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.

HOLLY HILL MENTAL HEALTH SERVICES 3019 FALSTAFF RD RALEIGH, NC 27610 July 7, 2011
VIOLATION: GOVERNING BODY Tag No: A0043
Based on review of hospital policies and procedures, medical records and staff interviews the hospital's governing body failed to provide leadership oversight by failing to ensure the promotion and protection of patients' rights and by failing to ensure an organized nursing service.

Findings include:

1. The hospital's staff failed to promote and protect patients' rights by failing to ensure informed consent for non-consenting minors and safe use of restraint and seclusion.

~ cross refer to 482.13 Patient Rights - Tag 0115

2. The hospital's nursing staff failed to demonstrate an organized nursing service as evidenced by failing to ensure safe medication use practices.

~ cross refer to 482.23 Nursing Services - Tag 0385
VIOLATION: PATIENT RIGHTS Tag No: A0115
Based on policy review, medical record review, and staff interview the hospital's staff failed to promote and protect patients' rights by failing to ensure informed consent for non-consenting minors and safe use of restraint and seclusion.

Findings include:

1. The hospital ensure patients' rights to make informed decisions regarding care by failing to obtain parental consent for psychotropic medications for 2 of 4 sampled minor patients that received psychotropic medications (#6, #5).

~ cross refer to 482.13(b)(2) Patient Rights: Informed Consent - Tag 0131

2. The hospital staff failed to debrief patients within 24 hours after restraint or seclusion per policy for 4 of 5 sampled patients that were restrained or secluded (#6, #1, #2, #3).

~ cross refer to 482.13(e)(4)(ii) Patient Rights: Restraint or Seclusion - Tag 0167

3. The hospital staff failed to ensure a time limited restraint/seclusion order was obtained for 3 of 5 sampled patients that were restrained or secluded (#6, #1, #2).

~ cross refer to 482.13(e)(8) Patient Rights: Restraint or Seclusion - Tag 0171

4. The hospital staff failed to monitor a restrained patient per policy for 2 of 5 patients that were restrained (#1, #3).

~ cross refer to 482.13(e)(10) Patient Rights: Restraint or Seclusion - Tag 0175

5. The hospital failed to ensure patients were seen face-to-face within 1 hour after the initiation of restraint by a physician, other licensed independent practitioner, or qualified registered nurse per policy for 2 of 5 sampled patients that were restrained (#1, #3).

~ cross refer to 482.13(e)(12) Patient Rights: Restraint or Seclusion - Tag 0178
VIOLATION: PATIENT RIGHTS: INFORMED CONSENT Tag No: A0131
**NOTE- TERMS IN BRACKETS HAVE BEEN EDITED TO PROTECT CONFIDENTIALITY**

Based on policy review, medical record review, and staff interview, the hospital ensure patients' rights to make informed decisions regarding care by failing to obtain parental consent for psychotropic medications for 2 of 4 sampled minor patients that received psychotropic medications (#6, #5).

The findings include:

Review of current hospital policy entitled "Medication Administration" dated 09/2010 revealed, "...PROCEDURE 1. Medications are not given without a physician's order and informed consent along with rationale or indication for use. 2. Informed consent form the parent or guardian must be obtained and documented before starting a child or adolescent on a new medication. This consent must be obtained and documented by the physician...."

Review of current hospital policy entitled "Administration of Psychotropic Medications to Non-Consenting Patients" dated 10/2009 revealed, "...PROCEDURE FOR NON-EMERGENCY CASES....If the patient is a minor..., the attending physician shall request, using Form med A, N-157, the consent of the parent/guardian for administration of the med(ication). 1. If the parent/guardian consents to the administration of the medication, the attending physician and the parent/guardian both shall sign Form Med A authorizing administration of the psychotropic med and the med may be administered. The form should be filed in the patient's record. 2. If the parent/guardian refuses to give consent, the physician and the parent/guardian shall both sign Form Med A to indicate refusal. If the parent/guardian refuses to give signature or does not respond to the consent request with 72 hours, the physician shall document this on the form. The following steps may be followed according to the patient's legal status: a. If the patient is a voluntary minor..., the medication cannot be administered. The treatment team shall review alternative methods for treatment. b. If the patient is an involuntary minor..., the medical director/designee is notified to examine the patient and review the medical record. His/her assessment should be documented on the reverse side of Form Med A. If the medical director/designee concurs with the team's recommendation, the med can be administered....If the medical director/designee does not concur, the medication cannot be administered and the team shall review alternative methods for treatment."

1. Open medical record review on 07/07/2011 for Patient #6 revealed a [AGE] year-old male that was voluntarily admitted on [DATE] with depressive disorder, oppositional defiant disorder, and antisocial behavior disorder. Review of physician's telephone admission orders dated 06/07/2011 at 2145 (and signed by the physician on 06/08/2011 at 1956) revealed, "...Zyprexa (antipsychotic medication) prot(ocol). PRN (as needed) (for) agitation." Review of "Zyprexa Protocol" form found in the medical record and signed by 2 nurses (no physician's signature) revealed, "Zyprexa 5 mg (milligrams) PO or IM (by mouth or intramuscular injection) q (every) 2 hours PRN agitation/upset, up to 4 times/day...." Record review revealed the patient had been given Zyprexa (either PO or IM) on the following dates/times: on 06/19/2011 at 1820 and 2100; on 06/20/2011 at 1530; on 06/23/2011 at 1040 and 1955; on 06/24/2011 at 1300, 1720, and 1925; on 06/26/2011 at 1450; on 06/27/2011 at 1313 and 1810; on 06/28/2011 at 1215; on 06/29/2011 at 1000, 1525, and 1740; on 07/02/2011 at 1530; on 07/04/2011 at 0740 and 2030; on 07/05/2011 at 1825 and 2050; and on 07/06/2011 at 2002 (21 doses since admission). Record review revealed no documentation of parental consent for the patient to be given Zyprexa.

Interview on 07/05/2011 at 1510 with the Assistant Director of Nursing revealed physicians must contact parents/guardians and obtain consent for all medications for minor patients. Interview revealed this consent should be documented in the patient's medical record. Interview confirmed there was no available documentation of parental consent for the patient to be given Zyprexa.




2. Open medical record review on 07/07/2011 for Patient #5 revealed a [AGE] year-old male that was admitted on [DATE] by Involuntary Commitment with mood disorder. Review revealed on 6/25/2011 at 2240 the Zyprexa (antipsychotic or psychotropic medication) Protocol was initiated with Zyprexa 5 milligrams orally or by injection every two (2) hours as needed for agitation/upset, up to four (4) times daily being implemented. Record review revealed nursing staff gave the patient intramuscular (IM) injections of Zyprexa on the following dates/times: on 06/25/2011 at 2015 and 06/28/2011 at 2015 (two (2) doses). Review of medical record document "Informed Consent of Psychotropic Medications" revealed the form was signed by the patient's primary psychiatrist on 06/29/2011 at 1030 (four days after the first dose of Zyprexa and one day after the second dose of Zyprexa). Further review of the document revealed a check by "Information Provided - Orally" and a check by "Three Way Telephone Consent" for the medications Zyprexa and Keflex (antibiotic). Further review of the informed consent document failed to reveal the name of the person from whom consent was obtained or the hospital staff member also on the call with the psychiatrist.

Interview on 07/07/2011 at 1300 with Patient #5's psychiatrist revealed any patient who is a non-consenting minor must have the parent/guardian contacted to obtain consent for any new medication the patient was not on at home. Interview revealed the psychiatrist called and spoke with Patient #5's guardian and obtained consent for the Zyprexa and Keflex four days after the first dose of Zyprexa and one day after the second dose of Zyprexa. Interview revealed the initial dose of Zyprexa given on 06/25/2011 at 2015 was an emergent dose to de-escalate the patient from harm to self and others and there may not have been sufficient time to obtain consent prior to the dose being given. Further interview revealed the parent/guardian should have been contacted soon after the initial dose was given to report the medication being given and to obtain consent for any future doses necessary. Interview revealed "I should have written the name of the person (the patient's guardian) I spoke with on the consent form." Further interview revealed "the nurse who was also a part of the conversation should have their name on the consent." Interview revealed the facility staff failed to follow facility policy by failing to obtain consent for the Zyprexa soon after the initial dose and before the second dose of Zyprexa was administered. Interview revealed there was no other available evidence in the medical record consent was obtained soon after the initial dose of Zyprexa was administered or before the second dose was administered on 06/28/2011 at 2015.
VIOLATION: PATIENT RIGHTS: RESTRAINT OR SECLUSION Tag No: A0167
**NOTE- TERMS IN BRACKETS HAVE BEEN EDITED TO PROTECT CONFIDENTIALITY**

Based on policy review, medical record review, and staff interview, the hospital staff failed to debrief patients within 24 hours after restraint or seclusion per policy for 4 of 5 sampled patients that were restrained or secluded (#6, #1, #2, #3).

