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.

WATAUGA MEDICAL CENTER 336 DEERFIELD ROAD BOONE, NC 28607 Sept. 14, 2011
VIOLATION: PATIENT RIGHTS: FREE FROM ABUSE/HARASSMENT Tag No: A0145
**NOTE- TERMS IN BRACKETS HAVE BEEN EDITED TO PROTECT CONFIDENTIALITY**

Based on staff interviews, Health Care Personel Requirements, patient medical record review and hospital investigation records review the hospital failed to report an allegation of abuse by the CNA (certified nurse assistant) to the HCPR (Health Care Personnel Registry) for 1 of 1 record reviews (Patient # 3).

Findings include:
Interview with the Vice President of Patient Care Services on 9/13/2011 at 1600 revealed the hospital had no written policy regarding the reporting of CNA to the HCPR. This interview indicated they followed the HCPR written guidelines.

Review of "The HEALTH CARE PERSONNEL REGISTRY INVESTIGATION PROCESS AND REPORTING REQUIREMENTS" revealed ..." 1. Allegations A. Allegations requiring investigation ...10. "All facilities are required to report allegations (before the facility's investigation), including injuries of unknown source to the Investigations Branch, Health Care Personnel Registry (HCPR) of the Division of Health Service Regulation (DHSR)."

Closed medical record review of patient #3 on 9/13/2011 revealed a [AGE] year old female admitted on [DATE] at 0005, with a Diagnosis of Facial Cellulitis versus Abscess. The H&P Assessment /Plan dictated 7/28/2011 at 00:29 states "1. Facial abscess. Likely causing the confusion and delirium. Possible sepsis. I would not say that she has a sepsis syndrome though. I recommend IV antibiotics with Unasyn which will be bacterial subtle and cover oropharyngeal flora and a parotidis. I recommend ENT evaluation in the morning and see if there is an abscess and/or stone. I recommend CT scan now if we can get her to hold still. Will treat her pain appropriately." Continued record review indicated the patient had an I & D (incision/drainage) procedure to drain the abscess on 8/1/2011. Further review of the medical record shows a physician order on 8/2/2011 at 1420 "Have patient shower & wash face/neck w/Hibicleans soap - wash hair as well w/ Hibicleans & shampoo."...
Review of the nursing notes dated 8/2/2011 at 1920 revealed "Awake & resting in bed without c/os (complaints of) of pain @ this time. Drsg (dressing) to R (right) side face intact with mod (moderate) amt (amount) of serosanquinous drainage. Pt has pulled out IV States no knowledge of doing so. ...2315 Pt up to shower & cleanse wound site & shampoo hair with hibicleanse. Pt had removed dressing prior to showering & penrose drain was gone upon examination of wound."

The hospital investigation records review on 9/13/2011 shows a letter sent to the Hospital CEO on 8/4/2011 from patient #3, alleging abuse by the CNA when giving the patient a shower. The letter states "During the early morning hours (prior to 7 AM) on 8/3/2011 CNA#1 (Certified Nurses Assistant) entered my room to give me a shower. I declined having CNA#1 giving me a shower. By declining the shower I believe that should have been the end of the shower issue. CNA #1 insisted that I was going to have a shower. Once in the shower stall CNA #1 closed the bathroom door and then began to wash me treating me very rough. CNA #1 shook my head by grabbing my hair. This action increased the pain to the side of my face and frightened me. I informed the staff doctor about the shower incident and she informed me to report CNA #1 to the Medical Center officials. The abusive treatment by CNA #1 caused me to have increased pain and it has affected me emotionally. I have difficulty sleeping because of the facial pain and stress of the abusive treatment. When I awake I am crying because I feel that I have been violated. No person is allowed to physically abuse another individual. This includes Ms. CNA #1, I am seriously considering bring criminal charges against Ms. CNA #1."

Review of the hospital investigation documentation shows a statement by the accused CNA "On 8/2/2011, the CNA was asked by RN #1 to carry out the order to shower and wash the patient's hair. At approximately 2230, CNA #1 went to the patient's room and explained to patient #3 that she was there to assist her with the shower that the MD had ordered. CNA #1 prepared the shower and assisted the patient into the shower. As soon as the patient was in the shower, she immediately began screaming at CNA #1 "I'm cold, I'm cold" "I don't like this." Working as calmly as possible , CNA #1 attempted to reassure the patient that she was there to help, but quickly realized the patient was too panicked to continue. CNA #1 attempted to wash the remaining soap from the patient's hair as quickly as possible. CNA #1 recalls the episode being less than one minute in length before the patient was back out of the shower. CNA #1 assisted the patient out of the shower and began to assist her with dressing and combing her hair. The patient then began to make the comments, "I'm so sorry" I'm so stupid, I shouldn't be acting this way". CNA #1 again, reassured her that she was there to help her and no one thought that about her. CNA #1 stayed with the patient in an attempt to calm."

