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Based on observations, interviews, review of facility Medical Staff Bylaws, and record reviews, the facility:
Failed to inform one patient and patient representative of the patient's rights prior to providing services (refer to A-0117);
Failed to have a specific policy timeframe for the review and provision of response to patient grievances (refer to A-0122);
Failed to send letters of response to grievances including the investigation steps taken on the behalf of the patient (refer to A-0123);
Failed to include the patient representative (healthcare surrogate) for one patient in the decisions of treatment prior to providing services (refer to A-0131);
Failed to ensure a signed physician order was obtained after security and nursing staff held one patient down to apply restraints (refer to A-0161);
Failed to ensure a signed physician orders were obtained included the type of restraint to be used prior to ongoing application of patients with restraints (refer to A-0165);
Failed to ensure a signed physician orders were obtained prior to ongoing application of patients with restraints (refer to A-0168);
Failed to ensure restraint orders are not written on as needed (PRN) basis (refer to A-0169;
Failed to ensure staff document monitoring assessments for one patient in restraints every two hours required by policy (refer to A-0175;
Failed to ensure one patient received a face-to-face assessment prior to ongoing use of behavioral restraints (refer to A-0184;
Failed to ensure security staff received first aide technique training prior to assisting staff with the application of patient restraints (refer to A-0206); and
Failed to have a policy addressing time frames for reporting deaths of patients while in restraints, and failed to report patients (#13) who died in restraints and patients who died within twenty-four hours of restraint use to the Centers for Medicare and Medicaid Services (CMS) (refer to A-0214)
The severity and cumulative effect of these systemic practices resulted in the hospital's failure to have a consistent practices related to patients' rights throughout the 39 patient care units on the main campus hospital and the facility is found to be out of compliance with 42 CFR 482.51 - Condition of Participation: Patient's Rights.

Based on record review and interview, the facility failed to inform one patient and patient representative (#7) of the patient's rights prior to providing services.

Findings included:

Review of the information packet given to patients by the registration department showed it contains information related to patient's rights, advanced directives, notice of patient privacy practices, infection control, visitation practices and grievances contacts.

Medical record review for patient #7, age 29, admitted on 08/16/2011 with a diagnosis of overdose showed there is no signed consent to treat the patient at the hospital. Review of the advanced directive showed the patient has designated her mother as health care surrogate in circumstances when she cannot speak for herself.

During an interview on 08/20/2011 at 10:40 a.m., patient #7's psychiatrist said he consulted on the patient on 08/16/2011 and the patient would not have been competent to make decisions on that day. He said he obtained the medical history from the mother, old charts, and by assessing the patient.

During an interview on 08/19/2011 at 3:15 p.m. the director of registration said the registration department is responsible for giving patients and/or representative's information on patient rights, advanced directives and Medicare information at the time of admission. Someone should have attempted to contact the healthcare surrogate for patient #7. However, a mistake was made when the patient was registered and the incorrect box was checked, so this patient would not have showed on the daily report run to identify patients needing to have consent to treat completed.

Review of the policy-"Consent to Treatment" (#720.380-1), dated effective 06/04/2009: Policy - Patients unable to sign or give verbal consent to treatment and authorization; Procedure - Adult Follow up process: Attempt to obtain consent from the patient or legal authorized person at least twice during the first shift the patient is admitted. Make one additional attempt during the second shift.

If the patient is unable or unavailable to sign during these attempts, leave signature request card in patient room requesting patient or legally authorized person to contact patient access when available to sign consent. Continue these daily attempts until signature is obtained or patient is discharged.

During an interview on 08/19/2011 at 3:30 p.m., the director of registration said patient #7 or her representative did not receive the information packet at registration or admission.

Based on record review and interview, the facility failed to have a specific policy timeframe for the review and provision of response to patient grievances.

Findings included:

Review of the policy - Patient Complaints/Grievances, dated as effective 05/31/2006, states, "The written response to the patient/legally authorized person shall occur with a reasonable time frame, after the grievance has been reviewed, investigated, and resolved. Note: If longer time is need, the patient/legally authorized person will be informed that the hospital is still working to resolve the grievance and the anticipated date of written response."