The findings include:

Review of current hospital policy entitled "Seclusion/Restraint/Physical Hold" dated 12/2009 revealed, "...18.03 Charge nurse/designee appoints a staff member to debrief the events which resulted in the S/R (seclusion/restraint) with the patient after she/he has regained enough composure to be able to communicate with the staff within their normal capacity, e.g. no longer acutely agitated; able to talk and listen to staff. a. Debriefing should occur within 24 hours of release from S/R, when possible....48.4 Staff assists the patient to identify the series of events which ultimately resulted in the S/R....18.5 Staff negotiates alternative actions for the patient and staff to take in order to prevent or minimize the need for future use of S/R should similar triggering events occur...."

1. Open medical record review on 07/07/2011 for Patient #6 revealed a [AGE] year-old male that was admitted on [DATE] with depressive disorder, oppositional defiant disorder, and antisocial behavior disorder. Record review revealed a physician's order dated 07/04/2011 at 2125 for the patient to be placed in seclusion and given an intramuscular injection of Zyprexa (antipsychotic medication). Review of a "Seclusion/Restraint Order" revealed, "...Reason for Intervention:...pulling staff hair, pushing and kicking staff...." Record review revealed the patient was placed in seclusion at 2125 and was released from seclusion at 2150. Record review revealed no documentation the staff debriefed the patient after the seclusion (3 days since seclusion with no debriefing documented).

Interview on 07/07/2011 at 1600 with the Risk Manager revealed staff must debrief patients within 24 hours of being restrained or secluded. Interview confirmed there was no available documentation staff had debriefed the patient after his seclusion on 07/04/2011 (3 days since seclusion with no debriefing documented).

2. Closed medical record review for Patient #1 revealed a [AGE] year-old male that was admitted on [DATE] with mood disorder and antisocial behavior disorder. Record review revealed the patient was treated and subsequently discharged to a psychiatric residential treatment facility on 12/28/2010. Record review revealed a physician's order dated 11/29/2010 at 0925 for the patient to be placed in a physical restraint (hold) and given an intramuscular injection of Zyprexa (antipsychotic medication). Review of a "Seclusion/Restraint Order" revealed, "...Reason for Intervention:...Hitting on window....Attempting to hit staff...." Record review revealed the patient was placed in a physical restraint at 0925 and was released at 0930. Record review revealed no documentation the staff debriefed the patient after the physical restraint.

Interview on 07/07/2011 at 1600 with the Risk Manager revealed staff must debrief patients within 24 hours of being restrained or secluded. Interview confirmed there was no available documentation staff had debriefed the patient after the physical restraint on 11/29/2010.






3. Closed medical record review on 07/05/2011 for Patient #2 revealed a [AGE] year-old male that was admitted on [DATE] with bipolar disorder and post-traumatic stress disorder. Record review revealed a physician's order dated 05/16/2011 at 2135 for the patient to be placed in seclusion with a physical hold and given an intramuscular injection of Thorazine (antipsychotic medication). Review of a "Seclusion/Restraint Order" revealed, "...Reason for Intervention: Danger to self/self Injurious Behavior...Danger to Others...Gross Property Destruction with Imminent Danger to Others..." Record review revealed the patient was placed in seclusion at 2135 and was released from seclusion at 2155. Record review revealed a partially completed form "Seclusion/Restraint Patient Debriefing" dated 5/16/2011. Review failed to reveal any further documentation the patient was debriefed following the physical restraint and seclusion on 05/16/2011. Record review revealed a physician's order dated 05/20/2011 at 1630 for a physical hold and given an intramuscular injection of Thorazine. Review of a "Seclusion/Restraint Order" revealed, "...Reason for Intervention: Danger to Others...Gross Property Destruction with Imminent Danger to Others..." Record review revealed the patient was placed in the physical hold at 1630 and was released from at 1633. Record review revealed no documentation the staff debriefed the patient after the physical restraint.

Interview on 07/07/2011 at 1600 with the Risk Manager revealed staff must debrief patients within 24 hours of being restrained or secluded. Interview confirmed there was no available documentation staff had debriefed the patient after his seclusion on 05/16/2011 or the physical hold on 05/20/2011.

4. Closed medical record review on 07/06/2011 for Patient #3 revealed a [AGE] year-old male that was admitted on [DATE] with psychotic disorder. Record review revealed a physician's order dated 05/22/2011 at 1950 for the patient to be placed in a physical hold and given an intramuscular injection of Haldol (antipsychotic medication). Review of a "Seclusion/Restraint Order" revealed, "...Reason for Intervention: Danger to Others..." Record review revealed the patient was placed in the physical hold at 1950 and was released from seclusion at 1955. Record review revealed no documentation the staff debriefed the patient after the physical restraint. Record review revealed a physician's order dated 05/23/2011 at 1100 for a physical hold and given an intramuscular injection of Haldol, Ativan (antianxiety medication) and Cogentin (medication to counteract potential side effects of Haldol). Review of a "Seclusion/Restraint Order" revealed, "...Reason for Intervention: Danger to Self/Self Injurious Behavior...Danger to Others...Gross Property Destruction with Imminent Danger to Others..." Record review revealed the patient was placed in the physical hold at 1415 and was released from at 1430. Record review revealed a partially completed form "Seclusion/Restraint Patient Debriefing" dated 05/23/2011.

Interview on 07/07/2011 at 1600 with the Risk Manager revealed staff must debrief patients within 24 hours of being restrained or secluded. Interview confirmed there was no available documentation staff had debriefed the patient after the physical restraint on 05/22/2011 or 05/23/2011.
VIOLATION: PATIENT RIGHTS: RESTRAINT OR SECLUSION Tag No: A0171
**NOTE- TERMS IN BRACKETS HAVE BEEN EDITED TO PROTECT CONFIDENTIALITY**

Based on policy review, medical record review, and staff interview, the hospital staff failed to ensure a time limited restraint/seclusion order was obtained for 3 of 5 sampled patients that were restrained or secluded (#6, #1, #2).

The findings include:

Review of current hospital policy entitled "Seclusion/Restraint/Physical Hold" dated 12/2009 revealed, "...4. The Physician/RN (Registered Nurse) assesses the need for restrictive intervention and a written or telephonic order is obtained from the physician for the S/R (seclusion/restraint) on the Seclusion/Restraint Order form as follows: 4.1 Adults 18 and older up to 4 hours; 4.2 Youth 9-17 up to 2 hours; 4.3 Children under age 9 up to 1 hour....4.4 The physicians' orders specify the reason for restraint and seclusion usage, the type of restraint and their duration. The length of the S/R can be ordered for less than the above stated maximum. The length of the S/R is limited by the continued need for the intervention rather than the length of the order...."

1. Open medical record review on 07/07/2011 for Patient #6 revealed a [AGE] year-old male that was admitted on [DATE] with depressive disorder, oppositional defiant disorder, and antisocial behavior disorder. Record review revealed a physician's order dated 07/04/2011 at 2125 for the patient to be placed in seclusion and given an intramuscular injection of Zyprexa (antipsychotic medication). Review of the Seclusion/Restraint Order revealed, "...Reason for Intervention:...pulling staff hair, pushing and kicking staff...." Further review of the Seclusion/Restraint Order revealed no documentation of a time limit for the duration of seclusion.

Interview on 07/07/2011 at 1600 with the Risk Manager revealed restraint/seclusion orders must contain a time limit for the intervention. Interview confirmed there was documentation of a time limit for the duration of seclusion on the 07/04/2011 seclusion order.

2. Closed medical record review for Patient #1 revealed a [AGE] year-old male that was admitted on [DATE] with mood disorder and antisocial behavior disorder. Record review revealed the patient was treated and subsequently discharged to a psychiatric residential treatment facility on 12/28/2010. Record review revealed on 11/27/2010 at 2215 the patient became upset and hit another patient in the dayroom. Record review revealed a physician's order dated 11/27/2010 at 2215 for the patient to be placed in a physical restraint (hold). Further review of the Seclusion/Restraint Order revealed no documentation of a time limit for the duration of the physical restraint. Record review revealed a physician's order dated 11/29/2010 at 0925 for the patient to be placed in a physical restraint and given an intramuscular injection of Zyprexa (antipsychotic medication). Review of the Seclusion/Restraint Order revealed, "...Reason for Intervention:...Hitting on window....Attempting to hit staff...." Further review of the Seclusion/Restraint Order revealed no documentation of a time limit for the duration of the physical restraint.

