HospitalInspections.org

Based on interview with the facility's staff and record reviews, it was determined that the hospital did not ensure compliance with all applicable Federal, State and local law requirements regarding conducting criminal background checks of security/police after rehire.

The findings include:

Review of the personnel file of Security Officer (SO) #2 provided by the Police and Security Department's Night Manager, revealed SO #2 was originally hired in 2/03. He left service for three years, but returned and was rehired in 5/05. The personnel file also confirmed only one criminal background check dated 2/03. This was acknowledged by the Night Manager during the interview on 2/10/10 at 12:00 p.m. Additionally, he stated that upon rehire all security and police staff should have a new criminal background check.

During an interview with the Human Resource Director (HRD) #1 on 2/10/10 at 2:45 p.m., she verified this information. She stated that the facility's policy indicated that employees, who return for employment six months from the date of their separation from services, must have a new criminal background check done upon rehire.

Based on observations, review of medical records, review of the General Hospital Corporation Bylaws of the Corporation and the Bylaws of the Professional Staff of the General Hospital, review of other facility documentation and staff interviews, it was determined that the hospital failed to meet the Conditions of Participation for Governing Body as evidenced by:

The Governing Body did not ensure that all services offered and provided met the Medicare Conditions of Participation. Areas of noncompliance identified included: Nursing Services, Medical Staff, Medical Record Services, Physical Environment, Infection Control, Surgical Services, and Rehabilitation Services.

The hospital failed to protect and promote the rights of each patient. (See A 115, A122, A123, A143, A144, A147, A164, A166, A168, A169, A185, A186, A188, A206, and A214).

The hospital failed to ensure that nursing services meet the needs of each patient. (See A385, A395, and A405).

The Medical Staff failed to operate under the Bylaws approved by the Governing Body. (See A338, A341, A357, A358, A359 and A363).

The hospital failed to ensure that medical record services were accountable for confidentiality and maintenance of medical records. (See A431, A438, A441, A449, and A450).

The hospital failed to ensure that the hospital's buildings and equipment were arranged and maintained to ensure the safety and well being of patients. (See A700, A701, and A724).

The hospital failed to have a hospital wide infection control program to control the transmission of infections and communicable diseases. (See A747, A749 and A750).

The hospital failed to ensure that surgical services were provided according to acceptable standards to achieve and maintain high standards of patient care. (See A940 and A951).

The hospital failed to ensure that rehabilitation services meet the needs of each patient. (See A1124 and A1132).

The findings include:

Review of the General Hospital Corporation Bylaws of the Corporation revealed that the hospital acting through its Board of Trustees "shall oversee the affairs" of the General Hospital Corporation. The "committees of the Trustees shall consist of the Patient Care Assessment Committee and such other committees as the Trustees may establish and charge." In addition, the bylaws indicated that the "Patient Care Assessment Committee shall be responsible for patient care assessment and shall be constituted, shall have, and may exercise and discharge such powers and duties as described in the Patient Care Assessment Plan." This written plan describes the various programs of the hospital which are designed to assure the effective assessment of patient care in the hospital.

During an interview on 2/11/10 at 7:00 a.m., with the hospital's Chief Executive Officer (CEO), he stated that the General Hospital Corporation is the governing body of the hospital which includes a minimum of twelve members of the Board of Trustees. The CEO confirmed that the governing body is responsible for the operation of the hospital.

Based on review of the General Hospital Corporation Bylaws of the Corporation and the Bylaws of the Professional Staff of the General Hospital, Governing Body Board Minutes, and staff interviews, it was determined that the Governing Body did not appoint members of the medical staff according to Medicare Conditions of Participation requirements.

The findings include:

Review of the General Hospital Corporation Bylaws of the Corporation revealed that the "Trustees may adopt, amend or repeal bylaws and similar instruments of governance for the organization and conduct of the affairs of the professional staff and any other functional entity of the Corporation. The bylaws of the professional staff shall provide for a general executive committee of the professional staff, which shall be constituted, shall have, and may exercise and discharge such powers and duties as provided in those bylaws or other instrument, including the power to consider and on behalf of the Trustees adopt policies and procedures relating to patient care and medical education and, at the request of the Trustees, other matters affecting the optimal operation of the General Hospital."

In addition, the General Hospital Corporation Bylaws of the Corporation indicated that the "bylaws of the professional staff shall establish procedures for processing and evaluating applications for appointment and reappointment to the staff, and for the granting of clinical privileges, which shall be consistent with these Bylaws; and every appointment to the staff shall be in accordance with such procedures."

During an interview on 2/11/10 at 7:00 a.m., with the hospital's CEO, he stated that the Chief of Services proposes medical staff appointments and the Chiefs' Council approves the medical staff appointments and then forwards the information to the Board of Trustees.

Review of the Board of Trustees Meeting Minutes indicated that the Trustees consider the recommendations of the Chiefs' Council for certain appointments and other actions related to the Professional Staff set forth in the lists made available at the meeting. The Board of Trustees then vote to adopt each recommendation of the Chiefs' Council concerning appointments to and changes in the professional staff as set forth in the lists presented at the meeting.

In order to appoint members to the medical staff, the Trustees review information provided by the Chiefs' Council. However, review of the 12/18/09 Trustees of the General Hospital Corporation Summary of First Time Clinical/Non-Clinical Staff Appointments, revealed that privileging information was not consistently included with the information about each candidate.

Examples include:

1. Doctor will work per diem in the main operating room (OR).
2. Doctor will be working as an assistant in Neurosurgery after having completed his residency training.
3. Doctor will see patients in the Structural Heart Disease Clinic.


Review of 13 of 23 credentials files indicated that the governing body's approval date occurred after the date that privileges were granted, resulting in physicians beginning clinical activities before Board approval. (See A341).

Clinical privileges are granted by individual clinical departments, resulting in clinical practice in the facility without Medical Staff recommendations for Board approval. (See A341).

Review of 1 of 1 RN/NP First Assistant's credential file revealed, "temporary Operating Room privileges" were granted by the Executive Medical Director of ORs and the Chief of Surgical Services, and the "temporary privileges" were extended until the next scheduled Surgical Committee meeting, resulting in clinical practice in the facility for a prolonged period of time without completing the facility's own approval process and without Medical Staff recommendation for Board approval. (See A341).

The Professional Staff Bylaws are missing candidate qualifications and description of the hospital's privileging process. (A357).

The Professional Staff Bylaws do not include the criteria for determining the privileges to be granted to individual practitioners and a procedure for applying the criteria to individuals requesting privileges. (A363).

Based on review of the General Hospital Corporation Bylaws of the Corporation and the Bylaws of the Professional Staff of the General Hospital, and interviews with staff, it was determined that the Governing Body has approved Medical Staff Bylaws that do not meet the Medicare Hospital Conditions of Participation.

The findings include:

The General Hospital Corporation Bylaws of the Corporation indicated that the "Bylaws of the professional staff shall establish procedures for processing and evaluating applications for appointment and reappointment to the staff, and for the granting of clinical privileges, which shall be consistent with these Bylaws; and every appointment to the staff shall be in accordance with such procedures."

During an interview on 2/11/10 at 7:00 a.m. with the hospital's CEO, he stated that the governing body of the hospital approves the bylaws of the medical staff.

Review of the Professional Staff Bylaws revealed the following information:

The Professional Staff Bylaws are missing candidate qualifications and description of the hospital's privileging process. (See A357).

The Professional Staff Bylaws do not include a requirement that a medical history and physical examination be completed and documented for each patient no more than 30 days before or 24 hours after admission or registration, but prior to surgery or a procedure requiring anesthesia services. (See A358).

The Professional Staff Bylaws do not include a requirement that an updated examination of the patient, including any changes in the patient's condition, be completed and documented within 24 hours after admission or registration, but prior to surgery or a procedure requiring anesthesia services, when the medical history and physical examination are completed within 30 days before admission or registration. (See A359).

The Professional Staff Bylaws do not include the criteria for determining the privileges to be granted to individual practitioners and a procedure for applying the criteria to individuals requesting privileges. (See A363).

Review of 13 of 23 credentials files revealed that the governing body's approval date occurred after the date that privileges were granted, resulting in physicians beginning clinical activities before Board approval. (See A341).

Clinical privileges are granted by individual clinical departments, resulting in clinical practice in the facility without Medical Staff recommendations for Board approval. (See A341).

Review of 1 of 1 RN/NP First Assistant's credential file revealed, "temporary Operating Room privileges" were granted by the Executive Medical Director of ORs and the Chief of Surgical Services, and the "temporary privileges" were extended until the next scheduled Surgical Committee meeting, resulting in clinical practice in the facility for a prolonged period of time without completing the facility's own approval process and without Medical Staff recommendation for Board approval. (See A341)

Based on review of the General Hospital Corporation Bylaws of the Corporation and the Bylaws of the Professional Staff of the General Hospital, and interviews with staff, it was determined that the Governing Body did not ensure that Allied Health Professionals were privileged according to the Medicare Hospital Conditions of Participation.

The findings include:

The General Hospital Corporation Bylaws of the Corporation indicated that the "Bylaws of the professional staff shall establish procedures for processing and evaluating applications for appointment and reappointment to the staff, and for the granting of clinical privileges, which shall be consistent with these Bylaws; and every appointment to the staff shall be in accordance with such procedures."

Review of clinical privileges revealed that privileges are granted by individual clinical departments, resulting in clinical practice in the facility without Medical Staff recommendations for Board approval. (See A341).

Review of 1 of 1 RN/NP First Assistant's credential file revealed that, "temporary Operating Room privileges" were granted by the Executive Medical Director of ORs and the Chief of Surgical Services, and the "temporary privileges" were extended until the next scheduled Surgical Committee meeting, resulting in clinical practice in the facility for a prolonged period of time without completing the facility's own approval process and without Medical Staff recommendation for Board approval. (See A341).

Review of the the Professional Staff Bylaws revealed the following information:
The Professional Staff Bylaws are missing candidate qualifications and description of the hospital's privileging process. (See A357).

The Professional Staff Bylaws do not include the criteria for determining the privileges to be granted to individual practitioners and a procedure for applying the criteria to individuals requesting privileges. (See A363).

During an interview on 2/11/10 at 7:00 a.m. with the hospital's CEO, he stated that the Allied Health Professionals are not members of the medical staff and are not privileged.

Based on review of the General Hospital Corporation Bylaws of the Corporation and the Bylaws of the Professional Staff of the General Hospital, and interviews with the facility's staff, it was determined that the Governing Body did not ensure that the primary source of verification of training is done according to the Medicare Hospital Conditions of Participation.

The findings include:

The General Hospital Corporation Bylaws of the Corporation indicated that the "Bylaws of the professional staff shall establish procedures for processing and evaluating applications for appointment and reappointment to the staff, and for the granting of clinical privileges, which shall be consistent with these Bylaws; and every appointment to the staff shall be in accordance with such procedures."

The hospital failed to include evidence of training and professional education through primary source verifications for all members of the medical staff.

On 2/4/2010, review of a letter "To Whom It May Concern" dated 1/16/09, from the Commonwealth of Massachusetts Board of Registration in Medicine, Regarding Primary Source Verification, indicated the following information, "Please be advised that the on-line verification information is maintained by the Massachusetts Board of Registration in Medicine and is updated every evening, in compliance with JCAHO (Joint Commission on Accreditation of Healthcare Organizations) and the National Committee on Quality Assurance (NCQA) standards for primary source verification of physician information."

During interview with the Director, MGH/GPO Medical Staff Office on 2/4/10 at 8:40 a.m., she stated that medical education is the only thing not done by primary source verification - done by the Board of Medicine "in compliance with the Joint Commission and the INCA."

During an interview on 2/11/10 at 7:00 a.m. with the hospital's CEO, he stated that the Medical Staff Office ensures that primary verification is utilized when performing credentialing of medical staff.

Based on, record review, staff interviews and review of the facility's internal investigation reports, it was determined that the facility failed to protect and promote patients rights. The facility failed to ensure that one of 84 patients (Patient #77) received care and services in a safe and timely manner to prevent lethal arrhythmias (any disturbance or irregularity of the heart beat.)

The facility failed to ensure that grievances were investigated and/or provided a written response in a timely manner for five of five grievances reviewed (Patients # 79, 80, 81, 82 & 83).

The facility to failed to ensure that the right to patient privacy was protected by the use of video cameras and personal and health information was accessible to unauthorized individuals.

The facility failed to ensure that the use of physical restraints as an intervention for seven of 84 patients were in accordance with the Medicare Requirements (Patients # 11, 38, 41, 61, 68, 75 & 76).
(See A122, A123, A143, A144, A147, A164, A166, A168, A169, A185, A186, A188, A206 &A214 )

Based on staff interview, and review of facility's policies, grievance files and other facility documents, it was determined that the facility failed to include specific time frames in their grievance procedures for review and resolution of grievances, and provision of a written response to the complainant. In addition, the facility failed to provide a written response in a timely manner for three of the five sampled grievances reviewed for Patients #81, #82 and #83.

The findings include:

Review of the facility's Patient Information Guide, provided to patients at the time of their admission, revealed patients are given the following information regarding registering a grievance (the term "complaint" is used by the facility):

Page 8: You, your family, or your guardian have the right to tell us when something is seriously wrong. This is called presenting a complaint. If you present a complaint, your care will not be affected in any way. Also, if you have a problem that you cannot solve with your doctor, nurse, or other caregiver, please call the Office of Patient Advocacy at (telephone number.)

Page 26: The Office of Patient Advocacy serves as the liaison between patients and the organization in their expressions of praise or concern so that moral, ethical, operational and care standards are upheld on behalf of MGH patients. Patient Advocates have the authority to communicate your complaints or to look into your complaint. If you have a complaint, we will work to resolve your problem in a neutral and non-threatening way.(The final sentence included the location of the Office of Patient Advocacy, telephone number, hours of operation and website address.)

The Patient Information Guide did not include specific time frames for review of the submitted complaint or for the provision of a written response.

During an interview on 2/9/10 at 9:00 a.m., the Director of the Office of Patient Advocacy, RN FF, provided a booklet labeled with "Office of Patient Advocacy,"on the front cover. The booklet included the following information:

Our investigation will include:
- Asking your permission to start the investigation;
- Talking with you and/or your family so that we know your concerns;
- Contacting and talking with the person(s) named in your complaint;
- Reviewing all appropriate documents, including your medical record, if necessary
- Collaborating with you on a possible resolution.

The MGH booklet contained the following information; MGH and outside regulatory agencies have set standards that we must follow when we manage patient or family complaints. These standards ensure that:
-Patients and families are told that they have a right to file a complaint and they are told how to do so;
- We look into the complaint and, when indicated, make efforts to correct the problem;
- Each patient or family that makes a complaint receives a response from us, and
- If you present a complaint, your care will not be affected in any way.

A section in the booklet for frequently asked questions included the question, "If I have a complaint, how will it be handled?" The response indicated: A Patient Advocate will be assigned to look into your complaint and work with you to resolve the issue. Your complaint is entered into our database and reports are sent to hospital leadership several times a year. This information is used to improve the care we deliver.
The Office of Patient Advocacy booklet did not include specific time frames for review of the submitted complaint or for the provision of a written response.

During the 2/9/10 interview, RN FF stated 90% (percent) of complaints received by the facility can be resolved within a day. RN FF stated 20% of the complaints received are in writing, 25% are received verbally, 50% are received via telephone call, and 5% are received by e-mail. RN FF stated their office tries to resolve grievances within one month. She stated, the Patient Advocate assigned to investigate the complaint sends an initial letter and also makes a telephone call to the complainant. RN FF stated they try to keep the complainant updated weekly or every other week of the progress of the investigation. At the conclusion of the investigation, a letter is sent and a telephone call is placed to the complainant to inform them of the outcome. Additionally, RN FF stated staff responds in writing to the individual making the complaint, but can't guarantee this happens 100% of the time.

Review of documents provided by RN FF on 2/2/10 indicated that the facility's complaint process involves three categories of complaints: Serious (defined by the facility as a report which alleges care that may have resulted in death, permanent or disabling injury, abuse or abandonment); ordinary (no definition provided); and difficult (no definition provided). The procedure for investigating serious complaints indicated notification of appropriate staff and investigation would occur within 24 hours of receipt of the complaint. The complainant would be informed during and after review of the complaint, as significant findings are determined, but at the very least within a week, and at completion of the investigation. The final communication with the complainant would be in writing.

The facility's procedure did not include time frames for the resolution of serious, ordinary or difficult complaints. Additionally, the procedures did not include provision of a written response to the complainant for ordinary or difficult complaints.

Review of a complaint letter received from Patient #81 on 12/4/09, indicated the patient complained of contracting a surgical site infection post-operatively secondary to an error in the surgery or in the surgical technique. The facility did not provide a written response to the patient's complaint until 1/26/10-53 days later.

Review of a complaint letter received from Patient #82 on 11/9/09, indicated the patient complained of being prescribed an antibiotic on two different occasions to treat a urinary tract infection. The patient noted she was allergic to both medications. A response to the patient's complaint was not sent until 12/15/09-36 days later.

Review of a complaint letter received from Patient #83 on 12/15/08, indicated that the patient complained about the management and dosage of prescribed Coumadin (blood thinner) medication. A written response to the patient's complaint was not sent until 1/12/09-28 days later.

Based on interview, policy review and review of patients' grievance files from 10/1/09 through 12/31/09, it was determined that the facility failed to provide a written response to the complainant for two of five patient grievances reviewed. (Patients #79 and #80)

The findings include:

1. A grievance received by telephone from Patient #79 on 10/30/09 indicated that a complaint relative to the patient's personal health information had been leaked to the press. The complaint file revealed that the patient was referred to the HIPAA (Health Insurance Portability and Accountability Act) compliance office. (HIPAA is a law designed to provide privacy standards to protect patients' medical records and other health information provided to health plans, doctors, hospitals and other health care providers.) The complaint file contained an address for the patient to forward written correspondences. There was no evidence in the complaint file indicating the facility's staff provided a written response to the patient of the results of the investigation.

2. A grievance received in person from Patient #80 on 11/9/09 revealed a report by the patient indicating that a volunteer in the Emergency Department (ED) had stolen a plastic bag from the basket on the patient's walker. The bag contained the patient's wallet, red folding card and emergency information. The patient identified the volunteer by name. The grievance file contained an address for the patient to forward written correspondences. The file lacked evidence indicating that the facility's staff provided a written response to the patient with the results of the investigation.

During an interview on 2/9/10 at 9:00 a.m., RN FF, Director of the Office of Patient Advocacy, stated their office tries to resolve grievances within one month. She stated the Patient Advocate assigned to investigate the complaint, forwards an initial letter, and also makes a telephone call to the complainant. RN FF stated they try to keep the complainant updated weekly or every other week relative to the progress of the investigation. At the conclusion of the investigation, another letter is sent and a telephone call is placed to the complainant to inform them of the outcome. RN FF stated staff respond in writing to the individual making the complaint but can't guarantee this happens 100% of the time.

Review of documents provided by RN FF on 2/2/10 indicated the facility's complaint process involves three categories of complaints: Serious (defined by the facility as a report which alleges care that may have resulted in death, permanent or disabling injury, abuse or abandonment); ordinary (no definition provided); and difficult (no definition provided). The procedure for investigating serious complaints indicated notification of appropriate staff and investigation would occur within 24 hours of receipt of the complaint. The procedure also indicated that the complainant would be informed during and after review of the complaint, as significant findings are determined, but at the very least within a week and at completion of the investigation. The final communication with the complainant would be in writing. The facility's procedure did not include timeframes for the resolution of serious complaints. The procedures for investigating ordinary and difficult complaints did not include specific time frames for review and resolution of the grievance, and provision of a written response to the complainant.

Based on observations and staff interviews it was determined that the facility failed to protect the patients' rights to personal privacy as well as having closed circuit surveillance monitoring cameras in the patients' rooms. Additionally, the facility had personal information visible to anyone in the hallway. This permitted the potential for observations of patients in various stages of undress, treatments, and care such as perineal, bed baths, bathing and catheter insertions.

The findings include:


Observations on all days of the survey revealed that Ellison Units 9, 11, and 12 had a white board hanging behind the nurses' stations facing toward the hallway visible to patients, staff and visitors. Information on these board included patients' names and their room numbers.


On 02/09/10 between 9:15 a.m. and 10:00 a.m. the Medical Intensive Care Unit (Blake 7-MICU) was toured in the presence of the assigned Clinical Nurse Specialist (CNS) F and the Unit Nursing Director B. Surveillance cameras were noted in the following rooms: 752, 758, 760, 766, 768 and 770. Three closed circuit TV (televisions) monitors were strategically located at the nurses' station, two of which were on.

The monitor located at the nurses' station in front of Rooms 774 and 776 designated "the high side" of the unit was visible to family, visitors, all staff alike from the corridor/hallway near stairway #3.

During the tour of Blake 7, a surveillance camera was noted in Room 768. In the room, a gentleman was seated in a chair. The gentleman identified himself as the husband of the female patient in the bed. During an interview with this gentleman/spouse, he stated that he had not been approached by any staff members regarding the use of the camera and had not consented to its use.

Interviews with the CNS, and the Unit Nursing Director on the afternoon of 2/9/10 revealed it was not the practice of the floor staff to obtain consents for the use of the surveillance cameras. They also stated the facility does not have a policy regarding obtaining consents for the use of the surveillance cameras.

During the tour of Blake 7- MICU on 2/9/10, an observation revealed that the privacy curtain when pulled did not obstruct the camera's view. The two staff members who acknowledged that the privacy curtains did not provide privacy from the cameras.

Interview with staff Nurse L during the mid-morning on 02/09/10 revealed that there is no policy in place to guide nursing staff regarding obtaining consent related to the use of the camera, or for informing patients and/or family members about its use.

Observation on 2/10/10 at 11:50 AM showed two monitors at the rear desk of Bigelow 9. The monitors were at the north-west end of the desk. The monitors were clearly visible when anyone approached to ask a question or stand close to the desk. One of the monitors was off. The second monitor showed a patient in bed with staff around performing a bronchoscopy (procedure in which a physician inserts a tube into the airways to examine the lungs for abnormalities).

Interview on 2/10/10 at the time of the observation with the Nurse Director of Bigelow 9 Staff CH revealed that the expectation would be that curtain would be drawn by the staff or the staff can turn the monitor off, at the monitor.

Observation on 2/10/10 at 12:09 p.m. revealed that two staff members were repositioning the patient on the monitor in bed.

Interview on 2/10/10 at 12:14 p.m. with the Nurse Director of Bigelow 9 Staff CH revealed that the hospital installed ceiling tracks about a year ago for lifts in some rooms. The curtain can be drawn in these rooms and would not block the camera's view. Staff could turn the camera but the camera is really high. Staff could shut the monitors off at the respiratory acute care unit but the monitors on the medical side of the unit are on a separate circuit.

Based on observation, record review, staff interviews and review of facility internal investigation reports, it was determined that the facility failed to ensure one patient (Patient #77) who required continuous cardiac rate and rhythm monitoring, from a sample of 84 patients, received the necessary nursing assessment, supervision and timely life-saving interventions when the patient developed lethal arrhythmias (any disturbance or irregularity of the heart beat) for approximately 22 minutes and asystole (absence of a heart beat) for approximately 17 minutes before staff found the patient unresponsive. Resuscitative measures were initiated, however, the patient died.


Additionally, the facility failed to ensure that patients' access to rooms and Emergency Department restrooms were not blocked to prevent possible injury.

The findings include:

1. Patient #77
On 2/10/10 review of Patient #77's closed medical record revealed a Cardiology Consultation Note, dated 1/20/10, that documented the following:
-89 years old, married, lives with spouse, still drives and remains active;
-Admitted to the hospital from home on 1/20/10 for newly diagnosed colorectal cancer;
-History of atrial fibrillation (an arrhythmia where the heart 's two upper chambers beat chaotically and irregularly), coronary artery disease, and four-vessel coronary artery bypass grafting in 2000;
-Underwent Abdominal Perineal Resection surgery with colostomy placement on 1/20/10;
-During the surgery the patient developed complete heart block and bradycardia with a heart rate of 15 beats per minute (bpm). The patient was treated successfully with intravenous medications to increase the heart rate and a temporary pacemaker wire was placed intravenously into the heart;
-The cause of the patient's complete heart block and bradycardia implies underlying conduction system disease;
-The patient transferred to the post-anesthesia care unit (PACU) on 1/20/10 following completion of the surgical procedure.

Cardiology Progress Notes, dated 1/20/10 at 9:00 p.m. showed the temporary pacemaker wire inserted during surgery failed to function properly while in the PACU. The temporary pacemaker wire was removed on 1/21/10 at 12:30 a.m. Nursing documentation showed the patient's heart rhythm in the PACU was atrial fibrillation with heart rates in the 50's and 60's (normal adult heart rate is 60-80 beats per minute).

Physician Progress Notes indicated that the patient was transferred from the PACU to the Cardiac Care Unit (CCU) on 1/21/10.

On 1/22/10 Cardiology Progress Notes indicated the patient to be in atrial fibrillation with heart rates was dropping into the 40's when asleep. Documentation indicated that the patient was scheduled for a permanent pacemaker on 1/25/10. The patient was approved for transfer from CCU to a surgical floor with telemetry monitoring.

Review of Nursing Flow Sheets and Progress Notes indicated that the patient was transferred to a surgical patient care floor at 6:00 p.m. on 1/22/10 with physician's orders for centralized cardiac telemetry (monitoring a patient's heart activity from a distance) and was a full code (wished resuscitation if the heart and/or breathing stopped). Nursing documentation on 1/22/10 at 5:55 p.m. 7:30 p.m. 8:30 p.m. and 10:00 p.m. revealed that the patient's vital signs after transfer to the surgical floor indicated heart rates from 59 to 74 bpm and a heart rhythm of atrial fibrillation.

Review of Surgical Progress Notes, dated 1/23/10 indicated:
The patient's heart rhythm was atrial fibrillation/SSS (sick sinus syndrome is a malfunction of the normal pacemaker of the heart in which the heart rate slows below normal limits);
-Monitor heart rate closely;
-Surgical placement of permanent cardiac pacemaker scheduled on 1/25/10.

