The information below comes from the statement of deficiencies compiled by health inspectors and provided to AHCJ by the Centers for Medicare and Medicaid Services. It does not include the steps the hospital plans to take to fix the problem, known as a plan of correction. For that information, you should contact the hospital, your state health department or CMS. Accessing the document may require you to file a Freedom of Information Request. Information on doing so is available here.

MILFORD HOSPITAL, INC 300 SEASIDE AVENUE MILFORD, CT 06460 Sept. 12, 2012
VIOLATION: GOVERNING BODY Tag No: A0043
Based on a review of clinical records, interviews, review of facility documentation and policies and procedures, the governing body failed to ensure that medical staff provided care and services in accordance with the Medical Staff Bylaws and Rules and Regulations.

Refer to A49
VIOLATION: MEDICAL STAFF - ACCOUNTABILITY Tag No: A0049
**NOTE- TERMS IN BRACKETS HAVE BEEN EDITED TO PROTECT CONFIDENTIALITY**


Based on a review of clinical records, interviews, review of facility documentation and policies and procedures, the hospital failed to ensure that a member of the medical staff (MD #1) appropriately delegated the medical management of four of five patients (Patients #1, 7, 9 and 10) and/or that the individual providing care and services to four patients (Patients #1, 7, 9 and 10) was a member of the medical staff and/or that non-invasive ventilator orders were complete and/or in place for one patient (#1) and/or that a staff member who had privileges suspended for delinquent medical records was allowed to perform surgery for one patient (#2) and/or that the medical staff members attended the medical staff meetings in accordance with the Medical Staff By-Laws. The findings include:

a. Patient #1 was admitted on [DATE] with diagnoses that included degenerative joint disease and was scheduled for left total hip replacement surgery. Review of the clinical record identified that RN #1 (not employed by the hospital and/or a credentialed member of the medical staff) dictated post-operative orthopedic notes including outcomes of physical examination assessments inclusive of mentation, auscultation of lungs, abdomen, wound and neurovascular sensation on 7/24/12, 7/25/12, 7/26/12 and 7/27/12. These notes identified that RN #1 interpreted data to determine the patient's medical status and the medical plan of care/protocol and the notes were not co-signed by the attending physcian (MD #1). In addition, RN #1 dictated a transfer summary, dated 7/27/12, which was electronically signed by MD #1.

Review of the physician orders for Patient #1, from 7/25/12 to 7/27/12, identified that RN #1 wrote three verbal orders from MD #1 for anticoagulant and narcotic medications and these orders were carried out by the hospital staff.

b. Patient #7 was admitted on [DATE] with diagnoses that included degenerative joint disease and was scheduled for a left total hip replacement surgery. Review of the clinical record identified that RN #1 (not employed by the hospital and/or a credentialed member of the medical staff) dictated post-operative orthopedic notes including outcomes of physical examination assessments inclusive of mentation, auscultation of lungs, abdomen, wound and neurovascular sensation on 8/1/12, 8/2/12 and 8/3/12. These notes identified that RN #1 interpreted data to determine the patient's medical status and the medical plan of care/protocol and the notes were not co-signed by the attending physcian (MD #1). In addition, RN #1 dictated a transfer summary, dated 7/31/12, which was electronically signed by MD #1.

Review of the physician orders for Patient #7, from 8/1/12 to 8/3/12, identified that RN #1 wrote two verbal orders from MD #1 for anticoagulant medications and these orders were carried out by the hospital staff.


c. Patient #9 was admitted on [DATE] with diagnoses that included degenerative joint disease and was scheduled for a right total hip replacement surgery. Review of the clinical record identified that RN #1 (not employed by the hospital and/or a credentialed member of the medical staff) dictated post-operative orthopedic notes including outcomes of physical examination assessments inclusive of mentation, auscultation of lungs, abdomen, wound and neurovascular sensation on 8/22/12, 8/23/12 and 8/24/12. These notes identified that RN #1 interpreted data to determine the patient's medical status and the medical plan of care/protocol and the notes were not co-signed by the attending physcian (MD #1). In addition, RN #1 dictated a transfer summary, dated 8/24/12, which was electronically signed by MD #1.