During an interview on 08/22/2011 at 4:15 p.m., the risk manager said the grievance policy does not have a timeframe specified, it states "reasonable timeframe."

Based on record review and interview, the facility failed to send letters of response to grievances including the investigation steps taken on the behalf of the patient for 3 of 6 patient grievances reviewed (#20, #21 & #22).

Findings included:

Review of the policy-Patient Complaints/Grievances, dated as effective 05/31/2006, states: "The written response to the patient/legally authorized person shall occur with a reasonable time frame, after the grievance has been reviewed, investigated, and resolved. Note; If longer time is need, the patient/legally authorized person will be informed that the hospital is still working to resolve the grievance and the anticipated date of written response."

1. Review of patient #20 showed the patient grievance as received on 07/19/2011 stating the patient received an abrasion to the forehead during a testing procedure. The letter sent to the patient on 07/20/2011 did not include the investigation steps taken on the behalf of the patient.

2. Review of patient #21 showed the patient grievance as received on 07/28/2011 stating patient problems during discharge. The letter sent to the patient on 08/09/2011 did not include the investigation steps taken on the behalf of the patient.

3. Review of patient #22 showed the patient grievance as received on 06/22/2011 stating the father's concern for emergency department physician techniques. The letter sent to the patient's father on 07/12/2011 did not include the investigation steps taken on the behalf of the patient.

All three grievances were reviewed with the Vice President of Risk Management and confirmed there was no investigation reported in the letters.

Based on record review and interview, the facility failed to include the patient representative (healthcare surrogate) for 1 patient in the decisions of treatment prior to providing services (#7).

Findings included:

Review of the information packet given to patients by the registration department showed it contains information related to patient's rights, advanced directives, notice of patient privacy practices, infection control, visitation practices and grievances contacts.

Medical record review for patient #7, age 29, admitted on 08/16/2011 with a diagnosis of overdose showed there was no signed consent to treat the patient at the hospital. Review of the advanced directive showed the patient designated her mother as health care surrogate in circumstances when she cannot speak for herself. There was no documentation in the medical record showing the mother was contacted or included in the treatment decision making process.

During an interview on 08/20/2011 at 10:40 a.m., patient #7's psychiatrist said he consulted on the patient on 08/16/2011 and the patient would not have been competent to make decisions on that day. He said he obtained the medical history from the mother, old charts, and by assessing the patient.

During an interview on 08/19/2011 at 3:15 p.m., the director of registration said the registration department is responsible for giving patients and/or representative's information on patient rights, advanced directives and Medicare information at the time of admission. Someone should have attempted to contact the healthcare surrogate for patient #7. However, a mistake was made when the patient was registered and the incorrect box was checked, so this patient would not have showed on the daily report run to identify patients needing to have consent to treat completed.

Review of the policy-Consent to Treatment (#720.380-1), dated effective 06/04/2009: Policy - "Patients unable to sign or give verbal consent to treatment and authorization" Procedure - Adult Follow up process: "Attempt to obtain consent from the patient or legal authorized person at least twice during the first shift the patient is admitted. Make one additional attempt during the second shift. If the patient is unable or unavailable to sign during these attempts, leave signature request card in patient room requesting patient or legally authorized person to contact patient access when available to sign consent. Continue these daily attempts until signature is obtained or patient is discharged."

During an interview on 08/19/2011 at 3:30 p.m., the director of registration said patient #7 or her representative did not receive the information packet at registration or admission.

Based on record review and interview, the facility failed to ensure a signed physician order was obtained after security and nursing staff held 1 patient down to apply restraints (#7).

Findings included:

Review of policy-Restraint Use in Acute Care Settings (100.94-1), effective date of 05/10/2007 defines a restraint as-Any manual method or physical or mechanical device that restricts freedom of movement, physical activity, or normal access to one ' s body, which the patient cannot remove.

Review of the medical record for patient #7 showed an unsigned physician's telephone order for restraints initiated on 08/17/20011 at 8:37 a.m. for wrist, ankle, and vest restraints. The restraint order did not include an order to hold the patient down to apply the restraints.