Phone interview with CNA #1 on 9/13/11 at 0315 PM confirmed the investigation documentation. Interview revealed the patient was in the shower 10 - 12 minutes, with the water on the patient about 3 minutes, and the patient did not get a complete shower. The CNA also indicated that she had explained to the patient about the shower and she had not refused until the patient was actually in the shower.

Interview on 9/14/2011 at 08:30 AM, with the Registered Nurse on duty that day revealed the patient had some hygiene issues , the wound dressing was not staying on and the patient's skin was oily and her hair was matted, prompting the Physician to write the orders for a shower. The Registered Nurse also indicated she had explained the Physician orders to the patient and there had been no objection.

Review of the Hospital documents showed no evidence that the HCPR had been notified prior to the Hospital investigation or after the investigation. This was confirmed by the VP of Patient Care Services. A phone interview with the Hospital educator on 9/14/2011 at 09:50 AM indicated they do teach reporting allegations of abuse within 24 hours, to the HCPR.
VIOLATION: PATIENT RIGHTS: RESTRAINT OR SECLUSION Tag No: A0171
**NOTE- TERMS IN BRACKETS HAVE BEEN EDITED TO PROTECT CONFIDENTIALITY**

Based on hospital policy review, medical record review and staff interview, the hospital staff failed to ensure a restraint order was time limited for 1 of 2 sampled patients who were restrained for the management of violet or self-destructive behaviors (#9).

The findings include:

Review of current hospital policy "Restraint Use: Nonviolent, Violent, and Chemical" Directive #: ADMI-68, revised 03/2008 revealed "...III Restraint Application Due to Violent or Self-Destructive Behavior: ...B. Orders: ...4. Each order may only be renewed in accordance with the following limits up to 24 hours in the following time limited increments: a. Adults 18 years or older: 4 hours. ..."
Closed record review on 09/13/2011 for Patient #9 revealed a [AGE] year-old male who presented to the hospital's emergency department on 07/13/2011 and was subsequently discharged on [DATE] with a diagnosis of acute and chronic alcohol abuse disorder and suicidal ideation (associated with alcohol intoxication), not actively suicidal. Record review revealed the patient was placed into restraints for the management of violent or self-destructive behaviors on 07/13/2011 at 2105 and was released on 07/14/2011 at 0220 (5 hours and 15 minutes later). Review revealed the patient was discharged into the custody of law enforcement.

Review of a "Restraint Physician Order & Assessment Form" (restraint renewal order) dated 07/14/2011 at 0120 revealed "Clinical Justification for Restraint Use: ...Violent or self-destructive behavior: ....[check mark placed in box] Protect from harm (self) [check mark placed in box] Protect from harm (others) Renewal: Adult every 4 hours; ...." Further review revealed in the section "Physician Order," "Restrain Patient (Violent or Self-destructive Behavior)....[box] Four (4) hours for adults [box] Two (2) hours for ages 9-17 [box] One (1) hour for under age 9." Review revealed no documentation of a check mark placed into the corresponding box next to the age appropriate time limit for restraint renewal by the ordering physician.

Interview on 09/14/2011 at 0843 with emergency department (ED) nursing management staff revealed a physician's order is required for the use of restraints. Interview revealed when restraints are used for the management of violent or self-destructive behaviors the initial order and subsequent renewal orders are required to be time limited according to patient age. Interview revealed the ED staff "rarely" use restraints for the management of violent or self-destructive behaviors. Interview confirmed the physician's order for restraint renewal dated 07/14/2011 at 0120 for Patient #9, did not have an age appropriate time limit marked (check placed in box) on the order form. Interview revealed the physician ordering the restraint should have placed a check mark into the box next to the appropriate time limit for restraint renewal. Interview revealed the order should have been time limited to no more than four hours.
VIOLATION: PATIENT RIGHTS: RESTRAINT OR SECLUSION Tag No: A0174
**NOTE- TERMS IN BRACKETS HAVE BEEN EDITED TO PROTECT CONFIDENTIALITY**

Based on hospital policy review, medical record review, and staff interview, nursing staff failed to assess and monitor patients to ensure restraints were discontinued at the earliest possible time for 1 of 2 sampled patients who were restrained for the management of violent or self-destructive behaviors (#10).

