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Based on interview and document review, the hospital failed to ensure 1 of 1 Heart Vascular Clinic patient (P6) admitted for open heart surgery received the Patient Bill of Rights information prior to surgery.

Findings include:

P6 was interviewed on 1/8/14, at 8:00 a.m. and did not recall receiving the Patient Bill of Rights information prior to coronary bypass surgery. The patient's record did not contain information related to the provision of the Bill of Rights.

The facility's policy on the Patients' Bill of Rights dated 3/20/13, directed staff to provide a copy of the Bill of Rights to patients who entered for registration through the south surgery desk. However, patients who were to receive open heart surgery did not go through the south surgery desk and normal registration process, rather they were admitted through the Heart Vascular Clinic (HVC). The HVC did not have a policy on giving the Bill of Rights to patients.

The director of surgical operations (DSO-C) was interviewed on 1/9/14, at 10:00 a.m. and she reported she was unable to determine whether P6 had received the patient's Bill of Rights. P6 had been admitted via the HVC and the surgical floor records did not indicate whether the Bill of Rights information had been provided to P6.

In an interview with the HVC manager on 1/9/14, at 1:00 p.m. it was explained that open heart surgical patients were not provided with information related to the Patient Bill of Rights. If patients asked for the information, it would be provided to them. During the interview, brochures were observed on the HVC desk area. The HVC manager verified they did not have a policy or procedure as to how patients would be informed of their rights.

Based on interview and document review, the facility failed to respond to patient grievances in writing as required for 5 of 10 patients (P1, P2, P3, P4, and P5) who filed grievances with the hospital.

Findings include:

P1 submitted a grievance dated 12/11/13, which was date stamped as received by the hospital 12/13/13. The following was noted: "My wife, [P1], passed away...I would like to share with you the experience we had with several departments...Radiology department...My wife went for a CT scan [computed tomography x-ray] twice under difficult circumstances. She was clearly uncomfortable and in distress. We were never told how long we would have to wait. No one asked if she was cold and wanted a blanket or a pillow or asked if there was anything they could do to make her more comfortable. We had no clue if we would wait 10 minutes or 40 minutes...Department...Department of surgery...One morning about 8:30 p.m. a surgeon came into her room when she was alone. She had no support of any kind, emotional or physical or spiritual, and told her there was nothing more they could do for her. Her nurse told me she didn't know the doctor was coming and she was a few steps behind him and was unable to stop him. I arrived about 30 minutes later and she was clearly distraught...Urology...A disappointment. My wife had a urostomy surgery and the stoma never healed properly with her skin so she had ongoing problems with leakage. Both the oncology department and the wound/ostomy nurses said they sent emails about this but never got a response...I write this letter with the wish that it can help to improve care...I would be happy to meet with any of the people involved and discuss these issues if they wish..." A note written by a hospital staff person indicated, "Please note that this is the 2nd letter from this patient's spouse."

An email dated 9/6/13 was attached to the grievance letter. The email was from patient representative (PR)-D and the subject was "Patient complaint letter [P1]--Radiology," however, the actual email was not included on the copy in the grievance file. The director of risk management (DRM)-A explained in an interview on 1/9/14, at 9:10 a.m. that P1's grievance had been forwarded on to a physician to investigate. DRM-A was unable to locate the first grievance filed on 9/6/13 from P1, and could not find any response from the hospital at that time. DRM-A stated a response letter had not been sent to P1's representative at the time of the initial grievance on 9/6/13, but should have been.

P2's daughter communicated concerns in an email dated 8/26/13, which had been forwarded from PR-D to DRM-A. The email read, "I had a call from [P2's daughter], who tells me although she's been extra careful in telling staff that her father is blind and needs extra care, that he fell off the table during recent MRI [magnetic resonance imaging], causing nose issues, smashed knee and leg pain. She stated that she left him at 8:00 p.m., and that she got a call at 9:00 p.m. telling her about this. She said that is the second fall he's experienced, the last time he had a broken ankle (I believe the first fall was not at this hospital).... "

An email response about P2's concern dated 8/27/13, written by the MRI supervisor indicated, "We have called the patient and spoke with her. If you hear anything more...please let me know. Thank you." There was no further communication regarding the patient grievance. DRM-A stated in an interview on 1/9/14, at 9:10 a.m. that she had been in touch with P2's daughter by phone, however, there was no further documentation, nor was a letter sent to P2 or the patient's representative regarding the grievance dated 8/26/13.

P3's Patient Relations Department Report dated 10/7/13 revealed, "I spoke with [P3's] daughter...daughter does not want a response back...after [P3] left the emergency center and the 7th floor, she was placed on 6th floor...her mother waited for over an hour for bathroom assistance. Two nurses (after noon on Wednesday) were really rough with her...They commented that they needed to 'do this fast' when getting her to the restroom...[P3] also waited for over 5 hours for her 3:00 p.m. medication...."

DRM-A stated in an interview on 1/9/14, at 9:10 a.m. there was no further documentation regarding P3's hospital stay. DRM-A explained that P3's daughter stated she did not need a response to the complaints, so there had been no further follow up completed.