Review of the nursing timed event for 08/17/2011 at 8:37 a.m. documented the following: "When I walked into the pt's (patient's) room the pt was being assisted to the restroom. When the pt was done the sitter and the nurse were trying to help the pt back into her bed but the pt became very violent trying to scratch, punch and kick the sitter and the nurse, the pt was saying many obscene words towards the sitter, security was called immediately while the pt was acting violent towards the nurse, sitter, charge nurse security came in and pt became even more violent. We had five of our securitys on the pt to calm her down. We finally laid her in bed and placed her back in her restraints but continued to become upset."

During an interview on 08/20/2011 at 10:35 a.m., the psychiatrist for patient #7 said "If the patient is at risk to hurt self or others, holding down to apply restraints would be a restraint."

During an interview on 08/20/2011 at 11:50 a.m., the security operations manager said "he does not consider holding a patient down as a restraint. Would only hold the patient down a couple of minutes to allow nursing staff to apply a restraint or give a medication."

During an interview on 08/22/2011 at 10:20 a.m., security staff officer (staff V) said "Sometimes he is called to patient care units to assist the staff when they apply restraints and would touch the patient leg or arm. He would hold a patient still, but does not consider this holding a patient down. On 08/17/2011 he held patient #7's leg lightly."

During an interview on 08/22/2011 at 10:40 a.m., the registered charge nurse on 08/17/2011 said she remembered patient #7 and on 08/17/2011 security coming to patient #7's room. Charge nurse said two security guards held the patient's arms and one security was between the patient's legs to prevent her from kicking.

During an interview on 08/22/2011 at 11:45 a.m., security staff officer (staff X) said on 08/17/2011 he was the second security officer to arrive at patient #7' s room. When he arrived, he found the patient on the floor on her back, combative, and staff were trying to control her to accomplish some type of procedure.

During an interview on 08/22/2011 at 12 noon, security staff officer (staff Y) said "patient #7 would not have been able to remove her arm from his hand. Staff Y does not consider this holding a patient down, he said it was holding her still."

Based on record review, observation and interview, the facility failed to ensure signed physician orders were obtained including the type of restraint to be used prior to applying restraints to 3 of 13 patient (#5, #6 & #17).

Findings included:

Review of the medical staff general rules and regulations, dated April 2011, states in the Clinical Restraint generally, "All restraint episodes require an immediate physician's order and/or the order of another practitioner credentialed to order restraints. The order shall include the type of restraint and the reason for the restraint.

Review of policy - "Restraint Use in Acute Care Settings" (100.94-1), effective date of 05/10/2007: Acute Medical/Surgical Restraint - A physician's order is required immediately for each episode of restraint. The order shall include the type of restraint and the reason for restraint.

1. During a tour and observation of the third floor intensive care unit on 08/19/2011 at 12:40 p.m., patient #5 was observed in bed, at rest, intubated (a tube into the lung for breathing) with mechanical ventilation, and restrained with bilateral soft wrist restraints.

Medical record review for patient #5, age 56, admitted on 07/14/2011 with a diagnosis of liver transplant rejection, showed the patient was in wrist restraints from 08/12/2011 to present. There was no physician order, type of restraint specified, or justification for the use of the restraints on 08/13/2011.

During an interview on 08/19/2011 at 1:05 p.m., assistant registered charge nurse confirmed the unit restraint log documented wrist restraints used the entire day (08/13/2011) and the medical record did not have a physician's order for 08/19/2011, and restraints require an order.

2. During a tour and observation of the third floor intensive care unit on 08/19/2011 at 12:40 p.m., patient #6 was observed in bed and at rest with bilateral wrist restraints in place.
Medical record review for patient #6, age 57, admitted on 08/03/2011 with a diagnosis of endometriosis and adenocarcinoma, showed the patient was in wrist restraints from 08/12/2011 to present. There was no type of restraint specified, or justification for the use of the restraints on 08/16/2011.

During an interview on 08/19/2011 at 1:15 p.m. assistant registered charge nurse confirmed the unit restraint log documented wrist restraint use the entire day (08/16/2011) and the medical record did not have a complete physician's order for 08/16/2011.