The findings include:

Review of current hospital policy "Restraint Use: Nonviolent, Violent, and Chemical" Directive #: ADMI-68, revised 03/2008 revealed "...III Restraint Application Due to Violent or Self-Destructive Behavior: ...C. Early Release Criteria: An RN with appropriate education may determine that restraints may be removed when the following criteria are met: 1. Assessment indicates patient is no longer a threat to self or others. 2. Agitation, hostility and abusive behaviors toward caregivers and others has abated. ..."

Review of the hospital's current "Violent Restraint Documentation form," dated August 2007, revealed "The patient has met the criteria for removal from restraints (check one or more) [] decreased agitation [] Follow verbal directions [] Verbalizes & demonstrates ability to maintain control x 30 minutes [] Sleeping x 30 minutes [] Other_____."

Closed emergency department (ED) record review on 09/13/2011 for Patient #10 revealed a [AGE] year old male who presented to the hospital's ED on 07/13/2011 at 2054 with a chief complaint of "Fall." Record review revealed the patient was subsequently discharged into the custody of law enforcement on 07/14/2011 at 2105. Record review revealed a discharge diagnosis of acute and chronic alcohol abuse disorder and suicidal ideation (associated with alcohol intoxication), not actively suicidal. Review of electronic nursing documentation at 2100 (07/13/2011) revealed "Pt (patient) placed in 4 point restraint for violent and combative behavior....Law Enforcement at bedside; Pt very combative against all staff. He is yelling profanity and uncontrollable at this time."

Review of a physician's order dated 07/13/2011 at 2105 revealed bilateral soft wrist and ankle restraints were ordered to protect the patient and others from harm due to violent and self-destructive behaviors. Further review revealed the order was time limited for four hours (expired at 0105 on 07/14/2011).

Review of a physician's order for restraint renewal dated 07/14/2011 at 0120 revealed bilateral soft wrist and ankle restraints were ordered to protect the patient and others from harm due to violent and self-destructive behaviors. Further review revealed the order was time limited for four hours (expired at 0520 on 07/14/2011).

Review of "Violent Restraint Documentation Forms" dated 07/13/2011 and 07/14/2011 revealed nursing documentation the patient was placed into restraints on 07/13/2011 at 2105 and remained in restraints until 0220 on 07/14/2011 (5 hours 15 minutes later). Review of the restraint monitoring documentation revealed the patient's behavior status was assessed by a RN as a "4 (four)" for "combative" on 07/13/2011 at 2120 through 2135 (15 minutes). Review revealed the patient's behavior status was assessed by a RN as a "1 (one)" for "sleeping" on 07/13/2011 at 2150 through 07/14/2011 at 0220 (4 hours and 30 minutes).

Record review revealed no available nursing documentation describing the patient's violent or self-destructive behaviors that required the use of the restraints from 07/13/2011 at 2150 through 07/14/2011 at 0220 (4 hours 30 minutes). Record review revealed no documentation for the need for continuation of restraints after 2150 on 07/14/2011.

Interview on 09/14/2011 at 0843 with emergency department (ED) nursing management staff revealed nursing staff should assess and document the need for continued use of restraints and discontinue restraints at the earliest possible time. Interview revealed when a patient meets one or more of the criteria printed at on the bottom of the Violent Restraint Documentation Form then the patient is to be released. Interview revealed "we give the patients 30 minutes to make sure their behavior maintains control and not a danger or threat to self or others." Interview confirmed there was no documentation of the need for continued use of restraints on 07/13/2011 at 2150 through 07/14/2011 at 0220 (4 hours and 30 minutes) Interview confirmed the patient had been assessed by an RN as "sleeping" for 4 hours and 30 minutes after restraints were applied. Interview revealed the patient should have been released after being asleep for 30 minutes (at 2220). Interview confirmed Patient #10's restraints were not discontinued at the earliest possible time.
VIOLATION: PATIENT RIGHTS: RESTRAINT OR SECLUSION Tag No: A0179
**NOTE- TERMS IN BRACKETS HAVE BEEN EDITED TO PROTECT CONFIDENTIALITY**

Based on hospital policy review, medical record review, and staff interview the hospital failed to ensure the physician or other licensed independent practitioner conducting the face-to-face evaluation within 1 hour after the initiation of restraint evaluated the patient's immediate situation; the patient's reaction to the intervention; the patient's medical and behavioral condition; and the need to continue or terminate the restraint for 2 of 2 sampled patients restrained for the management of violent or self-destructive behaviors (#9, #10).

