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.

VALLEY VIEW MEDICAL CENTER 5330 SOUTH HIGHWAY 95 FORT MOHAVE, AZ 86426 Feb. 11, 2011
VIOLATION: GOVERNING BODY Tag No: A0043
Based on observations during tour, review of hospital policies/procedures, medical records, hospital documents, medical staff peer review, and interviews, it was determined the Governing Body was not effective and failed to account for the conduct of all hospital operations, as evidenced by:

A0049: failing to ensure the Medical Staff was accountable to the Governing Authority for the quality of care provided by Physician #1; and failing to implement the policy titled Ongoing Professional Practice Evaluations/Focused Professional Practice Evaluation Process for the medical staff effective 10/2010;

A0115: the hospital failed to comply with the provisions of Patient Rights, related to informed consents and restraints, as evidenced by: A0117: failure to inform and provide patients/representatives a copy of their rights prior to receiving care, for 6 of 6 patients (#4, 13, 15, 16, 17, 18); A131: failure to demonstrate that 8 of 12 patients signing consents, were afforded the right to make informed decisions; Patients #1, 8, 9, 11, and 14, signed surgical consents that included optional techniques/procedures that were not physician discussed nor ordered; Patients #2 and 19, signed consents identified on surgery scheduling forms as the planned procedure, not a physician order; Patient #22 signed a surgical consent for a procedure the physician did not perform; A0166: failure to ensure the patient's plan of care was modified for the use of restraints for 2 of 2 patients restrained (#12 and 20); A0168: failure to require a physician's order was obtained for 2 of 2 patients restrained (#12 and 20); A0169: failure to require restraint orders were never written as a standing order or on an as needed or PRN basis for patient #3; and A0214: failure to report the death of Patient #12 who was in restraints;

A0263: the hospital failed to comply with the provisions of the Quality Assessment Performance Improvement Program to effectively analyze, measure and implement policies to assess processes of care, as evidenced by: A0267: failing to implement the Ongoing Professional Practice Evaluations (OPPE) policy and procedure for the medical staff; failing to identify and analyze restraint practice problems for 2 of 2 patients audited for restraints (Patients #12, and 20); and failing to monitor and analyze the hospital process for informed consent for 8 of 12 patients (#'s 1, 2, 8, 9, 11, 14, 19, and 22) signing consents for surgical or endoscopy procedures;

A0338: the hospital failed to comply with the provisions of Medical Staff Services, as evidenced by: A0347: failure to assume responsibility for the quality of care provided to patients by Physician #1; and failure to implement the policy titled Ongoing Professional Practice Evaluations/Focused Professional Practice Evaluation Process, for the medical staff; A0353: failure to require the departments of the medical staff had written rules and regulations which governed the activities of the departments as required by the medical staff bylaws; failure to require the privileges granted for the medical staff were specific and defined for the hospital medical staff and personnel for (Physician #1); failure to require the medical staff implemented the medical staff bylaws for appointing members to the medical staff, requiring the Department Chairperson review physicians' applications and recommend the physicians for appointment of clinical privileges (Physicians #1, #2, #3, and #6); and failure to require a physician did not order restraints on an as needed (PRN) basis for patient #3;

A431: the hospital failed to comply with the provisions of Medical Records, related to requiring adequate staff, and complete records, as evidenced by: A0432: failure to require adequately trained personnel were employed to ensure prompt completion of medical records; and A0450: failure to require all medical record entries were legible, complete, dated, timed, and authenticated by the persons responsible for providing or evaluating services provided; and

A0940: the hospital failed to comply with the provisions of Surgical Services, related to informed consents as evidenced by: A0955: patient #22 signed a surgical consent for a carotid-subclavian bypass and Physician #1 performed a carotid endarterectomy; patient #14 signed a surgical consent with the possibility of an optional procedure not explained to the patient, nor ordered by the physician; patient
#9 signed a surgical consent with the possibility of an optional technique not explained to the patient, nor ordered by the physician; patient #11 signed a consent that was different than the physician ordered; patients #1,and #8, signed surgical consents with the possibility of an optional technique not ordered by the physician; and patients #2 and #19 signed consents that were identified on the surgery scheduling form as the planned procedure, not a physician order.

The cumulative effect of these systemic deficient practices resulted in the hospital's failure to meet the requirements for the Condition of Participation for Governing Body.
VIOLATION: MEDICAL STAFF - ACCOUNTABILITY Tag No: A0049
**NOTE- TERMS IN BRACKETS HAVE BEEN EDITED TO PROTECT CONFIDENTIALITY**

Based on review of hospital policies, procedures, medical staff peer review policy and interview with staff, it was determined that the medical staff was not accountable to the governing authority for:

1. the quality of care provided to patients by Physician #1; and

2. the hospital has not implemented the policy titled Ongoing Professional Practice Evaluations/Focused Professional Practice Evaluation Process for the medical staff.

Findings include:

1. The hospital policy titled, Medical Staff Peer Review, dated 04/27/06 (in effect at the time of the Pt #22's surgery), included: "...Purpose: To define the process for peer review that contributes to...the improvement of the quality, performance...of patient care and investigate significant, potential or actual adverse patient occurrences...Peer Review Committee...The Medical Executive Committee will function as the Peer Review Committee...Procedure: A Peer Review process may be initiated by the Performance Improvement Department, Risk Management Department, Chief of Staff, Medical Staff and Department Mangers. Sources for identifying cases for review include but are not limited to...patient or family complaints...An initial review will be completed by the Director of Quality/Risk Management and forwarded to the Chief of the respective service...The physician reviewer will assign a criteria code using the peer review form...A second level review will be conducted by the MEC (medical executive committee)...."

According to the Medical Staff Bylaws adopted 12/07/06, they required: "...Article VI Corrective Action...Criteria for Initiation. Whenever activities, omissions, or any professional conduct of a practitioner with clinical privileges are detrimental to patient safety, to the delivery of quality patient care, are disruptive to hospital operations, or violate the provisions of these Bylaws, the Medical Staff Rules and Regulations, or duly adopted policies and procedures; corrective action against such practitioner may be initiated by any officer of the Medical Staff, by the CEO, or the Board Procedural guidelines from the Health Care Quality Improvement Act shall be followed and all corrective action shall be taken in good faith in the interest of quality patient care...."

Patient #22 was admitted on [DATE], for a carotid-subclavian bypass surgery to be performed by Physician #1. Pt #22 was discharged the next day after having a carotid endarterectomy procedure.

The Chief Nursing Officer (CNO) confirmed on 01/04/11, that the patient had come to the hospital in November 2008, voicing concerns regarding his/her outcome from the surgery. The patient returned approximately 2 weeks later and presented a "packet" of papers for the hospital documenting concerns. The hospital could not demonstrate that the medical staff reviewed the concerns or that the hospital investigated the case. The CNO explained that the concerns were addressed by the previous Chief Executive Officer (CEO) and Chief Nursing Officer (CNO). At that time they determined that the outcome the patient had was a potential risk of the surgery. The hospital did not have any documentation that showed the steps taken by the hospital to make that determination. The hospital did not investigate the claims made by the patient.

Peer review for Physician #1 was reviewed. Multiple cases (greater than 20) were reviewed in 2008. Some of the cases (greater than 10) reviewed determined patients had major adverse outcomes, including deaths. The Peer Review Committee, and Medical Executive Committee did not make any recommendations to the Governing Board for actions to be taken. The minutes for the Executive Session discussing Peer Review results were not provided by the hospital and on 02/10/11, the Director of Quality indicated the minutes for the Executive Session were not found. Physician #1 retired on 05/01/09.

Review of the Board of Trustees meeting minutes from 09/28/08 revealed the following: "...advised there is a peer review issue at hand relating to quality of care concerns. The MEC held an ad hoc meeting and voted to send the cases out for external peer review...reported findings might support a probable suspension...There is not enough information at this time...."

According to hospital documents for peer review, only one additional case was reviewed after the Board of Trustees Meeting on 09/28/08, and that case was scored as "minor adverse patient outcome."

The hospital did not follow their peer review policy and procedure and investigate Patient #22's concerns regarding Physician #1.

The hospital could not demonstrate the process for ensuring the medical staff was accountable to the governing authority for the quality of care provided to Pt #22. The hospital did not follow their peer review policy and procedure.