Interviews on 2/10/10 and 2/11/10 with hospital nursing administrative staff responsible for conducting the hospital's investigation into Patient #77's death - RN AA (Patient Staff Specialist), RN BB (Associate Chief Nurse), RN CC (Nurse Director), and RN DD (Clinical Nurse Specialist) - revealed the following:
-On 1/23/10 the patient's heart rate was 56-62 beats per minute (bpm) and the blood pressure was stable;
-During the night shift from 7:00 p.m. on 1/23/10 to 7:00 a.m. on 1/24/10 the patient's heart rate was 55-77 bpm, blood pressure stable, no nausea or vomiting, tolerating a liquid diet and bowel sounds present;
-Staff RN E assumed the care of the patient as well as two additional patients at 7:00 a.m. on 1/24/10;
-There were 32 inpatients including Patient 77-receiving care on this surgical floor the morning of 1/24/10 and 10 RN's on duty;

-Nursing staff did not continuously monitor the cardiac rates/rhythms at the central nurses' station monitors. This responsibility falls on all nursing staff on the unit. When an alarm sounds or a message appears on the alarm display unit, any available nurses are to evaluate the reason the alarms are sounding and respond as necessary;

-The patient's heart rate at 7:30 a.m. on 1/24/10 was 77 bpm and heart rhythm showed atrial fibrillation;

-The patient ate breakfast, ambulated in the hallway, family visited, morning bath taken and a pain medication was administered at 9:28 a.m.;

-Central nurses station cardiac monitor logs revealed:
· At 9:40 a.m. was 82 bpm,
· At 9:53 a.m. heart rate at 53 bpm,
· At 9:54 am heart rate at 44 bpm,
· From 9:56-9:58 a.m. heart rate at 0 bpm,
· From 9:59-10:01 a.m. heart rate at 0-29 bpm,
· From 10:02-10:16 a.m. heart rate at 0 bpm,
· A high-low audible warning alarm (alarm set to sound when the patient's heart rate exceeded 120 bpm or fell below 50 bpm) sounded for the patient from 9:53-10:01 a.m. and from 10:06-10:16 a.m. by repeatedly broadcasting two "beeps" at the central nurses station cardiac monitors.
· The three (3) ceiling mounted digital alarm display units that were located at the end of the two patient care hallways and near the central nurses station showed "HR LO" (heart rate low) and the patients room number during the time of the audible alarms;
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-The volume to the alarms on the patient's bedside cardiac monitor had been turned off at an unknown date and time and by an unknown person;

-No one was at the patient's bedside while the central nurses' station cardiac monitors were alarming and no staff responded to the alarms until 10:16 a.m. when RN E entered the patient's room to assess the patient's urinary output, a time span of 20 minutes after the alarms initially sounded. The patient was found unresponsive and with vomit on his/her mouth and gown. Cardio-pulmonary resuscitation was initiated and a Code Blue was called. Efforts to resuscitate the patient were unsuccessful and the patient expired;

-Administrative nursing staff interviews with the RN's on duty the morning of 1/24/10 revealed that no one could recall hearing the alarms that sounded from the central nurses' station cardiac monitors and no one recalled seeing the "HR LO" displayed on the alarm display units.

The 10 RNs interviewed said the alarm notifications that morning were no more than usual. If in a patient room with the door closed, staff could not hear the alarms coming from the central nurses' station;

-Nursing staff interviewed on the patient care unit said they were experiencing alarm fatigue and a desensitization to alarms after hearing them constantly throughout the workday.

Interviews on 2/10/10 and 2/11/10 with Biomedical Engineering Staff M and N and review of a Biomedical Engineering Findings Report, dated 2/4/10, revealed:

-In addition to the two "beep" high-low audible alarms on the central nurse's station cardiac monitors and bedside cardiac monitors, there is also an arrhythmia alarm that is supposed to be set to "Full," which means the alarms are on. This alarm triggers the broadcast of a three "beep" audible alarm when a patient develops a crisis or lethal arrhythmia-such as asystole.


An investigation conducted by Biomedical Engineering after Patient #77's death found the arrhythmia alarm on the patient's bedside cardiac monitor had been set to "Off" on 1/22/10 at approximately 6:15 p.m. As a result, on 1/24/10 between 9:54 a.m. and 10:16 a.m. the arrhythmia alarm did not broadcast the three "beep" audible alarm from the central nurses' station that would have signified to nursing staff that Patient #77 was experiencing a lethal arrhythmia.


The Biomedical Engineering Findings Report showed recommendations to install a distributed speaker system on the surgical patient care unit where Patient #77 had resided, which would make monitoring alarms more audible throughout the unit rather than only at the central monitors located at the nurse's station. The report also showed recommendations for the surgical patient care unit to make the necessary changes so that staff could not turn the arrhythmia alarms to "Off" and could not turn the alarm volume to "OFF" on patients' bedside cardiac monitors.

Observation on 2/10/10 at 1:00 p.m. of the surgical patient care unit where Patient #77 had resided showed two patient care hallways with the floor plan in the shape of the letter "V." The central nurse's station cardiac monitors with audible alarms were located near the point of the "V." Ceiling mounted digital alarm display units were located at the far end of the two hallways and at the point of the "V."

In addition, a wall-mounted flat screen cardiac monitor without audible alarms was located part way down each hallway. Six patient's heart rates/rhythms were being continuously monitored. However, no staff were observed at the central nurse's station monitoring these six patients' cardiac rates/rhythms continually. The room where Patient #77 had resided from 1/22/10 until 1/24/10 was across the hallway and slightly diagonal from the location of the central nurses' station cardiac monitors.

At approximately 2:15 p.m., Biomedical Engineering staff programmed an unused cardiac monitor at the central nurses' station to broadcast an alarm identical to the alarm that sounded on Patient #77's cardiac monitor on 1/24/10. The alarm volume was audible from the central nurses' station but was barely audible to inaudible when standing at the farthest ends of the hallways. Staff caring for patients in the rooms at the farthest end of the hallways would not be able to hear the alarms.

During an interview at 2:30 p.m., Biomedical Engineering Staff N said the Biomedical Engineering department had identified a need one to two years ago for the installation of additional speakers on all patient care units and was currently a work in progress. Installation of a distributed speaker system on this unit and all other patient care units would make the alarm volumes more audible throughout the unit rather than only at the central monitor's at the nurses' station. Speakers had been installed on some other patients' care units of the hospital, but had not been installed on this floor yet.

Review of documentation dated 2/2/10 by Medical Doctor (MD) AAA in a report that was prepared for medical peer review activities at the hospital revealed the preliminary autopsy report for Patient #77 revealed no pulmonary emboli (a sudden blockage in a lung artery - usually caused by a blood clot) and no aspiration. The patient's death appears due to unrecognized severe bradycardia from faulty alarm settings.

2. During an observation of the Emergency Department's (ED) Urgent A care area on 2/4/10 at 8:45 a.m., FW#1 was observed crafting a wooden crutch/walker holder on a work cart that blocked the entrance to two restrooms. Directly adjacent to the work cart were two fans, two large surgical lamps, three rolling blood pressure monitors, one oxygen tank, one scale and two pieces of respiratory equipment. Approximately three patients were observed on stretchers to the right of this area. RN EE acknowledged the observation, and confirmed that the restrooms can be used by patients awaiting treatment. Staff Member Q also acknowledged the observation, and stated that they would identify an area for placement of the equipment. A subsequent observation on 2/5/10 at approximately 10:00 a.m., revealed, the work cart had been removed, and the equipment was positioned close to the wall allowing accessibility into the restrooms.


3. During a tour of the Observation Unit on Ellison 12 on 2/3/10 at 10:40 a.m., the entrance to Rooms 1240 and 1238 were blocked by a housekeeping cart, a linen cart, a supply cart that contained paper towels and toilet paper, a dirty linen hamper, and a vital signs monitoring stand. Affixed to the windows outside of Rooms 1240 and 1236 were signs that indicated "fall precaution."

According to the facility's Policy and Procedure Document: FALL RISK ASSESSMENT STANDARD FOR THE ADULT IN PATIENT CARE UNITS approved by the Nursing Practice Committee 12/08: Universal Interventions for Fall Prevention.
The following interventions apply to all patients:
-Keep floors clutter/obstacle free...
-Remove excess equipment/supplies/furniture from rooms and hallways...

It was stated during an interview on 2/12/10 at 9:57 a.m. with Staff Member S that the patient care areas should be "maintained in a manner to minimize the potential for falls and should not impact patient flow."








18926

Based on observations, review of the facility's policies and reports, and interviews with staff, it was determined that the facility failed to ensure patients' right to personal privacy by posting notebooks containing patients' personal health information in areas accessible to unauthorized individuals. Additionally, the facility failed to ensure confidentiality of patients' clinical records when Nursing Directors and Clinical Nurse Specialists were able to access patients' health information from their non-secured personal home computers.

The findings include:


A. Patients' Health Information Accessible from Non-secured Home Computers.

On 2/10/10, the hospital policy was reviewed, "Patient Record, 7.16- The information or data contained in the record belongs to the patient and is protected against loss, unauthorized disclosure and destruction." The policy failed to contain any directions or safeguards to ensure that all information regarding patients is kept secure and inaccessible to people not involved in the care of patients.

During an interview on 2/5/10 at 9:45 a.m. with RN GG and CNS HH, they were asked for a list of restrained patients on the unit. CNS HH stated, every morning a list of restrained patients is sent out hospital-wide via e-mail to leadership staff, including the Nursing Director and CNS on each patient care unit. RN HH then accessed the hospital e-mail account and printed a document sent on 2/5/10 at 6:39 a.m. with the subject line showing, "Daily Patient Quality Needs E-Mail Report." Documentation on the report indicated, "Patient List - Vaccination and Restraint Orders, Tracheotomy, Warfarin Teaching and Heart Failure Instructions." RN HH stated, staff receiving the report on their e-mail at work can also access the report from their personal e-mail account on their home computer. RN GG acknowledged this information. Both RN GG and CNS HH stated their e-mail accounts from their home computers were password protected only, and were not encrypted. The report contained the following information for 7 patients: name, room number, admission date, primary diagnosis and information on pneumovax, fluvax, heart failure, tracheostomies, and restraints.

Interviews on 2/8/10 at 10:55 a.m., with the Nursing Director RN CC and CNS DD revealed identical information that had been provided by RN GG and RN HH relative to their ability to access the "Daily Patient Quality Needs E-Mail Report" from e-mail accounts on their home computers. Both RN CC and RN DD also stated their e-mail accounts from their home computers were password protected only, and were not encrypted.

Review of a "Daily Patient Quality Needs E-Mail Report," sent on 2/8/10 at 6:39 a.m. to RN CC and RN DD, revealed a list of six patients from the two patient care units that RN CC and RN DD were responsible for. Documentation on the report indicated, "Patient List - Vaccination and Restraint Orders, Tracheotomy, Warfarin Teaching and Heart failure Instructions." The report contained the same information for these 6 patients that was indicated for the aforementioned 7 patients.

Review of a facility's policy and procedure titled, "Patient Record," approved by the Medical Policy Committee in 7/09, indicated the following:
1.2: This policy defines the MGH patient's health record and the documentation, access, security and audit requirements for all patients record-keeping across the MGH continuum of care.
1.3: This policy is guided by the following principles:
· Records shall be easily accessible at any time and place where patient care information is needed, and available to persons with a legitimate reason for access.
·All users of the MGH electronic health record shall adhere to prevailing standards of confidentiality, quality and accountability, as defined by the MGH Clinical Policy and Records Committee.

The policy contained no further information or procedures for ensuring patients' health information is properly protected.

During an interview on 2/11/10 at 10:32 a.m., the Information Security Officer stated the following:
-The hospital utilizes several different methods to allow staff members to remotely access confidential patient information.
-the hospital utilizes several different methods to allow staff members to remotely access confidential patient information. These include remote access to the Longitudinal Medical Record (LMR); remote access to the MGH network (LAN) in which word documents, spreadsheets, databases and reports used for administrative and research purposes and containing protected information can be accessed and downloaded; and the ability to access hospital e-mail in which some e-mails or attachments may contain protected information. The hospital utilizes several technical strategies to facilitate remote access, including two types of virtual private networks (VPN clients such as gotomypc, which are used on laptops and home desktops; and SSL VPN which is loaded on MGH-issued laptops) to access the LAN and LMR; and Internet browsers to access webmail and a web version of their LMR from any computer with Internet access.

-Staff access information on their hospital desktop computer over the Internet via "gotomypc.com" from any computer using a user identifier and password to log-on to the "gotomypc.com" website and another user identifier and password to access their hospital computer, neither password is a randomly generated one-time synchronized password. Once the staff member accesses the hospital computer, it forms a secure tunnel of information that leaves no residual information on the computer used to access the information. Staff cannot download or print the information from the website;

-Staff access VPN Client from any computer to form a secure tunnel to access patient information. This information would not leave residual information nor could it be printed; however the information can be downloaded to an unencrypted (encrypt means to scramble access codes to computerized information so as to prevent unauthorized access) computer and printed once staff exits VPN client. This would leave residual information even if the staff member deleted the downloaded information.

-Staff access webmail from any computer;- patient information may be embedded in an e-mail or sent as an attachment. Information embedded into the e-mail could be downloaded to an unencrypted computer or portable storage device as a screen print or printed from the computer; however, the information security officer was not sure if the embedded e-mail would leave residual information on an unencrypted computer. Information accessed from the e-mail attachment would leave a temporary file on an unencrypted computer. The information can be downloaded to an unencrypted computer or portable storage device or printed from the computer; and both e-mails and attachments containing confidential information could be forwarded to another e-mail address outside the MGH system.

- Any documented that is downloaded to unencrypted computers or any residual information left on unencrypted computers via web browsers or any other software using temporary files is potentially accessible by unauthorized persons. The hospital has no definitive plans to restrict access to confidential patient information contained in e-mail, LAN or LMR to hospital-authorized and encrypted computers. The hospital is in the process of encrypting hospital issued laptop computers. The process is estimated to be 75-80% complete; however, staff is still locating computers that are issued to departments not an individual. The hospital has begun to encrypt staffs' personal laptops on a voluntary basis; however the information security officer was not sure to what extent, as there is not an inventory available of staffs' personal computers. The hospital has no definitive plans to encrypt staffs personal desktop home computers.


B. Notebooks Containing Patients' Personal Health Information

1. During an initial morning tour of the hospital on 2/2/10, the following was observed. In Phillips House 22, a surgical unit, books containing confidential patient information including treatment flow sheets and a pulse volume results form were located in a wooden holder outside patients' rooms that were accessible to unauthorized staff, family members and/or visitors passing in the area. The Unit's Nursing Director acknowledged that the books were not secured from personal view.

2. During morning observations on 2/10/10 of Phillips House 20 and 21, and Ellison 17, 18 and 19, it was observed that books containing confidential patient information were in unsecured common areas where unauthorized staff, visitors, and/or other patients could have access. The Staff Specialist in Women's Health at the time of the observations acknowledged that the books containing the confidential information was located in these unsecured locations.

3. Observation at 3:00 p.m. on 2/2/10 in the White Building, a 24-bed patient care unit, revealed large, green, three-ring binder notebooks in wooden holders outside each patient's occupied room. Each notebook maintained documents that contained the individual patient's name, birthdate, date of admission, advance directives and diagnoses. The notebooks included the nursing care flow sheet for 2/2/10, which indicated the following:
-patient's vital signs (temperature, blood pressure, pulse, respirations);
-patient's oxygen use, if applicable, and oxygen saturation percentage (a measure of the amount of oxygen that is carried in the bloodstream);
-pain assessment and pain management information;
-neurological assessment;
-oral, intravenous or tube feeding intake;
-urinary output and whether the patient urinates voluntarily, involuntarily or through an indwelling catheter;
-bowel movement information.

4. Observations on 2/3/10 at 3:00 p.m. of 20-bed patient care unit, on 2/5/10 at 8:00 a.m. of a 25 bed patient care unit, and on 2/5/10 at 1:45 p.m. of a 26 bed patient care unit all in the White Building revealed large, green, three-ring binder notebooks in wooden holders outside each patient's occupied room. The documents in the notebooks revealed the individual patient's name, date of birth, admission date, marital status, advance directives, and religion. The notebooks also included the nursing care flow sheet for 2/3/10 and the treatment flow sheet.


5. Observations on 2/8/10 at 8:35 a.m. of 30-bed patient care unit and of a 27 bed patient care unit in the White building revealed large, green, three-ring binder notebooks in wooden holders outside each patient's occupied room. Review of one patient's notebook revealed documents that contained the patient's name, date of birth, admission date, advance directives and a nursing care flow sheet.

Additionally, a notebook on the 27 bed unit had information attached to the front cover of one patient's notebook, a large, red sticker labeled, "Allergy," and documented the patient's full name and allergies to bee stings, acetaminophen, penicillin and amoxicillin. Review of another patient's notebook revealed documents that contained the patient's name, date of birth, payment source, nursing care flow sheet for 2/8/10 and a treatment flow sheet. The nursing care flow sheet included vital signs and documentation revealing that the patient had edema (excessive amount of watery fluid in the tissues) in the scrotum, flanks and ankles.

6. Observation on 2/10/10 at 9:30 a.m. of an 18-bed patient care unit in the Bigelow Building revealed large, green, three-ring binder notebooks in wooden holders outside each patient's occupied room. Review of one patient's notebook revealed documents containing the patient's name, date of birth, age, and physician's orders for the total parenteral nutrition (TPN) nursing care flow sheet for 2/10/10, and a treatment sheet. (TPN is an intravenous feeding that provides a patient with all of the fluid and essential nutrients they need when they are unable to feed themselves by mouth.) The treatment sheet revealed the patient required anti-embolism stockings and incentive spirometry.

7. Observation on 2/10/10 at 2:30 p.m. on Ellison 12 revealed fourteen of fifteen medical records (Patient Rooms 1232, 1230, 1228, 1224, 1220, 1218, 1216, 1214, 1212, 1210, 1208, 1206, 1204, and 1202) hanging outside patients' doors without securing personally identifiable patient information.

8. On 2/10/10 at 3:54 p.m., there were 33 patients admitted to the Ellison 7 Unit. Observations of the Ellison 7 Unit revealed that a green binder for each patient was located in a bin in the hallway outside each patient's room. Inside this green binder were the patient's flow sheets, nurses' progress notes, and other resource material. An interview with Nurse CC on 2/10/10 at 3:55 p.m., revealed that the green binders were kept in the hallway and were accessible to any staff member, patient or visitor, and that the information in the green binders is considered part of the patients' medical record.


C. On 2/8/10 at 2:17 p.m., CNS CI provided a patient list for vaccination and restraint orders, tracheotomy (incision directly into the airway to help the patient breath), Warfarin (medication to thin the blood) teaching and heart failure instructions for Ellison 19 for 2/8/10. There were five patient names and medical record numbers on the sheet. The sheet indicated that four of the five patients had a pneumovax vaccine and that one of the five patients had a tracheotomy.

During the interview with CNS CI, she revealed that this information is generated to Nursing Directors and Clinical Nurse Specialists daily via e-mail at 7:00 a.m. Nursing Directors and Clinical Nurse Specialists can retrieve information from other units via e-mail.

This is continued non-compliance as evidenced by citations written by the Department of Public Health during the surveys of 3/26/09 and 8/13/09.

Based on review of medical records and facility's policy, and interview with staff, it was determined that the facility failed to conduct an individualized, comprehensive assessment for two of 84 patients in the sample to ensure physical restraints were used only after lesser restrictive methods were determined to be ineffective to protect the patient from harm. (Patients #41 & #38)

The findings include:

1. Patient #41

Review of the facility's policy and procedure titled, "Restraint and Seclusion," approved by the Medical Policy Committee on 6/3/09, indicated the following:
3.1 - The decision to use a restraint or seclusion is driven not by diagnosis, but by a comprehensive individual assessment;
3.3 - Restraints shall not be used when less restrictive interventions would be effective. Restraint or seclusion should be considered only as a temporary means of intervention when the patient is in immediate danger of harming self or others;
3.4 - When a restraint or seclusion is required, the least restrictive method should be utilized;
5.1 - Non-behavioral medical restraint may be used for the following indications when less restrictive means would not be effective in protecting the patient: a) the patient is pulling at tubes, lines or dressings, b) the patient's actions are endangering themselves; for example the patient is thrashing around in bed or attempting to get out of bed in a way or under conditions where it might cause harm;
5.3 - Type and location of the restraining device(s) shall be documented at least once per shift and when changed; alternatives to and less restrictive forms of restraint considered by the care giver shall be documented at least once per shift.


Review of Patient #41's medical record on 2/4/10 at 2:00 p.m. revealed a nursing progress note on 2/1/10 at 4:15 a.m., that indicated the following:
-the patient was at risk for injury related to dementia;
-early in the shift, patient was extremely agitated-yelling and using oxygen cable to hit out at people;
-refused to take medications and spit them out when offered;
-physician notified and Haldol (antipsychotic) injection given as prescribed;
-took approximately one hour to quiet the patient;
-bed in low locked position with bed alarm on.


Review of the physician's orders indicated siderails were prescribed on 2/1/10 at 9:22 a.m. The orders indicated the reasons for the siderails were to limit the patient from pulling at/out equipment (such as intravenous lines, feeding tube, airway management tubes, urinary drains, to prevent injury), and to limit the patient's mobility to prevent injury. At 10:10 a.m., a physician ordered soft 2 point restraints (restraint device used on 2 extremities-usually the wrists) and the reason for the restraints was to limit mobility to prevent injury.


Review of a nursing progress note, dated 2/1/10 at 6:00 p.m. indicated the following:
-alert and oriented to self, agitated much of the a.m.;
-continues with 2 point soft restraint order although has not required restraints since daughter in to visit;
-patient has hallucinations, agitation and multiple attempts to get out of bed;
-per report patient is spitting out medications-daughter administered oral medications successfully this shift;
-patient much less agitated in afternoon.


Review of a document in the medical record titled, "Restraint Documentation Flow Sheet For Non-Behavioral Medical Restraint," dated 2/1/10, revealed nurses' initials indicating restraints were on at 9:00 a.m., 11:00 a.m., 1:00 p.m., 3:00 p.m., 5:00 p.m., 7:00 p.m., 8:00 p.m. and 10:00 p.m. There was no evidence documented in the patient's medical record indicating staff had conducted an assessment of the patient to determine if least restrictive methods than 2 point soft restraints would be effective or ineffective in protecting the patient.


In addition, the restraint flow sheet did not include the type of restraint device ordered or used, and did not reveal the extremities that were restrained. There was no documentation in the progress note indicating staff attempted to discontinue the patient's restraints during the time the Patient #41 was described as being much less agitated.


Review of the next nursing progress note, dated 2/2/10 at 4:40 a.m., indicated the following:
-patient extremely agitated, yelling out, swearing, kicking and hitting out;
-patient now has 4 point soft restraints on;
-patient attempted to bite staff, refused to take any medications and spit them out when offered;
-patient was medicated with intravenous Haldol with some calming effect after 1½ hours.


Review of the physician's orders, dated 2/2/10 at 9:59 a.m. indicated, in addition to the soft 2 point restraints the physician added another order for staff to use soft 4 point restraints (restraint device used on 4 extremities- usually the wrists and ankles) to limit the patient from pulling at/out equipment and to limit the patient's mobility to prevent injury. Review of the patient's Restraint Flow Sheet, dated 2/2/10, revealed nurses' initials indicating restraints were on at 12:00 a.m., 2:00 a.m., 4:00 a.m., 6:00 a.m., 8:00 a.m., 10:00 a.m. and 12:00 p.m.


There was no evidence documented in the patient's medical record indicating staff had conducted an assessment of the patient to determine if less restrictive methods, other than 2 and 4 point soft restraints, would be effective or ineffective in protecting the patient.


In addition, the Restraint Flow Sheet did not include the type of restraint device ordered or used and did not show the extremities that were restrained.


During an interview on 2/4/10 at 2:00 p.m., RN JJ stated she had been the patient's primary nurse on 2/1/10 and 2/4/10. RN JJ stated the restraints were used because the patient was receiving IV fluids and IV antibiotics, and the patient kept trying to pull out the IV. RN JJ stated the patient was swatting at staff and trying to get out of bed. RN JJ stated efforts were made to calm the patient prior to using restraints, including re-orientation to place and time, and touch therapy with a soft ball. RN JJ stated the patient calmed when the daughter came to visit. RN JJ could not find documentation in the patient's medical record revealing that staff had conducted an assessment of the patient to determine if less restrictive methods than 2 and 4 point soft restraints would be effective or ineffective in protecting the patient.


2. Patient #38

A patient with multiple fractures, bilateral pulmonary contusions and a left arm infiltrate was ordered four point leather restraints and two point leather restraints were applied for 3 hours and forty-five minutes without a least restrictive intervention being tried first.

On 2/10/10 at 1:35 a.m., the Nurse Practitioner ordered "Restraint Intervention-Non Behavioral (Medical/Surgical) Restraints: Leather 4-Point. Reasons: Limit pulling at/out equipment e.g. (that is), IVs, feeding tube, management tubes, urinary drains, to prevent injury. Expires: 2/11/10 at 11:59 p.m."

On 2/10/10 at 3:29 a.m., the nursing staff documented that the patient knows her name, year, and month (sometimes), but aware of place, amnesic to accident when asked. Patient restless and at times agitated throughout night, very impulsive and trying to climb out of bed stating she has to go to the bathroom. Patient reminded she has a catheter and offered a bedpan for a bowel movement with no results. 1:1 sitter at bedside, bed low and locked, and bed alarm on. Patient placed in locked leathers x ( times) 2 after pulling out Foley catheter and intravenous heparin lock. Foley reinserted this shift and urine currently pink-tinged.

Although four point leather restraints were ordered, two point leather restraints were applied. There was no documentation of a least restrictive intervention being implemented prior to the two point leather restraints being applied.

On 2/10/10 at 5:24 a.m., the physician ordered to discontinue the 4-point leather restraints.

During an interview with Nurse CC on 2/10/10 at 2:25 p.m., she stated that patients are not placed in 4 point leather restraints for pulling out their Foley catheters.

