HospitalInspections.org

Based on review of meeting minutes and interviews, it was determined that the hospital failed to comply with the provisions of the Governing Body, that require the Governing body to assume responsibility for the hospital as a separately certified institution, and holding it accountable for the quality of care, as demonstrated by:

the hospital did not maintain a separate governing body to ensure focus on the hospital's individual issues. The hospital shared a single governance with multiple Banner owned/operated facilities, and separately certified hospitals.

The cumulative effect of this systemic deficient practice resulted in the hospital's failure to meet the requirements of the Condition of Participation (COP) for the Governing Body.

Findings include:

The hospital's administration/management confirmed during the entrance conference conducted on 06/15/10, that Banner Del Webb Medical Center is separately certified and licensed from other Banner-based hospitals/entities.

The Staff Member/Secretary MD, representing the Governing Board, indicated during a teleconference conducted 06/16/10 at 1300, that the governing body is made up of 15 members who meet quarterly, and represent all Banner hospitals system wide. The Staff Member Secretary/MD stated, "...the same group looks at all (Banner) hospitals...." S/he indicated that individual hospital discussions/memos are appended to the Governing Body minutes.

The Interim Quality Manager stated during an interview conducted on 06/16/10 at 1300, "...Banner is the governing board - we don't have a separate governing board for each hospital...." S/he stated that the governing body meeting minutes were maintained "at the Banner corporate office." The surveyor requested the most recent minutes related to Banner Del Webb Medical Center. The minutes were provided for review on 06/17/10, and revealed the following:

The Minutes of the Regular Session of the Board of Directors Meeting of Banner Health, 11 page report dated 12/05/09, and 15 page report dated 03/13/10, Banner Health Care Management and Quality Committee meeting minutes, 6 page report dated 12/04/09, and 18 page report dated 03/12/10, indicated, "...this Board constitutes the 'governing body' for the following facilities owned by Banner Health...." Twenty-two (22) entities were listed.

The meeting minutes confirmed that the Governing Body discussed multiple separately certified hospitals, at the same time, at the same meeting, and did not focus on Del Webb Medical Center's specific issues, as a separately certified hospital.

The Chief Executive Officer confirmed during the exit conference conducted on 06/23/10 at 1700, that Banner Corporation has one governing body for all Banner owned and operated entities.

Based on review of hospital policies/procedures, Medical Staff Rules and Regulations, medical records, and interviews, it was determined the hospital failed to require patients were informed, prior to obtaining consents, as demonstrated by:

1. the consent for "Cesarean Section, Tubal Ligation" was obtained according to physicians' "standing orders" with no documentation to confirm that the orders were patient specific, for 1 of 1 obstetric patient (Patient #20); and

2. blood transfusion consents were obtained without a physician's order, for 2 of 2 obstetric patients (Patients #10 and 20), and 3 of 4 surgical patients (Patients #34, 35, and 37).

Findings include:

The hospital policy titled Consent Policy #9653.2 (effective 02/09) requires: "...Informed Consent...is...based upon a clear, concise explanation of the Patient's condition, any proposed treatments or procedures, the material risks and benefits of the proposed treatment and significant alternatives, and the identity of the physician who has primary responsibility for the procedure...."

1. The Medical Staff Rules and Regulations require: "...A physician order is needed...to complete a consent for surgery form, which confirms that the physician has obtained informed consent. The order will state the specific procedure to be performed...The surgeon is responsible for signing, dating and timing the orders...verifying that the correct surgical procedure has been indicated...."

The hospital policy titled Consent Guidelines #7391.2 (effective 02/09) requires: "...The responsible practitioner will discuss with the patient...adequate information about the Surgical Services so that an informed decision can be made...."

Patient #20 was admitted in labor on 06/20/10 at 0533. The physician's standing order 06/20/10 (no time) required, "consent for Cesarean Section, Bilateral Tubal Ligation." The patient signed a consent for "Primary Cesarean Section." The tubal ligation was not performed. There was no documentation to determine why the consent was not obtained according to the physician's order.

The Director of WIS indicated during an interview conducted on 06/16/10, that the tubal ligation likely did not apply to to the patient who was having her first baby, and confirmed that the physician's "standing order" was not specific to Patient #20.

2. The hospital policy titled Practitioner Orders: Accepting, Transcribing, and Signing-Off #9362.2 requires: "...Orders are required for all tests, services and procedures...."

The hospital policy titled Pre-Operative Preparation, General #4300.6 (effective 03/09) requires: "...Obtain signature on 'Authorization or Refusal to Authorize Transfusion of Blood' on Blood Products form, if ordered...."

The hospital policy titled Consent Policy #9653.1 (effective 02/09) requires: "...Treatment/Interventions Require...Separate Written Informed Consent:...All transfusions of blood and blood products...."

The RN Clinical Manager stated during an interview conducted on 06/23/10, "we routinely get the consent for blood transfusion on any surgical patient."

Patient #10 was admitted in labor on 06/18/10 at 0526. The consent for transfusion was obtained at 0545. There was no documented physician's order to obtain the transfusion consent, no documentation to conclude that the physician considered a transfusion, that the patient was transfused, or that the consent was informed.

Patient # 20 was admitted in labor on 06/20/10 at 0533. The consent for transfusion was obtained at 0640. The obstetrician visited at 1854, and performed a Primary Cesarean Section for fetal distress at 1935. There was no documented physician's order to obtain the transfusion consent, no documentation to conclude that the physician considered a transfusion, that the patient was transfused, or that the consent was informed.

