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1215 LEE STREET

CHARLOTTESVILLE, VA 22908

PATIENT RIGHTS

Tag No.: A0115

This Condition of Participation is not met based on a complaint investigation, Complainant interview, employee interview, clinical record review, policy and procedure review, and a review of hospital documentation, the hospital staff failed to ensure that one of six patient's reviewed (Patient # 5) was treated with dignity after his death. The hospital staff also failed to inform the patient's family/representative of the hospital's internal grievance process, including who to contact to file a complaint/grievance, or a phone number and address for lodging a complaint with the State agency.

The patient suffered a traumatic amputation of his right arm and left fingers. The patient died at the above named hospital and his amputated body parts were inadvertently given to his family, as his belongings. The hospital did not respond timely to the Complainant's request as to what actions he should take with the amputated limb and fingers and did not inform him of the procedure to file a complaint within the hospital system or to outside entities.

Findings:

A complaint investigation was conducted at the above named hospital on 3/20/12 through 3/22/12. The patient named in the allegations will be referred to as "Patient # 5." The complaint alleged that the Complainant (Patient # 5's Representative) contacted the hospital employees by telephone on 11/27/2011 at approximately 12:50 a.m. on behalf of the patient and the patient's wife. The Complainant did not receive immediate resolution to his complaint/grievance and has not yet (3/21/12) received a resolution to his concerns. The patient's representative was not informed of the hospital's policy or his right to file a grievance, or to contact the State Agency with his grievance.

The complaint alleged that after Patient # 5 experienced a traumatic accident resulting in the amputation of his right arm and fingers from his left hand, the patient died at this hospital and the amputated limbs were sent home with the patient's family.

The Complainant was interviewed by telephone on 3/20/12 at 3:00 p.m. This family member (Patient # 5's father-in-law) was present at the time of the notification of the death of Patient #5, the viewing of the body, and transported the bag of "Personal belongings" to their home. The family member detailed to the surveyor the events of November 26 and 27, 2011. The family member stated, "After we arrived at the hospital we were met by a hospital staff person and the Chaplain... The woman who had prepared (Patient #5) for us to see said, 'Here are his personal belongings, you can take them if you want' and looked at me and said, 'you will have to carry them because they are heavy.' The bag I was given was a plastic bag light blue colored and you could see there were also darker bags inside. It was hard to see in that room because the lights were dim...the bag was heavy. I carried it upstairs, out through the emergency department doors, out to the car...I said how heavy the bag was and (spouse of Patient #5) said, 'well it's probably the work boots because they are heavy'...I never gave it a thought and put it into the car. The bag was wet from the time we picked it up and (another family member) was sitting on the bag because we had to make room in the vehicle for several people. She (other family member) kept complaining that the bag was cold, so we re-arranged it...after we got home, (spouse of Patient #5) asked me to get (Patient #5's) wallet from the personal bag we were given at the hospital and just to put the rest of the things in the building and she would get to them later. I went out to the vehicle and the bag had a tag on it with numbers, I think, I can't remember and I opened it. There were other bags inside the bag, and when I opened those and stuck my hand down inside to get the wallet, I knew right then what I had grabbed hold of. I knew what it was. I thought, 'What kind of mess are you into now?' I didn't know what to do, I couldn't go back and tell (spouse of Patient #5) that somebody had messed up...I went back in and told (her), 'You know, honey, that stuff is such a mess and there is nothing that we need from that wallet right now anyway, so we'll just deal with that later...' I told my wife it was time for us to go home and when we got out I told her we had a 'serious problem' and I didn't see it, but I had touched it and knew what it was in the bag. I called (another family member) who was the first person to know, and he gave me the number to the hospital. It was about twenty minutes till one (12:40 a.m.) and when I called, I don't know who I spoke to because I just wasn't thinking to get a name or anything, I was just thinking I needed to know what to do with it (contents of the bag). This person said, 'Well you signed for it', like it was my fault we had taken home these body parts, and I told him that we had not signed for anything. He then told us again that we had 'signed for it' and that it wasn't his 'department' but gave me another number to call so I called the other number and that person, and again I did not get a name, said they couldn't believe that happened and they would be back in touch with me. (Spouse of Patient #5) did not know what was going on so I told the person on the phone under no circumstances to call her, to call me only. I waited. At six a.m., (6:00 a.m.), I still had not heard from anybody so I called back and talked to a person who identified themselves as the administrator or supervisor of the hospital, a woman, and she said she was going off duty at 7:30 a.m. and that she would have an answer for me. I said I expected a phone call in five minutes telling me what to do with this. In five minutes she called me back and said somebody would be in touch with me. At 7:30 a.m., (Employee #2) called me and he said 'I guess you need to take it to the funeral home." I called the funeral home and he (Funeral Director) said he wasn't sure if he could take it. I told him he was going to take it! He said he'd never heard of anything like this happening before. I told him, 'Well I have it and I need to get rid of it and get back to my family'. He asked me how soon I could bring it and I said 'Now!' Just as I went to leave my (name of another family member) came and he went to the funeral home with me. When we got there the guy at the funeral home met us at the door and said, 'I'll take that'. I said, 'No, not until you open the bag and I see what is in there." He said, 'I can't do that.'. I said, 'Oh yes you can and you will.' So he took us in the back to a private area and he cut open the bag. It was three bags deep, there was red bags and towels and the one right arm to the shoulder and the fingers from the other hand. That was all that was in the bag. There were no belongings...I called (Employee #2) back and asked him about the personal belongings. He said he would call me back. When he returned my call he told me the personal effects were in the safe and they would be fed-exed to (spouse of Patient #5) and she would have to sign for them. When I told her (spouse of Patient #5) the wallet and things were being mailed, she asked me what was in the bag. I told her it was just some old towels and stuff. I could not bring myself to tell her at that time what was in the bag. She was already all to pieces, and we all were, over the loss of (Patient #5). It was bad, real bad. It was about two months before I could bring myself to tell her. We never heard from the hospital again, not a word until I told her and she wanted to know what was going to be done about it. So I called them (the hospital back) and (Employee #2) told me I would have to fill out papers and that he was sure the hospital would take care of it. I filled out the papers and sent them in, and I got a letter from (Name of Employee #8) saying I had to contact someone else. Ma'am, you need to understand, this has never been about money, but now maybe it is because no one has done anything about this. No one has bothered to contact us or assure us that this could not happen to someone else...I just keep thinking, what if she (spouse of Patient #5) had told me to leave the bag on the porch and the animals had gotten to it, or if I had left it in the building and then months later she went and found it...I just can't imagine. The hospital never contacted us after that. I think they were hoping it would all just go away...No one ever told us we could make a complaint. We did not have any information on who to complain to other than the hospital and they never told us anything...".

A review of the clinical record did not include evidence that the severed arm and fingers were processed according to hospital policy. See A 0309 and A 0747 for additional information.

The policy regarding patient rights was reviewed: "Patient Rights and Responsibilities", revised 4/1/11. The policy included: "C. Policy: The (hospital name) is committed to providing an environment which fosters quality healthcare for its patients while respecting the rights of those patients. Employees are expected to assist patients, their legally responsible representatives, and their families in understanding and exercising each patient's rights. ..." The policy included: "1. Patient Rights: The Medical Center is dedicated to providing each patient the best health care and service possible. Medical Center staff understand that patients expect to receive considerate and respectful care. The Medical Center honors patients' rights to be informed about, and involved in, making decisions about care and treatment. Each patient and/or the patient's legally authorized representative has the following rights: a. to receive considerate and respectful care in an environment that preserves personal dignity. B. to have his/her cultural, psychosocial, spiritual and personal values, beliefs and preferences respected...";... to discuss concerns or file a complaint with the Medical Center's Patient Representative Office regarding experience as a patient of the Medical Center and to receive a response in a timely manner. There is also a right to an internal appeal to any such response and a right to file a complaint with an external agency..."
It could not be determined through interviews conducted with the Complainant, hospital employees or clinical record reviews, that the patient's right to a dignified death was honored. Due to a process failure of the hospital employees (see A 0309 for additional information), Patient # 5's family was presented his amputated limb and fingers, instead of his personal belongings. The family, including the patient's wife, two young children, grandmother in-law and parents-in-law were unaware of this incident until they traveled home with the patient's arm and fingers. The hospital staff did not immediately assist the family with the remains and then did not respond according to their own policy regarding complaints/grievance process.

2. The complainant also alleged that the hospital employees did not promptly respond to his phone calls and his responsibility/needed action to take with the amputated limb and fingers or respond to his continued verbal complaints regarding the incident. Documentation submitted with the complaint included letters from the hospital Administration sent to the Complainant dated 11/28/11 and 1/19/12. These letters did not include information regarding the patient's representative's right to file a grievance with the hospital directly or through the State Agency.

On 3/20/12 at 11:15 a.m. the hospital's Chief Quality and Process Improvement Officer (Employee # 1) was interviewed and the hospital's grievance log, the policy regarding patient's rights and grievance procedures was requested. The presented grievance logs did not include Patient # 5 or his representative or evidence that the hospital received or processed his complaint. At 2:30 p.m. additional information was requested of Employee # 1. She stated that if a written complaint is received it would be processed through the Patient Representative Department and these complaints were included on the log presented to the Survey Team. Employee # 1 stated the hospital should follow the same process if a verbal grievance is received by any staff member. Employee # 1 stated that at times complaints were forwarded to the Risk Management department. Further explanation of the determination of who/what department processed complaints was requested. Employee # 1 stated that if a grievance was received regarding the disposition/loss of patient belongings, the grievance was forwarded to the Risk Management department. These grievances were also requested by the Survey Team. Employee # 1 presented a log of complaint allegations that were currently un-resolved. Employee # 1 stated that there were no further complaint logs. Patient # 5 or his representative were also not on this log or any complaint/grievance tracking system presented by Employee # 1.