Interview on 07/07/2011 at 1600 with the Risk Manager revealed restraint/seclusion orders must contain a time limit for the intervention. Interview confirmed there was documentation of a time limit for the duration of seclusion on the 07/04/2011 seclusion order.




3. Closed medical record review on 07/05/2011 for Patient #2 revealed a [AGE] year-old male that was admitted on [DATE] with bipolar disorder and post-traumatic stress disorder. Record review revealed a physician's order dated 05/12/2011 at 1238 for the patient to be placed in seclusion with a physical hold and given an intramuscular injection of Thorazine (antipsychotic medication). Review of a "Seclusion/Restraint Order" revealed, "...Reason for Intervention: Danger to self/self Injurious Behavior...Danger to Others...Gross Property Destruction with Imminent Danger to Others..." Record review revealed the patient was placed in seclusion at 1236 and was released from seclusion at 1245. Record review revealed no documentation of a time limit for the physical restraint and seclusion episode.

Interview on 07/07/2011 at 1600 with the Risk Manager revealed restraint/seclusion orders must contain a time limit for the intervention. Interview confirmed there was documentation of a time limit for the duration of seclusion on the 05/12/2011 seclusion order.
VIOLATION: PATIENT RIGHTS: RESTRAINT OR SECLUSION Tag No: A0175
**NOTE- TERMS IN BRACKETS HAVE BEEN EDITED TO PROTECT CONFIDENTIALITY**

Based on policy review, medical record review, and staff interview, the hospital staff failed to monitor a restrained patient per policy for 2 of 5 patients that were restrained (#1, #3).

The findings include:

Review of current hospital policy entitled "Seclusion/Restraint/Physical Hold" dated 12/2009 revealed, "...13. RN (Registered Nurse) assigns a staff member...who has been trained and deemed competent in the usage and monitoring of seclusion and restraints, to conduct continuous in-person observation/monitoring for the duration of the seclusion/restraint episode....14. Assigned staff conducts 15-minute patient observations on the Seclusion/Restraint Hourly Flow Sheet that includes the following: 13.1 Reviews for signs of injury related to restraint application. 13.2 Evaluates patient behavior, staff interventions and patient responses. 13.3 Evaluates for breathing. 13.4 Monitors for circulation and skin integrity. 13.5 Performs range of motion exercises....13.6 offers food during meal times using paper products. 13.7 Offers fluids or upon request. 13.8 Assists with toileting. 13.9 Assists with personal hygiene. 13.10 Obtains vital signs. 13.11 Notifies RN of any changes in physical or psychological status/comfort need. 13.12 Assesses patient, every 15 minutes, to determine if release criteria is met. If criteria is met, immediately notify RN for final assessment and directive for release...."

1. Closed medical record review for Patient #1 revealed a [AGE] year-old male that was admitted on [DATE] with mood disorder and antisocial behavior disorder. Record review revealed the patient was treated and subsequently discharged to a psychiatric residential treatment facility on 12/28/2010. Record review revealed a physician's order dated 12/01/2010 at 1005 for the patient to be placed in a physical restraint (hold) and given an intramuscular injection of Zyprexa (antipsychotic medication) for "agitation". Review of the Seclusion/Restraint Order revealed, "...Reason for Intervention:...Threatening staff....Timeframe:...Up to 2 hours...." Record review revealed documentation the patient was placed in a physical restraint at 1005. Record review revealed no documentation of when the physical restraint was released or of monitoring/assessment of the patient during the restraint. Further record review revealed documentation of a physician's order dated 12/02/2010 at 1330 for the patient to be placed in a physical restraint and given an intramuscular injection of Zyprexa for "agitation". Review of the Seclusion/Restraint Order revealed, "...Reason for Intervention:...Pt (patient) hitting the AC box (thermostat)...hitting staff...." Record review revealed documentation the patient was placed in a physical restraint at 1330 and was released at 1405 (35 minutes). Review of the RN Seclusion and Restraint Note revealed documentation at 1330 (time restraint initiated) the patient complained of pain in his right hand. Further review of the RN Seclusion and Restraint Note revealed documentation at 1405 (time of release) the patient was calmer with no signs and symptoms of distress and "denies pain...refused nurse to assess the hand". Record review revealed no documentation of monitoring/assessment of the patient during the restraint (35 minutes).

Interview on 07/07/2011 at 1600 with the Risk Manager revealed staff must continuously monitor patients that are in restraint or seclusion. Interview revealed staff must document 15-minute patient observations/assessments on the Seclusion/Restraint Hourly Flow Sheet. Interview confirmed there was no available documentation of when the physical restraint initiated on 12/01/2010 at 1005 was released or of monitoring/assessment of the patient during the physical restraints on 12/01/2010 at 1005 and on 12/02/2010 at 1330.




2. Closed medical record review on 07/06/2011 for Patient #3 revealed a [AGE] year-old male that was admitted on [DATE] with psychotic disorder. Record review revealed a physician's order dated 05/23/2011 at 1100 for a physical hold and given an intramuscular injection of Haldol, Ativan (antianxiety medication) and Cogentin (medication to counteract potential side effects of Haldol). Review of a "Seclusion/Restraint Order" revealed, "...Reason for Intervention: Danger to Self/Self Injurious Behavior...Danger to Others...Gross Property Destruction with Imminent Danger to Others..." Record review revealed the patient was placed in the physical hold at 1415 and was released from at 1430. Record review revealed no documentation of monitoring/assessment of the patient during the restraint (15 minutes).

Interview on 07/07/2011 at 1600 with the Risk Manager revealed staff must continuously monitor patients that are in restraint or seclusion. Interview revealed staff must document 15-minute patient observations/assessments on the Seclusion/Restraint Hourly Flow Sheet. Interview confirmed there was no available documentation of monitoring/assessment of the patient during the physical restraints on 5/23/2011 at 1415.
VIOLATION: PATIENT RIGHTS: RESTRAINT OR SECLUSION Tag No: A0178
**NOTE- TERMS IN BRACKETS HAVE BEEN EDITED TO PROTECT CONFIDENTIALITY**

Based on policy review, medical record review, and staff interview, the hospital failed to ensure patients were seen face-to-face within 1 hour after the initiation of restraint by a physician, other licensed independent practitioner, or qualified registered nurse per policy for 2 of 5 sampled patients that were restrained (#1, #3).

The findings include:

Review of current hospital policy entitled "Seclusion/Restraint/Physical Hold" dated 12/2009 revealed, "...15. A Physician, Qualified RN (Registered Nurse) (QRN), or other Licensed Independent Practitioner as allowed by law and scope of practice conducts an in-person, face to face assessment of the patient in S/R (seclusion/restraint) within 1 hour of initiation and documents findings on the One Hour Face to Face Evaluation. The purpose of this evaluation by the Licensed Independent Practitioner (LIP) or QRN is to determine if the use of these measures is justified to prevent the patient from causing harm to self or others. it is also completed to ensure that the use of S/R poses no undue risk to the patient's medical or psychological well-being. The face to face evaluation is performed even in those situations where the person is released early (prior to one hour)...."