The Director of Surgical Services, and the Senior Clinical Manager of Surgical Service's confirmed during interviews conducted on 06/16/10, that the physicians did not order consents for authorization/refusal for transfusion of blood/blood products, that were obtained for 3 of 4 surgical patients (Patient #34 on 06/17/10, Patient #35 on 06/04/10, and Patient #37 on 06/14/10).

Based on review of hospital policy/procedure, medical records, and interview, it was determined that the hospital failed to require that a restraint is used only when less restrictive interventions have been determined to be ineffective for 1 of 3 patients (Pt #1).

Findings include:

The hospital's policy and procedure titled Restraint Use in Non Emergent Situations required: "...Definitions:...Restraint Use in Non-emergent Situations: Restraints applied in situations where less restrictive interventions have failed to produce the desired behavioral change to protect the patient from interfering with medical treatment or risk of physical harm...Procedure/Interventions:...Assessment and Alternative Interventions:...Implement preventive strategies and alternative interventions to meet the patient's needs and eliminate the cause of behaviors that put the patient at risk for restraint use. Several different measures may be required...Document the assessment, preventive strategies and alternative interventions that have been implemented and the results...Document the following in the medical record...alternative interventions used prior to initiation of restraints and the effectiveness...."

Pt. #1 was admitted to the hospital on 06/09/10. The medical record contains information to indicate that he required intubation and mechanical ventilation and was receiving treatment in the Intensive Care Unit (ICU). On 06/13/10, documentation indicates that Diprivan was started by intravenous infusion at 1411. He was on a mechanical ventilator at 1510. At 1600, an RN recorded a physician's order for soft wrist restraint. The order does not indicate whether to utilize single or bilateral wrist restraints. The reason for restraint is: "Facilitate Treatment...Placed on Ventilator." The space for duration of restraint is blank.

At 1744, documentation indicates that bilateral wrist restraints were initiated at 1600. Reason: "...Removing lines, dressings, equipment..." Space to document "Alternative attempted prior to restraint:" is blank. The record contains physician orders for "Fentanyl (Sublimaze) 25-50 mcg sol (solution) q (every) 30 min. (minutes) prn (as needed) agitation and Lorazepam .5 mg IV (Intravenous) q 8 h (hours) prn anxiety." The medical record contains no documentation that either of these medications were utilized or considered to be utilized as an alternative to the wrist restraints.

The Clinical Manager of the ICU confirmed during an interview conducted on 06/16/10, that the documentation did not include less restrictive alternatives utilized prior to application of wrist restraints.

Based on review of hospital policy/procedure, medical record, and interview, it was determined that the hospital failed to require restraints were discontinued as soon as possible, for 1 of 3 patients (Pt #1).

Findings include:

The hospital's policy titled Restraint Use in Non Emergent Situations, required: "...Policy...Non-emergent restraint will be an intervention of last resort to prevent interference with medical treatment. Restraints will be used in the least restrictive manner possible and will be discontinued as soon as possible...."

For specifics regarding patient #1, reference A-0164 Patient rights: Restraint or Seclusion.

Pt #1's medical record revealed that on 06/13/10, a nurse started an IV infusion of Versed at 1635. At 1744, a nurse documented that bilateral wrist restraints were initiated at 1600 due to the patient's "removing lines, dressings, equipment." At 1744, the nurse also documented the patient's response to restraint: "Sleeping." On 06/13/10, at 1844, a nurse documented that the patient remained in bilateral soft wrist restraints due to "continued behavior leading to restraint." The nurse also documented the patient's response to restraint, "Sleeping." At 2000, a nurse documented that the restraints were discontinued: "Pt. sedated...easily arousable...Calm and cooperative...."

The Clinical Manager of the ICU confirmed during an interview conducted on 06/16/10, that the documentation was not sufficient to explain why restraints would remain on the patient when the patient's response was "sleeping."

Based on review of hospital policies, documents, medical records, and staff interviews, it was determined that the hospital failed to comply with the provisions for Quality Assessment and Performance Improvement (QAPI) to identify and establish priorities that ensure clinical quality, process improvement, and patient safety, and by evaluating, implementing, and monitoring corrective actions, as demonstrated by:

A-0266: the hospital's QAPI process failed to identify, evaluate, require corrective action, and monitor processes, to ensure the health and safety of patients, related to medication ordering and administration, infection control, restraints, and patient consents.

The cumulative effect of this systemic deficient practice resulted in the hospital's failure to meet the requirement for the Condition of Participation for Quality Assessment and Performance Improvement.

Based on review of hospital policies, documents, medical records, and interviews, it was determined that the hospital's QAPI process failed to identify, evaluate, require corrective action, and monitor processes, to ensure the health and safety of patients, related to medication ordering and administration, infection control, restraints, and patient consents.

Findings include:

The hospital policy titled Banner Health Quality Plan #2878.7 (effective 05/10) requires: "...Criteria used for establishing priorities may include...clinical quality, patient safety...regulatory compliance...high risk or problem prone areas...When data indicates...an opportunity to move to a new level of performance, improvement projects are established...Define the project, Measure current performance, Analyze to identify causes, Improve, Control...The Care Management and Quality Committee of the Board...has the following duties and delegated responsibilities...Data for monitoring the effectiveness and safety of services and the quality of care...including clinical outcomes, patient safety...Quality Management:...Identification of patients...needs...Measurement and monitoring of process outcomes...Identification of improvement opportunities...."

The Director of Quality Management (DQM) indicated the following, during a teleconference conducted on 06/10/10 at 1430:

The DQM was uncertain as to the requirement for physicians to write orders for consents, and no monitoring was in place in ensure patients were informed (reference A-0131).

The DQM indicated that "all restraints are audited." The monitoring did not identify that restraints were initiated only when less restrictive actions had been attempted and determined ineffective, and that restraints were discontinued at the earliest possible time (reference A-0164 and A-0174).