2. The hospital policy titled Ongoing Professional Practice Evaluations/Focused Professional Practice Evaluation Process, effective 10/2010, required: "...Purpose:...To provide reliable, comparative data to physician(s) and non-physician providers pertaining to their performance which can improve the quality of the care they provide and identify opportunities for improvement and assist physician and non-physician providers with privileges at Valley View Medical Center. To clearly define the process utilized for facilitating the continuous evaluation of each practitioner's professional practice; To define the type of data (criteria/indicators) to be collected for the ongoing professional practice evaluation. (Note: The criteria defined for Ongoing Professional Practice Evaluation, will be utilized as screening triggers for a Focused Professional Practice Evaluation); To ensure the information resulting from the ongoing professional practice evaluation is used to determine whether to continue, limit, or revoke any existing privileges; To define the process for collecting, investigating, and addressing clinical practice concerns, including the process utilized to identify trends that impact quality of care and patient safety; To ensure reported concerns regarding a privileged practitioner's professional practice is uniformly investigated and addressed as defined by hospital policy and applicable law; To define those circumstances in which an external review of focused review may be necessary; and; To define the medical staff's leadership role in the organization's performance improvement activities related to practitioner performance and ensure that when the findings are relevant to an individual's performance, the findings in the ongoing evaluations of competence are in accordance with recognized standards...Ongoing Professional Practice Evaluation...a documented summary of ongoing data collected for the purpose of assessing a practitioner's clinical competence and professional behavior. There will be specific information collected and analyzed in order to make decisions about granting privileges. The medical staff will conduct an ongoing evaluation of each practitioner's professional performance. The information gathered during this process allows any potential problems with performance to be identified and resolved to foster a more efficient, evidenced-based privilege renewal process...Focused Professional Practice Evaluations...Renamed from Peer Review...."

The Medicine/ICU/ER/Family Practice Meeting Minutes were reviewed for March 4, 2010, which revealed the following: "...Ongoing Professional Practice Evaluation (OPPE). CNO reviewed a list of items to be monitored and reported for physician re-credentialing pursuant to Joint Commission standards. Each committee has reviewed and chosen 3-5 items for their criteria...."

The Director of Quality presented the Ongoing Professional Practice Evaluation spread sheet developed for data collection. She confirmed on 02/10/11, that the hospital has not implemented the OPPE policy and procedure and no data has been collected. She confirmed it was the responsibility of the Quality Department to collect the data identified for the OPPE evaluations.

The hospital could not demonstrate a current process for ensuring the medical staff was accountable to the governing authority for the quality of care provided to patients.
VIOLATION: PATIENT RIGHTS: RESTRAINT OR SECLUSION Tag No: A0169
**NOTE- TERMS IN BRACKETS HAVE BEEN EDITED TO PROTECT CONFIDENTIALITY**

Based on review of hospital policies/procedures, medical records, and interviews with staff, it was determined the hospital failed to require restraint orders were never written as a standing order or on an as needed or PRN basis for patient #3.

Findings include:

The hospital policy titled Restraints & Seclusion, effective 07/09, required: "...Procedure for Use Of Restraint...Initiation and Renewal of Orders...PRN orders are not permitted...."

Patient #3, (MDS) dated [DATE], with complaints of shortness of breath and weakness. The physician ordered, "...Soft bilat (bilateral) wrist restraints if needed..." on 12/28/10 at 2208.

The Director of Quality RN #12 confirmed the PRN order during an interview conducted on 02/09/11.
VIOLATION: PATIENT RIGHTS Tag No: A0115
Based on observations during tour, review of hospital policies/procedures, medical records, hospital documents, and interviews, it was determined the hospital failed to comply with the provisions of Patient Rights, related to informed consents and restraints, as evidenced by:

A0117: failure to inform and provide patients/representatives a copy of their rights prior to receiving care, for 6 of 6 patients (#4, 13, 15, 16, 17, 18);

A0131: failure to demonstrate that 8 of 12 patients signing consents, were afforded the right to make informed decisions; Patients #1, 8, 9, 11, and 14, signed surgical consents that included optional techniques/procedures that were not physician discussed nor ordered; Patients #2 and #19, signed consents identified on surgery scheduling forms as the planned procedure, not a physician order; Patient #22 signed a surgical consent for a procedure the physician did not perform;

A0166: failure to ensure the patient's plan of care was modified for the use of restraints for 2 of 2 patients restrained (#12 and 20);

A0168: failure to require a physician's order was obtained for 2 of 2 patients restrained (#12 and 20);

A0169: failure to require restraint orders were never written as a standing order or on an as needed or PRN basis for patient #3; and

A0214: failure to report the death of Patient #12 who was in restraints.

The cumulative effect of these systemic deficient practices resulted in the hospital's failure to meet the requirements for the Condition of Participation for Patient Rights.
VIOLATION: PATIENT RIGHTS: NOTICE OF RIGHTS Tag No: A0117
**NOTE- TERMS IN BRACKETS HAVE BEEN EDITED TO PROTECT CONFIDENTIALITY**

Based on observations during tour, review of hospital policies/procedures, medical records, and interviews, it was determined the hospital failed to inform and or provide a copy for patients/representatives (reps), of their rights prior to providing care and services for 6 of 6 patients (Patients #4, 13, 15, 16, 17, and 18).

Findings include:

The hospital policy titled Consents #MR-C-10 (established 09/05) required: "...The original of each completed and signed consent form should be made a part of the patient's permanent record. One copy should be given to the patient or his legally authorized representative or surrogate decision-maker at the same time that it is filed...The Conditions of Admission form authorizes general care in the hospital...."

The Consent For Services form describes the following 12 items: Medical Education, Personal Valuables, Patient's Certification, Authorization to Release Information and Payment Request, Financial Agreement, Physicians Are Not Hospital Employees (notification), Notice of Privacy, Patient Directory Preference, Election to Request Interpretative Services, Patient Rights, Smoke Free Facility Policy, Consent to Photograph, and Advance Directive Acknowledgement.

The form permits the patient/representative to mark a box addressing the following 6 items: Notice of Privacy declination, selecting their directory preferences (i.e.: name posting in the corridor), affirm smoking cessation materials were provided, consent to photograph refused, acknowledgement that advance directives are made, or that the patient/representative requests more information.

The form concludes with the following affirmation, to include the patient's/rep's and witness's signatures, dates and times: "I have carefully read and fully understand this Patient Consent and Financial Agreement and accept its terms...." The admission process requires patients/reps to sign documents electronically. The registrar, or witness, co-signs the form.

The following was determined during tours, and interviews, conducted in the Emergency (ED), Obstetrics (OB), and medical/surgical inpatient departments:

02/09/11 (1600): Patient #4 (and spouse) presented to ED Registrar #10, with "trouble breathing." ED Registrar #10 pulled up the "Consent to Treat" (Consent For Services) on the computer monitor, which was facing away from the patient. The spouse signed the electronic keyboard giving consent to treat, and marked the box declining a copy of the Notice of Privacy Act, after ED Registrar #10 asked, "do you want a copy of the privacy act?" There was no discussion of patient rights. ED Registrar #10 stated that the Consent for Services "includes the notice of privacy which also includes the patient's rights...when they (the patient) decline the Privacy Act (document), it includes all these (referencing the 6 afore mentioned boxes)...." ED Registrar #10 stated that her signature as the witness was "on file" and did not require documentation, date or time.

Patient #4, and spouse, confirmed during interviews conducted on 02/10/11 at 0815, that neither recalled what the spouse signed in the ED, and that they were not provided copies of what they signed. The spouse stated, "I don't know what patient's rights are." Both state:, "I don't know about complaints or grievances...they didn't ask or tell us anything about Medicare." The patient's spouse did not recall what she signed, and confirmed she was not provided with copies of the signed documents.

Patient #13 was admitted through the ED on 02/08/11, with abdominal pain. His medical record revealed an electronically signed Consent for Services, with no date or time. Patient #13 and his family, confirmed during interviews conducted on 02/10/11 at 0830, that he electronically signed the Consent For Services, and received a copy of the Notice of Privacy Practices, Patient Rights, and Advanced Directives information, on 02/09/11. Patient #13 and his family stated during interviews conducted on 02/10/11: "...no one talked about the grievance or complaint process...there was something on the paperwork that the hospital has a grievance process but we didn't get a copy of it."

