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.

LEWISGALE MEDICAL CENTER 1900 ELECTRIC ROAD SALEM, VA 24153 Aug. 22, 2011
VIOLATION: PATIENT RIGHTS Tag No: A0115
Based on observations, staff interviews, medical record reviews, policy and procedure reviews and process of complaint investigation, it was determined the facility failed to meet this Condition of Participation: Patients Rights to protect and promote the rights of each patient.

Refer to Tags A-0131, A-0144, A-0145 for details.
VIOLATION: PATIENT RIGHTS: INFORMED CONSENT Tag No: A0131
Based on medical records, staff interviews, policy and procedure review, and during the course of a complaint investigation, it was determined the facility failed to provide evidence 3 of 5 patients made informed decisions related to leaving the facility against medical advice. (Patient #8 , #9, #11).

Finding were:

Five medical records of patients who left the facility against medical advice (AMA) were reviewed on August 22, 2011. The facility's policy for patients leaving AMA included completing a form titled, "Waiver of Responsibility for Discharge" to be signed by the patient and witnessed by staff.

Two of the five records failed to contain the patient's signature or witness' signature indicating the patients were making an informed decision related to leaving the facility AMA (Patient #8 and Patient #11). One of the five records noted the patient refused to sign the AMA waiver but failed to contain the witness' signature (Patient #9).

On August 19, 2011 Nurse #4 who assigned to Patient #9 when the patient left AMA, was interviewed. The nurse acknowledged she wrote on the AMA waiver, "Patient refused to sign" and that she did not sign the witness signature area. When the surveyor asked why she did not sign as a witness, the nurse stated, "I didn't think I was supposed to sign it unless I was witnessing the patient's signature and when she refused, I just wrote she refused."

During an interview with the Vice President of Quality and Risk Management on August 22, 2011, she acknowledged a need for staff re-education related to the facility's policy titled "Leaving Against Medical Advice."

The facility's policy titled, "Leaving Against Medical Advice" states in part, "In the event the patient or the person responsible for the patient refuses to sign the waiver the patient's medical record should be documented with a statement signed by the physician and duly witnessed, setting forth the circumstances, reasons, and warnings against the premature departure."
VIOLATION: PATIENT RIGHTS: CARE IN SAFE SETTING Tag No: A0144
Based on observations, staff interviews, medical record reviews, policy and procedure reviews and during the course of two complaint investigations, it was determined the facility failed to ensure a safe environment for 2 of 11 patients (Patient #2 and Patient #9). Patient #2 alleged she was assaulted in her room. Patient #9's whereabouts were unknown after leaving the facility against medical advice.

The findings include:

1. Patient #2 informed the behavioral health nursing staff she had been sexually assaulted by another patient on July 21, 2011. The facility's staff subsequently had the patient assessed by forensics at the facility's emergency department (ED). A video tape documented a male patient entering Patient #2's room at 00:27:30 on July 21, 2011. The facility staff reported the incident to local authorities.

Note: Contributing to the facility's failure to provide a safe environment was inadequate night shift staffing on the Intensive Treatment Unit (ITU) within Behavioral Health Services. There were two nurses assigned to the ITU for night shift on July 20, 2011 with a patient census of 17.

Note: Please refer to Tag A-0392 for details related to inadequate staffing.

The facility's Behavorial Health Services is located in a separate building on the facility's main campus and is divided into three separate units: Acute Adult Unit (AAU), Intensive Treatment Unit (ITU) and an Adolescent/Pediatric Unit. Three MFIs toured the ITU on August 16, 2011 and observed two rooms (room 306 and 307) that exist on a hall that is not visible from the nurse's station. Patient #2 was admitted to room 306.