There were no audits for physicians' authenticating orders (signature, date, time). The DQM stated: "...I would think the 24 hour chart checks would pick up on that...." (reference A-0353).

Nursing audits did not identify medication errors related to unclear and/or incomplete physicians' orders. The DQM stated: "...the (audit) tool is not developed as well as it should be or needs to be, or we need to work with the auditors...." The DQM indicated that s/he was not informed of what exactly the nursing audits address (reference A-0405).

Pharmacy medication errors are investigated from occurrence reports or "through their own (the pharmacy) internal investigations - aggregate data is reported to QA (Quality Assurance)." The DQM was not aware that the pharmacy QA (Quality Assurance) process missed opportunities to clarify physicians' orders, and to identify that medications were administered according to complete physicians' orders (reference A-0492).

The DQM stated that "handwashing in the dialysis unit is absolutely monitored." The DQM indicated that s/he was not aware that handwashing was monitored by the dialysis staff, and that the monitoring did not identify deficient practices (reference A-0749).

Based on review of hospital policies/procedures, Medical Staff Bylaws, Rules and Regulations, medical records, and interviews, it was determined that the medical staff failed to enforce their bylaws as demonstrated by:

1. physicians' orders were incomplete for 1 of 1 patients (Patient #1);

2. "Standing Orders" were not reviewed and updated annually, according to the Medical Staff Bylaws Rules and Regulations, for 5 of 9 pediatricians (Physicians #10, 11, 12, 13, and 14);

3. physicians' orders for Fentanyl and Xopenx were not re-written for clarification, for 2 of 2 patients (Patients #1 and 2);

4. physicians' orders were not authenticated with signatures, dates, and times, for 7 of 7 patients; and

5. hypoglycemia management and Pitocin infusion ordered "per protocol," were not included in the medical records, for 2 of 2 patients (Patient #2 and 20).

Findings include:

1. The Medical Staff Rules and Regulations require: "...All medication orders must be complete including medication name, dose, route, and frequency...."

Patient #1:

06/10/10 (no time): "IVF (intravenous fluids) bolus 500 cc x 1." Solution type not identified.

06/13/10 (no time): "Propofol for sedation to keep at Ramsey 3." Dose, route, and frequency parameters not identified.

06/13/10 (1530): "Midazolam (Versed)...Start infusion at 2 mg/hr...." No sedation scale ordered.

06/09/10: "Ancef 2 gms." Route not identified.

06/14/10 (no time): "wean off Levophed as possible...MAP (mean arterial pressure) of 60 or sys BP (systolic blood pressure) greater than 100." Weaning parameters i:e: frequency, rate, and amount, not identified.

06/15/10 (1045): "Esmolol...maintain SBP (systolic blood pressure) less than___mm/Hg or HR (heart rate) less than____." Parameters not identified.

06/15/10 (no time): "May run Esmolol at 1/2 dose 25 mcg/kg/hr." The physician did not clarify if the medication was to be administered at 25 mcg/kg/hr (1/2 dose of the usual protocol) or 1/2 of 25 mcg/kg/hr = 12.5 mcg/kg/hr.

06/15/10 (1100): "start Neosynephrine...then wean Esmolol." The Neosynephrine orders did not identify the strength, starting/weaning dose, frequency, or parameters. Esmolol weaning parameters were not identified.

2. The hospital policy titled Practitioner Orders: Accepting, Transcribing, and Signing-Off #9362.2 (effective 04/09) requires: "...Standing orders must include the specific duration and frequency and will only be valid for up to 12 months...."

The Director of Women/Infant Services (WIS) stated during an interview conducted on 06/18/10 at 1100, that physicians' standing orders are updated and approved annually.

Nine(9) currently privileged and practicing pediatricians' Nursery Admission Order Set(s) were reviewed to confirm annual updates/approval. Documentation confirmed that Five (5) of the 9 order sets had not been reviewed and updated for 2 or more years, for physicians #10, 11, 12, 13 and 14. The Director of WIS verified the outdated standing orders, during the interview conducted on 06/18/10.

3. The hospital policy titled Practitioner Orders: Accepting, Transcribing, and Signing-Off #9362.2 require: "...Orders as originally written cannot be changed or modified. Clarifications are to be re-written as a new order...."

The Medical Staff Rules and Regulations require: "...All practitioners entries in the record must be legible, pertinent, complete, and current...."

Patient #1: The physician's telephone order on 06/15/10 (no time), was documented: "...fentanyl IVP (intravenous push) 50 mg x 2...." The order was originally written as "25," then marked over with "50." The order was not re-written for clarification.

Patient #2: The physician's telephone order on 06/13/10 (0415), was documented: "...start Xopenx SVN (small volume nebulizer)...." The pharmacy's copy of the original order was stamped with a message to the physician that instructed: "...please clarify the dose, strength and/or frequency of this medication. Please rewrite order and re-scan to Pharmacy...." The same order, reviewed on 06/16/10, included, "...start Xopenx SVN .63 Q (every) 8 H (hours)...." The order was amended, and not re-written for clarification, according to the policy.

The Director of Nurses confirmed the order findings during medical record reviews, and interview conducted on 06/18/10.

4. The Medical Staff Rules and Regulations, require: "...Where a practitioner has written a set of orders or is using a preprinted order set continued on one page or on several pages, the practitioner must sign, date, and time each page of orders...."

The hospital policy titled Practitioner Orders: Accepting, Transcribing, and Signing-Off #9362.2 requires: "...Orders must be dated, timed and signed by the ordering practitioner...."