1. Closed medical record review for Patient #1 revealed a [AGE] year-old male that was admitted on [DATE] with mood disorder and antisocial behavior disorder. Record review revealed the patient was treated and subsequently discharged to a psychiatric residential treatment facility on 12/28/2010. Record review revealed a physician's order dated 11/29/2010 at 0925 for the patient to be placed in a physical restraint (hold) and given an intramuscular injection of Zyprexa (antipsychotic medication). Review of the "Seclusion/Restraint Order" revealed, "...Reason for Intervention:...Hitting on window....Attempting to hit staff...." Record review revealed the patient was placed in a physical restraint at 0925 and was released at 0930. Record review revealed documentation of a face to face assessment of the patient conducted by a QRN at 1130 (2 hours after initiation of the physical restraint). Further record review revealed a physician's order dated 12/01/2010 at 1005 for the patient to be placed in a physical restraint (hold) and given an intramuscular injection of Zyprexa for "agitation". Review of the Seclusion/Restraint Order revealed, "...Reason for Intervention:...Threatening staff....Timeframe:...Up to 2 hours...." Record review revealed documentation the patient was placed in a physical restraint at 1005. Record review revealed no documentation of when the physical restraint was released. Record review revealed documentation of a 2-sided "Seclusion and Restraint Initial LIP First Hour Face to Face Evaluation" form. Review of the form revealed the front side (which contained spaces to document the intervention type and duration, the reason for the intervention, patient's response to the intervention, review of systems, and mental status/behavioral assessment) was blank. Review of the back side of the form revealed documentation (not signed or dated and timed) as follows: "Patient's response to emergency or PRN (as needed) medications: effective. Physical/Medical History: The patient has the following, which may put them at greater risk for harm during seclusion or restraint: (checked) None Present or Denied. Describe condition and adjustments made for optimal patient safety and beneficial outcome of intervention: (checked) none, no risk factors present. Patient's most recent lab values have been reviewed...(checked) yes. document any concerns: 0 (zero)....Clinical Summary of Intervention: Pt (patient) placed in therapeutic hold d/t (due to) threatening staff." Record review revealed no documentation the patient was seen face-to-face within 1 hour after the initiation of the restraint by a physician, other licensed independent practitioner (LIP), or qualified registered nurse. Record review revealed documentation that the next time the patient was seen by a physician, LIP, or QRN was on 12/02/2010 at 1521, when his physician assessed him (29 hours and 16 minutes after initiation of the physical restraint). Further record review revealed a physician's order dated 12/23/2010 at 1845 for the patient to be placed in a physical restraint and 4 point mechanical restraints. Review of the "Seclusion/Restraint Order" revealed, "...Reason for Intervention:...threw trashcan towards staff...threatening staff and peers...." Record review revealed the patient was placed in a physical restraint at 1845 and was released at 1850. Record review revealed the patient was placed in 4 point mechanical restraints at 1845 and was released at 1930 (45 minutes). Record review revealed no documentation the patient was seen face-to-face within 1 hour after the initiation of the restraint by a physician, other licensed independent practitioner (LIP), or qualified registered nurse. Record review revealed documentation that the next time the patient was seen by a physician, LIP, or QRN was on 12/24/2010 at 0734, when his physician assessed him (12 hours and 49 minutes after initiation of the physical and 4 point mechanical restraints).

Interview on 07/07/2011 at 1600 with the Risk Manager revealed house (nursing) supervisors were trained to conduct face to face assessments at the hospital (QRN). Interview revealed patients that are restrained or secluded must be seen face-to-face and assessed within 1 hour after the initiation of restraint or seclusion by a physician or QRN. Interview confirmed there was no available documentation the patient was seen face-to-face by a physician, other licensed independent practitioner (LIP), or qualified registered nurse within 1 hour after the initiation of restraints on 11/29/2010 at 0925, 12/01/2010 at 1005, and 12/23/2010 at 1845.






2. Closed medical record review on 07/06/2011 for Patient #3 revealed a [AGE] year-old male that was admitted on [DATE] with psychotic disorder. Record review revealed a physician's order dated 05/23/2011 at 1100 for a physical hold and given an intramuscular injection of Haldol, Ativan (antianxiety medication) and Cogentin (medication to counteract potential side effects of Haldol). Review of a "Seclusion/Restraint Order" revealed, "...Reason for Intervention: Danger to Self/Self Injurious Behavior...Danger to Others...Gross Property Destruction with Imminent Danger to Others..." Record review revealed the patient was placed in the physical hold at 1415 and was released from at 1430. Record review revealed documentation of a face to face assessment of the patient conducted by a QRN on 5/24/2011 at 1000 (23 hours after initiation of the physical restraint). Further review of the face to face documentation by the QRN revealed "I wasn't notified re: this at all on the 23rd."

Interview on 07/07/2011 at 1600 with the Risk Manager revealed house (nursing) supervisors were trained to conduct face to face assessments at the hospital (QRN). Interview revealed patients that are restrained or secluded must be seen face-to-face and assessed within 1 hour after the initiation of restraint or seclusion by a physician or QRN. Interview confirmed there was no available documentation the patient was seen face-to-face by a physician, other licensed independent practitioner (LIP), or qualified registered nurse within 1 hour after the initiation of restraints on 05/23/2011 at 1100.
VIOLATION: PROGRAM SCOPE, PROGRAM DATA Tag No: A0273
Based on review of facility Restraint and Seclusion Audit Tools, Quality Assessment and Performance Improvement (QAPI) data and staff interview the facility failed to ensure the effectiveness and safety of restraint and seclusion by failing to aggregate data collected to monitor for improvements in the quality of care provided.

Findings included:

Review on 07/07/2011 of the "(Hospital Name) Seclusion/Restraint Audit Tool" (no date) revealed the following data elements related to use of restraints was being collected "...3. A time-limited order...6. The patient was evaluated face to face by a LIP within 1 hour of the initiation of episode...10. Appropriate patient checks were documented every 15 minutes on the restraint and seclusion hourly flow sheet...18. Patient debriefing was completed within 24 hours of the episode..."

Review on 07/07/2011 of the facility's Restraint and Seclusion QAPI data revealed the facility was monitoring the incidence of restraint and seclusion use. Review failed to reveal data being reported into the QAPI program in regards to Restraint and Seclusion ordering practices, face to face evaluations, patient monitoring while in restraint and seclusion or patient debriefing being conducted.

Interview with the facility's risk manager on 07/07/2011 at 1615 revealed "We are collecting data using the "Seclusion/Restraint Audit Tool, but the data is not being aggregated." Interview revealed the data is being utilized to counsel individual employees, however, the data is not being aggregated, analyzed and trended to monitor for improvement. Interview revealed the facility's QAPI program has no evidence that there has been any improvement in the elements regarding restraint use to include Restraint and Seclusion ordering practices, face to face evaluations, patient monitoring while in restraint and seclusion or patient debriefing being conducted.
VIOLATION: NURSING SERVICES Tag No: A0385
Based on review of hospital policies and procedures, medical records and staff interviews the hospital's nursing staff failed to demonstrate an organized nursing service as evidenced by failing to ensure safe medication use practices.

Findings include:

1. The hospital's registered nursing staff failed to supervise and evaluate patient care by: failing to assess the need for and response to PRN (as needed) medications; failing to monitor vital signs per physicians' orders, and/or failing to ensure lab work was done per physicians' orders for 5 of 6 sampled patients (#6, #1, #2, #5, #3).

~ cross refer to 482.23(b)(3) RN Supervision of Care - Tag 0395

2. The hospital's nursing staff failed to document the administration site of intramuscular (IM) injections for 5 of 6 sampled patients (#6, #1, #2, #5, and #3).

~ cross refer to 482.23(c) Administration of Drugs - Tag 404

3. The hospital's nursing staff failed to ensure a physician signed drug orders for 4 of 5 sampled patients that received psychotropic drugs per hospital drug protocols (#6, #1, #5, #3).

~ cross refer to 482.23(c)(2) Written Medical Orders for Drugs- Tag 406
VIOLATION: RN SUPERVISION OF NURSING CARE Tag No: A0395
**NOTE- TERMS IN BRACKETS HAVE BEEN EDITED TO PROTECT CONFIDENTIALITY**

Based on policy review, medical record review, and staff interview, the hospital's registered nursing staff failed to supervise and evaluate patient care by: failing to assess the need for and response to PRN (as needed) medications; failing to monitor vital signs per physicians' orders, and/or failing to ensure lab work was done per physicians' orders for 5 of 6 sampled patients (#6, #1, #2, #5, #3).

The findings include:

Review on 7/06/2011 of facility policy "Medications PRN, STAT and Single-dose" dated 09/2009 revealed "Procedure...Documentation - 1. Document the reason for administering PRN medication on the PRN Medication form. enter the date, time, name of PRN medication, reason given, and your initials in spaces indicated. 2. Document the patient's response to the PRN medication within one hour, indicating the time, and initial..."

Review on 7/06/2011 of facility policy "Vital Signs/Weight" dated 02/06/2010 revealed "Procedure...3. Physicians requesting vital signs to be taken more often than once a day will specify by written order...6. Vital signs will be recorded in the medical record..."