P4 voiced a grievance noted in an email communication dated 12/10/13, written by PR-D that read, "Call today was life partner of [P4]. She stated she was too emotional to call before now. She reports that [P4] was in the hospital on a Friday and they were assured...his pain would be managed. However, she believes that he did not get appropriate care in the hospital and that his status as a 'medical patient' versus a 'hospice patient' was the reason that he was not given adequate pain control...she said 'we begged for them' [regarding P4's pain medication]...."

DRM-A stated in an interview on 1/9/14, at 9:10 a.m. that the life partner made the complaint more than one year after the hospital stay in 12/12. Although the hospital looked at the pain medication administration system, they did not respond in writing to P4's representative, as the hospital staff believed the information was just "feedback" and not an actual grievance.

P5 had written a patient grievance dated 9/17/13 which included; "A social worker came to speak to me in my room. Had already spoken to one in the hall as I was being transported to therapy. The one in my room asked the same questions but when I said I was going home, she said you are not allowed to do that! I told her that was the first I heard that but I was going home and already had two therapy sessions scheduled...Worst of all on Friday September 13 around 9:00 p.m. a woman with unknown viral infection was put in the other bed in my room. I was beside myself and considered calling my family to come get me. Was that the only bed in the hospital? How did she end up in a surgical unit?"

An email communication related to P5's grievance dated 11/5/13, was documented in the file, "Please see the attached letter we received from the patient. I apologize for the delay in getting this to you. I found it in my drafts this morning. I did speak to P5 in September and apologized for her dissatisfaction and informed her I would forward on for review. There is no expectation of a call back." DRM-A stated in an interview on 1/9/14, at 9:10 a.m. that the hospital did not send a follow up written response to R5 regarding her grievance, as the patient's letter had been considered more "feedback" than a grievance.

The hospital's policy, Patient Grievance Mechanism dated 3/09, instructed, "Patient complaints are handled in a timely manner not to exceed 30 days...." DRM-A stated on 1/9/14, at 11:30 a.m. that the grievance policy had been updated 11/13, but had not been approved by the governing board.

Based on interview and document review, the hospital failed to ensure a system for informing patients of their right to formulate an advanced directive in the Heart Vascular Center (HVC) for 1 of 1 patient (P6) who reported not receiving the required information.

Findings include:

P6 was interviewed on 1/8/14, at 8:00 a.m. and did not recall receiving information on the right to formulate an advanced directive prior to coronary bypass surgery. The patient's record did not contain information noting the information was provided.

The facility's policy, Patients' Bill of Rights dated 3/20/13, directed staff to provide a copy of the Bill of Rights to patients who entered for registration through the south surgery desk. However, patients who were to receive open heart surgery did not go through the south surgery desk and normal registration process, rather they were admitted through the Heart Vascular Clinic (HVC).

The director of surgical operations (DSO-C) was interviewed on 1/9/14, at 10:00 a.m. and she reported she was unable to determine whether P6 had received information to show the patient had received the required advanced directive information at the time of admission.

In an interview with the HVC manager on 1/9/14, at 1:00 p.m. it was explained that open heart surgical patients were not provided with information related to the Patient Bill of Rights including information for formulating an advance directive. The HVC manager said if patients asked for the information, it would be provided to them. During the interview, brochures were observed on the HVC desk area. The HVC manager verified they did not have a policy or procedure as to how patients would be informed of their rights.

Based on observation, interview, and document review the hospital failed to ensure a safe environment for 1 of 1 patient (P8) who eloped from the hospital while on a 72-hour hold.

Findings include:

P8 was the subject of an Event Description dated 10/21/13 which revealed, "On 10/21/13 at approximately 1500 [3:00 p.m.] this patient eloped from 5 West. Patient was placed on a 72-hour hold earlier in the day. He was on vide [sic] monitoring during the shift and was also on a 2:1 [two staff monitoring one patient]. At the time the patient eloped the NA [nursing assistant] who was providing close observation in the room had gone to ultrasound with the roommate. The video monitoring tech [VMT-A] did not see the patient on the screen any longer so he called the NA [NA-A] on the wing to check on him, at that point [VMT-A] felt [NA-A] had the situation under control. [NA-A] misunderstood [VMT-A] and thought he was asking to go to the bathroom, therefore she came into the video monitoring room to break him [relieve the staff person]. The Code White [missing patient alert] was finally called at 1515 [3:15 p.m.]. Patient did have clothes on and had a belongings bag with him when he left the hospital per the housekeeping staff member who witnessed him leaving...."
P8's discharge summary dated 10/21/13 indicated the patient was admitted to the hospital on 10/21/13 via ambulance and was diagnosed with acute alcohol intoxication, gastrointestinal (GI) bleed, cirrhosis, hepatic encephalopathy, pancytopenia and alcohol withdrawal.

History: "Patient is a 56 y.o. [year old] male with a history of alcohol dependence, cirrhosis, SBP [spontaneous bacterial peritonitis], and variceal bleeding in the past who is admitted from the ED [emergency department] for acute intoxication and a several day history of melena. He drinks 1 pint per day and is not taking any of his medications (which should include PPI [proton pump inhibitor], rifamixin, lactulose, pentoxifylline among others). He denies any abdominal pain. Has had emesis, but not hematemesis. Additionally, has fallen multiple times in the past week. Has a black eye on the R [right] side but no other definite injuries. He was actually brought in by EMS [emergency medical services] after his girlfriend called, concerned about the falls and confusion."