Physicians' written/telephone orders were not authenticated with the signature/date/time, as follows:

Patient #1: 26 of 66 physicians' orders dated 06/09/10 through 06/15/10.
Patient #2: 30 of 64 physicians' orders dated 06/09/10 through 06/15/10.
Patient #4: 20 of 24 physicians' orders dated 06/14/10 through 06/17/10.
Patient #5: 30 of 55 physicians' orders dated 06/11/10 through 06/16/10.
Patient #6: 52 of 82 physicians' orders dated 06/05/10 through 06/17/10.
Patient #7: 47 of 88 physicians' orders dated 06/05/10 through 06/17/10.
Patient #8: 9 of 24 physicians' orders dated 06/15/10 through 06/17/10.

The Director of Nurses confirmed during medical records reviews and interview conducted on 06/18/10, that the orders were not authenticated with the physicians' signatures, dates, and times.

5. The Medical Staff Rules and Regulations, require: "...No 'Per Protocol' Medication orders...using the words 'per protocol' constitutes an invalid order and must be clarified...unless the order refers to a specific Medical Staff approved protocol...and includes the name and/or number of the protocol, and a written copy is available...."

The hospital policy titled Medication Orders #3656.6 (effective 08/09) requires: "...Definition:...Protocol: specific set of guidelines based on clearly defined parameters approved by the Medical Staff...."

Patient #2: The physician ordered, "...hypoglycemia protocol" on 06/10/10 (no time), however, there was no documented "hypoglycemia protocol" available in the medical record. The Director of Nurses confirmed the absent hypoglycemia protocol, during the medical record review, and interview conducted on 06/18/10.

Patient #20: The physician ordered, "start Pitocin per protocol" on 06/20/10 (no time). There was no "Pitocin protocol" available in the medical record. The Director of WIS confirmed the absent Pitocin protocol, during the medical record review and interview conducted on 06/16/10.

Based on review of hospital policies/procedures, medical records, and staff interviews, it was determined that the nursing staff failed to administer patient medication, as the physician(s) ordered and intended, as demonstrated by:

1. the nursing staff did not clarify physicians' orders for type, route, dose, frequency, and parameters, prior to administration, for 2 of 2 patients (Patients #1 and 20); and

2. the nursing staff did not administer medications according to physicians' orders, for 3 of 5 patients (Patients #1, 7, and 8).

Findings include:

The hospital policy titled Practitioner Orders: Accepting, Transcribing, and Signing-Off #9362 (last reviewed 04/09) requires: "...Orders as originally written cannot be changed or modified. Clarifications are to be re-written as a new order...Orders that are not legible will be clarified with the responsible physician before they are carried out...All handwritten and paper-based orders will be dated, timed and authenticated by the responsible physician...Telephone/verbal orders shall be countersigned by the responsible physician according to the Medical Staff Rules and Regulations...Telephone and verbal orders are read back to the physician/practitioner for verification prior to implementation...All orders must be reviewed by an RN prior to implementation...."

The hospital policy and procedure titled Medication...Taper/Titrate Orders, requires: "...adjust dose and/or flow rate to achieve desired parameters specified by the physician or LIP (licensed independent practitioner)...."

1. The nursing staff did not clarify the following incomplete physician's medication orders, prior to administration:

Patient #1:

06/13/10 (no time): "Propofol for sedation to keep at Ramsey 3." The medication was initiated on 06/13/10 at 1411, at 50 mcg/kg/min (micrograms/kilogram/min), decreased to 10 mcg/kg/min, then discontinued at 1552. The order did not identify the dose, route, or frequency parameters.

06/15/10 (1045): "Esmolol...maintain SBP (systolic blood pressure) less than___mm/Hg (millimeters/mercury) or HR (heart rate) less than____." The order did not identify the desired patient parameters.

06/15/10 (no time): "May run Esmolol at 1/2 dose 25 mcg/kg/hr (hour)." The nurse initiated the medication at 25 mcg/kg/hr, however, the order was not clarified to verify if the physician intended the medication to be administered at 1/2 the usual (order set) 50 mcg/kg/hr (25 mcg/kg/hr) or, 1/2 of 25 mcg/kg/hr = 12.5 mcg/kg/hr.

06/15/10 (1100): "start Neosynephrine...then wean Esmolol." The order did not identify the strength, starting/weaning dose, frequency, or parameters of administration for either medication.

Patient #20:

06/20/10 (no time): "start Pitocin per protocol." There was no order set/protocol included in the medical record to clarify the route, dose, frequency, and desired patient parameters.

2. The nursing staff did not administer the following medications, according to physicians' orders:

Patient #1:

06/09/10 (no time): "Propofol...start infusion at 5 mcg/kg/min every 5 minutes...titrate 5 mcg/kg/min...maximum of 50 mcg/kg/min." The medication was not initiated until 06/13/10 at 1411. There was no documentation to verify why the medication was not initiated when the physician ordered it, or that the physician was notified of the delay.

06/13/10 (1530): "Midazolam (Versed)...Start infusion at 2 mg/hr...." No sedation scale ordered. The medication was initiated at 1635 at 1 mg/hr, titrated, then discontinued on 06/17/10 at 0642. There was no order to initiate the Versed at 1 mg/hr, and no order to discontinue the Versed on 06/17/10.

06/15/10 (1100): "start Neosynephrine...then wean Esmolol." Neosynephrine was initiated at 2230, according to the medical record. Esmolol was never initiated. The pharmacist indicated during the record review and interview conducted on 06/18/10, that Esmolol was never dispensed, pending order clarification.