1. Open medical record review on 07/07/2011 for Patient #6 revealed a [AGE] year-old male that was admitted on [DATE] with depressive disorder, oppositional defiant disorder, and antisocial behavior disorder. Review of a telephone physician's order dated 06/07/2011 at 2145 (and signed by Physician #1 on 06/08/2011 at 1956) revealed, "...Zyprexa (antipsychotic medication) prot(ocol)...PRN (as needed for) agitation...." Further record review revealed a physician's order (documented and signed by Physician #1 on 06/08/2011 at 1957) for "Zyprexa protocol prn major agitation". Record review revealed documentation of a form entitled "Zyprexa Protocol", dated 06/07/2011 at 2145 and 06/08/2011 at 0130 and signed by two registered nurses (no physician's signature). Review of the Zyprexa Protocol form revealed, "...Child protocol (less than 16 yrs [years] old), or geriatric, neurologically-impaired, or med sensitive: (checked) Zyprexa 5 mg (milligrams) PO (by mouth) or IM (intramuscular injection) q (every) 2 hours PRN agitation/upset, up to 4 times/day. (checked) Vital Signs QID (four times per day) X 24 hours after each IM given. (checked) Q15" (minute) BO (behavioral observation) Precautions X 48 hours after IM given. (checked) Labs: serum Creatinine, BUN (blood urea nitrogen), Serum NA+ (sodium), Cl- (chloride), K+ (potassium), CO2 (carbon dioxide), HCT (hematocrit), HGB (hemoglobin) and U/A (urinalysis) STAT (immediately) following the AM (the following morning) after IM meds given." Record review revealed nursing staff gave the patient intramuscular injections of Zyprexa on the following dates/times: on 06/19/2011 at 1820; on 06/23/2011 at 1040 and 1955; on 06/24/2011 at 1300; on 06/27/2011 at 1313; on 07/04/2011 at 2150; and on 07/05/2011 at 2050 ( 7 doses). Record review revealed documentation the patient's vital signs were monitored as follows (after the patient received IM Zyprexa injections): once on 06/19/2011 (no time); once on 06/20/2011 (no time); once on 06/23/2011 (at 1000); once on 06/24/2011 (at 1015); once on 06/25/2011 (no time); once on 06/27/2011 (no time); once on 06/28/2011 (no time); once on 07/05/2011 (at 0900); and twice on 07/06/2011 at (0900 and 1800). Record review revealed no documentation nursing staff monitored the patient's vital signs four times per day for 24 hours following each IM injection of Zyprexa per physician's orders. Further record review revealed no documentation of the patient's serum Creatinine, BUN, serum NA+, Cl-, K+, CO2, HCT, HGB and U/A since 06/08/2011. Record review revealed no documentation lab work (serum Creatinine, BUN, serum NA+, Cl-, K+, CO2, HCT, HGB and U/A) was done on 06/20/2011, 06/24/2011, 06/25/2011, 06/28/2011, 07/05/2011, or 07/06/2011 (the morning following each IM injection of Zyprexa) per physician's orders.

Interview on 07/07/2011 at 1330 with Physician #1 revealed, "I order Zyprexa protocol for major agitation....I write the order for the protocol and the nurse gets the protocol and puts it in the chart." Interview revealed the physician "always" ordered lab work to be done per the Zyprexa protocol in order to assess for"muscle necrosis at the injection site and to ascertain that the medication didn't generate any other difficulties". Further interview revealed, "I think the purpose of (monitoring) vital signs (after Zyprexa injections) its to ensure no other acute or toxic effect is going on with the meds and to monitor general measures of health. I expected them to co vital signs QID after IM injections (of Zyprexa)."

Interview on 07/05/2011 at 1510 with the Assistant Director of Nursing confirmed there was no available documentation staff obtained lab work or monitored the patient's vital signs as ordered following IM injections of Zyprexa.

2. Closed medical record review for Patient #1 revealed a [AGE] year-old male that was admitted on [DATE] with mood disorder and antisocial behavior disorder. Record review revealed the patient was treated and subsequently discharged to a psychiatric residential treatment facility on 12/28/2010. Review of a telephone physician's order dated 11/21/2010 at 0935 (and signed by Physician #1 on 11/23/2010 at 1845) revealed, "Zyprexa (antipsychotic medication) prot(ocol)." Record review revealed documentation of a form entitled "Zyprexa Protocol", dated 11/21/2010 at 0935 and signed by a registered nurse (no physician's signature). Review of the Zyprexa Protocol form revealed, "...Child protocol (less than 16 yrs [years] old), or geriatric, neurologically-impaired, or med sensitive: (checked) Zyprexa 5 mg (milligrams) PO (by mouth) or IM (intramuscular injection) q (every) 2 hours PRN agitation/upset, up to 4 times/day. (checked) Vital Signs QID (four times per day) X 24 hours after each IM given. (checked) Q15" (minute) BO (behavioral observation) Precautions X 48 hours after IM given. (not checked) Labs: serum Creatinine, BUN (blood urea nitrogen), Serum NA+ (sodium), Cl- (chloride), K+ (potassium), CO2 (carbon dioxide), HCT (hematocrit), HGB (hemoglobin) and U/A (urinalysis) STAT (immediately) following the AM (the following morning) after IM meds given." Record review revealed nursing staff gave the patient intramuscular (IM) injections of Zyprexa (antipsychotic medication) on the following dates/times: on 11/21/2010 at 1000; on 11/29/2010 at 0930; on 12/01/2010 at 1015; on 12/02/2010 at 1330; on 12/10/2010 at 1345; on 12/13/2010 at 2030; on 12/14/2010 at 1555; on 12/15/2010 at 1820; on 12/17/2010 at 1000 and 1830; on 12/18/2010 at 0950 and 2120; on 12/19/2010 at 1400; on 12/20/2010 at 0945; on 12/21/2010 at 1345; on 12/22/2010 at 2230; on 12/23/2010 at 1257; on 12/24/2010 at 1735; on 12/25/2010 at 1045; on 12/26/2010 at 1650; and on 12/27/2010 at 1450. Record review revealed documentation the patient's vital signs were monitored as follows (after the patient received IM Zyprexa injections): "refused" documented once on 11/21/2010 (0900); no vital signs documented on 11/29/2010; once on 12/01/2010 (no time); none documented on 12/02/2010 or 12/10/2010; once on 12/13/2010 (0900); "refused" documented once on 12/14/2010 (no time); once on 12/15/2010 (no time); once on 12/17/2010 (no time); once on 12/18/2010 (0900); once on 12/19/2010 (1000); none documented on 12/20/2010; once on 12/21/2010 (no time); none documented on 12/22/2010, 12/23/2010, 12/24/2010, or 12/25/2010; once on 12/26/2010 (no time); and once on 12/27/2010 (no time). Record review revealed no documentation nursing staff monitored the patient's vital signs four times per day for 24 hours following each IM injection of Zyprexa per physician's orders. Further record review revealed documentation the patient was given Zyprexa 5 mg PO on 11/22/2011 at 1115 for agitation. Record review revealed documentation the nurse reassessed the patient's level of agitation at 1305 (1 hour and 50 minutes later). Record review revealed documentation the patient was given Zyprexa 5 mg PO on 11/22/2011 at 1335 for agitation. Record review revealed documentation the nurse reassessed the patient's level of agitation at 1505 (1 hour and 30 minutes later). Record review revealed the patient was given Zyprexa 5 mg IM on 12/17/2010 at 1830. Record review revealed no documentation of the reason the patient was given the medication or of a reassessment of the patient following the medication.

Interview on 07/07/2011 at 1330 with Physician #1 revealed, "I order Zyprexa protocol for major agitation....I write the order for the protocol and the nurse gets the protocol and puts it in the chart." Interview revealed, "I think the purpose of (monitoring) vital signs (after Zyprexa injections) its to ensure no other acute or toxic effect is going on with the meds and to monitor general measures of health. I expected them to co vital signs QID after IM injections (of Zyprexa)."

Interview on 07/05/2011 at 1510 with the Assistant Director of Nursing confirmed there was no available documentation staff the patient's vital signs as ordered following IM injections of Zyprexa. Further interview revealed nursing staff should assess and document the reason for administering PRN medications, including Zyprexa. Interview revealed nursing staff should reassess the patient within one hour of administering any PRN medication. Interview confirmed there was no available documentation of the reason the nurse gave the patient Zyprexa on 12/17/2010 at 1830 or that the nurse reassessed the patient within one hour of administering Zyprexa PRN on 11/22/2010 at 1115, 11/22/2010 at 1335, and on 12/17/2010 at 1830.








3. Closed medical record review on 07/06/2011 for Patient #2 revealed an [AGE] year-old male that was admitted on [DATE] by Involuntary Commitment with bipolar disorder and post-traumatic stress disorder. Review revealed the patient was discharged from the hospital on [DATE]. Record review revealed a physician's order written 05/06/2011 at 2015 "Vital signs: (check) Twice Daily." Record review of vital signs documentation from 05/06/2011 through 06/04/2011 revealed documentation the patient's vital signs were monitored only once in a 24 hour period on the following dates: 05/08/2011, 05/09/2011, 05/10/2011, 05/13/2011, 05/14/2011, 05/17/2011, 05/18/2011, 05/19/2011, 05/20/2011, 05/23/2011, 05/24/2011, 05/25/2011, 05/26/2011, 05/27/2011, 05/30/2011 and 06/03/2011.