The hospital's policy "Patient Concerns and Grievance, dated October 1, 2011 was presented by Employee # 1. The policy stated: "The (hospital name) is committed to responding in a timely manner to Concerns and Grievances about patient care and services, whether expressed by a patient or other person on behalf of the patient. Concerns and Grievances shall be handled and resolved in a respectful, non-retaliatory manner and shall be managed in a manner consistent with applicable law, regulatory requirements and this Policy." This policy also stated: "It is the responsibility of all members of the Clinical Staff and Medical Center employees to listen to patient Concerns and Grievances, and to initiate or conduct follow-up. The Patient Representative Department ("Department") serves as a resource for the Medical Center and the Clinical Staff in addressing and resolving Patient Concerns and Grievances. The Medical Center Operating Board delegates to the Medical Center Patient Grievance Committee the responsibility for the Grievance process. The Patient Grievance Committee is responsible for the review, resolution, tracking and reporting of all Medical Center patient Grievances. Data and information regarding patient Concerns and Grievances shall be utilized by administrative and clinical leader to continually assess and improve care and services at the Medical Center." This policy also stated: "E. Procedure: 1. Concern Management Procedure: a. Upon notification of a Concern, the individual receiving it ("Recipient") must seek clarification of details from the patient or other person on behalf of a patient and determine whether the nature of the Concern falls within the scope of the Recipient's job responsibility to resolve. b. If the concern falls within the scope of the Recipient's job responsibilities, the Recipient is empowered to address and resolve the concern, either directly or with assistance from another Staff Present as needed. The Concern is considered resolved when the patient, or the person reporting the Concern on behalf of the patient, indicates that he/she is satisfied that the Concern has been addressed, in which case no further follow-up is needed. C. If the Concern falls outside the scope of the Recipient's job responsibility, he/she must immediately notify the appropriate Staff Present who can immediately address the Concern, seek immediate resolution, with assistance as required (see Section E. 3 below), and seek the immediate satisfaction of the person expressing the Concern. Once the patient or person reporting a Concern on behalf of the patient is satisfied that the Concern has been addressed, no further follow-up is needed or required. d. If a Concern is not immediately resolved to the satisfaction of the complainant, the Recipient or the individual addressing the Concern shall notify the Patient Representative Department. Notification to the Patient Representative shall include patient demographic information and a summary of the patient's Concern. The Patient Representative shall register the patient's concern as a Grievance and shall be responsible for managing the Grievance process as outlined in Item 2 below. 2. Grievance Management Procedure: a. Grievances can be lodged verbally or in writing, in person, via telephone, fax, mail or e-mail and can be addressed to any member or the Clinical Staff and/or Medical Center employee. b. Upon receipt of a Grievance, the Patient Representative and/or other person receiving it (Grievance Recipient) shall acknowledge such receipt to the complainant within seven (7) business days. The acknowledgement may be by personal visit, telephone call, e-mail or letter. All information pertinent to the Grievance shall be documentable in the Grievance management system. C. The Patient Representative and/or the Grievance Recipient shall facilitate the investigation of the Grievance by contacting the responsible member of the Clinical Staff and/or Medical Center employee who can best investigate and address the patient's Grievance. Members of the clinical staff and/or employees shall respond to the Patient Representative and/or Grievance Recipient within 48 hours from receipt of this request...d. The substance of the Grievance must be fully investigated. If the substance of the Grievance is validated, the involved service(s) or department(s) must take corrective action. The Patient Representative Department shall coordinate and review all responses. e. The Patient Representative Department and/or the departments involved in Grievance resolution shall provide the Medical Center Patient Grievance Committee with sufficient information to ensure resolution of complaints in accordance with CMS Guidelines. f. Within seven (7) days, the Medical Center must provide the patient with a written response that contains the name of the Medical Center's contact person, the steps taken to investigate the Grievance, the results of the investigation and the date of completion. If the investigation is not completed within seven (7) days, the patient or his/her representative shall be informed in writing that the investigation is underway and will be completed as soon as possible and optimally, within thirty (30) days of the receipt of the Grievance. 3. Concern and Grievance Management; Notification for Assistance: a. Depending on the nature of the Concern or Grievance, the Recipient, Manager, Staff Present or Patient Representative Department is/are responsible for notifying the following Medical Center Departments for prompt assistance in resolution:...iii. Concerns or Grievances with potential legal implications-notify Medical Center Risk Management...vii. Allegations of ....hospital compliances with CMS requirements: Notify Medical Center Office of Patient Safety..." This policy included the patient's right to lodge a complaint with outside agencies, but did not include the procedure in which the patient was informed of this recourse. The policy stated: "4. Lodging Grievances with Outside Agencies: In lieu of, or in addition to using the Grievance process outlined in this Policy, patients have the right to contact outside agencies directly to lodge a Grievance..." This policy did not include the procedure in which the patient or his representative would be notified of this option.

It could not be determined through interviews, clinical record review or hospital documentation that this policy was followed.

On 3/20/2012 at 3:25 p.m. Employee # 1 was specifically interviewed regarding Patient # 5 and his representative, including any complaint or grievance filed on Patient # 5's behalf. Employee # 1 did acknowledge that the patient's representative (Complainant) contacted the hospital by telephone at approximately 12:50 a.m. on 11/27/2011, called multiple times and did not receive an immediate answer/resolution to his immediate concern regarding Patient # 5's amputated body parts.

Employee # 1 stated that the Complainant was contacted by Employee # 2, the Associate Vice President of Hospital and Clinic Operations on 11/27/2011 at approximately 7:30 a.m. At that time, the Complainant was directed to contact a funeral home in his locality to relinquish the decedent's (Patient # 5) arm and fingers.

Employee # 1 stated that the Complainant did not file a written grievance, so the concern was not tracked or logged in the normal grievance procedure. Employee # 1 stated: "When it came back as a concern, it was about compensation." The "concern" was not processed as a complaint, but as a financial compensation request. Employee # 1 stated that the first written notification of the patient's representative was through the hospital's Risk Management Department not the Patient Representative department, as it (complaint) was "Treated as a belongings issue, not a care issue."

Employee # 1 was interviewed regarding the patient and representatives notification of their right to file an internal grievance or how/who to contact outside of the hospital to file a complaint. Employee # 1 stated that each patient received an admission packet at admission, and that the information is "Posted in the emergency department", or in the patient handbook. When informed that the patient was unable to receive the complaint information while in the Emergency Department, died before being admitted to the hospital, and that his family/representatives did not go to the ED, Employee # 1 stated: "They likely didn't get an admission packet." When asked how and when the patient's representatives were informed of their right, and how to file an internal grievance or to contact the State agency, Employee # 1 stated she was unsure, but that a letter had been sent to the patient's wife. This letter, dated 11/28/11 was reviewed by the Survey Team, and it did not include information regarding the patient's representative's right to file a grievance with the hospital or State Agency. Employee # 1 presented additional written communication between the hospital and the patient's representatives, dated 1/19/12 and 3/13/2012. Hand written documentation of telephone communication between the patient's representation with the Associate Vice President of Hospital and Clinic Operations (Employee # 2), dated 3/8/12 and 3/9/12 did not evidence that the patient's representative was informed of the hospital's grievance options, or the option to file a grievance with the State Agency.

On 3/21/2012 at 12:45 p.m. Employee # 2, the Associate VP of Hospital and Clinic Operations and Employee # 1 were interviewed. Employee # 2 stated that the Complainant's initial phone call came in at approximately 1:00 a.m. on 11/27/12, and it is unknown which hospital employee took the first phone call. Employee # 2 stated that he was not on call that night, and the Administrator on call was not able to be reached.

Employee # 2 stated that he was contacted between 6:30 a.m. and 7:00 a.m. by the House Supervisor (Employee # 7), who informed him of the event and the inability to contact the on call Administrator (Employee # 5). Employee # 2 stated that he was the first senior level Administrator notified and was not certain why he was not contacted sooner with this concern, or when the Administrator on call could not be reached. Employee # 2 stated that his first concern was contacting the family to assist them in processing the patient's remains. Employee # 2 stated that the Complainant (Patient # 5's father-in-law) repeatedly told him: "I'm not happy." When asked why this verbal complaint/grievance was processed according to the hospital's grievance policy, Employee # 1 stated the complaint "did not come through or processed as a grievance", as there was no one in the Patient/Guest Services Department on the weekends. The call went to the "Bed Center", which is the Patient Care Administrator or the Nursing Supervisor. Employee # 1 stated: "The difference is they didn't get a letter from the patient representative." Employee # 1 stated the hospital's grievance policy was not implemented, because the event occurred on a weekend and: "On Monday we could have engaged (the) Patient Representatives at that time, it did not occur to add another person into the situation." Employee # 1 stated the event information was "Transferred to Risk (management department)."

On 3/22/12 at 09:30 a.m. Employee # 1 was interviewed regarding Patient # 5's Representative's concerns and the apparent failure to implement the hospital's policy-Patient Concerns ad Grievances. Employee # 1 stated: "If it is related to belongings, it is sent to RM (Risk Management); "Once a person is deceased it is no longer a quality of care issue, it is now a belongings issue."

Employee # 1 stated that in a verbal conversation with the hospital's Risk Manager, he stated when the claim was received, they would determine what to do then. Employee # 1 stated that the hospital's policy directed that the employee who received a grievance or complaint should document the intake. Evidence that this occurred was not presented during the survey. Employee # 1 stated that the usual action for a complaint/grievance process was for the Patient Services Department to investigate and resolve, and that on the weekends the Nursing Supervisors were considered the Patient Representative. Evidence that this process was followed was not presented during the survey.