Review of the physician orders for Patient #9, from 8/22/12 to 8/24/12, identified that RN #1 wrote two verbal orders from MD #1 for anticoagulant medications and these orders were carried out by the hospital staff.


d. Patient #10 was admitted on [DATE] with diagnoses that included degenerative joint disease and subsequently underwent a left total hip replacement surgery. Review of the clinical record identified that RN #1 (not employed by the hospital and/or a credentialed member of the medical staff) dictated post-operative orthopedic notes including outcomes of a physical examination assessments inclusive of mentation, auscultation of lungs, abdomen, wound and neurovascular sensation on 5/11/11 and 5/12/11. These notes identified that RN #1 interpreted data to determine the patient's medical status and the medical plan of care/protocol and the notes were not co-signed by the attending physcian (MD #1). In addition, RN #1 dictated a transfer summary, dated 5/12/11, which was electronically signed by MD #1.

Review of the physician orders for Patient #10, dated 5/11/11, identified that RN #1 wrote a verbal order from MD #1 for an anticoagulant medication and this order was carried out by the hospital staff.

In addition, Patient #10 was admitted on [DATE] with diagnoses that included degenerative joint disease and was scheduled for a right total hip replacement surgery. Review of the clinical record identified that RN #1 (not employed by the hospital and/or a credentialed member of the medical staff) dictated post-operative orthopedic notes including outcomes of physical examination assessments inclusive of mentation, auscultation of lungs, abdomen, wound and neurovascular sensation on 8/1/12, 8/2/12 and 8/3/12. These notes identified that RN #1 interpreted data to determine the patient's medical status and the medical plan of care/protocol and the notes were not co-signed by the attending physcian (MD #1). In addition, RN #1 dictated a transfer summary and an addendum summary, dated 8/2/12 and 8/3/12, which were electronically signed by MD #1.

Review of the physician orders for Patient #10, from 8/1/12 to 8/4/12, identified that RN #1 wrote five verbal orders from MD #1 for anticoagulant, narcotic, antihypertensive medications and for diagnostic tests and these orders were carried out by the hospital staff.


Review of the hospital credential and personnel file identified that RN #1 was not employed by the hospital and was not a credentialed member of the medical staff, although s/he had started an application dated 7/18/05.

Interview with MD #1, on 9/6/12 at 3:30 P.M., identified that RN #1 was employed by him, and that RN #1's role was to round with and without him on MD #1's surgical patient's and to dictate post-operative orthopedic notes and transfer summaries.

Interview with the Chief of Surgery, on 9/12/12 at 10:16 A.M., identified that this practice was not acceptable as RN #1 was not credentialed as a member of the medical staff.

Review of the Medical Staff By-Laws and Rules and Regulations, dated 9/27/11, identified that the medical staff, who are privileged to attend patients, are responsible for the quality of medical care in the Hospital and are responsible for obtaining the services of another qualified medical staff member to provide care and services in his/her absence. The Rules and Regulations identified that all patients in the hospital are visited at least daily by the attending physician and/or a designated medical staff member and all orders for care and services are in writing-including verbal orders.


e. Patient #1 was admitted on [DATE] with diagnoses that included degenerative joint disease and was scheduled for a left total hip replacement surgery. Review of a verbal order, dated 7/23/12 at 9:30 P.M. and signed by MD #1 on 7/24/12 at 12:00 Noon, directed staff to administer Continuous Positive Airway Pressure (non-invasive ventilation) at hour of sleep with auto peep (pressure range of 10-20 centimeters of water). The order failed to include an oxygen saturation goal.
On 7/24/12, Patient #1 required a second surgery for removal of a retained instrument piece. Review of the clinical record failed to reflect that the physician and/or provider directed staff to administer CPAP orders, although the clinical record reflected that Patient #1 was provided CPAP non-invasive ventilation from 7/24/12 to 7/27/12.

Interview with the Director of the Cardiopulmonary Department, on 9/12/12 at 10:42 P.M., identified that the order on 7/23/12 was incomplete and there was no physician order for the non-invasive ventilation after the second surgery on 7/24/12.

Review of a policy and procedure, titled Non-Invasive Pressure Ventilation CPAP/BiPAP, identified that initiation of non-invasive ventilation requires a physician order and the order must include an oxygen saturation goal.

Review of the Medical Staff By-Laws and Rules and Regulations, dated 9/27/11, identified that all orders for treatment will be in writing and all previous orders are canceled when patients go to surgery.


f. During a tour of the hospital, on 9/6/12 from 10:00 A.M. to 12:48 P.M., it was identified that as of 9/5/12 three surgeons (MD #4, 5 and 6) were suspended on 7/17/12, 9/5/12 and 6/26/12 respectively for delinquent medical record deficiencies. Interview with the Operating Room Scheduler, during the tour on 9/6/12, identified that MD #4 had completed his/her delinquent medical records. On 9/6/12, MD #4 performed surgery on Patient #2 although surgical privileges were not reinstated in accordance with Medical Staff By-laws.