3. Closed medical record review for patient #17, age 88, expired on 07/25/2011 showed the patient in bilateral wrist restraints at intervals from 05/14/2011 to the day of expiration on 07/25/2011. Review of the computerized restraint Monitor/DC flow sheet for 05/17/2011, 05/18/2011, and 05/23/2011 showed twelve entries each day documenting restraint monitoring. There was no physician order on those days for restraint application specifying the type of restraint to be used. The medical record was reviewed with the Administrative Director of Health Information Systems and she confirmed there was no physician order for restraints for 05/17/2011, 05/18/2011, and 05/23/2011.

Based on record review, observation and interview, the facility failed to ensure signed physician orders were obtained prior to ongoing application of 5 of 13 patient with restraints (#2, #5, #6, #7 & #17).

Findings included:

Review of policy - "Restraint Use in Acute Care Settings" (100.94-1), effective date of 05/10/2007: "Continuation of Restraints-Note: Renewal orders cannot be made verbally or by telephone. Standing protocol, PRN and verbal orders for restraint are prohibited. Behavioral Restraints: Physician-Face-to-face evaluation within one (1) hour of order and every four (4) or (8) hours as required by age."

1. Medical record review for patient #2, age 44, admitted on 08/15/2011 with a diagnosis of alcohol withdrawal, and discharged on 08/19/2011 showed patient #2 in ankle and wrist restraints at 1 a.m. on 08/16/2011. A restraint continuation order was written on 08/16/2011 by the nurse from the physician for behavioral restraints, ankle and wrist, beginning at 5:40 a.m. The physician did not document/sign the behavioral restraint until 7:30 a.m. to show assessment of patient #2.

Review of the medical record on 08/23/2011 at 12:35 p.m. with the nurse educator confirmed the order was either a telephone or a verbal order and the patient did not have a face-to-face assessment for approximately two hours following the application of the restraints.

2. During a tour and observation of the third floor intensive care unit on 08/19/2011 at 12:40 p.m., patient #5 was observed in bed, at rest, intubated (a tube into the lung for breathing) with mechanical ventilation, and restrained with bilateral soft wrist restraints.

Medical record review for patient #5, age 56, admitted on 07/14/2011 with a diagnosis of liver transplant rejection, showed the patient was in wrist restraints from 08/12/2011 to present. There was no physician order, type of restraint specified, or justification for the use of the restraints on 08/13/2011.

During an interview on 08/19/2011 at 1:05 p.m. assistant registered charge nurse confirmed the unit restraint log documented wrist restraint use the entire day (08/13/2011) and the medical record did not have a physician order for 08/19/2011, and restraints require an order.

3. During a tour and observation of the third floor intensive care unit on 08/19/2011 at 12:40 p.m., patient #6 was observed in bed and at rest with bilateral wrist restraints in place.

Medical record review for patient #6, age 57, admitted on 08/03/2011 with a diagnosis of endometriosis and adenocarcinoma, showed the patient was in wrist restraints from 08/12/2011 to present. There was no type of restraint specified, or justification for the use of the restraints on 08/16/2011.

During an interview on 08/19/2011 at 1:15 p.m. assistant registered charge nurse confirmed the unit restraint log documented wrist restraint use the entire day (08/16/2011) and the medical record did not have a complete physician order for 08/16/2011.

4. Observation of patient #7 on 08/19/2011 at 1:25 p.m. showed a female patient in bed sleeping, with bilateral wrist restraints, bilateral ankle restraints, and a vest restraint in place. The patient had a sitter at her bedside.

Review of the medical record for patient #7 showed a signed physician restraint orders initiated on 08/16/20011 at 3:07 p.m. The next order for restraints was dated 08/17/2011 at 8:25 a.m. and was a telephone order taken by the staff nurse.

During an interview on 08/20/2011 at 1 p.m., the nursing manager for the medical psychiatric unit confirmed the restraint order on 08/17/2011 at 8:25 a.m. was a telephone order and was not signed by the ordering physician.