On Thursday August 18, 2011 Nurse #1 who was assigned to the ITU on night shift (which began on July 20, 2011 at 11 p.m. and extended into July 21, 2011 at 7:30 a.m.) was interviewed via phone by two MFIs . When asked about staffing and patient acuity, she stated, "We were stressed, we had quite a few psychotic patients on the floor that night and they can go off at any time." The nurse recalled that shortly after the shift began, she was caring for a patient who was beginning to act out and had to call for a second nurse to assist her in the patient's room. Nurse #1 eventually left that room to retrieve medication and when she arrived at the nurses' station, she encountered Patient #2. The nurse recalled Patient #2 telling her, "That big black boy tried to rape me." Nurse #1 told the MFIs, "I'm not sure now whether she used the word rape or attack." Nurse #1 assisted Patient #2 and called the night shift supervisor. The nurse stated the supervisor came to ITU promptly and was informed of the allegation. She also said that security had left that night although they are usually there until 1 a.m. When asked about the physical layout of ITU, specifically the hall including Patient #2's room, she stated that she didn't like that area because, "you're out by yourself." The second nurse working in the ITU on July 20, 2011 night shift was unable to be interviewed since she no longer worked at the facility.

On Thursday August 18, 2011 the night shift supervisor of the behavioral health services who was working on July 20, 2011 was interviewed via phone by two MFIs . She stated that when Nurse #1 called for assistance on ITU, she was on another unit within behavioral health services assisting with 3 admissions. When asked about her thoughts on the physical layout of the unit, especially where Patient #2's room was located she stated, "You can't see down that far, that room is isolated." This supervisor also indicated that security is usually on site every night until 1a.m. but on the night of July 20, 2011 they weren't onsite at the time of the event.

The physician on call for behavorial health services on July 20, 2011 was interviewed by one MFI on August 18, 2011. In discussing the physical layout of the ITU, the physician stated that there is part of the floor you can't see and if staff are busy attending other patients, it can be a high risk.

The medical director of behavioral health services was interviewed on Wednesday August 17, 2011 by one MFI. He acknowledged the layout of ITU was not ideal.

On Wednesday August 17, 2011, the Vice President of Quality and Risk Management was interviewed by one MFI. She said, "The geographical layout of the ITU is not conducive to full visualization of the department from a central location, particularly on one end of the patient care area. This end of the unit is more secluded and is most remote from the nurse's desk.

During the survey process the facility management shared a surveillance video with three MFIs. The video showed a male (Patient #1) entering Patient #2's room at 00:27:30 on July 21, 2011 and exiting at 00:29:43. At 00:29:49 the surveillance video showed Patient #2 exiting her room and walking in the direction of the nurses station. The case is currently under investigation by local authorities.

The facility's policy titled, "Patient Rights and Patient Responsibilities" was reviewed. The policy included the Patient Rights, "#17. To expect security, personal privacy, a safe environment, and confidentiality of information, except as otherwise required by law or according to the terms of the Medial Center's Consent For Treatment."


2. Patient #9 left the facility against medical advice (AMA) on June 10, 2011. The facility's staff walked with the patient and her son out of the unit to the elevator. The patient's son left Patient #9 in the facility's lobby while he got the car. When the son returned to the main entrance with the car, Patient #9 was no longer in the lobby. Security was notified and began looking for the patient. The unit in which Patient #9 had just left AMA received a call from a nearby hotel saying Patient #9 was at that hotel.