Review of a letter sent to MD #4, dated 8/7/12, and interviews with Medical Records Staff #1 and the Director of Medical Records, on 9/6/12 at 4:05 P.M., identified that MD #4 was placed on automatic suspension on 7/17/12 for delinquent record deficiencies and was informed that if the records were not completed by 8/17/12, his/her privileges would be revoked.

Interview with the Chief of Surgery, on 9/12/12 at 10:16 A.M., identified that MD #4 should not have performed surgery for Patient #2 on 9/6/12 because s/he had suspended privileges.

Interview with the Scheduler for Cardioversion, on 9/6/12 at 11:20 A.M., identified that although s/he always received the physician suspension list, s/he deleted the list as it was not related to booking cardioversion procedures/surgeries. Interviews with the Radiology Scheduler #1 and the Director of Diagnostic Imaging, on 9/6/12 at 2:12 P.M., identified that they do not receive the physician suspension list.

Review of the Medical Staff By-Laws and Rules and Regulations, dated 9/27/11, identified that a physician who following a suspension of privileges has not completed delinquent medical records after thirty days will have his/her privileges revoked and privileges may be restored only by a formal new application for privileges.


g. Review of the hospital Medical Staff Meeting Minutes, from 1/6/12 to 6/1/12, identified that in May 2012 it was identified that not all of the Medical Staff is involved in the meetings and the minutes failed to reflect that a quorum of active medical staff members were present. The hospital identified that there were eighty-one (81) members of the active medical staff and that between eighteen to twenty-one members of the active medical staff attended the Medical Staff Meeting from 1/6/12 to 6/1/12.

In addition, MD #1 had not attended any Medical Staff Meetings from 1/6/12 to 6/1/12.

Interview with the Chief of orthopedics, on 9/12/12 at 12:02 P.M., had no response with regards to MD #1 not attending medical staff meetings.

Review of the Medical Staff By-Laws and Rules and Regulations, dated 9/27/11, identified that active staff members must attend at least one-half of the meetings.
VIOLATION: PATIENT RIGHTS Tag No: A0115
Based on a review of clinical records, interviews, review of hospital documentation and policies and procedures, the Hospital failed to protect and promote the rights of fourteen of fourteen patients. The findings include:

Please refer to A 132, A 143, A144, A147, A164, A 174 and A186.
VIOLATION: PATIENT RIGHTS: ADVANCED DIRECTIVES Tag No: A0132
Based on a review of clinical records, interviews and policies and procedures for ten of fourteen patients (Patients #1, 2, 3, 4, 5, 6, 7, 8, 9 and 10) that were provided care and services, the hospital failed to ensure that staff inquired whether patient (s) and/or the patient representative (s) had executed advanced directives and/or provided information to the patient and/or patient representative regarding advanced directives and/or obtained a copy of the patient's advanced directive for the clinical record in accordance with policy. The findings include:

a. Patients #1, 2, 3, 4, 5, 6, 7, 8, 9 and 10 were admitted to the hospital from 7/23/12 to 9/6/12 for provision of care and services. Review of the clinical records failed to reflect that the nursing staff during a pre-admission telephone call and/or the admission staff inquired about advanced directives.

Interview with RN #3, during tour of the Post Anesthesia Care Unit on 9/6/12 at 11:10 A.M., identified that during the nursing pre-admission call to outpatients the nurse does not inquire if the patient had executed an advanced directive.

Interviews with the Admission Director, on 9/6/12 at 1:45 P.M. and on 9/12/12 at 10:55 A.M., identified that the admission staff are instructed to ask inpatients if they have executed a living will and not advanced directives. The Admission Director stated that the record lacked documentation that staff inquired if the patient and/or patient representative had executed advanced directives.

Interview with the Vice President of Patient Care Services, on 9/12/12 at 11:16 A.M., identified that during the nursing pre-admission telephone call, advance directives are reviewed although he/she could not explain the questions that are asked during this process.

Review of the policy and procedure, titled Advanced Directives, identified that on admission, the admitting staff asks the patient and/or representative if they have executed an advanced directives.

A policy and procedure, titled Preoperative Nursing Assessment, identified that prior to surgery the nurse reviews the patient's advance directive.

Review of the information packet, titled Connecticut Advance Directives, identified that Connecticut recognizes four types of advance directives-living will, health care representative, conservator and/or an anatomical gift donation.


b. Patients # 1, 3, 4, 5, 9 and 10 were admitted to the hospital from 7/23/12 to 9/6/12 for care and services. Review of the clinical records identified that these patients had not executed a living will. The record failed to reflect that the hospital staff provided information regarding formulation of advanced directives.