Based on clinical record review and staff interviews, it was determined that the facility failed to ensure that patient care plans were modified whenever there was a use of restraints for two of 84 clinical records reviewed. (Patient #75 and Patient #76)

The findings include:

1. Patient #75 was admitted to the hospital on 1/31/10 with diagnoses which included a gunshot wound to the face and hand.

A clinical record review was conducted at approximately 10:30 a.m. on 2/10/10 on the PICU. The review revealed that the patient had been placed in 2 point soft restraints in accordance with the physician's orders. The clinical record lacked documentation of an individualized patient assessment before the use of restraints.

The patient had a pre-printed, unsigned care plan titled, "Patient in Non-Behavioral Medical Restraint." This care plan also lacked any written assessment, dates, times and/or behaviors that necessitated the use of restraints during the dates that the patient was in restraints.

An interview with Clinical Nurse Specialist of the Neurologic Intensive Care Unit, Nurse CNS G was conducted at the time of the clinical record review. She acknowledged that the clinical record lacked documentation of any changes in the care plans of Patient #75 regarding the use of restraints.

2. Patient #76 was admitted to the hospital on 1/13/10 with diagnoses that included Tubal Ovarian Abscess, Pelvic Inflammatory Disease, and Sepsis.

A clinical record review was conducted on the morning of 2/10/10. The clinical record revealed that there were no written individualized assessments and/or any alternatives or interventions documented in the clinical record or care plans for the use of restraints.

Review of the care plan revealed a "Patient in Non-Behavioral Medical Restraint" care plan. The preprinted care plan had only an undated entry that indicated, "ET (Endotracheal) tube safety," that was hand printed.

An interview with CNS G and Charge Nurse KK of the PICU was conducted at the time of the clinical record review. Both acknowledged that there were no documented care plan modifications to the care plans of Patient #76 regarding the use of restraints.

Based on review of clinical records and hospital policies, and staff interviews, it was determined that two of 84 patients (Patient #75 and Patient #76) had been placed into restraints without a physician's order after a surgical intervention.

The findings include:

1. Patient #75 was admitted to the hospital on 1/31/10 with diagnoses which included a gunshot wound to the face and hand.

On 2/10/10 a clinical record review was conducted on PICU. The review revealed that the Patient #75 had been placed in 2 point soft restraints by a physician's order on 2/3/10 at 10:09 a.m., and the order was to expire on 2/4/10 at 11:59 p.m.

Documentation in the clinical record also revealed that the patient was removed from the nursing unit to the OR (operating room) and remained there from about 1:00 p.m. to 4:00 p.m. The clinical record lacked any documentation of a new physician's order to re-start the restraints upon return to the unit. The next physician's order for 2 point soft restraints was documented at 8:18 a.m. on 2/4/10, and expired at 11:59 p.m. on 2/5/10.

The clinical record lacked a physician's order for restraints between approximately 4:00 p.m. on 2/3/10, and 8:18 a.m. on 2/4/10. However, the "Restraint Documentation Flow Sheet for Non-Behavioral Medical Restraint" contained documentation that the patient was in restraints on 2/3/10 from 2:00 p.m. to 3:00 p.m., 4:00 p.m. to 5:00 p.m., and 8:00 p.m. to 2/4/10 at 8:18 a.m. without a physician's order for restraints.

On 2/9/10, the patient returned to the OR where she remained from approximately 9:00 a.m. to 9:00 p.m. Upon return to the unit, the patient was again placed into restraints without a new physician's order for restraints. The patient remained in restraints until 2/10/10 at 6:34 a.m., when a new physician's order for 2 point soft restraints was obtained.

2. Patient #76 was admitted to the hospital on 1/13/10 with diagnoses that included Tubal Ovarian Abscess, Pelvic Inflammatory Disease, and Sepsis.

A clinical record review was conducted on the morning of 2/10/10 on PICU. The clinical record revealed that there was a physician's order for 2 point soft restraint which expired on 1/29/10 at 11:59 p.m. The next physician's order for restraints was on 1/30/10 at 3:02 a.m.

A review of the "Restraint Documentation Flow Sheet for Non-Behavioral Medical Restraint" contained documentation that Patient #76 remained in restraints without a physician's order for approximately three hours, from 12:00 a.m. until 3:00 a.m. on 1/30/10 when a new physician's order for restraints was obtained.

On 2/11/10 at 9:00 a.m., during an interview with the Staff Specialist Women's Health, she acknowledged that the clinical record lacked physician's restraint orders documented for Patient #75 on 2/3/10 from approximately 4:00 p.m. until 8:18 a.m. on 2/4/10, and again from 9:00 p.m. 2/9/10 until 6:34 a.m. 2/10/10. She also acknowledged that Patient #76 had been placed in restraints without a physician's orders between 12:00 a.m. through 3:00 a.m. on 1/30/10.

On 2/11/10 a review of the facility's policy, "Patient Orders 2.14.2." indicated "Pre-operative orders which will continue post-operatively must be rewritten. 6.1 "Orders shall be rewritten, whenever the patient has been to the OR."

Based on clinical record reviews, observations and staff interview, it was determined that the hospital failed to ensure that physicians' orders for restraints were obtained for three of 84 patients based on individual assessments and behaviors indicating a need for restraint usage. (Patients #11, #68 and #76)

The findings include:

1. Review of medical record for Patient #68 revealed an untimed nurses' note between the hours of 8:55 a.m. and 9:30 a.m. on 2/1/10 that stated, Pt (patient) swung and hit RN (registered nurse) with mitted hand, soft restraints applied until mom arrives. The medical record does not specify the type of soft restraint or where staff applied the restraint.

The Nursing Admission Note dated 2/1/10 at 11:00 p.m. indicated, 1:1 sitter, seizure pads, bed low, soft mitts as ordered.

Review of Physician's Orders from 1/31/10 at 10:57 a.m. through 2/2/10 at 2:19 a.m., lacked evidence of a physician order for hand mitts or soft restraints. At 2:19 a.m. on 2/2/10, the physician wrote an order for Restraints: Mitts with Wrist Restraints Soft 2-point Start 2/2/10 at 2:19 a.m. Expires on 2/3/10 at 11:59 p.m.

2. Patient #76 was admitted to the hospital on 1/13/10 with diagnoses that included Tubal Ovarian Abscess, Pelvic Inflammatory Disease, and Sepsis.

A clinical record review was conducted on the morning of 2/10/10 on PICU. The clinical record revealed that there was a physician's order for 2 point soft restraint on 1/15/10 at 5:12 a.m., that would have expired on 1/16/10 at 11:59 p.m.

The clinical record lacked any documentation of an assessment or other interventions attempted prior to the restraint being ordered. The clinical record lacked a "Restraint Documentation Flow Sheet for Non-Behavioral Medical Restraint" for this time period.

The clinical record also contained documentation of a physician's order for 2 point soft restraints from 2/2/10 through 11:59 p.m. on 2/3/10. There was an additional physician's order for 2 point soft restraint on 2/3/10 until 11:59 p.m. on 2/4/10.

A review of the "Restraint Documentation Flow Sheet for Non-Behavioral Medical Restraint" contained documentation that the restraints were, "d/c'd" (discontinued) on a (unknown date) after 2/2/10 at approximately 12:00 p.m. However, the physician's orders for restraints continued until 2/4/10 at 11:59 p.m. There was no documentation in the clinical record that a physician's order to discontinue the restraints was obtained for the period between 12:00 p.m. on 2/3/10 and 1:50 p.m. on 2/4/10.

An interview of the CNS of the Neurologic Intensive Care Unit, CNS G was conducted at approximately 10:30 a.m. She acknowledged that the clinical record of Patient #76 lacked a "Restraint Documentation Flow Sheet for Non-Behavioral Medical Restraint" in the clinical record for the physician's order for restraints of 1/15/10 through 1/16/10. She also said that the clinical record lacked a "Restraint Documentation Flow Sheet for Non-Behavioral Medical Restraint" after the handwritten documentation that the restraints were "d/c'd" on what appeared to be 12:00 p.m. on 2/3/10. She also acknowledged that there were no physician's orders to discontinue the restraints after 2/3/10.



06340

3. On 02/10/10 at approximately 2:05 p.m., Patient #11 was observed sitting in a chair in Room 828, appropriately dressed in street clothes which were clean and intact, his skin was dry and clean, nails and hair were neatly trimmed and he was clean shaven. The patient would answer simple questions, but would not initiate conversation. There was a Patient Care Aide (PCA) sitting in room with the patient, and a security guard posted outside the room.
Patient #11's, clinical record was reviewed on 2/10/10 at approximately 2:15 p.m.
Patient #11 is a 67 year old who was admitted to the hospital on 10/10/09 with Hypertension, Diabetes Mellitus, Seizure Disorder, Mood Disorder, Chronic Behavioral Issues, Subgaleal Hematoma, secondary to recurrent progressive falls, and Lewy Body Dementia. Patient #11 also fell at home and sustained compression fractures of vertebrae T4 (Thoracic), T5 and T11. The patient does not speak English and must have an interpreter to convey needs.
Included with medication, diet and treatment orders, were an order for restraints which read; Restraints Intervention-Non-Behavioral (Medical/Surgical)
Restraints:
Side Rails
Safety Net Bed
Soft 2 Point
Soft 4 Point
Reason:
Limit Mobility to prevent injuryStart 2/10/10 at 9:18 a.m., expires 02/11/10 at 11:59 p.m.

There were no written specific reasons for the application of any of the restraint intervention orders.

At 02/10/10 at approximately 2:30 p.m., the ND #1 for the unit was interviewed. ND #1 stated that Patient #11 has displayed many episodes of agitation and has caused injuries to the staff. That is why we have PCA in the room to help with care and treatments. A security guard is outside the room to assist us when the patient gets extremely agitated. There has been an increase in the psychoactive medications which has decreased acting out behaviors. We haven't had to use any restraints for a couple of days. When asked about what type of restraint would be used, it was stated that the orders should have been more specific.

Based on clinical record review, staff interview, and facility policy review, it was determined that the hospital failed to ensure that patients' clinical records contained documentation of patient's behaviors and the interventions used in conjunction with restraints for two of 84 patients. (Patients #75 and #76)

The findings include:

1. Patient #75 was admitted to the hospital on 1/31/10 with diagnoses which included a gunshot wound to the face and hand.

A clinical record review was conducted on the morning of 2/10/10 on PICU. The clinical record revealed that the patient had been placed in physician ordered restraints periodically between 1/31/10 through 2/10/10. The patient's care plans lacked any documentation of the patient's behaviors requiring restraints or any interventions attempted before the patient was placed in restraints.

The clinical record contained a pre-printed, unsigned Care Plan titled, "Patient in Non-Behavioral Medical Restraint." The care plan lacked any written assessment, dates, times, behaviors and/or interventions attempted prior to the use of restraints.

2. Patient #76 was admitted to the hospital on 1/13/10 with diagnoses that included Tubal Ovarian Abscess, Pelvic Inflammatory Disease, and Sepsis.

A clinical record review was conducted on the morning of 2/10/10. The clinical record revealed a lack of a written assessment, documentation of behaviors, or interventions attempted before the patient had been placed into restraints.

An interview with the CNS of the Neurologic Intensive Care Unit, CNS G and the Charge Nurse KK of the PICU, was conducted at the time of the clinical record review. They acknowledged that there were no behaviors documented or alternatives attempted prior to the use of restraints for Patients #75 and #76.

3. Review of the facility's policy and procedure titled, "Restraint and Seclusion", approved by the Medical Policy Committee on 6/3/09, indicated the following:
3.1 - The decision to use a restraint or seclusion is driven not by diagnosis, but by a comprehensive individual assessment;
3.3 - Restraints shall not be used when less restrictive interventions would be effective. Restraint or seclusion should be considered only as a temporary means of intervention when the patient is in immediate danger of harming self or others;
3.4 - When a restraint or seclusion is required, the least restrictive method should be utilized;
5.1 - Non-behavioral medical restraint may be used for the following indications when less restrictive means would not be effective in protecting the patient: a) the patient is pulling at tubes, lines or dressings, b) the patient's actions are endangering themselves; for example the patient is thrashing around in bed or attempting to get out of bed in a way or under conditions where it might cause harm;
5.3 - Type and location of the restraining device(s) shall be documented at least once per shift and when changed; alternatives to and less restrictive forms of restraint considered by the care giver shall be documented at least once per shift

Based on clinical record review and staff interviews, and facility policy review, it was determined that the hospital failed to ensure that alternatives or interventions were attempted prior to the use of restraints for two of 84 patients. (Patients #75 and #76).

The findings include:

1. Patient #75 was admitted to the hospital on 1/31/10 with diagnoses which included a gunshot wound to the face and hand.

A clinical record review was conducted on 2/10/10 at approximately 10:30 a.m. on the PICU. The clinical record revealed that the patient had been placed in restraints between 1/31/10 through 2/10/10. The clinical record lacked any documented interventions or alternatives attempted prior to the use of restraints.

The clinical record contained a pre-printed, unsigned care plan titled "Patient in Non-Behavioral medical Restraint." The care plan lacked any documentation of behaviors, alternatives or interventions attempted prior to the use of 2 point soft restraints.

2. Patient #76 was admitted to the hospital on 1/13/10 with diagnoses that included Tubal Ovarian Abscess, Pelvic Inflammatory Disease, and Sepsis.

A clinical record review was conducted on the morning of 2/10/10 on PICU. The clinical record revealed that there were no written assessment, alternatives, or interventions prior to or after the patient had been placed into restraints. The patient had been placed into 2 point soft restraints from 1/19/10 through 2/3/10.

An interview of the CNS of the Neurologic Intensive Care Unit, CNS G and the Charge Nurse KK of the PICU, was conducted at approximately 10:30 a.m. They acknowledged that there were no changes in the clinical records of Patient #75 or Patient #76 concerning changes or interventions attempted for the use of restraints.

3. Review of the facility's policy and procedure titled, "Restraint and Seclusion", approved by the Medical Policy Committee on 6/3/09, indicated the following:
3.1 - The decision to use a restraint or seclusion is driven not by diagnosis, but by a comprehensive individual assessment;
3.3 - Restraints shall not be used when less restrictive interventions would be effective. Restraint or seclusion should be considered only as a temporary means of intervention when the patient is in immediate danger of harming self or others;
3.4 - When a restraint or seclusion is required, the least restrictive method should be utilized;
5.1 - Non-behavioral medical restraint may be used for the following indications when less restrictive means would not be effective in protecting the patient: a) the patient is pulling at tubes, lines or dressings, b) the patient's actions are endangering themselves; for example the patient is thrashing around in bed or attempting to get out of bed in a way or under conditions where it might cause harm;
5.3 - Type and location of the restraining device(s) shall be documented at least once per shift and when changed; alternatives to and less restrictive forms of restraint considered by the care giver shall be documented at least once per shift

Based on clinical record reviews and staff interviews, and review of facility policy, it was determined that the hospital failed to ensure that patients' clinical records contained documentation of patients' responses to attempted interventions and the staffs' rationale to continue the interventions used for two of 84 patients. (Patients #75 and #76)

The findings include:

1. Patient #75
Patient #75 was admitted to the hospital on 1/31/10 with diagnoses which included a gunshot wound to the face and hand.

A clinical record review was conducted on the morning of 2/10/10 on the PICU. The clinical record revealed that the patient had been placed in restraints periodically. The clinical record lacked any documented interventions attempted prior to or after the use of restraints, thus there was not a rationale.

The clinical record contained a pre-printed, unsigned care plan titled, "Patient in Non-Behavioral Medical Restraint." This care plan lacked any written interventions or a rationale for the use of restraints.

2. Patient #76

Patient #76 was admitted to the hospital on 1/13/10 with diagnoses that included Tubal Ovarian Abscess, Pelvic Inflammatory Disease, and Sepsis.

A clinical record review was conducted on the morning of 2/10/10 on the PICU. The clinical record lacked documentation of any interventions attempted, patient response to those interventions or rationale for implementing an intervention. The clinical record contained documentation that Patient #76 had been periodically been in 2 point wrist restraints from 1/19/10 through 2/3/10.

An interview with CNS G and Charge Nurse KK of the PICU, was conducted at approximately 10:30 a.m. They both acknowledged that the clinical records lacked documentation of interventions attempted, the patient's response to those interventions and any rationale for the interventions.

3. Review of the facility's policy and procedure titled, "Restraint and Seclusion", approved by the Medical Policy Committee on 6/3/09, indicated the following:
3.1 - The decision to use a restraint or seclusion is driven not by diagnosis, but by a comprehensive individual assessment;
3.3 - Restraints shall not be used when less restrictive interventions would be effective. Restraint or seclusion should be considered only as a temporary means of intervention when the patient is in immediate danger of harming self or others;
3.4 - When a restraint or seclusion is required, the least restrictive method should be utilized;
5.1 - Non-behavioral medical restraint may be used for the following indications when less restrictive means would not be effective in protecting the patient: a) the patient is pulling at tubes, lines or dressings, b) the patient's actions are endangering themselves; for example the patient is thrashing around in bed or attempting to get out of bed in a way or under conditions where it might cause harm;
5.3 - Type and location of the restraining device(s) shall be documented at least once per shift and when changed; alternatives to and less restrictive forms of restraint considered by the care giver shall be documented at least once per shift

Based on observation, record review and interview with the facility's staff, it was determined that the facility failed to ensure that security personnel received 1st. Responder training and are certified in first aide procedures, Cardio-Pulmonary Resuscitation (CPR) and use of the AED (Automated External Defibrillator.)


The findings include:


During an observation in the hallway leading to the Emergency Department (ED) on 2/3/10 at approximately 7:45 a.m., Security Officer (SO) #1 was observed assisting in restraint of Patient #61 who exhibited aggressive behavior while waiting to be seen in the ED. According to a statement documented in a follow-up report dated 2/4/10 by SO #1, he stated, "...This officer then went to the ground and attempted to hold his legs down and to try to get him to stop kicking anyone."


Review of SO #1's personnel file revealed he was hired on 3/4/09. Further review of his personnel file revealed, that as of 2/10/10, SO #1 has not received training in CPR and has not been certified as a 1st. Responder.


SM #1 stated during an interview on 2/10/10 at 12:00 p.m., that all security/police staff are required to be certified as a 1st Responder and trained in CPR, and use of the AED. He also stated the training is done monthly. SM #1 went on to state that secondary to difficulties in scheduling and staffing SO #1 had not attended the required training, but he was expected to attend the course scheduled for 3/15-18/10.

Review of the personnel files for six other security/police/ambassadors revealed that there was a training class conducted in 5/09, but SO #1 had not attended the training on that date. This was acknowledged by SM #1.

Based on record review and interview, it was determined that the facility failed to report by telephone to the Centers for Medicare & Medicaid Services' (CMS) Regional Office each patient's death that occurred while the patient was in restraints or seclusion; each patient's death that occurred within 24 hours after the patient was removed from restraints or seclusion; or each patient's death known to the hospital that occurred within one week after restraints or seclusion where it would have been reasonable to assume that use of restraint or placement in seclusion contributed directly or indirectly to the patient's death. The facility did not report to CMS Regional Office twenty-four patients' deaths that occurred between 8/19/09 and 2/4/10 that were associated with one of the afore mentioned categories.

The findings include:

During an interview on 2/4/10 at 11:35 a.m., the Director and Associate Director of Corporate Compliance, Staff O and Staff P, stated each morning their offices receive an electronic file that lists all patients that died in the past 24 hours. Staff O, Staff P or another member of their staff immediately review each deceased patient's electronic medical record to determine if the patient died while in restraints or seclusion, if the patient died within 24 hours after their restraints or seclusion were removed, or if the patient died within one week after being in restraints or seclusion and it's reasonable to assume the use of restraint or seclusion contributed directly or indirectly to the patient's death.

If the deceased patient falls into one of these categories, a worksheet is completed with information required by CMS concerning the death, and faxed to the CMS Regional Office. The worksheet is faxed the same day the Corporate Compliance staff learns of the death. Staff O and Staff P stated their office does not report the deaths to the CMS Regional Office by telephone.

On 2/4/10, Staff O provided a list of 24 patients' names who died in the facility between 8/18/09 and 2/4/10 and whose deaths fit one of the restraint death reporting categories. During an interview on 2/5/10 at 1:30 p.m., Staff P acknowledged that none of the deaths had been reported to the CMS Regional Office by telephone.

Review of the facility's policy and procedure titled, "Restraint and Seclusion" approved by the Medical Policy Committee on June 3, 2009, indicated the following:
8.1 There are specific requirements to report any death associated with the use of restraint or seclusion.
-These requirements can be located in the Patients Rights section of the Medicare Hospital Conditions of Participation.
-The following must be reported within twenty four hours following knowledge of the patient's death: each death that occurs while a patient is in restraint or seclusion; each death that occurs within 24 hours after the patient has been removed from restraint or seclusion; each death known to the hospital that occurs within one week after restraint or seclusion where it is reasonable to assume that the use of restraint or placement in seclusion contributed directly or indirectly to the patient's death.

8.2 The Hospital will screen deaths to determine reportability.

8.3 Any staff member who has knowledge about the afore mentioned criteria should report this immediately to the Office of Quality and Safety or by use of the safety reporting system.

8.4 The Compliance Officer will file a copy of the report to CMS in the patient record after reporting is complete.

Review of the facility's policy and procedure for reporting patient deaths associated with the use of restraint or seclusion, did not follow the death reporting requirements by failing to include directions in submitting the reports to the CMS Regional Office by telephone.

Based on the review of the Departmental Quality Assurance Measures and staff interviews, it was determined that the facility failed to integrate its departmental Quality Assessment and Performance Improvement (QAPI) programs into the hospital wide program.

The findings include:


1. Ongoing routine Departmental Quality Assurance Measures are not being reported to the facility's centralized Quality Assurance Safety Committee. The following departments/services are not reporting:
Radiology Services - During an interview with Radiology Director #1 of the Radiology Department on 02/02/10 at 9:30 a.m., the non-reporting QA measures were acknowledged.

Nuclear Medicine Service - During an interview with Technical Manager #1 of the Nuclear Medicine Service 02/02/10 at 10:30 a.m.,. the non-reporting QA measures were confirmed.

Cardiac Catheterization Services - During an interview with Technical Manager #1 on 02/02/10 at 11:30 a.m., the non-reporting QA measures were confirmed.

Pharmacy Services - During an interview with the CPO (Chief Pharmacy Officer) of the Pharmacy on 02/05/10 at 10:00 a.m. the non-reporting QA measures were confirmed

Day Surgical unit at Danvers Outpatient facility - During an interview with the ED (Executive Director) North Shore Center for Outpatient Care on 02/08/10 at 09:30 a.m., .the non-reporting QA measures were confirmed.

Radiation Oncology at Dancers Outpatient facility - During an interview with the Radiology Director#1 in the department on 02/02/10 at 10:30 a.m.,. the non-reporting QA measures were confirmed.

Outpatient Services at Charleston - During an interview with the MD (Medical Director) #1 of the Center on 02/09/10 at 10:30 a.m., the non-reporting QA measures was confirmed.

Yawkey Center for Outpatient Services - During an interview with Technical Manager #1 on 02/09/10 at 1:30 p.m., the non-reporting QA measures were confirmed

Outpatient Services at Emerson - During an interview with the ND (Nursing Director) #2, Radiology Oncology service on 02/03/10 at 10:30 a.m., the non-reporting QA measures were confirmed.

Food and Nutrition Services (FNS) - During an interview with the Food and Nutrition Service Director on 2/2/10 at approximately 2:30 p.m., the Food and Nutrition Services' Director (FS #1) stated that statistics are reported to the Senior Vice President of Operations. During an interview with Assistant Food and Nutrition Services' Director (FS #2) on 2/5/10, at approximately 9:30 a.m., she stated that hand hygiene is a QAPI activity carried out by departments across the board and is integrated into the hospital wide QAPI program. On 2/8/10, at approximately 9:40 a.m., an interview with Food and Nutrition Services' Senior Vice President of Operations (FS #3) who is responsible for the Food and Nutrition Services Department was conducted. In response to questioning on integration into hospital wide QAPI it was stated that the hospital does not spend time to put it all together in one central repository. There was no indication that FNS QAPI activities are integrated into the hospital wide QAPI program.


06340

Based on record review and interview, it was determined that the Medical Staff failed to make recommendations to the Governing Body for privileges of Medical Staff as well as non-physicians, prior to clinical practice in the facility. In addition, the Medical Staff failed to incorporate specific criteria for privileges and timeliness of history and physical examination documentation within Professional Staff Bylaws. (See A341, A357, A358, A359 & A363)

The findings include:

1. In 13 of 23 credentials files reviewed, the governing body approval date occurred after the date that privileges were granted, resulting in physicians beginning clinical activities before Board approval.

2. Clinical privileges are granted by individual clinical departments, resulting in clinical practice in the facility without Medical Staff recommendations for Board approval.

3. In 1 of 1 RN/NP First Assistant's credential files reviewed, "temporary Operating Room privileges" were granted by the Executive Medical Director of ORs and the Chief of Surgical Services, and the "temporary privileges" were extended until the next scheduled Surgical Committee meeting, resulting in clinical practice in the facility for a prolonged period of time without completing the facility's own approval process and without Medical Staff recommendation for Board approval.

4. In 1 of 23 credential files reviewed, "preliminary approval" was granted by the Chief Medical Officer for an Assistant in Neurosurgery two days prior to placement on the Surgical Committee's agenda, resulting in clinical practice in the facility without completing the facility's own approval process and without Medical Staff recommendation for Board approval.

5. The hospital failed to include evidence of training and professional education through primary source verification for all members of the Medical Staff.

6. The Professional Staff Bylaws are missing candidate qualifications and description of the hospital's privileging process.

7. The Professional Staff Bylaws do not include a requirement that a medical history and physical examination be completed and documented for each patient no more than 30 days before or 24 hours after admission or registration, but prior to surgery or a procedure requiring anesthesia services.

8. The Professional Staff Bylaws do not include a requirement that an updated examination of the patient, including any changes in the patient's condition, be completed and documented within 24 hours after admission or registration, but prior to surgery or a procedure requiring anesthesia services, when the medical history and physical examination are completed within 30 days before admission or registration.