Nurse #4 who was assigned to Patient #9 on June 10, 2011 dayshift was interviewed on August, 19, 2011 by one MFI with the facility's Manager of Risk and Patient Safety present per the nurses' preference. The nurse stated she had familiarized herself with Patient #9's medical record and also recalled Patient #9. The nurse described the patient as alert and oriented to person, place and time. The patient told the nurse her name and voiced a question about why she was having to remain in bed. Nurse #4 informed Patient #9 why the physicians wanted her to remain in bed. The nurse stated that after she mentioned the patient's daughter had informed the staff about the patient's history of falls, the patient informed the nurse she did not agree with her daughter and recalled one fall she had at home that was because her pant leg got caught on her chair. Nurse #4 then said her impression of Patient #9 was that she was restless because she was used to doing her own thing, that although she was in her 80s, she appeared in her 60s and insisted on doing her hair and makeup. The nurse told the MFI, Patient #9 was being monitored for her cardiac condition, she was being given the same medications she was on at home and although she had a heparin lock (Intravenous access- IV), she was not on any IV fluids. The nurse continued saying that suddenly, Patient #9 was dressed with her monitors off and she was ready to go. The nurse offered the patient some medication to calm her but the patient refused saying, "Absolutely not." Nurse #4 said that after she offered Patient #9 the medication, the patient's affect toward the nurse changed and the patient wanted to leave the facility. The nurse asked the patient to sit down so she could remove the heparin lock and the patient sat down for the heparin lock removal. The nurse then called the patient's daughter twice and her son to notify them the patient wanted to leave against medical advice (AMA). Nurse #4 said both family members indicated they wanted the facility to hold their mother and the nurse explained they were unable to hold her. The family told the nurse they had been wanting their mother worked up for possible dementia and was hoping it could be done during this admission. The nurse continued by saying the patient's son told her, "I'm not coming to get her." Nurse #4 stated the patient's daughter didn't want to come get her either and told the nurse that the family had called APS (Adult Protective Services) previously on their mother but that the patient had passed a small initial test and then refused further dementia testing. Nurse #4 told the patient's daughter she'd have the case manager (CM) speak with her about Patient #9 and the nurse said the CM came right away to speak with the daughter. Nurse #4 said that while she was on the phone with the daughter, the patient became more restless and wanting to leave. Patient #9's son called and told the nurse he was in the parking lot but would not come up to the unit although the nurse stated he did show up on the unit. She recalled the son told Patient #9 he would not take her home, that he wanted to have a discussion with her. Nurse #4 said she told the patient's son that Patient #9 was not being discharged , that she was insisting on leaving AMA since her physicians were wanting to perform more studies. The nurse said that while the patient's son was standing there, Patient #9 moved him out of the way with her arm and took off out of the room. The son followed his mother and the unit's manager went out with them. Patient #9's daughter called and the nurse told her the patient had left with her son and the unit manager. The nurse said the daughter reiterated how they wanted mental testing done and Nurse #4 reinforced that they could not hold Patient #9 since she was alert and oriented to person, place and time but that the family could always bring their mother back to the ED if necessary. The daughter mentioned to the nurse that the family would have to get APS involved when the patient got home. Nurse #4 stated that after hanging up with the daughter, she went to check on Patient #9 when she saw the unit's manager who informed her the patient and son had left going down the elevator. The unit's manager told Nurse #4 that she told the patient and son twice to return to ED if needed. Nurse #4 said she sat down to chart and approximated that 10 minutes had passed when she received another phone call from Patient #9's daughter saying the patient's son had called to say their mother was lost; He'd left her in the lobby to get the car and she was not in the lobby when he returned. Nurse #9 called the facility's security. The nurse recalled that after hanging up with security, she received a call from a local hotel telling her Patient #9 was there and that she could not remember her son's phone number. The nurse then called security to inform them of the patient's whereabouts and then called the patient's daughter to tell her the patient had been found. When asked why no one from the facility escorted the patient completely out of the facility, the nurse said she was unaware of any policy or procedure that required staff to escort patients out and in this case, there was no time for any discharge routine like providing the patient discharge instructions which she would have attempted to give her even though she was leaving AMA. The nurse stated that Patient #9 was adamant about leaving; The nurse said, "We weren't going to be able to hold her much longer if her son hadn't shown up. She was leaving." The nurse added that if the patient had left the unit alone, she would have had to call security. Nurse #4 said that she had called Patient #9's physician who said since the patient was not on any critical drips, they could not hold her. The nurse did not recall any discussion about the patient's mental status with the physician. Nurse #4 said she never thought the patient was demented, she just thought the patient was head strong and recalled the patient saying, "I've lived with my body all of these years and I know it better than these doctors."