On 3/22/12 at 10:15 a.m. the Administrator of Patient and Guest Services (also referred to as the Patient Representatives Department by hospital policy) (Employee # 4) and Employee # 3, Patient/Guest Services Representative were interviewed. Employee # 4 stated after business hours or during weekends, the hospital's Nursing Supervisors were paged to deal with complaints or concerns. Employee # 4 stated the Supervisors are required to document complaints or concerns and this documentation would be forwarded to the Patient/Guest Services Department the next business day. Employee # 4 stated that if the concern or complaint could not be immediately resolved, or the Complainant was not satisfied within twenty-four hours, "It becomes a grievance." Employee # 4 stated all patient/patient representative complaints or grievances were to be processed through her department. Employee # 3 stated that a complainant would be informed verbally of the hospital's grievance process, and if not happy with the outcome, a second review would be conducted and the complainant would be given the option to contact the State Agency. Employee # 4 stated that complaints did not always get processed through the weekly Grievance Committee review, and there is "more than one data base", related to the nature of the complaint, yet all complaints should be processed according to the policy and "be reviewed, should track and treat as a grievance." Employee # 3 stated that grievances sent to the Risk Management department are also processed through the Patient/Guest Services Department and are included in the Quality Report system. Employee # 3 and # 4 stated they had no knowledge of a complaint filed by or on behalf of Patient # 5 or his representative, that the complaint was not processed through their department or Quality Committee, or Grievance Committee.

On 3/22/12 at 11:20 a.m. Employee # 1 was interviewed and she stated not all grievances are sent to Risk Management, "...Only those we feel may be a claim." Employee # 1 also stated: "...(Complaint) went directly to RM (risk management department)", and "this is about remains or property risk." Employee # 1 stated she was not certain why it was not incorporated or processed by the Patient's Grievance investigators (Patient and Guest Services).
The hospital staff failed to process Patient # 5's representative's grievance through its own policy and did not provide the representative with further information regarding his right to file a grievance with the State agency.

PATIENT RIGHTS: GRIEVANCES

Tag No.: A0118

Based on a complaint investigation, Complainant interview, employee interview, clinical record review, policy and procedure review, and a review of hospital documentation, the hospital staff failed for one of six patient's reviewed (Patient # 5), to inform the patient's family/representative of the hospital's internal grievance process, including who to contact to file a complaint/grievance, or a phone number and address for lodging a complaint with the State Agency.

The patient suffered a traumatic amputation of his right arm and left fingers. The patient died at the above named hospital and his amputated body parts were inadvertently given to his family, as his belongings. The hospital did not inform his family of the procedure to file a complaint within the hospital system or with outside entities.

Findings:

A complaint investigation was conducted at the above named hospital on 3/20/12 through 3/22/2012. The patient named in the allegations will be referred to as "Patient # 5." The complaint alleged that the Complainant (Patient # 5's Representative) contacted the hospital employees by telephone on 11/27/2011 at approximately 12:50 a.m. on behalf of the patient and the patient's wife. The Complainant did not receive immediate resolution to his complaint/grievance and has not yet (3/21/12) received a resolution to his concerns. The patient's representative was not informed of the hospital's policy or his right to file a grievance, or to contact the State Agency with his grievance.

1. The complaint alleged that after Patient # 5 experienced a traumatic accident resulting in the amputation of his right arm and fingers from his left hand. The patient died at this hospital and the amputated limbs were sent home with the patient's family. The Complainant was interviewed by telephone on 3/20/12 at 3:00 p.m. and he stated, in part: "It was about twenty minutes till one (12:40 a.m.) and when I called, I don't know who I spoke to because I just wasn't thinking to get a name or anything, I was just thinking I needed to now what to do with it (contents of the bag). This person said, 'Well you signed for it', like it was my fault we had taken home these body parts, and I told him that we had not signed for anything. He then told us again that we had 'signed for it' and that it wasn't his 'department' but gave me another number to call do I called the other number and that person, and again I did not get a name, said they couldn't believe that happened and they would be back in touch with me. (Spouse of Patient #5) did not know what was going on so I told the person on the phone under no circumstances to call her, to call me only. I waited. At six a.m., (6:00 a.m.), I still had not heard from anybody so I called back and talked to a person who identified themselves as the administrator or supervisor of the hospital, a woman, and she said she was going off duty at 7:30 a.m. and that she would have an answer for me. I said I expected a phone call in five minutes telling me what to do with this. In five minutes she called me back and said somebody would be in touch with me. At 7:30 a.m., (Employee #2) called me and he said 'I guess you need to take it to the funeral home." I called the funeral home and he (Funeral Director) said he wasn't sure if he could take it. I told him he was going to take it! He said he'd never heard of anything like this happening before. I told him, 'Well I have it and I need to get rid of it and get back to my family'. He asked me how soon I could bring it and I said 'Now!' Just as I went to leave my (name of another family member) came and he went to the funeral home with me. When we got there the guy at the funeral home met us at the door and said, 'I'll take that'. I said, 'No, not until you open the bag and I see what is in there." He said, 'I can't do that.'. I said, 'Oh yes you can and you will.' So he took us in the back to a private area and he cut open the bag. It was three bags deep, there was red bags and towels and the one right arm to the shoulder and the fingers from the other hand. That was all that was in the bag. There were no belongings...I called (Employee #2) back and asked him about the personal belongings. He said he would call me back. When he returned my call he told me the personal effects were in the safe and they would be fed-exed to (spouse of Patient #5) and she would have to sign for them. When I told her (spouse of Patient #5) the wallet and things were being mailed, she asked me what was in the bag. I told her it was just some old towels and stuff. I could not bring myself to tell her at that time what was in the bag. She was already all to pieces and we all were over the loss of (Patient #5). It was bad, real bad. It was about two months before I could bring myself to tell her. We never heard from the hospital again, not a word until I told her and she wanted to know what was going to be done about it. So I called them (the hospital back) and (Employee #2) told me I would have to fill out papers and that he was sure the hospital would take care of it. I filled out the papers and sent them in, and I got a letter from (Name of Employee #8 ) saying I had to contact someone else. Ma'am, you need to understand, this has never been about money, but now maybe it is because no one has done anything about this. No one has bothered to contact us or assure us that this could not happen to someone else...I just keep thinking, what if she (spouse of Patient #5) had told me to leave the bag on the porch and the animals had gotten to it, or if I had left it in the building and then months later she went and found it...I just cant imagine. The hospital never contacted us after that. I think they were hoping it would all just go away...No one ever told us we could make a complaint. We did not have any information on who to complain to other than the hospital and they never told us anything...".

The policy regarding patient rights was reviewed: "Patient Rights and Responsibilities", revised 4/1/11. The policy included: "C. Policy: ... to discuss concerns or file a complaint with the Medical Center's Patient Representative Office regarding experience as a patient of the Medical Center and to receive a response in a timely manner. There is also a right to an internal appeal to such response and a right to file a complaint with an external agency..."

It could not be determined through interviews conducted with the Complainant, hospital employees, policy review or clinical record reviews, that the patient's representative's right to file a complaint or grievance process was honored.

The complaint alleged that the hospital employees did not promptly respond to his phone calls and his responsibility/needed action to take with the amputated limb and fingers or respond to his continued verbal complaints regarding the incident. Documentation submitted with the complaint included letters from the hospital Administration sent to the Complainant dated 11/28/11 and 1/19/12. These letters did not include information regarding the patient's representative's right to file a grievance with the hospital directly or through the State Agency.

On 3/20/12 at 11:15 a.m. the hospital's Chief Quality and Process Improvement Officer (Employee # 1) was interviewed and the hospital's grievance log, the policy regarding patient's rights and grievance procedures was requested. The presented grievance logs did not include Patient # 5 or his representative or evidence that the hospital received or processed his complaint. At 2:30 p.m. additional information was requested of Employee # 1. She stated that if a written complaint is received it would be processed through the Patient Representative Department and these complaints were included on the log presented to the Survey Team. Employee # 1 stated the hospital should follow the same process if a verbal grievance is received by any staff member. Employee # 1 stated that at times complaints were forwarded to the Risk Management department. Further explanation of the determination of who/what department processed complaints was requested. Employee # 1 stated that if a grievance was received regarding the disposition/loss of patient belongings, the grievance was forwarded to the Risk Management department. These grievances were also requested by the Survey Team. Employee # 1 presented a log of complaint allegations that were currently un-resolved. Employee # 1 stated that there were no further complaint logs. Patient # 5 or his representative were also not on this log or any complaint/grievance tracking system presented by Employee # 1.