Closed medical record review for patient #17, age 88, expired on 07/25/2011 showed the patient in bilateral wrist restraints at intervals from 05/14/2011 to the day of expiration on 07/25/2011. Review of the computerized restraint Monitor/DC flow sheet for 05/17/2011, 05/18/2011, and 05/23/2011 showed twelve entries each day documenting restraint monitoring. There was no physician order on those days for restraint application. The restraint order for bilateral wrist restraints dated 05/24/2011 was not signed by the physician. The medical record was reviewed with the Administrative Director of Health Information Systems and she confirmed there was no physician order for restraints for 05/17/2011, 05/18/2011, and 05/23/2011 and the order on 05/24/2011 was unsigned.

Based on medical staff rules and regulations, record review and interview, the facility failed to ensure restraint orders were not written on as needed (PRN) basis for 1 patient (#1).

Findings included:

PRN is defined as Pro re nata, a Latin phrase meaning "in the circumstances" or "as the circumstance arises". It is commonly used in medicine to mean "as needed" or "as the situation arises."


Review of the medical staff general rules and regulations, dated April 2011, states in the Clinical Restraint generally, "There shall be no standing or PRN orders for restraints."


Medical record review for patient #1, age 72, admitted on 08/15/2011 with a diagnosis of dementia with behavior problems, showed the patient was in wrist and vest restraints from 08/16/2011 to 08/19/2011. On 08/19/2011 at 10:45 a.m., the registered nurse documented a verbal/telephone order "continue wrist restraints as needed. MD will come in today to write new order."


During an interview on 08/19/2011 at 12:10 p.m., the nurse manager and the graduate nurse taking care of patient #1 both said an "as needed order is not a PRN order."


During an interview on 08/22/2011 at 10:40 a.m., MSU nursing unit charge nurse said an order as needed is the same as PRN.


Review of policy "Restraint Use in Acute Care Settings" (100.94-1), effective date of 05/10/2007 states Standing protocol, PRN and verbal orders for restraints are prohibited.

Based on record review, observation and interview, the facility failed to ensure staff document monitoring assessments to 1 patient in restraints every two hours required by policy (#7).

Findings included:

Review of policy "Restraint Use in Acute Care Settings" (100.94-1), effective date of 05/10/2007: instructs staff: "The patient shall be monitored at least every two (2) hours to assess: skin integrity, respirations and circulation-not impaired, restraint is intact and positioned correctly, cognitive and mental status level of distress or agitation, pain, hydration/nutrition, hygiene and elimination, and range of motion."

Observation of patient #7 on 08/19/2011 at 1:25 p.m. showed a female patient in bed sleeping, with bilateral wrist restraints, bilateral ankle restraints, and a vest restraint in place. The patient had a sitter at her bedside.

Review of the medical record showed patient #7 was in a vest, ankle, and wrist restraints from 08/16/2011 at 3:15 p.m. until 08/19/2011 at 2:30 p.m. Review of the computerized restraint monitoring/dc flow sheet showed no monitoring on 08/18/2011 at 5 p.m. related to fluids/nutrition, toileting, skin, and range of motion for patient #7.

During the medical record review with the nurse manager on 08/20/2011 at 11:45 a.m., she confirmed the lack of documented monitoring on 08/18/2011.

Based on record review and interview, the facility failed to ensure 1 patient received a face-to-face assessment prior to ongoing use of behavioral restraints (#2).

Findings included:

Review of policy "Restraint Use in Acute Care Settings" (100.94-1), effective date of 05/10/2007: "Continuation of Restraints-Note: Renewal orders cannot be made verbally or by telephone. Standing protocol, PRN and verbal orders for restraint are prohibited. Behavioral Restraints: Physician-Face-to-face evaluation within one (1) hour of order and every four (4) or (8) hours as required by age."

Medical record review for patient #2, age 44, admitted on 08/15/2011 with a diagnosis of alcohol withdrawal, and discharged on 08/19/2011 showed patient #2 in ankle and wrist restraints at 1 a.m. on 08/16/2011. A continuation order was written on 08/16/2011 by the nurse from the physician for behavioral restraints, ankle and wrist, beginning at 5:40 a.m. The physician did not document/sign the behavioral restraint until 7:30 a.m. showing a face-to-face assessment of patient #2.

Review of the medical record on 08/23/2011 at 12:35 p.m. with the nurse educator confirmed the order was either a telephone or a verbal order and the patient did not have a face-to-face assessment for approximately two hours following the application of the restraints.