P8's Hospital Course summary read: "The patient was admitted to 5-West med-surg [medical-surgical] nursing unit for further evaluation and treatment...He was counseled that he needs to abstain from alcohol completely to avoid any further worsening of his alcohol-related encephalopathy and/or dementia, and to avoid recurrence of his GI bleed or worsening of his cirrhosis. The patient agreed that he needs assistance to stop drinking, but wished to go to an 'outpatient' alcohol treatment program. Because of the severity of his condition and the frequent readmissions (4 admissions in the past four months), the Psychiatrist, Gastroenterologist, and Chemical Dependency Social Worker all endorsed commitment to an Inpatient Alcohol Treatment Program. The Patient was placed on a 72-hour hold after he was informed of the commitment intentions, but unfortunately he eloped from the hospital...."

According to the record, the examiner's statement in support of an emergency admission (72-hour hold), indicated P8 had been placed on the hold on 10/21/13, at 11:30 a.m.

P8's 1:1 Risk for Harm/Treatment Interference progress notes revealed:

1) 10/15/13 at 2:49 p.m. "1:1 was initiated on 10/15. Patient needs a 1:1 because the patient is at risk for harm/interfering with medical care/high falls risk. During this shift the patient was High falls risk and bed exit alarm alone has been ineffective. Interventions to address these behaviors included orientation, safe environment provided, room cleared of obstacles. Patient tolerated interventions as evidenced by patient remaining safe throughout shift. Patient slept 3 hours. Recommend continuing 1:1."
2) 10/16/13 at 10:54 p.m. "1:1 Patient needs a 1:1 because the patient is at risk for harm/interfering with medical care. During the shift the patient was High fall risk and bed exit alarm alone has been ineffective Alcohol and/or drug withdrawal Interventions to address these behaviors included attempting to wean 1:1 and institute video monitoring. Ambulating frequently. Reorienting patient. Educating patient on plan of care and importance of safety. Patient did not tolerate interventions as evidenced by continuing to be impulsive and unresponsive to video monitoring. Needs staff at bedside to help with impulsiveness. Patient slept 3 hours. Recommend continuing 1:1."

Video Monitoring (VM) progress notes were as follows:

1) 10/17/13, at 11:07 p.m. "Patient will remain safe and free of injury during video monitoring. Video monitoring initiated on 10/15/13. VM indication(s): Fall risk and staff safety. Patient previously during this hospitalization made aggressive statements and actions towards staff. Patient video monitoring events: None. Patient response impulsive and responds appropriately. Recommend 1:1 close observation and continue video monitoring."
2) 10/18/13, at 6:53 a.m. revealed, "Fall risk. Patient video monitoring events patient redirected. Patient educated on video monitoring process. Patient response impulsive, responds appropriately and resting/sleeping. Recommend continue video monitoring. "
3) 10/19/13, at 6:40 p.m. "Impulsive; Fall risk. Patient video monitoring events called patient care team for follow-up with patient. Patient educated on video monitoring process. Patient response responds: patient still impulsive doesn't use call light, falls risk. Recommend continue video monitoring."
4) 10/20/13, at 6:20 a.m. revealed. "Patient will remain safe and free of injury during video monitoring. a/o [alert and orientated] with occasional confusion--forgetfulness. Sba [stand by assist] as patient can be slightly unsteady on feet. Continues to be impulsive, not using call light. Multiple calls from VM tech [technician] and bed alarm sounding through out night- usually patient was getting up to use the bathroom or needing a snack. Slept for very brief periods (15-30 min [minutes] at a time) then would be awake for awhile/total maybe slept 3 hours. Slight tremors in hands. Denies pain or nausea. No irritability or agitation noted. gave prn Ativan x 2 per pt [as needed twice per patient] request. Continue video monitoring for safety."
5) 10/20/13, at 2:55 p.m. revealed, "Patient will remain safe and free of injury during video monitoring. Video monitoring was initiated on, VM indications: Impulsive, a & o, SBA. Mild tremors, denies pain, no nausea, calm cooperative, uses call light, slept for about two hours, ambulated in the hallway x4. Patient video monitoring events called patient care team for follow-up with patient. Patient educated on the video monitoring process. Patient response was calm. Recommend discontinue video monitoring."
6) 10/20/13 at 10:29 p.m. revealed, " Patient will remain safe and free of injury during video monitoring. Video monitoring initiated on pt...impulsive, anxious denies pain or discomfort. C/o [complaint of] occasional anxiety Po [by mouth] Ativan given, occasional mild tremors. Ambulated hall x2. Patient video monitoring events patient redirected. Patient educated on video monitoring process. Patient response impulsive. Recommend 1:1 close observation and continue video monitoring."
7) 10/21/13 at 6:37 a.m. "Patient will remain safe and free of injury during video monitoring. Video monitoring was initiated on 10/15...Impulsive & possible flight risk. a/o [alert and orientated] with forgetfulness. Pleasant, no agitation noted. mild tremors in hands. Denies pain/nausea. sleep better tonight--maybe a total of 5 hours. Ativan given x 1 per pt request. Patient video monitoring events called patient care team for follow-up with patient. Goal met. Patient response calm, impulsive, responds appropriately and resting/sleeping. Recommend continued video monitoring."
8) 10/21/13 at 3:21 p.m. "Patient will remain safe and free of injury during video monitoring. Video monitoring was initiated on 10-19...Impulsive. Patient video monitoring events no called received but at 1515 [3:15 p.m.] pt. is missing from his room. Housekeeper said he took his belongings and left. Patient educated on video monitoring process. Patient response impulsive. Recommend continue video monitoring. Recommend pt be moved to another video monitoring room further from the elevators. "

A social work progress note dated 10/21/13, at 3:59 p.m. revealed, Pt [patient] refusing to go to CD [chemical dependency] treatment. Discussed with MD [medical doctor], psychiatry and RN [registered nurse] and all have determined we need to pursue commitment. Referral made to Hennepin County pre-petition screeners. Pt. now on 72-hour hold...."