Interview on 07/07/2011 at 1030 with the Risk Manager revealed nurses must document vital signs on the "Vital Signs" flowsheet as ordered by the physician. Interview revealed nursing staff failed to monitor the patient's vital signs as ordered by the physician on 05/08/2011, 05/09/2011, 05/10/2011, 05/13/2011, 05/14/2011, 05/17/2011, 05/18/2011, 05/19/2011, 05/20/2011, 05/23/2011, 05/24/2011, 05/25/2011, 05/26/2011, 05/27/2011, 05/30/2011, 06/03/2011, 06/04/2011. Interview failed to reveal any further documentation of the vital signs being monitored as ordered by the physician or documentation as to why the vital signs were not monitored as ordered by the physician.

Interview on 07/07/2011 at 1330 with Physician #1 revealed "I think the purpose of (monitoring) vital signs (after injections of antipsychotic medications) its to ensure no other acute or toxic effect is going on with the meds and to monitor general measures of health..."

4. Open medical record review on 07/07/2011 for Patient #5 revealed a [AGE] year-old male that was admitted on [DATE] by Involuntary Commitment with mood disorder. Record review revealed documentation of a form entitled "Zyprexa Protocol", dated 6/25/2011 at 2030 and 6/25/2011 at 2240 and signed by two registered nurses (no physician's signature). Review of the Zyprexa Protocol form revealed, "...Child protocol (less than 16 yrs [years] old), or geriatric, neurologically-impaired, or med sensitive: (checked) Zyprexa 5 mg (milligrams) PO (by mouth) or IM (intramuscular injection) q (every) 2 hours PRN agitation/upset, up to 4 times/day. (checked) Vital Signs QID (four times per day) X 24 hours after each IM given..." Record review revealed nursing staff gave the patient intramuscular (IM) injections of Zyprexa (antipsychotic medication) per the protocol on 06/28/2011 at 2015. Record review revealed the patient's vital signs were only recorded once in the 24 hour period following the Zyprexa administration on 06/25/2011.

Interview on 07/07/2011 at 1030 with the Risk Manager revealed nurses must document vital signs on the "Vital Signs" flowsheet as ordered by the physician. Interview revealed nursing staff failed to monitor the patient's vital signs as ordered by the physician on 05/08/2011, 05/09/2011, 05/10/2011, 05/13/2011, 05/14/2011, 05/17/2011, 05/18/2011, 05/19/2011, 05/20/2011, 05/23/2011, 05/24/2011, 05/25/2011, 05/26/2011, 05/27/2011, 05/30/2011, 06/03/2011, 06/04/2011. Interview failed to reveal any further documentation of the vital signs being monitored as ordered by the physician or documentation as to why the vital signs were not monitored as ordered by the physician.

Interview on 07/07/2011 at 1330 with Physician #1 revealed "I think the purpose of (monitoring) vital signs (after injections of antipsychotic medications) its to ensure no other acute or toxic effect is going on with the meds and to monitor general measures of health..."

5. Closed medical record review on 07/06/2011 for Patient #3 revealed a [AGE] year-old male that was admitted on [DATE] by Involuntary Commitment with psychotic disorder. Review revealed the patient was transferred to another psychiatric hospital on [DATE]. Review of form "Physician's Orders (Admission)" dated 5/22/11 at 1500 revealed "Vital Signs: (check) Twice Daily." Record review of vital signs documentation from 05/21/2011 through 05/26/2011 revealed documentation the patient's vital signs were monitored only once in a 24 hour period on 05/24/2011. Review revealed no documentation of vital signs on 05/23/2011 and 05/25/2011. Review of form "Physician's Admission Orders - Medication Reconciliation" dated 5/22/11 at 1500 revealed "New Medication Orders...Haldol protocol for severe agitation (without labs)." Record review revealed nursing staff gave the patient separate intramuscular (IM) injections of haloperidol (or Haldol - an antipsychotic medication) 5mg (milligrams), Cogentin (used to control tremors from haloperidol) 2mg and lorazepam 2mg (antianxiety medication) on 05/23/2011 at 1400.

Interview on 07/07/2011 at 1030 with the Risk Manager revealed nurses must document vital signs on the "Vital Signs" flowsheet as ordered by the physician. Interview revealed nursing staff failed to monitor the patient's vital signs as ordered by the physician on 05/24/2011, 05/23/2011 and 05/25/2011. Interview failed to reveal any further documentation of the vital signs being monitored as ordered by the physician or documentation as to why the vital signs were not monitored as ordered by the physician. Further interview revealed when the Haldol protocol is ordered, the patient's vital signs should be increased to four times daily for the 24 hour period following the administration of the Haldol, Cogentin and lorazepam. Record review during the interview revealed the patient's vital signs were not monitored at any time during the 24 hours after the Haldol, Cogentin and lorazepam was administered to the patient on 05/23/2011 at 1400. Interview revealed nursing staff failed to monitor the patient appropriately after the patient was administered the medications on 05/23/2011 at 1400 by failing to monitor the vital signs at least four times following the medication administration.

Interview on 07/07/2011 at 1330 with Physician #1 revealed "I think the purpose of (monitoring) vital signs (after injections of antipsychotic medications) its to ensure no other acute or toxic effect is going on with the meds and to monitor general measures of health..."
VIOLATION: ADMINISTRATION OF DRUGS Tag No: A0405
**NOTE- TERMS IN BRACKETS HAVE BEEN EDITED TO PROTECT CONFIDENTIALITY**

Based on policy review, medical record review, and staff interview, the hospital's nursing staff failed to document the administration site of intramuscular (IM) injections for 5 of 6 sampled patients (#6, #1, #2, #5, and #3 ).

The findings include:

Review on 07/06/2011 of facility policy "Medication Administration Sites" dated 09/2009 revealed "Policy - When administering injectable medications, the site of administration will be rotated with each dose given to protect the integrity of the administration site. Procedure...2. Prior to administering the medication, check the prior dose to determine the site used at that time. 3. Administer the current dose at a different site and indicate on the MAR (Medication Administration Record) the letter code from the legend that identifies the site..."

1. Open medical record review on 07/07/2011 for Patient #6 revealed a [AGE] year-old male that was admitted on [DATE] with depressive disorder, oppositional defiant disorder, and antisocial behavior disorder. Record review revealed nursing staff gave the patient intramuscular (IM) injections of Zyprexa (antipsychotic medication) on the following dates/times: on 06/19/2011 at 1820; on 06/23/2011 at 1040 and 1955; on 06/24/2011 at 1300; on 06/27/2011 at 1313; on 07/04/2011 at 2150; and on 07/05/2011 at 2050 ( 7 doses). Further record review revealed no documentation of the intramuscular injection site for the doses of Zyprexa administered to the patient on 06/19/2011 at 1820, 06/27/2011 at 1313, 07/04/2011 at 2150, and 07/05/2011 at 2050 (4 of 7 doses).

Interview on 07/05/2011 at 1510 with the Assistant Director of Nursing revealed nurses must document intramuscular injection sites in patients' medical records. Interview confirmed there was no available documentation of the intramuscular injection site for the doses of Zyprexa administered to the patient on 06/19/2011 at 1820, 06/27/2011 at 1313, 07/04/2011 at 2150, and 07/05/2011 at 2050 (4 of 7 doses).