Based on interview and record review, the facility failed to ensure security staff received first aide technique training prior to assisting staff with the application of patient restraints for 5 of 5 security staff (staff H, V, W, Y & Z) reviewed.

Findings included:

Review of the security officer job description, dated as revised on 01/26/2011, does not include applying or assisting with applying restraints for patients.

Review of policy "Restraint Use in Acute Care Settings" (100.94-1), effective date of 05/10/2007 shows the policy specifies responsible persons as: "Advanced licensed Practical Nurse; Advanced Registered Nurse Practitioner; Assistant Nurse Manager; Charge Nurse; Nurse Manager; Nurse Technician; Patient Care Technician; Physician; Physician Assistant; and Registered Nurse. Security officer staff is not listed."

Restraint Competency/Education states "Only staff members, who have successfully completed the Florida Hospital Restraint Education, shall oversee episodes of restraint utilization."

Review of education form provided by the VP of Risk Management for security staff H, V, W, Y, and Z did not show first aide training.

During an interview on 08/22/2011 at 10:20 a.m. security staff officer (staff V) said he has not received any first aide training other than CPR (cardio pulmonary resuscitation).

During an interview on 08/22/2011 at 11 a.m. security staff officer (staff H) said she does not receive any first aide training, only CPR. The security operations manager also said at this time that none of the security officers receive first aide training.

During an interview on 08/22/2011 at 11:30 a.m., security staff officer (staff W) said he has not received any first aide training other than CPR related to restraints.

During an interview on 08/22/2011 at 11:45 a.m. security staff officer (staff X) said he has not received any first aide training related to restraints.

During an interview on 08/22/2011 at 12 noon, security staff officer (staff Y) said he has not received any first aide training related to restraints.

Based on interview and record review, the facility failed to have a policy that addresses time frames for reporting deaths of patients while in restraints, and failed to report 1 of 6 patients who died in restraints (#13), and 2 of 6 patients who died within twenty-four hours of restraint use (#15 & #17) to the Centers for Medicare and Medicaid Services (CMS).

Findings included:

Review of policy "Restraint Use in Acute Care Settings" (100.94-1), effective date of 05/10/2007 does not specify any facility specific requirements for reporting patient deaths while in restraints, reporting patient deaths within 24 hours of restraint use, or patient deaths within seven days of restraint use. On 08/22/2011 at 4:15 p.m., the Risk Manager said this is the only policy related to death in restraints and deaths would be reported by staff to Risk Management who would then report to CMS.

On 08/22/2011 at 4:15 p.m., the Risk Manager said there have been no patient deaths while in restraints since prior to 01/01/2011 (this is date range requested for survey purposes).

1. Closed medical record review for patient #13 showed the patient was admitted on 02/22/2011 and expired on 03/16/2011. Review of the medical record showed six entries in the Restraint Monitor/DC computerized flow sheet related to the monitoring of the restraints, with no documentation of the restraints being removed up to the time of the patient ' s death at 12:15 p.m. The medical record does not have documentation of the event reported to CMS.

2. Closed medical record review for patient #15 showed the patient was admitted on 03/22/2011 and expired on 04/16/2011. Review of the medical record showed entries in the Restraint Monitor/DC computerized flow sheet related to the monitoring of the restraints, with documentation of the restraints removed at 2:50 p.m. on 04/15/2011. The patient expired at 10:10 a.m. on 04/16/2011, approximately 20 hours after removal from the restraints. The medical record does not have documentation of the event reported to CMS.

3. Closed medical record review for patient #17 showed the patient was admitted on 005/10/2011 and expired on 07/25/2011. Review of the medical record showed entries in the Restraint Monitor/DC computerized flow sheet related to the monitoring of the restraints, with documentation of the restraints removed at 8:20 a.m. on 07/25/2011. The patient expired on 11:50 a.m. on 07/25/2011 approximately 2 hours after removal from the restraints. The medical record does not have documentation of the event reported to CMS.

During an interview on 08/23/2011 at 3 p.m., the Vice President of Risk Management said no deaths were reported to risk management, and none of the patients reviewed were reported to CMS related to death in restraints.