Interview with the Admission Director, on 9/6/12 at 1:45 P.M., identified that the hospital provides information regarding formulation of advanced directives via informational booklet to all inpatients only. The Admission Director stated that the record lacked documentation that staff provided information to the patient regarding formulation of advanced directives.

Review of the policy and procedure, titled Advanced Directives, identified that the hospital provides all patients written information on formulation of advanced directives and will provide the information to outpatients upon request.


c. Patients #5, 6 and 8 were admitted to the hospital from 7/31/12 to 9/4/12 for care and services. Review of the clinical records identified that these patients had executed a living will. The record failed to reflect that a copy of the living will was requested and/or obtained.

Interviews with the Admission Director, on 9/6/12 at 1:45 P.M. and on 9/12/12 at 10:55 A.M., identified that if a patient had an executed a living will, the admission staff will ask the patient and/or patient representative to bring a copy to add to the hospital medical record.

Review of the policy and procedure, titled Advanced Directives, identified that all copies of advance directives will be made part of the medical record.
VIOLATION: PATIENT RIGHTS: PERSONAL PRIVACY Tag No: A0143
Based on a review of clinical records, interviews, facility policies/procedures and review of facility documentation for seven of ten patients (Patients # 1, 5, 6, 7, 8, 9 and 10) that had surgery, the hospital failed to obtain the patient's consent for industry/company representatives to be present during the surgical procedures. The findings include:


a. Patients # 1, 5, 6, 7, 8, 9 and 10 were admitted to the hospital from 7/23/12 to 9/4/12 for surgery. Review of the clinical records identified that Persons # 1, 2, 3, 4 and 5, all industry/company representatives, were present for Patients # 1, 5, 6, 7, 8, 9 and 10 surgeries. Review of the clinical records failed to reflect that the hospital obtained the patient's consent for representatives to be present during the surgical procedures.

Interview with the Nurse Manger of the Operating Room, on 9/6/12 at 3:15 P.M., could not explain how the patient consents to industry/company representatives to be present during the surgical procedures.

Interview with MD #1, on 9/6/12 at 3:30 P.M., identified that he/she did not inform and/or get consent from Patient #1 that industry/company representatives, Persons #1 and #2, would be present during his/her surgery on 7/23/12.

Interview with the Chief of Surgery, on 9/12/12 at 10:16 A.M., identified that the surgeon is responsible to inform the patient that industry/company representatives will be present during surgery.

Review of the hospital policy and procedure, titled Sales Representatives in the Operating Room, identified that the physician informs and obtains consent form the patient to have a sales representative in the Operating Room.
VIOLATION: PATIENT RIGHTS: CARE IN SAFE SETTING Tag No: A0144
Based on observation, review of the clinical record, interviews and review of policy and procedure for one patient (Patient #14) that required observation for safety, the hospital failed to ensure that the staff member responsible for monitoring was apprised of patient specific information. The finding includes:

Patient #14 arrived at the Emergency Department on 9/12/12 with a Police Emergency Examination request (PEER) after s/he verbalized suicidal ideation. Tour of the ED, on 9/12/12 from 5:00 P.M. to 5:15 P.M., identified that ED Technician #1 was seated outside of Patient #14's ED room.

Interview with ED Technician #1, on 9/12/12 at 5:02 P.M., failed to identify the specific behaviors that needed to be monitored and/or reported to nursing staff. Interview with the nurse assigned to the patient, RN #8, on 9/12/12 at 5:12 P.M., identified that although the technician did have a communication sheet which contained a list of behaviors that must be immediately reported to the nurse, s/he had not yet given report to ED Technician #1 regarding the specific behaviors that should be monitored for Patient #14.

Review of the policy and procedure, titled Behavioral Emergencies, identified that if the patient requires observation, the nurse will complete a sitter communication document outlining the individual needs of the patient.
VIOLATION: PATIENT RIGHTS: CONFIDENTIALITY OF RECORDS Tag No: A0147
**NOTE- TERMS IN BRACKETS HAVE BEEN EDITED TO PROTECT CONFIDENTIALITY**

Based on review of clinical records, interviews and review of facility documentation for four of five patients (Patients #1, 7, 9 and 10) and an unknown number of other patients that were provided care and services, the hospital failed to protect each patient's personal information from a non-hospital employee. The findings include:

a. Patient #1 was admitted on [DATE] with diagnoses that included degenerative joint disease and was scheduled for left total hip replacement surgery. Review of the clinical record identified that RN #1 (not employed by the hospital and/or a credentialed member of the medical staff) dictated post-operative orthopedic notes including outcomes of physical examination assessments inclusive of mentation, auscultation of lungs, abdomen, wound and neurovascular sensation on 7/24/12, 7/25/12, 7/26/12 and 7/27/12. These notes identified that RN #1 interpreted data to determine the patient's medical status and the medical plan of care/protocol and were not co-signed by the attending surgeon, MD #1. In addition, RN #1 dictated a transfer summary, dated 7/27/12, which was electronically signed by MD #1.

