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Based on review of facility documents, medical records, and interviews, it was determined the govering body had not been effective in carrying out the functions of the hospital as evidenced by the failure of the hospital to be in compliance with the Conditions of Participation for Quality Management Performance Improvement, Patient Rights, and Medical Staff.

Findings:

Refer to the following:

Tag A 115 CFR 482.13 Patient Rights
Tag A 263 CFR 482.21 QAPI
Tag A 340 CFR 482.22 Medical Staff

The cumulative effect of these systemic problems resulted in the hospital's governing board being ineffective with the performance of the healthcare team posing a potential risk to patients medical care and treatment.

Based on a review of medical records, policies and procedures, and interviews, it was determined the hospital failed to promote patient rights as evidenced by the following references to standard level deficiencies in six of nine records reviewed for informed consent and in six of six records reviewed for restraints:

Tag A123; 482.13(a)(2)(iii) Patient Rights: Notice of Grievance Decision: Failed to require that the policy and procedure for submitting a grievance was followed as evidenced in the failure to have a process to know of all grievances filed within the Risk Management department and the Patient Relations department and to address and evaluate grievances submitted and/or to respond to the complainant once the investigation is completed in two of four records reviewed for grievances. (Patient #51 and 49)

Tag A 131; 482.13(b)(2) Patient Rights: Informed Consent: Failed to require that physicians signed informed consents, according to policy for 6 of 8 informed consents reviewed.. (Patient #3, 53, 56, and 63.

Tag A 164; 482.13(e)(2) Patient Rights: Restraint or Seclusion: Failed to require that hospital personnel and medical staff followed the approved policies and procedures for restraints by documenting the alternative interventions that were initiated and the results of the use of those alternatives. (Patient #49)

Tag A 166; 482.13(e)(4)(i) Patient Rights: Restraint or Seclusion: Failed to use restraints in accordance with a written modification of the patient's plan of care. (Patient #11, 6, 3, and 21)

Tag A 168 ;482.13(e)(5) Patient Rights: Restraint or Seclusion: Failed to require that hospital personnel and medical staff followed the approved policies and procedures for restraints, as evidenced by the failure to require an order was documented for each patient in restraints in 4 of 4 records reviewed for physician orders for restraints. (Patient #11, 6, 3, and 21);

Tag A 169; 482.13(e)(6) Patient Rights: Restraint or Seclusion: Failed to ensure the written order for the use of a restraint was never written on an as needed basis (PRN) as evidenced in Patient #63.

Tag A 174; 482.13(e)(9) Patient Rights: Restraint or Seclusion: Failed to discontinue restraints at the earliest possible time on a patient whom the RN (registered nurse) documented the patient was unresponsive. (Patient #49)

Tag A 214; 482.13(g)Patient Rights: Seclusion or Restraint: Failed to report deaths of patients while in restraints in two of two records reviewed for restraints and deaths. (Patient #11, 49, and 21)

The cumulative effect of these systemic problems resulted in the hospital's governing board being ineffective with carrying out the rights of each patient for informed consents and restraints.

Based on a review of medical record, policy and procedure, and interview, the Department determined the Administrator failed to require that the policy and procedure for submitting a grievance was followed as evidenced in the failure to have a process to know of all grievances filed within the Risk Management department and the Patient Relations department and to address and evaluate grievances submitted and/or to respond to the complainant once the investigation is completed in two of four records reviewed for grievances. (Patient #51 and 49)

Findings include:

The hospital policy, "Patient Grievance Complaint" requires: "... Each hospital must investigate and respond to each Complaint and Grievance as promptly as possible as specified by this policy... Monitoring... Hospital must have an effective procedure for periodically monitoring an analyzing complaints and grievances...."

On 01/05/10, the Director of Quality Management (QM) stated all complaints are either filed with Patient Relations Department or with the Risk Manager. She stated if patients/family/visitors file a complaint it is usually with the Patient Relations Department. She stated if a complaint/occurrence is filed internally, via the computer system, it is with the Risk Manager.

Patient #51 The Director of Quality Management confirmed Patient Relations has no record of a complaint filed on behalf of Patient #51.

The Director of Quality Management was unable to confirm if a complaint was filed with the Risk Manager. The Risk Manager was not available for interview and was not present during the survey. On 01/08/2010 the Director of Quality Management was asked if the Risk Manager would be available or if the hospital could contact the Risk Manager to determine if there was documentation and the Director revealed that this would not be possible.

Interview with the patient revealed the patient had filed a complaint about the failure of the patient being assessed in the ED.

The Director of Quality Management confirmed the QM is unable to effectively monitor and analyze complaints and grievances accepted by the Risk Manager, since they are unable to determine if there was a complaint filed on behalf of Patient #51.

The hospital did not have a process in place to ensure that all grievances were recorded and followed up on between the risk management department and the patient relations department.

Patient #49's hospital documentation revealed the hospital had received a formal letter of concern related to Patient #49's care and services during the hospitalization of October 4 - 6, 2008. The hospital received a two page letter addressing the specifics of the concern.

The hospital provided documentation that the risk manager had spoken with the author of the complaint letter on September 3, 2009. The letter from the complainant was dated September 1, 2009.

The documentation provided to the surveyor indicated that peer review was completed and there was no quality of care concerns found. This peer review is dated as 01/06/2010 for the medical review and 01/12/2010 for the surgical review. These were both dated after the surveyors entered the hospital to complete the complaint investigation.

There was no further documentation of communication with the complainant who submitted to the facility the letter of concern from the date of the letter, September 1, 2009 the to date of the exit of this survey 01/21/2010.

Based on review of hospital policies/procedures, patient medical records, and interview with staff, it was determined that the administrator failed to require that physicians signed informed consents, according to policy for 6 of 8 informed consents reviewed forPatient #3, 53, 56, and 63.

Findings include:

The hospital policy titled Informed Consent (last revision 06/08) requires: "...the physician who performs or orders the treatment or procedure is personally responsible for ensuring that the informed consent process has taken place and that the patient has consented to the treatment or procedure...'Written Informed Consent' means that the patient and physician have signed a document...requires informed consent to be in writing...the hospital must verify that written informed consent is in the patient's record before permitting the procedure to be performed...The physician must obtain the patient's informed consent before the procedure is administered...."

Medical records identified were reviewed with the hospital personnel, Medical Director, and Director of Medical Records throughout the survey process from 01/05/2010 through 01/08/2010. It was identified in the medical record reviews that patients were taken to surgery without the informed consent form being signed by the physician as required by the hospital policy and procedure.

Patient #3's Informed Consent for the Coronary Artery Bypass Graft surgical procedure was signed by the patient on 10/27/09 at 2245. The physician signed the consent (electronic signature) on 12/06/09 at 0932, 6 weeks after the procedure.

The findings were verified by the Medical Director and the CEO during the medical record review and interviews conducted on 01/07/10.

Patient #53's Informed Consent form for an ultrasound guided paracentesis was signed by the patient on 12/30/09 and the procedure was performed on 12/30/09. The consent form revealed the physician signed the form on 12/31/09 one day after the procedure.

The informed consent for a Tracheostomy was signed by the patient's mother on 12/28/09 at 1815. At the time of the survey 01/05/2010 the consent form had not been authenticated or signed by the physician.

The informed consent for a peripheral line insertion was documented as having received consent via telephone from a family member on 12/19/09 at 1335. There was no documented evidence of the physician providing informed consent as of the time of the record review on 01/06/2010, 17 days after the procedure was performed.

Patient #56's informed consent for Coronary Artery Bypass Graft revealed the patient and the registered nurse signed the form on 01/05/2010 at 2325. There was no documented evidence of a physician signature on the form at the time of the survey review on 01/06/2010. The procedure was performed without the physician's signature on the form. The surgical checklist dated 01/05/2010 indicated the consent was on the chart and signed.

Patient #63's Informed Consent for invasive cardiovascular laboratory study revealed the patient signed the consent at 1300 on 11/24/09 and the physician authenticated the informed consent on 01/05/2010, 42 days after the procedure was performed.

The Director of Surgical Services confirmed during an interview on 01/06/2010 the operating room staff were considering the consent completed without the signature or authentication by the physician.

Based on a review of the medical records both concurrent and retrospective, policy and procedure, and interview, it was determined the administrator failed to require that hospital personnel and medical staff followed the approved policies and procedures for restraints by documenting the alternative interventions that were initiated and the results of the use of those alternatives. (Patient #49)

Findings include:

The hospital policy revealed under assessment that the use of the restraint is based on the assessed needs of the patient. The policy revealed the following: "... The use of restraint is to occur only after all non-physical restraint alternatives to such use have been considered and attempted as appropriate. Such alternatives include, but are not limited to: re-orientation ... De-escalation ... Limit Setting ... Increased observation and monitoring ... Use of a sitter ... Change in the patient's physical environment ,,, Review and modification of medication regimens. The lease restrictive, safe, and effective method of restraint is to be used. Restraint use is to be discontinued when there is no longer adequate and appropriate justification for use. The nursing assessment and plan of care will be documented in the patient's medical record...."

Patient #49's medical record revealed the RN documented in the nursing narrative notes on 10/05/08 at 0630 the patient was "restrained". The nursing narrative documentation at 1330 on 10/05/08 revealed the patient returned from the operating room and the patient was in restraints, "no spontaneous movement noted at this time, Pt non responsive to commands or stimuli at this time". The nursing documentation indicated the patient remained in restraints at 1430 and 1700 the nursing assessment was that the patient remained unresponsive.

There was no documented evidence the nursing personnel assessed the patients condition related to the need for restraints when the patient was unresponsive.

On 10/05/08 there was a order for the patient to be in restraints. The signature of the individual ordering is not legible and was timed at 5:38 PM.

The medical record was reviewed with the Director of Intensive Care and confirmed the patient was unresponsive and remained in restraints.

Based on the review of records and policy and procedure, it was determined the hospital failed to use restraints in accordance with a written modification of the patient's plan of care.Patient #11, 6, 3, and 21)


Findings include:

The hospital approved policy and procedure on restraints included the patient's care plan would be utilized and adjusted when restraints are identified as the method to keep the patient safe.

The medical records of all patients who were restrained Patient #11, 6, 3, and 21)
revealed the RN (registered nurse) failed to adjust the patient's plan of care when there was restraints in use. There was no documented evidence in the care plans of alternative interventions that may or may not be effective as an alternative to the use of restraints.

For example: Patient #21's medical record revealed the plan of care was initiated on 05/05/09 and identified physical mobility, sensory/perceptual, cardiovascular, and respiratory function. The patient was admitted to the intensive care unit and deteriorated throughout the hospital stay and expired on 05/08/09. The patient was restrained during the hospitalization from 05/06/09 through the time of death and this was not included in the patient's plan of
care documentation.

Based on a review of the medical records both concurrent and retrospective, policy and procedure, and interview, the Department determined the administrator failed to require that hospital personnel and medical staff followed the approved policies and procedures for restraints, as evidenced by the failure to require an order was documented for each patient in restraints in 4 of 4 records reviewed for physician orders for restraints. (Patient #11, 6, 3, and 21);

Findings include:

The hospital policy and procedure revealed: "... Restraints may only be used if needed to improve the patient's well-being AND less restrictive interventions have been determined to be ineffective in protecting the patient or others from harm...decisions regarding the use of restraints are discussed with them...."

The policy identified that for patient safety, to prevent harm to self or others, a RN may initiate a restraint, but must obtain a physician order, verbal or written, as soon as possible but within no later than twelve (12) hours and the physician must do a face-to-face assessment within 12 hours. The physician must document the assessment in the patient's medical record. The order is time limiting and expires in 24 hours. For continued use of restraints beyond the first 24 hours, the physician must either renew the original order or issue a new order documenting the clinical justification based on his or her examination. The procedure indicated: "... Documentation of Reassessments and Alternatives attempted will be completed on Physician Restraint Order/Observation From...Healthcare providers with direct patient contact will have on-going education and training in the proper and safe use of restraint application and removal techniques. This training will occur prior to any application of restraint...."

Patient #11: The restraint form dated 05/16/09 at 0140, revealed a physician's verbal order. The physician's signature however was not authenticated with a date or time. In addition, there was no documented evidence of a physician evaluation of the patient.