Patient #7:

06/10/10 (no time): "...Norepinephrine...Initiate...at 2 mcg/min. and titrate every one minute by increments of 5 mcg/min (Max rate=50 mcg/minute) to maintain: MAP (mean arterial pressure) greater than 65 mmHg...." The medication administration record (MAR) revealed RN #9 initiated the medication at 8 mcg/min., rather than 2 mcg/min., as ordered.

06/10/10 (no time, no date): "Midazolam (order set): "...infusion at 2 mg/hr. Titrate 1 mg/hr, Max of 8 mg/hr...." The MAR revealed RN #9 initiated the medication at 4 mg/hr., rather than 2 mg/hr., as ordered.

06/10/10: "...Fentanyl (Sublimaze)...start infusion at 25 mcg/hr. Titrate 25-100 mcg/hr IV...." The MAR revealed RN #9 documented the medication was initiated at 50 mcg/hr., rather than 25 mcg/hr, as ordered.

Patient #8: 06/15/10: "...Diltiazem...Start infusion at 10 mg/hr, may titrate by 5 mg/hr every 15 minutes, to a max dose of 15 mg/hr. IV...." The MAR revealed RN #10 initiated the medication at 15 mg/hr., rather than 5 mg/hr., as ordered.

The Senior Clinical Manager of ICU and the Director of Nursing, confirmed the findings of incorrect medication dosing and titration, during interviews conducted on 06/16/10.

Based on review of hospital policies, Medical Staff Rules and Regulations, medical records, and staff interviews, it was determined the pharmacist failed to require that physicians' orders were clarified, for 2 of 2 patients (Patients #1 and 20).

Findings include:

The hospital policy titled Practitioner Orders: Accepting, Transcribing, and Signing-Off #9362 (last reviewed 04/09) requires: "...Orders as organically written cannot be changed or modified. Clarifications are to be re-written as a new order...."

The Medical Staff Rules and Regulations require: "...All medication orders must be complete including medication name, dose, route, and frequency...."

There was no documentation to confirm that the following incomplete physicians' orders were clarified:

Patient #1:

06/09/10: "Ancef 2 gms." Route unidentified.

06/10/10 (no time): "IVF (intravenous fluids) bolus 500 cc x 1." Solution type not identified.

06/13/10 (no time): "Propofol for sedation to keep at Ramsey 3." Dose, route, or frequency parameters not identified.

06/13/10 (1530): "Midazolam (Versed)...Start infusion at 2 mg/hr...." No sedation scale ordered.

06/14/10 (no time:) "wean off Levophed as possible...MAP (mean arterial pressure) of 60 or sys BP (systolic blood pressure) greater than 100." Weaning parameters i:e: frequency, rate, and amount not identified.

06/15/10 (1045): "Esmolol...maintain SBP (systolic blood pressure) less than___mm/Hg or HR (heart rate) less than____." Parameters not identified.

06/15/10 (no time): "May run Esmolol at 1/2 dose 25 mcg/kg/hr." No clarification to determine if the medication was to be administered at 25 mcg/kg/hr (1/2 dose of the protocol) or 1/2 of 25 mcg/kg/hr = 12.5 mcg/kg/hr.

06/15/10 (1100): "start Neosynephrine...then wean Esmolol." The order did not identify the medications' strengths, starting/weaning doses, frequencies, or parameters.

Patient #20: 06/13/10 (no time): "Propofol for sedation." Dose, route, or frequency parameters not identified.

The pharmacist confirmed the incomplete orders, during interviews conducted on 06/18/10.

Based on observations during tour, review of hospital policies, documents, medical records, and staff interviews, it was determined the hospital failed to comply with the provisions for Physical Environment to identify, evaluate, and implement corrective actions related to the hospital's physical environment to ensure the health and safety for all patients, as demonstrated by:

A-0701: the psychiatric units contained multiple environmental safety hazards that were not identified and corrective actions taken, when patients at high risk for self-injury were present;

A-0724: hemodialysis equipment and practices were not maintained including testing the pHoenix meter, machine disinfection was not documented for verification, negative residual bleach post disinfection were not documented, total dissolved solids (TDS) monitor alarms were not set at the appropriate level, machine pH and conductivity were not documented appropriately, and the bicarbonate solution was not mixed according the the manufacturer's instructions; and

A-0726: policies were not developed and implemented for monitoring, maintaining, and documenting the obstetric unit's surgical suites temperatures and humidity.

The cumulative effect of these systemic deficient practices resulted in the hospital's failure to meet the requirement for the Condition of Participation for the Physical Environment.

Based on observation, review of hospital policy/procedure, and interview, it was determined that the hospital failed to develop and maintain the environment in the psychiatric units to assure the safety and well-being of patients.

Findings include:

On 6/22/10, during tour of the Medical Psychiatric Unit located on 4A, the patient bathroom in room 415 was observed to contain two grab bars and a toilet fixture which present safety hazards for patients who may be self injurious. In addition, the two patient beds in the room were observed to have electrical cords and cords attached to the nurse call system which were of sufficient length to be safety hazards. A sink in the patient room had exposed pipes which also presented a safety hazard.

The Director of Behavioral Health Services confirmed that all of the patient rooms and bathrooms on 4 A contain the same fixtures and equipment. When asked if she was aware of modifications of the grab bars which could be made to prevent suicide attempts, she was unaware of such possible modifications. In addition, the Director confirmed that frequently patients use the bathrooms without direct supervision. During tour, several patients on 4A were observed resting in their rooms without supervision and many were observed to be independently ambulating.

Two shower rooms are located on 4A, since the individual patient bathrooms do not include showers. One shower room was directly observed to contain a hand held shower head with a hose of sufficient length and a shower fixture of sufficient length to jeopardize patient safety. The Director confirmed that some patients are able to shower independently.