2. Closed medical record review for Patient #1 revealed a [AGE] year-old male that was admitted on [DATE] with mood disorder and antisocial behavior disorder. Record review revealed the patient was treated and subsequently discharged to a psychiatric residential treatment facility on 12/28/2010. Record review revealed nursing staff gave the patient intramuscular (IM) injections of Zyprexa (antipsychotic medication) on the following dates/times: on 11/21/2010 at 1000; on 11/29/2010 at 0930; on 12/01/2010 at 1015; on 12/02/2010 at 1330; on 12/10/2010 at 1345; on 12/13/2010 at 2030; on 12/14/2010 at 1555; on 12/15/2010 at 1820; on 12/17/2010 at 1000 and 1830; on 12/18/2010 at 0950 and 2120; on 12/19/2010 at 1400; on 12/20/2010 at 0945; on 12/21/2010 at 1345; on 12/22/2010 at 2230; on 12/23/2010 at 1257; on 12/24/2010 at 1735; on 12/25/2010 at 1045; on 12/26/2010 at 1650; and on 12/27/2010 at 1450 (21 doses). Further record review revealed no documentation of the intramuscular injection site for the doses of Zyprexa administered to the patient on the following dates/times: on 11/21/2010 at 1000; on 11/29/2010 at 0930; on 12/01/2010 at 1015; on 12/02/2010 at 1330; on 12/10/2010 at 1345; on 12/13/2010 at 2030; on 12/14/2010 at 1555; on 12/15/2010 at 1820; on 12/17/2010 at 1830; on 12/18/2010 at 0950 and 2120; on 12/20/2010 at 0945; on 12/21/2010 at 1345; on 12/22/2010 at 2230; on 12/23/2010 at 1257; on 12/24/2010 at 1735; on 12/25/2010 at 1045; and on 12/26/2010 at 1650 (18 of 21 doses).

Interview on 07/05/2011 at 1510 with the Assistant Director of Nursing revealed nurses must document intramuscular injection sites in patients' medical records. Interview confirmed there was no available documentation of the intramuscular injection site for the doses of Zyprexa administered to the patient on 11/21/2010 at 1000; on 11/29/2010 at 0930; on 12/01/2010 at 1015; on 12/02/2010 at 1330; on 12/10/2010 at 1345; on 12/13/2010 at 2030; on 12/14/2010 at 1555; on 12/15/2010 at 1820; on 12/17/2010 at 1830; on 12/18/2010 at 0950 and 2120; on 12/20/2010 at 0945; on 12/21/2010 at 1345; on 12/22/2010 at 2230; on 12/23/2010 at 1257; on 12/24/2010 at 1735; on 12/25/2010 at 1045; and on 12/26/2010 at 1650 (18 of 21 doses).





3. Closed medical record review on 07/06/2011 for Patient #2 revealed an [AGE] year-old male that was admitted on [DATE] by Involuntary Commitment with bipolar disorder and post-traumatic stress disorder. Record review revealed nursing staff gave the patient intramuscular (IM) injections of Thorazine (antipsychotic medication) on the following dates/times: on 05/12/2011 at 1238, on 05/16/2011 at 2137, on 05/19/2011 at 0930, on 05/20/2011 at 1030, on 05/21/2011 at 0915, on 05/22/2011 at 0930, on 05/22/2011 at 1030, on 05/23/2011 at 0830, on 05/26/2011 at 1740 and 05/29/2011 at 1430 (10 doses). Further record review revealed no documentation of the intramuscular injection site for the doses of Thorazine administered to the patient.

Interview on 07/07/2011 at 1030 with the Risk Manager revealed nurses must document intramuscular injection sites in patients' medical records. Interview confirmed there was no available documentation of the intramuscular injection site for the 10 doses of Thorazine administered to the patient on 05/12/2011 at 1238, on 05/16/2011 at 2137, on 05/19/2011 at 0930, on 05/20/2011 at 1030, on 05/21/2011 at 0915, on 05/22/2011 at 0930, on 05/22/2011 at 1030, on 05/23/2011 at 0830, on 05/26/2011 at 1740 and 05/29/2011 at 1430.

4. Open medical record review on 07/07/2011 for Patient #5 revealed a [AGE] year-old male that was admitted on [DATE] by Involuntary Commitment with mood disorder. Record review of nursing documentation dated 6/25/2011 at 2210 revealed "New admission...Order received to give Zyprexa 10mg (milligram) tab(let)/or IM (intramuscular injection)...Pt accepted to receive IM Zyprexa." Review of the Medication Administration Record (MAR) failed to reveal the injection site utilized for the IM medication administration.

Interview on 07/07/2011 at 1030 with the Risk Manager revealed nurses must document intramuscular injection sites in patient's medical record. Interview confirmed there was no available documentation of the intramuscular injection site for the IM dose of Zyprexa administered to the patient on 06/25/2011.

5. Closed medical record review on 07/06/2011 for Patient #3 revealed a [AGE] year-old male that was admitted on [DATE] by Involuntary Commitment with psychotic disorder. Review of form "Physician's Admission Orders - Medication Reconciliation" dated 5/22/11 at 1500 revealed "New Medication Orders...Haldol protocol for severe agitation (without labs)." Record review revealed nursing staff gave the patient separate intramuscular (IM) injections of haloperidol (or Haldol - an antipsychotic medication) 5mg (milligrams), Cogentin (used to control tremors from haloperidol) 2mg and lorazepam 2mg (antianxiety medication) on 05/23/2011 at 1400. Record review failed to reveal the injection sites utilized for the administration of the IM medication doses.

Interview on 07/07/2011 at 1030 with the Risk Manager revealed nurses must document intramuscular injection sites in patient's medical record. Interview confirmed there was no available documentation of the intramuscular injection site(s) for the IM doses of Haldol, Cogentin and lorazepam administered to the patient on 05/23/2011 at 1400.
VIOLATION: WRITTEN MEDICAL ODERS FOR DRUGS Tag No: A0406
**NOTE- TERMS IN BRACKETS HAVE BEEN EDITED TO PROTECT CONFIDENTIALITY**

Based on policy review, medical record review, and staff interview, the hospital failed to ensure a physician signed drug orders for 4 of 5 sampled patients that received psychotropic drugs per hospital drug protocols (#6, #1, #5, #3).

The findings include:

Review on 7/06/2011 of facility policy "Medication Administration" dated 09/2010 revealed "Procedure - 1. Medications are not given without a physician's order..."

1. Open medical record review on 07/07/2011 for Patient #6 revealed a [AGE] year-old male that was admitted on [DATE] with depressive disorder, oppositional defiant disorder, and antisocial behavior disorder. Review of a telephone physician's order dated 06/07/2011 at 2145 (and signed by Physician #1 on 06/08/2011 at 1956) revealed, "...Zyprexa (antipsychotic medication) prot(ocol)...PRN (as needed for) agitation...." Further record review revealed a physician's order (documented and signed by Physician #1 on 06/08/2011 at 1957) for "Zyprexa protocol prn major agitation". Record review revealed documentation of a form entitled "Zyprexa Protocol", dated 06/07/2011 at 2145 and 06/08/2011 at 0130 and signed by two registered nurses (no physician's signature). Review of the Zyprexa Protocol form revealed, "...Child protocol (less than 16 yrs [years] old), or geriatric, neurologically-impaired, or med sensitive: (checked) Zyprexa 5 mg (milligrams) PO (by mouth) or IM (intramuscular injection) q (every) 2 hours PRN agitation/upset, up to 4 times/day. (checked) Vital Signs QID (four times per day) X 24 hours after each IM given. (checked) Q15" (minute) BO (behavioral observation) Precautions X 48 hours after IM given. (checked) Labs: serum Creatinine, BUN (blood urea nitrogen), Serum NA+ (sodium), Cl- (chloride), K+ (potassium), CO2 (carbon dioxide), HCT (hematocrit), HGB (hemoglobin) and U/A (urinalysis) STAT (immediately) following the AM (the following morning) after IM meds given." Record review revealed the patient was given Zyprexa (either PO or IM) on the following dates/times: on 06/19/2011 at 1820 and 2100; on 06/20/2011 at 1530; on 06/23/2011 at 1040 and 1955; on 06/24/2011 at 1300, 1720, and 1925; on 06/26/2011 at 1450; on 06/27/2011 at 1313 and 1810; on 06/28/2011 at 1215; on 06/29/2011 at 1000, 1525, and 1740; on 07/02/2011 at 1530; on 07/04/2011 at 0740 and 2030; on 07/05/2011 at 1825 and 2050; and on 07/06/2011 at 2002 (21 doses since admission). Record review revealed no documentation of a physician's signature on the Zyprexa Protocol form.

Interview on 07/06/2011 at 1500 with the hospital's Pharmacist revealed the physician should sign drug protocol order sheets. Interview revealed, "When the physician gives a verbal (or telephone) order to implement a (drug) protocol, he tells the nurse which options to choose (on the protocol form). He should then sign the protocol order sheet."

Interview on 07/07/2011 at 1100 with the hospital's Medical Director revealed Zyprexa Protocol had been in place for several years. Interview revealed, "When developed, it was intended to be used for emergency doses of medication. It seems we have started using it as (orders for) regular PRNs, rather than writing orders....The physician should always review and sign the protocol order sheet....We have gotten sloppy with the protocols."