Patient #6: The physician's telephone orders were: 04/21/09 1945: "...wrist restraints bilat (bilateral)...." (initial restraint order)...04/22/09 1930: "...wrist restraints bilat (bilateral) PRN (as needed) (illegible)...."

The nursing staff documented: 04/21/09 (2030) restraints placed; 04/21/09 (2300) restraints removed...patient sleeping; 04/22/09 (0400) restraints reapplied, "sitter at bedside", patient pulling at lines (IVs) and disoriented; 04/22/09 (0600) through 04/22/09 (1830) restraints in place; 04/22/09 (2230), (2100) and (2200) restraints in place; No restraint documentation 04/22/09 (2200) through 04/23/09 (0400; 04/23/09 (0500) restraints in place; 04/23/09 (0900) "no restraints applied;" 04/23/09 (1700) restraints were discontinued.

There was no documentation to verify that the nursing staff obtained a new physician's order for each event requiring restraints. In addition, the CNO (Chief Nursing Officer) explained during an interview conducted on 01/07/2010, that when the physician writes a restraint order, it indicates that the physician has actually seen the patient and has determined that s/he requires restraints, there was no documentation to conclude that the physician had actually seen the patient when the telephone orders were received.

Patient #3: Bilateral wrist restraints were applied on 10/23/09 at 1500, and discontinued at 2350. The Medical ...Restraint Assessment and Order record dated 10/23/09, did not include documentation of the following elements (required on the form): Indications for Restraint Use; Restraint Alternatives Attempted; and Restraint Type and Location.

There was no documented evidence the physician evaluated the patient and ordered the appropriate restraint with consideration of the least restrictive alternatives.

Patient #21 was admitted to the hospital on 05/06/09 with an admitting diagnosis of sepsis, acute respiratory failure, acute renal failure, possible seizure activity, hyponatremia, and leukocytosis. The discharge diagnosis was massive cerebrovascular accident, multisystem organ failure, ventilator-dependent respiratory failure, and acute renal failure.

On 05/06/09 the scanned medical record revealed a restraint order form that had the following areas blank. The time the restraint was applied, time the physician assessed the patient, application of restraint, and order written by physician. The attending physician signed the order form with a date of 05/06/09 with no time of the signature.

The medical record revealed there was a restraint order form dated 05/08/09 that was not completed with the time the restraint was applied, time of physician assessment or verbal order. The form was documented as being authenticated by the attending physician on 05/15/09 at 7:45 am.

Based on review of policy and procedure, record review, and interview, it was determined that the hospital failed to ensure the written order for the use of a restraint was never written on an as needed basis (PRN) as evidenced in Patient #63.

Findings include:

The hospital's policy and procedure #NUR.0003, entitled Restraints and Alternatives, revealed, in part: "Procedure...Physician Orders - For use of a restraining Device for Acute Medical/Surgical Care: 1. For patient safety, to prevent harm to self or others, a (sic) RN may initiate a restraint, but must obtain a physician order, verbal or written, as soon as possible but within no later than twelve hours....The order is time limiting and expires in 24 hours....Attachment A...No PRN orders ....Attachment B...No PRN orders...."

Patient #63's record was chosen for review from the November and December, 2009 ICU (intensive care unit) Restraint and Alternatives Monitoring Log. This Log revealed that Patient #63 was on "Medical Restraints" using "Chemical Restraint Ativan PRN."

Patient #63 presented to the Emergency Department (ED), via air transport, on 11/22/09 at 9:26 a.m. in "Acute Respiratory Failure." The patient was intubated with an endotracheal tube, in the ED, as "the patient agreed he had no strength to continue breathing." The ED physician ordered "soft restraint protect patient and ET (endotracheal) tube and lines" at 11:00 a.m. on 11/22/09. The patient was admitted to the intensive care unit (ICU) at 1:30 p.m. on 11/22/09.

The record of Patient #63 revealed that the patient was "improving" and was extubated on 11/23/09 at 2:10 p.m. A Clinical Institute Withdrawal Assessment (CIWA) protocol was ordered by the physician, at 8:15 p.m. on 11/23/09, to be implemented for alcohol withdrawal.

Patient #63's record revealed that the CIWA protocol listed the following medications on the physician order set: Ativan 2 mg intravenous (IV) or intramuscular (IM) every (q) 30 minutes PRN for a CIWA-Ar score of 8 or greater; Ativan 4 mg IV for an ICU patient only dose q 30 minutes PRN for a CIWA-Ar score of 8 or greater; or Haldol 2 mg IV/IM q 30 minutes PRN with the requirements "use only after a sufficient trial of Ativan and before administration of Haldol, magnesium level must be within normal limits and EKG (electrocardiogram) must be performed."

The record of Patient #63 revealed that, on 12/5/09 at 9:05 a.m., the nurse documented "Patient agitated. Attempted to calm. Meds given, see MAR (medication administration record)." The MAR revealed the patient received Ativan 2 mg IV at 9:05 a.m. The nurse documented, on 12/5/09 at 10:40 a.m., "Patient agitated, receiving Ativan PRN per orders." The evening nurse documented, on 12/5/09 at 7:00 p.m. the patient "became restless at 1900 (7:00 p.m.), given 2 mg IV Haldol."

Patient #63's record did not contain any evidence that the patient had been scored for a CIWA -Ar score on 12/5/09 or that the Ativan or the Haldol had been given as ordered in the CIWA protocols for alcohol withdrawal.

A review of the orders for Patient #63 in the record revealed the Ativan and the Haldol was ordered only as part of the CIWA protocols. The record revealed no evidence that any chemical restraints were ordered for Patient #63.

The Chief Nursing Officer and the ICU Manager agreed, during interview on 1/8/10, that there had been some mixing of CIWA orders for alcohol withdrawal symptoms with some of the CIWA medications used for restraining Patient #63.

Based on a review of medical records, policy and procedure and interview, it was determined the hospital personnel and medical staff failed to discontinue restraints at the earliest possible time on a patient whom the RN (registered nurse) documented the patient was unresponsive. (Patient #49)

Findings include:

The approved policy and procedure under the Assessment section revealed: "... In addition to adequate and appropriate clinical assessment and justification, the following must be met when restraint is used: The sue of restraint is based on the assessed needs of the patient. ... The least restrictive, safe, and effective method of restraint is to be used. Restraint use is to be discontinued when there is no longer adequate and appropriate justification for use...."

Patient #49's medical record revealed the RN documented in the nursing narrative notes on 10/05/08 at 0630 the patient was "restrained". The nursing narrative documentation at 1330 on 10/05/08 revealed the patient returned from the operating room and the patient was in restraints, no spontaneous movement noted at this time, patient non responsive to commands or stimuli. The nursing documentation indicated the patient remained in restraints at 1430 and 1700 the nursing assessment was that the patient remained unresponsive.

There was no documented evidence the nursing personnel assessed the patients condition related to the need for restraints when the patient was unresponsive.

On 10/05/08 there was a order for the patient to be in restraints. The signature of the individual ordering is not legible and was timed at 5:38 PM.

There was no evidence in the medical staff documentation the physician assessed the patient for the need for restraints when the patient was unconscious.

The medical record was reviewed with the Director of Intensive Care and confirmed the patient was unresponsive and remained in restraints.

Based on review of medical records, policy and procedure, and interview, it was determined the hospital failed to report deaths of patients while in restraints in three of three records reviewed for restraints and deaths. (Patient #11, 49, and 21 )

Findings include:

The hospital policy revealed the following: " ... Reporting of Deaths related to Patient Restraint ... 1. Staff will report to the manager, and/or administrative supervisor and Director of Quality and Risk any death that occurs under the following conditions; 2. Any death that occurs while a patient is in a restraint or within 24 hours of restraint removal or any death that is reasonable to believe may be related to restraint must be reported to Centers for Medicare and Medicaid Services (CMS). Date and time of the notification via telephone to CMS must be documented in the patient's medical record...."

Patient #11 was admitted on 05/15/09 and expired on 05/16/09. The patient was admitted with a history of seizures, osteoarthritis and developmental delay who presents to the hospital with altered mental status according to the history and physical. The patient has been having flu symptoms for approximately 2 days that included fever, anorexia, and not eating or drinking anything. The patient's family member had given the patient her medications the previous night and the patient had emesis, so the family member repeated the dose of her medications. Then in the morning the patient had altered mental status and the family called 911. The paramedics documented the patient's blood sugar as 43 on arrival to the patient's home.

The patient was evaluated in the ED (emergency department) and it was determined to admit the patient to the intensive care unit. The admitting diagnosis based on the admitting history and physical revealed sepsis, right lower lobe pneumonia, acute renal failure, elevated liver enzymes, hypocalcemia, hyponatremia, thrombocytopenia and elevated cardiac enzymes. The consulting physician documented in the consultation report that the patient had required emergency endotracheal intubations and full mechanical ventilations support and was on 3 intravenous vasopressor drips. The patient developed disseminated intravascular coagulation.

The nursing documentation on the flow sheets and in the notes revealed the patient was restrained at the time of the patient's death.

There is no documented evidence of the patient's death while in restraints being reported to CMS.

Patient #49 revealed the patient expired on 10/06/09 and the documentation revealed the patient had been in restraints within 24 hours of the patient's death. There was no documented evidence that the death had been reported to the regional office for CMS as required by the regulation.

Patient #21 on 05/06/09 and 05/08/09 the scanned medical record revealed a restraint orders and the nursing documentation revealed the patient was restrained based on the physician's orders.

The medical record revealed there was a restraint order form dated 05/08/09 that was not completed with the time the restraint was applied, time of physician assessment or verbal order. The form was documented as being authenticated by the attending physician on 05/15/09 at 7:45 am.

There was no documentation indicating the reporting to CMS of the death of Patient #21 who was in restraints within 24 hours of the patient's death.

Interview with the Director of Quality completed on 01/07/2010 confirmed that the deaths were not being reported to the Center of Medicare and Medicaid as required by the regulations.

Based on a review of the hospital documents, quality program, and interview, it was determined the hospital failed to implement and maintain an effective, onging quality assessment and performance improvement program as evidenced by the failure to be in compliance with the standards found in this Condition of Particpation.

Tag A 267; 482.21(a)(2) QAPI Quality Indicators: Failed to require:
1) the Governing Body established and implemented a method to identify, document, and evaluate incidents/occurrences, as part of the Performance Improvement Plan;
2) an occurrence report was initiated and analyzed after Patient #3 died within 24 hours post surgery;
3) occurrence reports on 2 of 4 patients had documentation of the investigation, findings, and actions taken by the Department Director and Risk Manager (Patient #7 and 50); and
4) the identified ongoing monitoring for restraints was implemented as required in the hospital policy for Restraints and Seclusion, NUR.0003, dated July 2009.

Tag A 289; 482.21(c)(3) QAPI Improvement Actions: The Governing Board did not ensure the quality analysis action plan was implemented regarding the analysis of the care provided to Patient #52 as required in the hospital quality plan for a Root Cause Analysis.

Tag A 311; 428.21(e)(1) Executive Responsibilities: Failed to be responsible and accountable for ensuring the quality management program was implemented and maintained related to:
1) reporting and analysis of occurrence reports and
2) ongoing monitoring of patient's in restraints.

The cumulative effect of these systemic problems resulted in the hospital's governing board being ineffective with ensuring the quality program is implemented to identify and take corrective action to minimize the risk to patients.

Based on a review of the hospital's Performance Improvement Plan, policies and procedures, medical records, and interviews, it was determined that the Administrator failed to require:

1) the Governing Body established and implemented a method to identify, document, and evaluate incidents/occurrences, as part of the Performance Improvement Plan;

2) an occurrence report was initiated and analyzed after Patient #3 died within 24 hours post surgery;

3) occurrence Reports on 2 of 4 patients had documentation of the investigation, findings, and actions taken by the Department Director and Risk Manager (Patient #7 and 50); and

4) the require that the identified ongoing monitoring for restraints was implemented as required in the hospital policy for Restraints and Seclusion, NUR.0003, dated July 2009.

