acute renal failure, and malnutrition.

Patient #4's nursing interactive flowsheet and assessment form, dated 10/28/09 at 12:00 p.m., stated ". . . NG [nasogastric tube] placed . . . pt. [patient] tolerated . . . restraints placed on pt. at this time to prevent pulling out NG tube." Record review showed soft limb restraints (a type of cuff placed around patient's wrists and tied to the bed) applied 10/28/09 at 12:00 p.m. per physician orders. Review of the restraint forms and nursing interactive flowsheets, dated 10/28/09 at 12:00 p.m., indicated Patient #4's behavior/mental status as awake, disoriented, and restless.

Patient #4's record lacked appropriate alternatives attempted or rationale for not using alternatives, patient response, and less restrictive interventions tried before staff placed restraints on Patient #4.


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During interview on the afternoon of 02/17/10, administrative staff nurses (#2 and #4) identified the types of physical restraints available for use on the medical units in the facility include either roll belts (a type of soft canvas restraint applied around a patient's torso/waist) or limb restraints (a soft canvas restraint applied to a patient's limb - wrist or ankle). Administrative staff nurse (#2) stated a "roll belt" restraint when applied on a patient in bed, still allows the patient to move or roll from side to side and identified this type of restraint as being "less restrictive."

Observation of roll belts available for use at the facility occurred on 02/18/10 at 9:50 a.m. and identified one roll belt available for patient use located in the facility's 2nd, 4th, and 6th floor clean linen supply closets.

During interview on the morning of 02/18/10, an administrative staff nurse (#2) stated the facility's medical record/computer charting program does not allow staff to specify which type of restraint (whether limb [wrist] or torso [roll-belt]). Administrative staff nurse (#2) stated staff only have the option of documenting/entering "soft limb" restraint.

Based on record review, policy and procedure review, and staff interview, the Hospital failed to determine, attempt and document less restrictive interventions or alternatives prior to restraint application for 3 of 8 closed patient (Patient #1, #2, and #3) records reviewed. Failure to determine less restrictive measures were ineffective before using restraints may compromise patients' safety.

Findings include:

Review of facility policy "Restraints/Seclusion" occurred 02/17/10. This policy, revised May 2008, stated, ". . . It is Trinity's commitment to limit restraint use to clinically justified situations where there is imminent risk of a patient physically harming him/herself or others. Leaders and patient caregivers strive to create a safe environment where restraint use can be prevented or where alternatives to restraint can be employed. . . . Procedure: A. Restraint use for medical and surgical care (to support physical healing): 1. Assessment: The RN [registered nurse], in collaboration with the charge nurse or supervisor, assesses the need for patient restraint. After assessment, chooses least restrictive restraint method. . . . D. Documentation . . . 1. Complete restraint initiation power form: date/time, reason for restraint and alternatives attempted . . . A clinical note or the power form comment fields may be used to document additional information or assessment . . . ."

- Review of Patient #1's closed medical record occurred 02/17/10. The record identified the Hospital admitted this 90 year old 02/06/10 with diagnoses of chronic obstructive pulmonary disease (COPD) and bilateral pneumonia. Record review showed a roll belt restraint (a type of soft canvas restraint applied to a patient's torso/waist and ties to the bed) ordered and applied at 12:20 a.m. on 02/07/10.

Patient #1's restraint forms and nursing interactive flowsheets, dated 02/07/10 at 12:20 a.m., showed roll belt restraint placed due to cognitive impairment that interferes with medical care and interferes with medical care and medical devices, tubes, and dressings. The forms/flowsheets showed reality orientation as an alternative attempted before staff applied the roll belt restraint. These forms indicated Patient #1's behavior/mental status as agitated, restless, and uncooperative.

Patient #1's record lacked documentation of appropriate alternatives attempted or rationale for not using alternatives, patient response, and less restrictive interventions tried before staff applied restraints.

- Review of Patient #2's closed medical record occurred 02/17/10. The record identified the Hospital admitted this 98 year old 12/19/09 with diagnoses of acute CHF (congestive heart failure) and acute lower extremity cellulitis. Record review showed a roll belt restraint ordered and applied at 3:50 p.m. on 12/25/09.

Patient #2's restraint forms and nursing interactive flowsheets, dated 12/25/09 at 3:50 p.m., showed staff placed a roll belt restraint due to cognitive impairment that interferes with medical care. The forms/flowsheets showed reality orientation as an alterative attempted before staff applied the roll belt restraint. These forms indicated Patient #2's behavior/mental status as calm and disoriented.

Patient #2's record lacked documentation of appropriate alternatives attempted and/or rationale for not using alternatives, patient response, and less restrictive interventions tried before staff applied a roll belt restraint.

- Review of Patient #3's closed medical record occurred 02/17/10. The record identified the Hospital admitted this 73 year old 12/11/09 with diagnoses of increased confusion and possible sepsis. Record review showed soft restraint ordered and initiated at 7:46 p.m. on 12/11/09.

Patient #3's restraint forms and nursing interactive flowsheets, dated 12/11/09 at 7:46 p.m., showed four side rails elevated as restraint due to cognitive impairment that interferes with medical care. The forms/flowsheets identified Patient #3's behavior/mental status as "restless."