The 4A Unit contains 11 semi-private rooms; a total of 11 bathrooms, 11 sinks, and 22 beds. During interviews conducted with the Director of Behavioral Health Services on 6/22/10, she described the patient population as age 55 and over, with primary psychiatric disorders. The patients may also have comorbid medical conditions requiring medical and nursing care, but the psychiatric diagnosis must be the principal reason for admission. The medical condition of the patients are not of sufficient severity to require hospitalization for the medical condition itself.

During tour of the 12-bed Dementia Unit located on 4W, the patient bathroom in W459 was observed to have exposed pipes under the sink, grab bars and a toilet fixture which present safety hazards. The electrical cords attached to the bed and the nurse call system also presented safety hazards.

The 4W Unit contains 12 private rooms; a total of 11 bathrooms (including sinks), and 12 beds. All rooms contain the same beds and nurse call system. All bathrooms contain the same fixtures. Ten bathrooms are equipped with half-doors to permit observation of the patient by staff standing outside of the bathroom itself. However, not every patient is directly observed while in the bathroom.

On 6/23/10, the Social Worker responsible for Utilization Review confirmed during interview that patients are admitted to Behavioral Health Services due to danger to self, danger to others or psychosis.

The BDWMC (Banner Del Webb Medical Center) Plan for the Provision of Care; Behavioral Health SAGE Units 2010 Scope of Service revealed: "...provides an inpatient program for persons over 55 years of age, with severe disabling psychiatric symptoms or cognitive impairment...Type and ages of patients:...Patients must have a principal diagnosis which is one of the 13 CMS which consists of psychiatric symptom disorders that require intensive treatment that cannot be performed on an outpatient basis...Patients must have severity of illness and medical necessity requiring 24 hour hospital care. Patients with medical comorbidities may be admitted however the psychiatric diagnosis must be the principal reason for admission...."

The hospital policy titled Behavioral Health: Suicide and Self-harm Precaution Protocol revealed: "...Patients who present as a suicide risk through gestures, statements, and or circumstances surrounding the admission will be placed on one of three levels of suicide precaution:...Minimum Close Watch...Patients having suicidal ideation and/or other risk factors...Minimum Interventions...Bathroom Use: Door may be closed, however patient must be visualized if in the bathroom at the time of a scheduled 15 min. round check...Conduct a search to remove patient contraband or other potentially dangerous items from the patient's immediate environment...Suicidal Risk Factors:...History of depression or other mood disorders including schizophrenia and bipolar disorder...Chronic or terminal illness or uncontrollable pain...."

The American Institute of Architects' 2006 Guidelines for Design and Construction of Health Care Facilities, pp. 60 & 61 revealed: "...3.8 Psychiatric Nursing Unit...A3.8.1.4 A safe environment is critical...Patients of inpatient psychiatric treatment facilities are considered at high risk for suicide; the environment should avoid physical hazards while maintaining a therapeutic environment...Staff awareness of their environment, latent risks of that environment, and the behavior risks and needs of the patient served in the environment are absolute necessities...."

Patients admitted to Behavioral Health Services are at high risk for self-injury and there are numerous environmental factors which present serious safety hazards.

Based on observations during tour, review of hemodialysis documents, and staff interviews, it was determined that the hospital failed to require equipment and practices were maintained, related to hemodialysis, as demonstrated by:

1. the pHoenix Meter (dialysis) was not tested daily in order to ensure accuracy in determining the hemodialysis machines' conductivity;

2. residual bleach was not verified and documented for hemodialysis machines, prior to treatment;

3. hemodialysis machines were not bleached or heat disinfected after treatment;

4. Total Dissolved Solids (TDS) monitor alarms were not set at twice the level of the initial TDS readings for the hemodialysis machines, according to the manufacturer's recommendations;

5. the hemodialysis machines' pH and conductivity were recorded when the machines were not in use;

6. the hemodialysis machines' pH and conductivity were recorded when the machines were in use; and

7. the staff did not mix the bicarbonate solution for dialysate, according to the manufacturer's instructions.

Findings include:

The following was observed during the tour conducted on 06/15/10:

The hospital maintains a Dialysis Unit, and provides bedside hemodialysis for patients in the Intensive Care Unit (ICU). Hemodialysis is performed using Fresenius H and K machines, that are equipped with individual portable reverse osmosis filters (membranes) and carbon tanks. The acid and bicarbonate solutions are mixed in jugs.

The RN Dialysis Unit Director provided the following on 06/22/10:

Osmonics ZyzaTech Water Systems manual (F-801).
Fresenius A2008 Hemodialysis System Operators Instructions (E and K).
Water and Dialysate Culture (log) 2010.
Equipment Checklist (2010).
pHoenix Meter Calibration Guide.

The Fresenius H machine manual was not available.

1. The pHoenix Meter Calibration Log Sheet requires the meter to be disinfected, rinsed, and verified daily. On 06/15/10 at 1015, dialysis RN #33, stated that the meter is verified daily before any patients are initiated on hemodialysis. RN #33, confirmed that the Patient Care Technician (PCT) performs the daily checks.

The Log Sheet revealed NO meter checks on the following days when patients were dialyzing, according to the Renal Dialysis Schedule:

03/10: 02, 06, 09, 14, 16, 20 through 23, 25, 26, 28 through 30.
04/10: 01, 04 through 10, 15, 18, 24, and 31.
05/10: 08, 16, 22, 25, and 30.
06/10: 01, 05, 06, 08, 13, and 14.

Three (3) patients were dialyzing at the time of the tour conducted on 06/15/10. PCT #32 stated that the log sheet was used to document conductivity tests for each dialysis machine, and confirmed that s/he had not verified the pHoenix Meter on the day of survey, 06/15/10.