Patient #15, (MDS) dated [DATE] at 0810, with a nosebleed (related to chemotherapy). The medical record included the Consent for Services with the patient's electronic signature, but no date or time. The patient indicated by marking the box, that he was provided a copy of the "Patient Handbook." The patient and spouse both indicated during interviews conducted on 02/10/11 at 0955, that the patient was provided a copy of his rights, but neither recall staff discussion of the rights, and no discussion related to Advanced Directives.

Patient #16, (MDS) dated [DATE] at 0908, with a cough. The patient confirmed during an interview conducted on 02/10/11 at 1000, that she signed a paper regarding smoking cessation, and electronically signed the Consent for Services. The patient stated, however, that the staff did not discuss patient rights, or Advanced Directives. The patient declined the Notice of Privacy, and stated that the ED clerk asked the patient after she signed paperwork, "what are you here for?"

Patient #18, (MDS) dated [DATE] at 0821, with abdominal pain at 17 weeks twin gestation. The patient confirmed during an interview conducted on 02/10/11 at 1015, that she signed 2 forms: "...patient rights and something else - I don't know what I signed electronically - I didn't see what I signed." The patient indicated that she received a copy of the Patient Handbook.

Patient #17 (a minor), (MDS) dated [DATE] at 0844, with an ankle injury. The patient was discharged prior to the surveyor's interview, however, the medical record revealed the child's parent electronically signed the Consent for Services (no date or time indicated), and was provided information related to Medicare Rights.

All of the patients/reps interviewed recalled electronically signing the Consent for Services, however, none recalled actually seeing or reading the document. None of the interviewees could articulate their patient rights to include Care Plan participation, informed decisions, advanced directives, privacy, safe environment, confidential patient records, nor the right to access information in their own medical record.
VIOLATION: PATIENT RIGHTS: INFORMED CONSENT Tag No: A0131
**NOTE- TERMS IN BRACKETS HAVE BEEN EDITED TO PROTECT CONFIDENTIALITY**

Based on review of hospital policies/procedures, medical records, and interviews, it was determined the hospital failed to demonstrate that 8 of 12 patients (#'s 1, 2, 8, 9, 11, 14, 19, and 22) signing consents for surgical or endoscopy procedures were afforded the right to make informed decisions regarding their surgical care as evidenced by:

1. Patient #22 signed a surgical consent for a carotid-subclavian bypass and Physician #1 performed a carotid endarterectomy;

2. Patient #14 signed a surgical consent with the possibility of an optional procedure not explained to the patient, nor ordered by the physician;

3. Patient #9 signed a surgical consent with the possibility of an optional technique not explained to the patient, nor ordered by the physician;

4. Patient #11 signed a consent that was different than the physician ordered;

5. Patients #1,and #8, signed surgical consents with the possibility of an optional technique not ordered by the physician; and

6. Patients #2 and #19 signed consents that were identified on the surgery scheduling form as the planned procedure, not a physician order.

Findings include:

The hospital policy titled Consents, Inclusive of Minors, effective 08/12/08, required: "...Informed Consent is consent based upon clear, concise explanation of the patient's condition, any proposed treatments or procedures, the risks, complications and expected benefits or effects the proposed treatment and significant alternatives...informed consent must be obtained for any procedure performed in the operating room...It is the treating physician's responsibility to obtain informed consent...if a procedure is to be changed between the time of consent and surgery, additional 'Informed Consent' should be obtained for the new procedure...."

The medical staff bylaws approved in 2006 and current, required: "...Now, Therefore, the practitioners practicing in Valley View Medical Center hereby organize themselves into a Medical Staff conforming to these bylaws...Article XIV General Provisions...Such rules and regulations and above referenced policies shall be considered a part of these bylaws...."

The medical staff rules and regulations adopted 2006 and current required: "...Article IV General Rules Regarding Surgical Care...A written, informed and signed surgical consent shall be obtained and placed on the patient's chart prior to all operative procedures, except in those situations wherein the patient's life is in jeopardy...."

The hospital's Medical Staff Rules and Regulations required: "...it shall...be the practitioner's obligation to obtain proper consent before the patient is treated in the hospital...After informed consent has been obtained by the surgeon, the nurse, shall obtain the patient's signature on the consent form and shall witness the signature...The anesthesia will be responsible to obtain and document informed consent for anesthesia in the medical record...."

1. Patient #22 was admitted on [DATE], for a carotid-subclavian bypass surgery, to be performed by Physician #1. Pt #22 was discharged the next day after having a carotid endarterectomy procedure.

The Surgeon documented in the Pre-Operative Orders, and progress notes that the planned procedure was a Subclavian Carotid Bypass and ordered the consent to be for the same procedure.

The patient signed a surgical consent for the planned procedure, carotid subclavian bypass, on 08/12/08, at 1100 hours. The Surgeon signed the consent form on the same day and did not include a time that he signed the consent form.

The history and physical documented by the Surgeon on 08/04/08, while the patient was at an office visit, indicated that that the planned procedure was a carotid subclavian bypass.

The Surgeon dictated the following at 1906 hours, on 08/12/08, after the procedure: "...A carotid subclavian bypass or endarterectomy of the common carotid was advised and accepted...."

Post-operative documentation by the Surgeon indicated the procedure performed was a carotid endarterectomy. Surgery personnel documentation indicated the planned procedure was a carotid subclavian bypass and the actual procedure performed was a carotid endarterectomy.

The Anesthesiologist documented the procedure as a Carotid Subclavian Bypass on the intraoperative anesthesia form. The CNO spoke with the anesthesiologist on 01/05/11, who said she documented the planned surgical procedure documented by the Surgeon.

The hospital could not demonstrate the patient was informed on the alternatives to the medical procedure.

The patient signed a consent form for a carotid subclavian bypass only. The patient did not sign a consent for the endarterectomy.

2. The hospital policy titled Cesarean Delivery #2115 (effective 09/05) required: "...Patient Preparation for Cesarean Delivery as Per Physician Order:...Consent for cesarean delivery; other consents if ordered...."

The Obstetrics unit had 2 patients during the tour conducted on 02/10/11; 1 laboring patient, and 1 post repeat cesarean section (scheduled) patient in recovery. Patient #14, Gravida 1 Para 0, was admitted on [DATE] at 0600 for labor induction/augmentation. The following was determined during the interview and record review conducted on 02/10/11 at 0915:

The Anesthesia Informed Consent, revealed: "...I acknowledge that I have had the opportunity to discuss the anesthetic plan and consent form with the anesthesiology staff, have given a complete and accurate history to them, and consent to the use of anesthesia. I have had my questions answered and believe I have adequate information to give consent...." The patient, and witness signed, the form but neither documented the time. The Anesthesiology Questionnaire requiring "reviewed by doctor (signature)" was blank. Patient #14, confirmed she signed the consent but stated she had not spoken to the anesthesiologist. Post interview, a physician identified by the staff as Patient #14's anesthesiologist, presented to the nurses' station, stating that she was there for the patient's initial visit.

The "Consent To Operate and Other Medical Services...Cesarean Section," signed by the patient and witnessed on 02/10/11 at 0730, revealed, "...The following have been fully discussed with me and explained to me by my physician: the nature and purpose of the operation, possible alternatives methods of treatment, including the associated risk and benefits of the alternatives, the risk and benefits involved with the operation, the side effects and complications, the likelihood of achieving goals and the risks and prognosis if no treatment is rendered...." Patient #14, stated that the physician discussed the possibility of a cesarean section during her prenatal visit, however, did not mention the risks, and alternatives.

The hospital did not demonstrate that Patient #14's rights were honored to ensure informed decisions were made regarding anesthesia, and cesarean section surgery.

3. Patient #9's medical record was reviewed. The patient had surgery on 02/07/11. The physician sent a form into the hospital titled Surgical Scheduling and the "Planned Procedure" for a "Laparoscopic Cholecystectomy." The surgical consent read "Laparoscopic Cholecystectomy possible open." Patient
#9 was interviewed on 02/10/11 at 0815 hours. She was asked if she signed a consent for the procedure and she admitted she had signed the consent. She was asked what "possible open" meant on the consent, she admitted she did not know. When asked if the surgeon explained that he may need to surgically take the gall bladder out through a larger incision, she said the surgeon never explained that until after the surgery and added she wouldn't have cared she just wanted "it" out.

The Director of Surgery talked with the surgery nurses regarding the consent and reported that the nurses had been told by the surgeon to always include "possible open" on all of his consents. The Director of Quality confirmed the nurse did not write the physician's directions as an order.