The hospital's policy "Patient Concerns and Grievance, dated October 1, 2011 was presented by Employee # 1. The policy stated: "The (hospital name) is committed to responding in a timely manner to Concerns and Grievances about patient care and services, whether expressed by a patient or other person on behalf of the patient. Concerns and Grievances shall be handled and resolved in a respectful, non-retaliatory manner and shall be managed in a manner consistent with applicable law, regulatory requirements and this Policy." This policy also stated: "It is the responsibility of all members of the Clinical Staff and Medical Center employees to listen to patient Concerns and Grievances, and to initiate or conduct follow-up. The Patient Representative Department ("Department") serves as a resource for the Medical Center and the Clinical Staff in addressing and resolving Patient Concerns and Grievances. The Medical Center Operating Board delegates to the Medical Center Patient Grievance Committee the responsibility for the Grievance process. The Patient Grievance Committee is responsible for the review, resolution, tracking and reporting of all Medical Center patient Grievances. Data and information regarding patient Concerns and Grievances shall be utilized by administrative and clinical leader to continually assess and improve care and services at the Medical Center." This policy also stated: "E. Procedure: 1. Concern Management Procedure: a. Upon notification of a Concern, the individual receiving it ("Recipient") must seek clarification of details from the patient or other person on behalf of a patient and determine whether the nature of the Concern falls within the scope of the Recipient's job responsibility to resolve. b. If the concern falls within the scope of the Recipient's job responsibilities, the Recipient is empowered to address and resolve the concern, either directly or with assistance from another Staff Present as needed. The Concern is considered resolved when the patient, or the person reporting the Concern on behalf of the patient, indicates that he/she is satisfied that the Concern has been addressed, in which case no further follow-up is needed. C. If the Concern falls outside the scope of the Recipient's job responsibility, he/she must immediately notify the appropriate Staff Present who can immediately address the Concern, seek immediate resolution, with assistance as required (see Section E. 3 below), and seek the immediate satisfaction of the person expressing the Concern. Once the patient or person reporting a Concern on behalf of the patient is satisfied that the Concern has been addressed, no further follow-up is needed or required. d. If a Concern is not immediately resolved to the satisfaction of the complainant, the Recipient or the individual addressing the Concern shall notify the Patient Representative Department. Notification to the Patient Representative shall include patient demographic information and a summary of the patient's Concern. The Patient Representative shall register the patient's concern as a Grievance and shall be responsible for managing the Grievance process as outlined in Item 2 below. 2. Grievance Management Procedure: a. Grievances can be lodged verbally or in writing, in person, via telephone, fax, mail or e-mail and can be addressed to any member or the Clinical Staff and/or Medical Center employee. b. Upon receipt of a Grievance, the Patient Representative and/or other person receiving it (Grievance Recipient) shall acknowledge such receipt to the complainant within seven (7) business days. The acknowledgement may be by personal visit, telephone call, e-mail or letter. All information pertinent to the Grievance shall be documentable in the Grievance management system. C. The Patient Representative and/or the Grievance Recipient shall facilitate the investigation of the Grievance by contacting the responsible member of the Clinical Staff and/or Medical Center employee who can best investigate and address the patient's Grievance. Members of the clinical staff and/or employees shall respond to the Patient Representative and/or Grievance Recipient within 48 hours from receipt of this request...d. The substance of the Grievance must be fully investigated. If the substance of the Grievance is validated, the involved service(s) or department(s) must take corrective action. The Patient Representative Department shall coordinate and review all responses. e. The Patient Representative Department and/or the departments involved in Grievance resolution shall provide the Medical Center Patient Grievance Committee with sufficient information to ensure resolution of complaints in accordance with CMS Guidelines. f. Within seven (7) days, the Medical Center must provide the patient with a written response that contains the name of the Medical Center's contact person, the steps taken to investigate the Grievance, the results of the investigation and the date of completion. If the investigation is not completed within seven (7) days, the patient or his/her representative shall be informed in writing that the investigation is underway and will be completed as soon as possible and optimally, within thirty (30) days of the receipt of the Grievance. 3. Concern and Grievance Management; Notification for Assistance: a. Depending on the nature of the Concern or Grievance, the Recipient, Manager, Staff Present or Patient Representative Department is/are responsible for notifying the following Medical Center Departments for prompt assistance in resolution:...iii. Concerns or Grievances with potential legal implications-notify Medical Center Risk Management...vii. Allegations of ....hospital compliances with CMS requirements: Notify Medical Center Office of Patient Safety..." This policy included the patient's right to lodge a complaint with outside agencies, but did not include the procedure in which the patient was informed of this recourse. The policy also stated: "4. Lodging Grievances with Outside Agencies: In lieu of, or in addition to using the Grievance process outlined in this Policy, patients have the right to contact outside agencies directly to lodge a Grievance..." This policy did not include the procedure in which the patient or his representative would be notified of this option.

It could not be determined through interviews, clinical record review or hospital documentation that this policy was followed.

On 3/20/2012 at 3:25 p.m. Employee # 1 was specifically interviewed regarding Patient # 5 and his representative, including any complaint or grievance filed on Patient # 5's behalf. Employee # 1 did acknowledge that the patient's representative (Complainant) contacted the hospital by telephone at approximately 12:50 a.m. on 11/27/2011, called multiple times and did not receive an immediate answer/resolution to his immediate concern regarding Patient # 5's amputated body parts. Employee # 1 stated that the Complainant was contacted by Employee # 2, the Associate Vice President of Hospital and Clinic Operations on 11/27/2011 at approximately 7:30 a.m. At that time, the Complainant was directed to contact a funeral home in his locality to relinquish the decedent's (Patient # 5) arm and fingers. Employee # 1 stated that the Complainant did not file a written grievance, so the concern was not tracked or logged in the normal grievance procedure. Employee # 1 stated: "When it came back as a concern, it was about compensation." The "concern" was not processed as a complaint, but as a financial compensation request. Employee # 1 stated that the first written notification of the patient's representative was through the hospital's Risk Management Department not the Patient Representative department, as it (complaint) was "Treated as a belongings issue, not a care issue." Employee # 1 was interviewed regarding the patient and representatives notification of their right to file an internal grievance or how/who to contact outside of the hospital to file a complaint. Employee # 1 stated that each patient received an admission packet at admission, and that the information is "Posted in the emergency department", or in the patient handbook. When informed that the patient was unable to receive the complaint information while in the Emergency Department, died before being admitted to the hospital, and that his family/representatives did not go to the ED, Employee # 1 stated: "They likely didn't get an admission packet." When asked how and when the patient's representatives were informed of their right, and how to file an internal grievance or to contact the State agency, Employee # 1 stated she was unsure, but that a letter had been sent to the patient's wife. This letter, dated 11/28/11 was reviewed by the Survey Team, and it did not include information regarding the patient's representative's right to file a grievance with the hospital or State Agency. Employee # 1 presented additional written communication between the hospital and the patient's representatives, dated 1/19/12 and 3/13/2012. Hand written documentation of telephone communication between the patient's representation with the Associate Vice President of Hospital and Clinic Operations (Employee # 2), dated 3/8/12 and 3/9/12 did not evidence that the patient's representative were informed of the hospital's grievance options, or the option to file a grievance with the State Agency.

On 3/21/2012 at 12:45 p.m. Employee # 2, the Associate VP of Hospital and Clinic Operations and Employee # 1 were interviewed. Employee # 2 stated that the Complainant's initial phone call came in at approximately 1:00 a.m. on 11/27/12, and it is unknown which hospital employee took the first phone call. Employee # 2 stated that he was not on call that night, and the Administrator on call was not able to be reached. Employee # 2 stated that he was contacted between 6:30 a.m. and 7:00 a.m. by the House Supervisor (Employee # 7), who informed him of the event and the inability to contact the on call Administrator (Employee # 5). Employee # 2 stated that he was the first senior level Administrator notified and was not certain why he was not contacted sooner with this concern, or when the Administrator on call could not be reached. Employee # 2 stated that his first concern was contacting the family to assist them in processing the patient's remains. Employee # 2 stated that the Complainant (Patient # 5's father-in-law) repeatedly told him: "I'm not happy." When asked why this verbal complaint/grievance was processed according to the hospital's grievance policy, Employee # 1 stated the complaint "did not come through or processed as a grievance", as there was no one in the Patient/Guest Services Department on the weekends. The call went to the "Bed Center", which is the Patient Care Administrator or the Nursing Supervisor. Employee # 1 stated: "The difference is they didn't get a letter from the patient representative." Employee # 1 stated the hospital's grievance policy was not implemented, because the event occurred on a weekend and: "On Monday we could have engaged (the) Patient Representatives at that time, it did not occur to add another person into the situation." Employee # 1 stated the event information was "Transferred to Risk (management department)."

On 3/22/12 at 09:30 a.m. Employee # 1 was interviewed regarding Patient # 5's Representative's concerns and the apparent failure to implement the hospital's policy-Patient Concerns ad Grievances. Employee # 1 stated: "If it is related to belongings, it is sent to RM (Risk Management); "Once a person is deceased it is no longer a quality of care issue, it is now a belongings issue." Employee # 1 stated that in a verbal conversation with the hospital's Risk Manager, he stated when the claim was received, they would determine what to do then. Employee # 1 stated that the hospital's policy directed that the employee who received a grievance or complaint should document the intake. Evidence that this occurred was not presented during the survey. Employee # 1 stated that the usual action for a complaint/grievance process was for the Patient Services Department to investigate and resolve, and that on the weekends the Nursing Supervisors were considered the Patient Representative. Evidence that this process was followed was not presented during the survey.

On 3/22/12 at 10:15 a.m. the Administrator of Patient and Guest Services (also referred to as the Patient Representatives Department by hospital policy) (Employee # 4) and Employee # 3, Patient/Guest Services Representative were interviewed. Employee # 4 stated after business hours or during weekends, the hospital's Nursing Supervisors were paged to deal with complaints or concerns. Employee # 4 stated the Supervisors are required to document complaints or concerns and this documentation would be forwarded to the Patient/Guest Services Department the next business day. Employee # 4 stated that if the concern or complaint could not be immediately resolved, or the Complainant was not satisfied within twenty-four hours, "It becomes a grievance." Employee # 4 sated all patient/patient representative complaints or grievances were to be processed through her department. Employee # 3 stated that a complainant would be informed verbally of the hospital's grievance process, and if not happy with the outcome, a second review would be conducted and the complainant would be given the option to contact the State Agency. Employee # 4 stated that complaints did not always get processed through the weekly Grievance Committee review, and there is "more than one data base", related to the nature of the complaint, yet all complaints should be processed according to the policy and "be reviewed, should track and treat as a grievance." Employee # 3 stated that grievances sent to the Risk Management department are also processed through the Patient/Guest Services Department and are included in the Quality Report system. Employee # 3 and # 4 stated they had no knowledge of a complaint filed by or on behalf of Patient # 5 or his representative, that the complaint was not processed through their department or Quality Committee, or Grievance Committee.

On 3/22/12 at 11:20 a.m. Employee # 1 was interviewed and she stated not all grievances are sent to Risk Management, "...Only those we feel may be a claim." Employee # 1 also stated: "...(Complaint) went directly to RM (risk management department)", and "this is about remains or property risk." Employee # 1 stated she was not certain why it was not incorporated or processed by the Patient's Grievance investigators (Patient and Guest Services).
The hospital staff failed to process Patient # 5's representative's grievance through it's own policy and did not provide the representative with further information regarding his right to file a grievance with the State agency.