Findings include:

1. The hospital policy titled Occurrence Reporting requires: "...Uses of the Occurrence Report are...a part of a statistical base for comprehensive risk management and prevention studies and the continuous improvement process...."

The Performance Improvement Plan (last reviewed 07/08), did not specify a method to identify, document, and evaluate incidents/occurrences.

Patient #33 was admitted to the inpatient unit on 09/10/09 at 1835. The Patient Care Flow Sheet revealed hourly checkmarks verifying call light within reach' from 09/10/09 1900, through 09/12/09 1700.

The nurse documented: 09/11/09 0725: "...pt. (patient) states...has not had a call light all night, RN went into empty room and obtained and set up for pt. use...." Nursing continued hourly documentation that the call light was within reach until 4 hours after the patient was discharged on 09/12/09 at 1310, according to the medical record. There was no documentation that included a review/analysis of nursing pre-charting and/or false documentation. There was not action plan implement specific to this review.

The documentation for Patient #50 revealed a report that there was an identified event where the patient had an infiltration after the infusion of a contrast media. The interim Director of Radiology ws interviewed on 01/06/2010 and confirmed there was an event that was identified and there was an evaluation of the event with identified action plan that was to be implemented. There was no documentation of the action plan that included counseling and follow-up training for the technician, MRI Tech #19. The interim Director contacted the previous Director to see if there was documentation that there had been follow through and the previous Director indicated the follow through would be in the personnel file. A review of the personnel file revealed no documentation of the implementation of the action plan. The previous Director informed the interim Director that all the follow-up interventions, and training documentation was given to the Risk Manager for trending and reporting to QM (quality management).

2. The hospital policy titled Occurrence Reporting (last revision 01/07) requires: "...Report an occurrence when...anything inconsistent with a completely 'uneventful' course of patient hospitalization...."

Patient #3 was admitted as a transfer from another hospital on 10/23/09, post retroperitoneal bleed following cardiac catheterization. Coronary artery bypass (CABG) surgery was performed on 10/28/09. The patient developed complications and expired on 10/29/09.

The Director of Quality Management confirmed during an interview conducted on 01/07/10, that an occurrence report was not documented though is required when a death occurs less than 24 hours post surgery.

3) The hospital policy, "Occurrence Reporting" requires: "...(Responsibly of) Department Director...Reviews Occurrence Report, follow-ups and forwards findings to the Risk Management within 5 business days, noting the actions taken and resolutions....

(Responsibility of ) Risk Manager...Reviews Occurrence Report and forwards for follow-up and resolutions to the appropriate Department Director and/or designee... Reports any unusual trends on quarterly risk management reports and reports findings to Quality Council...."

Occurrence Reports will be logged/tracked/filed/trended in the Quality/Risk Management and kept indefinitely...."

Patient #7 was admitted to the Telemetry Unit on 11/12/08, for chest pain.

On 11/14/08, the nursing staff documented starting an intravenous (IV) in the right forearm (RFA), with a 18 gauge needle.

On 11/14/08, the physician ordered at 0630: "...CTA (computed tomography angiography) of the chest to rule out PE (pulmonary embolism)...."

On 11/14/08, the patient signed the "Consent for Radiological Procedure with IV (intravenous) Contrast" form which was witnessed by a radiology staff member, and included the benefits and the risks of the procedure, such as hypersensitivity to the contrast, possible allergic reactions, and pain.

The patient's Medical Imaging Department Contrast Record completed by the Radiology Technician (tech) #13, on 11/14/08, had documentation that the tech had: checked the physician's orders, and verified the identification of the patient; and recorded: the normal BUN (blood urea nitrogen) and creatinine lab results.

The patient's CTA Medical Imaging Report dictated on 11/14/08, by the Medical Director of Radiology Services revealed the CTA was done at 1254, and reported: "...80 cc (cubic centimeters) of contrast was extravasated into the right arm. The patient did not have pain initially. The technician informed the patient's nurse and (patient's attending physician) and another IV was started. After the second IV was started, 125cc of Isovue 370 was administered without incident. At 1600, I was called to evaluate the patient who had a tensely swollen right forearm. Orthopedic surgery performed compartmental pressures and after the compartmental pressures were found to be unacceptably high, the patient was taken for fasciotomy...."

On 01/05/10, the Director of Quality Management (QM) provided the Occurrence Report regarding this incident for review. She stated this occurrence report was filed by the Radiology Tech #13, on 11/20/08, and the Risk Manager had reviewed the occurrence report and had forwarded to the Radiology Director for review and to implement any actions to improve the process.

Patient #7's Occurrence Report included a note by the Risk Manager on 11/25/08, "Copy to...Director of Radiology for follow-up and intervention...on 01/05/09...Met with the Director of Radiology and his staff and put in place safeguards to identify where IVs were started, and will be validating IV competencies for Nursing and Radiology staff at the next skills fair...."

On 01/06/10, the Interim Director of Radiology confirmed she was not the Radiology Director at the time of the incident, and any documentation regarding a review of the incident and interventions implemented would have been forwarded to the Risk Manager.

On 01/05/10, the Director of QM confirmed the Risk Manager is no longer employed at the facility.

She stated she was unable to obtain what safeguards were placed by the Risk Manager, or if the Risk Manager had validated any of the nursing staff or radiology staff's IV competencies, due to the inability to access either the Risk Manager's computer files, or locate evidence of actions taken by the Risk Manager.

She confirmed the Quality Council was unable to effectively monitor and evaluate Patient #7's occurrence since the Director of Radiology, and the Risk Manager failed to document and maintain information of their investigation, findings, and actions taken.

Patient #50 was admitted on 04/12/09 with a chief complaint of chest pain.

On 04/17/09, (no time) the physician's orders included: "...MRI (magnetic resonance imaging ) of lumbar spine..."

On 04/17/09, the patient signed the "Patient History and Safety Screening" from completed by the radiology staff and included that the patient did not have "monitor electrodes on the body or head."

The patient received a MRI of the spine without contrast, performed by the MRI Tech.

The Nursing Documentation form dated 04/19/09, at 1145, under the skin assessment section, the registered nurse (RN) documented after the patient returned from radiology: "left upper chest...blister and red...blebs noted, left open to air...Wound care consult ordered...."

The Wound Care evaluation by a wound care nurse dated 04/20/09, included: "...left chest, length 1.5 centimeters by width 1.5 centimeters, blister and red in color...." The wound was left open to area, and no treatment was recommended.

On 01/04/10, the Director of Quality Management (QM) provided an Occurrence report dated 04/21/09, completed by the Director of the Intensive Care Unit (ICU), that revealed: "...Patient was sent to MRI...placed in MRI with monitor (cardiac) and electrodes on. The (MRI) technician XXX removed the monitor once he realized and...There is a blister on the patient's left chest area from the electrode. Patient stated he/she felt it burn....Copy to Director of Radiology, for follow-up and intervention. Staff counseled, and intervention underway per Radiology Director.

On 01/06/10, the Interim Director of Radiology confirmed she was not the Radiology Director at the time of the incident, and any documentation regarding a review of the incident and interventions implemented would have been forwarded to the Risk Manager.

On 01/07/10, the Director of QM stated she was unable to located any documentation of what interventions were implemented or what follow -up was done by the Director of Radiology and if it was reviewed and trended by the Risk Manager.

She confirmed the Quality Council was unable to effectively monitor and evaluate Patient #50's occurrence since the Director of Radiology, and the Risk Manager failed to document and maintain information of their investigation, findings, and actions taken.

4. The policy for Restraints and Alternatives...Ongoing Monitoring and Education revealed: "... 4. To provide optimal care to patients requiring the use of any restraint device and their reduction of risk, West Valley Hospital is committed to ongoing data collection, process improvement, and analysis regarding the use of restraints to maximize the alternatives and minimize the use of restraints including: Identifying the frequency which it analyses data on non-behavioral restraints; Use statistical tools and techniques to analyze and display the data on non-behavioral; Analyzes and compares its data on the use over time to identify levels of performance, patterns, trends, and variations; Use the results of the data to identify opportunities for improvement; Prioritizes opportunities to improve; Takes action on the improvement priorities; Evaluates the changes to confirm they resulted in improvement; and Take action when planned improvement are not achieved or sustained...."

The policy under Reporting of Deaths related to Patient Restraint revealed: "... Performance Improvement 1. Analysis of data related to restraint and seclusion will pay particular attention to: A. Multiple instances of restraint experienced (sic) an individual within a 12 hour timeframe. B. Number of episodes per individual. C. Instances of restrain that extend beyond 12 consecutive hours, and ... D. use of psychoactive medications as an alternative for, or to discontinue any restraints. E. Data will routinely be analyzed, action plans developed and reported to the appropriate committees of the hospital...."

Interview with the Director of Quality on 01/08/2010 revealed there was no documented evidence of implementation of a quality monitoring for restraints for the past year.

A review of meeting minutes revealed there was no documented evidence of reporting monitoring activity related to restraints in the Governing Body minutes or the Medical Staff meeting minutes for the past year.

Based on review of the policies and procedures, medical record, facility documents, and interview, it was determined the Governing Board did not ensure the quality analysis action plan was implemented regarding the analysis of the care provided to Patient #52 as required in the hospital quality plan for a Root Cause Analysis.

Findings include:

The hospital policy, "Root Cause Analysis" requires: "... Definitions...Root Cause: the underlying process or system factor that results in a particular outcome...The Risk Manager...with Qa\quality Director will be responsible for initiating, facilitating, and completing the RCA...A action plan must be developed that does the following...Identifies changes that can be implemented to reduce risk...Identifies who is responsible for implementation of any changes, a timeline for implementation and the methods of evaluation of the effectiveness of changes...."

Patient #52 presented to the Emergency Department (ED) on 09/14/08, at 1355, with no pulse and no spontaneous respirations. The patient 35.5 weeks gestation, was found unresponsive for an unknown amount of time by the significant other. Upon arrival to the ED, the patient was intubated, and placed on mechanical ventilation.

The OB physician's dictated operative report revealed: "...This is a 24 year old...dead on arrival...into emergency department, found to be in asystole and under going a code protocol to revive (the patient) back...At the time of my presentation the infant had been delivered via a lower vertical skin incision and the...staff along with the Intensivist were reviving the baby...."

He confirmed this incident was reviewed by Quality Council and a Root Cause Analysis was done.

On 01/07/10, the Director of Quality Management (QM) provided a copy of the Root Cause Analysis of a maternal death and infant delivered under those circumstances.

The Root Cause Analysis identified possible risk factors and developed an action plan.

The action plan included:
1) Development and initiation of Nursing audit tools. The Risk Manager and the Quality Director would present the monitoring and analysis of the nursing audit tools and present the results to the Patient Safety Committee, and Quality Counsel on a quarterly basis.
2) OB Staff competencies were assessed and an OB Skills Fair was developed and conducted.

On 01/07/10, the Director of Nursing stated all nursing units and departments conducted the nursing audits as required by the action plan.

She confirmed the Risk Manager and the Quality Director, did not present the monitoring and analysis of the nursing audits, on a quarterly basis, to the Patient Safety Committee and Quality Counsel.

Based on a review of the hospital's Performance Improvement Plan, policies and procedures, medical records, and interviews, it was determined that the governing body, medical staff, and administrative officials failed to be responsible and accountable for ensuring the quality management program was implemented and maintained related to:

1) reporting and analysis of occurrence reports; and

2) ongoing monitoring of patient's in restraints.

Findings include:

1) The hospital policy titled Occurrence Reporting requires: "...Uses of the Occurrence Report are...a part of a statistical base for comprehensive risk management and prevention studies and the continuous improvement process...."

The Performance Improvement Plan (last reviewed 07/08), did not specify a method to identify, document, and evaluate incidents/occurrences. There was no documented evidence of consistent implementation of a method to identify, document, and evaluate incidents/occurrences, as part of the Performance Improvement Plan.

There was no evidence of a process to ensure that occurrence reports were documented and analysis initiated for deaths within 24 hours of surgery, which was identified as a criteria for reports within the hospital's plan.

Occurrences were documented in two patients with no documented evidence of an investigation, findings, and actions that would minimize the risk of the event occurring to another patient. (Patient #7 and 50).