Patient #3's record lacked documentation of appropriate alternative attempted and/or rationale for not using alternatives, patient response, and less restrictive interventions tried before staff applied restraints.

During interview on 02/18/10 at 8:25 a.m., a nursing staff member (#4) stated staff need to try different alternatives and determine less restrictive interventions before restraint application and must document this in the medical record.

Based on record review, review of facility policy and procedure, and staff interview, the Hospital failed to discontinue restraints at the earliest possible time for 2 of 8 closed patient (Patient #2 and #4) records reviewed. Failure to discontinue a restraint as soon as the unsafe situation ends has the potential to risk patient safety, restrict patients' rights, and contribute to the inappropriate use of restraints.

Findings include:

Review of facility policy "Restraints/Seclusion" occurred 02/17/10. This policy, revised May 2008, stated, ". . . It is Trinity's commitment to limit restraint use to clinically justified situations where there is imminent risk of a patient physically harming him/herself or others. Leaders and patient caregivers strive to create a safe environment where restraint use can be prevented or where alternatives to restraint can be employed. . . ."

- Review of Patient #2's closed medical record occurred 02/17/10. The record identified the Hospital admitted this 98 year old patient on 12/19/09 with diagnoses of acute CHF (congestive heart failure) and acute lower extremity cellulitis. Record review showed a roll belt restraint (a type of soft canvas restraint applied to a patient's torso/waist and ties to the bed) applied 12/25/09 at 3:30 p.m. per physician orders. Review of Patient #2's physician orders, dated 12/26/09 at 1:56 p.m., identified a renewed restraint order.

Patient #2's restraint forms and nursing interactive flowsheets, dated 12/27/09 from 12:00 a.m. to 2:00 p.m., showed roll belt restraint on and "patient behavior/mental status" documented as appropriate, calm, cooperative, and at times disoriented/not oriented. Review of physician progress note, dated 12/27/09 at 1:44 p.m., revealed no mention of patient behavior or restraint. The note stated, "The patient is doing fine." Review of Patient #2's physician orders, dated 12/27/09 at 2:34 p.m,. identified another renewed restraint order.

Review of Patient #2's restraint forms and nursing interactive flowsheets, dated 12/27/09 at 4:00 p.m. to 12/28/09 at 12:00 p.m., showed roll belt restraint on and "patient behavior/mental status" documented as appropriate, calm, cooperative, and at times disoriented/not oriented. The record identified Patient #2 discharged sometime after 12:00 p.m. on 12/28/09.

Patient #2's record lacked documentation of appropriate interventions/alternatives tried to discontinue restraint and lacked documentation of patient response to them. The record lacked appropriate documentation of Patient #2's ongoing clinical needs to support the continued need of restraint.

- Review of Patient #4's closed medical record occurred 02/18/10. The record identified the Hospital admitted this 87 year old patient on 10/27/09 with diagnoses of altered mental status, septicemia, urinary tract infection, dehydration, acute renal failure, and malnutrition. Record review showed soft limb restraints (a type of cuff placed around patient's wrists and tied to the bed) applied 10/28/09 at 12:00 p.m. per physician orders. Review of Patient #4's physician orders, dated 10/29/09 at 8:22 a.m., identified a renewed restraint order.

Patient #4's restraint forms and nursing interactive flowsheets, dated 10/29/09 from 4:00 p.m. to 10/30/09 at 8:00 a.m., showed soft limb restraints on and "patient behavior/mental status" documented as calm, cooperative, appropriate, confused, lethargic, and asleep. Review of physician progress note, dated 10/30/09, revealed no mention of patient behavior or restraint. The note stated patient somewhat confused. Review of Patient #4's physician order, dated 10/30/09, identified a renewed restraint order.

Patient #4's restraint forms and nursing interactive flowsheets, dated 10/30/09 from 8:00 a.m. to 10/31/09 at 8:00 a.m., showed soft limb restraints on and "patient behavior/mental status" documented as appropriate, lethargic, disoriented, no distress, and resting. Review of physician progress note, dated 10/31/09, revealed no mention of patient behavior or restraint. The progress note stated the patient had poor responsiveness, was nonverbal, and doesn't follow direction. Review of Patient #4's physician order, dated 10/31/09, identified a renewed restraint order.

Patient #4's restraint forms and nursing interactive flowsheets, dated 10/31/09 at 8:00 a.m. to 11/01/09 at 12:00 p.m., identified "patient behavior/mental status" documented as appropriate, no distress, lethargic, and cooperative. These forms and flowsheets showed soft limb restraints remained on until 11/01/09 at 2:00 p.m.

Patient #4's record lacked documentation of appropriate interventions/alternatives tried to discontinue restraint and lacked documentation of patient response to them. The record lacked appropriate documentation of Patient #4's ongoing clinical needs to support the continued need of restraint.

During interview on 02/18/10 at 9:05 a.m., a nursing staff member (#5) confirmed documentation in Patient #2 and Patient #4's medical records lacked evidence to support the continued use of restraints and stated she would expect discontinuation of the restraint.