9. The Professional Staff Bylaws do not include the criteria for determining the privileges to be granted to individual practitioners and a procedure for applying the criteria to individuals requesting privileges.

Based on interviews and review of the "Bylaws of the Professional Staff of the General Hospital, Section 2.04-Allied Health Practitioners, and Massachusetts General Hospital, Department of Nursing, Credentialing and Authorization of Nurses in the Expanded Roles- Who are MGH and MGHO Employees," it was determined that the medical staff failed to make recommendations to the governing body for privileging of Allied Health Practitioners, and failed to make recommendations on the appointment of candidates that are specific to the type of appointment, and extent of the individual practitioner's specific clinical privileges. In 13 of 23 credential files reviewed, the facility also failed to make recommendations to the governing body prior to practice at the hospital for 1 of 1 RN/NP First Assistant, and failed to make recommendations for privileges for two of five surgeons prior to performing surgery in the facility, and one of five surgeons prior to scheduling surgery. In addition, the facility failed to include evidence of training and professional education as part of the credentials of candidates for Medical Staff membership.

The findings include:

A. The Governing Body approval date occurred after the date that privileges were granted resulting in physicians beginning clinical activities before Board approval.

1. The hospital notification letter to Physician MS 19, dated 11/14/08 indicated that "the Trustees of The General Hospital Corporation, at a meeting on 11/21/08, appointed you as Physician (Medicine Service) for the period from 11/10/08 to and including 11/9/10." This physician's appointment was effective 11 days prior to Governing Body approval.

2. The hospital notification letter to Physician MS 23 dated 4/21/08 indicated that "the Trustees of The General Hospital Corporation, at a meeting on 4/18/08, appointed you as Physician (Medicine Service) for the period from 4/14/08 to and including 4/13/10." This physician's appointment was effective 4 days prior to Governing Body approval.

3. The hospital notification letter to Physician MS 24 dated 7/20/09 indicated that "the Trustees of The General Hospital Corporation, at a meeting on 7/17/09, appointed you as Dermatologist (Dermatology Service) for the period from 7/16/09 to and including 7/15/11." This physician's appointment was effective 1 day prior to Governing Body approval.

4. The hospital notification letter to Physician MS 25 dated 12/22/08 indicated that "the Trustees of The General Hospital Corporation, at a meeting on 12/19/08, appointed you as Physician (Emergency Service) for the period from 12/4/08 to and including 12/3/10." This physician's appointment was effective 15 days prior to Governing Body approval.

5. The hospital notification letter to Physician MS 26 dated 11/23/09 indicated that, "the Trustees of The General Hospital Corporation, at a meeting on 11/20/09, appointed you as Visiting Surgeon (Surgery Service) for the period from 10/30/09 to and including 10/29/11." This physician's appointment was effective 22 days prior to Governing Body approval.

6. The hospital notification letter to Physician MS 27 dated 7/20/09 indicated that "the Trustees of The General Hospital Corporation, at a meeting on 7/17/09, appointed you as Assistant In Neurosurgery (Neurosurgery Service) for the period from June 15, 2009 to and including 12/21/09." This physician's appointment was effective 33 days prior to Governing Body approval.

7. The hospital notification letter to Physician MS 28 dated 2/22/10 indicated that "the Trustees of The General Hospital Corporation, at a meeting on 2/19/10, appointed you as Visiting Oral and Maxillofacial Surgeon (Oral and Maxillofacial Surgery) for the period from 2/14/10 to and including 2/13/12." This physician's appointment was effective 5 days prior to Governing Body approval. MS 28 was scheduled to perform a Bilateral Endoscopic Coronoidectomy on 2/16/10. The surgical procedure was scheduled three days prior to the governing body meeting and subsequent appointment on 2/19/10 as a Visiting Oral and Maxillofacial Surgeon.

8. The hospital notification letter to Physician MS 29 dated 9/21/09 indicated that "the Trustees of The General Hospital Corporation, at a meeting on 9/18/09, appointed you as Podiatrist (Orthopaedic Surgery) for the period from 8/14/09 to and including 8/13/11." This physician's appointment was effective 36 days prior to Governing Body approval.

9. The hospital notification letter to Physician MS 30 dated 9/21/09 indicated that, "the Trustees of The General Hospital Corporation, at a meeting on 9/18/09, appointed you as Assistant Pathologist (Pathology Service) for the period from 9/3/09 to and including 5/31/11." This physician's appointment was effective 15 days prior to Governing Body approval.

10. The hospital notification letter to Physician MS 31 dated 7/21/08 indicated that, "the Trustees of The General Hospital Corporation, at a meeting on 9/18/08, appointed you as Psychologist (Psychiatry Service) for the period from 9/25/08 to and including 9/24/10." This physician's appointment was effective 69 days prior to Governing Body approval.

11. The hospital notification letter to Physician MS 32 dated 5/18/09 indicated that, "the Trustees of The General Hospital Corporation, at a meeting on 5/15/09, appointed you as Clinical Affiliate (Radiology Service) for the period from 5/7/09 to and including 1/2/11." This physician's appointment was effective 8 days prior to Governing Body approval.

12. The hospital notification letter to Physician MS 33 dated 4/20/09 indicated that, "the Trustees of The General Hospital Corporation, at a meeting on 4/17/09, appointed you as Associate Visiting Surgeon (Surgery Service) for the period from 4/12/09 to and including 4/11/11." This physician's appointment was effective 5 days prior to Governing Body approval. MS 33 performed one surgical procedure, a Laparoscopic Distal Pancreatectomy with Splenectomy on 4/16/09. This procedure was performed one day prior to the appointment by the governing body as an Associate Visiting Surgeon on 4/17/09.

13. An e-mail from the Program Manager, MGH/MGPO Medical Staff Office to the Chief Medical Officer dated 6/9/09 at 3:27 p.m., requesting "preliminary approval" for an Assistant in Neurosurgery beginning 6/15/09 for an application that, "will be on the 6/17/09 agenda" was approved via e-mail by the Chief Medical Officer on 6/9/09 at 3:41 p.m. The "preliminary approval" was not recommended by the Medical Staff for approval by the Governing Body.

Physician MS 34 performed fifty-four neurosurgery procedures between the dates of 6/15/09 through 7/17/09. These procedures were performed with "preliminary approval" of privileges granted by the Chief Medical Officer on 6/9/09.

Privileging cannot be delegated by the governing body. The governing body is required to take the final appropriate action for granting or refusing privileges.

14. Review of delineation of privileges for Day Surgical unit at Danvers Outpatient facility and the Cardiac Catheterization Services indicated that there is insufficient documentation to confirm that clinical privileges were confirmed by the Governing Body.

During an interview with Operations Director of the Cardiac Catheterization Service on 02/02/10 at 11:30 a.m., it was determined that privileges to perform invasive procedures are only approved at the departmental level with no participation by the Governing Body.

During an interview with the Executive Director of the North Shore Center for Outpatient Care on 02/08/10 at 09:30 a.m., it was determined that privileges for surgeons at Day Surgical unit are only approved at the departmental level only with no participation by the Governing Body.


During an interview with the Director, MGH/MGPO Medical Staff Office on 2/2/10 at 10:00 a.m., she stated that, "Physicians can begin clinical activities before Board approval."

B. The hospital failed to make recommendations to the Governing Body for privileging of Allied Health Professionals.

1. The medical staff failed to make recommendations to the governing body for two Allied Health Practitioners CRNA #6 and RN/NP First Assistant #7, specifically the type of appointment and extent of the individual practitioner's specific clinical privileges. The privileging process for Allied Health Practitioners stops with authorization for practice with the Senior Vice President for Patient Care, Chief Nurse Executive.

2. During an interview with the Chief Medical Officer on 2/2/10 at 1:50 p.m., he stated that Physicians' Assistants and Nurse Practitioners are credentialed through the Health Professions Committee, not through Medical Staff recommendation to the Governing Body.

3. According to Massachusetts General Hospital Department of Nursing policy titled, " Credentialing and Authorization of Physician Assistants Who Are MGH and MGPO Employees", Initial Authorization and the re-approval process is facilitated by the patient care services credentialing program coordinator within The Institute for Patient Care. Physician Assistants practice in accordance with guidelines mutually developed with their supervising physician. Candidates requesting authorization to practice cannot practice as physician assistants until they have submitted the credentialing application with accompanying forms to the credentialing program coordinator; their application is reviewed by the Health Professions Staff Committee (a committee with representation from each of the nurses in the expanded role groups and physician assistants) and receives final approval to practice by the Senior Vice President for Patient Care and Chief Nurse or designee." Medical Staff recommendation to practice is not made to the Governing Body.

4. Review of the facility's policy "Credentialing and Authorization of Nurses in the Expanded Roles Who Are MGH (Massachusetts General Hospital) and MGPO (Massachusetts General Physician's Organization) Employees", Page 9-10, under the heading "AUTHORIZATION PROCESS", "Initial Authorization for nurses in the expanded role" indicated, "Protocols should be described using the scope for practice and must be reviewed and approved by the Health Professions Staff Committee. The credentialing program coordinator will forward this recommendation to the Senior Vice President for Patient Care and Chief Nurse, or designee for approval." In the same document, Page 10-11, under "Nurses in the expanded role in the First or Second Assist Role", Section 2.6.1.1, indicated, "Nurses in the expanded role who want to practice in the Operating Room in the First or Second Assist role must have credentials authorized and approved by the Health Professions Staff Committee and then reviewed by the Surgical Coordinating Committee for access to the Operating Room. The Associate Chief for Perioperative Services coordinates this process." There were no signatures or statements regarding approval of privileging for Allied Health Practitioners by the governing body.

5. Review of the facility's policy "Credentialing and Authorization of Nurses in the Expanded Roles Who Are MGH and MGPO Employees", Page 9-10, under the heading "AUTHORIZATION PROCESS", "Initial Authorization for nurses in the expanded role," "Initial Authorization and re-approval process is facilitated by the patient care services credentialing program coordinator within The Institute for Patient Care. Candidates requesting authorization to practice cannot practice in the expanded role until they have submitted the credentialing application with accompanying forms to the credentialing program coordinator; their application is reviewed by the Health Professions Staff Committee (a committee with representation from each of the nurses in the expanded role groups) and receives final approval to practice by the Senior Vice President for Patient Care and Chief Nurse or designee." There were no signatures or statements regarding approval of privileging for Allied Health Practitioners by the governing body.

6. Review of a document entitled "Process to credential and privilege CRNA's (Certified Registered Nurse Anesthetists)" provided by the Clinical Director of Anesthesia outlines the steps of privileging for CRNAs. The steps included:

- Obtain Curriculum Vitae (CV) and written references.
- Interview applicant.
- Review written references and follow-up via phone with references. The goal of these conversations is to understand the hospital setting where the CRNA has practiced and their scope of practice at that facility.
- Applicant completes MGH CRNA scope of practice document.
- Requested privileges approved, denied or given conditional approval depending on previous scope of practice, skills and knowledge.
- Packet reviewed and approved by collaborating physician, Chief CRNA, Departmental Chair and then sent to PCS (Patient Care Services) Institute for Patient Care Credentialing Coordinator.

7. Review of the privileging file for CRNA #6 revealed a "Massachusetts General Hospital Nurses in Expanded Roles Authorization to Practice Form" that displayed on the "Certification Signatures" page, the following signatures: the requesting Advanced Practice Nurse, the Collaborating Physician, and the Chief of Service. Under the heading "Reviewing Signature" was indicated the signature of the Associate Chief for Nursing Practice. Under the heading, "Approval Signature" was the signature of the Health Professions Staff Committee Designee. Lastly, the "Authorization Signatures" included the signatures of the Senior Vice President for Patient Care, Chief Nurse Executive, and Chair of the PCS Executive Committee dated 12/16/09. There were no signatures or statements regarding approval of privileging for Allied Health Practitioners by the governing body.

Review of the privileging file for CRNA #6 revealed a letter from the Health Professions Staff Committee dated 12/18/09, indicating that the practice guidelines submitted by CRNA #6 had been approved by the Senior Vice President and Chief Nurse.

8. Record review of re-privileging for RN/NP First Assistant #7 revealed a "Massachusetts General Hospital Nurses in Expanded Roles Authorization to Practice Form" that displayed on the "Certification Signatures" page the following signatures including: the requesting Advanced Practice Nurse, and the Collaborating Physician. The signature for the Chief of Service was blank. Under the heading "Reviewing Signature" was indicated the signature of the Associate Chief for Nursing Practice. Under the heading "Approval Signature" was the signature of the Health Professions Staff Committee Designee. Lastly, the "Authorization Signatures" included the signatures of the Senior Vice President for Patient Care, Chief Nurse Executive, and Chair of the PCS Executive Committee dated 12/16/09. There were no signatures or statements regarding approval of privileging for Allied Health Practitioners by the governing body.

In an interview on 2/3/10 at 11:25 a.m., the Executive Medical Director of the OR and Associate Chief Nurse of Perioperative Services were asked to explain the privileging process for CRNA #6. They stated the credentialing process was completed by the Health Professions Staff Committee and the privileging is completed by the Collaborating Physician, Chief CRNA, and the Department Chair. They were asked if anyone else participated in the privileging process. The Executive Medical Director of the OR stated there is no other committee that reviews this process.

In an interview on 2/9/10 at 9:05 a.m., the Chief of Anesthesia and the Clinical Director of Anesthesia were asked to explain the privileging process for nurses in the expanded role. The Executive Medical Director of the OR and Associate Chief Nurse of Perioperative Services were in attendance. The Clinical Director of Anesthesia stated, privileges are reviewed and recommended by the Clinical Director, the Chief of that Service, Associate Chief Nurse, and then approved by the Senior Vice President for Patient Care and Chief Nurse.

In an interview on 02/11/10 at 10:00 a.m. with the Senior Vice President for Patient Care and Chief Nurse, she stated, the final approval for practice of "Nurses in the Expanded Roles" is delegated to her by the General Executive Committee.

9. The hospital notification letter to NP 34 from the Executive Medical Director, Operating Rooms, dated 1/26/07 indicated that, "effective 1/26/07, (MS 35) and I grant you temporary Operating Room privileges as an MGH RN First Assistant in the Department of Orthopedics as requested in your application. The Surgical Coordinating Committee will meet on 2/13/07 and final approval will be granted at that time." Temporary privileges are not recommended by the Medical Staff for approval by the Governing Body.

C. The hospital failed to include evidence of training and professional education through primary source verifications for all members of the medical staff.

1. A letter, "To Whom It May Concern" dated 1/16/09, from the Commonwealth of Massachusetts Board of Registration in Medicine, RE: (regarding) Primary Source Verification, provided by the Director, MGH/MGPO Medical Staff Office on 2/4/10 indicated, "The Licensing Division of the Board of Registration in Medicine requires primary source verification of the following documents for M.D.'s (Medical Doctor) and D.O.'s (Doctor of Osteopathic Medicine) prior to issuing a medical license . . . Completion of two years of premedical school education; Completion of medical school training; Examination scores from United States Medical Licensing Examination (USMLE), National Boards and/or Federal Licensing Examination (FLEX); Postgraduate training from an Accreditation Council for Graduate Medical Education (A.C.G.M.E.) approved programs, one year of postgraduate training for U.S. graduates, (including Canadian and graduates of medical schools in Puerto Rico) and two years of postgraduate training for international medical graduates. All years of postgraduate training are collected and primary source verified . . . Please be advised that the on-line verification information is maintained by the Massachusetts Board of Registration in Medicine and is updated every evening, in compliance with JCAHO (Joint Commission on Accreditation of Healthcare Organizations) and the National Committee for Quality Assurance (NCQA) standards for primary source verification of physician information."

During interview with the Director, MGH/MGPO Medical Staff Office on 2/4/10 at 8:40 a.m., she stated that medical education is the only thing not done by primary source verification - done by the Board of Medicine "in compliance with the Joint Commission and the INCA."






06340

Based on documentation review and interview, it was determined that the Bylaws of the Professional Staff of the General Hospital failed to detail the qualifications to be met by a candidate in order for the medical staff to recommend that the candidate be appointed by the governing body.

The findings include:

1. During interview with Legal Counsel on 2/3/10 at 11:15 a.m., she stated that the qualifications of candidates for the Medical Staff could be found in Section 3.02.1 of the Bylaws of the Professional Staff of the General Hospital.

2. Section 3.02.1 of the Bylaws of the Professional Staff of the General Hospital state, "Every application for Membership on the Staff shall be in writing, submitted on forms prescribed by the Hospital, and signed by the applicant. The application shall include without limitation a specific request indicating the staff category or clinical privileges being applied for; verifiable information concerning the applicant's education, training and experience; the names of all health care facilities with which the applicant has been associated and the reasons for discontinuance of these associations; a listing and description of all malpractice claims pending or closed during the previous ten (10) years; a statement authorizing the applicant's insurance carrier to release specified information relating to claims or actions for damages; a statement authorizing any health care facility with which the applicant has been associated to release information which is relevant to the applicant's character and professional competence; a statement authorizing the Hospital to exchange information with any other health care facility or professional organization with which the applicant has been associated regarding any pending or final disciplinary action; and such other information as may be required from time to time by the Hospital or the applicable Service or Department. An applicant must submit a copy of his or her most recent Massachusetts licensure application form and must agree to undergo a mental or physical examination if requested. An application shall not be considered unless supplemented by written references attesting to the applicant's professional competence and ethical practice - at least three references in the case of Clinical Staff and at least two references in the case of Non-Clinical Staff."

Section 3.02.1 does not include either a description of candidate qualifications or criteria for specific privileges that must be met for the Medical Staff to recommend the candidate to the governing body. This finding was verified with Legal Counsel on 2/3/10 at 11:15 a.m.

Based on interview and document review, it was determined that the Bylaws of the Professional Staff of the General Hospital do not include a requirement pertaining to the completion and documentation of a medical history and physical examination for each patient no more than 30 days before or 24 hours after admission or registration, but prior to surgery or a procedure requiring anesthesia services.

The findings include:

1. Review of the Bylaws of the Professional Staff of the General Hospital revealed the absence of a requirement pertaining to the completion and documentation of a medical history and physical examination for each patient no more than 30 days before or 24 hours after admission or registration, but prior to surgery or a procedure requiring anesthesia services.

2. During an interview with Legal Counsel on 2/3/10 at 11:55 a.m., she stated that the Bylaws of the Professional Staff of the General Hospital do not have a statement regarding a requirement pertaining to the completion and documentation of a medical history and physical examination for each patient no more than 30 days before or 24 hours after admission or registration, but prior to surgery or a procedure requiring anesthesia services.

3. During an interview with Legal Counsel on 2/5/10 at 9:40 a.m., she stated that physicians are bound by hospital policies through Articles 2.01 and 3.01 of the Bylaws of the Professional Staff of the General Hospital.

4. Review of Article 2.01 of the Bylaws of the Professional Staff of the General Hospital revealed that, "In discharging the duties and exercising the privileges of his or her appointment, each Staff Member shall be subject to these Bylaws and to all applicable rules and regulations and policies of the Hospital and shall be responsible to his or her Chief of Service or Department, the Hospital's President, and the Trustees." Article 2.01 does not include a requirement that a medical history and physical examination be completed and documented for each patient no more than 30 days before or 24 hours after admission or registration, but prior to surgery or a procedure requiring anesthesia services.

5. Review of Article 3.01 of the Bylaws of the Professional Staff of the General Hospital revealed that, "Each initial appointee to the Professional Staff shall be given a copy of the Bylaws of the Professional Staff and shall agree to be bound by the Bylaws and all applicable rules and regulations of the Hospital and the Professional Staff." Article 3.01 does not include a requirement that a medical history and physical examination be completed and documented for each patient no more than 30 days before or 24 hours after admission or registration, but prior to surgery or a procedure requiring anesthesia services.

6. Section 3.2.1, Admission Assessment, Patient Record Policy, Clinical Policy & Procedure Manual, provided by the Director of Compliance indicated, "The patient's history, physical examination, provisional diagnosis, and diagnostic or treatment plan shall be completed and entered into the record by either a physician, a nurse in the expanded role, a supervised medical student or a PA (Physician's Assistant) within the first twenty-four (24) hours of admission, and prior to any surgical procedure. The attending/responsible physician shall review the admission history, physical examination, provisional diagnosis and diagnostic or treatment plan and enter an appropriate note of his/her own." This policy does not meet the requirement that the bylaws include a requirement that a medical history and physical examination be completed and documented for each patient no more than 30 days before or 24 hours after admission or registration, but prior to surgery or a procedure requiring anesthesia services.

7. Section 3.5.5, Patient Record Policy, Clinical Policy and Procedure Manual, provided by the Director of Compliance indicated, "If any physician has three (3) or more delinquent records or any delinquent dictation older than thirty (30) days, he/she shall receive a Suspension Warning and have seven (7) calendar days to complete all available delinquent records." This policy does not meet the requirement that the bylaws include a requirement that a medical history and physical examination be completed and documented for each patient no more than 30 days before or 24 hours after admission or registration, but prior to surgery or a procedure requiring anesthesia services.

Based on interview and document review, it was determined that the Bylaws of the Professional Staff of the General Hospital do not include a requirement pertaining to the completion and documentation of an updated examination of the patient, including any changes in the patient's condition, within 24 hours after admission or registration, but prior to surgery or a procedure requiring anesthesia services, when the medical history and physical examination are completed within 30 days before admission or registration.

The findings include:

1. Review of the Bylaws of the Professional Staff of the General Hospital revealed the absence of a requirement pertaining to the completion and documentation of an updated examination of the patient, including any changes in the patient's condition, within 24 hours after admission or registration, but prior to surgery or a procedure requiring anesthesia services, when the medical history and physical examination are completed within 30 days before admission or registration.

2. During interview with Legal Counsel on 2/3/10 at 11:55 a.m., she stated that the Bylaws of the Professional Staff of the General Hospital do not have a statement regarding a requirement pertaining to the completion and documentation of an updated examination of the patient, including any changes in the patient's condition, within 24 hours after admission or registration, but prior to surgery or a procedure requiring anesthesia services, when the medical history and physical examination are completed within 30 days before admission or registration.

3. During an interview with Legal Counsel on 2/5/10 at 9:40 a.m., she stated that physicians are bound by hospital policies through Articles 2.01 and 3.01 of the Bylaws of the Professional Staff of the General Hospital.

4. Review of Article 2.01 of the Bylaws of the Professional Staff of the General Hospital revealed that, "In discharging the duties and exercising the privileges of his or her appointment, each Staff Member shall be subject to these Bylaws and to all applicable rules and regulations and policies of the Hospital and shall be responsible to his or her Chief of Service or Department, the Hospital's President, and the Trustees."

Article 2.01 does not include a requirement that an updated examination of the patient, including any changes in the patient's condition, be completed and documented within 24 hours after admission or registration, but prior to surgery or a procedure requiring anesthesia services, when the medical history and physical examination are completed within 30 days before admission or registration.

5. Review of Article 3.01 of the Bylaws of the Professional Staff of the General Hospital revealed that, "Each initial appointee to the Professional Staff shall be given a copy of the Bylaws of the Professional Staff and shall agree to be bound by the Bylaws and all applicable rules and regulations of the Hospital and the Professional Staff."

Article 3.01 does not include a requirement that an updated examination of the patient, including any changes in the patient's condition, be completed and documented within 24 hours after admission or registration, but prior to surgery or a procedure requiring anesthesia services, when the medical history and physical examination are completed within 30 days before admission or registration.

6. Section 3.2.1, Admission Assessment, Patient Record Policy, Clinical Policy and Procedure Manual, provided by the Director of Compliance indicated, "The patient's history, physical examination, provisional diagnosis, and diagnostic or treatment plan shall be completed and entered into the record by either a physician, a nurse in the expanded role, a supervised medical student or a PA within the first twenty-four (24) hours of admission, and prior to any surgical procedure. The attending/responsible physician shall review the admission history, physical examination, provisional diagnosis and diagnostic or treatment plan and enter an appropriate note of his/her own."

This policy does not meet the requirement that the bylaws include a requirement that an updated examination of the patient, including any changes in the patient's condition, within 24 hours after admission or registration, but prior to surgery or a procedure requiring anesthesia services, when the medical history and physical examination are completed within 30 days before admission or registration.

7. Section 3.5.5, Patient Record Policy, Clinical Policy and Procedure Manual, provided by the Director of Compliance indicated, "If any physician has three (3) or more delinquent records or any delinquent dictation older than thirty (30) days, he/she shall receive a Suspension Warning and have seven (7) calendar days to complete all available delinquent records."

This policy does not meet the requirement that an updated examination of the patient, including any changes in the patient' s condition, within 24 hours after admission or registration, but prior to surgery or a procedure requiring anesthesia services, when the medical history and physical examination are completed within 30 days before admission or registration.

Based on interview and document review, it was determined the hospital failed to include specific criteria for determining privileges to be granted to individual practitioners, and a procedure for applying the criteria to individuals requesting privileges.

The findings include:

1. During an interview with Legal Counsel on 2/3/10 at 11:55 a.m., she stated that granting of privileges is addressed in Article 4.01 Delineation of Privileges in General, of the Bylaws of the Professional Staff of the General Hospital.

2. Article 4.01 of the Bylaws of the Professional Staff of the General Hospital indicated, "Each appointment shall confer on the appointee only such privileges as have been granted in the written notice of appointment by the Trustees or by virtue of his or her staff category under these Bylaws. These privileges shall limit the appointee to activities in which he or she has demonstrated current competence and which are within the scope of his or her license to practice. The Chief of each Service and Department, following review and recommendation by the Quality Assessment Committee, and subject to review and approval of the General Executive Committee (GEC), shall develop criteria for use in the granting of privileges in that Service or Department."

3. The Bylaws of the Professional Staff of the General Hospital do not include specific criteria for determining the privileges to be granted to individual practitioners and a procedure for applying the criteria to individuals requesting privileges.

4. These findings were verified with Legal Counsel on 2/3/10 at 11:55 a.m.

Based on observations, review of clinical records, review of policies and procedures and facility internal investigation reports, and patient and staff interviews, it was determined that the hospital failed to meet the Condition of Participation for Nursing Services as evidenced by:

1. The facility failed to ensure that a Registered Nurse supervised and evaluated the nursing care for 14 of 84 patients.