The hospital did not demonstrate that Patient #9's rights included informed decisions regarding the possibility of an open cholecystectomy.

4. Patient #11's medical record indicated he was admitted on [DATE] for the following procedure ordered by the surgeon on the pre-op order form: "Cystoscopy with possible bladder biopsy possible transurethral resection of prostate, possible holmium laser ablation of the prostate, possible greenlight laser ablation of prostate, circumcision." Review of the patient's consent form revealed the patient signed a consent for "Circumcision-LASER ablation (illegible word)." The Director of Quality confirmed the consent was not the same as the physician ordered and she could not read the consent.

5. Patient #1's medical record included the Surgical Scheduling document indicating, "...Procedure: Laparoscopic Cholecystectomy...." The patient signed the Consent to Operate, for "Laparoscopic cholecystectomy, possible open" on 01/26/11 at 0815. The surgical nurse documented confirmation on the Preoperative Checklist, that the operative consent was complete "as stated on Physician Order." The surgeon co-signed the consent on 01/26/11 at 1030, indicating the patient was informed of the procedure, however there was no physician order for the procedure, nor to include "possible open."

Patient #8's medical record was reviewed. The patient had surgery on 02/09/11. The physician sent a form into the hospital titled Surgical Scheduling and the "Planned Procedure" was for a "Laparoscopic Cholecystectomy." Patient #8 was interviewed on 02/10/11 at 0830 hours. The patient confirmed the surgeon explained the possibility of an open cholecystectomy to her. The surgeon did not order the consent to include "possible open."

The director of quality talked with surgery personnel regarding the consents and reported that the nurses had been told by Physician #2 to always include "possible open" on all of his consents. The Director of Quality confirmed the nurses did not write the physician's directions as an order.

6. Patient #2's medical record included the Surgical Scheduling form indicating, "...Procedure: Right Modified Radical Mastectomy with SLN (sentinel lymphatic node) mapping." There was no documented physician's order for the consent.

Patient #19's medical record included the Surgical Scheduling form indicating, "...Procedure: Esophagogastroduodenoscopy, Possible Biopsy...." The surgical nurse documented confirmation on the Preoperative Checklist, that the operative consent was complete "as stated on Physician Order," however, there was no documented physician's order for the consent.

The patients signed consents prepared from procedures identified on the Surgery Schedules, and not according to physicians' documented orders.
VIOLATION: MEDICAL RECORD SERVICES Tag No: A0450
**NOTE- TERMS IN BRACKETS HAVE BEEN EDITED TO PROTECT CONFIDENTIALITY**

Based on review of hospital policies/procedures, medical records, and interviews, it was determined that the hospital failed to require all patient medical records were complete, as demonstrated by:

1. medical records staff did not identify that 1 of 1 patient's medical record contained information from 2 other patients (Patient #2); and

2. medical records were incomplete and did not include documentation to verify that the nursing staff noted (initialed and timed) each physicians' orders, per policy (Patients #1, 2, 3, 6, and 13).

Findings include:

The hospital policy titled Completeness of a Medical Record #MR-303 (revised 04/09) required: "...The medical record will be considered complete when the entire contents...are assembled and signed...all entries requiring counter-signature are signed, and nursing documentation is complete...."

1. Patient #2 was admitted on [DATE] for a modified right radical mastectomy, and discharged on [DATE]. The closed medical record included information from 2 other discharged patients as follows: Patient #23's Authorization for Release of Protected Information, and Patient #24's Medication Administration Record.

The Director of Health Information Management Services (Medical Records) confirmed during an interview conducted on 02/09/11 at 1415, that the staff did not identify that Patient #2's medical record included 2 other patients' information.

2. The hospital policy titled Discharge and Quantitative Analysis #MR D2 (established 09/05) required, "...Physician Orders...Each order initialed and timed by RN on duty...."

Medical records did not include documentation to verify the nursing staff noted (initialed and timed) each physicians' orders, per policy, as follows:

Patient #1:

01/26/11 (0900) post anesthesia care unit (PACU) Physicians Orders
01/26/11 (1040) Pre-operative Physician orders
01/27/11 (1245) discharge

Patient #2:

02/02/11 (0900): nurse noted but did not sign/initial
02/02/11 (1251): pre-printed PACU Physician Orders
02/03/11 (not timed): lab studies
02/04/11 (0830): pain medication
02/04/11 (time illegible): lab studies
02/04/11 (1500): physical therapy

Patient #3:

01/03/11 (1800) intravenous (IV), diet, medication

The patient's Home Medication Reconciliation Order Sheet listed 8 medications. The form requires the physician's and nurse's signatures and dates, on admission and discharge (01/06/11). Neither physician nor nurse authenticated the order sheet.

12/29/10 (1800): echocardiogram
01/04/11 (1340): 2 pages of Discharge Medication Orders were documented with "VOVRB" (verbal order verified and read back). There was no documentation identifying who wrote and noted the order.
01/05/11 (1129): transfer to another hospital
01/05/11 (1240): patient status order.
01/05/11 (1300): "Parenteral Nutrition Order...For Central Lines Only"
01/05/11 (1800): medications, diet
01/06/11 (0003: pain medication

Patient #6:

A review of the medical record on 02/10/11 at 0730 hours revealed the following physician telephone orders taken at 0230 on 02/10/11: "Give Narcan 0.4 mg (milligrams) IM (intramuscularly) now...EKG now...." None of the orders had been signed by a RN per hospital policy. The medical record was immediately given to the Director of Quality accompanying the Surveyor and shown these orders. The nurse caring for the patient was alerted regarding the orders. She said the orders had already been completed in the early morning hours by the night shift nurse and she guessed the nurse forgot to sign off the orders.

Patient #13:

02/08/11 (1338): Admission Orders (pre-printed)
02/08/11 (1540): medication
02/08/11 (1630): pharmacist's medication clarification
02/08/11 (2000): medication, cardiology consultation

The Director of Quality RN #12, confirmed that the medical records were incomplete, and that insufficient nursing documentation for noting physicians' orders, was "absolutely unacceptable," during an interview conducted on 02/10/11 at 1420.
VIOLATION: PATIENT RIGHTS: RESTRAINT OR SECLUSION Tag No: A0166
**NOTE- TERMS IN BRACKETS HAVE BEEN EDITED TO PROTECT CONFIDENTIALITY**

Based on review of policies/procedures, medical records, and interviews with staff, it was determined the hospital failed to ensure the patient's plan of care was modified for 2 of 2 patients with restraints (Patients #12 and #20).

Findings include:

The hospital policy titled Restraints & Seclusion, effective 07/09, required: "...Modification to patient's Plan of Care...The plan of care should clearly reflect a loop of assessment, intervention, evaluation and re-intervention. Restraint use must be in accordance with a written modification to the patient's plan of care...."

Patient #12 was admitted on [DATE]. The medical record contained restraint order sheets titled, Physician Orders & Daily Record for Medical Restraints for 01/06/10 (sic), 01/07/11, 01/08/11, and 01/09/11.

Documentation in the medical record indicated Patient #12 was restrained on those days.

On 01/10/11, there was a blank order sheet with the date of 01/10/11 written in. The restraint order sheet did not contain any other documentation. Review of nursing notes for 01/10/11 indicated nursing documented at 0710 hours: "...bilateral wrist restraints to keep from pulling R (right) groin temp. (temporary) pacer and L (left) groin temp. HD (hemodialysis) port. L leg restrained as well for HD safety...."

The patient's plan of care was not updated to reflect restraints.

The Director of ICU/Med/Surg/Peds confirmed the findings on 02/10/11 at 1510 hours.

Patient # 20 was admitted on [DATE]. The medical record contained restraint order sheets for 01/30/11, at 2200 hours and 01/30/11 at 0900 hours. Nursing documented monitoring the patient while in restraints.

The patient's plan of care was not updated to reflect restraints.

The Director of ICU/Med/Surg/Peds confirmed the findings on 02/10/11 at 1510 hours.
VIOLATION: PATIENT RIGHTS: RESTRAINT OR SECLUSION Tag No: A0168
**NOTE- TERMS IN BRACKETS HAVE BEEN EDITED TO PROTECT CONFIDENTIALITY**

Based on review of policies/procedures, medical records, and interviews with staff, it was determined the hospital failed to require a physician's order was obtained for 2 of 2 patients reviewed for restraints (Patients #12 and #20).