PATIENT RIGHTS: GRIEVANCE PROCEDURES

Tag No.: A0121

Based on a complaint investigation, Complainant interview, employee interview, clinical record review, policy and procedure review, and a review of hospital documentation, the hospital staff failed for one of six patient's reviewed (Patient # 5), to inform the patient's family/representative of the hospital's internal grievance process, including who to contact to file a complaint/grievance, or a phone number and address for lodging a complaint with the State agency.

The patient suffered a traumatic amputation of his right arm and left fingers. The patient died at the above named hospital and his amputated body parts were inadvertently given to his family, as his belongings. The hospital did not inform his family of the procedure to file a complaint within the hospital system or with outside entities.

Findings:

A complaint investigation was conducted at the above named hospital on 3/20/12 through 3/22/2012. The patient named in the allegations will be referred to as "Patient # 5." The complaint alleged that the Complainant (Patient # 5's Representative) contacted the hospital employees by telephone on 11/27/2011 at approximately 12:50 a.m. on behalf of the patient and the patient's wife. The Complainant did not receive immediate resolution to his complaint/grievance and has not yet (3/21/12) received a resolution to his concerns. The patient's representative was not informed of the hospital's policy or his right to file a grievance, or to contact the State Agency with his grievance.

1. The complaint alleged that after Patient # 5 experienced a traumatic accident resulting in the amputation of his right arm and fingers from his left hand. The patient died at this hospital and the amputated limbs were sent home with the patient's family. The Complainant was interviewed by telephone on 3/20/12 at 3:00 p.m. and he stated, in part: "It was about twenty minutes till one (12:40 a.m.) and when I called, I don't know who I spoke to because I just wasn't thinking to get a name or anything, I was just thinking I needed to now what to do with it (contents of the bag). This person said, 'Well you signed for it', like it was my fault we had taken home these body parts, and I told him that we had not signed for anything. He then told us again that we had 'signed for it' and that it wasn't his 'department' but gave me another number to call do I called the other number and that person, and again I did not get a name, said they couldn't believe that happened and they would be back in touch with me. (Spouse of Patient #5) did not know what was going on so I told the person on the phone under no circumstances to call her, to call me only. I waited. At six a.m., (6:00 a.m.), I still had not heard from anybody so I called back and talked to a person who identified themselves as the administrator or supervisor of the hospital, a woman, and she said she was going off duty at 7:30 a.m. and that she would have an answer for me. I said I expected a phone call in five minutes telling me what to do with this. In five minutes she called me back and said somebody would be in touch with me. At 7:30 a.m., (Employee #2) called me and he said 'I guess you need to take it to the funeral home." I called the funeral home and he (Funeral Director) said he wasn't sure if he could take it. I told him he was going to take it! He said he'd never heard of anything like this happening before. I told him, 'Well I have it and I need to get rid of it and get back to my family'. He asked me how soon I could bring it and I said 'Now!' Just as I went to leave my (name of another family member) came and he went to the funeral home with me. When we got there the guy at the funeral home met us at the door and said, 'I'll take that'. I said, 'No, not until you open the bag and I see what is in there." He said, 'I can't do that.'. I said, 'Oh yes you can and you will.' So he took us in the back to a private area and he cut open the bag. It was three bags deep, there was red bags and towels and the one right arm to the shoulder and the fingers from the other hand. That was all that was in the bag. There were no belongings...I called (Employee #2) back and asked him about the personal belongings. He said he would call me back. When he returned my call he told me the personal effects were in the safe and they would be fed-exed to (spouse of Patient #5) and she would have to sign for them. When I told her (spouse of Patient #5) the wallet and things were being mailed, she asked me what was in the bag. I told her it was just some old towels and stuff. I could not bring myself to tell her at that time what was in the bag. She was already all to pieces and we all were over the loss of (Patient #5). It was bad, real bad. It was about two months before I could bring myself to tell her. We never heard from the hospital again, not a word until I told her and she wanted to know what was going to be done about it. So I called them (the hospital back) and (Employee #2) told me I would have to fill out papers and that he was sure the hospital would take care of it. I filled out the papers and sent them in, and I got a letter from (Name of Employee #8 ) saying I had to contact someone else. Ma'am, you need to understand, this has never been about money, but now maybe it is because no one has done anything about this. No one has bothered to contact us or assure us that this could not happen to someone else...I just keep thinking, what if she (spouse of Patient #5) had told me to leave the bag on the porch and the animals had gotten to it, or if I had left it in the building and then months later she went and found it...I just cant imagine. The hospital never contacted us after that. I think they were hoping it would all just go away...No one ever told us we could make a complaint. We did not have any information on who to complain to other than the hospital and they never told us anything...".

The policy regarding patient rights was reviewed: "Patient Rights and Responsibilities", revised 4/1/11. The policy included: "C. Policy: ... to discuss concerns or file a complaint with the Medical Center's Patient Representative Office regarding experience as a patient of the Medical Center and to receive a response in a timely manner. There is also a right to an internal appeal to such response and a right to file a complaint with an external agency..."

It could not be determined through interviews conducted with the Complainant, hospital employees, policy review or clinical record reviews, that the patient's representative's right to file a complaint or grievance process was honored.

The complaint alleged that the hospital employees did not promptly respond to his phone calls and his responsibility/needed action to take with the amputated limb and fingers or respond to his continued verbal complaints regarding the incident. Documentation submitted with the complaint included letters from the hospital Administration sent to the Complainant dated 11/28/11 and 1/19/12. These letters did not include information regarding the patient's representative's right to file a grievance with the hospital directly or through the State Agency.

On 3/20/12 at 11:15 a.m. the hospital's Chief Quality and Process Improvement Officer (Employee # 1) was interviewed and the hospital's grievance log, the policy regarding patient's rights and grievance procedures was requested. The presented grievance logs did not include Patient # 5 or his representative or evidence that the hospital received or processed his complaint. At 2:30 p.m. additional information was requested of Employee # 1. She stated that if a written complaint is received it would be processed through the Patient Representative Department and these complaints were included on the log presented to the Survey Team. Employee # 1 stated the hospital should follow the same process if a verbal grievance is received by any staff member. Employee # 1 stated that at times complaints were forwarded to the Risk Management department. Further explanation of the determination of who/what department processed complaints was requested. Employee # 1 stated that if a grievance was received regarding the disposition/loss of patient belongings, the grievance was forwarded to the Risk Management department. These grievances were also requested by the Survey Team. Employee # 1 presented a log of complaint allegations that were currently un-resolved. Employee # 1 stated that there were no further complaint logs. Patient # 5 or his representative were also not on this log or any complaint/grievance tracking system presented by Employee # 1.

The hospital's policy "Patient Concerns and Grievance, dated October 1, 2011 was presented by Employee # 1. The policy stated: "The (hospital name) is committed to responding in a timely manner to Concerns and Grievances about patient care and services, whether expressed by a patient or other person on behalf of the patient. Concerns and Grievances shall be handled and resolved in a respectful, non-retaliatory manner and shall be managed in a manner consistent with applicable law, regulatory requirements and this Policy." This policy also stated: "It is the responsibility of all members of the Clinical Staff and Medical Center employees to listen to patient Concerns and Grievances, and to initiate or conduct follow-up. The Patient Representative Department ("Department") serves as a resource for the Medical Center and the Clinical Staff in addressing and resolving Patient Concerns and Grievances. The Medical Center Operating Board delegates to the Medical Center Patient Grievance Committee the responsibility for the Grievance process. The Patient Grievance Committee is responsible for the review, resolution, tracking and reporting of all Medical Center patient Grievances. Data and information regarding patient Concerns and Grievances shall be utilized by administrative and clinical leader to continually assess and improve care and services at the Medical Center." This policy also stated: "E. Procedure: 1. Concern Management Procedure: a. Upon notification of a Concern, the individual receiving it ("Recipient") must seek clarification of details from the patient or other person on behalf of a patient and determine whether the nature of the Concern falls within the scope of the Recipient's job responsibility to resolve. b. If the concern falls within the scope of the Recipient's job responsibilities, the Recipient is empowered to address and resolve the concern, either directly or with assistance from another Staff Present as needed. The Concern is considered resolved when the patient, or the person reporting the Concern on behalf of the patient, indicates that he/she is satisfied that the Concern has been addressed, in which case no further follow-up is needed. C. If the Concern falls outside the scope of the Recipient's job responsibility, he/she must immediately notify the appropriate Staff Present who can immediately address the Concern, seek immediate resolution, with assistance as required (see Section E. 3 below), and seek the immediate satisfaction of the person expressing the Concern. Once the patient or person reporting a Concern on behalf of the patient is satisfied that the Concern has been addressed, no further follow-up is needed or required. d. If a Concern is not immediately resolved to the satisfaction of the complainant, the Recipient or the individual addressing the Concern shall notify the Patient Representative Department. Notification to the Patient Representative shall include patient demographic information and a summary of the patient's Concern. The Patient Representative shall register the patient's concern as a Grievance and shall be responsible for managing the Grievance process as outlined in Item 2 below. 2. Grievance Management Procedure: a. Grievances can be lodged verbally or in writing, in person, via telephone, fax, mail or e-mail and can be addressed to any member or the Clinical Staff and/or Medical Center employee. b. Upon receipt of a Grievance, the Patient Representative and/or other person receiving it (Grievance Recipient) shall acknowledge such receipt to the complainant within seven (7) business days. The acknowledgement may be by personal visit, telephone call, e-mail or letter. All information pertinent to the Grievance shall be documentable in the Grievance management system. C. The Patient Representative and/or the Grievance Recipient shall facilitate the investigation of the Grievance by contacting the responsible member of the Clinical Staff and/or Medical Center employee who can best investigate and address the patient's Grievance. Members of the clinical staff and/or employees shall respond to the Patient Representative and/or Grievance Recipient within 48 hours from receipt of this request...d. The substance of the Grievance must be fully investigated. If the substance of the Grievance is validated, the involved service(s) or department(s) must take corrective action. The Patient Representative Department shall coordinate and review all responses. e. The Patient Representative Department and/or the departments involved in Grievance resolution shall provide the Medical Center Patient Grievance Committee with sufficient information to ensure resolution of complaints in accordance with CMS Guidelines. f. Within seven (7) days, the Medical Center must provide the patient with a written response that contains the name of the Medical Center's contact person, the steps taken to investigate the Grievance, the results of the investigation and the date of completion. If the investigation is not completed within seven (7) days, the patient or his/her representative shall be informed in writing that the investigation is underway and will be completed as soon as possible and optimally, within thirty (30) days of the receipt of the Grievance. 3. Concern and Grievance Management; Notification for Assistance: a. Depending on the nature of the Concern or Grievance, the Recipient, Manager, Staff Present or Patient Representative Department is/are responsible for notifying the following Medical Center Departments for prompt assistance in resolution:...iii. Concerns or Grievances with potential legal implications-notify Medical Center Risk Management...vii. Allegations of ....hospital compliances with CMS requirements: Notify Medical Center Office of Patient Safety..." This policy included the patient's right to lodge a complaint with outside agencies, but did not include the procedure in which the patient was informed of this recourse. The policy stated: "4. Lodging Grievances with Outside Agencies: In lieu of, or in addition to using the Grievance process outlined in this Policy, patients have the right to contact outside agencies directly to lodge a Grievance..." This policy did not include the procedure in which the patient or his representative would be notified of this option.