MFI interviewed the CM twice, once on August 18, 2011 and again on August 19, 2011. The CM stated that her encounter with Patient #9 leaving AMA was brief, maybe 5 minutes. She said the nurse called and requested her to come talk with patient's family on the phone. The CM stated she immediately began talking with the daughter-in-law on the phone and told her the patient had the right to leave since she had not been diagnosed with dementia. The family member told her the patient had missed her psych appointments. The CM said although she never went into Patient #9's room, she could tell from the nurse's desk the patient was agitated, very angry and wanted to go home. The CM stated she never talked with the patient's son either but felt his actions indicated he was angry too. The CM stated she called APS and spoke with someone there who was familiar with Patient #9 and gave no indication there was a reason to keep the patient against her will.

The manager for Cardiac Care Unit (CCU) was interviewed on August 18, 2011 at 10:55a.m. The manager recalled going to talk with Patient #9 after Nurse #4 informed her the patient wanted to leave. The manager told the MFIs that Patient #9 was very alert, her gait was steady, she was walking around the room and was oriented. The manager said she wouldn't describe the patient as agitated, she was describe her as "persistent" and did not want to be in the hospital. The manager said when she walked out of the unit to the elevator with the patient and son, there was "tension" between the son and patient." She said the son was aggravated with the patient and the patient was aggravated with her son, recalling the patient said to her son, "We're not talking about this anymore. You're taking me home and we'll talk about it later." The manager stated she felt the staff had done all they could do to keep her admitted saying, "I was not willing to restrain her. Dementia did not get mentioned."

The hospitalist assigned to care for Patient #9 was interviewed on August 22, 2011 at 2:08 p.m. The physician recalled the patient and said she was admitted by cardiology for complaint of chest pain on June 9, 2011. The patient had initially refused to be admitted but later changed her mind however the patient kept wanting to leave. The physician recalled the nursing staff contacting her on June 10, 2011 to inform her Patient #9 wanted to leave AMA. The physician said she told the staff to do appropriate paperwork for AMA because they couldn't keep her. When the physician got to the unit, Patient #9 was still there so she went to see the patient. She said the patient got very angry with the physician's questions but the patient was not having delusions or hallucinations.

The Vice President of Quality and Risk Management was interviewed on August 22, 2011 at 3:40 p.m. and said the facility did not have a policy requiring patients to be escorted to the door regardless of whether the patient was discharged or decided to leave AMA. She said their practice is to escort a discharged patient to the door but with patients deciding to leave AMA, they attempt to have them leave with someone like a family member.

Patient #9's medical record was reviewed initially on August 17, 2011. The record documented the patient was originally seen in the facility's ED on June 9, 2011. The ED note dated June 9, 2011 at 8:07 p.m. documented the patient notified the cardiologist that she did not want to be admitted but when presented with AMA papers to sign, the patient said she was willing to stay if she did not have to remain in the ED bed. The patient was advised she would be admitted to CCU and therefore would be in a different bed and the patient was then willing to stay. The CCU nurse's notes dated June 9, 2011 at 10:00 p.m. documented, "Pt (patient) is alert andoriented (sic) and abel (sic) to mae (sic) strong hand and foot strenght (sic)." Another CCU nurses' note dated June 10, 2011 at 5:20 a.m. documented, "Pt is oriented and cooperative at this time."

Nurse #4's notes were reviewed for June 10, 2011. The nurse's notes were consistent with the information provided during Nurse #4's interview on August 19, 2011. The nurse documented her conversations with the patient regarding leaving AMA and the reasons to stay, several conversations she had with the son and daughter as well as a hospitalist and cardiologist. Nurse #4's nurse note documented in part, "Son came to floor and told patient he wanted to talk to her but he would not take her home. Patient stated, ' I don't care. I am going home anyway' and started walking toward the doors. Son and (unit manager) followed patient out the door. Son informed by (unit manager) twice, that if they needed to bring her back for any reason to bring her back to the emergency department. Daughter was also instructed over the telephone to bring patient to the Emergency Department if needed. Son-in-law called wanting the staff to make the patient stay. Informed son-in-law the staff could not physically make the patient stay. Patient was getting more aggressive as the day progressed."