The RN Dialysis Unit Director, and the Biomedical Technician, both stated during interviews conducted 06/19/10, that the pHoenix Meter requires daily documented verification to confirm the individual hemodialysis machines and dialysates operate at the correct conductivity.

2. The hospital document titled Chapter 5 - Disinfection and Maintenance (2008K Operator's Manual) requires: "...When chemicals are used internally, machines must be thoroughly rinsed and tested for residual disinfectant before using the machine for treatment...."

The Dialysis Equipment Checklist revealed the hemodialysis machines were NOT verified free of bleach disinfectant prior to the next patient treatment, as follows:

06/10: Machine/RO #61/62: 09, 19.
Machine/RO #57/58: 04, 10.

05/10: Machine/RO #66/67: 28.

3. The Dialysis Equipment Checklist revealed that hemodialysis machines were NOT bleached or heat disinfected after treatment, as follows:

06/10: Machine/RO #57/58: 02.

05/10: Machine/RO #57/58: 21.
Machine/RO #61/62: 06.
Machine/RO #66/67: 13.
Machine/RO #90/91: 18.
Machine/RO #94/94: 18.

4. The hospital document titled Zyza Tech Water Systems F-801 Internal RO System (03/99) requires: "...Total Dissolved Solids (TDS)...is an indicator of final product water quality...Choose the alarm set point that is closest to twice the initial installation TDS reading...The Alarm should be set to twice the initial TDS reading...."

The dialysis staff indicated during interviews conducted on 06/16/10, that the TDS should be less than 20%.

The following was observed during a tour of the Dialysis Unit conducted on 06/15/10 at 1015: Two (2) patients were hemodialyzing. Both machines' Total Dissolved Solids (TDS) monitors registered less than 10 mg/L, however, the alarms were set at 50%, which were greater than twice the TDS level.

5. The Dialysis Equipment Checklist revealed that hemodialysis machines were tested for conductivity and pH when the machines were NOT in use. It was unclear how or why the results were obtained and recorded, as follows:

06/10: Machine/RO #90/91: 12.
Machine/RO #61/62: 16.
Machine/RO #66/67: 03.

05/10: Machine/RO #66/67: 02.

6. The Dialysis Equipment Checklist revealed NO documentation that the machines conductivity and pH were obtained and recorded on days when the individual hemodialysis machines were used, as follows:

06/10: Machine/RO #90/91: 10, 20, 23.
Machine/RO #66/67: 04, 05.
Machine/RO #57/58: 03, 08.

05/10: Machine/RO #60/59: 03, 11.
Machine/RO #57/58: 07, 27.
Machine/RO #94/94: 03, 10.
Machine/RO #90/91: 04.
Machine/RO #93/97: 26.
Machine/RO #92/93: 28.
Machine/RO #66/67: 07,10, 12, 13, 27.
Machine/RO #61/62: 07, 10.

7. The hospital's dialysis unit mixes NaturaLyte 4000 (powder dry pack) with treated water in a 10 Liter (L)jug, to make bicarbonate solution for dialysate.

The jug label indicated: "...mix according to label directors or the operator's manual...."

The NaturaLyte container label indicated: "...mix the...dry pack...add purified water to the container (jug)...Fill to the 7.7 liter mark...when mixed according to directions, produces 8 liters or 2.1 gallons of bicarbonate base concentrate...."

The Patient Care Technician (PCT #32) described the mixing process, during an interview conducted on 06/15/10 at 1015, as follows: Fill the jug with treated water to about 8.2 - 8.5 L, then add the bicarb (dry pack).

The bicarbonate solution was not mixed according to the manufacturer's requirements.

Based on review of nationally accepted standards, hospital policies and procedures, facility documentation, observation, and staff interviews, it was determined the facility failed to develop a policy for monitoring, maintaining, and documenting the temperature/humidity in the operating rooms located in the surgical and labor and delivery suites.

Findings include:

The National Fire Protection Association's NFPA 1999 Standard for Health Care Facilities requires operating rooms to be maintained with a humidity of 35% or greater.

The Association of periOperative Registered Nurses' (AORN) Perioperative Standards and Recommended Practices 2010 Edition, p. 221, V.b. revealed: "...Relative humidity should be maintained between 30% and 60% within the perioperative suite, including operating rooms, recovery area...instrument processing areas, and sterilizing areas...Low humidity increases the risk of electrostatic charges, which pose a fire hazard in an oxygen-enriched environment or when flammable agents are in use and increases the potential for dust. High humidity increases the risk of microbial growth in areas where sterile supplies are stored or procedures are performed...Vc.Temperature should be monitored and recorded daily using a log format or documentation provided by the HVAC system...V.c.1.Temperature should be maintained between 68 degrees F to 73 degrees F...within the operating room suite and general work areas in sterile processing...."

A review of the hospital's policies and procedures revealed there was no policy for the monitoring and maintaining the temperature and humidity in the operating rooms.

A review of the hospital's documents revealed no log for monitoring the temperature and humidity in the operating rooms.

On 6/18/10, the Director of Surgical Services, confirmed the hospital did not have a log or policy to maintain and monitor the temperature and humidity in the operating rooms.

On 6/23/10, the Supervisor of Facility Maintenance, stated if the humidity in the operating room was too low, the hospital would be unable to increase the humidity because the "steam humidification system was removed at least 3-4 years ago." The supervisor also confirmed the hospital did not have a policy to maintain, document, or report any temperature and humidity that were found to be outside of the safety regulations in the operating rooms.