It could not be determined through interviews, clinical record review or hospital documentation that this policy was followed.

On 3/20/2012 at 3:25 p.m. Employee # 1 was specifically interviewed regarding Patient # 5 and his representative, including any complaint or grievance filed on Patient # 5's behalf. Employee # 1 did acknowledge that the patient's representative (Complainant) contacted the hospital by telephone at approximately 12:50 a.m. on 11/27/2011, called multiple times and did not receive an immediate answer/resolution to his immediate concern regarding Patient # 5's amputated body parts. Employee # 1 stated that the Complainant was contacted by Employee # 2, the Associate Vice President of Hospital and Clinic Operations on 11/27/2011 at approximately 7:30 a.m. At that time, the Complainant was directed to contact a funeral home in his locality to relinquish the decedent's (Patient # 5) arm and fingers. Employee # 1 stated that the Complainant did not file a written grievance, so the concern was not tracked or logged in the normal grievance procedure. Employee # 1 stated: "When it came back as a concern, it was about compensation." The "concern" was not processed as a complaint, but as a financial compensation request. Employee # 1 stated that the first written notification of the patient's representative was through the hospital's Risk Management Department not the Patient Representative department, as it (complaint) was "Treated as a belongings issue, not a care issue." Employee # 1 was interviewed regarding the patient and representatives notification of their right to file an internal grievance or how/who to contact outside of the hospital to file a complaint. Employee # 1 stated that each patient received an admission packet at admission, and that the information is "Posted in the emergency department", or in the patient handbook. When informed that the patient was unable to receive the complaint information while in the Emergency Department, died before being admitted to the hospital, and that his family/representatives did not go to the ED, Employee # 1 stated: "They likely didn't get an admission packet." When asked how and when the patient's representatives were informed of their right, and how to file an internal grievance or to contact the State agency, Employee # 1 stated she was unsure, but that a letter had been sent to the patient's wife. This letter, dated 11/28/11 was reviewed by the Survey Team, and it did not include information regarding the patient's representative's right to file a grievance with the hospital or State Agency. Employee # 1 presented additional written communication between the hospital and the patient's representatives, dated 1/19/12 and 3/13/2012. Hand written documentation of telephone communication between the patient's representation with the Associate Vice President of Hospital and Clinic Operations (Employee # 2), dated 3/8/12 and 3/9/12 did not evidence that the patient's representative were informed of the hospital's grievance options, or the option to file a grievance with the State Agency.

On 3/21/2012 at 12:45 p.m. Employee # 2, the Associate VP of Hospital and Clinic Operations and Employee # 1 were interviewed. Employee # 2 stated that the Complainant's initial phone call came in at approximately 1:00 a.m. on 11/27/12, and it is unknown which hospital employee took the first phone call. Employee # 2 stated that he was not on call that night, and the Administrator on call was not able to be reached. Employee # 2 stated that he was contacted between 6:30 a.m. and 7:00 a.m. by the House Supervisor (Employee # 7), who informed him of the event and the inability to contact the on call Administrator (Employee # 5). Employee # 2 stated that he was the first senior level Administrator notified and was not certain why he was not contacted sooner with this concern, or when the Administrator on call could not be reached. Employee # 2 stated that his first concern was contacting the family to assist them in processing the patient's remains. Employee # 2 stated that the Complainant (Patient # 5's father-in-law) repeatedly told him: "I'm not happy." When asked why this verbal complaint/grievance was processed according to the hospital's grievance policy, Employee # 1 stated the complaint "did not come through or processed as a grievance", as there was no on in the Patient/Guest Services Department on the weekends. The call went to the "Bed Center", which is the Patient Care Administrator or the Nursing Supervisor. Employee # 1 stated: "The difference is they didn't get a letter from the patient representative." Employee # 1 stated the hospital's grievance policy was not implemented, because the event occurred on a weekend and: "On Monday we could have engaged (the) Patient Representatives at that time, it did not occur to add another person into the situation." Employee # 1 stated the event information was "Transferred to Risk (management department)."

On 3/22/12 at 09:30 a.m. Employee # 1 was interviewed regarding Patient # 5's Representative's concerns and the apparent failure to implement the hospital's policy-Patient Concerns ad Grievances. Employee # 1 stated: "If it is related to belongings, it is sent to RM (Risk Management); "Once a person is deceased it is no longer a quality of care issue, it is now a belongings issue." Employee # 1 stated that in a verbal conversation with the hospital's Risk Manager, he stated when the claim was received, they would determine what to do then. Employee # 1 stated that the hospital's policy directed that the employee who received a grievance or complaint should document the intake. Evidence that this occurred was not presented during the survey. Employee # 1 stated that the usual action for a complaint/grievance process was for the Patient Services Department to investigate and resolve, and that on the weekends the Nursing Supervisors were considered the Patient Representative. Evidence that this process was followed was not presented during the survey.

On 3/22/12 at 10:15 a.m. the Administrator of Patient and Guest Services (also referred to as the Patient Representatives Department by hospital policy) (Employee # 4) and Employee # 3, Patient/Guest Services Representative were interviewed. Employee # 4 stated after business hours or during weekends, the hospital's Nursing Supervisors were paged to deal with complaints or concerns. Employee # 4 stated the Supervisors are required to document complaints or concerns and this documentation would be forwarded to the Patient/Guest Services Department the next business day. Employee # 4 stated that if the concern or complaint could not be immediately resolved, or the Complainant was not satisfied within twenty-four hours, "It becomes a grievance." Employee # 4 sated all patient/patient representative complaints or grievances were to be processed through her department. Employee # 3 stated that a complainant would be informed verbally of the hospital's grievance process, and if not happy with the outcome, a second review would be conducted and the complainant would be given the option to contact the State Agency. Employee # 4 stated that complaints did not always get processed through the weekly Grievance Committee review, and there is "more than one data base", related to the nature of the complaint, yet all complaints should be processed according to the policy and "be reviewed, should track and treat as a grievance." Employee # 3 stated that grievances sent to the Risk Management department are also processed through the Patient/Guest Services Department and are included in the Quality Report system. Employee # 3 and # 4 stated they had no knowledge of a complaint filed by or on behalf of Patient # 5 or his representative, that the complaint was not processed through their department or Quality Committee, or Grievance Committee.

On 3/22/12 at 11:20 a.m. Employee # 1 was interviewed and she stated not all grievances are sent to Risk Management, "...Only those we feel may be a claim." Employee # 1 also stated: "...(Complaint) went directly to RM (risk management department)", and "this is about remains or property risk." Employee # 1 stated she was not certain why it was not incorporated or processed by the Patient's Grievance investigators (Patient and Guest Services).
The hospital staff failed to process Patient # 5's representative's grievance through its own policy and did not provide the representative with further information regarding his right to file a grievance with the State agency.

QAPI

Tag No.: A0263

This Condition is not met based on a complaint investigation, interviews, medical record reviews and hospital document reviews. The facility staff failed to ensure that the quality assurance performance improvement (QAPI) program addressed and took action to prevent errors and to prevent breaks in infection control standards for two of six patient's (Patient #5 and Patient #6). In addition, the facility staff failed to support patient rights and the grievance process for one patient, Patient #5.

The findings include:

On 11/26/2011 Patient #5 was brought to the Emergency Department (ED) with an amputated right arm and several fingers of the left hand due to a farming accident. The staff, including physicians, nurses and on-call administrators failed to ensure that the amputated limb and fingers were properly placed in the appropriate bag, failed to label the bag and failed to dispose of the patient's limb and fingers according to the hospital's policies.

The amputated body parts were given to the family, after Patient #5's demise, in an inappropriate bag, and family members unknowingly traveled home with the bag, resulting in the family being responsible for delivering the body parts to a funeral home.

The administrative staff on call (Staff #7) did not respond when hospital staff attempted to contact her regarding this event. The hospital's QAPI review did not address the first line administrative employee's failure to respond to the Nursing Supervisor's attempts to contact her.

The hospital staff failed to process Patient #5's representative's grievance through its own policy and did not provide the representative with further information regarding his right to file a grievance with the State Agency. A review of the QAPI program documentation did not evidence that this failure was addressed or acknowledged. The failure to include this family member's grievance was not incorporated or addressed in the hospital's QAPI program or the Root Cause Analysis completed by the hospital after the event.