Interview on 07/07/2011 at 1330 with Physician #1 revealed the Zyprexa Protocol was already in use at the hospital when the physician began practicing there in August of 2010. Interview revealed, "In order to avoid mistakes they developed protocols with standard dosages, etcetera....I order Zyprexa protocol for major agitation....Its a way of having an emergency plan for meds and a formalized way of doing them PRN, to decrease transcription errors....I write the order for the protocol and the nurse gets the protocol and puts it in the chart. We (physicians) usually sign the protocol order sheets." Interview revealed prior to Christmas 2010, the physician thought he wasn't required to sign the protocol order form. Interview revealed, "That changed and now we sign them all. They put stickies in the chart that tell me to sign them within 24 hours....I thought we didn't have to (sign the Zyprexa Protocol order form )because we sign the order." Further interview confirmed there was no available documentation the physician signed the Zyprexa Protocol order form for Patient #6.

2. Closed medical record review for Patient #1 revealed a [AGE] year-old male that was admitted on [DATE] with mood disorder and antisocial behavior disorder. Record review revealed the patient was treated and subsequently discharged to a psychiatric residential treatment facility on 12/28/2010. Review of a telephone physician's order dated 11/21/2010 at 0935 (and signed by Physician #1 on 11/23/2010 at 1845) revealed, "Zyprexa (antipsychotic medication) prot(ocol)." Record review revealed documentation of a form entitled "Zyprexa Protocol", dated 11/21/2010 at 0935 and signed by a registered nurse (no physician's signature). Review of the Zyprexa Protocol form revealed, "...Child protocol (less than 16 yrs [years] old), or geriatric, neurologically-impaired, or med sensitive: (checked) Zyprexa 5 mg (milligrams) PO (by mouth) or IM (intramuscular injection) q (every) 2 hours PRN agitation/upset, up to 4 times/day. (checked) Vital Signs QID (four times per day) X 24 hours after each IM given. (checked) Q15" (minute) BO (behavioral observation) Precautions X 48 hours after IM given. (not checked) Labs: serum Creatinine, BUN (blood urea nitrogen), Serum NA+ (sodium), Cl- (chloride), K+ (potassium), CO2 (carbon dioxide), HCT (hematocrit), HGB (hemoglobin) and U/A (urinalysis) STAT (immediately) following the AM (the following morning) after IM meds given." Record review revealed the patient was given Zyprexa (either PO or IM) on the following dates/times: on 11/21/2010 at 1000; on 11/22/2010 at 1115 and 1335; on 11/24/2010 at 1500; on 11/26/2010 at 1300; on 11/29/2010 at 0930; on 11/30/2010 at 1755; on 12/01/2010 at 1015; on 12/02/2010 at 1220 and 1330; on 12/10/2010 at 1345; on 12/13/2010 at 2030; on 12/14/2010 at 1555; on 12/15/2010 at 1820; on 12/17/2010 at 1000 and 1830; on 12/18/2010 at 0950 and 2120; on 12/19/2010 at 1400; on 12/20/2010 at 0945; on 12/21/2010 at 1345; on 12/22/2010 at 2230; on 12/23/2010 at 1257; on 12/24/2010 at 1735; on 12/25/2010 at 1045; on 12/26/2010 at 1650; on 12/27/2010 at 1450; and on 12/28/2010 at 1245 (28 doses). Record review revealed no documentation of a physician's signature on the Zyprexa Protocol form.

Interview on 07/06/2011 at 1500 with the hospital's Pharmacist revealed the physician should sign drug protocol order sheets. Interview revealed, "When the physician gives a verbal (or telephone) order to implement a (drug) protocol, he tells the nurse which options to choose (on the protocol form). He should then sign the protocol order sheet."

Interview on 07/07/2011 at 1100 with the hospital's Medical Director revealed Zyprexa Protocol had been in place for several years. Interview revealed, "When developed, it was intended to be used for emergency doses of medication. It seems we have started using it as (orders for) regular PRNs, rather than writing orders....The physician should always review and sign the protocol order sheet....We have gotten sloppy with the protocols."

Interview on 07/07/2011 at 1330 with Physician #1 revealed the Zyprexa Protocol was already in use at the hospital when the physician began practicing there in August of 2010. Interview revealed, "In order to avoid mistakes they developed protocols with standard dosages, etcetera....I order Zyprexa protocol for major agitation....Its a way of having an emergency plan for meds and a formalized way of doing them PRN, to decrease transcription errors....I write the order for the protocol and the nurse gets the protocol and puts it in the chart. We (physicians) usually sign the protocol order sheets." Interview revealed prior to Christmas 2010, the physician thought he wasn't required to sign the protocol order form. Interview revealed, "That changed and now we sign them all. They put stickies in the chart that tell me to sign them within 24 hours....I thought we didn't have to (sign the Zyprexa Protocol order form )because we sign the order." Further interview confirmed there was no available documentation the physician signed the Zyprexa Protocol order form for Patient #1.





3. Open medical record review on 07/07/2011 for Patient #5 revealed a [AGE] year-old male that was admitted on [DATE] by Involuntary Commitment with mood disorder. Record review revealed documentation of a form entitled "Zyprexa Protocol", dated 6/25/2011 at 2030 and 6/25/2011 at 2240 and signed by two registered nurses (no physician's signature). Review of the Zyprexa Protocol form revealed, "...Child protocol (less than 16 yrs [years] old), or geriatric, neurologically-impaired, or med sensitive: (checked) Zyprexa 5 mg (milligrams) PO (by mouth) or IM (intramuscular injection) q (every) 2 hours PRN agitation/upset, up to 4 times/day. (checked) Vital Signs QID (four times per day) X 24 hours after each IM given. (checked) Q15" (minute) BO (behavioral observation) Precautions X 48 hours after IM given. (checked) Labs: serum Creatinine, BUN (blood urea nitrogen), Serum NA+ (sodium), Cl- (chloride), K+ (potassium), CO2 (carbon dioxide), HCT (hematocrit), HGB (hemoglobin) and U/A (urinalysis) STAT (immediately) following the AM (the following morning) after IM meds given." Record review revealed nursing staff gave the patient intramuscular (IM) injections of Zyprexa (antipsychotic medication) per the protocol on 06/28/2011 at 2015. Record review revealed no documentation of a physician's signature on the Zyprexa Protocol form.

Interview on 07/06/2011 at 1500 with the hospital's Pharmacist revealed the physician should sign drug protocol order sheets. Interview revealed, "When the physician gives a verbal (or telephone) order to implement a (drug) protocol, he tells the nurse which options to choose (on the protocol form). He should then sign the protocol order sheet."

Interview on 07/07/2011 at 1100 with the hospital's Medical Director revealed Zyprexa Protocol had been in place for several years. Interview revealed, "When developed, it was intended to be used for emergency doses of medication. It seems we have started using it as (orders for) regular PRNs, rather than writing orders....The physician should always review and sign the protocol order sheet....We have gotten sloppy with the protocols."

4. Closed medical record review on 07/06/2011 for Patient #3 revealed a [AGE] year-old male that was admitted on [DATE] by Involuntary Commitment with psychotic disorder. Review of form "Physician's Admission Orders - Medication Reconciliation" dated 5/22/11 at 1500 revealed "New Medication Orders...Haldol protocol for severe agitation (without labs)." Record review revealed nursing staff gave the patient separate intramuscular (IM) injections of haloperidol (or Haldol - an antipsychotic medication) 5mg (milligrams), Cogentin (used to control tremors from haloperidol) 2mg and lorazepam 2mg (antianxiety medication) on 05/23/2011 at 1400. Record review failed to reveal any physician's order for the doses administered for the Haldol, Cogentin and Lorazepam administered on 05/23/2011 at 1400.

Interview on 07/06/2011 at 1500 with the hospital's Pharmacist revealed once the nursing staff noted the order for the Haldol protocol, a Haldol protocol form should have been completed and entered into the medical record then signed by the physician. Interview revealed without the completed Haldol protocol form in the record, there is no documentation of an order for the Haldol dose, route or frequency. Further interview revealed without the completed protocol form in the medical record there is no order for the medications Cogentin or Ativan, which are a part of the protocol. Interview further revealed the protocol also includes an order for increased observation and vital signs as well as labs which should be done after each dose of medication given under the protocol. Interview revealed staff failed to follow facility procedure for implementing the Haldol protocol by failing to ensure a physician's order for medication was entered into the patient's medical record prior to administration of any medication. Interview revealed there was no other documentation available of a physician's order for the Haldol, Cogentin and Lorazepam administered on 05/23/2011 at 1400.

NC 713 and NC 130