The nursing staff failed to respond to alarm indicators for Patient #77 who required continuous cardiac and rhythm rate monitoring and the heart rate decreased to asystole (without a heart beat.).

The nursing staff failed to assess for pain and medicate as necessary Patient #38, Patient #21, Patient #24, Patient #28, Patient #56 and Patient #84.

Patient #33 and Patient #36's pressure sores were not continually assessed. The facility did not have a Policy and Procedure for the steps staff were to take to assess and document a description of a pressure ulcer.

Patient #22 and Patient #34's medications were not administered by the nurse in accordance with the physician's orders. The nurse left oral medications and eye drops in Patient #23 and Patient #78's rooms.

Patient #12's care plan did not address pain or being on the transplant waiting list.
(See A395)

2. The facility failed to follow standard blood product verification procedures for one of 84 patients, Patient #65.
(See A405)

Based on observations, review of the facility's policies and procedures, medical record reviews, and patient and staff interviews, it was determined that for 14 of 84 patients, the registered nurses did not evaluate the care for each of these patients and did not on an ongoing basis assess the patients' care needs related to cardiac monitoring, pain, pressure ulcers, and medication administration, and did not assess the patients' response to interventions. The nursing staff failed to respond to alarm indicators for Patient #77 who required continuous cardiac and rhythm rate monitoring and developed asystole (without a heart beat.).The nursing staff failed to assess for pain and medicate as necessary Patient #38, Patient #21, Patient #24, Patient #28, Patient #56 and Patient #84. Patient #33 and Patient #36's pressure sores were not continually assessed. The facility did not have a Policy and Procedure for the steps staff were to take to assess and document a description of a pressure ulcer. Patient #22 and Patient #34's medications were not administered by the nurse per physician orders. The nurse left oral medications and eye drops in Patient #23's room and an inhalation medication in Patient #78's rooms. In addition, Patient #12's care plan did not address pain or being on the transplant waiting list.

The findings include:

1. Patient #77
On 2/10/10, review of Patient 77's closed medical record showed a Cardiology Consultation Note dated 1/20/10, that documented the following:
-89 years old, married, lives with spouse, still drives and remains active;
-Admitted to the hospital from home on 1/20/10 for newly diagnosed colorectal cancer;
-History of atrial fibrillation (an arrhythmia where the heart's two upper chambers beat chaotically and irregularly), coronary artery disease, and four-vessel coronary artery bypass grafting in 2000;
-Underwent Abdominal Perineal Resection surgery with colostomy placement on 1/20/10;
-During the surgery the patient developed complete heart block and bradycardia with a heart rate of 15 beats per minute (bpm).
-The patient was treated successfully with intravenous medications to increase the heart rate and a temporary pacemaker wire was placed intravenously into the heart;
-The cause of the patient's complete heart block and bradycardia implies underlying conduction system disease;
-The patient transferred to the post-anesthesia care unit (PACU) on 1/20/10 following completion of the surgical procedure.

Cardiology Progress Notes dated 1/20/10 at 9:00 p.m. showed the temporary pacemaker wire inserted during surgery failed to function properly while in the PACU. The temporary pacemaker wire was removed on 1/21/10 at 12:30 a.m.
Nursing documentation indicated that the patient's heart rhythm while in the PACU indicated that the patient was in atrial fibrillation reflecting a heart rate with beats per minute in the 50's and 60's. (normal adult heart rate is 60-80 beats per minute).

Physician Progress Notes indicated the patient was transferred from the PACU to the Cardiac Care Unit (CCU) on 1/21/10.

On 1/22/10 Cardiology Progress Notes showed the patient was in atrial fibrillation with heart rates dropping into the 40's when asleep. Documentation indicated the patient was scheduled for a permanent pacemaker on 1/25/10. The patient was approved for transfer from CCU to a surgical floor with telemetry monitoring.

Review of Nursing Flow Sheets and Progress Notes indicated that the patient was transferred to a surgical patient care floor at 6:00 p.m. on 1/22/10, with physician's orders for centralized cardiac telemetry (monitoring a patient's heart activity from a distance) and was a full code (wished resuscitation if the heart and/or breathing stopped).

Nursing documentation on 1/22/10 at 5:55 p.m., 7:30 p.m., 8:30 p.m. and 10:00 p.m. relative to the patient's vital signs after transfer to the surgical floor indicated heart beats from 59 to 74 and a heart rhythm reflecting of atrial fibrillation.

Review of Surgical Progress Notes, dated 1/23/10, showed:
-The patient's heart rhythm was in atrial fibrillation/SSS (sick sinus syndrome is a malfunction of the normal pacemaker of the heart in which the heart rate slows below normal limits);
-Monitor heart rate closely;
-Surgical placement of permanent cardiac pacemaker scheduled on 1/25/10.

Interviews on 2/10/10 and 2/11/10 with hospital nursing administrative staff responsible for conducting the hospital's investigation into Patient #77's death, RN AA (Patient Staff Specialist), RN BB (Associate Chief Nurse), RN CC (Nurse Director), and RN DD (Clinical Nurse Specialist) - revealed the following:
-On 1/23/10 the patient's heart rate was 56-62 beats per minute (bpm) and the blood pressure was stable;
-During the night shift from 7:00 p.m. on 1/23/10 through 7:00 a.m. on 1/24/10, the patient's heart rate was 55-77 bpm, blood pressure stable, no nausea or vomiting, tolerating a liquid diet and bowel sounds present;
-Staff RN E assumed the care of the patient as well as two additional patients at 7:00 a.m. on 1/24/10;
-There were 32 inpatients-including Patient #77-receiving care on this surgical floor the morning of 1/24/10, and 10 RN's on duty;
-Nursing staff did not continuously monitor the cardiac rates/rhythms at the central nurses' station monitors. This responsibility falls on all nursing staff on the unit. When an alarm sounds or a message appears on the alarm display unit, available nurses are to evaluate the reason the alarms are sounding, and respond as necessary;
-The patient's heart rate at 7:30 a.m. on 1/24/10 was 77 bpm, and heart rhythm indicated the patient was in atrial fibrillation;
-The patient ate breakfast, ambulated in the hallway, family visited, had his morning bath and was administered pain medication at 9:28 a.m.;
-Central nurses' station cardiac monitor logs indicated that:
· At 9:40 a.m. heart rate was 82 bpm,
· At 9:53 a.m. heart rate at 53 bpm,
· At 9:54 am heart rate at 44 bpm,
· From 9:56-9:58 a.m. heart rate at 0 bpm,
· From 9:59-10:01 a.m. heart rate at 0-29 bpm,
· From 10:02-10:16 a.m. heart rate at 0 bpm,
· A high-low audible warning alarm (alarm set to sound when the patient's heart rate exceeded 120 bpm or fell below 50 bpm) sounded for the patient from 9:53-10:01 a.m., and from 10:06-10:16 a.m. by repeatedly broadcasting two "beeps" at the central nurses' station cardiac monitors.
· The three (3) ceiling mounted digital alarm display units that were located at the end of the two patient care hallways and near the central nurses' station indicated "HR LO" (Heart Rate Low) and the patients room number during the time of the audible alarms;
¿-The volume to the alarms on the patient's bedside cardiac monitor had been turned off at an unknown date and time and by an unknown person;
-No one was at the patient's bedside while the central nurses' station cardiac monitors were alarming. No staff responded to the alarms until 10:16 a.m., when RN E entered the patient's room to assess the patient's urinary output. This reflected a time span of 20 minutes after the alarms initially sounded. The patient was found unresponsive, and with vomit on his/her mouth and gown. Cardio-pulmonary resuscitation was initiated and a Code Blue was called. Efforts to resuscitate the patient were unsuccessful and the patient expired;

-Administrative nursing staff interviews with the RN's on duty the morning of 1/24/10 revealed that no one could recall hearing the alarms that sounded from the central nurses' station cardiac monitors, and no one recalled seeing the "HR LO" displayed on the alarm display units. All 10 RN's interviewed stated the alarm notifications that morning were no more than usual. If in a patient room with the door closed, staff could not hear the alarms coming from the central nurses' station;

-Nursing staff interviewed on the patient care unit said they were experiencing alarm fatigue and a desensitization to alarms after hearing them constantly throughout the workday.

Interviews on 2/10/10 and 2/11/10 with Biomedical Engineering Staff M and N, and review of a Biomedical Engineering Findings Report, dated 2/4/10, revealed:

-In addition to the two "beep" high-low audible alarms on the central nurses' station cardiac monitors and bedside cardiac monitors, there is also an arrhythmia alarm that is supposed to be set to "Full," which means the alarms are on. This alarm triggers the broadcast of a three "beep" audible alarm when a patient develops a crisis or lethal arrhythmia-such as asystole.


An investigation conducted by Biomedical Engineering after Patient #77's death, found the arrhythmia alarm on the patient's bedside cardiac monitor had been set to "Off" on 1/22/10 at approximately 6:15 p.m. As a result, on 1/24/10 between 9:54 a.m. and 10:16 a.m., the arrhythmia alarm did not broadcast the three "beep" audible alarm from the central nurse's station that would have signified to nursing staff that Patient #77 was experiencing a lethal arrhythmia.


-The Biomedical Engineering Findings Report showed recommendations to install a distributed speaker system on the surgical patient care unit where Patient #77 had resided, which would make monitoring alarms more audible throughout the unit rather than only at the central monitors located at the nurse's station. The report also showed recommendations for the surgical patient care unit to make the necessary changes so that staff could not turn the arrhythmia alarms to "Off" and could not turn the alarm volume to "OFF" on patients' bedside cardiac monitors.

Observation on 2/10/10 at 1:00 p.m. of the surgical patient care unit where Patient #77 had resided revealed two patient care hallways with the floor plan in the shape of the letter "V." The central nurses' station cardiac monitors with audible alarms were located near the point of the "V." Ceiling mounted digital alarm display units were located at the far end of the two hallways and at the point of the "V." In addition, a wall-mounted flat screen cardiac monitor without audible alarms was located part way down each hallway. Six patients' heart rates/rhythms were being continuously monitored. However, no staff were observed at the central nurse's station monitoring these six patient's cardiac rates/rhythms continually.

The room where Patient #77 had resided from 1/22/10 until 1/24/10 was across the hallway and slightly diagonal from the location of the central nurse's station cardiac monitors. At approximately 2:15 p.m., Biomedical Engineering staff programmed an unused cardiac monitor at the central nurse's station to broadcast an alarm identical to the alarm that sounded on Patient #77's cardiac monitor on 1/24/10. The alarm volume was audible from the central nurse's station but was barely audible to inaudible when standing at the farthest ends of the hallways. Staff caring for patients in the rooms at the farthest end of the hallways would not be able to hear the alarms.

During an interview at 2:30 p.m., Biomedical Engineering Staff N said the Biomedical Engineering department had identified a need one to two years ago for the installation of additional speakers on all patient care units and was currently a work in progress. Installation of a distributed speaker system on this unit and all other patient care units would make the alarm volumes more audible throughout the unit rather than only at the central monitor's at the nurse's station. Speakers had been installed on some other patient care units of the hospital but had not been installed on this floor yet.

Review of documentation dated 2/2/10, by Medical Doctor (MD) AAA in a report that was prepared for medical peer review activities at the hospital revealed the preliminary autopsy report for Patient #77 showed no pulmonary emboli (a sudden blockage in a lung artery - usually caused by a blood clot) and no aspiration. The patient's death appears due to unrecognized severe bradycardia from faulty alarm settings.

2. Patient #38

Although Patient #38 had multiple fractures, bilateral pulmonary contusions and a left arm infiltrate, the patient was not continuously assessed for pain using a non-verbal pain assessment and the patient did not receive pain medication as ordered by the physician.

Patient #38 was brought into the Emergency Department at 9:10 a.m. on 2/8/10 after being hit by a taxi cab with the complaint of neck pain. The patient's pain assessment during the time in the Emergency Department from 9:15 a.m. until 4:15 p.m. was documented as "unable to be determined" or left blank.

The FLACC Scale (FACE, Legs, Activity, Cry, Consolability) is a behavior pain assessment scale utilized by the hospital for use in non-verbal patients unable to provide reports of pain. The patient is rated a 0, 1, or 2 in each of the five measurement categories (face, legs, activity, cry and consolability), the scores are added together for a total pain score. The scores of zero are given when the patient has no issues, a one is given for the following reasons: face (occasional grimace or frown, withdrawn, disinterested), legs (uneasy, restless, tense), activity (squirming, shifting back/forth, tense), cry (moans or whimpers, occasional complaint), and consolability (reassured by occasional touching, hugging, talking to, distractible). A score of two is given for the following reasons: face (frequent to constant frown, clenched jaw, quivering chin), legs (kicking or legs drawn up), activity (crying steadily, screams, sobs, frequent complaints), and consolability (difficult to console or comfort).

Review of the Emergency Department Trauma Flow Sheet and Emergency Nursing Continuation Sheet revealed the following documentation:
9:10 a.m. Time of arrival. Ground transport. Immobilization with collar, headrolls and backboard. Responds to pain. Head hematoma. Comments: Positive loss of consciousness, "complains of neck pain? Dislocation of shoulder."
9:15 a.m. Two large bore intravenous (IVs) placed, one in the right arm and one in the left arm. Trauma team at bedside. Collar in place.
9:18 a.m. Labs sent.
9:20 a.m. Chest x-ray/pelvic at bedside.
9:23 a.m. Removed from back board.
9:28 a.m. To Cat Scan for stat CT of the head without IV contrast, cervical spine without IV contrast, thoracic spine without IV contrast, lumbar spine without IV contrast, chest with IV contrast; abdomen/pelvis with IV contrast.
9:37 a.m. Combative at CT. Haldol 5 mg IV (an antipsychotic medication) was given.
9:50 a.m. Haldol 5 mg IV given.
10:04 a.m. Calm. Head CT Scan done.
10:20 a.m. Restless. Questionable infiltrate of contrast in left arm. CT stopped secondary to movement.
10:33 a.m. Repeat head CT without contrast. Haldol 2.5 mg IV given for restlessness.
10:40 a.m. Hot pack applied to left arm IV site. Physician ordered to keep left arm elevated as there is contrast extravasation.
10:45 a.m. Return from CT.
10:50 a.m. Calm on stretcher.
11:00 a.m. Foley placed #16. Return to CT with registered nurse.
11:15 a.m. Return to CT for CT of head. Moving all over patient will follow commands at times.
11:30 a.m. Back to the emergency department.
11:50 a.m. Stat Fosphenytoin 1000 milligrams (mg) Phenytoin Equivalents IV (antiepileptic medication) administered.
12:00 noon Vomited, medicated with Zofran 4 mg IV (used to prevent nausea and vomiting).
12:30 p.m. Calm, will arouse.
1:30 p.m. Family present. Foley draining clear fluid.
2:00 p.m. Family here. Restless.
2:45 p.m. Confused at times. Tries to get up. Reassure about Foley.
3:00 p.m. Report to Ellison 7 nursing staff. Bed not ready. At times will follow commands, confused, sometimes understands.
4:15 p.m. To room on Ellison 7.

Review of the patient's 2/8/10 Patient Problem/Outcome/Intervention Sheet revealed that acute pain related to trauma injury was identified as a problem. Interventions included but were not limited to: monitor patient's pain level at least every shift, administer pain medication according to prescribed regimen and reassess after intervention provided.

Review of the Physician's orders revealed the following information:

Acetaminophen (Tylenol) 325-650 mg by mouth every four hours as needed for mild pain was ordered on 2/8/10 at 11:50 a.m.

Side Rail Restraints was ordered on 2/8/10 at 5:24 p.m.

On 2/8/10 at 6:00 p.m. upon admission to the Ellison 7 unit, the nursing staff completed the Nursing Dataset Form and initialed the completion of Section 2, Cognitive/Perceptual. The nurse indicated in Section 2 that the patient responded that the month was February and year 2010. Section 3 - Pain was checked no for pain, but was not dated, timed nor initialed by the nurse. The last page of the Nursing Dataset Form was dated as completed on 2/8/10 at 6:30 p.m. and the nurse documented that the information for the Nursing Dataset Form was obtained by the family-fiancé.

Review of the patient's Nursing Progress Notes revealed the following information:
2/8/10 at 10:06 p.m. Patient was struck by a taxi cab going 30 miles per hour. Patient landed on the taxi's windshield and it was destroyed. Patient was combative and confused at the scene. For CT scans the patient received 12.5 mg total of Haldol. Injuries: bilateral pulmonary contusions, subdural hematoma, frontal contusion, fracture of right temporomandibular joint, minimally displaced fracture of right parietal bone, right occipital fracture. Pain: Patient unable to use pain scale to rate pain due to confusion. When asked if patient has pain she will sometimes say yes, but when asked where she won't answer. Usually seems to be related to positional discomfort. Awake and oriented to self. Patient at times knows month and year, but not place or why she is here. Patient follows simple commands at times. Waxes and wanes. Patient took antibiotic by mouth for jaw fracture. Patient took pills ok with sips of water. Left arm is slightly edematous from IV that infiltrated. Ice packs applied and arm elevated. Patient impulsive at times, says she has to void, catheter does seem to be positional. Patient moves in bed at times impulsive. Bed alarm on for safety. Cervical collar remains intact. Side rail restraints up for safety.

2/9/10 at 4:01 a.m. CT scan done on 2/8/10 resulted in left arm swelling due to CT contrast infiltrated. Warm pack applied to left arm and elevated on a pillow. Patient states she does not have any pain. Did not require any pain medication was able to sleep for short periods of time during the night will continue to assess. Foley draining clear urine. Patient frequently attempting to get out of bed. States she has to void. Patient obeys some commands, good strength to arm and legs moves well. Continues to attempt to get up out of bed frequently and pulling at IV and catheter. Four side rails up in bed for safety, constant supervision to prevent injury.

Review of the Physician Progress Note reveal the following documentation:
2/9/10 at 6:00 a.m. Alert and responds appropriately to questions, but waxes and wanes, follows commands. Neuro exam stable-improved. Cervical collar. Clindamycin/sinus precautions.

Review of the patient's 2/8/10 flow sheet revealed that the patient was assessed as unable to quantify pain at 4:30 p.m., 5:30 p.m., 6:30 p.m., 8:00 p.m., 9:00 p.m., and 10:00 p.m. and no interventions for pain management were implemented.

Although the Nursing Progress Note on 2/9/10 at 4:01 a.m. indicated that the patient denied pain, review of the patient's 2/9/10 flow sheet revealed the patient was assessed as unable to quantify pain at 12:00 midnight, 1:00 a.m., 2:00 a.m., 3:00 a.m., 4:00 a.m., 5:00 a.m., 6:00 a.m., 7:00 a.m., 8:00 a.m., and at 9:00 a.m. and no interventions for pain management were implemented.

Review of the hospital's 1992 Guidelines for Pain Assessment and Management which was reviewed in 2000 revealed that the section entitled Method of Pain Assessment indicated that staff should assume, "pain is present for patients with conditions (e.g. broken bone) or procedures (e.g. dressing changes) known to be painful to other patients."

Although the patient had multiple fractures, bilateral pulmonary contusions and a left arm infiltrate, review of the patient's electronic Medication Administration Record on 2/9/10 at 10:21 a.m. revealed that the Acetaminophen (Tylenol) 325-650 mg ordered on 2/8/10 at 11:50 a.m. for mild pain had not been administered.

An interview was conducted on 2/9/10 at 10:30 a.m. with Nurse E who was caring for the patient for the 7:00 a.m. to 7:00 p.m. shift on 2/9/10. Nurse E stated that the patient was restless, tries to get out of the bed to go to the bathroom and has to be constantly reminded that the Foley is in place. The nurse stated that the patient's pain is assessed as unknown because the patient is confused at times. Nurse E confirmed that the patient has multiple fractures and that Tylenol could be given for pain, but the nurse stated she did not know if the patient had Tylenol ordered.

Observation of the patient on 2/9/10 at 10:40 a.m., revealed that the patient was lying in bed on the left side with a cervical collar around her neck. The patient removed a probe from her finger and removed the blanket and sheet from her torso. The patient then laid her head back on the pillow, the nurse attempted to replace the probe and the patient sat up. The nurse asked her where she was going and the patient stated she had to go to the bathroom. The nurse reminded the patient that she had a Foley catheter.

During an interview with the Clinical Nurse Specialist B on 2/9/10 at 11:00 a.m., she confirmed that the FLACC Scale for the assessment of pain was not in Patient #38's binder with the patient's flow sheets. Clinical Nurse Specialist B stated that staff could have obtained the FLACC Scale from the computer in order to assess the patient's pain.

3. Patient #21

There was a delay in implementing interventions to reduce the patient's pain resulting from multiple rib, cervical and thoracic spine fractures.

Patient #21 was admitted on 1/31/10 with multiple right rib fractures, a cervical spine fracture at C-2 and thoracic spine fracture at T-7.

Review of the hospital's 1992 Guidelines for Pain Assessment and Management which was reviewed in 2000 revealed that the definition of pain is "whatever the experiencing person says it is, existing whenever he says it does." The section entitled Principles of Care of the Patient Experiencing Pain indicated that staff are to reassess "pain and response to treatment regularly." The desired outcomes included pain relief and the patient, "reports acute pain severity of 4 or less on a 0-10 scale or other acceptable point on a scale as defined by patient and provider." The numerical equivalents for the 0-10 pain scale are as follows: zero equals no pain, 5 equals quite a lot of pain, and 10 equals the worst pain imaginable. The section entitled Method of Pain Assessment included physical "assessment of the painful area and suspected sources of pain, when appropriate." "Assume pain is present for patients with conditions (e.g. broken bone) or procedures (e.g. dressing changes) known to be painful to other patients." Pain management indicated that regular assessment is needed to ensure that optimal control of pain and treatment-related side effects are achieved.

Review of the patient's Progress Notes revealed the following information:

Nursing Progress Note on 2/1/10 at 5:35 a.m., 73 year old admitted on 1/31/10 with right parietal hematoma, C-2 fracture, T-7 fracture and multiple right side rib fractures status post fall one week ago. Patient had been taking greater than 15 Tylenol per day. Multiple ecchymotic areas present on extremities. Aspen collar on at all times. Awake and oriented times three. Distinct short-term memory deficits apparent. Pleasant and cooperative, able to follow commands. Patient complained of pain being a four on a scale from 0-10 in neck, shoulder and back/rib area. Refusing analgesia. Continue to assess level of pain. Offer and provide appropriate analgesia and comfort measures to maintain goal of less than 4 pain level or optimal level of comfort.

Surgical Attending Note on 2/1/10 at 9:20 a.m. Patient is doing very well. Observed sitting on the bed eating breakfast wearing a cervical collar. Complains of mild to moderate posterior rib pain but moves easily and take deep breaths without a problem. We discussed the importance of adequate respiratory effort and will continue pain control.

Review of the patient's Electronic Medication Administration Report Overview revealed that the patient had the following orders for pain medication: Morphine immediate release 5 milligrams (mg) by mouth twice a day as needed for pain. The patient received a dose at 11:45 a.m. The patient's pain level was rated a 6 prior to the pain medication being administered and at 12:57 p.m. the pain was assessed as having increased to a 7. Although a pain consult had been ordered, no other interventions were implemented to reduce the patient's pain level until four hours later at 5:15 p.m. after the patient was assessed by the physician from the Pain Service.

Review of the Acute Pain Service Note dated 2/1/10 at 5:38 p.m., revealed that the Patient had a fall seven days ago resulting in a C-2 fracture, right side rib fractures (1-8) and small T-7 body fracture. Cervical collar in place. Pain mostly along the right posterior chest and spine, minimal cervical spine pain. Plan: Fentanyl patch 12.5 mcg every 72 hours. Fentanyl patch will take 16 hours to take full effect, recommend low dose Morphine immediate release 5-10 mg by mouth every four to six hours as needed for pain until patch is fully effective.

Review of the patient's Electronic Medication Administration Report Overview revealed that the patient had the following orders for pain medications: Fentanyl Patch 12.5 micrograms (mcg)/hour transdermal every 72 hours was ordered by the Pain Service physician. The Fentanyl patch was applied at 5:15 p.m. The patient's pain was assessed as a 6 on a 0-10 scale prior to the administration of the patch and as a 4 at 6:26 p.m.

Also ordered was Morphine immediate release 5 mg by mouth every six hours as needed for pain. The patient received a dose at 5:16 p.m. and was assessed as a 6 on a 0-10 scale prior to administration of the medication and an 8 at 6:34 p.m.

Review of the Nursing Progress Note dated 2/1/10 at 6:30 p.m., revealed the following: Patient alert and oriented times three, short term memory deficits at times. Pleasant and cooperative. Reports pain in right rib area and lower back. Ecchymosis noted throughout body. Morphine elixir given, states, "it didn't work that well." Pain service up to consult, Fentanyl patch placed to left shoulder and Morphine elixir now ordered every six hours. Reports pain is worse one hour after morphine given at 5:15 p.m. Physician notified at 6:30 p.m. about back pain, awaiting response. Plan: Assess comfort level, medicate as needed. Aspen collar in place at all times.

In response to the patient's continued complaints of pain, at 6:58 p.m., the physician ordered the patient to receive Morphine immediate release 5-10 mg tablet by mouth every six hours as needed for pain. The nurse reviewed the order at 7:39 p.m.

Despite the patient's pain assessment being an 8 on a 0-10 scale at 6:34 p.m. and the physician increasing the Morphine dosage to 5-10 mg, the patient did not receive pain medication until 9:18 p.m. when the patient received all the evening medications and the dose administered was Morphine 5 mg. The reassessment of the patient's pain level did not occur until two and a half hours later at 11:50 p.m. and the patient's pain was a 6 on a 0-10 scale. However, there was no documentation that additional interventions to reduce the patient's pain were implemented.

Review of the Nursing Progress Note dated 2/2/10 at 4:44 a.m., revealed the following: The Patient is alert and oriented times three. Does have short term memory loss. Patient rates pain in back and all over an 8 on a 0-10 scale. Pain consult yesterday and Fentanyl patch applied. Also has Morphine elixir ordered 5-10 mg every six hours as needed; given 5 mg before bed. Requesting Remeron and Trazodone for sleep. Remeron given and patient found to be sleeping after medication - appears comfortable. Aspen collar at all times; ecchymosis noted on body.