A case management (CM) note dated June 10, 2011 at 2:33 p.m. documented, "Patient left AMA. Family is very angry/upset. Son called to take patient home. Spoke with son and daughter-in-law on the phone. Daughter stated that APA (sic) is working with patient but there is nothing further they can do. Patient has not shown up for psychiatric appointments and therefore does not have a definitive diagnosis of dementia. Ativan offered multiple times by RN. (Hospitalist) contacted by (a second CM). According to (Hospitalist), patient's (sic) troponins are trending down. patient (sic) is not on critical drips. Therefore, patient cannot be TDO (Temporary Detainment Order). Patient apparently escaped from son who left her alone in the lobby. Security called." At 3:50 p.m. on the same day, the same CM documented, "Spoke with (APS supervisor) at APS in (local county). Son-in-law had already contacted this lady and was quite upset with her as well. according (sic) to (APS supervisor). (APS supervisor) concurs there is nothing further we can do as this patient does not have a diagnosis of dementia. Spoke with (facility's CM supervisor) who also advised that I leave a message with forensic nurse. Left message with (forensics) on 6/10/11."
VIOLATION: PATIENT RIGHTS: FREE FROM ABUSE/HARASSMENT Tag No: A0145
Based on staff interviews, medical record reviews, policy and procedure reviews and during the course of a complaint investigation it was determined the facility failed to prevent Patient #2 from an alleged assault.

The findings include:

Refer to Number 1 write-up under tag A-0144 and tag A-0392

The facility's forensic nurse on call July 20, 2011 was interviewed by one MFI on Wednesday August 17, 2011. The forensic nurse stated that during her assessment of Patient #2, the patient was quiet and gave short answers. The nurse also said the patient presented with a flat affect and made no eye contact. Patient #2 told the forensic nurse a "big black boy was on top of me having sex". The forensic nurse stated swabs and smears were taken but no results were available upon the conclusion of the investigation.

Patient #2's medical record was reviewed throughout the investigation. The physician on call for behavorial health services on July 20, 2011 had written a progress note dated July 21, 2011 at 10:34 a.m. which documented the physician met with Patient #2 and the patient informed the physician she had been sexually assaulted the night before. The progress note documented that after Patient #2 informed the behavorial health staff of the sexual assault, the patient was immediately sent for forensic evaluation and that detectives and or police were also present.

Nurse #1 documented at 12:30 a.m. on July 21, 2011, "The patient was observed at the nurse's station crying and stated, 'That big black boy tried to rape me. I woke up and he was on top of me.' Notified supervisor at that time and informed her of accusation. She came to speak with patient. Notified security to come to (behavorial health services). Patient spoke with supervisor and M.D. notified. Patient sent to ER for evaluation."

Patient #2's medical record included an Emergency Department Triage Assessment conducted on July 21, 2011 at 1:30 a.m. The assessment documented the patient stating, "I woke up and some guy was on top of me. It happened so fast. It's like a nightmare. Where was everybody while this was going on?"

The facility's policy titled, "Patient Rights and Patient Responsibilities" included a listing of patient rights. #16 under Patient Rights stated, "To be free from all forms of abuse or harassment."
VIOLATION: NURSING SERVICES Tag No: A0385
Based on staff interviews, review of staffing and scheduling assignments and staffing matrix plan, and during the course of a complaint investigation, it was determined the facility failed to meet adequate staffing schedules/assignments to ensure Patient #2's right to receive care in a safe setting.

Refer to tag A-0392 for details.
VIOLATION: STAFFING AND DELIVERY OF CARE Tag No: A0392
Based on staff interviews, staffing plan and matrix, and during the investigation of a complaint it was determined the facility failed to provide adequate numbers of staff to ensure the safety of Patient #2.