The Director of Quality was interviewed on 01/07/2010 and 01/08/2010 and confirmed there was no documentation to support that the facility had reported and/or analyzed the reports of the patients events.

2) There was not documented evidence that restraints were integrated into the data analysis of the quality of care as required within the policy for restraints and alternatives that had been approved by the medical staff and the administrative policy and procedure committee.

Based on review of the policies and procedures, medical record, facility documents, and interview, it was determined that the Governing Board did not ensure the Root Cause Analysis's (RCA) action plan was implemented regarding the analysis of the care provided to Patient #52.

Findings include:

The hospital policy, "Root Cause Analysis" requires: "... Definitions...Root Cause: the underlying process or system factor that results in a particular outcome...The Risk Manager...with Qa\quality Director will be responsible for initiating, facilitating, and completing the RCA...A action plan must be developed that does the following...Identifies changes that can be implemented to reduce risk...Identifies who is responsible for implementation of any changes, a timeline for implementation and the methods of evaluation of the effectiveness of changes...."

Refer to Tag 289 for the specifics of the patient care situation.

On 01/07/10, the Director of Nursing stated all nursing units and departments conducted the nursing audits as required by the action plan.

She confirmed the Risk Manager and the Quality Director, did not present the monitoring and analysis of the nursing audits, on a quarterly basis, to the Patient Safety Committee and Quality Counsel.

Based on a review of hospital documentation, medical staff bylaws rules and regulations, and interview, it was determined the organized medical staff failed to operate under the bylaws that were approved by the governing authority as evidenced in the non-compliance with the standards identified in the following:

Tag 340; 482.22(a)(1) Medical Staff Accountability: Failed to evaluate the care provided by the medical staff as required in the Medical Staff Bylaws as evidenced in 1 of 3 medical records reviewed. (Patient #16)

Tag 347; 482(b) Medical Staff Accountability: Failed to be directly accountable to the governing authority for the quality of care provided by medical staff members to patients in the hospital as evidenced by the medical staff not responding to changes in patients' conditions, in 4 of 6 records reviewed. (Patient #13, 15, 16, and 34)

Tag 353: 482.22(c) Medical Staff Bylaws: Failed to require that the medical staff followed the bylaws rules and regulations as evidenced by:
1. the failure to authenticate physician orders within 48 hours as required by the medical staff bylaws rules and regulation; (Patient #11),
2a. the failure to document a discharge summary on all patients who are hospitalized over 48 hours (Patient #28 and 46) or 2b. the failure to complete a death summary for all inpatients who expire in the hospital setting; and (Patient #3, 11 and 13);
3. the failure to authenticate, date and time physician orders documented on the patient's medical record ( Patients # 53, 43, 45, and 46);
4. the failure to sign within 24 hours restraint orders and document the patient's assessment requiring restraints ( Patients 11 and 21);
5. the failure to document in the medical record clearly and legibly (Patients #13 and 53);
6. the failure of the physician documented an order to initiate a nasogastric tube (NG) and connect the tube to low intermittent suction, as the nursing staff documented, for Patient #2; and
7. the failure of the medical staff to follow the hospital policy and procedure for informed consent in 5 of 6 records reviewed for informed consent.

Tag 364; 482.22(d) Autopsies: Failed to follow the documented Medical Staff Bylaws Rules and Regulations for reviewing autopsy criteria on patients who have expired and/or requesting autopsy consent on patient's who meet the criteria for autopsy as evidenced in Patient #16 and 49.

The cumulative effect of these systemic problems resulted in the hospital's governing board being ineffective with ensuring the medical staff operate under the bylaws approved by the governing board and monitors the quality of care provided to patients in the hospital to minimize the risk of adverse outcomes to patients.

Based on review of Medical Staff Bylaws Rules and Regulations, medical records, and interview, it was determined the hospital's medical staff failed to evaluate the care provided by the medical staff as required in the Medical Staff Bylaws as evidenced in 1 of 3 medical records reviewed. (Patient #16)

Findings include:

The Medical Staff Bylaws Rules and Regulations referenced that the determination of staff privileges will be based on the quality review of cases throughout the credentialing process. The Bylaws revealed the anticipated timeframe for professional review would be 60 days. If the review is not completed in 60 days there should be a report to the Medical Executive Committee as to why the timeline needs to be extended.
It was identified that some reviews do take more than 60 days.

The Director of Quality, on 01/07/10, reviewed the process utilized at the facility for physician review of cases that are identified based on criteria as meeting review criteria. The process was defined as the first step is that the records are reviewed by the Quality Analyst and the case is referred to the Department Chairperson if the record falls out for review based in the established criteria. When the Department Chairperson determines there is verification that the review of a broader committee is required the case is taken to the appropriate Department committee and a review is completed. Based on this review the case may be sent to the Medical Executive Committee and then on to the Governing Board.

The Director of Quality provided the surveyor with a document titled West Valley Hospital OPPE (Ongoing Professional Practice Evaluation) and FPPE (Focused Review Triggers) Indicators. This documented identified Focused Review Triggers and Ongoing Professional Practice Evaluation triggers for each Medical Staff Department at West Valley.

The Medicine Department revealed the following for focused review triggers: Unplanned transfer to special care unit; Adverse outcome unrelated to natural course of illness; Critical/abnormal test result unaddressed; Death in low mortality DRGs (Diagnostic Related Groupings), as defined by CMS; and Delay in consultation/care/documentation as defined by rules and regulations.

Patient #16 was admitted to the hospital on 1020/09 and expired on 10/26/09. The documentation provided to the surveyor revealed the record had been reviewed on 11/12/09 by the Quality Analyst.

There was no documented evidence of a peer review having been completed for this case. There was a documented Quality review completed for all deaths in the intensive care unit for the month of October 2009. Patient #16 was integrated into this review process. The outcome of this review process was that Patient #16 be presented to peer review.

Chief Medical Officer (CMO) for West Valley Hospital reviewed this case with the surveyor. The CMO recalled that this case had been reviewed in the sampling of all deaths for October in the intensive care unit but was not sure of the current status of the review.

Patient #16 had an unexpected transfer to the intensive care unit and the critical lab values and the clinical status of the patient may or may not have met the criteria of adverse outcome unrelated to natural course of illness.

As of 01/20/2010 there was no documented evidence the case had been completed in the full peer review process. This date was three months after the patient's death and 60 days after the summary review of the deaths that was completed with a recommendation of peer review.

Based on a review of medical records and interviews, it was determined the medical staff failed to be directly accountable to the governing authority for the quality of care provided by medical staff members to patients in the hospital as evidenced by the medical staff not responding to changes in patients' conditions, in 4 of 6 records reviewed. (Patient
#13, 15, 16, and 34)

Findings include:

Patient #13 presented to the ED on 10/01/09. The noted time to room was 0630. The chief complaint was nausea vomiting for the past day, shortness of breath, and back pain. The nursing documentation revealed mild respiratory distress. The physician documentation revealed clinical impressions of advanced liver disease, ascites, juandice, weakness, and two other impressions that were not legible.

The ED RN documented the patient was transferred to the firth floor nursing unit at 0935 on 10/01/09. The RN (registered nurse) documented the physician's verbal order for pain medication; Demerol 1 mg (milligram) IV (intravenous) every 4 hours, at 1130 on 10/01/09.

The nursing progress notes indicated that the physician was present and "seeing" the patient on 10/01/09 at 1300.

There was no documented evidence of physician orders to manage the patient other than the Demerol for pain from the time the patient left the emergency department until the patient was resuscitated and admitted to the intensive care unit, which was 8 hours after the admission to the hospital.

The progress notes at 1350 revealed decreasing level of consciousness and lethargy with noted Karsmal respirations. Nursing documentation revealed the physician was notified but no new orders received.

There was no medical assessment of the patient when the physician was notified that the patient's respirations were at risk.

At 1600, the nursing notes revealed rapid response called and the decision to transfer the patient to ICU (intensive care unit) pending bed availability. Physician was documented in attendance. The medical record documentation indicated a code was called at 1615, but was not clear as to the interventions for the emergency situation.

The first documented inpatient admission orders revealed handwritten orders on 10/01/09 with no time documented. The orders were documented as being noted at 1855, 9 hours after the patient was admitted to inpatient status, after the physician had been called for pain medication, after a change in the patient's condition for what the RN documented as Karsmal respirations, and after a rapid response/code arrest was called.

Interview with the Chief Medical Officer conducted on 01/07/10, revealed the medical record had been reviewed, however there was no documented evidence that concerns regarding the delay in the physician response had been identified and evaluated by the medical staff.

The nursing documentation on 10/01/09 at 1900, revealed the physician was at the bedside in the intensive care unit. The patient was taken to radiology for a CT scan at 0100 on 10/02/09, with 2 nurses and a respiratory therapist. The notes indicated the physician was paged at 0330 with the CT report and labs. The CT scan revealed an active retroperitoneal hemorrhage. The notes continued to reveal that at 0430, there was no return call from the physician. A second physician was called and updated on the patient's condition. There was an hour delay in a physician response to the critical results of the CT scan.

Patient #15 was admitted to the ED with palpitations and bradycardia at 0440 on 11/03/09. The ED physician ordered the patient to be admitted to a hospitalist. The ED orders included vitals every 4 hours, up ad lib, 1800 cal (calorie) diet, cardiac monitor and continuous pulse oximetry. In addition to these order the patient was to receive ECASA (enteric coated aspirin) 325 mg po every day, Oxygen at 2 liters and laboratory studies of CK, CKMB, Troponin every 6 hours X 3. The orders were effective until 0800. The patient's care was transferred to the hospitalist at 0610.

The ED RN documented the patient was transferred to the inpatient unit room 511B at 0820, with report given to the RN. The nursing graphic record indicated vital signs documented at 11/03/09 at 1200, indicated pulse 78, respirations 20, oxygen saturation 99 percent, and blood pressure 156/88.

There is no documented evidence of nursing care after admission to the inpatient unit. An AMA (against medical advice) form was signed by the patient on 11/03/09 at 1300. There is no evidence of a facility representative signature on the form.

There was no documented evidence of physician orders after the ED orders expired at 0800 on 11/03/09. There was no documented evidence the patient was placed on telemetry and a continuous pulse oximetry or discontinuance of the orders documented by the ED physician.

Patient #16 was admitted to the intensive care unit on 10/20/09 with difficulty breathing and dizziness, and a new diagnosis of atrial fibrillation with a rapid ventricular response. An Esmolol drip, Lovenox, Aspirin, and Coumadin were initiated. The medical record revealed the patient was determined to be appropriate for transfer to the telemetry unit after stabilization in the intensive care unit. The pulmonolgist consulted for the respiratory insufficiency. The patient was on BiPAP at night. While on telemetry on 10/25/09, the patient had episodes of nausea without vomiting. The patient did not complain of abdominal pain, chest pain, or difficulty breathing, however the nursing documentation revealed the patient had developed right flank pain and was refusing to move in the bed due to the pain. The patient died on 10/26/09.

The following represents the interventions related to the reported pain that nursing documented. Nursing documented on 10/24/09 at 1500 that the patient was very uncomfortable, and it took 5 people to move her (up) in bed. The patient was treated for pain. Documentation on the MAR confirmed the patient was given Oxycodone one tablet at 1104, and 1510. Nursing documentation at 2000, revealed: "... the patient was in pain and did not want to change positions due to the pain...." Oxycodone two tablets was documented as administered at 1945 and 2340.

The nursing documentation page 5 of 6 revealed a flow chart for pain and listed the patient was in pain on a scale of 7-2 from 1130 through 0550 on 10/25/09. The location of the pain was described as right flank pain. The ranking of 2 was recorded as the reassessment after pain intervention.

On 10/25/09, the patient received Dilaudid 1 mg IV at 0045 and 0520. On 10/25/09 at 1300, the patient received Oxycodone one tablet for pain of 5/10. The physician was notified and aware of the pain since the Dilaudid was a verbal order.

There were telephone orders on 10/25/09 at 0045, 0500, and 0800. The physician was notified of the patient's blood pressure of 74/33 at 1120 on 10/25/09, and gave telephone orders for a Normal Saline bolus of 500 cc, then 100 cc/hour, and medication adjustments to the Digoxin and the Lisinopril.