During an interview with Patient #21 on 2/2/10 at 2:45 p.m., the patient confirmed that she continued to have pain after receiving pain medication yesterday, 2/1/10. The patient stated that if offered pain medication, the patient would not refuse it.

During an interview with Unit Nursing Director A on 2/2/10 at 2:55 p.m., she stated that if something "is not documented, it is not done."

During an interview with Nurse A on 2/2/10 at 3:30 p.m., she stated that the patient described the pain on 2/1/10 as "it was awful." The nurse also stated that Patient #21 had complained that the pain medication given at 5:15 p.m."didn't help." The nurse stated she paged the physician in response to the patient's complaint.

During an interview with Nurse B on 2/3/10 at 7:28 a.m., she stated that on 2/1/10 she did not give the pain medication to the patient until 9:18 p.m. because the patient was sleeping. The nurse confirmed that she did not document that the patient was sleeping in the electronic medication administration record or in her progress notes.

4. Patient #24

There was a delay in implementing interventions to reduce the patient's pain resulting from a long spiral humeral shaft fracture.

Patient #24 was admitted on 2/1/10 with a long spiral humeral shaft fracture. The patient was alert and oriented on admission and rated the pain as an 8 on a scale from 1-10 with one being no pain and 10 being severe pain. The nursing staff initiated a Plan of Care that identified pain as a problem. Interventions included assess and document pain level using appropriate pain scale and medicate for pain/pre-medicate for painful interventions.

An orthopaedic consultation performed on 2/1/10 indicated that the patient had tenderness to palpation at mid-humerus, slight discomfort with palpation of right 5th metacarpal and mild discomfort with palpation of the left antero-superior shoulder. The patient continued to have pain over the superior aspect of the left shoulder. The physician indicated that these fractures are treated non-operatively and the patient was placed back into a coaptation splint. The left shoulder imagining studies showed no evidence of fracture or bone injury. The patient may have had a rotator cuff injury and if the patient remains symptomatic would consider an MRI of the left shoulder.

Review of the Nursing Progress Note written on 2/3/10 at 5:30 a.m. for the shift that began on 2/2/2010 at 7:00 p.m., revealed the following information: Patient's pain located in the right arm and shoulder from recent fracture. The patient rates pain a 9/10. Ortho was consulted yesterday and right arm placed in fracture brace. Right arm elevated on a pillow for increased comfort. The patient can receive 1 mg Dilaudid as needed every 2 hours for pain. Administered Dilaudid x 3 this shift. Patient's pain decreased a 6-7/10 after receiving Dilaudid. Ice pack applied and patient reported good relief with ice pack. Patient received Ativan x 1 for complaints of anxiety and difficulty sleeping. Patient has been sleeping in naps overnight. Plan: continue to assess pain per protocol and administer pain medications as ordered.

Although the Nursing Progress Note indicated that the patient's level of pain decreased during the night, review of the Electronic Medication Administration Record (EMAR) revealed the following information: The patient was ordered to receive Hydromorphone (Dilaudid) 1 milligram (mg) intravenously (a narcotic analgesic) every 2 hours as needed for pain. On 2/3/10 at 12:10 a.m. the patient received Dilaudid 1 mg for pain that was assessed as a 9 on a scale from 0-10. At 3:07 a.m., the post medication pain scale indicated that the patient's pain remained a 9 on a scale from 0-10. At 2:42 a.m., two and a half hours after the 12:10 a.m. dose of Dilaudid, the patient received another dose of Dilaudid 1 mg for the continuation of pain at a level of 9 on a pain scale from 0-10. At 4:18 a.m., the post medication assessment indicated that the patient's pain was only reduced to a 7 on a pain scale from 0-10. There is no documentation that the patient was o

Based on review of clinical records, facility policies, and staff interview, it was determined that the facility failed to follow standard blood product verification procedures to ensure that 1 of 84 patients received compatible blood components to prevent transfusion error.

The findings include:

1. Patient #65

Review of Nursing Progress Notes on 1/13/10 at 7:30 p.m. revealed "A second six-pack was started, fifteen minutes into the infusion the pt (patient) c/o (complained of) chills, became hypertensive (elevated blood pressure), tachycardic (rapid heart rate) and hypoxic (inadequate oxygen in the blood). Transfusion stopped, treated pt with IV (intravenous) Benadryl (medication used to suppress the body's reaction to allergic responses), IV steroids (medication used to treat inflammation), IV Zantac (medication used to suppress the release of stomach acid), IV Lopressor (medication used to decrease the workload of the heart and make it beat more regularly also lowers blood pressure), and 100% non-rebreather mask (mask with one way valves so that patient breaths oxygen that is not mixed with room air)."

Review of flowsheet for 1/13/10 revealed platelets started at 12:30 p.m., and stopped at 12:45 p.m. with a notation c/o feeling cold.

Review of Patient #65's clinical record revealed the following information relative to the procedure of verification of blood products:
-Fresh Frozen Plasma (blood product that contains clotting factors used when patients are actively bleeding to assist with clotting or if the patient received multiple units of red blood cells) on 1/11/10 at 7:20 p.m. lacked evidence that there was a mark beside Name and MR # (medical record number) on the slip that matches the patient's armband, bag # on this slip matches bag label, expiration date OK.
-Fresh Frozen Plasma with a crossmatch date of 1/12/10 at 1:22 a.m. lacked evidence of a date and time when started.
-Fresh Frozen Plasma with a crossmatch date of 1/12/10 at 5:28 a.m. lacked evidence of a date and time when started, and lacked evidence of the staff member starting the blood product.
-Red Blood Cells (blood product that transports oxygen and carbon dioxide) with a crossmatch date of 1/12/10 at 2:42 p.m. lacked evidence of a date and time when started, and that there was no verification of the name and medical record noted on the blood verification administration slip.
- Platelets (blood product containing cells that stick together to form clots) on 1/13/10 at 12:30 p.m. the box indicating "If reaction, check here" is not checked and there is no evidence that nursing staff notified the lab.
-Platelets with a crossmatch date of 1/13/10 at 8:24 a.m. lacked a time when started.
-Platelets on 1/14/10 at 10:15 p.m. lacked evidence of the staff member starting the blood product.
-Platelets with a crossmatch date of 1/15/10 at 11:08 p.m. lacked a time when started.

Review of the facility's policy titled "Transfusion Therapy Overview" received on 2/4/10 at 8:10 a.m. indicated in part under the heading "Bedside Donor and Patient Verification Prior to Transfusion" that staff "Mark the checklist areas on the Transfusion Record as the bedside check is done. The two individuals checking the blood sign the Transfusion Record."

Interview with Quality and Safety Staff CG on 2/3/10 at 3:00 p.m., acknowledged that the expectation would be for staff members to completely document the process, to verify that the correct patient received the correct blood product, that staff sign, date, and time the transfusion record.

Based on record review and interview, it was determined that the hospital failed to meet the Conditions of Participation for Medical Records. (See A438, A441, A449 & A450)

The findings include:



1. The facility failed to ensure that each patient's clinical record was properly filed.


2. The facility failed to have a procedure for ensuring the confidentiality of patients' records.


3. The facility failed to ensure that medical records contained information to describe patients' progress and responses.

4. The facility failed to ensure that medical record entries were legible and complete.

Based on medical record reviews and staff interview, it was determined that the facility failed to ensure that medical records were accurately written and/or complete for 4 of 84 patients in the survey sample. (Patents #26, #27, #29 and #52). Patient #26, Patient #27 and Patient #29's flow sheets and the Electronic Medication Administration Record (EMAR) contained inconsistent or inaccurate pain documentation. Patient #52's Medical Record was incomplete.

The findings include:

1. Patient #26's
Patient #26's Electronic Medication Administration Record (EMAR) contained inaccurate post medication documentation.

Review of the patient's EMAR revealed that the 1/30/10 and 1/31/10 post medication assessments were documented on 2/1/10. Additionally, the record revealed that the patient's pain assessments were "0" (zero) on a scale from 0-10.

During an interview with Nurse C on 2/4/10 at 12:15 p.m., she stated that the nurse should have indicated "unknown" for the post medication assessments instead of indicating a "0."

2. Patient #27
Patient #27's flow sheets and the EMAR contained inconsistent pain documentation.
Review of the patient's flow sheet for 2/3/10 indicated that from 12:00 p.m. to 8:00 p.m., the patient's pain was assessed as "0." However, review of the patient's EMAR indicated that the patient received Dilaudid 0.35 mg. IV at 1:47 p.m. for pain assessed as a 10 on a scale from 0-10. The patient also received another dose of Dilaudid 0.35 mg IV at 5:23 p.m. for a pain level of "6" on a pain scale of 0-10.

3. Patient #29
Patient #29's flow sheets and the EMAR contained inconsistent pain documentation.
Review of the patient's EMAR revealed that the patient had an order for Acetaminophen 650 mg by mouth every four hours for pain as needed. On 1/29/10, the patient received the Acetaminophen 650 mg at 5:55 p.m. for pain assessed as a "2" on a scale of 0-10.

Review of the patient's flow sheet on 1/29/10 at 9:00 p.m., indicated that the patient's pain level was "0." However, review of the patient's EMAR indicated that the Acetaminophen post medication pain scale was not documented until 1/30/10 at 8:33 a.m., and indicated that the patient's pain level was still "2" on a scale from 0-10.

During an interview with Nurse C on 2/5/10 at 12:05 p.m., she stated that the EMAR system was in the process of evolving and post pain medication assessments will be part of the updates to the system.

4. Patient #52
Review of Patient #52's active inpatient record on the morning of 02/04/10, revealed an incomplete medical record.

In the presence of the RN M, Unit Nursing Director C and Clinical Nurse Specialist H, it was noted that there were no notes in the patient's paper-based chart for 12/25/09 through 01/25/10. The missing documents included lab reports, and consultants, nursing, social work, and doctor's progress notes.

The patient was admitted to the Blake 11 Unit on 12/25/09 from the hospital's Emergency Department with a diagnosis of Psychosis.
According to an interview with the Nursing Director on (date & time), there had not been any interim or departmental transfers for this patient. During the interview, the CNS and the Unit Nursing Director were unable to state where or what had happened to the information. After approximately 20 -30 minutes of investigating; the CNS revealed that the chart had been thinned and should have been labeled accordingly. The information was not available.

On 02/04/10 during an interview with the Unit's Nursing Director at approximately 10:30 a.m., she acknowledged that the staff had failed to implement the facility's "Thinning Records" policy.
Upon requesting the Thinning Record Policy, a memo on the topic, not policy was furnished. The staff member handed the Regional Surveyor the memo stating "this is the thinning policy that we use." The memo, dated 5/21/09, detailed which parts of the record should be removed when thinning and how they should be designated and notated.

Based on medical record review and interview with staff, it was determined that the hospital failed to provide safeguards to ensure the confidentiality of patients' records.

On 2/8/10 at 2:17 p.m., CNS CI provided a patient list for vaccination and restraint orders, tracheotomy (incision directly into the airway to help the patient breath), Warfarin (medication to thin the blood) teaching and heart failure instructions for Ellison 19 for 2/8/10. There were five patient names and medical record numbers on the sheet. The sheet indicated that four of the 5 patients had a pneumovax vaccine and that one of the five patients had a tracheotomy.

During the interview with CNS CI, she revealed that this information is generated to Nursing Directors and Clinical Nurse Specialists daily via e-mail at 7:00 a.m. Nursing Directors and Clinical Nurse Specialists can retrieve information from other units via e-mail. (See A147)

This is continued non-compliance as evidenced by citations written by the Department of Public Health during the surveys of 3/26/09 and 8/13/09.

Based on medical record review and staff interviews, it was determined that the hospital failed to ensure that the medical record contained all necessary information reflecting the progress of the patient and the patient's response to treatment for 2 of 84 patients in the survey sample. (Patients #37 and #12)

The findings include:

1. Patient #37
Patient #37's medical record did not contain information describing the progress of the patient's labia wound, and did not describe the wound's response to treatment.

There was no consistent description of the patient's wound from 12/31/09 through 2/2/10 even though dressing changes have been done daily by the Physician's Assistant.

Review of the patient's medical record revealed that the Physician's Assistant was changing the patient's right labia wound dressing and documenting the findings in the Cardiac Surgery Progress Notes
.
The notes revealed the following information:

Cardiac Surgery Progress Note on 12/31/09 at 9:12 a.m., indicated lesion on right labia; pus expressed with mild manual pressure this morning. Incision and drainage of area at bedside. Gram stain and culture sent. Packing placed. Plan first change in the morning.

Cardiac Surgery Progress Note on 1/01/10 at 6:53 p.m., indicated lesion on right labia opened at bedside on 12/31/ 09. Culture no growth. Wound packing changed this morning; plan to change daily.
Cardiac Surgery Progress Note on 1/02/10 at 3:27 p.m. indicated lesion on right labia opened at bedside on 12/31/09. Culture no growth. Wound packing changed this morning; plan to change daily.
Cardiac Surgery Progress Note on 1/03/10 at 1:21 p.m. indicated lesion on right labia opened at bedside on 12/31/09. Culture no growth. Wound packing changed this morning; plan to change daily.

Infectious Disease (ID) Attending Team A 1/3/10 at 1:45 p.m. indicated right mons (pubic area) incision and drainage-clean small incision.

ID Attending 1/4/10 at 5:30 p.m. indicated site of incision and drainage with healed incision.

Although the 1/4/10 ID Attending note indicated that the site had healed, review of the patient's medical record revealed the following documentation:

Cardiac Surgery Progress Note on 1/07/10 at 11:57 a.m. indicated lesion on right labia opened at bedside on 12/31/09. Culture no growth to date. Wound packing changed this morning; change daily.

Cardiac Surgery Progress Note on 1/08/10 at 9:58 a.m. indicated lesion on right labia opened at bedside on 12/31/09. Culture no growth to date. Wound packing changed this morning; change daily.

Cardiac Surgery Progress Note on 1/11/10 at 2:22 p.m. Right groin incision and drainage remains with wick in place, changing daily.

Although there was a change in the patient's wound status documented on 1/15/10, this same documentation is repeated on 1/16/10, 1/17/10 and 1/18/10.

Cardiac Surgery Progress Note on 1/15/10 at 3:21 p.m. indicated right labia incision and drainage remains with wick in place, dressing changed twice on 1/15/10 for pus like discharge, now serous sanguineous, can do daily dressing changes.

Cardiac Surgery Progress Note on 1/16/10 at 5:40 p.m. indicated right labia incision and drainage remains with wick in place, dressing changed twice on 1/15/10 for pus like discharge, now serous sanguineous, can do daily dressing changes.

Cardiac Surgery Progress Note on 1/17/10 at 6:39 p.m. indicated right labia incision and drainage remains with wick in place, dressing changed twice on 1/15/10 for pus like discharge, now serous sanguineous, can do daily dressing changes.

Cardiac Surgery Progress Note on 1/18/10 at 2:03 p.m. indicated right labia incision and drainage remains with wick in place, can do daily dressing changes.

On 2/9/10 at 9:05 a.m., review of the patient's medical record and interview with Nurse C revealed that from 1/18/10 until 2/3/10 the same information was documented, "right labia incision and drainage remains with wick in place, can do daily dressing changes." Nurse C acknowledged that the patient's right labia wound documentation was the same from 1/18/10 until 2/3/10, and it did not describe the patient's progress and/or response to treatment.

Interview with Physician's Assistant A on 2/9/10 at 9:16 a.m., revealed that there are eleven or twelve Physician's Assistants for the Cardiac Surgery Service and they rotate duties. Physician's Assistant A stated that a wound assessment should be documented daily each time a dressing change is performed. The assessment should include what the wound looks like including shape and size, if it is painful, warm, and if it is getting any better.

2. Patient #12
Patient # 12's medical record was reviewed on 10/10/10 at approximately 1:45 p.m. Patient #12 is a 57 year old who was admitted to the hospital on 02/07/10 with Cirrhosis, Hepatitis C and Esophageal Reflux. Included with medication, diet and treatment orders, there was an order for pain which reads; Oxycodone 5-10 mg, Q6H PRN for pain.

The order did not stipulate the level of pain intensity for which the medication is to be given nor which amount of medication was to be given. The lack of specificity of the order was acknowledged at approximately 2:30 p.m., during an interview with the ND #1.

Based on review of clinical records, facility's policies, and staff interview, it was determined that for nine of 84 patients, the hospital failed to ensure that clinical records were complete, legible and/ or authenticated. (Patients #16, #39, #41, #45, #65, #77, #PP1, #PP9 and #80)

The findings include:

1. Review of the facility's policy and procedure titled, "Patient Record," approved by the Medical Policy Committee 7/2009, indicated the following:
3.4.1 Each clinician shall enter dated and timed notes documenting their visits.
7.1 All entries in the patient record, written or electronic, will be authenticated by the author. An authentication will include the author's signature and credential along with either a pager number (the pager number must be legible) or printed first and last name to assist in uniquely identifying the author.
7.2 When multi-authored documentation occurs on a single form, each author is responsible for their own individual entries regarding dating, timing and authentication as outlined in this policy. Each form shall provide a means to determine who completed the entry.
7.3 The entire contents of the record must be legible.


2. Patient #77

Review of Patient # 77's medical record on 2/10/10 revealed the following:

~ Post-op anesthesia note written on 1/22/10 did not include the time and credential(s) of the author;
~ progress notes written on 1/22/10 contained illegible signature; did not include the authors credentials; and did not include either a pager number or printed first and last name;
~ Progress notes written on 1/23/10 did not include the time;
~ Progress notes written on 1/20/10 did not include the time; the signature of the author was not legible; the credentials of the author were not included; the pager number was illegible;
~ Post-anesthesia care unit (PACA) overnight admission form did not include the date, time and signature of the author.


3. Patient #41

Review of Patient #41's medical record on 2/4/10 indicated the following:
~medical progress notes dated 1/31/10 and 2/4/10 did not include the credentials of the authors and the time.

4. Patient #45

Review of Patient 45's medical record on 2/8/10 showed the following:
~operative report dated 2/5/10 contained an illegible signature and no credentials, pager number or printed first and last name of the author;
~progress notes dated 2/6/10 contained an illegible signature and pager number, and no printed first and last name;
~surgical progress note lacked the date, time, and author's credentials.


5. Patient #39

Review of Patient #39's medical record on 2/3/10 showed the following:

~clinician's progress note lacked the date, time and author's credentials.


6. Patient #65

Review of policy titled "Bladder Irrigation Adult Manual" indicated under the heading "Applicable Policy Statement" A physician's order is required.
Review of the Physician's Orders for 1/13/10 through 1/15/10 revealed the following:
-1/13/10 at 12:05 p.m. Irrigate bladder q 4 h.
-1/13/10 at 10:03 p.m. D/C Irrigate bladder q 4 h. Murphy drip, titrate to clear urine.

There was no physician's order to manually irrigate the Foley catheter after beginning the Murphy drip and no orders to change the Foley catheter.

Review of flowsheets from 1/13/10 through 1/15/10 for Patient #65 revealed the following:
-1/13/10 at 1:00 p.m. irrigated Foley changed to Murphy gtt (drip) (large volume continuous irrigation of the bladder)
-1/13/10 at 9:00 p.m. Foley catheter irrigated manually for large amount clot
-1/14/10 at 3:00 p.m. Manually irrigated for large amount of clot
-1/14/10 at 4:30 a.m. Manual flush clots in Foley
-1/14/10 at 10:00 a.m. Irrigated manually for clots
-1/14/10 at 10:00 p.m. Manually flushed 50 cc (cubic centimeter)
-1/14/10 at 11:00 p.m. Manually flushed 40 cc
-1/15/10 at 11:00 p.m. Unable to flush Foley catheter changed blood clot
-1/15/10 at 4:00 p.m. Foley changed flush but unable to aspirate from Foley

Review of Nursing Progress Notes from 1/13/10 through 1/15/10 for Patient #65 revealed the following:
-1/13/10 at 7:30 p.m. shift 7 a.m. 7 p.m.- Hematuria - symptoms as above starting at 9:00 a.m., flushed with 30 cc NS (normal saline) with no clot return. Foley changed to a 3-way Foley, small clot at end of original catheter, Murphy gtt started and multiple clots were flushed.
-1/14/10 at 5:30 p.m. F/C (Foley catheter) manually irrigated (symbol for approximately) q 2 o (2 hours) for large amount of clot as well.
-1/14/10 time 6 p.m. shift 7-7 p.m. Continues on Murphy gtt for hematuria. Foley manually flushed q 2-3 hrs (hours) for thick bloody clots however urine has cleared this afternoon to a "kool aide" color.
-1/15/10 at 7:15 a.m. Hematuria: Murphy gtt (drop) going through 3 way Foley clotting frequently frequent manual flushing. Foley completely clotted at midnight. d/c and replaced since platelets up, hematuria has slowed oozing from Foley insert site.
-1/15/10 at 7 p.m. Foley catheter changed and appeared to be draining.

During an interview with CNS CG and Staff Nurse CH for the Surgical Intensive Care Unit on 2/4/10 at 9:15 a.m., they stated that there were no specific orders to manually flush the Foley catheter it was in the procedure for the Murphy drip. CNS CG reviewed the orders for Patient #65 and acknowledged that there was no physician's order to manually irrigate the Foley catheter after beginning the Murphy drip and no orders to change the Foley catheter.

7. Patient #PP1

During the medical record review at MGH Sports Medicine on 2/5/10, the Health Questionnaire dated 12/30/09 for Patient #PP1 was not signed by the Physical Therapist. This finding was verified with ADM17.


8. Patient #PP9

During medical record review on Ellison 12 on 2/10/10, the General Release Informed Consent for Admission, Procedures, and Treatment for Patient #PP9 was missing corresponding staff signatures for their initials on the referenced documents. This finding was acknowledged by OT2. Additionally, signatures for PP9 were missing from the
"One Time Treatment Record" and "Non Ventilator Charting Record."

9. Patient #80

Review of the ED Triage/Screening record for Patient #80 dated 1/22/10 at 9:00 a.m., revealed an Emergency Nursing Flow Sheet, that indicated that the nurse inserted an IV to the patient's right wrist with a 20 gauge needle, but there was not a physician's order noted for the IV. The ED Nursing Manager, and the ED CNS both acknowledged on 2/5/10 at approximately 8:00 a.m., that the ED physician's orders and notes are done in the electronic record.

Upon request for the orders for this patient, they were provided by the CNS. Review of the electronic physician's order and notes for Patient #80 did not reveal an order for the IV insertion. During a subsequent interview with the Nurse Manager on 2/10/10 at 10:30 a.m., she stated the order should have been in the clinical record.


10. Patient #16


During clinical record review for Patient #16 on 2/9/10, the record contained ED documentation including an Emergency Nursing Flow Sheet dated 2/4/10 that was illegible and difficult to read. The information was provided to the ED Nursing Manager on 2/10/10 at 10:30 a.m. She stated during the interview that all documentation by ED staff should be legible.


The hospital staff provided a hospital wide "Policy and Procedure: Patient Record" reviewed, revised and approved 7/09 that revealed:

DOCUMENTATION, ACCESS AND SECURITY
7.1 All entries in the patient record, written or electronic will be authenticated by the author. An authentication will include the author's signature and credentials along with either a pager number or printed first and last name to assist in uniquely identifying the author.

7.3 The entire contents of the record must be legible.

Based on observations, record review and interview with the staff, it was determined that the facility failed to properly store medications including intravenous antibiotic refrigerated medication, and failed to maintain the Operating Room Pharmacy and drug storage areas in accordance with their pharmacy policy and procedure, and acceptable standards of practice.

The findings include:

1. On the morning of 2/9/10 during a tour of the medication room on Blake 7 MICU, 1 250 ml (milliliters) D5W (dextrose 5% water) bag was noted in a blue bin, identified as the "pharmacy in box" by CNS F and Unit Nursing Director B. The 250 ml D5W bag did not contain any patient information/identifiers. It had a pharmacy applied label that read the following:
Total amount of Vancomycin 1000 mg
D5W 250 ml bag
For IV use only
Refrigerate

Review of the facility's policy and procedure for medication distribution as outlined in the CEN-005 Omnicell Manual (Rev. 06-21-07), Section #3.1 Omnicell Distribution, revealed the following work instructions:

" .... Hand-delivered drugs are placed in the pharmacy in-box, the blue drop off bin. The OA (Operations Assistant) must monitor this box hourly and place medications in the appropriate location ... "

" .... If a medication is refrigerated, it will be tubed to the floor and placed in the pharmacy in-box. The technician will check this bin daily and place them in the Omnicell under refrigerated medication."


During an interview with the assigned CNS, and the Nursing Director, they acknowledged that the Vancomycin 1000 mg/250 ml D5W bag should have been refrigerated.

The Unit's Pharmacist stated during an interview on 02/9/10 at 10:00 a.m., that the Vancomycin 1000 mg/250 ml D5W bag should have been refrigerated. She stated that it was impossible to know when it arrived to the unit and why it had not been placed in the Omnicell's refrigeration section.

2. During a tour of Bigelow 13, Burn and Plastic Surgery Unit, on 2/4/10 at 10:35 a.m., an observation revealed a warming cabinet. The warming cabinet registered a temperature of 38 degrees Celsius (C) or 100.4 degrees Fahrenheit (F). The warming cabinet contained 43 bottles of Silver Nitrate Solution .5%, 13 - 500 ml bottles of normal saline, and 2 - 50 ml bottles of sterile water. Hospira manufactured the normal saline and sterile water. None of the bottles bore a label or date when staff placed them in the warmer or when to remove them.

Review of the label on one of the bottles of Silver Nitrate Solution indicated in part, "Store at controlled room temperature 20 - 25 degrees C 68 - 77 degrees F."

The Director of the Burns/Plastic Surgery unit Staff CC acknowledged that there was not any manner of identification to determine when staff placed the bottles in the warmer but stated that it was little more than a 24 hour supply.