The findings include:

The survey process included the review of adequate staffing as it related to the alleged assault of Patient #2.

On Thursday August 18, 2011 Nurse #1 who works in the facility's ITU (Intensive Treatment Unit of Behavorial Health Services) was interviewed via phone by two MFIs. When asked about staffing and patient acuity related to night shift on July 20, 2011 (beginning at 11 pm July 20, 2011 and extending until 7:30 a.m. on July 21, 2011) the nurse stated, "We were stressed, we had quite a few psychotic patients on the floor that night and they (the psychotic patients) can go off at any time." The nurse recalled specifically that on that night, shortly after beginning her shift, she was caring for a patient who was beginning to "act out." She had to call a second nurse for assistance with the patient acting out. When asked whether any other staff was available, she stated that there was just the two of them working in ITU that night which was not unusual. She added that the nursing supervisor was assisting in a different unit and that security had already left that night. When asked how often she felt the unit was understaffed, she stated that during the three years she has worked in the behavorial health services of this facility, she would estimate 50% of the time she felt there was inadequate staffing.

On Thursday August 18, 2011 a night shift supervisor of the behavioral health services was interviewed by two MFIs via phone. During the course of this interview, she stated that on July 20, 2011 night shift, "we did not have enough staff." She said, "Staffing is always tight on night shift" but "now (after the July 21, 2011 event) the staffing ratio is four to one (four patients to one staff member)." When asked how long night shift staffing had been an issue she replied, "We've addressed it for a long time because we've lost staff and we weren't getting replacements." This supervisor also indicated that security is usually on site every night until 1a.m. but on the night of July 20, 2011 security was gone before 1 a.m. She added that currently, security is present 24 hours a day.

The physician on call for behavorial health services on July 20, 2011 was interviewed by one MFI on August 18, 2011. The physician indicated that the census and acuity was high and the staffing was not adequate prior to July 20, 2011.

The medical director of behavioral health services was interviewed on Wednesday August 17, 2011 by one MFI. When asked about staffing ratios, the medical director stated that he felt a census of 15 or more patients on ITU with two staff working night shift was inadequate. When asked about the fact that on July 20, 2011 there were two staff members assigned to provide care for 17 patients on ITU, he stated there was not enough staff that night.

The dayshift supervisor of behavioral health services was interviewed on August 18, 2011. When asked about staffing adequacy she stated, "It's tight when census is high."

The Vice President of Quality and Risk Management was interviewed by one MFI on August 17, 2011. She stated, "Structured and consistent methods for determining staffing ratios based on volume and acuity were not utilized, which resulted in inconsistent staffing levels that were sub-optimal." She also stated, "Backup staffing was primarily dependent on the Shift Supervisor." The VP added that, "Additional staff positions had been approved and posted to accommodate increases in patient volume, but not yet hired."

During an interview with the Vice President of Behavioral Health Services and the Clinical Director of Behavioral Health Services, the clinical director stated that the patients were coming faster than they were staffed for and that even prior to July 20, 2011 the facility was advertising and interviewing to fill needed vacant positions. She stated the facility continues to try and fill vacant positions.

Throughout the complaint investigation and survey process, the facility's administrative staff provided several different staffing matrix tools for Behavorial Health Services. Until the last day of the survey it remained unclear which tool was being utilized on July 20, 2011. The MFIs requested the final clarification for the facility's staffing process as of July 20, 2011 and the matrix the facility provided covered a census up to 40 patients. For the night shift on July 20, 2011 there was a census of 41 patients within the behavioral health services. Actual staffing ratios between the dates of July 16, 2011 through July 20, 2011 were reviewed. The census for ITU was 15 or greater on 4 of the 5 of those nights shifts; The ITU had two staff members assigned each of those nights. During the interview with the medical director on August 17, 2011 he indicated that with a census of 15 or more on ITU, he would like to see 3 staff on night shift.

Please refer to tag A-0144, write up #1 and tag A-0145