The first evidence of a physician presence at the patient's bedside was with handwritten orders that were not timed but dated 10/25/09 and noted by the nursing staff at 1310. This was hours after the patient developed pain and required additional pain medication that the patient had not required prior, and two hours after the patient's blood pressure had changed to 74/33.

There was a physician order to transfer the patient to ICU on 10/25/09 at 1450. An arterial line was placed and stat labs were completed. The patient was given fresh frozen plasma and vitamin K since the INR was 3.5. The patient's hemoglobin on 10/25/09 at 1645 was 5.2, the INR at 2022 was 3.1, and on 10/26/09 at 0533 the INR was 2.2.

There were physician orders not timed for type and screen 2 units of packed red blood cells. There was no documented evidence of the nurses noting the order with a time. The following orders were not timed by the physician, however were noted by the nursing staff at 1640. Based on the documentation, the order to type and screen would have been written between 1450 and 1640 PM on 10/25/09.

At 1720, the physician orders revealed telephone orders for 2 units of fresh frozen plasma stat and to stay 2 units ahead. This would have been after the laboratory results indicated a hemoglobin of 5.2. The blood transfusion form revealed the FFP was initiated at 1740, and completed at 1850, and the second unit was initiated at 2030, with no documentation of a finished time. A third unit was documented as infused at 2055, and completed at 2125. There were two additional units documented as administered on 10/26/09 at 1750, with completion time of 1805.

The physician orders on 10/25/09 documented the patient was to be a DNI (do not intubate) and further documented no shock, pressors okay, but in event of heart stopping no epi or Atropine.

There was an order for Dilaudid 1 mg IV every 4 hours prn on 10/25/09 as a phone order. On 10/26/09 at 0630 there was an order for Dilaudid 4 mg IV now and Ativan 2 mg IV now and withdrawal of care. Orders at 0645 revealed Ativan 2 mg IV every 3 hours for agitation and Morphine 4 mg IV times 1 now at 0710.

Patient died on 10/26/09 at 0913.

Patient #34 was admitted to the hospital on October 2, 2009 and died on October 21, 2009. The patient had a cardiac catheterization at another acute care facility and then was transferred for cardiac surgery to West Valley Hospital. The medical record revealed a chest x-ray that was completed on 10/19/09 at 0014 and the dictated report revealed the following: " ... Conclusion: interval development of large Right pneumothorax with collapse of the right lung. Findings were conveyed to the patient's nurse by telephone at the time of this dictation...."

The physician progress notes on 10/19/09 at 0700 revealed the patient was to have a chest tube placed based on the chest x-ray showing a right pneumothorax with complete collapse of the lung. The progress note indicated the physician was notified to place the chest tube.

The nursing assessment for respiratory revealed breath sounds at the 0600 through 1800 for the right lung as expiratory wheezes for the upper, middle, and lower. The same was documented for the left upper and lower. The 1800 to the 0600 respiratory assessment by the RN revealed coarse inspiratory and expiratory wheezes to the upper lung, diminished to the middle and lower lung.

The patient remained on the mechanical ventilator.

On 10/19/09 the nursing narrative notes revealed at 1800 the patient was assessed and noted no chest tube placed as of yet. "Family explained will work on getting Chest tube placed this PM." The notes continued to stated at 2000 the physician was at the bedside and the chest tube was inserted at 2030.

The x-ray identified the right pneumothorax at 0014, physician requested the chest tube at 0700, and the chest tube was placed at 2030. This was 22 hours after the x-ray confirmed a "large pneumothorax."

The patient developed renal failure and fluid overload. Hemodialysis was initiated. On 10/20/09 the patient developed thrombocytopenia and the physician documented in the discharge summary the patient "rapidly progressed to have critical thrombocytopenia. The patient had a cardiac arrest and died on 10/21/09.

On 10/21/09 the nursing narrative notes revealed a code was called at 1540 and "see code sheet".

The code sheet revealed at 1540 the blood pressure was 58/34 with no pulses and no spontaneous respirations. The code record revealed the code was called and the patient expired at 1545.

The CMO (Chief Medical Officer) was interviewed and the case review with the CMO and the Director of Quality. The fact that there was a 22 hour delay in the placement of the chest tube had not been previously identified in the medical staff reviews.

Patient #34's case was reviewed as part of the overall death quality summary completed by the hospital. The outcome of the review that was completed by the CMO and the CMO for the regional office revealed there was no quality of care concerns.

The patient had a change in condition and the treatment was that of placement of a chest tube and it took 22 hours before the chest tube was placed.

Based on a review of medical records, policies and procedures, and interviews, the Department determined the governing authority failed to require that the medical staff followed the bylaws rules and regulations as evidenced by:

1. the failure to authenticate physician orders within 48 hours as required by the medical staff bylaws rules and regulation; (Patient #11),

2a. the failure to document a discharge summary on all patients who are hospitalized over 48 hours (Patient #28 and 46) or 2b. the failure to complete a death summary for all inpatients who expire in the hospital setting; and (Patient #3, 11 and 13);

3. the failure to authenticate, date and time physician orders documented on the patient's medical record ( Patients # 53, 43, 45, and 46);

4. the failure to sign within 24 hours restraint orders and document the patient's assessment requiring restraints ( Patients 11 and 21);

5. the failure to document in the medical record clearly and legibly (Patients #13 and 53);

6. the failure of the physician documented an order to initiate a nasogastric tube (NG) and connect the tube to low intermittent suction, as the nursing staff documented, for Patient #2; and

7. the failure of the medical staff to follow the hospital policy and procedure for informed consent in 5 of 6 records reviewed for informed consent.

Findings include:

1. The Medical Staff Rules and Regulations revealed: "... A practitioner's routine orders, when applicable, to a given patient, shall be reproduced in detail on the order sheet of the patient's record ... authenticated and signed by the practitioner...."

A random review of the physician orders on Patient #11's medical record revealed the RN (registered nurse) documented on 05/16/09 at 0645 telephone orders for the patient that included medications. The authenticated electronic document revealed the physician authentication on 06/04/09 at 3:19 PM. This was 19 days after the order was documented in the medical record.

The RN documented on 05/16/09 at 0425 a telephone order for Na Bicarb to be added to the intravenous fluids. The authentication was documented on 06/04/09, 19 days after the order was documented and implemented.

The RN documented telephone orders on 05/15/09 at 2220 for an arterial line, blood gases, and chest x-ray. There was no documented evidence of physician authentication of these orders as of the date of the survey, 01/06/09.

2a. The Medical Staff Rules and Regulations revealed at 2.10 Discharge Documentation the following: "... At the time of discharge or as soon after as possible, the attending physician is responsible for completing the record and signing all applicable areas in the chart. b. A discharge summary is required for all patients hospitalized over 48 hours...."

The record of Patient #28, for the hospitalization of 6/22/09 to 6/26/09, revealed the record did not contain a discharge summary by the physician. The Director of Medical Records agreed, on interview 1/5/09, that there had not been a Discharge Summary done by the physician for Patient #28 for the hospitalization of 6/22/09 to 6/26/09.

Patient #46 was admitted to the hospital on 10/21/2010 with a gastrointestinal bleed and was transferred to another acute care hospital on 10/22/09. There was no documented evidence of a discharge summary or transfer summary in the patient's medical record.

2b. The Medical Staff Rules and Regulations revealed at 2.10 Discharge Documentation the following: " ... In the event of death, a Death Summary is required and shall include the reason for admission, findings, course in the hospital and events leading to death.

Patient #3 was admitted as a transfer from another hospital on 10/23/09, post retroperitoneal bleed following a cardiac catheterization. Coronary artery bypass (CABG) surgery was conducted on 10/28/09. The patient developed complications and expired on 10/29/09.

The Medical Staff Rules and Regulations require: "...The medical records shall contain...Discharge/Death Summary, final Progress Note or Transfer Summary...In the event of death, a Death Summary is required and shall include the reason for admission, findings, course in the hospital and events leading to death...."

There was no documentation of Patient #3's Discharge Summary that included the death. The findings were verified by the Medical Director and the CEO during the medical record review and interviews conducted on 01/07/2010.

Patient #11 was admitted on 05/15/09 and expired on 05/16/09. The medical record was reviewed and there was no discharge summary or death summary completed by the physician. There was no discharge summary available on the record, which would not have been required since the patient was not hospitalized for 48 hours.

Interview with the Director of Heath Information Systems confirmed that even though the patient was hospitalized less than 24 hours a death summary was required.

Patient #13 presented to the ED on 10/01/09 and the noted time to room was 0630. The chief complaint was nausea vomiting for the past day and shortness of breath and back pain. The nursing documentation revealed mild respiratory distress. The physician documentation revealed clinical impressions of advanced liver disease, ascites, juandice, weakness, and two other impressions that were not legible.

The patient died on 10/02/09 and there was no death summary documented in the patient's medical record by the attending physician.

3. The Medical Staff Rules and Regulations revealed: "... 2.6 ... A practitioner's routine orders, when applicable, to a given patient, shall be reproduced in detail on the order sheet of the patient's record dated, timed ... and signed by the practitioner... All verbal/telephone orders must be dated, timed, authenticated and signed by the ordering physician within 48 hours...."

Patient #46's medical record physician orders dated 10/22/09 at 0720 and 0745 revealed a verbal order for a PICC line. There was no documented evidence of this order being authenticated with a physician's signature at the time of the survey 01/07/2010. On 10/22/09 at 0130 there was a telephone order for clarification of cardiac enzymes and there was no documented evidence of authentication of this order by a physician at the time of the survey 01/07/2010. At 0528 on 10/22/09 there were documented physician orders for Zosyn, hold for FFP, and laboratory studies. There was no documented authentication of a physician's order. On 10/21/09 there was a set of typed orders for Potassium Protocol that was documented as a telephone order and there was no documented authentication of these orders by the ordering physician at the time of the medical record review of 01/07/2010.

Patient #45's medical record revealed on 08/15/09 verbal orders for TPA infusion at 6:10 PM and the orders were authenticated electronically by the ordering physician on 11/12/09, 3 months after the order was provided to the RN (registered nurse). On 08/15/09 at 1930 a telephone order for Morphine IV (intravenous) was documented by the RN. The order was authenticated electronically by the physician on 10/13/09. This was 2 months after the order was documented.

Patient #43's medical record revealed on 10/14/09 verbal orders for Nitro past and Nitro sublingual at 1205. There was no documented evidence of this order being authenticated by a physician at the time of the survey on 01/07/2010, 3 months after the order was documented.

Patient #53 was a concurrent record that was reviewed at the time of the survey. In review of the physician's orders on 01/04/2010 there was a telephone order for Physical Therapy to evaluate and treat the patient at 1400 and a telephone order for bilateral wrist restraints at 1845. The order appears (signature is not legible) to have been authenticated by the ordering physician, however there is not a date and time of the authentication.

These were examples of the failure to authenticate orders within the 48 hours required by the medical staff bylaws, date, and time orders.

4. The Medical Staff Rules and Regulations revealed: " ... 2.6 ... Restraint orders (verbal or telephone) must be signed within 24 hours. Failure to do so shall be brought to the attention of the practitioner, and chairman of the appropriate Department. Persistent or repeated failure to meet this requirement shall be reported to the Executive Committee for appropriate action...."

Patient #11: The restraint form dated 05/16/09 at 0140, revealed a physician's verbal order. The physician's signature however was not authenticated with a date or time.

Patient #21 was admitted to the hospital on 05/06/09 with an admitting diagnosis of sepsis, acute respiratory failure, acute renal failure, possible seizure activity, hyponatremia, and leukocytosis. The discharge diagnosis was massive cerebrovascular accident, multisystem organ failure, ventilator-dependent respiratory failure, and acute renal failure.

On 05/06/09 the scanned medical record revealed a restraint order form that had the following areas blank. The time the restraint was applied, time the physician assessed the patient, application of restraint, and order written by physician. The attending physician signed the order form with a date of 05/06/09 with no time of the signature.

The medical record revealed there was a restraint order form dated 05/08/09 that was not completed with the time the restraint was applied, time of physician assessment or verbal order. The form was documented as being authenticated by the attending physician on 05/15/09 at 7:45 am.