Progress noted dated 10/22/13 at 11:07 a.m. revealed, "Pt. be compliant with 72-hour hold...initiated at about 1115 [11:15 a.m.] on 10-21. Pt. was read his rights by charge nurse. This nurse saw pt. several times after hold started and he was pleasant and cooperative. At 1515 pt. noted to be missing from his room. Code White was called, security up to floor to get more information. [Social worker] called the police when he could not be found on hospital property. Pt. had been on video monitoring and had made no attempts to leave earlier in day. Nrsg. [nursing] assistant had received call from VM tech but this nurse did not get a call that he was trying to leave."

The 5 West unit was observed on 1/9/14, at 2:10 p.m. The unit had thirty-five rooms with 64 beds, and 12 rooms had patient doors labeled with "video monitoring system" on the outside of the doors.

The hospital's Close Supervision Policy dated 6/13 read, "...Flight risk patients need to be placed in paper pajamas."

On 1/9/14 at 3:40 p.m. an interview was conducted with the director of nursing quality and patient safety (DNQPS), and RN-I. During the interview they explained that P8 had been on video monitoring when he'd left the hospital unsupervised. The DNQPS stated the hospital staff had not conducted a root cause analysis of this event, rather had completed a 'Just Culture Algorithm, The Duty to Follow a Procedural Rule' (system controlled by the employer). Staff were instructed to counsel the employees involved and to conduct a human error investigation. A note on the algorithm included, "This test applies when the employee works within a system and is responsible for being a reliable component within that system." The DNQPS stated they had determined during the hospital's internal investigation, that VMT-A had not called an overhead Monitor Alert which would have been the appropriate protocol when he was no longer able to see P8 on the video monitor. Instead VMT-A had directly called NA-A. There was then a miscommunication between the two staff members as NA-A thought she was being called to provide a break for VMT-A, so NA-A had gone directly to the video monitoring room, and had not checked on P8 prior as was intended by VMT-A. The DNQPS confirmed there had been a time lapse of 15 minutes when the patient had no longer been visible on the video monitoring screen and when the Code White was called. The DNQPS said during the interview that the time period was too long. In addition, the DNQPS stated that although the 5 West team had been familiar with the VM policy, there had been a communication failure and misunderstanding between two staff members. She verified the staff working on the 5 West unit had been re-trained, and stated there had been no further elopements by patients who were being monitored by video.

On 1/10/14, at 2:50 p.m., the director of emergency center and nursing services (D)-D stated the hospital had determined the elopement event for P8 had been caused by a communication error with specific staff failure to follow protocol. The specific staff involved, and all other staff on 5 West were retrained. D-D verified P8 had left the hospital in his personal clothing, carrying his personal belongings, and confirmed P8 should have had his personal clothing removed from his possession once it was determined he was a flight risk, according to the hospital's Close Supervision policy (dated 6/13). DD also confirmed that although the staff on 5 West had been retrained, no additional training had occurred for staff on other hospital units where 72 hour holds may be utilized.

Based on document review and staff interview the facility failed to ensure their Quality Assessment Performance Improvement (QAPI) program analyzed missing person (Code White) events to determine root cause in order to develop and implement preventative actions to minimize the risk of future Code White events for 5 of 5 patients (P8, P13, P14, P11, P12) reviewed who had Code White events documented.

Findings include:
P8 was the subject of an Event Description dated 10/21/13 which revealed, "On 10/21/13 at approximately 1500 [3:00 p.m.] this patient eloped from 5 West. P8 had been placed on a 72-hour hold earlier in the day. He was on vide [sic] monitoring during the shift and was also on a 2:1 [two staff monitoring one patient]. At the time the patient eloped the NA [nursing assistant] who was providing close observation in the room had gone to ultrasound with the roommate. The video monitoring tech [VMT-A] did not see the patient on the screen any longer so he called the NA [NA-A] on the wing to check on him, at that point [VMT-A] felt [NA-A] had the situation under control. [NA-A] misunderstood [VMT-A] and thought he was asking to go to the bathroom, therefore she came into the video monitoring room to break him [relieve the staff person]. The Code White [missing patient alert] was finally called at 1515 [3:15 p.m.]. Patient did have clothes on and had a belongings bag with him when he left the hospital per the housekeeping staff member who witnessed him leaving...."
P8's discharge summary dated 10/21/13 indicated the patient was admitted to the hospital on 10/12/13 via ambulance and was diagnosed with acute alcohol intoxication, gastrointestinal (GI) bleed, cirrhosis, hepatic encephalopathy, pancytopenia and alcohol withdrawal.