The QAPI program documentation did not contain evidence that this failure to follow policy and procedure that allowed the inappropriate handling of Patient #5's limb and fingers was immediately addressed. This resulted in the same type of failure that occurred six days later with Patient #6.

Patient #6 presented to the ED with an amputation of his finger. The finger was not reattached and the hospital staff failed to document the disposition of the amputated part. See A 747 for additional information.

On 3/22/12 at 10:40AM Employee #1 stated, "The ED guidelines govern our practice...it does not happen that often (patients in ED with amputations)..." Employee #1 presented the policy titled "Surgical Pathology Specimen Handling." A Post-it note was attached to this policy which stated, "OR (operating room) has no specific procedure for receiving patients into the OR with limbs for reattachment. This is the process should the re-attachment not be possible and the patient lives." This policy directed that the circulating nurse or scrub person would be responsible for collection, labeling and ensuring delivery to pathology, under the direction of the physician. The policy included a procedure, "4. Sending a large specimen: A. Circulator covers a small table with a disposable chucks/sheet to wrap the specimen...B. Scrub person removes all clamps and sponges from specimen and places on the draped table. C. MD specifies test and how to label specimen. Circulator and scrub person together verify information on label as above. D. Circulator wraps specimen in the disposable chuck/sheet and puts in a large plastic bag. NOTE: Double bag the specimen and secure. Use heavy plastic bags designated for heavy large specimens, available in the cores. Do not use thin trash bags or red contaminated materials bag...CHECK OUT TO VERIFY SPECIMENS AT END OF PROCEDURE:...As the time approaches to perform the Check Out (immediately prior to closure commencing), the circulation nurse will verify all pathology specimens with the surgical team. This will include confirming that no specimens have been sent. A complete rundown of all specimens their type and their labels will be reviewed. Any discrepancies need to be reconciled prior to closure..." This policy had an attached diagram with the "Date of approval - 8/84" and "Review Revision date of 5/11" directing the action to take, "Process for disposition of body parts amputated pre-hospital." This diagram began with the steps to be taken in the ED, "Body part (re) packaged in clear plastic bag; labeled with patient information and Biohazard sticker=if the patient dies in the ED=Body part in clear plastic bag packaged inside body bag (in lower half of bag)=sent to morgue with body." The policy directed events to occur if the patient was sent to the Operating Room and died there, "Body part (re) packaged in clear plastic bag; labeled with patient information and Biohazard sticker=Pt sent to OR - Body part sent with patient to OR=if body part not reattached and patient dies in OR - Body part in clear plastic bag; labeled with patient information and Biohazard sticker - Body part in clear plastic bag packaged inside body bag (in lower half of bag) - Body sent to morgue."

This policy did not direct the action to be taken if the amputated body part was not reattached and the patient was discharged from the ED.

Employee #1 also presented a document which she identified as the "new process." The document did not have a date of development or revision and was labeled "Process for disposition of body parts amputated pre-hospital." This document was a diagram directing action to be taken in the event a patient presented to the ED with an amputated body part. The diagram was identical to the previous diagram presented, and still did not include the procedure to be completed if the patient presented with an amputation and was discharged from the ED without a surgical reattachment of the body part (as Patient #5 and Patient #6 did).

Employee #1 also presented a document, "Traumatic Amputation," revised July 9, 2011 which directed "Caring for a Severed Body Part." The document directed that the severed body part be covered with saline gauze, wrapped with saline moistened roller gauze, then a sterile towel and then into a watertight container and bag, then seal. The body part is then to be placed inside another plastic bag with ice and water. The exterior bag is to be labeled with the patient's name, identification number, identification of the amputated part, hospital identification number and the date and time the part was processed. The clinical records of Patients #5 and #6 did not evidence this policy was followed. No documentation was present related to the processing of either patient's amputated body part.

Employee #1 and !2 were interviewed on 3/23/12 and they acknowledged the above concerns.

QAPI EXECUTIVE RESPONSIBILITIES

Tag No.: A0309

Based on facility policy, record review, and staff interviews, the facility failed to assure that there was an administrative official available to the supervisory staff on 11/26/11, when a serious event occurred requiring their level of expertise. There was only one nursing supervisor (Staff #7) on the 11-7 shift, one administrator (Staff #5) on call and involvement of one patient (Patient #5).

The findings include:

On 11/26/2012 Patient #5 arrived to the facility after a right arm and several fingers of the left hand were amputated in a farming equipment accident in West Virginia. The patient's amputated arm was placed in a red bag that started leaking, so it was covered with blue towels and placed in a blue linen bag. This bag was opaque, not normally used for body parts, and it was not labeled with biohazard signage.

The patient was then taken to emergency surgery, along with the un-labeled bag with Patient # 5's arm and fingers. The surgeon directed that there would be no attempt to re-attach the arm, and that it should not be brought to the OR. The patient had massive internal bleeding, and his spleen was removed. Patient #5 had a cardiac arrest in the OR, and could not be revived.

Staff #9, the Trauma Surgeon was interviewed on 3/22/12 at 11:10 a.m. He stated that after the patient had expired, he saw the bag in the corner of the operating room (OR) suite. and he opened it to see the body parts. He stated there was something that flew out. He did not identify this, but he tied up the bag and told the nurse to take it to the morgue with the body. He did not label this as a surgical pathology specimen, because he did not remove these body parts during surgery. The surgeon did not label this bag with Patient #5's identification, nor was it labeled as biohazard waste. He did not deal any more with the case.

The description of the rest of the incident was documented in the incident report of the incident. The body was placed in a body bag and labeled with one of the three morgue pack tags provided. Another of the tags was placed on the blue bag, which was then put in a large clear plastic specimen bag with no biohazard signage. This bag was placed on the morgue stretcher beside the morgue bag that contained the patient's body, and was taken to the morgue.

After the family viewed the body at around 6:30 p.m., the family asked about the patient's wedding band and boots. The Nursing Supervisor (Staff # 7) stated that the only belongings present with the patient on arrival to the viewing room were the ones in the blue bag laying beside the body, and they were welcome to take them. Even though the bag was heavy, the family thought it was the heavy boots Patient #5 was wearing at the time of the accident. The bag with his son-in-law's arm and fingers was given to the father-in-law. The family then drove home to West Virginia with this blue bag in the back seat of the car.

On 3/21/12 at 10:25 a.m. Staff #7, the Nursing Supervisor, was interviewed. She stated when the family arrived, she prepared the body for viewing. The blue bag was normally where belongings were kept. The surgeon was not there to indicate what was in the bag. Patient belongings were not inventoried prior to release of the belongings. Normally biohazard bags were put between the legs of the deceased, or in a clear bag. The next morning she said she talked to Staff #9, the Nursing Supervisor leaving duty. Staff #7 said she was not aware that the Bed Center was unable to get in touch with the Administrator on call, and she was not aware the family had called about the arm and fingers in the bag sent with them as belongings until that next morning.

Phone records from the Bed Center were unable to be pulled, and thus did not confirm the Administrator on Call was called. However, Staff #6, the Chief Resident on Call for General Surgery confirmed in an interview 3/21/12 at 12: 10 p.m. the family called him with their concerns that body parts were in Patient #5's belongings bag. Staff #6 stated he apologized to the family, but he did not notify the Nursing Supervisor of the family's concerns.

On 3/21/12 at 11:45 a.m., Staff #5, the Administrator on call and the Chief of Nursing Services, was interviewed. She stated her beeper was not working during the night shift, and the Nursing Supervisor did not try to text her or call her cell phone. She further stated this was one of those cases the Nursing Supervisor should have called someone on the Administrative level. She finally stated that had she been made aware of the family's call and error in sending home Patient #5's arm instead of his belongings. She said that she would have called the family to apologize and made arrangements to pick up the blue bag.

On 3/12/12 at 12:45 a.m., Staff #2, the Associate Vice President of Hospital/Clinic operation, was interviewed. He stated,"We did a bad thing. Staff #5's administrative beeper was turned off, and it will never happen again." Regarding this concern, Staff #2 stated the Bed Center (operator) should have contacted the Nursing Supervisor and the Administrator on call immediately. He stated he was notified somewhere around 6-7 a.m. from the House Supervisor and the Bed Center (Decedent Affairs). He was aware the family had called the Bed Center during the night, but did not get a return call. He called the father-in-law, who had possession of the blue bag, and apologized . The father in law of Patient #5 asked, "What do you want me to do with this (referring to the blue bag containing his son-in-law's arm and fingers)? Do we need to get the body and the arm together?" Staff #2 said he contacted the Medical Examiner, who did not want the severed arm or fingers. He then called the family back, and the family took the blue bag to the funeral home. He also found out the watch, ring, and boots were locked in security, and he arranged for them to be sent to the family. He informed a member of the Governing Body of the incident later that same day.

The Medical Center Policy dated 10/1/2011 titled Patient Concerns and Grievances stated that the facility is committed to responding in a timely manner to concerns and grievances about patient care and services, whether expressed by a patient or other persons on behalf of the patient. If the concerns fall outside of the Recipient's job responsibility, he or she must notify the appropriate staff present who can immediately address the concern.

INFECTION PREVENTION CONTROL ABX STEWARDSHIP

Tag No.: A0747

Based on record review, and staff interviews, the facility failed to provide appropriate bagging and labeling of biohazardous wastes in the emergency department, the operating room, and on into the morgue and home with family members for one of 6 patients reviewed, Patient # 5. These aberrances provided an environment that was not sanitary in order to avoid infections and communicable diseases. There was no Emergency Department (ED), Operating Room (OR), or institutional policy/procedure to describe the biohazardous packaging of body parts amputated pre-hospital.

The hospital staff also failed to document the disposition of the amputated finger tip, of one of six patients, Patient # 6.