5. The Medical Staff Rules and Regulations revealed: "... 2.4 ... All Clinical entries in the patient's medical record shall be legible, accurately completed, dated and timed an authenticated by written or electronic signature... 2.6 ... The practitioner's orders must be written clearly, legibly and completely. Orders which are illegible or improperly written will not be carried out until rewritten or understood by the person to whom they are given...."

Patient #13's medical record revealed a form called The Universal Protocol Validation form dated 08/01/09 at 1347. The electronic record that was not legible for the signatures, procedure, and procedure provider. A review of the medical record revealed this may have been for an abdominal paracentesis.

Patient #13's medical record included a documented report for the US Guided Paracentesis. The Medical imaging report revealed a dictated report that revealed: " ...she gave her consent and elected to proceed...." The documentation in the patient's medical record revealed this patient was a male. This report indicated a female when it was dictated for a male patient.

Patient #13's record revealed the Endoscopy/Physician's signature on the record dated 08/04/09 was not legible.

Patient #53 was a concurrent record that was reviewed at the time of the survey. In review of the physician's orders on 01/04/2010 there was a telephone order for Physical Therapy to evaluate and treat the patient at 1400 and a telephone order for bilateral wrist restraints at 1845. The order appears (signature is not legible) to have been authenticated by the ordering physician, however there is not a date and time of the authentication.

6. The hospital's Medical Staff Rules and Regulations require: "...All orders for treatment shall be in writing...."

Patient #2 nurses' notes revealed, "...03/21/09 (1145)...NG to R (right) nares...(1845) NG tube hooked to low intermittent suction...."

There was no documented physician order for the NG tube, nor to connect the NG tube to low intermittent suction. The findings were confirmed during the medical record review and interviews conducted with the Medical Director and the Chief Executive Officer (CEO) on 01/07/10 at 1600.

All of the above are examples of the failure of the medical staff to follow the bylaws rules and regulations. The examples were reviewed with the hospital personnel to include the Director of Quality and the Chief Medical Officer on 01/07/2010 and 01/08/2010 and the findings were confirmed.

7. The medical staff failed to follow the policy and procedure of the hospital for informed consent. The physician performed surgery on Patient #41 without a surgical consent signed by the patient.

The hospital policy, "Informed Consent" requires: "...The physician who will administer or supervise the treatment or procedure...is responsible for obtaining the patient's informed consent...Requires informed consent... for the following procedures... Surgical procedures... invasive medical imaging...the physician who will administer the procedures or treatment must sign the Verification of Informed Consent... For the patient's consent to be informed, the physician must provide and discuss with the patient...who will perform the procedure...."

The Medical Staff Bylaws Rules and Regulations under Article II Medical Record Policies 2.2 Content of Medical Record revealed: "... To facilitate consistency and continuity of care the medical records shall contain at least the following: ... j. Evidence of informed consent, when required by hospital policy ...."

Patient #5 was taken to surgery and a cardiac catheterization was performed without the physician's name being identified on the consent.

There was no documented evidence of a physician's signature, date, and time on the consents for surgical/invasive procedures performed on Patient's #5, 13, 34, 41, and 56.

The detail of each of these patient records can be found in Tag 955 Informed Consent.

Based on a review of the medical staff bylaws rules and regulations, medical records, death data and interviews, the Department determined the hospital failed to follow the documented Medical Staff Bylaws Rules and Regulations for reviewing autopsy criteria on patients who have expired and/or requesting autopsy consent on patient's who meet the criteria for autopsy as evidenced in Patient #16, 11, and 49.

Findings include:

A review of the deaths documented for the months of January 2009 through December 2009 revealed there were several number of deaths at the hospital. The hospital had completed a special quality review of all deaths for the month of October for patient who had expired in the intensive care unit. There was no indication that the cases reviewed were reviewed for meeting the criteria for autopsy and then not requested and/or obtained.

There were a total of 8 deaths in the month of October 2009 and there were no autopsies completed on any of these deaths. There was no documentation in the patient records to indicate that the patient case was reviewed to determine if there were indications for requesting an autopsy.

The Medical Staff Rules and Regulations revealed under Article VII General Policies 7.3 the following: " ... Every member of the medical staff is expected to be actively interested in securing autopsies using the autopsy criteria that identify deaths in which an autopsy should be performed. No autopsy shall be performed without written consent of a relative or legally authorized agent. All autopsies shall be performed by the hospital pathologist or by a physician delegated this responsibility..."

The medical record form titled Record of Death had in section #6 of the form area that read as follows: " ... Autopsy Criteria Med? Yes ... No ... (Autopsy criteria listed on back of form) Physician notified of Case Meeting Criteria: --- Date --- Time ---..."

The criteria on the back of the form included the following: " ... 1. Deaths in which an autopsy may help explain unknown and unanticipated medical complications. 2. Death in which the cause is not known with certainty on clinical grounds. 3. Sudden, unexpected, or unexplained deaths, which are apparently natural and not subject to forensic medical jurisdiction. 4. Natural deaths that are subject to but waived by medical-legal jurisdiction...."

Interview with hospital staff conducted on 01/06/2010 revealed the documentation on the after death form for autopsy was determined to be a yes or no based on if the patient met the criteria as a medical examiner case and if the medical examiner accepted or not accepted the case as a medical examiners case.

The staff was not aware of the criteria established by the Medical Staff Bylaws Rules and Regulations related to autopsies.

Patient #16 was admitted to the hospital on 10/20/09 with difficulty breathing and dizziness, atrial fibrillation with a rapid ventricular response. The patient was admitted to the intensive care unit and was started on esmolol drip, Lovenox, aspirin and Coumadin. Cardiology consultation was completed. The patient was stabilized and was transferred to the telemetry unit. There was a pulmonology consult due to respiratory insufficiency. The patient was on BiPAP at night. While on telemetry on October 25, 2009 the patient was having some episode of nausea without any vomiting. The patient did not complain of any abdominal pain, chest pain, or difficulty breathing, however the nursing documentation revealed the patient had been having right flank pain and required oral and intravenous pain medication. The patient's blood pressure was running low into the 80s/50s. The patient was transferred back to the intensive care unit and an A-line was placed and the patient had stat labs completed. The patient's hemoglobin at that time came back at 5.2 on 10/25/09 at 1600. The patient was given fresh frozen plasma since the INR was 3.5 and she was also given some vitamin K. Blood transfusion was started. The patient was started on pressors to keep the blood pressure up. The patient expired after the family decided to only do comfort measure.

This was a patient who was admitted to the hospital's critical care unit, stabilized, transferred to the telemetry unit, and suddenly became critically ill with critical laboratory values and expired less than 24 hours after the change in the patient's condition.

The Death summary described the death as anemia blood loss, which was probably secondary to blood thinners. "It looks like probably the patient had some hematoma going on at the site of the Lovenox."

Patient #11 was admitted on 05/15/09 and expired on 05/16/09. The patient was admitted with a history of seizures, osteoarthritis and developmental delay who presents to the hospital with altered mental status according to the history and physical. The patient has been having flu symptoms for approximately 2 days that included fever, anorexia, and not eating or drinking anything. The patient's family member had given the patient her medications the previous night and the patient had emesis, so the family member repeated the dose of her medications. Then in the morning the patient had altered mental status and the family called 911. The paramedics documented the patient's blood sugar as 43 on arrival to the patient's home.

The patient was evaluated in the ED (emergency department) and it was determined to admit the patient to the intensive care unit. The admitting diagnosis based on the admitting history and physical revealed sepsis, right lower lobe pneumonia, acute renal failure, elevated liver enzymes, hypocalcemia, hyponatremia, thrombocytopenia and elevated cardiac enzymes. The consulting physician documented in the consultation report that the patient had required emergency endotracheal intubations and full mechanical ventilations support and was on 3 intravenous vasopressor drips. The patient developed disseminated intravascular coagulation. The patient expired.

The death record revealed no documented evidence of an autopsy being considered.

Patient #49's medical record was reviewed and revealed the patient was admitted to the hospital and expired at the hospital. The history was documented as the patient had not been feeling well for approximately two days. The patient was not eating or drinking and had symptoms that started with myalgias. No previous history of liver disease, gastrointestinal bleed. The only history documented was hypercholesterolemia.

This patient was admitted to October 4, 2008 with sepsis, acute renal failure and severe metabolic acidosis. She was admitted to the intensive care unit. ABGs (arterial blood gases) were repeated which once again showed severe acidosis with pH of 6.85. She was given Sodium Bicarbonate IV (intravenously) and repeated ABGs still showed a pH of 6.9. Nephrology was called for an emergent hemodialysis. Pulmonology was also consulted for respiratory distress and placement of hemodialysis catheter. There was no urine output. The chest x-ray showed marked pulmonary infiltrates. The patient remained acidotic. Hemodialysis was initiated in the morning of October 5, 2008. The assessment was acute renal failure with acute tubular necrosis, probably urinary tract infection, hypokalemia, anemia, and severe metabolic acidosis.

On 10/04/08 the physician had a telephone order for a DIC panel. On 10/5/08 the physician documented the patient was to be admitted to ICU at 1315 in septic shock. At 1650 there was a verbal order for PT, PTT, INR stat by the physician.

A ultrasound retroperitoneal was completed at 0729 on 10/05/08 and revealed acute renal failure as the indication. Patient unable to roll from side to side so limited exam. the summary was unremarkable appearance of both kidneys.

Ultrasound of the abdomen was completed on 10/05/08 at 1045. The documented results indicated no acute abnormality. The study is somewhat limited due to overlying bowel gas.

The physician ordered a surgical consult on 10/05/08 for possible ischemic colitis and Dr. Khan was paged.

The surgeon was consulted on October 5, 2008. The surgeon documented in the consultation report on October 5, 2008: "... I don't know, I think ischemic colitis ..." as the reason for consultation.

The medical record revealed the patient did go to surgery on the 5th of October, however there was no documentation in the progress notes by the surgeon as to the decision to take the patient to surgery when the surgeon had indicated in the consultation that the patient needed to have a CT scan completed in order to diagnose the patient to determine if surgery was indicated.

The entire case was reviewed by the Board of Medicine for Arizona and the facility shared with the surveyor that the Board did not find any failure to the level of care provided by the attending physician nor the surgeon who provided services and medical direction for the patient's care.

The patient was taken for an exploratory laparotomy for further evaluation of her lactic acidosis. No pathology was found.

On October 6, 2008 the patient continued to have bleeding from all orifices. On 10/06/08 at 0500 the RN documented blood noted on the blanket and gown. The RN documented "oozing blood from nose, eyes, mouth, and line sites. Hematology-oncology was consulted with the hematologist. The physician spent time with the family and the hematologist documented that the family made the decision to make the patient a DNR (do not resuscitate).

The patient was documented as being pronounced at 2220.

A review of the death record revealed the patient was not a medical examiners case and the documentation on the after death record indicated the patient did not meet autopsy criteria.

Interview with the Director of Nursing revealed the nursing staff mark the patient does not meet autopsy criteria when the medical examiner refuses the patient. There was no indication that the physician reviewed the patient's case to consider if this case met the governing body criteria for autopsy.

Based on review of hospital policies/procedures, staffing assignment records, and interviews with staff, it was determined that the nurse executive failed to require the acuity plan was implemented for all hospital units; that the plan included a process for determining how the accumulated patient acuity scores were interpreted for each nurse; and how adjustments would be made if the patient acuity/activity changed on one or more of the inpatient nursing units (Patient #15).

Findings include:

The hospital policy titled Staffing By Acuity System Patient Classification System (last revision 07/09) requires: "...The registered nurse will complete the Acuity Assessment form and give a verbal report to the Director/Supervisor for review. The Director/Supervisor will use the acuity levels to determine the appropriate staffing levels for the upcoming shift...Acuity Guidelines should be used in Medical/Surgical, Medical/Surgical Telemetry, Cardiac-Telemetry, and Intensive Care Unit...."

The Acuity Assessment and Staff Assignment For Upcoming Shift document requires: "...Document assignments on this form...Maintain this document with your unit staffing records...."