Progress notes dated 10/22/13 at 11:07 a.m. revealed, "Pt. (patient) be compliant with 72-hour hold...initiated at about 1115 [11:15 a.m.] on 10-21. Pt. was read his rights by charge nurse. This nurse saw pt. several times after hold started and he was pleasant and cooperative. At 1515 pt. noted to be missing from his room. Code White was called, security up to floor to get more information. [Social worker] called the police when he could not be found on hospital property. Pt. had been on video monitoring and had made no attempts to leave earlier in day. Nrsg. [nursing] assistant had received call from VM tech but this nurse did not get a call that he was trying to leave."

On 1/9/14 at 3:40 p.m. an interview was conducted with the director of nursing quality and patient safety (DNQPS), and RN-I. During the interview they explained that P8 had been on video monitoring when he'd left the hospital unsupervised. The DNQPS stated the hospital staff had not conducted a root cause analysis of this event, rather had completed a 'Just Culture Algorithm, The Duty to Follow a Procedural Rule' (system controlled by the employer). Staff were instructed to counsel the employees involved and to conduct a human error investigation. A note on the algorithm included, "This test applies when the employee works within a system and is responsible for being a reliable component within that system." The DNQPS stated they had determined during the hospital's internal investigation, that VMT-A had not called an overhead Monitor Alert which would have been the appropriate protocol when he was no longer able to see P8 on the video monitor. Instead VMT-A had directly called NA-A. There was then a miscommunication between the two staff members as NA-A thought she was being called to provide a break for VMT-A, so NA-A had gone directly to the video monitoring room, and had not checked on P8 prior as was intended by VMT-A. The DNQPS confirmed there had been a time lapse of 15 minutes when the patient had no longer been visible on the video monitoring screen and when the Code White was called. The DNQPS said during the interview that the time period was too long. In addition, the DNQPS stated that although the 5 West team had been familiar with the VM policy, there had been a communication failure and misunderstanding between two staff members. She verified the staff working on the 5 West unit had been re-trained, and stated there had been no further elopements by patients who were being monitored by video.

On 1/10/14, at 2:50 p.m., the director of emergency center and nursing services (D)-D stated the hospital had determined the elopement event for P8 had been caused by a communication error with specific staff failure to follow protocol. The specific staff involved, and all other staff on 5 West were retrained. However, this incident had not been evaluated by the hospital's QAPI, and no additional training had occurred for staff on other hospital units where 72 hour holds were utilized.

According to a review of P13's medical record, a Code White (missing person alert) had been called on 11/25/13. Record review indicated P13 had presented as anxious, confused and inebriated to the hospital's emergency department (ED) on 11/25/13. An occurrence report dated 11/25/13, revealed P13 had subsequently left the ED without staff knowledge and was located by security staff near a building adjacent to the hospital campus.

P13's medical record was reviewed and revealed the following:

P13 was placed in room E27 on 11/25/13, at 2:41 p.m. and a psychiatric assessment immediately followed. The patient displayed anxiety, depression/sadness and confusion. A triage assessment addendum at 2:43 p.m. read, "Patient arrived via EMS [emergency medical services] from home. Paramedics reports that patient was found at home with an empty bottle of vodka near him as well as some tequila bottles. P13's wife apparently called EMS as patient has a history of ETOH [alcohol] abuse, but she was not on the scene when paramedics arrived. Patient had been sober for 2 years per paramedics. They were unable to ascertain patient's birth date and patient is unable to give his age or the year he was born. Patient is unable to give a phone number or social security number. He is confused about time and place and is tearful on arrival. When asked about his birth date, he states that he arrived here from South Carolina and 'then they sent me to Vietnam and I killed a bunch of people. Patient then became tearful and could not complete his thoughts or a coherent sentence.' "

Additional ED notes from 11/25/13 read:
1) 3:40 p.m. "Writer stepped into room to assess patient and found the patient had eloped. I did notify MD [medical doctor] and a Code White was called. Discussed the need for locked room due to altered mental status. Security is attempting to locate patient now."
2) 3:51 p.m. "Patient brought back here by security. Patient being changed into blue scrubs. Security present at this time."

On 1/10/14, at 11:45 a.m. the director of patient care services was interviewed, and verified staff had implemented the appropriate Code White protocols when they had found P13 missing, and security had located the patient. The director of patient care services indicated a Code White was used for patients who were missing and verified the security department tracked incidents. However, the patient care services director also confirmed the incident had not been further investigated, nor had it been reported to the Quality Assurance and Performance Improvement (QAPI) committee for review.


10155


P14 was admitted to the hospital on 12/10/13, at 3:38 p.m. with upper gastrointestinal bleeding and a red blood cell transfusion and gastroenterology physician visit. An occurrence report dated 12/11/13 indicated P14's physician had been in to see the patient, and had stepped out of the room because P14 was on the phone. According to the occurrence report, the patient had informed the physician he planned to leave against medical advice (AMA), and when the physician had returned to the room, the patient was gone. It was not documented whether the physician informed the patient of the risks of leaving AMA, nor was their documentation the incident was investigated. P14 had left the hospital with an intravenous (IV) access in his arm. The documentation indicated the nursing staff were concerned the patient still had the IV access in his arm, and a Code White was called. Security officers had searched the hospital but had not found the patient. No further documentation was located regarding the incident.