Review of policy titled, "Medication Management Standards" provided to the survey team on 2/3/10 at 3:20 p.m., lacked evidence in the heading titled "Storage," that staff should ensure medications are stored at appropriate temperature. Under the heading titled "Monitoring" point #1 indicates "Refrigerated storage areas are monitored for appropriate temperature control." This section failed to address the monitoring of warming cabinets for appropriate temperature control.

Review of a letter dated 8/10/09 and provided to the survey team on 2/8/10 at 10:55 a.m. indicated in part, "Solutions for irrigation 1 Hospira's Aqualite plastic pour bottles, with their plastic screw cap intact and unopened, may be warmed up to 40 degrees C (104 degrees F) (unless specified otherwise on the product label), and for a period no longer than two weeks (14 days)."

Review of an e-mail from Teva Pharmaceuticals, manufacturer of the Silver Nitrate Solution, no date as to when the hospital received the e-mail and provided to the survey team on 2/9/10 indicated in part, "Regulatory Affairs Department has documentation that the Teva Pharmaceuticals Silver Nitrate Solution 0.5% is stable for 24 hours at 104 F and those conditions will not adversely effect the product. Please note the Silver Nitrate Solution labeling does not support these storage temperatures."

3. On 2/8/10 at 10:35 a.m., a quart of Golden Vanilla flavored Hood New England Ice Cream was observed in the freezer of the refrigerator. This refrigerator was located in the pharmacy of the main operating room. The refrigerator and freezer each had a bold green tag on the outside indicating, "Medication only, No Food or Drink."

During an interview on 2/8/10 at 10:35 a.m. with Pharmacist #1, it was stated this was not standard practice. Pharmacist #1 then took the ice cream out of the freezer and put it in the trash can.

During an interview on 2/11/10 at 9:45 a.m. with Pharmacist #2 and Pharmacist #3, both stated the expectation is there will be no food items in a medication refrigerator. They went on to say, if it were to happen again disciplinary action would be taken immediately.



06340

Based on observations, interviews and review of facility's documents, it was determined that the hospital failed to ensure that drugs or biologicals were kept in a secure and in a locked area when appropriate.

The findings include:

On 2/5/10 during the morning hours during a tour of the PACU (Post Anesthesia Care Unit) located on Ellison 3, a Lidocaine 1% Ampoule 10 mg was found in an unlocked insertion cart.
The PACU Nurse Manager and Senior Vice President Management of Care acknowledged the aforementioned observation.

On 2/9/10 a review of the hospitals policy, "Medication Security," documented, Storage #5. "Medications not administered to a patient must be returned to secured storage or placed in the Pharmacy return bin as soon as possible. Placing medications on counter-tops, top of medicine carts, or any other location is not allowed."


06340

During tour of Bigelow 14, Vascular Unit, on 2/3/10 at 1:55 p.m., an observation revealed an open three shelf cart with two bins on the top shelf and 3 bins on the second shelf. The cart sat outside the medication room for the unit in a busy hallway with visitors and staff walking by it. No staff member was close to the cart or monitoring the cart. Pharmacy Technician Staff CD was in the medication room stocking the medication dispensing unit with the door closed and locked.

During an interview with the Chief of Pharmacy Operations (CPO) on 02/05/10 at approximately 10:30 a.m., she was asked, when medications are sent via the tub system to the nursing units is there any system to verify that the medications that were sent arrived on the unit. The CPO responded that there was no system of accountability to determine what was received on the units.


Interview with Pharmacy Technician Staff CD at the time of the observation revealed that she leaves the cart in the hallway because it is too large to fit into the medication room. If nursing staff come in to get medications while she is filling the medication dispensing unit the drawers of the unit bump into the cart. Pharmacy Technician Staff CD further stated that she delivers medications to Bigelow 13, Blake 12, White 13, Blake 6, Dialysis, White 8, and Ellison 8 in addition to Bigelow 14. Bigelow 14 and Blake 6 are the only units that he/she cannot bring the medication delivery cart into the medication room while filling the medication dispensing unit.

Review of the medications on the cart included:
-Omeprazole DR (delayed release) 20 mg capsule (32) - medication to treat too much acid in the stomach
-Potassium Chloride 20 mEq (milliequivalent) tablet (15) - medication to replace potassium excreted by the body
-Furosemide 20 mg tablet (33) - medication to increase urine production
-Senna tablets (10) - medication used to relieve constipation
-Thiamine 100 mg tablet (13) - medication used to replace the B vitamin Thiamine
-Levothyroxine 75 mcg (micrograms) (12) - medication used to treat a thyroid deficiency
-Mupirocin Nasal 2% ointment (3) - an antibiotic that can be used to treat skin infections
-Ketorolac 15 mg/ml vial (5) - a non-steroidal anti-inflammatory medication used to treat pain
-Hydrochlorothiazide 25 mg tablet (13) - medication to increase urine production
-Simethicone 80 mg tablet (30) - medication used to relief stomach pain from excessive gas
-Labetalol 300 mg tablet (11) - medication used to reduce the workload of the heart and help the heart beat more regularly, also reduces blood pressure
-Benadryl 25 mg tablet (11) - medication used to treat allergic reactions
-Trazodone 50 mg tablet (5) - medication used to treat depression
-Buspirone 5 mg tablet (12) - medication used to treat anxiety disorders
-Fragmin 5000 u (units) syringe (9) - medication used to thin the blood
-Albuterol 0.83% vial (13) - medication to open the airways and make breathing easier
-Ipratropium 0.02% vial (8) - medication to open the airways and make breathing easier
-Lactulose 20 Gm (gram)/20 ml syrup cup (6) - medication to relieve constipation
-Neutra-Phos packages (5) - medication used to replace phosphorus or to acidify the urine
-Metoprolol 50 mg tablet (16) - medication used to reduce the workload of the heart and help the heart beat more regularly, also reduces blood pressure
-Metoprolol 25 mg tablet (10)
-Simvastatin 20 mg tablet (12) - medication to lower cholesterol and fat in the bloodstream
-NPH Insulin bottle (1) - a hormone used to control blood sugar levels
-Colace 100 mg soft gel tablet (22) - medication to soften stool
-Lipitor 80 mg tablet (10) - medication to lower cholesterol and fat in the bloodstream
-Calcium 1250 mg tablet (15) - dietary supplement to replace calcium in the body
-Tylenol 325 mg tablet (50) - medication to relieve pain
-Warfarin 5 mg tablet (20) - anticoagulant medication
-Prednisone 20 mg tablet (11) - medication used to treat inflammation
-Metformin 500 mg tablet (1) - medication used to help control blood sugar in diabetics
-Betamethasone 6 mg/ml 5 ml vial (1) - medication used to treat inflammation
-Erythromycin ointment 1 Gm (1) - antibiotic used to treat bacterial infections
-Ferrous gluconate 325 mg tablet (1) - supplement used to replace iron in the body

Further interview with Pharmacy Technician Staff CD on 2/3/10 at 2:23 p.m., revealed that she has been working in this position since 2001 and has never been able to get the medication delivery carts into the medication rooms on Bigelow 14 or Blake 6.

During an interview with Pharmacy Staff CE and Pharmacy Staff CF on 2/3/10 at 2:40 p.m., she stated that medications should be secured at all times.

Review of policy titled, "Medication Management Standards" provided to the survey team on 2/3/10 at 3:20 p.m. under the heading of "Security" indicated in part, "...Only authorized persons, in accordance with the hospital's policy, law or regulations, can access medications."

Based on observations, staff interviews, and review of the facility's policy and procedures, it was determined that the facility failed to be constructed, arranged, and maintained to ensure the safety of the patients. There are Hospital Regulation Standard level deficiencies as well as Life Safety Code Standard level deficiencies for all certified buildings. The accumulative effect that the facility does not meet the NFPA Life Safety Code Standard, therefore, the Condition of Participation: Physical Environment is not met and is a system wide failure. See Hospital Regulation and Life Safety Code Statements of Deficiencies for specific findings.

(See A701 and A724)

Based on observations, staff interviews, and review of the facility's policies and procedures, it was determined that the facility failed to ensure that the hospital environment was maintained in a manner to assure the safety and well-being of all patients as evidenced by; dirty floor sinks, ice machines lacking air-gaps or backflow preventers, dusty ice machine air vents, items stored under sinks inappropriately, dusty ceiling air vents, microwave ovens containing food crumbs, sticky refrigerator shelves, closet storage of items above 18 inches of ceilings, stained ceiling tiles, trash on closet floors, dusty stairwells, inoperative out light bulbs, dirty linen in shower room, peeling paint in environmental services closet and shower room, standing water in ice machine trough, missing ceiling tiles, protruding escutcheon partially blocking a sprinkler head, and a black substance on a stained ceiling tile.

The findings include:

On 2/2/10 during a tour of the physical environment, the following was observed:

Ellison 22-Surgical Unit
Room 2200J1- Environmental Services closet, floor sink with heavy accumulation of dirt, grime on the floor of the closet.
Room 2204-Dirty patient bath-tub with dust and dirt
Surgical Unit Clean Supply room- boxes of specimen containers stored under the sink inappropriately
Room 2200J2- f Environmental Services closet, floor sink with a heavy accumulation of dirt.
Galley Area 2231-ice machine without an air-gap or backflow preventer. Dust in ice machine air vents.

Ellison 21-Oncology Unit
Room 2100J1- Environmental Services closet, dirty floor sink
Room 2100J2- Environmental Services closet, dirty floor sink
Clean Utility room-Box of laundry bags stored underneath sink
Room 2131 Area under ice machine had heavy accumulation of dust and dirt.
Room 2100J3- Environmental Services closet, dirty floor sink.

Ellison 20-Medical Unit
Room 2100J1- Environmental Services closet, dirty floor sink.
Room 2017-Patient tub room- Oxygen canister stored in bathtub, dirt and dead spider in bathtub.
Room 200J2- Environmental Services closet, dirty floor sink.
Galley Area 2031- dust and dirt under ice machine.
Room 2000J3- Environmental Services closet, dirty floor sink.

Ellison 19- Thoracic Surgery Unit
Room 1900J1- Environmental Services closet, dirty floor sink.
Room 1900J2- Environmental Services closet, dirty floor sink.
Galley Area- dusty air vents on ice machine, no air-gap or backflow preventer on ice machine, microwave oven contained dried food and crumbs.
Room 1900J3-Environmental Services closet, floor sink contained dirty socks.

Ellison 18-Pediatric Unit
Galley Area- ice machine lacked an air-gap or backflow preventer.
Room 1840A- boxes stored above 18 inches from the ceiling.

Ellison 17-Pediatric Unit
Room 1700J2- Environmental Services closet, dirty floor sink.
Galley Area- ice machine lacked air-gap or back flow preventer, ice machine air vents dusty.
Unlabeled Room-Environmental Services closet dirty floor sink.

Ellison 16-Medicine Unit
Room 1600J2- Environmental Services closet, dirty floor sink.
Room 1600J3- Environmental Services closet, dirty floor sink.

Ellison 14-Oncology Unit
Room 1400J2- Environmental Services closet, dirty floor sink.

Ellison 13-Nursing Unit
Room 1300J3- Environmental Services closet, dirty floor sink.
Galley Area-ice machine air vents dirty.

Ellison 11-Cardiology Unit
Room 1100J1- Environmental Services closet, dirty floor sink.
Galley Area-ice machine lacked air-gap or backflow preventer.

Ellison 10-Medical Step Down Unit
Room 1000J1- Environmental Services closet, dirty floor sink.
Room 1000J2- Environmental Services closet, dirty floor sink.

Ellison 9-Cardiac Care Unit
900J1- Environmental Services closet, dirty floor sink.

Ellison 8-Cardiac Surgery Unit
Room 800J2- Environmental Services closet, dirty floor sink.
Galley Area-ice machine lacked air-gap or backflow preventer, ice machine air vents dirty.

On 2/3/10 the following observations were made during a tour of the physical environment.

Ellison 7-Surgical Unit
Room 700J2- Environmental Services closet, dirty floor sink.
Galley Area-ice machine lacked air-gap or backflow preventer.
Room 731 Pantry-Environmental Services floor drain dirty.

Ellison 6-Orthopedic/Urology Unit
Room 600J2- Environmental Services closet, 2 stained ceiling tiles.
Galley Area-ice machine lacked air-gap or backflow preventer, ice machine had dusty air vents.

Ellison 4-Surgical Intensive Care Unit
Galley Area-ice machine with dusty air vents.

Ellison 2-Radiology
Soiled Utility Room- unused red bags stored under sink.
Room 219D- paper towels and cleaning materials stored under sink.
Room 240- Environmental Services closet, dusty air vent.
Room 200J1-Environmental Services closet, dirty floor sink.

Ellison 1-Emergency Department
Room 106J Supply Closet-dust and trash on floor.
Room 146-boxes stored against ceiling, 2 stained ceiling tiles, ceiling air vent dusty.
Emergency Department-Fast Track Galley Area-ice machine had dusty air vents, lacked an air-gap or backflow preventer and had a sign " broken since 1/28/2010. "
Urgent A Area-ice machine lacked air-gap or backflow preventer, sink bottom contained rust stains and small black pellet type objects.

Blake 14-Labor and Delivery Unit
Gallery Area-ice machine lacked air-gap or backflow preventer.

Blake 13-Post Partum Unit
Room 1300J3- Environmental Services closet, dirty floor sink.
Room 1300J6- Environmental Services closet, dirty floor sink.
Galley Area- ice machine lacked air-gap or backflow preventer.

Blake 12-Neurologic Intensive Care Unit
Room 1200J3- Environmental Services closet, dirty floor sink.
Room 1200J6- Environmental Services closet, dirty floor sink.
Galley Area-ice machine lacked air-gap or backflow preventer, ice machine air vents dusty.

Blake 11-Psychiatry Unit
Room 1100J3- Environmental Services closet, dirty floor sink.
Stairwell Area- dusty
Sensory Hallway-2 stained ceiling tiles.
Kitchen Area-ice machine lacked air-gap or backflow preventer, under sink shelf dirty with granules of a gray substance.
Room 1100J6- Environmental Services closet, dirty floor sink.

Blake 9-Cardiac Catheterization Laboratory
Hall Closet- medical records stored from floor to ceiling in locked hall closet.
Blake stairwell #3-dust and dirt on landing.
Galley Area-ice machine lacked air-gap or backflow preventer.

Blake 8-Cardiac Care Unit
Room 800J02-Environmental Services closet, dusty air vent.
Galley Area-ice machine lacked air-gap or backflow preventer.

Blake 7-Medical Intensive Care Unit
Room 700J2- Environmental Services closet, dirty floor sink, stained ceiling tile.
Galley Area-ice machine lacked air-gap or backflow preventer, sink contained storage of 4 boxes of tea bags inappropriately.

Blake 6-Transplant Unit
Room 600J3- Environmental Services closet, stained ceiling tile.
Room 659-dusty ceiling vent
Galley Area-ice machine lacked air-gap or backflow preventer, ice machine air vents dusty.
Room 600J6- Environmental Services closet, dusty ceiling air vent.
Galley 2-microwave oven contained an unknown spilled liquid and food particles.

Blake 4-Endoscopy Unit
Gallery Area-ice machine tube drainage tube approximately 2 inches into sink and lacked a backflow preventer.

CT scanner
Room 200J4- Environmental Services closet, overhead light inoperable, floor mop stored in sink.

On 2/4/2010 the following observations were made on a tour of the physical environment.

14 Gray/Bigelow-Vascular Surgery Unit
Galley Area-ice machine lacked an air-gap or backflow preventer, refrigerator had sticky shelves with food crumbs, shower room contained dirty linen lying on floor and shower chair.
Room 1419-Environmental Services closet had a dirty floor drain and dusty ceiling air vent.

13 Gray/Bigelow-Unit
Room 1320A-ice machine drain pipe lacked an air-gap or backflow preventer.

12 Gray/Bigelow-Emergency Department Observation Unit
1200T3 Restroom-dusty ceiling air vent.
Pantry Area-trash including plastic ware, cups, dust and dirt under refrigerator, ice machine had dusty air vents.

11 Gray/Bigelow-General Medicine Unit
Room opposite 1100T1-dusty ceiling air vent
Room 1139 Shower-contained unlabeled bar of soap and body powder in shower stall.
1137 Area-ice machine lacked air-gap or backflow preventer, ice machine air vents dusty.

10 Gray/Bigelow-End Stage Renal Disease Unit
Galley-ice machine lacked air-gap or backflow preventer
Room B1000J1- Environmental Services closet had a dirty floor drain and a hole in the wall above the floor sink approximately 3 inches high by 8 inches wide.

9 Gray/Bigelow-Respiratory Acute Care Unit
Room 900T1-restroom, dusty air vent
Room 900J2-wall paint peeling above floor sink.
Room 908-dusty ceiling air vent in bathroom.
Room 914-broken tile on floor of bathroom.
Room 918-dusty ceiling air vent in bathroom.
Medical side-ice machine lacked an air gap or backflow preventer.
Room B952Y-boxes were stored not greater than 18 inches of ceiling.

8 Gray/Bigelow-Outpatient Cardiology Unit
Room 800T1-dusty vent in bathroom.
Room opposite 800T1-supply room-dusty vent, dusty floor.
Room 827A-stained ceiling tile, personal care items stored not greater that 18 inches of ceiling.
Room 800T5-dusty vent in bathroom.

7 Gray/Bigelow-Gynecology Unit
Room 700T2-dusty ceiling air vent in bathroom.
Galley Area-ice machine lacked an air-gap or backflow preventer.
Environmental Services closet- paint peeling around floor sink.

6 Gray/Bigelow-Pediatric Intensive Care Unit
Area 9615-ice machine lacked an air-gap or backflow preventer.
1 Gray/Jackson-Admitting/Pre-Admitting
Patient Waiting Area-2 stained ceiling tiles
Room 100J- Environmental Services closet had a dirty floor drain and dusty air vent

13 White-Research Unit
Room 1329-dusty air vent in tub room
Room 1322A-dusty air vent in bathroom.

12 White-Neurology Unit
Room 1233-overhead light inoperable in tub room.
Room 1216-2 stained ceiling tiles in the clean utility room.

11 White-General Medicine Unit
Room 1100J1- Environmental Services closet had a cracked wall approximately 3 inches by 10 inches and paint peeling above the floor sink.
Room 1000J5- Environmental Services closet had a dirty floor drain.
Room 1000J2- Environmental Services closet had a dirty floor drain.

9 White-General Medicine Unit
Galley Area-ice machine lacked an air-gap or backflow preventer.
Room 900J2- Environmental Services closet had a dirty floor drain.
Room 915- ceiling paint peeling in shower room.

8 White-General Medicine Unit
Room 800J1-a live insect in ceiling light of environmental services closet.
Room 853-dusty ceiling air vent in patient shower room.
Area 827-ice machine lacked air-gap or backflow preventer.
Room 851-closet of Physical Therapy Department had dirty floor with dust and dirt.
Room 800J5- Environmental Services closet had a dirty floor drain.
Room 800J6- Respiratory Services closet had an inoperable ceiling light.

7 White-General Surgery Unit
Area 724-ice machine lacked an air-gap or backflow preventer
Room 700J6- Environmental Services closet had a dirty floor drain.

On 2/5/2010 the following observations took place during a tour of the hospital's physical environment.

6 White-Orthopedics Unit
Room 600J1-closet with inoperable ceiling light, items stored above 18 inches from the ceiling.
Room 600J7- Environmental Services closet had a dirty floor drain.
Area 608-ice machine lacked air-gap or backflow preventer, standing water in trough of ice machine, ice machine air vents dusty, stained ceiling tile.

Sterile Processing Area
Sterile operating room equipment packaging area-dusty ceiling air vents.
Room 400J2- Environmental Services closet had a dirty floor drain.

2 White-Radiology
Room 200J1-floor sink wall were dirty with paint and lathe peeling in an area of approximately 2 feet by 3 feet in diameter.

Basement Morgue
Environmental Services closet had a dirty floor sink.

WACC 7th floor-Outpatient Neurology
Room 800J1- Environmental Services closet had a dirty floor sink, dusty air vent.
Room 800T2-2 dusty air vents in ladies bathroom
Environmental Services closet had a dusty ceiling air vent.

WACC 7th floor-Outpatient Endocrine/Reproductive
Room 700J01- Environmental Services closet had a dirty floor drain and dusty ceiling air vent.

WACC 5th floor-Outpatient Urology
Room 500T1-stained ceiling tile.
Room 500T2-dusty ceiling air vent.
Room 500J1- Environmental Services closet had a dirty floor sink.

WACC 4th floor-Outpatient Surgery
Room 400J01- Environmental Services closet had a dusty ceiling air vent.

WACC 3rd floor Outpatient Pain Management
Room 300J1- Environmental Services closet had a dirty floor sink, dusty ceiling air vent and stained ceiling tile.
Room 300T40-2 missing ceiling tiles, ceiling air vent dusty.

On 2/8/2010, the following observations were made during a tour of the hospital's outpatient areas:

WACC 2nd floor-Outpatient Laboratory
Outpatient Oral Maxofacial Surgery
Room 230E-ceiling air vent in bathroom dusty.
Outpatient Physical Therapy/Occupational Therapy
Room WooJ1- Environmental Services closet had a dirty floor sink, missing ceiling tile.
Room 129C-dusty ceiling vent in bathroom.
1st floor-Medical Walk-in
Room 108N-ceiling vent dusty in bathroom.
Room 000J1- Environmental Services closet had a dirty floor sink and 2 stained ceiling tiles.

Yawkey Building

8th floor-Outpatient Adult Infusion
Area 8.111A-ice machine lacked an air-gap or backflow preventer.
Area 8.33A-ice machine lacked air-gap or backflow preventer.
Area 8.157A-ice machine lacked air-gap or backflow preventer.

6th floor-Outpatient Radiology
Room 6890-ceiling air vent dusty in supply closet.
Room 300J60-dusty ceiling air vent in environmental services closet.
Room 300T61-ceiling air vent dusty in bathroom
2nd floor hallway
Room 2.00J01- Environmental Services closet had a dirty floor sink.
Room EVS013-paper towels stored within 18 inches of ceiling.

165 Cambridge Street

3rd floor-Outpatient Transplant Services
Room 303-ice machine lacked air-gap or backflow preventer; sink had plastic bags stored underneath inappropriately.
Room 300T05-dusty ceiling air vent dusty, trash can overflowing.
Room 367-items stored above 18 inches from ceiling.

5th floor-Outpatient End Stage Renal Disease
Hallway- Environmental Services closet had a dirty sink.

8th floor-Outpatient Neuromuscular Diagnostic Center
Room 852-dusty ceiling air vent in the clean storage room.
Room 849-storage of boxes of dry ice above 18 inches of ceiling

9th floor-Outpatient Endoscopy
Room 900J04- Environmental Services closet had a dirty sink.
Area 904B-ice machine lacked an air-gap or backflow preventer

On 2/10/2010, the following observations were made during a tour of the physical environment for the following outpatient units:

149 13th Street-Outpatient Imaging
Room 1.010A-under sink storage of chemicals ' , dirt and debris on shelf.
Room 1.010E-stained ceiling tile in clean utility room, dust in ceiling air vent, boxes stored above 18 inches of ceiling.
Area 1.010C- stained ceiling tile with a black substance.
Room 107C-dusty ceiling air vent in bathroom.
Room 102B-ceiling light inoperable in storage closet.
Main Patient waiting area-stained ceiling tile, 11 chairs with dirty upholstery.

75 High Street Charlestown-Outpatient Services
Room 211-stained ceiling tile in reception area, escutcheon partially blocking sprinkler head.
Room 215-stained ceiling tile in Pediatric/Adolescent waiting area.

1st floor-Outpatient Adult Medicine
Rear entrance-stained ceiling tile.
Elevator B-3 light bulbs inoperative.

175 Cambridge Street-Sports Physical Therapy
Outside Room 455-ice machine lacked an air-gap or backflow preventer.

The observations of the Physical Environment tour were confirmed by the following staff that was present at various times during the tours:
Staff Specialist, Women's Health
Senior Construction Manager Buildings and Grounds
Patient Safety Staff Specialist
Quality and Safety Nurse
Senior Vice President Management of Care
Plumbing Shop Supervisor

Review of the 2006 International Plumbing Code section 802.2.1- Air-gap. "The air-gap between the indirect waste pipe and the flood level rim of the waste receptor shall be a minimum of twice the effective opening of the indirect waste pipe."

On 2/10/10 review of policy CS968, Cleaning, revealed the following:
Section 7.22 "The following guidelines must be adhered to: Supplies stored 6-8 inches off the floor to facilitate cleaning of floors ... Supplies should be stored at least 3 feet away from a water source ...Supplies must be at least 18 inches from the sprinkler ... "

Section 7.24 Soiled Linen, "Soiled linen should be placed in designated linen bags."
Section 8.8 Guidelines for the Use of Sterilizing Processes, Storage of Sterile items,
"Sterilized items should be stored in an area that is well ventilated, and promotes protection against dust, moisture, insects, and temperature and humidity extremes."

A review of the cleaning specifications for 165 Cambridge Street and 175 Cambridge Street revealed the following; Night Cleaning, Bathrooms, Monthly, "Dust all ceiling vents." Cleaning Specific for Medical Space, "Dust all ventilating, air conditioning covers and grills."

On 2/12/10 a review of a facility policy titled, "Care of Non-Critical patient care Equipment Storage of Clean/Sterile Supplies was reviewed. The review revealed the following; Section C "This equipment does not make direct contact with the patient or makes contact only with the patient's skin ...The major requirement for non critical equipment is cleaning to remove dirt and soil and destruction of the ordinary vegetative bacteria. Non-critical equipment requires intermediate-or low level disinfection as can be achieved by cleaning with hospital-approved disinfectant." Procedures, A. Cleaning, "Equipment must be free of gross soil for surface disinfection to be accomplished. Heavy soiled items must be cleaned first with a detergent or combination detergent disinfectant to remove soil. Disinfectant is then applied to clean surface."

Based on observations, staff interviews, and review of the facility's policies and procedures, it was determined that the facility failed to ensure that hospital's equipment was maintained in a manner to assure the safety and well-being of all patients as evidenced by, failure to check emergency equipment, dirty code cart, failure to inspect eye-wash station, and no changing enzymatic solution containers in a timely manner.