The findings include:

1. On 11/26/2012 Patient #5 arrived to the facility after a right arm and several fingers of the left hand were amputated in a farming equipment accident in West Virginia. The patient's amputated arm was placed in a red bag that started leaking, so it was covered with blue towels and placed in a blue linen bag. This bag was opaque, not normally used for body parts, and it was not labeled with biohazard signage.

The patient was then taken to operating room (OR) suite, along with the un-labeled blue bag with Patient # 5's severed arm and fingers. The surgeon had directed that there would be no attempt to re-attach the arm, and that it should be brought to the OR. The patient had massive internal bleeding, and his spleen was removed. Patient #5 had a cardiac arrest in the OR, and could not be revived.

Staff #9, the Trauma Surgeon was interviewed on 3/22/12 at 11:10 a.m. He stated that after the patient had expired, he saw the bag in the corner of the operating room (OR) suite and opened it to examine the body parts. He stated there was something that flew out. He did not identify this, but he tied up the bag and told the nurse to take it to the morgue with the body. He did not include this as a surgical pathology specimen, because he did not remove these body parts during surgery. The surgeon said he did not label this bag with Patient #5's identification, nor was it labeled as biohazard waste. He did not deal any more with the case.

The description of the rest of the incident was documented in the incident report by the quality assessment staff. The body was placed in a body bag, and labeled with one of the three morgue pack tags provided. Another of the tags was placed on the blue bag, which was placed in a large clear plastic specimen bag, again with no biohazard signage. This bag was placed on the morgue stretcher beside the morgue bag that contained the patient's body, and was taken to the morgue.

After the family viewed the body at around 6:30 p.m., the family asked about the patient's wedding band and boots. The Nursing Supervisor (Staff # 7) stated that the only belongings present with the patient on arrival to the viewing room were the ones in the blue bag laying beside the body, and they were welcome to take them. Even though the bag was heavy, the family thought it was the heavy boots Patient #5 was wearing at the time of the accident. The bag with his son-in-law's arm and fingers was given to the father-in-law. The family then drove home to West Virginia with this blue bag still unlabeled as biohazardous waste in the back seat of the car.

On 3/21/12 at 10:25 a.m. Staff #7, the Nursing Supervisor, was interviewed. She stated when the family arrived, she prepared the body for viewing. The blue bag was normally where belongings were kept. The surgeon was not there to indicate what was in the bag. Patient belongings were not inventoried prior to release of the belongings. Normally biohazard bags were put between the legs of the deceased, or in a clear bag. The nest mooring Staff #7 talked to Staff #9, the Nursing Supervisor coming on duty. She said she was not aware the family had called about the arm and fingers in the bag that was sent with them as belongings until the next morning.

Staff #1, Chief Quality Improvement and Process Officer, was interviewed on 3/12/12 at 10:12 a.m. She stated that the contributing causes for the event was that the arm was placed in two types of bags that should not be used for this purpose: a red biohazard bag, too small to hold this heavy item, and a blue plastic bag for dirty linens. These bags are opaque and prevented visualization of the bag's contents. Had the arm been in a clear plastic bag or had the contents of the blue linen bag been inventoried with the family prior to return, this event would not have occurred.

On 3/21/12 at 11:45 a.m., Staff #5, the Administrator on call and the Chief of Nursing Services, was interviewed. She stated that had she been made aware of the family's call and error in sending home Patient #5's arm instead of his belongings, she would have called the family to apologize and made arrangements to pick up the blue bag.

On 3/12/12 at 12:45 p.m., Staff #2, the Associate Vice President of Hospital/Clinic operation, was interviewed. He stated he was notified somewhere around 6-7 a.m. from the House Supervisor and the Bed Center (Decedent Affairs). He called the father-in-law, who had possession of the blue bag, and apologized . The father in law of Patient #5 asked, "What do you want me to do with this (referring to the blue bag containing his son-in-law's arm and fingers)? Do we need to get the body and the arm together?" Staff #2 said he contacted the Medical Examiner, who did not want the severed arm or fingers. He then called the family back, and they took the blue bag to the funeral home.

The facility's policies were reviewed, and none of the policies were specific to these circumstances. The plan of action included a procedure for disposition of body parts when amputated pre-hospital that will be the same for both the ED and the OR. This new policy will specify when and how these specimens will be bagged and labeled, in order to prevent spread of infection and control of contaminates, or if they are to remain with the body of the patient if they are deceased


20367

2. Patient # 6 presented to the Emergency Department with an amputation of his finger. The finger was not reattached and the hospital staff failed to document the disposition of the amputated part.

A review of Patient # 6's clinical record was conducted on 3/21/2012. Patient # 6 presented to the ED on 12/01/2012 at 4:36 p.m. with the chief complaint "left 5 th finger partial amputation while lifting weights." The ED physician (Employee # 12) documented on 12/01/11 at 5:17 p.m.: "...EMS (rescue squad) wrapped the detached tip of his 5 th finger in gauze and surrounded it with ice PTA (prior to arrival in the ED). The patient arrived in the ED wit h the detached part of his 5 th finger in his possession." The physician also documented: "Orthopedics Hand consult requested. orthopedics assessed the patient, felt there was no possibility of reattachment of the fingertip, and stated that they would close the wound. Orthopedics cleaned ans closed the wound in the ER (emergency room). The Orthopedic physician also noted in the clinical record on 12/1/11 at 7:00 p.m.: "...Transverse amputation of left small finger mid-distal phalanx. Noted exposed bone..."; "Images: Noted amputation of the mid-distal phalanx of left small finger."
The clinical record did not include any documentation related to the disposition of the patient's amputated finger tip.

On 3/22/12 at 10:10 a.m., the surveyor interviewed Employee # 11 who was an Emergency Department (ED)Registered Nurse. Employee #11 stated, " Our department guidelines says if a patient presents with an amputation, and they go to the OR (operating room), the part goes with them. If they expire in the ED, the part is placed into the body bag and goes with the body to the morgue. If the patient is admitted, and the part not reattached, it is submitted to surgical pathology. The ED staff document the care, storage, and disposition of the body part. A nurse or physician would document in the chart the disposition. " The surveyor inquired, where in the clinical record for (Patient #----), was the documentation regarding the disposition of the amputated finger tip. Employee #11 reviewed the clinical record and stated, " I don't find anything. It would have been documented as a free text ...there is no documentation ...it was probably disposed of in a biohazard container ... "

On 3/22/12 at 10:40 a.m. Employee #1 stated: " The ED guidelines govern our practice ...it does not happen that often (patients in ED with amputations) ... "

On 3/22/12 Employee # 1 presented the policy "Surgical Pathology Specimen Handling." A Post-it note was attached to this policy which stated: "OR (operating room) has no specific procedure for receiving patients into the OR with limbs for reattachment. This is the process should the re-attachment not be possible an the patient lives." This policy directed that that the circulating nurse or scrub person would be responsible for collection, labeling and ensuring delivery to pathology, under the direction of the physician. The policy included a procedure "4. Sending a large specimen: A. Circulator covers a small table with a disposable chucks/sheep to wrap the specimen...b. Scrub person removes all clamps and sponges from specimen and places on the draped table. C. MD specifies test and how to label specimen. Circulator and scrub person together verify information on label as above. d. Circulator wraps specimen in the disposable chuck/sheet and puts in a large plastic bag, NOTE: Double bag the specimen and secure. Use heavy plastic bags designated for heavy, large specimens, available in the cores. Do not use thin trash bags or red contaminated materials bag....CHECK OUT TO VERIFY SPECIMENS AT END OF PROCEDURE: ...As the time approaches to perform the Check Out (immediately prior to closure commencing), the circulation nurse will verify all pathology specimens with the surgical team. This will include confirming that no specimens have been sent. A complete rundown of all specimens their type and their labels will be reviewed. Any discrepancies need to be reconciled prior to closure..."
This policy had an attached diagram with the "Date of Approval-8/84" and "Review Revision date of 5/11) directing the action to take: "Process for disposition of body parts amputated pre-hospital." This diagram began with the steps to be taken in the ED: "Body part (re) packaged in clear plastic bag; labeled with patient information and Biohazard sticker=if the patient dies in the ED=Body part in clear plastic bag packaged inside body bag (in lower half of bag)=sent to morgue with body." The policy directed events to occur if the patient was sent to the Operating Room and died there: "Body part (re) packaged in clear plastic bag; labeled with patient information and Biohazard sticker=Pt sent to OR-Body part sent with patient to OR=If body part not reattached and patient dies in OR-Body part in clear plastic bag; labeled with patent information and Biohazard sticker-Body part in clear plastic bag packaged inside body bag (in lower half of bag)-Body sent to morgue."

This policy did not direct the action to be taken if the amputated body part was not reattached and the patient was discharged from the ED.

Employee # 1 also presented a document which she identified as the "new process." The document did not have a date of development or revision and was labeled "Process for disposition of body parts amputated pre-hospital." This document was a diagram directing action to be taken in the event a patient presented to the ED with an amputated body part. The diagram was identical to the previous diagram presented, and still did not include the procedure to be completed if the patient presented with an amputation and was discharged from the ED, without a surgical reattachment of the body part (as Patient # 6 did.).

Employee # 1 also presented a document: "Traumatic Amputation", revised July 09, 2011 which directed "Caring for a Severed Body Part." The document directed the severed body part to be covered with saline gauze, wrapped with saline moistened roller gauze, then a sterile towel and then into a watertight container and bag, then seal. The body part is then to be placed inside another plastic bag with ice and water. The exterior bag is to be labeled with the patient's name, identification number, identification of the amputated part, hospital identification number and the date and time the part was processed. The clinical records of Patient # 5 and # 6 did not evidence this policy was followed. No documentation was present related to the processing of either patient's amputated body part.

The policy "Regulated Medical Waste Policy" was reviewed. The policy defined "Human tissue and other anatomical wastes", as regulated medical waste.

Employee # 1 and # 2 were interviewed on 3/23/12 and they acknowledged the above concerns.