Review of the physician orders for Patient #1, from 7/25/12 to 7/27/12, identified that RN #1 wrote three verbal orders from MD #1 for anticoagulant and narcotic medications and these orders were carried out by the hospital staff.

b. Patient #7 was admitted on [DATE] with diagnoses that included degenerative joint disease and was scheduled for a left total hip replacement surgery. Review of the clinical record identified that RN #1 (not employed by the hospital and/or a credentialed member of the medical staff) dictated post-operative orthopedic notes including outcomes of physical examination assessments inclusive of mentation, auscultation of lungs, abdomen, wound and neurovascular sensation on 8/1/12, 8/2/12 and 8/3/12. These notes identified that RN #1 interpreted data to determine the patient's medical status and the medical plan of care/protocol and were not co-signed by the attending surgeon, MD #1. In addition, RN #1 dictated a transfer summary, dated 7/31/12, which was electronically signed by MD #1.

Review of the physician orders for Patient #7, from 8/1/12 to 8/3/12, identified that RN #1 wrote two verbal orders from MD #1 for anticoagulant medications and these orders were carried out by the hospital staff.


c. Patient #9 was admitted on [DATE] with diagnoses that included degenerative joint disease and was scheduled for a right total hip replacement surgery. Review of the clinical record identified that RN #1 (not employed by the hospital and/or a credentialed member of the medical staff) dictated post-operative orthopedic notes including outcomes of physical examination assessments inclusive of mentation, auscultation of lungs, abdomen, wound and neurovascular sensation on 8/22/12, 8/23/12 and 8/24/12. These notes identified that RN #1 interpreted data to determine the patient's medical status and the medical plan of care/protocol and were not co-signed by the attending surgeon, MD #1. In addition, RN #1 dictated a transfer summary, dated 8/24/12, which was electronically signed by MD #1.

Review of the physician orders for Patient #9, from 8/22/12 to 8/24/12, identified that RN #1 wrote two verbal orders from MD #1 for anticoagulant medications and these orders were carried out by the hospital staff.


d. Patient #10 was admitted on [DATE] with diagnoses that included degenerative joint disease and subsequently underwent a left total hip replacement surgery. Review of the clinical record identified that RN #1 (not employed by the hospital and/or a credentialed member of the medical staff) dictated post-operative orthopedic notes including outcomes of a physical examination assessments inclusive of mentation, auscultation of lungs, abdomen, wound and neurovascular sensation on 5/11/11 and 5/12/11. These notes identified that RN #1 interpreted data to determine the patient's medical status and the medical plan of care/protocol and were not co-signed by the attending surgeon, MD #1. In addition, RN #1 dictated a transfer summary, dated 5/12/11, which was electronically signed by MD #1.

Review of the physician orders for Patient #10, dated 5/11/11, identified that RN #1 wrote a verbal order from MD #1 for an anticoagulant medication and this order was carried out by the hospital staff.

In addition, Patient #10 was admitted on [DATE] with diagnoses that included degenerative joint disease and was scheduled for a right total hip replacement surgery. Review of the clinical record identified that RN #1 (not employed by the hospital and/or a credentialed member of the medical staff) dictated post-operative orthopedic notes including outcomes of physical examination assessments inclusive of mentation, auscultation of lungs, abdomen, wound and neurovascular sensation on 8/1/12, 8/2/12 and 8/3/12. These notes identified that RN #1 interpreted data to determine the patient's medical status and the medical plan of care/protocol and were not co-signed by the attending surgeon, MD #1. In addition, RN #1 dictated a transfer summary and an addendum summary, dated 8/2/12 and 8/3/12, which were electronically signed by MD #1.

Review of the physician orders for Patient #10, from 8/1/12 to 8/4/12, identified that RN #1 wrote five verbal orders from MD #1 for anticoagulant, narcotic, antihypertensive medications and for diagnostic tests and these orders were carried out by the hospital staff.