On 1/10/14, at 11:45 a.m., the director of patient care services was interviewed regarding the incident, and verified an investigation and report to the QAPI committee had not been made.


18622


P11 was admitted for suspected drug intoxication secondary to methamphetamines and alcohol. The discharge summary, dated 10/25/13, indicated P11 had been placed in restraints due to uncooperativeness and attempts to bite and spit on staff at the time of the patient's admission to the emergency department (ED) 10/23/13. The patient was admitted for observation for further evaluation and management, and was placed on 1:1 observation monitoring. P11 remained stable overnight and by the next day was reportedly improving. P11's case was discussed with psychiatry and given the patient was not threatening to harm herself or others, the patient was not placed on a hold. The discharge summary further indicated, "Unfortunately she left against medical advice [AMA] and without being seen." At the time the patient left the hospital AMA, an intravenous (IV) access was still in place. The hospital contacted the police and informed them the patient needed to return to the ED to have the IV removed, because the patient was identified as being at "high risk of complications with this."

A note by a hospital social worker (SW) dated 10/25/13, at 10:29 a.m. indicated P11 had asked about being discharged and was told she first needed to be seen by the physician. The patient informed the SW she wanted to leave, as she had to do something at 2:00 p.m. The SW left to obtain information from the nursing desk, and returned to find the patient gone from the room.

A RN progress note, dated 10/25/13, at 10:57 a.m. indicated P11's call light had been activated, and the patient had asked when the physician would arrive to discharge her. The nurse discussed a possible discharge time with the patient. According to the note, the physician had been paged at 8:30 a.m. regarding the pending discharge. The note indicated P11 had activated the call light and asked when the doctor would be there to discharge her. The nurse who'd answered the light had discussed a possible discharge time with the patient, and said the physician would come when he was able. When the nurse returned, the patient was gone. A Code White was called and the physician was paged and updated.

A SW progress note on 10/25/13, at 11:22 a.m. indicated the SW walked into patient's room ten minutes after talking to her and the patient was gone. P11's room and unit were searched by staff and patient was not present. P11 still had IV access in her right arm and was a known drug user. The SW consulted with security, hospitalist, and risk management staff. The SW also called P11's mother to inform her of the situation and to call 9-1-1 if the patient showed up and still had the IV access. The SW informed the Minneapolis police department that if found, P11 should be returned to the hospital ED so the IV access could be removed.

On 1/10/14, at 2:45 p.m. the chief compliance officer (CCO) was interviewed and stated the hospital had no further information about P11 after she left the hospital 2 1/2 months prior. The Patient Safety and security department staff were aware of the situation, as a Code White had been called however, the incident had not been reported to the QAPI committee.



30951


P12 arrived via ambulance on 11/3/13, at 12:14 p.m. to the Emergency Care Center (ECC).
Nursing progress notes revealed that at 3:45 p.m. P12 was educated that a friend (sober ride) would need to come into the ECC before she could be discharged to ensure her safety, and the patient verbalized understanding. At 3:56 p.m. The patient wanted to make phone calls and was offered a room for privacy for the phone calls, however, she refused the room because it didn't have a phone jack, and instead requested to use the family room. According to the event report, at 4:15 p.m. staff "Went to room to provide medications, the patient was not in her room, but the consulting nurse was there and stated [P12] went home." There was confusion relayed in the notes regarding who if anyone at the hospital had informed the patient she could go home. The notes further indicated a Code White had been called at 4:20 p.m. and a message had been left on the patient's cell phone. At 4:50 p.m. the Minneapolis police department was notified, and reported back that the patient had not lived at the address she'd provided for 1.5 years. At 4:56 p.m. the administrative nursing supervisor cleared the Code White.

On 1/10/14 at 12:15 p.m. an interview was held with the chief compliance officer (CCO), the director of nursing/chief operating officer (DON/COO), the director of the ECC and nursing (D-D), and the director of risk management/legal council (D-A). They reported they were unaware of the Code White for P12, as it had not been entered into the quality tracking system. D-D indicated P12 was considered to have left against medical advice (AMA).

An AMA policy was requested. At 2:45 p.m. the CCO, DON/COO, D-D, and D-A reported the hospital had no AMA policy, but it would generally mean the patient had been informed of the risks and benefits of treatment options, and that the patient had refused those options and instead chose discharge. The hospital used the term AMA interchangeably with an elopement, where the patient left the hospital without information regarding the risks and benefits of leaving. They also confirmed that although Code White incidents were tracked by the safety committee, they were not brought forward to the QAPI committee.

Based on observation, interview, and document review, 8 of 21 surgical suite anesthesia carts had locks that did not consistently work, and narcotic and anesthesia agents were left unlocked, potentially allowing unauthorized access.

Findings include:

Although the locks were engaged, anesthesia cart drawers were found unlocked during an operating room (OR) tour on 1/7 and 1/8/14 in OR1, OR7, OR9, OR15, and OR18. The unlocked drawers contained both opened and unopened bottles of liquid inhalation anesthesia agents including: 6 bottles of Sevoflurane USP Inhalation anesthesia 250 milligrams (mg), 7 bottles of Forane Liquid 100 mg, and 7 bottles of Suprame 240 mg.