The findings include:

Review of current hospital policy "Restraint Use: Nonviolent, Violent, and Chemical" Directive #: ADMI-68, revised 03/2008 revealed "...III. Restraint Application Due to Violent or Self-Destructive Behavior: ...B. Orders: ...2. A credentialed physician/LIP must see the patient face-to-face within 1 hour after the initiation of the restraint. 3. The physician/LIP will document in the progress note: a. The patient's immediate situation. b. The patient's reaction to the intervention. c. The patient's medical and behavioral condition. d. The need to continue or terminate the restraint. ..."

1. Closed emergency department (ED) record review on 09/13/2011 for Patient #9 revealed a [AGE] year old female who presented to the hospital's ED on 08/09/2011 at 2147 with a chief complaint of "Overdose." Record review revealed the patient was subsequently transferred to an acute care hospital with psychiatric services on 08/11/2011 at 1428. Review of electronic documentation by the physician at 1206 (08/10/2011) revealed "Pt (patient) acting out and requiring physical restraint to avoid harm to self or others. Will sedate with Ativan."

Review of a "Restraint Physician Order & Assessment Form" dated 08/10/2011 at 1215 revealed a physician's order for the use of bilateral soft wrist and ankle restraints for "Clinical Justification for Restraint Use: ...Violent or self-destructive behavior: ....[check mark placed in box] Protect from harm (others)..."

Review of a "Violent Restraint Documentation Form" dated 08/10/2011 revealed nursing documentation the patient was placed into restraints on 08/10/2011 at 1215 and was released from restraints at 1315 (60 minutes later).

Record review revealed no available documentation the physician conducted a face-to-face evaluation within 1 hour (1215 to 1315) after the initiation of restraint on 08/10/2011 at 1215 to evaluate the patient's immediate situation, the patient's reaction to the intervention, the patient's medical and behavioral condition, and the need to continue or terminate the restraint or seclusion.

Interview on 09/13/2011 at 1340 with ED nursing management and Performance Improvement staff revealed the nurses do not conduct the one hour face-to-face evaluation when restraints are used for the management of violent and self-destructive behaviors. Interview revealed the physicians conduct the evaluation. Interview revealed the physicians document their findings in their notes. Interview confirmed there was no available documentation in Patient #9's medical record the ED physician conducted a face-to-face evaluation within one hour after the initiation of restraint on 08/10/2011 at 1215 to evaluate the patient's immediate situation; the patient's reaction to the intervention; the patient's medical and behavioral condition; and the need to continue or terminate the restraints. Interview revealed the staff were unaware the CMS regulation required the face-to-face evaluation to be conducted within one hour after the initiation of restraint.

2. Closed emergency department (ED) record review on 09/13/2011 for Patient #10 revealed a [AGE] year old male who presented to the hospital's ED on 07/13/2011 at 2054 with a chief complaint of "Fall." Record review revealed the patient was subsequently discharged into the custody of law enforcement on 07/14/2011 at 2105. Record review revealed a discharge diagnosis of acute and chronic alcohol abuse disorder and suicidal ideation (associated with alcohol intoxication), not actively suicidal. Review of electronic nursing documentation at 2100 (07/13/2011) revealed "Pt (patient) placed in 4 point restraint for violent and combative behavior....Law Enforcement at bedside; Pt very combative against all staff. He is yelling profanity and uncontrollable at this time."

Review of a "Restraint Physician Order & Assessment Form" (initial order) dated 07/13/2011 at 2120 revealed a physician's order for the use of bilateral soft wrist and ankle restraints for "Clinical Justification for Restraint Use: ...Violent or self-destructive behavior: ....[check mark placed in box] Protect from harm (self) [check mark placed in box] Protect from harm (others)..."

Review of a "Violent Restraint Documentation Form" dated 07/13/2011 revealed nursing documentation the patient was placed into restraints on 07/13/2011 at 2105 and was released from restraints at 0220 on 07/14/2011 (5 hours 15 minutes later).

Record review revealed no available documentation the physician conducted a face-to-face evaluation within 1 hour (2105 to 2205) after the initiation of restraint on 07/13/2011 at 2105 to evaluate the patient's immediate situation, the patient's reaction to the intervention, the patient's medical and behavioral condition, and the need to continue or terminate the restraint or seclusion.