Review of the hospital credential and personnel file identified that RN #1 was not employed by the hospital and was not a credentialed member of the medical staff, although s/he had started an application dated 7/18/05.

Interview with MD #1, on 9/6/12 at 3:30 P.M., identified that RN #1 was employed by him, and that RN #1's role was to round with and without him on MD #1's surgical patient's and to dictate post-operative orthopedic notes and transfer summaries.

Interview with the Chief of Surgery, on 9/12/12 at 10:16 A.M., identified that this practice was not acceptable as RN #1 was not credentialed as a member of the medical staff.

Interview with the Information Technology (IT) Director, on 9/12/12 at 3:10 P.M., and review of IT documentation, titled Milford Hospital Confidentiality of Information Statement & Account Request Form and dated 7/10/05, identified that RN #1 rounds for MD #1, was not credentialed by the hospital and per IT Director it was "OK" for RN #1 to have Meditech Access. Review of the document identified that Meditech Access includes access to imaging and therapeutic services, admissions, enterprise medical records, laboratory, pharmacy, order entry, accounts payable/billing and case management.

Interviews with the Hospital Privacy Officer, on 9/12/12 at 11:07 A.M. and 12:44 P.M., identified that s/he was not aware how RN #1 was able to access patient records, the number of patient records that were accessed and has initiated an investigation.

Interview with the Director of Quality Improvement and the Vice President of Patient Care Services, on 9/12/12 at 11:31 A.M., identified that on 9/6/12 after it was identified that RN #1 had access to patient records as described, the hospital informed MD #1 and the Chief of Orthopedics that RN #1 is not to return to the hospital.

A Notice of Privacy practices, dated 4/14/03, identified that the hospital ensures that patient medical information is protected and may be disclosed to a selected workforce-including physicians and/or employees.

A policy and procedure, titled Commitment to Patient Privacy Program, identified that all patient identifiable information is protected in any form- electronic, written, faxed and oral, and is strictly confidential. In addition, the Privacy officer is responsible for monitoring and enforcing the policy with assistance from the Medical Record Department staff and the Department Heads.

A policy and procedure, titled Patient Privacy Rights, identified that each patient is entitled to privacy of their personal health information (PHI) and the hospital ensures patient privacy rights as specified in the Health Insurance Portability and Accountability Act (HIPPA) of 1996.

A policy and procedure, titled Confidentiality, identified that it is the responsibility of the Hospital to protect the privacy and confidentiality of individual PHI as well as all other Hospital confidential data and access is controlled.

A policy and procedure, titled Verification of PHI Recipient's Identity, identified that the Hospital takes reasonable measures to ensure that individuals requesting PHI have the identity and authority to receive the PHI.

A policy and procedure, titled User Authorization to Access Confidential Electronic Data, identified that users must be formally authorized by the Hospital to access PHI.
VIOLATION: PATIENT RIGHTS: RESTRAINT OR SECLUSION Tag No: A0164
Based on review of clinical records, interviews and policies and procedures for one of three patients (Patient #13) that required restraints, the hospital failed to ensure that less restrictive restraints were utilized prior to the institution of seclusion. The finding includes:

Patient #13 arrived at the ED on 9/2/12 at 10:50 A.M. with a family member who identified that the patient was suicidal with a past medical history included bipolar disorder and epilepsy. Review of the admission nursing assessment identified that the patient was calm, cooperative and demonstrated a normal thought process. A sitter was assigned to observe the patient for safety. Review of the clinical record identified that at approximately 11:30 A.M., a psychiatrist completed a Physician's Emergency Certificate (PEC) which determined the patient was gravely disabled and a danger to self and/or others due to psychiatric disabilities.

At 12:10 P.M., the patient and two family members left the ED. Review of a nurses note identfied that the patient returned to the hospital, via ambulance at 1:47 P.M., at the families request.

At 3:10 P.M. Patient #13 "bolted" from the ED room into the lobby, was physically held down by two staff members then returned to the ED room. After the interventions of one to one conversation, redirection, limitation of activity, decrease of stimulation and verbal de-escalation, the staff placed Patient into four point restraints for the identified behavior of elopement. At 3:30 P.M. the four point restraints were removed, absent of an assessment. A physician's order at 3:30 P.M. directed that staff lock the door to the patient's room. Documentation supported this was initiated at 3:30 P.M.

Interviews with RN #5, 6 and 7, on 9/12/12 from 5:07 P.M. to 5:20 P.M., identified that they had never locked an ED patient door and/or been directed to lock an ED patient door per physician order.