The Director of Nurses confirmed during an interview conducted on 01/07/2010, that the hospital employs RNs and CNAs, although the acuity policy refers to LPNs which the hospital does not employ. The DON stated: "...The acuity policy is used for the entire hospital - it's not individualized for any area other than OB (obstetrics)...each patient unit has their own interpretation of the acuity plan for example how many total points an RN can have...it differs from unit to unit...."

The Acuity plan requires the RN to assign an acuity score for each patient, for each of the following categories: Medications, Psychosocial needs, Assessment/Observation, Interventions/Treatments, and Assistance with Daily Living. The nurse assigns a score of 1 to 4 (4 being the most complicated) for each category. The scores are totaled for each patient. The total score determines the patient's complexity of care. Five (5) is the lowest possible score and 20 is the highest possible score.

The 5th floor and 4th floor Directors and the DON stated during interviews conducted on 01/06/2010 and 01/07/2010, that each nurse can be assigned no more than 50-55 points total. The policy however, does not specify how many total points a nurse can be assigned.

The 3rd floor Charge Nurse, #21, could not produce a documented acuity record and stated: "...we haven't done acuities since at least October...." RN #21 stated that patient complexities were discussed but not documented. Assignments are made based on discussions. RN #21 could not articulate the acuity plan, when asked to do so during an interview conducted on 01/07/2010 at 1300. The DON and the Clinical Director 3rd and 5th Floors were included in the interview. Both indicated that they were not aware that the 3rd floor inpatient unit did not document acuities.

The Intensive Care Unit (ICU) assigns the patients one total acuity score as 1, 2, 3 or 4 (4 being the most critical). The ICU acuity process does not include scoring each category, as the medical/surgical and telemetry units do and as the DON stated.

The acuity policy requires: "...Staffing Levels for Intensive Care Unit...Ratios: 1:2 one registered nurse to two patients...1:1 one registered nurse to one patient...1:3 one registered nurse to three patients...." The ICU staff stated that the nurse can be assigned up to 2 patients and a 3rd if the 3rd patient is a stepdown (waiting for transfer to telemetry, etc.), however the policy does not specify how many total points a nurse can be assigned.

A review of documentation provided to the surveyor related to the nursing services for Patient #15 revealed nursing acuity concerns that impacted the availability of an RN to provide services to a new admission to the fifth floor who was to be cardiac monitored.

On 01/21/2010, the surveyor reviewed the documentation indicating that there was a request to complete an analysis related to the hand off communication for an ED patient being admitted to the inpatient nursing unit. The meeting was to be held on 11/05/09. The documentation presented to the surveyor had a handwritten date on the problem list of 11/05/09. This list included 23 identified problems.

Included in these identified problems revealed the RN accepting the patient had 3 new admits and 1 transfer and a nurse was also in split hallways. The charge nurse had a patient assignment.

There was no documentation that identified if the acuity plan had been implemented that would have triggered an adjustment in the staffing to meet the needs of the patients on the nursing unit.

Based on a review of medical records, and interviews, the Department determined the nurse executive failed to require that all patients' nursing care was directed by a registered nurse (RN) and evidenced in 5 of 10 medical records reviewed, as evidenced by the failure to:

1. require that all patients admitted to the nursing unit are assessed and nursing services initiated based on the patient's needs (Patient #15);

2. document the skin assessment and treatment of a patient who received a "blister" during a surgical procedure (Patient #40);

3. to implement the orders to place the patients on telemetry monitoring (Patients #27 and #35); and

4. to take vital signs on a newly postoperative patient (Patient #31).

Findings include:

1. Patient #15 was admitted to the ED with palpitations and bradycardia at 0440 on 11/03/09. The ED orders included vitals every 4 hours, up ad lib, 1800 calorie (cal) diet, cardiac monitor and continuous pulse oximetry. In addition to these orders, the patient was to receive "ECASA (enteric coated aspirin) 325 mg po every day," Oxygen at 2 liters and laboratory studies of CK, CKMB, Troponin every 6 hours X 3.

The ED RN documented the patient was transferred to the inpatient unit room 511B at 0820, with report given to the RN.

The nursing graphic record indicated vital signs documented at 11/03/09 at 1200, of pulse 78, respirations 20, oxygen saturation 99 percent, and blood pressure 156/88. This was the only documentation of nursing care provided to this patient from 0820 until the patient signed out of the hospital.

There is no documented evidence of nursing care after admission to the inpatient nursing unit. There is an against medical advice (AMA) form signed by the patient on 11/03/09 at 1300. There is no evidence of a facility representative signature on the AMA form.

There was no documented RN assessment of the patient once the patient was transferred to the inpatient nursing unit.

An analysis of ED admission to inpatient bed was initiated by the hospital personnel and an action plan was identified, however had not been implemented at the time of the investigation.

2. Patient #40 was admitted to the hospital with a diagnosis of implant failure. The patient had a Left Total Knee Replacement on 12/16/08.

The Nursing Director of Surgical Services and the Clinical Coordinator of Surgical Services confirmed the following during interviews conducted on 1/7/10: The operative record revealed the patient was positioned supine with a 5 pound sandbag under the left hip; A DeMayo leg holder was placed for patient's left leg. The intraoperative note at 1504, revealed "blistered area approximately ? to ? posterior calf area when applying DeMayo leg holder; and Dr. (name of physician) visualized and opsite applied...."

The medical record reviewed during the week of 01/04/10, revealed no documented evidence of nursing assessment and care of the "blistered" area during the post operative period.

3. Patient #27 presented to the ED on 9/13/09 at 7:25 p.m., was admitted to "ED Holding" on 9/14/09 at 12:30 a.m., and was admitted to the nursing unit at 1:20 p.m. on 9/14/09. The physician's orders revealed an order for "cardiac telemetry" written at 2:30 a.m. on 9/14/09. The patient's record revealed the first telemetry strip was dated and timed 9/14/09 at 6:02 p.m., 15 hours and 32 minutes later.

The Medical Telemetry Director agreed, on 1/6/10, that the record did not contain documentation that the patient was placed on telemetry at the time of the physician order. The Medical Telemetry Director stated that the ED Holding area had bedside monitors but agreed the record did not contain documentation that the patient was on the monitor during that time. The Director stated that after checking the monitors on the nursing unit, she found the monitors store telemetry data for 48 hours only. There was no capability of retrieving the information from September of 2009.

Patient #35 presented to the ED on 9/7/09 at 5:16 p.m., and was admitted to the nursing unit at 10:30 p.m. A physician order was written at 5:30 a.m. on 9/08/09 for "medical floor with remote monitoring." The record revealed no documentation in the nurses notes that the telemetry monitoring was initiated. The Cardiovascular flow record did not include a "Tele Pack Number" which, the Medical Telemetry Director stated, would have recorded if the telemetry monitor had been placed on the patient. The patient's record revealed the first telemetry strip was dated and timed 9/8/09 at 6:52 p.m.

The Medical Telemetry Director agreed, on interview 1/6/10, that the record revealed a delay in starting the cardiac monitoring from the time of the order at 5:30 a.m. until 6:52 p.m. on 9/8/09, 13 hours and 22 minutes later.

4. Patient #31 was admitted to the hospital with a diagnosis of Uterine Prolapse on 4/22/08. The patient underwent surgery, beginning at 8:13 a.m. on 4/22/08, for a "total vaginal hysterectomy, with bilateral salpingo oophorectomy, cystoscopy with bilateral stent placement, removal right stent placement, and complex repair of incidental bladder injury." The record revealed the patient was admitted to the post anesthesia care unit (PACU) at 1:35 p.m. and then was admitted to the nursing unit at 3:00 p.m.

Patient #31's record revealed a nurses note dated 4/22/08 at 4:00 p.m., that the patient had been received "earlier" and that the patient was "very sedated" with the blood pressure of 95/52. A nursing assessment was documented at 4:00 p.m. and a re-assessment was documented at 6:30 p.m. on 4/22/08. No other vital signs were found to be documented in the record for the evening of 4/22/08.

The Clinical Coordinator agreed, on 1/6/10, that there was no documented evidence of Patient #31's vital signs for 4/22/08, other than the one at 4:00 p.m. The Clinical Coordinator stated that the post operative vital signs are documented frequently on a specific flow sheet. The Clinical Coordinator reviewed Patient #31's record and agreed that the vital sign flow sheet was not present in the record for the post operative period of 4/22/08.

Based on review of the policy and procedures, medical records, and interview, it was determined the Nurse Executive failed to update care plans based on the inpatient's needs for nursing services in the review of 8 of 8 nursing care plans (Patients #7, 13, 16, 21, 44, 47, 54, and 63).

Findings include:

The hospital policy, "Patient Care Plans" requires: "...A care plan will be updated and added to at least every 24 hours, according to the patient's condition and progress of illness in relationship to outcomes and goals that should be achieved by the time of discharge...Care plans will be based on the nursing assessment...."

Patient #7's Telemetry nursing notes post fasciotomy surgery on 11/14/08, included: "at 1950...Received in bed from postanesthesia care unit...right arm elevated on 3 pillows...neurovascular checks performed...patient able to make a partial fist...capillary refill less than 3 seconds...at 2010 Wound vacuum turned on as ordered...at 2035...serosanguinous fluid draining...."'

From 11/14/08 through day of discharge on 11/17/08, the nursing staff continued to document neurovascular assessments, condition of the wound dressing, and wound vacuum used and type of drainage.

On 11/13/08, the nursing care plan was initiated, and included: Alteration in Comfort, Altered Cardiovascular Perfusion, Alteration of Health Maintenance related to knowledge deficient, Potential Fluid Electrolyte Imbalance, Alteration in Coping related to Anxiety.

The nursing staff did not document or update the care plan to include the patient's problem of alteration of skin integrity of the right arm on 11/14/08, through day of discharge on 11/17/08.

The RN documented on Patient #13's plan of care as initiated on the 30th of July with problems identified, expected outcomes, and standard of care. There were no documented interventions for the problems identified from the date of admission to the date of discharge. There was no documented date and time of other problems being address on the plan of care. The patient was diagnosed with end stage liver disease and required paracentesis as well as other diagnostic procedures.

The RN documented Patient #16's care plan as being initiated on 10/20/09, with identified problems of cardiovascular, skin integrity, physical mobility and respiratory function. There was no additions or changes to the care plan until 10/25/09, when a Foley catheter was added and the plan for cardiovascular and respiratory was updated. There was no documentation evidence the patient's plan of care was adjusted to reflect the patient's change in condition that resulted in the patient's need to be transferred from the medical surgical unit to the intensive care unit with critical lab values, documented pain requiring intervention intravenously and orally, a wound identified on the buttocks, and the patient being diagnosed as terminal and expiring on the 26th of October.

Patient #21's medical record revealed the plan of care was initiated on 05/05/09, and identified physical mobility, sensory/perceptual, cardiovascular, and respiratory function. There were no documented updates to the plan of care. The patient was admitted to the intensive care unit and deteriorated throughout the hospital stay and expired on 05/08/09. There were no additions to the plan of care to include the changes in the patient's condition and to include the emotional support required for the patient and family regarding end of life decisions. The patient was restrained during the hospitalization from 05/06/09, through the time of death and this was not included in the patient's plan of care documentation.

Patient #44 was admitted to the ICU from the ED on 09/07/09, with vomiting, cough, fever, and diabetic keto-acidosis. Co-morbidities included: asthma, anxiety, gastroparesis, interstitial cystitis, and anemia. The patient was treated with aggressive IV fluids, and an insulin drip. S/he was discharged 09/10/09. The plan of care did not address the patient's diabetes.

Patient #47 was admitted on 07/24/09, for treatment of chest pain, fever, chills, and altered level of consciousness. Co-morbidities included: chronic obstructive pulmonary disease, congested heart failure, diabetes, hypertension, and left lower extremity pressure sores. The plan of care, initiated on admission, identified the following patient problems: skin integrity, comfort, mobility, sensory/perceptual deficiencies, chest pain, respiratory function altered, and knowledge deficit. The plan of care included expected outcomes, standard of care and interventions. There were no additions or changes to the plan of care that included the date and time the patient's identified problems were resolved or not resolved from 07/24/09 when the plan of care was initiated, to 07/28/09 when the patient was discharged. In addition, the plan of care did not include diabetes for which the patient received treatment.