Findings include:

The hospital policy titled Restraints & Seclusion, effective 07/09, required: "...Procedure For Use Of Restraint: Initiation and Renewal of Orders...Restraint orders will be documented on the 'Physician Orders & daily (sic) Record for Medical Restraints' or ' Physician Orders & Daily Record for behavioral Restraints' order sheets...."

Patient #12 was admitted on [DATE]. The medical record contained restraint order sheets titled Physician Orders & Daily Record for Medical Restraints, for 01/06/10 (sic), 01/07/11, 01/08/11, and 01/09/11.

The order sheets for 01/06/10 (sic), 01/07/11, and 01/08/11 did not contain the signature of the nurse obtaining an order from a physician, nor did it contain the name of the physician ordering the restraint. The orders were never signed by a physician. It is unclear if a physician was contacted for an order.

The order sheet for 01/09/11, indicated a nurse (not identified) took a verbal order. The nurse did not document their name, nor did they document the name of the physician giving the verbal order. It is unclear if a physician was contacted for an order.

Documentation in the medical record indicated Patient #12 was restrained on those days.

On 01/10/11, there was a blank order sheet with the date of 01/10/11 written in. The restraint order sheet did not contain any other documentation. Review of nursing notes for 01/10/11 indicated nursing documented at 0710 hours: "...bilateral wrist restraints to keep from pulling R (right) groin temp. (temporary) pacer and L (left) groin temp. HD (hemodialysis) port. L leg restrained as well for HD safety...."

The Director of ICU/Med/Surg/Peds confirmed the findings on 02/10/11 at 1510 hours.

Patient # 20 was admitted on [DATE]. The medical record contained restraint order sheets for 01/30/11, at 2200 hours and 01/30/11 at 0900 hours.

The restraint order dated 01/30/11 at 2200 hours, indicated nursing took a verbal order at this time. The nurse did not document the reason for the restraint or the type of restraint the physician ordered. The ordering physician did not sign the order or authenticate the order.

The restraint order dated 01/30/11 and timed 2200 hours by the physician signature line and dated 01/31/11 and timed 0900 hours by the nursing signature line was in the medical record. The reason for restraint and the type of restraint were not indicated on the order sheet. The Director of ICU/MS/ED/Peds could not understand the order as it contained two different dates and times on the same order sheet. The physician did not sign the order or authenticate the order.

The Director of ICU/Med/Surg/Peds confirmed the findings on 02/10/11 at 1510 hours.
VIOLATION: PATIENT RIGHTS: SECLUSION OR RESTRAINT Tag No: A0214
**NOTE- TERMS IN BRACKETS HAVE BEEN EDITED TO PROTECT CONFIDENTIALITY**

Based on review of hospital policies/procedures, documents, medical records and interviews with staff, it was determined the hospital failed to report the death of Patient #12 who was restrained.

Findings include:

Patient #12 was admitted on [DATE]. The medical record contained restraint order sheets for 01/06/10 (sic), 01/07/11, 01/08/11, and 01/09/11. Documentation in the medical record indicated Patient #12 was restrained on those days.

None of the restraint orders were complete or signed by a physician.

On 01/10/11, there was a blank order sheet with the date of 01/10/11 written in. The restraint order sheet did not contain any other documentation. Review of nursing notes for 01/10/11 indicated nursing documented at 0710 hours: "...bilateral wrist restraints to keep from pulling R (right) groin temp. (temporary) pacer and L (left) groin temp. HD (hemodialysis) port. L leg restrained as well for HD safety...."

The medical record also indicated the patient died on [DATE]. Documentation in the medical record did not indicate CMS was notified of the patient's death while in restraints.

The hospital policy titled Restraints & Seclusion, effective 07/09, was reviewed. The policy did not contain a requirement for reporting to CMS death of patients while in restraints according to 482.13(g).

The Director of ICU/Med/Surg/Peds confirmed the findings on 02/10/11 at 1510 hours, and explained that another hospital policy titled "Reportable Events" covered reporting patient deaths in restraints. The hospital was given additional time to provide this policy and as of 02/17/11, no additional policy was provided reflecting adherence to the CMS reporting requirements.
VIOLATION: QAPI Tag No: A0263
Based on observations during tour, review of hospital policies/procedures, medical records, hospital documents, and interviews, it was determined the hospital failed to comply with the provisions of the Quality Assessment and Performance Improvement Program to effectively analyze, measure and implement policies to assess processes of care, as evidenced by:

A0267: failing to implement the Ongoing Professional Practice Evaluations (OPPE) policy and procedure for the medical staff; failing to identify and analyze restraint practice problems for 2 of 2 patients audited for restraints (Patients #12, and 20); and failing to monitor and analyze the hospital process for informed consent for 8 of 12 patients (#'s 1, 2, 8, 9, 11, 14, 19, and 22) signing consents for surgical or endoscopy procedures.

The cumulative effect of these systemic deficient practices resulted in the hospital's failure to meet the requirements for the Condition of Participation for Quality Assessment and Performance Improvement.
VIOLATION: PROGRAM SCOPE, PROGRAM DATA Tag No: A0273
**NOTE- TERMS IN BRACKETS HAVE BEEN EDITED TO PROTECT CONFIDENTIALITY**

Based on review of policies/procedures, medical records, restraint audits, patient and staff interviews, it was determined the hospital failed to measure and analyze hospital processes for physician quality of care, restraint practices, and informed consent practices, as evidenced by:

1. failing to implement the Ongoing Professional Practice Evaluations/Focused Professional Practice Evaluation (OPPE/FPPE) Process for the medical staff;

2. failing to identify and analyze restraint practice problems for 3 of 3 patients audited for restraints (Patients #3, 12, and 20); and

3. failing to monitor and analyze the hospital process for informed consent for 8 of 12 patients (#'s 22, 14, 9, 11, 1, 8, 2, and 19) signing consents for surgical or endoscopy procedures.

Findings include:

1. The hospital policy titled Ongoing Professional Practice Evaluations/Focused Professional Practice Evaluation Process, effective 10/2010, required: "...Purpose:...To provide reliable, comparative data to physician(s) and non-physician providers pertaining to their performance which can improve the quality of the care they provide and identify opportunities for improvement and assist physician and non-physician providers with privileges at Valley View Medical Center. To clearly define the process utilized for facilitating the continuous evaluation of each practitioner's professional practice; To define the type of data (criteria/indicators) to be collected for the ongoing professional practice evaluation. (Note: The criteria defined for Ongoing Professional Practice Evaluation, will be utilized as screening triggers for a Focused Professional Practice Evaluation); To ensure the information resulting from the ongoing professional practice evaluation is used to determine whether to continue, limit, or revoke any existing privileges; To define the process for collecting, investigating, and addressing clinical practice concerns, including the process utilized to identify trends that impact quality of care and patient safety; To ensure reported concerns regarding a privileged practitioner's professional practice is uniformly investigated and addressed as defined by hospital policy and applicable law; To define those circumstances in which an external review of focused review may be necessary; and; To define the medical staff's leadership role in the organization's performance improvement activities related to practitioner performance and ensure that when the findings are relevant to an individual's performance, the findings in the ongoing evaluations of competence are in accordance with recognized standards...Ongoing Professional Practice Evaluation...a documented summary of ongoing data collected for the purpose of assessing a practitioner's clinical competence and professional behavior. There will be specific information collected and analyzed in order to make decisions about granting privileges. The medical staff will conduct an ongoing evaluation of each practitioner's professional performance. The information gathered during this process allows any potential problems with performance to be identified and resolved to foster a more efficient, evidenced-based privilege renewal process..Focused Professional Practice Evaluations...Renamed from Peer Review...."

The Medicine/ICU/ER/Family Practice Meeting Minutes were reviewed for March 4, 2010, which revealed the following: "...Ongoing Professional Practice Evaluation (OPPE). CNO reviewed a list of items to be monitored and reported for physician re-credentialing pursuant to Joint Commission standards. Each committee has reviewed and chosen 3-5 items for their criteria...."

The Director of Quality presented the Ongoing Professional Practice Evaluation spread sheet developed for data collection. She confirmed on 02/10/11 that the hospital has not implemented the OPPE policy and procedure and no data has been collected. She confirmed it was the responsibility of the Quality Department to collect the data identified for the OPPE evaluations.