The director of surgical operations (DSO) stated during interview at 11:45 a.m. on 1/8/14, that they had over 20 operating rooms and more than 200 staff including maintenance staff, housekeepers who worked after hours, orderlies, vendors, water striders (duties included cleaning between surgeries), as well as contracted staff who repaired equipment, who might have access to the surgical areas when not supervised. The DSO verified these staff had access to the unlocked anesthesia agents, and that the medications should have been kept locked.

The hospital policy, Anesthesia Medications, Safe and Available (reviewed 1/13), directed staff to ensure "all carts containing anesthesia drugs will be locked when ever anesthesia personnel are not present at the location."

Interview with the certified registered nurse anesthetist (CRNA) manager on 1/9/14, at 8:50 a.m. revealed the drawers to the anesthesia carts should have locked, and had locked when they were new. The CRNA manager reported the carts had been checked, and that they'd found that 8 of the 21 carts did not lock.

Three small boxes of narcotics and anesthesia drugs were left on top of the anesthesia carts in operating room (OR)1, OR4, and OR23 that were not currently in use and were not being monitored at the time of the tour 1/7 and 1/8/14. The boxes were approximately 6.5 x 6.5 x 2 inches, and could easily have been removed from the room unnoticed. Each box contained Versed (used to induce relaxation and sleepiness prior to surgery) 1 mg per milliliter (ml), for a total of 20 ml, as well as narcotic pain medications Demerol one 25 mg vial, five Fentanyl 2 ml vials and four 5 ml vials, and two Hydromorphone each 1 mg/ml.

The CRNA manager also reported on 1/8/14, at 2:30 p.m. that the anesthesia drugs should have been locked in the anesthesia cart when not in use, and that some of the older drawers did not lock any longer. The manager felt the CRNAs would have noticed if the medications had been missing when they returned to the carts for their next patient.

The director of pharmacy stated during interview at 9:20 a.m. on 1/9/14, that cleaning and maintenance staff, as well as orderlies and vendors, should not have had access to the medications in the OR suites.

Based on observation, interview, and record review, the hospital was found to be out of compliance with the Condition of Participation related to the Physical Environment (42 CFR 482.41) related to lack of compliance with Life Safety Code requirements. These findings have the potential to affect all patients in the hospital.

Findings include:

The hospital was found out of compliance with the Condition of Participation related to the Physical Environment (42 CFR 482.41) as evidenced by deficiencies issued as a result of a Life Safety Code inspection.

Please refer to Life Safety Code inspection tags: K-0011, K-0018; K-0029; K-0076; K-0077; K-0078, K0140, K0141, K0144 and K-0147.

Based on observation and interview, the hospital failed to ensure sharps and chemicals were securely stored in the Emergency Care Center's (ECC) unlocked utility room. This had the potential to affect patients and visitors who traversed the area adjacent to the waiting room.

Findings include:

Unlocked needles and syringes were observed in A-6, an unsecured trauma room on 1/7/14, at 1:30 p.m. In addition, a supply of approximately 20 Cavicide spray bottles were stored in an open cupboard in a soiled utility room near the ECC waiting area.

At the time of the tour, registered nurse (RN)-F reported being unaware that supplies were to be stored to ensure their safety (prevention against theft or damage, contamination, or deterioration) in patient care areas. In addition, RN-F was not aware that chemical disinfectant supply could not be stored in an unlocked soiled utility room. RN-E, also present during the tour, was not aware that supplies and chemical disinfectants were to be secured in patient care areas. RN-E stated that most of the chemical disinfectant supply was in the back room and secure, and stated the products available were probably overstock that would not fit in the usual supply room. RN-E stated she was not aware that the soiled utility room should be locked if it was used for storage of chemicals.

The Cavicide Material Safety Data Sheet (MSDS) revised 2011, included: "contains Hazardous Ingredients of Isopropanol and Ethylene Glycol Monobutyl Ether." Health Hazard Data read: "May be harmful if swallowed...Seek medical attention."

The Employee Right to Know and Personal Protective Equipment policy (revised 5/13), indicated: "Chemical Storage--The separation of chemicals (solids or liquids) during storage is necessary to reduce the possibility of unwanted chemical reactions caused by accidental mixing. Use either distance or barriers to isolate chemicals into the following groups. Housekeeping--maintain the smallest possible inventory of chemicals to meet immediate needs. Ensure that storage area or equipment containing large quantities of chemicals are secure from accidental spills."

On 1/9/14, at 1:30 p.m. the director of nursing (DON) verified that supplies and chemical disinfectants should have been secured to ensure patient safety.

Based on observation, interview and document review, the hospital failed to utilize proper infection control procedures for 1 of 1 patients (P7) observed during an epidural procedure.

Findings include:

P7 was admitted to the hospital on 1/8/14 with leaking amniotic fluids, and subsequently went into labor.

On 1/8/14, at 10:30 a.m. the anesthesiologist medical doctor (MD)-A, was observed to insert an epidural catheter into P7's spinal area to provide anesthesia. MD-A washed his hands, applied sterile gloves, and cleansed P7's spinal area. MD-A then removed his gloves, washed his hands, and donned sterile gloves. Without wearing a face mask, MD-A proceeded to insert the epidural catheter into P7's spine.

On 1/8/14, at 1:45 p.m. the manager of labor and delivery, registered nurse (RN)-A was interviewed and stated she would have expected the anesthesiologist to wear a face mask during the insertion of an epidural catheter.