Review of the policy and procedure, titled Behavioral Restraint, identified that use of the restraint will be the least restrictive intervention that protects the patient's safety.

A policy and procedure, titled Behavioral Emergencies, identified that a patient will be placed in seclusion when a patient is threatening, out of control, or the staff feel their safety is threatened and the patient remains in seclusion until sufficient personnel is convened to properly gain control of the patient or otherwise creates a safe environment.
VIOLATION: PATIENT RIGHTS: RESTRAINT OR SECLUSION Tag No: A0174
**NOTE- TERMS IN BRACKETS HAVE BEEN EDITED TO PROTECT CONFIDENTIALITY**


Based on review of clinical records, interviews and policies and procedures for two of three patients (Patients #12 and 13) that required restraints, the hospital failed to ensure that the restraints were discontinued at the earliest possible time. The findings include:

1. Patient #12 arrived at the ED on 9/3/12 at 9:06 P.M. via ambulance with alcohol ingestion and a reported seizure with a past medical history that included alcoholism and Chronic Obstructive Pulmonary Disease. Review of the admission nursing assessment identified that the patient's behaviors were within normal limits. A second nursing assessment, timed 9:10 P.M., identified that the patient was combative, threatening and verbally abusive to the staff. Review of the restraint documentation sheet/order sheet, dated 9/3/12 at 9:30 P.M., identified that the patient required four point restraints for the demonstrated behaviors including aggression, agitation, combative and threatening behaviors and persistently attempting to get out of bed. Review of the Behavioral Restraint Flowsheet, dated 9/3/12, identified that although Patient #12 was observed sleeping from 11:15 P.M. to 12:00 Midnight, the patient remained in four-point restraints until 12:00 Midnight.

2. Patient #13 arrived at the ED on 9/2/12 at 10:50 A.M. with a family member who identified that the patient was suicidal with a past medical history included bipolar disorder and epilepsy. Review of the admission nursing assessment identified that the patient was calm, cooperative and demonstrated a normal thought process. Review of the clinical record identified that around 11:30 A.M. a psychiatrist completed a Physician's Emergency Certificate (PEC) which determined the patient was gravely disabled and a danger to self and/or others due to psychiatric disabilities.

At 12:10 P.M., the patient and two family members left the ED. Review of a nurse's note identfied that the patient returned to the hospital, via ambulance at 1:47 P.M., at the families request.

At 3:10 P.M. Patient #13 "bolted" from the ED room into the lobby, was physically held down by two staff members then returned to the ED room. After the interventions of one to one conversation, redirection, limitation of activity, decrease of stimulation and verbal de-escalation, the staff placed Patient into four point restraints for the identified behavior of elopement. At 3:30 P.M. the four point restraints were removed, absent of an assessment. A physician's order at 3:30 P.M. directed that staff lock the door to the patient's room. Documentation supported this was initiated at 3:30 P.M.

Review of the clinical record, from 9/2/12 at 4:00 P.M. through 9/3/12 at 8:15 A.M., identified that although Patient #13 was calm, cooperative and verbalized that s/he would not leave the hospital, the door to the patient's room remained lock until discharged on [DATE] at 8:50 A.M.

Interviews with RN #5, 6 and 7, on 9/12/12 from 5:10 P.M. to 5:15 P.M., identified that they had never locked an ED patient door and/or been directed to lock an ED patient door per physician order.

Review of the policy and procedure, titled Behavioral Restraint, identified that use of the restraint will end as soon as possible when the patient no longer meets the criteria requiring the restraint.
VIOLATION: PATIENT RIGHTS: RESTRAINT OR SECLUSION Tag No: A0186
Based on review of clinical records, interviews and policies and procedures for two of three patients (Patients #11 and 12) that required restraints, the hospital failed to ensure that alternatives listed as trialed prior to the application of restraints was attempted. The findings include:

1. Patient #11 arrived at the Emergency Department (ED) on 8/18/12 at 5:59 P.M. via ambulance with alcohol ingestion and a fall. Review of the restraint documentation sheet/order sheet, dated 8/18/12 at 6:00 P.M., identified that prior to application of four point restraints, a sitter was trialed. Record review and interviews with the ED Clinical Nurse Manager and the ED Nurse Manger, on 9/12/12 at 4:10 P.M., failed to reflect the time in which the sitter was utilized prior to the application of four point restraints.