2. The hospital policy titled Restraints & Seclusion, effective 07/09, required: "...Procedure For Use Of Restraint: Initiation and Renewal of Orders...Restraint orders will be documented on the 'Physician Orders & daily (sic) Record for Medical Restraints' or 'Physician Orders & Daily Record for behavioral Restraints' order sheets...."

The hospital policy titled Restraints & Seclusion, effective 07/09, required: "...Modification to patient's Plan of Care...The plan of care should clearly reflect a loop of assessment, intervention, evaluation and re-intervention. Restraint use must be in accordance with a written modification to the patient's plan of care...."

The hospital policy titled Restraints & Seclusion, effective 07/09, required: "...Procedure for Use Of Restraint...Initiation and Renewal of Orders...PRN orders are not permitted...."

The hospital maintained a restraint log which identified patients who were in restraints. The hospital was auditing the medical records for compliance by completing a form and addressing the questions on the form. Two patients identified on the restraint log were reviewed by the Surveyors (Patient #12, and #20). The CNO explained on 02/09/11, that it was the hospital's goal to audit all patients in restraints as soon as possible after the restraint was ordered to determine compliance.

Restraint audits had been completed on patients #12 and #20.

Patient #12 was admitted on [DATE]. The medical record contained restraint order sheets for 01/06/10 (sic), 01/07/11, 01/08/11, and 01/09/11.

The order sheets for 01/06/10 (sic), 01/07/11, and 01/08/11 did not contain the signature of the nurse obtaining an order from a physician, nor did it contain the name of the physician ordering the restraint. The orders were never signed by a physician.

The order sheet for 01/09/11, indicated a nurse (not identified) took a verbal order. The nurse did not document their name, nor did they document the name of the physician giving the verbal order.

Documentation in the medical record indicated Patient #12 was restrained on those days.

On 01/10/11, there was a blank order sheet with the date of 01/10/11 written in. The restraint order sheet did not contain any other documentation. Review of nursing notes for 01/10/11 indicated nursing documented at 0710 hours: "...bilateral wrist restraints to keep from pulling R (right) groin temp. (temporary) pacer and L (left) groin temp. HD (hemodialysis) port. L leg restrained as well for HD safety...."

The medical record also indicated the patient died on this day. Documentation in the medical record did not indicate CMS was notified of the patient's death while in restraints.

The patient's plan of care was not updated to reflect restraints.

The restraint audit tools filled out for Patient #12, on 01/31/11 and 02/01/11, indicated the night supervisor did not find any problems with the restraint documentation or orders.

The Director of ICU/MS/ER/Peds confirmed the medical record audit was not accurate and did not identify problems with Patient #12's restraints.

Patient # 20 was admitted on [DATE]. The medical record contained restraint order sheets for 01/30/11, at 2200 hours and 01/30/11 at 0900 hours.

The restraint order dated 01/30/11 at 2200 hours, indicated nursing took a verbal order at this time. The nurse did not document the reason for the restraint or the type of restraint the physician ordered. The ordering physician did not sign the order or authenticate the order.

The restraint order dated 01/30/11 and timed 2200 hours by the physician signature line and dated 01/31/11 and timed 0900 hours by the nursing signature line was in the medical record. The reason for restraint and the type of restraint were not indicated on the order sheet. The Director of ICU/MS/ED/Peds could not understand the order as it contained two different dates and times on the same order sheet. The physician did not sign the order or authenticate the order.

The patient's plan of care was not updated to reflect restraints.

The night supervisor audited Patient #20's medical record for restraints on 4 different days, 01/07/11, 01/08/11, 01/09/11, and 01/10/11. Problems were found on the 01/07/11 audit tool. The audit tool dated 01/08/11 indicated the initial restraint order was not obtained immediately when applied, but also added it had been corrected and action taken. The audits for 01/09/11 and 01/10/11 did not find any problems with restraints.

The Director of ICU/MS/ER/Peds confirmed the medical record audit was not accurate and did not identify problems with Patient #20's restraints.

The Quality Director confirmed on 02/10/11, that the hospital was conducting audits of patients restrained and patients identified on the restraint log were reviewed. All patient records contained deficiencies regarding restraint practice. Audits did not identify problems, therefore, actions were not taken by the hospital to remedy the deficient practices. The Quality Department reported that the Chief Nursing Officer collected information regarding restraints, however, the Quality Department did not have any reported data regarding restraints.

3. See citation at A0131: 482.13(b)(2).

Patient #22 signed a surgical consent for a carotid-subclavian bypass and Physician #1 performed a carotid endarterectomy;

Patient #14 signed a surgical consent with the possibility of an optional procedure not explained to the patient, nor ordered by the physician;

Patient #9 signed a surgical consent with the possibility of an optional technique not explained to the patient, nor ordered by the physician;

Patient #11 signed a consent that was different than the physician ordered;

Patients #1 and #8 signed surgical consents with the possibility of an optional technique not ordered by the physician; and

Patients #2 and #19 signed consents that were identified on the surgery scheduling form as the planned procedure, not a physician order.

The Quality Department confirmed the hospital was "looking at" consents within the Surgery Department. The Quality Department did not have data submitted regarding consents and the Quality Department did not have a reporting requirement for the Surgery Department to report data and actions taken to remedy identified problems. See citation at 482.21(a)(2).
VIOLATION: PATIENT SAFETY Tag No: A0286
**NOTE- TERMS IN BRACKETS HAVE BEEN EDITED TO PROTECT CONFIDENTIALITY**

Based on review of policies/procedures, medical records, restraint audits, patient and staff interviews, it was determined the hospital failed to measure and analyze hospital processes for physician quality of care, restraint practices, and informed consent practices, as evidenced by:

1. failing to implement the Ongoing Professional Practice Evaluations/Focused Professional Practice Evaluation (OPPE/FPPE) Process for the medical staff;

2. failing to identify and analyze restraint practice problems for 3 of 3 patients audited for restraints (Patients #3, 12, and 20); and

3. failing to monitor and analyze the hospital process for informed consent for 8 of 12 patients (#'s 22, 14, 9, 11, 1, 8, 2, and 19) signing consents for surgical or endoscopy procedures.

Findings include:

1. The hospital policy titled Ongoing Professional Practice Evaluations/Focused Professional Practice Evaluation Process, effective 10/2010, required: "...Purpose:...To provide reliable, comparative data to physician(s) and non-physician providers pertaining to their performance which can improve the quality of the care they provide and identify opportunities for improvement and assist physician and non-physician providers with privileges at Valley View Medical Center. To clearly define the process utilized for facilitating the continuous evaluation of each practitioner's professional practice; To define the type of data (criteria/indicators) to be collected for the ongoing professional practice evaluation. (Note: The criteria defined for Ongoing Professional Practice Evaluation, will be utilized as screening triggers for a Focused Professional Practice Evaluation); To ensure the information resulting from the ongoing professional practice evaluation is used to determine whether to continue, limit, or revoke any existing privileges; To define the process for collecting, investigating, and addressing clinical practice concerns, including the process utilized to identify trends that impact quality of care and patient safety; To ensure reported concerns regarding a privileged practitioner's professional practice is uniformly investigated and addressed as defined by hospital policy and applicable law; To define those circumstances in which an external review of focused review may be necessary; and; To define the medical staff's leadership role in the organization's performance improvement activities related to practitioner performance and ensure that when the findings are relevant to an individual's performance, the findings in the ongoing evaluations of competence are in accordance with recognized standards...Ongoing Professional Practice Evaluation...a documented summary of ongoing data collected for the purpose of assessing a practitioner's clinical competence and professional behavior. There will be specific information collected and analyzed in order to make decisions about granting privileges. The medical staff will conduct an ongoing evaluation of each practitioner's professional performance. The information gathered during this process allows any potential problems with performance to be identified and resolved to foster a more efficient, evidenced-based privilege renewal process..Focused Professional Practice Evaluations...Renamed from Peer Review...."

The Medicine/ICU/ER/Family Practice Meeting Minutes were reviewed for March 4, 2010, which revealed the following: "...Ongoing Professional Practice Evaluation (OPPE). CNO reviewed a list of items to be monitored and reported for physician re-credentialing pursuant to Joint Commission standards. Each committee has reviewed and chosen 3-5 items for their criteria...."

The Director of Quality presented the Ongoing Professional Practice Evaluation spread sheet developed for data collection. She confirmed on 02/10/11 that the hospital has not implemented the OPPE policy and procedure and no data has been collected. She confirmed it was the responsibility of the Quality Department to collect the data identified for the OPPE evaluations.