Patient #54 was admitted to the hospital and was a post transplant patient. The physician had documented an order for the patient to use and administer his own transplant medications. The plan of care for this patient failed to address this unusual practice for a patient to administer own medications. There was no documentation as to what medications were being administer and the consistent plan for documenting and supervising the administration of the medications by the patient.

Patient #63 was admitted to the hospital and was placed on a CIWA (Clinical Institute Withdrawal Assessment Tool) medical plan. The nursing staff failed to implement the plan according to the procedure approved by the leadership of the hospital.

The policy and procedure "Managing the Patient at Risk for Experiencing Alcohol Withdrawal" revealed, in part: "Purpose: The CIWA is used to determine the amount of sedation necessary to prevent severe symptoms of alcohol withdrawal, including delirium tremens, seizures, and other severe symptoms."

The CIWA protocol listed the following medications on the physician order set:
Ativan 2 mg intravenous (IV) or intramuscular (IM) every (q) 30 minutes PRN for a CIWA-Ar score of 8 or greater; Ativan 4 mg IV for an ICU patient only dose q 30 minutes PRN for a CIWA-Ar score of 8 or greater; or, Haldol 2 mg IV/IM q 30 minutes PRN with the requirements "use only after a sufficient trial of Ativan and before administration of Haldol, magnesium level must be within normal limits and EKG (electrocardiogram) must be performed."

The record of Patient #63 revealed multiple Alcohol Withdrawal Assessment Flowsheets with the CIWA-Ar score, both at 8 or above and below 8. The record of Patient #63 revealed documentation on the CIWA flowsheet of medication with Ativan and with Haldol. The record also revealed administration of the Ativan and of the Haldol without a corresponding CIWA flowsheet, but with the medication documented in the nursing notes or on the medication administration record ( MAR ).

The record of Patient #63 revealed that, on 12/5/09 at 9:05 a.m., the nurse documented "Patient agitated. Attempted to calm. Meds given, see MAR." The MAR revealed the patient received Ativan 2 mg IV at 9:05 a.m. The nurse documented in the nursing notes, on 12/5/09 at 10:40 a.m., "Patient agitated, receiving Ativan PRN per orders." The evening nurse documented in the nursing notes, on 12/5/09 at 7:00 p.m., the patient "became restless at 1900 (7:00 p.m.), given 2 mg IV Haldol."

Patient #63's record did not contain any evidence that the patient had been scored for a CIWA -Ar score on 12/5/09, or that the Ativan or the Haldol had been given as ordered in the CIWA protocols for alcohol withdrawal.

A review of the orders for Patient #63 in the record revealed the Ativan and the Haldol were ordered only as part of the CIWA protocols. The record revealed no evidence that any chemical restraints were ordered for Patient #63.

The Chief Nursing Officer and the ICU Manager agreed, during interview on 1/8/09, that there had been some mixing of CIWA orders for alcohol withdrawal symptoms with some of the CIWA medications used for restraining Patient #63.

There was no documentation in the patient's medical record that the CIWA plan was integrated into the patient's plan of care.

Based on a review of the hospital policies and procedures, medical records, and interview, it was determined the administrator failed to require that the approved medical staff policy and hospital pharmacy policy for dispensing and preparation of Patient's Home Medications was followed, as evidenced by one of one concurrent patient administering the patient's own medications (Patient #54).

Findings include:

The hospital policy Use of A Patient's Own Medication In The Hospital revealed: "...In the event that a patient's own medication needs to be utilized due to the unavailability of the medication or acceptable alternatives at West Valley Hospital Pharmacy, the following procedure shall be followed: An order must be written specifically for each home medication that the patient will be using. Blanket orders such as 'Patient may take home meds' are NOT acceptable...."

The hospital policy Self-Administration of Medications revealed: "...Whether a patient is using his/her own medication or a medication supplied by the Pharmacy department, a patient may not self-administer his/her dose. The only time a patient may administer his/her dose is under the supervision of a qualified individual who is instructing the patient on proper technique so that the patient may appropriately administer his/her med once the patient is discharged...."

The hospital policy Ordering and Administration of Medications revealed: "...Procedure...B. Administration 1. Only medications that are dispensed from West Valley Hospital's Pharmacy may be administered...."

Patient #54's medical record revealed the physician wrote an order that the patient could take his own transplant medications.

The RN on the nursing unit responsible for the care of Patient #54 informed the surveyor that the patient has all of the patient's medications in the patient's room locked in a drawer, and the key to the drawer was kept on the patient. The medications included all medications and was not limited to the transplant medications as ordered.

The order did not specify the medications as required by the hospital policy.

The order was not questioned or clarified by the nursing staff or the pharmacy staff as to the non compliance with the hospital policy.

Based on a review of medical records, policies and procedures, and interview, it was determined surgical department personnel failed to require informed consents be completed prior to a procedure being performed for 6 of 6 patient's, as evidenced by:

1. the failure to have a signed patient consent in Patient #41's medical record prior to the surgical procedure being performed;

2. the failure of Patient #5's informed consent form to include the name of the physician who would perform a cardiac catheterization; and

3. the failure of the physician to sign, date, and time the informed consent prior to a surgical/invasive procedure being performed (Patient's #5, 13, 34, and 56).

Findings include:

The hospital policy, "Informed Consent" requires: "...The physician who will administer or supervise the treatment or procedure...is responsible for obtaining the patient's informed consent...Requires informed consent...for the following procedures...Surgical procedures...invasive medical imaging...the physician who will administer the procedures or treatment must sign the Verification of Informed Consent...For the patient's consent to be informed, the physician must provide and discuss with the patient...who will perform the procedure...."

1. Patient #41's medical record revealed the patient did not sign a consent for the hysterectomy. Patient #41 was admitted to the hospital with a complaint of pelvic pain and a diagnosis of adenomyosis. The patient was scheduled for a Total Abdominal Hysterectomy on 6/25/09.

The record revealed, on 1/5/10, that the informed surgical consent did not contain a valid patient signature. According to the "Informed Consent" dated 6/25/09, in what appeared to be the patient's writing the patient wrote that she was agreeing to the removal of her uterus. The surgeon and the anesthesiologist signed the informed consent; however, the patient did not. The patient did sign the "sterility" permit required for a hysterectomy.

The Nursing Director of Surgical Services and the Clinical Coordinator of Surgical Services, during an interview conducted on 1/7/2010, confirmed the findings that the patient did not sign the informed consent.

The hospital policy informed consent requires the physician who will administer the treatment or procedure is responsible for obtaining the patient's informed consent. The exceptions to informed consent requirements are emergencies and court order treatment. This was not an emergency or court ordered treatment.

Review of the risk management worksheet on 1/7/2010, confirmed that the physician failed to verify the patients signature on the informed consent. The physician states the consent was signed in the office and agreed to send a copy of the signed consent to be placed in the patient's record. There is no signed consent in the patient's record, greater than 6 months ago.

The patient was sent to surgery and surgery performed without an informed consent signed by the patient.

2. Patient #5 was admitted to the Telemetry Unit on 10/15/09, with 4+ mitral regurgitation and coronary artery disease.

On 10/15/09, Patient #5 had a left and right cardiac catheterization with bilateral coronary angiography.

On 01/07/10, the Chief Medical Officer (CMO) confirmed the consent form for Right and Left Heart Catheterization, dated on 10/15/09, at 1200, did not include the name of the physician who would perform the procedure.

3. On 10/15/09, Patient #5 had a left and right cardiac catheterization with bilateral coronary angiography.

On 01/07/10, the CMO confirmed the cardiologist did not include the time when he authenticated and dated the informed consent for Right and Left Heart Catheterization, on 10/15/09.

On 10/18/09, the patient had a Thrombin Injection procedure performed in the Medical Imaging Department.

On 01/07/10, the CMO confirmed the consent form for Thrombin Injection into the Right Femoral Artery, dated on 10/18/09, at 1700, did not include the Interventional Radiologist's signature authenticating that the radiologist had discussed the procedure, the risks, and benefits with Patient #5.

On 10/19/09, the patient had a Coronary Artery Bypass Graft (CABG) and a Mitral Valve Repair.

On 01/07/10, the CMO confirmed the cardiac surgeon did not include the date and time when he authenticated the informed consent for a Coronary Artery Bypass Graft and a Mitral Valve Repair to be performed on 10/19/09.

On 10/19/09, the patient had an Emergent Sternotomy with Mediastinal Exploration.

On 01/07/10, the CMO confirmed the cardiac surgeon electronically authenticated the consent form for an Emergent Sternotomy with Mediastinal Exploration on 10/29/09, at 0816, ten (10) days following the procedure.

Patient #13's documented consent on the electronic record revealed there was no date or time associated with the patient's signature consenting to the paracentesis procedure that was completed on the first of August. There was a witness signature that is not legible and it is dated 08/01/09 at 1315.

The informed consent for the paracentesis revealed a stamped authentication by the providing physician that was dated 09/25/09 at 0951. This was 24 days after the procedure was performed. There was no evidence there was informed consent provided to the patient prior to the procedure being conducted.

A review of the informed consent for the EGD dated 08/03/09, revealed the physician signature for the following statement: "...I have discussed the procedure and the information stated above with the patient (or patient representative) and answered their questions. The patient or their representative consented to the procedure...." There was a typed or stamped entry that included Authenticated by (name of physician) on 10/12/2009 at 02:25:41 PM. This was greater than two months after the procedure was performed. There was no documented evidence the patient was provided informed information regarding the procedure prior to the procedure being performed by the physician.

Patient #34's medical record revealed a consent for blood transfusion that was signed by the patient on 10/02/09, and witnessed by a hospital staff member on the same date. The physician authentication was completed on 12/06/09 at 0932, as an electronic authentication. This was two months after the consent was signed. The patient died at the hospital on 10/21/09. The physician authenticated the consent form not only two months after the consent was signed but also 46 days after the patient expired.

Patient #56's informed consent form was titled Cardio Vascular Invasive Lab. The form had the patient's name on the top of the form. The form had a typed in statement that included the following: "...Left heart catheterization with possible percutaneous transluminal coronary angioplasty, possible stent placement, possible intra-aortic balloon pump insertions, possible temporary pacemaker, renal angiography, and stent placement and possible arterial closure device...." The next statement on the form revealed a second procedure name (if applicable) including the following: "...I consent to the performance of any related or procedures other than or in addition to the above if deemed necessary or advisable by my physician for therapeutic or for diagnostic purposes during the course of the operations or procedures performed above...."

The facility name was blank, the reason for the procedure was blank, who was to do the procedure or supervise the procedure was blank, and there was no identified key team members that would be assisting with the procedure. The patient signed a blank form on 01/03/2010 at 1915. The form was witnessed by an RN on 01/03/1010 at 1915. The physician signature was documented as having signed the informed consent form at 0900 on 01/03/2010.






17939

Based on review of medical record and interview, it was determined the Administrator did not require a Labor and Delivery Anesthesiologist document administering epidural medication on the Anesthesia Record form for Patient #22.

Findings include:

The Hospital document, "Epidural Competency" requires: "...policy at West Valley Hospital...does not allow RN's (registered nurse) to inject epidural bolus drugs, regulate the narcotic rate, and/or change any tubing. Intrathecal medications are administered only by the physician...."

Patient #22 presented to Obstetrics (OB) triage on 03/26/08, at 1410, for a Non stress test (NST) and was then admitted to Labor and Delivery (L&D), at 1530, for induction of labor. The patient was 39 week gestation with oligohydramnios, gravida 1, para 0.

On 03/27/08, at 0159, the anesthesiologist initiated an epidural, and documented the treatment on the Anesthesia Record.

At 1133 the L&D registered nurse documented the anesthesiologist had given the patient a bolus dose of the epidural.

On 01/05/10, the Director of Women's Infants Services confirmed the anesthesiologists are responsible for epidural initiation, administration, monitoring and documentation.

She reviewed Patient #22's Anesthesia Record and confirmed the anesthesiologist did not document what and how much of the epidural medication was given on 03/27/08, at 1133.