Interview on 09/13/2011 at 1340 with ED nursing management and Performance Improvement staff revealed the nurses do not conduct the one hour face-to-face evaluation when restraints are used for the management of violent and self-destructive behaviors. Interview revealed the physicians conduct the evaluation. Interview revealed the physicians document their findings in their notes. Interview confirmed there was no available documentation in Patient #10's medical record the ED physician conducted a face-to-face evaluation within one hour after the initiation of restraint on 07/13/2011 at 2105 to evaluate the patient's immediate situation; the patient's reaction to the intervention; the patient's medical and behavioral condition; and the need to continue or terminate the restraints. Interview revealed the staff were unaware the CMS regulation required the face-to-face evaluation to be conducted within one hour after the initiation of restraint.
VIOLATION: PATIENT RIGHTS: SECLUSION OR RESTRAINT Tag No: A0214
**NOTE- TERMS IN BRACKETS HAVE BEEN EDITED TO PROTECT CONFIDENTIALITY**

Based on hospital policy review, Hospital Restraint/Seclusion Death Report Worksheet reviews, medical record reviews and administrative staff interview, the hospital staff failed to ensure the report to the Centers for Medicare and Medicaid Services (CMS) of the death of a patient that occurred while restrained and/or within 24 hours after being removed from restraints, was documented in the medical record for 2 of 3 sampled patient deaths reported to CMS (#2, #8).

The findings include:

Review of current hospital policy "Restraint Use: Nonviolent, Violent, and Chemical" Directive #: ADMI-68, revised 03/2008 revealed "...IV. Death Reporting. A. ...Risk Management will notify CMS of any patient death that occurs. ...5. Date and time of call must be recorded in the medical record.

1. Review on 09/13/2011 of a Hospital Restraint/Seclusion Death Report Worksheet for Patient #2, revealed a [AGE] year-old patient was admitted on [DATE] for Uremic [DIAGNOSES REDACTED], Metabolic Acidosis, and Acute Renal Failure. Further review revealed the patient expired on [DATE] at 1215. Further review revealed the patient was placed in a physical restraint(s) on 05/08/2011 at 2200 and was last monitored on 05/11/2011 at 0500. Review revealed a total length of time in restraints: 56 hours. Review revealed the CMS Regional Office was notified of the death via facsimile and telephone on 05/12/2011 at 0823 and 0826 respectively.

Closed Medical Record review for Patient #2 on 09/13/2011 failed to reveal any available documentation in the patient's medical record of the date and time the death was reported to CMS.

Interview on 09/13/2011 at 1515 with administrative management staff revealed the hospital's Vice President (VP) of Quality and Risk Management is responsible for notifying CMS for all deaths associated with the use of restraints. Interview revealed the Restraint/Seclusion Death Report form is generated by nursing staff and is sent to the risk management department. Interview revealed the form is then completed and the risk manager calls CMS via telephone and faxes the completed form to the Regional Office. Interview revealed the VP is responsible for documenting the date and time of CMS notification into the patient's medical record. Interview confirmed no available documentation in the medical record for Patient #2 of the date and time the death was reported to CMS. Interview revealed the VP was currently on vacation and unavailable for interview during survey.

2. Review on 09/13/2011 of a Hospital Restraint/Seclusion Death Report Worksheet for Patient #8, revealed a [AGE] year-old patient was admitted on [DATE] for Right Hip Fracture. Further review revealed the patient expired on [DATE] at 0610. Further review revealed the patient was placed in a physical restraint(s) on 05/04/2011 at 0010 and was last monitored on 05/04/2011 at 0300. Review revealed a total length of time in restraints: 4 hours. Review revealed the CMS Regional Office was notified of the death via facsimile and telephone on 05/04/2011 at 0800 and 0802 respectively.

Closed Medical Record review for Patient #8 on 09/13/2011 failed to reveal any available documentation in the patient's medical record of the date and time the death was reported to CMS.

Interview on 09/13/2011 at 1515 with administrative management staff revealed the hospital's Vice President (VP) of Quality and Risk Management is responsible for notifying CMS for all deaths associated with the use of restraints. Interview revealed the Restraint/Seclusion Death Report form is generated by nursing staff and is sent to the risk management department. Interview revealed the form is then completed and the risk manager calls CMS via telephone and faxes the completed form to the Regional Office. Interview revealed the VP is responsible for documenting the date and time of CMS notification into the patient's medical record. Interview confirmed no available documentation in the medical record for Patient #8 of the date and time the death was reported to CMS. Interview revealed the VP was currently on vacation and unavailable for interview during survey.