2. The hospital policy titled Restraints & Seclusion, effective 07/09, required: "...Procedure For Use Of Restraint: Initiation and Renewal of Orders...Restraint orders will be documented on the 'Physician Orders & daily (sic) Record for Medical Restraints' or 'Physician Orders & Daily Record for behavioral Restraints' order sheets...."

The hospital policy titled Restraints & Seclusion, effective 07/09, required: "...Modification to patient's Plan of Care...The plan of care should clearly reflect a loop of assessment, intervention, evaluation and re-intervention. Restraint use must be in accordance with a written modification to the patient's plan of care...."

The hospital policy titled Restraints & Seclusion, effective 07/09, required: "...Procedure for Use Of Restraint...Initiation and Renewal of Orders...PRN orders are not permitted...."

The hospital maintained a restraint log which identified patients who were in restraints. The hospital was auditing the medical records for compliance by completing a form and addressing the questions on the form. Two patients identified on the restraint log were reviewed by the Surveyors (Patient #12, and #20). The CNO explained on 02/09/11, that it was the hospital's goal to audit all patients in restraints as soon as possible after the restraint was ordered to determine compliance.

Restraint audits had been completed on patients #12 and #20.

Patient #12 was admitted on [DATE]. The medical record contained restraint order sheets for 01/06/10 (sic), 01/07/11, 01/08/11, and 01/09/11.

The order sheets for 01/06/10 (sic), 01/07/11, and 01/08/11 did not contain the signature of the nurse obtaining an order from a physician, nor did it contain the name of the physician ordering the restraint. The orders were never signed by a physician.

The order sheet for 01/09/11, indicated a nurse (not identified) took a verbal order. The nurse did not document their name, nor did they document the name of the physician giving the verbal order.

Documentation in the medical record indicated Patient #12 was restrained on those days.

On 01/10/11, there was a blank order sheet with the date of 01/10/11 written in. The restraint order sheet did not contain any other documentation. Review of nursing notes for 01/10/11 indicated nursing documented at 0710 hours: "...bilateral wrist restraints to keep from pulling R (right) groin temp. (temporary) pacer and L (left) groin temp. HD (hemodialysis) port. L leg restrained as well for HD safety...."

The medical record also indicated the patient died on this day. Documentation in the medical record did not indicate CMS was notified of the patient's death while in restraints.

The patient's plan of care was not updated to reflect restraints.

The restraint audit tools filled out for Patient #12, on 01/31/11 and 02/01/11, indicated the night supervisor did not find any problems with the restraint documentation or orders.

The Director of ICU/MS/ER/Peds confirmed the medical record audit was not accurate and did not identify problems with Patient #12's restraints.

Patient # 20 was admitted on [DATE]. The medical record contained restraint order sheets for 01/30/11, at 2200 hours and 01/30/11 at 0900 hours.

The restraint order dated 01/30/11 at 2200 hours, indicated nursing took a verbal order at this time. The nurse did not document the reason for the restraint or the type of restraint the physician ordered. The ordering physician did not sign the order or authenticate the order.

The restraint order dated 01/30/11 and timed 2200 hours by the physician signature line and dated 01/31/11 and timed 0900 hours by the nursing signature line was in the medical record. The reason for restraint and the type of restraint were not indicated on the order sheet. The Director of ICU/MS/ED/Peds could not understand the order as it contained two different dates and times on the same order sheet. The physician did not sign the order or authenticate the order.

The patient's plan of care was not updated to reflect restraints.

The night supervisor audited Patient #20's medical record for restraints on 4 different days, 01/07/11, 01/08/11, 01/09/11, and 01/10/11. Problems were found on the 01/07/11 audit tool. The audit tool dated 01/08/11 indicated the initial restraint order was not obtained immediately when applied, but also added it had been corrected and action taken. The audits for 01/09/11 and 01/10/11 did not find any problems with restraints.

The Director of ICU/MS/ER/Peds confirmed the medical record audit was not accurate and did not identify problems with Patient #20's restraints.

The Quality Director confirmed on 02/10/11, that the hospital was conducting audits of patients restrained and patients identified on the restraint log were reviewed. All patient records contained deficiencies regarding restraint practice. Audits did not identify problems, therefore, actions were not taken by the hospital to remedy the deficient practices. The Quality Department reported that the Chief Nursing Officer collected information regarding restraints, however, the Quality Department did not have any reported data regarding restraints.

3. See citation at A0131: 482.13(b)(2).

Patient #22 signed a surgical consent for a carotid-subclavian bypass and Physician #1 performed a carotid endarterectomy;

Patient #14 signed a surgical consent with the possibility of an optional procedure not explained to the patient, nor ordered by the physician;

Patient #9 signed a surgical consent with the possibility of an optional technique not explained to the patient, nor ordered by the physician;

Patient #11 signed a consent that was different than the physician ordered;

Patients #1 and #8 signed surgical consents with the possibility of an optional technique not ordered by the physician; and

Patients #2 and #19 signed consents that were identified on the surgery scheduling form as the planned procedure, not a physician order.

The Quality Department confirmed the hospital was "looking at" consents within the Surgery Department. The Quality Department did not have data submitted regarding consents and the Quality Department did not have a reporting requirement for the Surgery Department to report data and actions taken to remedy identified problems. See citation at 482.21(a)(2).
VIOLATION: MEDICAL STAFF Tag No: A0338
Based on review of hospital policies, procedures, medical staff peer review, medical staff bylaws rules and regulations, and interviews, it was determined the hospital failed to comply with the provisions of Medical Staff Services, as evidenced by:

A0347: failure to assume responsibility for the quality of care provided to patients by Physician #1; and failure to implement the policy titled Ongoing Professional Practice Evaluations/Focused Professional Practice Evaluation Process, for the medical staff; and

A0353: failure to require the departments of the medical staff had written rules and regulations which governed the activities of the departments as required by the medical staff bylaws; failure to require the privileges granted for the medical staff were specific and defined for the hospital medical staff and personnel for (Physician #1); failure to require the medical staff implemented the medical staff bylaws for appointing members to the medical staff, requiring the Department Chairperson review physicians' applications and recommend the physicians for appointment of clinical privileges (Physicians #1, #2, #3, and #6); and failure to require a physician did not order restraints on an as needed (PRN) basis for patient #3.

The cumulative effect of these systemic deficient practices resulted in the hospital's failure to meet the requirements for the Condition of Participation for Medical Staff.
VIOLATION: MEDICAL STAFF ACCOUNTABILITY Tag No: A0347
Based on review of hospital policies, procedures, medical staff peer review policy and interview with staff, it was determined that the medical staff was not accountable to the governing authority for:

1. the quality of care provided to patients by Physician #1; and

2. the hospital has not implemented the policy titled Ongoing Professional Practice Evaluations/Focused Professional Practice Evaluation Process for the medical staff.

Findings include:

See citation under Governing Body A0049: 482.12(a)(5)
VIOLATION: MEDICAL STAFF BYLAWS Tag No: A0353
**NOTE- TERMS IN BRACKETS HAVE BEEN EDITED TO PROTECT CONFIDENTIALITY**

Based on review of the medical staff bylaws, hospital documents, and interview with staff, it was determined the medical staff failed to implement the bylaws, as evidenced by failing to require:

1. the departments of the medical staff had written rules and regulations which governed the activities of the departments;

2. the privileges granted for the medical staff were specific and defined for the hospital medical staff and personnel (Physician #1);

3. the hospital Department Chairperson(s) reviewed physicians' applications and recommended the physicians for appointment of clinical privileges (Physicians #1, #2, #3, and #6); and

4. a physician did not order restraints on an as needed (PRN) basis for patient #3.

Findings include:

1. The medical staff bylaws adopted in 2006 and current, required: "...Article XII Clinical Services...Departments & Services...Family Practice...Surgery...Organization of Department...All organized departments shall have written rules and regulations which govern the activity of the department. These rules and regulations shall be approved by the Governing Board. The exercise of clinical privileges within any department is subject to the departmental rules and regulations and the the authority of the Department Chairperson...."

The Surveyors requested the Departmental Rules and Regulations of each department of the medical staff, the CNO confirmed that the hospital did not have medical staff departmental rules and regulations. The CEO explained on 02/10/11, that the hospital would just remove that requirement from the medical staff bylaws and not require departmental rules.