The findings include:

On 2/3/10 the following observations were made during a physical environment tour:

Ellison 1-Emergency Department (ED)
Emergency Department-Fast Track Galley-ice machine had a sign posted, "broken since 1/28/2010."
Dirty instrument container
No documentation of date when Enzymatic Cleaner changed.
ED Laboratory-emergency eye wash station not cleaned according to policy
The eyewash station lacked documentation of weekly inspection for the following periods, 4/13/09 to 4/27/09, 6/29/09 to 7/17/09, 11/2/09 to 2/3/10.

Cox 1-Infusion and Bone Marrow Transplant Unit
Soiled Utility Room-container of Enzymatic cleaner had a date of 1/26. There were instruments in the container. The date of the observation was 2/3/10.

On 2/4/10 the following observations were made on a tour of the physical environment.

12 Gray/Bigelow-Emergency Department Observation Unit
Room 1249- container of enzymatic solution dated 2/2. The container contained instruments.

WACC 3rd floor-Outpatient Pain Management
Room 354-Soiled Holding room-container of Enzymatic cleaner dated 1/26

On 2/8/10, the following observations were made of the outpatient areas of the hospital;

Breast Imaging
Emergency Code Cart-#111 dusty Gomco machine and tubing, top shelf of cart dusty and had a brown stain.

Yawkey Building

Outpatient Rheumatology
Emergency Code cart lacked documentation of being inspected on 2/1/10 and 2/2/10
2nd floor
Eye Wash Station-no container of eye wash solution in holder.

165 Cambridge Street

3rd floor Outpatient Transplant Services
Enzymatic container-no date when cleaning solution changed.

On 2/10/10, the following observations were made during a tour of the physical environment;

75 High Street Charlestown-Outpatient Services

1st floor-Outpatient Adult Medicine
Elevator B-3 light bulbs inoperative.

The observations of the Physical Environment tour were confirmed by the following staff that was present at various times during the tour.
Staff Specialist, Women's Health
Senior Construction Manager Buildings and Grounds
Patient Safety Staff Specialist
Quality and Safety Nurse
Senior Vice President Management of Care
Technical Director Care Laboratory
Technical Manager Breast Imaging
Manager Outpatient Rheumatology

On 2/10/10 a review of facility policy and procedure titled Code Cart/Emergency Equipment in Ambulatory Settings documented the following; Policy, 6. "Defibrillators and Suction devices are checked daily on days of unit/department operation. A Code Cart/Emergency Equipment record will be maintained for all code carts and emergency equipment. Staff who have checked the lock and emergency equipment will record date, time, and signature. The current record will be located at the code cart."

On 2/9/10, the following Safety Manual section 1.4.2 was reviewed, "Supervisors need to assure the weekly activation of any plumbed eyewash and/or equipment installed in their unit to flush the lines and verify equipment operation. This check is also to be documented and the record maintained on the unit."

On 2/10/10 a review of the facility policy, Cleaning Sterilization and Disinfection page 25 Guidelines for Use of Cleaners indicated,. #12. "Enzymatic solution may be used as a soak for multiple instruments. Solution should be mixed fresh at least daily and changed as often when visibly soiled." #13. Soaking container must be labeled and dated." 14. Discard Enzymatic-cleaning solution after each use. Solution may be poured down sanitary waste system."

Based upon observations, staff interviews and review of infection control policies, it was determined that the hospital failed to provide a sanitary environment in order to avoid the transmission of infections, communicable diseases. The hospital failed to develop, implement and maintain an active, hospital -wide program for the prevention, control and investigation of infections and communicable diseases. (See A749 & A750)


The findings include:


1. The Infection Control Officer (ICO) failed to have an active hospital wide infection control program and ensure infection control policies were being followed to control the spread of infections and communicable diseases.


2. The Infection Control Officer (ICO) failed to control infections throughout the hospital when the ICO failed to monitor sanitary conditions throughout the hospital.



3. The Infection Control Officer (ICO) failed to maintain an accurate and up to date log of infections and communicable diseases.

Based on observation, document review, and staff interview, it was determined that the facility failed to ensure the provision of a sanitary environment and to have processes in place that identified and investigated the potential infectious disease processes present in 1 of 83 patients on admission. (Patient #66)

The findings include:

Review of the Infection Control Program 2010 received 2/9/10, revealed that one of the infection control priorities is - Daily cleaning and disinfection of high touch surfaces and bathrooms in patient rooms. The evaluation for this priority is - Monitor new HAI (Healthcare Associated Infection) cases in real time for clusters and review rates quarterly.

Observations on 2/8/10 at 10:25 a.m., revealed Staff CJ, Unit Service Associate (USA) mop room 910 on Bigelow 9 with a solution of Virex 256. Staff CJ, USA exited the room removed the mop head from the mop, removed gloves sanitized hands, replaced gloves. The floor remained wet for 6 minutes. At 10:30 a.m. Staff CJ, USA entered room 910 with a bottle containing Virex 256. Staff CJ, USA sprayed the top of a footstool with the Virex 256 and wiped the solution off. Staff CJ, USA then sprayed the cloth with Virex 256 and wiped a shelf on the far side of the room next to the window that held a radio and wiped around the radio sitting on the shelf. Staff CJ, USA then used the Virex 256 and sprayed the counter to the right of the sink and wiped it off and then sprayed the counter to the left of the sink and wiped it off. Staff CJ finished by spraying the cloth with Virex 256 and wiping the inside of the sink.

Observations on 2/8/10 at 10:37 a.m. revealed, Staff CK, Registered Nurse (RN) enter room 910 and remove a large blue recliner. Staff CK, RN sprayed Virex 256 on the chair and wipe the cushion, back, and along the sides of the chair.

Observations on 2/10/10 at 10:59 a.m. revealed, Staff CL, USA spray the sink outside of room 710 on Ellison 7 with Virex 256. Staff CL, USA walked approximately 7 feet to the cart containing cleaning supplies and retrieved a dry cloth. Staff CL, USA wiped the Virex off of the sink with the dry cloth. Staff CL, USA wet the cloth in the sink and used it to wipe the metal covered corner of the wall adjacent to the sink. Staff CL, USA sprayed Virex 256 on the metal covered corner while wiping it with the wet cloth. Staff CL, USA used the same wet cloth to wipe the door frame of room 710. Staff CL, USA then removed gloves sanitized hands and replaced gloves. Staff CL, USA placed a clean dry cloth into a solution of Virex 256 sitting on the cleaning supply cart. Staff CL, USA wrung the cloth to a damp state and wiped the metal wrapped corner by room 708 and then dried it. Staff CL, USA placed a clean dry cloth into a solution of Virex 256 sitting on the cleaning supply cart. Staff CL, USA wrung the cloth to a damp state and wiped the monitor with the first damp cloth then dried it with a second cloth. Staff CL, USA repeated this process with the keyboard, picture on the wall, chair rail along the wall and window. Staff CL, USA wiped the top of the heating system and window sill with the damp cloth and did not wipe it with the second cloth.

On interview on 2/10/10 at 11:21 a.m. Staff CL, USA stated, I use a wet cloth and then dry it off with another cloth. No, I don't leave it wet.

Observation on 2/10/10 at 11:32 a.m. on Bigelow 9 in a room on the RACU (respiratory acute care unit) side of the unit across from the medication dispensing area, revealed Staff CM, USA dip a clean dry cloth into Virex 256, wring the cloth to a damp state enter the room and wipe the top of the soiled linen container first and then proceed to wipe the top of the bedside table. The table top remained wet for approximately 2 minutes.

Interview with Nursing Director of Bigelow 9, Staff CH at the time of the observation indicated that it would not be appropriate to use the same cloth to clean the soiled linen hamper and then a bedside table. The Nursing Director of Bigelow 9, Staff CH asked to interrupt the cleaning process and redirect Staff CM, USA.

Interview on 2/10/10 at 11:45 a.m. with Operations Manager for Environmental Care, Staff CP indicated that the top of the soiled linen hamper should be cleaned last.

Observation on 2/10/10 at 12:20 p.m. revealed Staff CO, USA enter the negative pressure room on the north west corner of Bigelow 9 wearing gown and gloves. The room had a Precautions plus sign to the right side of the door. This is the sign used when the patient has Clostridium difficile (bacteria that causes symptoms ranging from diarrhea to life threatening inflammation of the bowel). Staff CO, USA took a cloth with Virex 256 that was still dry around the edges and wiped the door handle, window, front of a 5 drawer supply cart, and the wall behind the bed. Staff CO, USA exited the room placed his/her left hand on the left front corner of the housekeeping supply cart and retrieved supplies to clean the bathroom in the isolation room. Staff CO did not remove gloves or sanitize hands.

Interview on 2/10/10 at 12:25 p.m. with Operations Manager for Environmental Care, Staff CP indicated that USA staff is to use a bleach solution when cleaning isolation rooms for Clostridium difficile.

Observation of the housekeeping supply cart at 12:32 p.m. revealed a divided bucket on top of the cart with a bottle of Virex 256 inside. Both sides of the divided bucket were dry.

Further interview on 2/10/10 at 12:32 p.m., with Operations Manager for Environmental Care, Staff CP revealed that the bucket should have been filled with Virex 256 solution and that the cloth should be saturated with the Virex 256 solution to clean a room. Environmental surfaces should stay wet 5-6 minutes after cleaning with the Virex 256.

Review of manufacturer recommendations received from the hospital on 2/11/10 at 10:05 a.m. revealed, Cautions: To disinfect hard, non-porous surfaces, treated surfaces must remain wet for 10 minutes. Allow surfaces to remain wet for 1-minute to kill HIV-1 (Human Immunodeficiency virus), 5-minutes to kill HBV (hepatitis B virus).

Interview on 2/11/10 at 10:05 a.m. with the Director of Infection Control, Staff CQ, stated that it would depend on the bioburden (number of bacteria living on an area before it is sterilized) how long the surface would need to remain wet.

Review of policy titled, "Room Cleaning Procedures" received 2/11/10 at 10:05 a.m. directed USA staff to use Clorox Germicidal Spray instead of Virex for cleaning all surfaces of a Contact Precautions Plus room with the exception of the floor. The policy further directed that the areas of the room to be cleaned are door knobs, light switches, chairs, counters, overbed table, bedside table, window sills, telephone; bed rails (if possible) spot wash window glass, doors, and walls. The policy further instructs that surfaces should be thoroughly cleaned and wet and allowed to air dry. A cloth should be used until it no longer wets the surface. It should take about 4 cloths for each side of a semi-private room.

Interview on 2/10/10 at 3:00 p.m. with the Director of Infection Control, Staff CQ indicated that all horizontal surfaces and high touch areas should be cleaned by USA staff in patient rooms and that Virex 256 should not be wiped off but allowed to air dry.

Review of medical record for patient #66 admitted 2/3/10 revealed the following:

-Preadmission Testing Area History and Physical Examination and Anesthesia Assessment on 1/29/10 stated " Continues on antibiotics for C-Diff (Clostridium difficile). Continues with some loose stools and is incontinent. "
-Nursing Admission Note on 2/3/10 listed C Diff in the past medical history however under the heading of Risk of Infection staff documented orders for both oral and IV (intravenous) Vancomycin (medication indicated for infections resistant to other antibiotics and colitis caused by C Diff).

Observation on 2/4/10 at 12:30 p.m. showed staff exit patient #66's room use alcohol gel on hands and proceed to the nurses' station.
Observation on 2/4/10 at 12:34 p.m. showed staff exit patient #66's room use alcohol gel on hands and proceed to the nurses' stations.
Observation on 2/4/10 at 12:35 p.m. revealed a contact precaution sign outside of patient #66's room. The sign directed staff to use alcohol hand sanitizer when leaving the room.

Interview with Infection Control Specialist CR on 2/4/10 at 3:10 p.m. revealed that even if a patient had a negative lab culture for C Diff if the patient continued to have diarrhea they should still be flagged as having C Diff. The patient should be treated presumptively and still placed on Contact Precautions Plus.

Review of signage for Contact Precautions Plus revealed that hand should be washed and dried and then use alcohol hand sanitizer. (Alcohol hand sanitizer is not effective against C Diff.)Observation on 2/5/10 at 8:16 a.m. revealed Contact Precaution Plus outside of patient #66's room.

Interview with Infection Control Specialist CR on 2/5/10 at 8:50 a.m. revealed that there was a "break in the system." The nurse didn't call the infection control department and that would be the only way we would know to come up and assess the situation. The plan is to get a stool sample and check for C Diff because of the change from 1/15/10 from soft stool to diarrhea on 1/29/10. If you hadn't found it; it would not have been caught.

Review of Infection Control policy titled, "Isolation Precautions" received 2/10/10 at 2:10 p.m. indicated in part under the Contact Precautions Plus heading subheading 3.1 Indication/Duration "Patients being admitted/readmitted with a history of C. difficile disease, who have completed a course of appropriate antibiotic therapy and are asymptomatic need not be put on precautions. Patients who have completed a course of antibiotic therapy for C difficile disease, but continue to be symptomatic, should be put on precautions upon admission/readmission."

Interview with Infection Control Specialist CS on 2/5/10 at 2:21 p.m. revealed that VRE (Vancomycin resistant enterococci) and MRSA (methicillin resistant staphylococcus aureus) are the only two infectious processes that stay flagged in the system from admission to admission. If a patient is admitted with documentation of an infections process, the nurse usually notifies the infection control department. Infection Control Specialist CS did not know if there was a policy to notify the infection control department, but stated it was the practice. The infection control department verifies there has not been a diagnosis of an infectious process from an outside source. However there is not a system in place to document either the nurse's call to the infection control department. Infection control staff don't document the review of the patient to determine if there was an infection unless it is confirmed there is an infection.

Review of Infection Control policy titled, "Nursing Service" documented in part under the heading of Patient Care Standards #10 "Infection Control Unit notification: The registered nurse will notify the Infection Control Department when: a. A patient is diagnosed or suspected of having an infectious or communicable disease, which requires infection control precautions."

During observations on 2/2/10 at 11:55 a.m. in Post Anesthesia Care Unit (PACU) of Ellison building, two white packs with blue labeling were observed in a patient nourishment refrigerator. The patient refrigerator was labeled "Food only." The packs were identified as "Cryotherm" cold packs. The packs had the hand written word "pathology" in black marker printed on one side. The two "Cryotherm" cold packs were in a partially opened clear plastic bag. The cold packs were removed and discarded by the Charge Nurse, PACU-Ellison.

In an interview on 2/2/10 at 11:56 a. m., with the Charge Nurse PACU- Ellison Building, she stated this is not normal procedure. She also stated the cold packs should not be kept in the nourishment refrigerator.

During observation of equipment cleaning demonstration by the athletic trainer at MGH Sports Medicine on 2/5/10, the sides of the cushion on the equipment were not cleaned, and cleaning was performed without gloves. Following equipment cleaning, staff washed dirty hands in an examination room during another patient ' s treatment.

Based on interview and document review, it was determined that the hospital failed to have a system in place to actively track infections in short stay or outpatient surgical cases, employee illnesses, or volunteer illnesses.

The findings include:

During the tour of the Day Surgical unit at Danvers Outpatient facility on 02/08/10 at approximately 10:30 a.m., the Regional Office Evaluator (ROE) asked the Executive Director of the North Shore Center for Outpatient Care if there was any system for patient follow-up for post operative infections. It was stated that the outpatient staff make a phone call usually within a day of surgery. They inquire how the patient feels, where they have any pain and if there are questions about post operative care. The staff normally does not ask any questions about infections. If the patient experienced an infection they would go to their primary physician for treatment. When the ROE said, therefore there is no system to report post operative infection, the Executive Director said yes.

Interview with Director of Infection Control, Staff CQ and Chief of Infection Control, Staff CT on 2/9/10 at 3:05 p.m., revealed that infection control staff looks at the return to surgery report and the physicians performing the above surgical procedures are asked to respond if there is an infection. Staff CQ indicated that the system would be blind to the infections treated in the community. The hospital asks physicians and case managers to self-report any surgical infections of which they become aware.

Further interview with Director of Infection Control Staff CQ on 2/10/10 at 8:30 a.m., revealed that infection control monitoring of outpatient surgical centers, health centers, and ambulatory practices is passive. Staff would review admission logs or re-operative reports to determine if the patient appeared to have a surgical wound infection and would follow it up. There is no system in place to determine if a patient that is treated in the community has a wound infection.

Review of the Infection Control Plan for 2010 lacked a system to monitor community acquired infections. Interview with Director of Infection Control Staff CQ on 2/11/10 at 2:15 p.m. revealed there is no log of community acquired infections.

Further interview with Director of Infection Control Staff CQ on 2/11/10 at 2:15 p.m., revealed that there is no tracking of hospital acquired pneumonia with the exception of ventilator acquired pneumonia in MICU or SICU. When asked, Director of Infection Control Staff CQ indicated that there is no tracking mechanism for catheter associated urinary tract infections or for any urinary tract infections at all.

Review of policy titled, "Work Health Clearance" documented in part under Definitions and Regulations at 2.4 and 2.5 "All employees who have been exposed to an infectious disease or have a condition which might place them at increased risk of being exposed (refer to isolation Precautions-Infection Control Policies), think they might have an infectious disease, or have been diagnosed with an infectious disease must report to Occupational Health Services for a work clearance and /or exposure assessment. Infectious diseases and conditions include, but are not limited to the following common diseases which are potentially transmissible to patients and/or employees ...2. Strep throat."

On 2/8/10 at approximately 11:45 a.m., Registered Nurse (RN) II, a Nurse Clinician in Patient Care Services, verbalized that s/he hoped the surveyor did not become ill over the previous week-end (2/6/10 and 2/7/10). RN II said s/he had a very sore throat during the day on 2/5/10 while escorting the surveyor around the facility. RN II said on 2/6/10 s/he was diagnosed with Strep throat (an infection of the mucous membranes lining the throat and caused by Streptococcus bacteria; the disease passes directly from person to person by coughing, sneezing, and close contact) and prescribed an antibiotic.

Interview with Staff CU regarding employee health indicated that they captured some strep throat in the reporting system but not all of it and that there were no reports of strep throat for the month of February. Occupational health is not made aware of every employee call-in and the system relies on the employee to do the right thing and the person receiving the call-in to notify us.

Interview with Director of Volunteer Service, Staff CV on 2/11/10 at 8:24 a.m., revealed the hospital doesn't log when a volunteer calls in ill and there are no hard and fast rules about not coming to the hospital if the volunteer has an illness.

Based on observation, interview and record review, the facility failed to meet the Condition of Participation, Surgical Services. Surgical Services must be well organized and provided in accordance with acceptable standards of practice. Policies governing surgical services must be designed to assure the achievement and maintenance of standards of medical and patient care. The facility failed to demonstrate the immediate availability of an emergency medication to treat Malignant Hyperthermia (MH) in the Endoscopy unit according to accepted high standards of medical practice and patient care. (See A941)

The findings include:

The facility failed to ensure that in the event of an episode of Malignant Hypothermia, the medication necessary to reverse life threatening event was immediately available.

No additional information was provided by the facility.

Based on observation, interview and record review, it was determined that the facility failed to demonstrate the immediate availability of an emergency medication to treat Malignant Hyperthermia (MH) according to accepted high standards of medical practice and patient care.

The findings include:

During observations on 2/5/10 at 10:50 a.m. in the Endoscopy clinic, Anesthesiologist #1 was asked to locate the Malignant Hyperthermia (MH) Kit. This kit is stocked with Dantrolene, a medication that is required to be immediately available for the treatment of MH according to the Malignant Hyperthermia Association of the United States (MHAUS). The MH crisis is a biochemical chain reaction response, "triggered" by commonly used general anesthetics and the paralyzing agent succinylcholine, within the skeletal muscles of susceptible individuals. Severe complications include: cardiac arrest, brain damage, internal bleeding or failure of other body systems. Thus, death, primarily due to a secondary cardiovascular collapse, can result according to MHAUS. Anesthesiologist #1 looked in several places within the Endoscopy clinic for the MH kit. Anesthesiologist #1 was unable to locate the MH kit. He indicated it is normally kept on a cart in this hallway.

Anesthesiologist #1 was then asked what he would do in case of an emergency. He indicated he would call the pharmacy for an MH emergency kit. At 10:55 a.m., he was asked to implement his secondary emergency protocol. Anesthesiologist #1 called the pharmacy and stated he had a MH emergency in the Endoscopy clinic, Room #6. The MH kit arrived in Room #6 at 11:04 a.m. The emergency MH kit arrived nine minutes after the medical emergency was first announced by Anesthesiologist #1.

Interview on 2/8/10 at 9:45 a.m. with the Executive Medical Director of Operating Room's he stated he a heard about the confusion with the MH kit. He stated the kits are not required to be in the operating room. He was informed the MH kit took nine minutes to arrive from the pharmacy.

Review of the endoscopy operating room schedule for 2/5/10 revealed ten general anesthetic cases were performed that day.

The facility's policy entitled, "Policy for the Treatment of Malignant Hyperthermia," was reviewed 1/2009 by the Clinical Director of Anesthesia. Page 1, paragraph 4 documents, "Because these processes, unless interrupted, causes more calcium ions to enter the muscle, a self-perpetuating cycle ensues from which the patient cannot recover."

Paragraph 5 documents, "Dantrium (Dantrolene) I. V. is the first drug therapy available for the treatment of malignant hyperthermia."

Paragraph 6 documents, "A successful outcome of this catastrophic disease depends on prompt initiation of aggressive therapy."

Based on staff interview and document review, it was determined that the facility failed to confirm the final location of the disposal site for radio nuclides, unused radio pharmaceuticals and radioactive waste.

The findings include:

The Regional Office Evaluator (ROE) toured the Nuclear Medicine Department (NMD) on 02/02/10 at 10:15 a.m.. During the tour, the Technical Manager of the NMD was asked to explain what happens to the radioactive waste from the NMD. The manager answered that, it is picked up by a nuclear waste disposal but I don't know what they do with it. Review of the NMD policy on nuclear waste disposal confirmed that there is no policy to report final location of the disposal site for radioactive waste.

The NMD was unable to verify that the radioactive materials were properly disposed.

Based on interview, record review, and observation, it was determined that the Hospital failed to provide appropriate numbers of qualified personnel necessary to furnish the physical therapy services offered by the Hospital; and failed to deliver services in accordance with orders of practitioners who are authorized by the Medical Staff to order the services. (See A1124 & A1132)

The findings include:

1. Rehabiliation services are not staffed to ensure the needs of the patients are met as ordered.


2. Physical therapy, occupational therapy, and speech language pathology services are carried out through referrals and consults, without valid orders for evaluation and treatment.

Based on record review and interview, it was determined that patients receiving physical therapy services are missing treatments that are expected according to their treatment plan.

The findings include:

Record review for patient Patient #PP6 on 2/9/10 revealed that the patient missed a physical therapy visit on 2/3/10 per patient request, next scheduled to be seen on 2/4/10. The patient was seen on 2/4/10 and scheduled for followup on 2/5/10. The patient was not seen on 2/5/10 due to being off the floor for a procedure, scheduled for follow-up on 2/8/10. The patient was not seen on 2/8/10. The next scheduled visit for this patient was on 2/9/10. The patient was not seen by a physical therapist from 2/4/10 until 2/9/10, which was not in accordance with the patient's treatment plan.

Physical Therapy Services Policy 200.006, issued on 06/1994, revised/reviewed without revision: 01/2006, indicated, "Staffing resources are deployed to both inpatient and outpatient settings based on clinical need (Demand). Prompt patient access and frequency of treatment (the ability to provide care at a frequency and intensity per the patient's treatment plan) are critical factors in establishing and modifying staffing levels." The hospital is not in compliance with its own staffing policy.

During interview with PT1, PT8, PT36, and PT37, they stated that assignments are based on volume, not acuity, and are prioritized according to need.

Based on record review for 9 of 9 records reviewed (Patient # PP10, #PP9, #PP6,# PP7, #PP11, #PP12, # PP4, #PP13, and #PP14) and interview, it was determined that the Hospital failed to obtain valid orders for physical therapy, occupational therapy, and speech language pathology services by practitioners who are authorized by the Medical Staff to order the services.

The findings include:

Record review on 2/10/10 revealed an occupational therapy order dated 2/4/10 for a "consult" for Patient #PP10. The order did not specify reason and expectations for evaluation and treatment.

Record review on 2/10/10 revealed an occupational therapy order dated 2/8/10 for a "consult" for Patient #PP9 without specifying reason and expectations for evaluation and treatment.

Record review on 2/9/10 revealed a physical therapy order for "Consult: PT Physical Therapy" for Patient #PP6 that does not specify the reason and expectations for evaluation and treatment.

Record review on 2/9/10 revealed a physical therapy order for "Consult: Physical Therapy," for Patient #PP7 that does not specify the reason and expectations for evaluation and treatment.

Record review on 2/9/10 revealed speech-language pathology referral for speech-language evaluation/treatment signed on 3/19/08 for Patient #PP11. There is no order specifying the reason and expectations for speech-language evaluation and treatment.

Record review on 2/9/10 revealed undated speech-language pathology referral for speech-language evaluation/treatment for Patient #PP12. There is no order specifying expectations for speech-language evaluation and treatment.

Record review on 2/9/10 revealed the absence of a valid speech-language pathology order for "hearing screening requested ant (sic) Speech department" on 6/23/08, and conducted on 6/30/08; absence of speech-language pathology orders for individual treatment from 7/8/08-8/25/08 for Patient #PP4.

Record review on 2/9/10 revealed the absence of a valid speech-language pathology order for evaluation and treatment provided on 9/30/08 and 4/10/09 for Patient #PP13.

Record review on 2/9/10 revealed the absence of a valid speech-language pathology order for evaluation and treatment provided to Patient #PP14 on 4/3/09, 4/6/09 and 10/5/09.

Draft Outpatient Services policy provided by SLP7 on 2/9/10 indicates, "Referrals are accepted from any source, including self referral. Requirements for prior approval or authorization is dependent on several factors, including but not limited to payor source or nature of the appointment."

During interview with SLP7, she state that "doctors' orders are only required for swallowing, modified barium swallow, and pharyngeal insufficiency studies...All medicare patients are required to have an order."