2. Patient #12 arrived at the ED on 9/3/12 at 9:06 P.M. via ambulance with alcohol ingestion and a reported seizure with a past medical history that included alcoholism and Chronic Obstructive Pulmonary Disease. A nursing assessment, timed 9:10 P.M., identified that the patient was combative, threatening and verbally abusive to the staff. Review of the restraint documentation sheet/order sheet, dated 9/3/12 at 9:30 P.M., identified that prior to application of four point restraints, a sitter was trialed. Record review and interviews with the ED Clinical Nurse Manager and the ED Nurse Manger, on 9/12/12 at 4:10 P.M., failed to reflect the time in which the sitter was utilized prior to the application of four point restraints.

Review of the policy and procedure, titled Behavioral Restraint, identified that restraints are used only if less restrictive measures are ineffective or inappropriate.
VIOLATION: PROGRAM SCOPE, PROGRAM DATA Tag No: A0273
Based on review of facility documentation and interviews, the hospital failed to incorporate collected data into the quality program in order to improve patient outcomes. The findings include:

a. During a tour of the hospital, on 9/6/12 from 10:00 A.M. to 12:48 P.M., and interviews with the Operating Room (OR) Nurse Manager and the Supervisor of the Sterile Processing Department identified that the hospital routinely sterilizes items via immediate use sterilization and the numbers are reported to the OR Committee.
Review of the OR Committee Meeting Minutes, from 12/21/11 to 8/15/12, identified that the immediate use sterilization rate was between 8 to 19 %. In addition, it was identified that that immediate use rate was elevated due to wet packs and in August 2012 the rate had decreased related to recent instrument purchases.

Interview with the Chief of Surgery, on 9/12/12 at 10:16 A.M., identified that the immediate use sterilization rate needs to be addressed.


b. In addition, during the tour of the hospital, on 9/6/12 from 10:00 A.M. to 12:48 P.M., and interview with the Supervisor of the Sterile Processing Department (SPD) identified that surgical instruments that are broken and/or need to be repaired are placed in the repair bin and are sent out every ninety days. The Supervisor stated that although s/he collects the list of items that are sent out, patterns of recurring broken and/or instruments in disrepair are not monitored and/or this information is not part of any quality/performance improvement program.
Review of the repair slips, dated from 4/8/12 to 8/8/12, identified that instruments sent out for repair on 4/8/12 and 6/28/12 included needle holders, scissors, hemostats, thumb forceps, curettes, and bone cutters.


Review of the Performance Improvement Committee, from January 2012 to June 2012 failed to reflect that either the immediate use sterilization rates and/or the instrument repair data was reported to this committee.
VIOLATION: SURGICAL PRIVILEGES Tag No: A0945
Based on a review of clinical records, interviews and review of facility documentation, the hospital failed to ensure that a staff member who had privileges suspended for delinquent medical records was allowed to perform surgery for one patient (#2) and/or that a physician suspension list was provided to staff who were responsible to schedule procedures and/or surgeries. The finding includes:

a. During a tour of the hospital, on 9/6/12 from 10:00 A.M. to 12:48 P.M., it was identified that as of 9/5/12 three surgeons (MD #4, 5 and 6) were suspended on 7/17/12, 9/5/12 and 6/26/12 respectively for delinquent medical record deficiencies. Interview with the Operating Room Scheduler, during the tour on 9/6/12, identified that MD #4 had completed his/her delinquent medical records. On 9/6/12, MD #4 performed surgery on Patient #2 although surgical privileges were not reinstated in accordance with Medical Staff By-laws.

Review of a letter sent to MD #4, dated 8/7/12, and interviews with Medical Records Staff #1 and the Director of Medical Records, on 9/6/12 at 4:05 P.M., identified that MD #4 was placed on automatic suspension on 7/17/12 for delinquent record deficiencies and was informed that if the records were not completed by 8/17/12, his/her privileges would be revoked.

Interview with the Chief of Surgery, on 9/12/12 at 10:16 A.M., identified that MD #4 should not have performed surgery for Patient #2 on 9/6/12 because he/she was suspended.

Interview with the Scheduler for Cardioversion, on 9/6/12 at 11:20 A.M., identified that although s/he always received the physician suspension list, s/he deleted the list as it was not related to booking cardioversion procedures/surgeries. Interviews with the Radiology Scheduler #1 and the Director of Diagnostic Imaging, on 9/6/12 at 2:12 P.M., identified that they do not receive the physician suspension list.

Review of the Medical Staff By-Laws and Rules and Regulations, dated 9/27/11, identified that a physician who following a suspension of privileges has not completed delinquent medical records after thirty days will have his/her privileges revoked and privileges may be restored only by a formal new application for privileges.