2. The hospital Medical Staff Bylaws approved 2006 and current, required: "...Article VII Determination of Clinical Privileges...Exercise of Privileges: Every practitioner providing direct clinical services at this hospital shall...be entitled to exercise only those clinical privileges or services specifically granted to him/her by the Board...."

Physician #1's credential file contained a form titled Request For Privileges--General Surgery which contained a list of surgical procedures that the physician had requested for privileges. The form required that the physician place a checkmark by the privileges requested. The procedures were typed in for the physician to check. Physician #1 requested the following general surgical procedure, Extra Thoracic Vascular Surgery and the following Thoracic & Cardiovascular surgical procedures, Arterial Grafts, Carotid Surgery.

The person responsible for scheduling surgical procedures was interviewed on 01/05/11 at 0945 hours. The scheduler could not name the procedures that were included under "Carotid Surgery." When asked if that included Carotid Subclavian Bypass surgery she could not answer and could not define what procedures were included with Carotic Surgery privileges.

The CNO and Chief of Staff, both confirmed on 01/05/11, at 1300 hours, the form titled Request For Granting Privileges--General Surgery was vague and they could not define what surgeries could be included under Carotid Surgery, Extra Thoracic Vascular Surgery, and Esophageal Surgery.

3. The medical staff bylaws approved and current since 2006, required: "...Article VI Procedures For Appointment & Reappointment...Recommendation of Department Chairperson...The Chairperson of the appropriate department shall review the application, the supporting documentation, reports and recommendations, and such other relevant information available to him/her, and shall transmit to the Credentials Committee on the prescribed form a written report and recommendation as to staff appointment and, if appointment is recommended, clinical privileges to be granted and any specific conditions to be attached to the appointment...."

Reviews of Physician #1, #2, #3, and #6's credential files were conducted.

The credential files included a form titled Recommendations, which required four signatures to recommend a physician for the requested privileges. The forms for Physician #1, #2, #3, and #6 did not include a signature representing review by the Department Chairperson, as required by the medical staff bylaws.

The CNO confirmed on 01/06/11, that the Department Chairperson did not sign the Recommendations form and indicated that the hospital had reinstituted the requirement for the Department Chairperson to review the appointment and reappointment recommendations.

4. The medical staff bylaws, rules and regulations approved and current since 2006, required: "...Patient Restraint Orders...PRN orders may not be used to authorize use of restraint...."

The hospital policy titled Restraints & Seclusion, effective 07/09, required: "...Procedure for Use Of Restraint...Initiation and Renewal of Orders...PRN orders are not permitted...."

Patient #3, (MDS) dated [DATE], with complaints of shortness of breath and weakness. The physician ordered, "...Soft bilat (bilateral) wrist restraints if needed..." on 12/28/10 at 2208.

The Director of Quality RN #12 confirmed the PRN order during an interview conducted on 02/09/11.
VIOLATION: MEDICAL RECORD SERVICES Tag No: A0431
Based on review of hospital policies/procedures, medical records, and interviews, it was determined the hospital failed to comply with the provisions of Medical Records, related to requiring adequate staff, and complete records, as evidenced by:

A0432: failure to require adequately trained personnel were employed to ensure prompt completion of medical records; and

A0450: failure to require all medical record entries were legible, complete, dated, timed, and authenticated by the persons responsible for providing or evaluating services provided.

The cumulative effect of these systemic deficient practices resulted in the hospital's failure to meet the requirements for the Condition of Participation for Medical Records.
VIOLATION: ORGANIZATION AND STAFFING Tag No: A0432
Based on review of hospital policies/procedures, medical records, and interviews, it was determined the hospital's Medical Record department failed to employ adequate personnel to ensure complete and accurate medical records, as demonstrated by:

1. failure to require adequately trained staff;

2. failure to require job descriptions delineated duties; and

3. failure to require department specific performance evaluations.

Findings include:

1. One (1) of 2 personnel files of employees who identified themselves as performing the duties of Medical Record Analysts during interviews conducted on 02/09/11, revealed the following:

HIMS Clerk #3, date of hire 08/10, has no documented experience specific to medical records. The employee is provided on-the-job-training. The Clerk stated: "...if (HIMS Clerk #2) or (HIMS Clerk #6) weren't here, I wouldn't know what to look for..." during an interview conducted on 02/09/11.

The hospital's Medical Record Department employs 4 personnel performing the duties of Medical Records Analyst, according to staff interviewed on 02/09/11.

HIMS Clerk #2, stated that besides herself and (HIMS Clerk #4), "...no one else has medical record experience..." during an interview conducted on 02/09/11 at 1030. The personnel file documented extensive experience in all areas of HIMS, as well as certifications, education, and training related to HIMS.

HIMS Clerk #4, is a registered Information Technologist, according to the personnel file. The Clerk stated: "...we all kind of help each other - I do very little training...I don't train the analysts..." during an interview conducted on 02/0911 at 1030.

2. HIMS Clerk #2, stated: "...The Director has never sat down with anyone about their job or what they do...everyone is a clerk - we don't have job descriptions...there is no job description or policy that tells us what to look for...I'm doing this (assigned duties) by experience..." during an interview conducted on 02/09/11 at 1030.

HIMS Clerk #3's Position Description describes: "...filing of all medical records, responds to external inquiries for medical records...retrieves information from computer for the HIMS Department and other departments as needed, purges files, supports other department employees in their tasks as trained...performs other duties as assigned...Required Experience: N/A (not applicable)...." The job description did not identify specific tasks.

The Clerk stated during an interview conducted on 02/09/11, that she analyzes patients' medical records to ensure completeness, and to identify deficiencies related to required documented histories/physicals, signed progress notes, signed physicians' orders, admission diagnoses, and discharge summaries.

Both Clerks described themselves as medical record analysts.

The Director of Health Information Management Services (HIMS) #1 stated: "all employees are considered clerks so that they can help one another and no one is compartmentalized" during an interview conducted on 02/09/11. She however confirmed that the department had no policy/procedure or organized education process that identified and described the specific tasks required of the staff.

3. The Medical Records Annual Competency Overview, dated 06/17/10, is the employee check list for demonstrating competencies related to infection control, fire safety, emergency codes, equipment operation, medical records filing and "signing out."

The Director of HIMS #1 confirmed that the required annual competencies did not identify or include tasks specific to employees of the medical record department, in order to demonstrate that the services provided were evaluated, and performed adequately.
VIOLATION: SURGICAL SERVICES Tag No: A0940
Based on review of hospital policies/procedures, medical records, and interviews, it was determined the hospital failed to comply with the provisions of Surgical Services, related to informed consents as evidenced by:

A0955: patient #22 signed a surgical consent for a carotid-subclavian bypass and Physician #1 performed a carotid endarterectomy; patient #14 signed a surgical consent with the possibility of an optional procedure not explained to the patient, nor ordered by the physician; patient #9 signed a surgical consent with the possibility of an optional technique not explained to the patient, nor ordered by the physician; patient #11 signed a consent that was different than the physician ordered; patients #1 and #8 signed surgical consents with the possibility of an optional technique not ordered by the physician; and patients #2 and #19 signed consents that were identified on the surgery scheduling form as the planned procedure, not a physician order.

The cumulative effect of these systemic deficient practices resulted in the hospital's failure to meet the requirements for the Condition of Participation for Surgical Services.
VIOLATION: INFORMED CONSENT Tag No: A0955
Based on review of hospital policies/procedures, medical records, and interviews, it was determined the hospital failed to demonstrate that 8 of 12 patients (#'s 1, 2, 8, 9, 11, 14, 19, and 22) signing consents for surgical or endoscopy procedures had properly executed informed consent, to ensure that the patient, or the patient's representative, is provided information necessary to enable him/her to evaluate a proposed surgery before agreeing to the surgery, as evidenced by:

1. patient #22 signed a surgical consent for a carotid-subclavian bypass and Physician #1 performed a carotid endarterectomy;

2. patient #14 signed a surgical consent with the possibility of an optional procedure not explained to the patient, nor ordered by the physician;

3. patient #9 signed a surgical consent with the possibility of an optional technique not explained to the patient, nor ordered by the physician;

4. patient #11 signed a consent that was different than the physician ordered;

5. patients #1,and #8, signed surgical consents with the possibility of an optional technique not ordered by the physician; and

6. patients #2 and #19 signed consents that were identified on the surgery scheduling form as the planned procedure, not a physician order.

Findings include:

See citation A0131 Patient Rights 482.13(b)(2).