On 1/8/14, at 2:45 p.m. RN-B, the director of infection control services and the senior infection preventionist were interviewed, and both verified a face mask should have been worn by MD-A during epidural procedures.

The Hospital Communicable Disease Guidelines: Acute Care, Emergency Care revised 7/13, indicated that staff when performing procedures that entered deep tissue or body fluid "including spinal/epidural anesthesia, requires mask and eye protection."

Based on interview and document review, the facility failed to accurately document the reporting of patient deaths to the Organ and Tissue Procurement Organization (LifeSource) for 5 of 5 (P9, P10, P16, P17, P18) deceased patient records reviewed.

Findings include:

Five deceased patient records lacked documentation of the date and time the referral to LifeSource was made.

The following death records were reviewed:

P9's, Park Nicollet Methodist Hospital Decedents Release form undated, identified the patient died on 10/27/13, at 9:15 p.m. Under the section Organ/Tissue/Eye Donation it specified a referral was made to LifeSource, however neither the time nor date of the referral had been recorded.

P10's, Park Nicollet Methodist Hospital Descendents Release form, undated, identified the patient died on 8/9/13 at 0730 a.m. Under the section Organ/Tissue/Eye Donation it specified a referral was made to LifeSource, however neither the time nor date of the referral had been recorded.

P16's, Park Nicollet Methodist Hospital Descendents Release form, undated identified the patient died on 9/28/13 at 7:00 p.m. Under the section Organ/Tissue/Eye Donation it specified a referral was made to LifeSource however, neither the time nor the date of the referral had been recorded.

P17's, Park Nicollet Methodist Hospital Decedents Release form, undated, identified the patient died on 8/16/2013 at 10:10 p.m. Under the section Organ/Tissue/Eye Donation it specified a referral was made to LifeSource however, neither the time nor date of the referral had been recorded.

P18's, Park Nicollet Methodist Hospital Decedents Release form, undated, identified this patient died on 8/3/2013 at 7:20 p.m. Under the section Organ/Tissue/Eye Donation it specified a referral was made to LifeSource however, neither the time nor date of the referral had been recorded.
The hospital's policy, Organ, Tissue and Eye Donation Form, Reference number A. 17-MH8500-1198 (updated 7/13) specified; "Timely referral of patients (within one hour) when brain death is imminent and after cardiac death is made by law, and is essential for procure of potentially transplantable organs, tissues and eyes."

In an interview with registered nurse (RN)-D, the director of critical care service on 1/9/14, at 1:10 p.m., she explained that the time and date of referrals to LifeSource were not being documented, because the hospital was depending upon the quarterly report from LifeSource to determine if the hospital was in compliance with the required time frame for reporting patients deaths.

Based on observation, interview, and document review, the hospital failed to ensure the safe use of an electro-cautery device (cautery pencil) for 1 of 3 patients (P6) whose surgical procedure was observed.

Findings include:

P6 had a coronary artery bypass graft with left radial artery graft and was given general anesthesia on 1/8/14, at 10:00 a.m. At 10:15 a.m. P6's body was cleansed with the skin preparations Povidone Iodine solution and Povidone Iodine Scrub. The patient was covered with the surgical drape. The cautery holster was attached to the drape on the left side of P6's lower chest area, across from where surgeon (S-A) stood. The senior director of surgical operations (D-C) also observed the surgery.

At 10:47 a.m. S-A was observed to have used the cautery. He set the cautery tool on the white cotton sponge laying on the drape for 30 seconds, and two additional times between five to ten seconds. The cautery was then laid on the surgical drape three times for five to 15 seconds. At 10:51 a.m. the circulating registered nurse (RN)-I said something inaudible to the surgical technician (ST)-A. ST-A then put the cautery in the holster for the first time. At 10:53 a.m., the cautery tip was changed to a larger green tip, which was laid on the cotton surgical drape. At 11:04 a.m. ST-B replaced ST-A to assist S-A. At 11:07 a.m. ST-B held the cautery for the surgeon, and when it was placed on the drape, it was picked up after two seconds by ST-B. The cautery tool was placed on the drape by S-A nine more times during the procedure, but was picked up by ST-B within two to ten seconds.

D-C stated on 1/7/14, at 1:30 p.m. that the cautery was holstered if the skin preparation (prep) had an alcohol base of 24% or greater. If it was not alcohol based, they did not need to holster the cautery tool. The following day D-C stated at 11:30 a.m. that they had experienced no fires or burns to patients in the operating room. The certified registered nurse anesthetist (CRNA) manager was present, and agreed with D-C's report and stated it would only be a problem if the alcohol prep had not been allowed to dry for three minutes. S-A was unavailable for an interview.

The facility's policy Electro-Surgery Safety Guidelines (revised 1/13), indicated the holster would be attached to the sterile field on every case that requires cautery. The cautery would be placed inside the holster or sleeve when not in active use.

The manufacturer's recommendations for use of the Valley Lab cautery device used by the hospital were reviewed and identified warnings related to use. Under Fire Hazard, the following was identified: "Do not place active accessories near or in contact with flammable materials (such as gauze or surgical drapes), flammable gases, or high levels of oxygen. Electro-surgical accessories that are activated or hot can cause a fire. When not using active accessories, place them in a holster or in a clean dry, nonconductive, and highly visible area not in contact with the patient. Inadvertent contact with the patient may result in burns."