Based on review of hospital policies/procedures, the 2010 Infection Control Plan, hemodialysis documents, and staff interviews, it was determined the hospital failed to comply with the provisions for Infection Control, as demonstrated by:

A-0749: the hemodialysis staff did not practice appropriate handwashing when removing gloves, the RN Dialysis Director and the Biomedical Technician were not advised of monthly machine and water culture results, the Infection Prevention RN was minimally involved with the hemodialysis' unit's infection control practices related to handwashing, and prompt action was not taken on unacceptable machine and water culture results.

The cumulative effect of these systemic deficient practices resulted in the hospital's failure to meet the requirements for the Condition of Participation for Infection Control.

Based on observations during tour, review of hospital policies/procedures, the 2010 Infection Control Plan, American National Standards Institute, hemodialysis documents, and staff interviews, it was determined the Infection Prevention RN failed to require that the infection control process for identifying, reporting and investigating potential risks, was comprehensive for hemodialysis patients, as demonstrated by:

1. the dialysis staff did not cleanse hands after removing gloves;
2. the RN Dialysis Director and the Biomedical Technician were not advised of water and machine culture results;
3. the Infection Prevention RN was minimally involved with the dialysis unit's infection control practices i:e: handwashing and machine cultures; and
4. prompt action was not taken on unacceptable hemodialysis water cultures.

Findings include:

The hospital's Infection Prevention and Control Plan 2010, requires: "...Goals...Facilitate hospital compliance with Conditions of Participation of the Medicare and Medicaid Program...and other federal, state and regulatory agencies...."
1. The hospital policy titled Hemodialysis Infection Control #2780.4 (effective 09/08) requires: "...Hand hygiene...after removing gloves...."

The following was observed during a tour of the dialysis unit conducted on 06/15/10:

1050: Patient Care Technician (PCT) #32 discontinued the patient's hemodialysis treatment, wiped down the hemodialysis machine (with Cavicide), gave the patient ice chips, removed gloves, then re-gloved without hand cleansing, handled the patient's cardiac monitor lines, removed gloves, opened a new bag of intravenous (IV) fluid, and set up new bloodlines without cleansing hands or donning new gloves.

1140: PCT #32 attended the patient's hemodialysis treatment, removed gloves, disconnected the bloodlines, hung a new bag of IV fluid, connected new bloodlines, then moved to another hemodialysis machine, and connected the bicarbonate container (jug), without cleansing hands.

The Infection Prevention RN indicated during an interview conducted on 06/16/10 at 1300, that handwashing is monitored for the dialysis unit per the "infection control liaison." The Infection Prevention RN stated that the dialysis staff conduct their own internal handwashing monitoring, and that s/he does not observe or monitor handwashing himself/herself for the dialysis staff.

2. The dialysis unit's document titled Action Plan for Positive Dialysate and RO (reverse osmosis) Water Cultures, requires: "...Review dialysate culture results...Results 50 - 199 CFU/ml (colony forming units/ml)...Notify Facility Manager and Biomedical Technician."

The RN Director of Dialysis and the Biomedical Technician stated during interviews conducted on 06/18/10 at 0915, that they were not advised of water/machine testing results (cultures).

3. The hospital policy titled Hemodialysis: Infection Control #2780.4 (effective 09/08) requires: "...Results of all water treatment tests are monitored as part of the unit's Quality Management Program...."

The Infection Prevention RN indicated during an interview conducted on 06/16/10 at 1300, that the dialysis unit reports machine cultures, but that s/he was not otherwise "much involved."

4. The hospital policy titled Hemodialysis: Infection Control #2780.4 (effective 09/08) requires: "...These policies and procedures are based on the standards and guidelines determined by regulatory agencies including CDC (Centers for Disease Control)...AAMI (Association for the Advancement of Medical Instrumentation), and manufacturer recommendations...."

According to the American National Standards Institute (ANSI): "...48 hours can elapse between water sampling, microbial contamination, and obtaining results. Bacterial proliferation can be rapid. Prompt action for microbial levels for microbial counts would be met if taken within 48 hours of receiving test (culture) results...."

The dialysis unit performs cultures on the hemodialysis machines and portable ROs. The Renal Dialysis Culture Colony Count log revealed: "...benchmark less than 50 CFU (colony forming units)...." The log requires the following documentation: Machine/RO #, date cultures taken, results, action taken, date retest, retest result, action taken, and (results) reviewed by manager. Documentation, however, did not confirm the date action was taken, or that the manager reviewed the results.

Prompt action was not taken for unacceptable hemodialysis machines and portable ROs microbial levels, as follows:

RO #97:
05/17/10, CFU 200...disinfect...05/26/10 negative (neg). 9 days (between culture results)...06/17/10, CFU 200. 9 days, and 22 days.

Machine #94:
05/10/10, CFU 64...disinfect...05/26/10 neg. 16 days.

RO #94:
05/10/10, CFU 150...disinfect...05/26/10 neg. 16 days.

RO #93:
03/31/10, CFU 104...disinfect...4/7/10, CFU 46. 7 days.

RO #91:
02/15/10, CFU 154...disinfect...02/25/10, CFU 116 CFU (10 days)...03/11/10, CFU 14. 17 days.
04/21/10, CFU 200...disinfect...04/26/10, CFU 150. 5 days.
05/10/10, CFU 66...disinfect...05/26/10 negative (neg). 16 days.

Machine #90:
02/15/10, CFU 144...disinfect...2/25/10, CFU 26. 10 days.
05/10/10, CFU 58...disinfect...05/28/10 neg. 18 days.

Machine #61: 01/21/10, CFU 200...disinfect...01/22/10 neg. It was unclear how the culture results were obtained in 24 hours.
04/08/10, CFU 80...disinfect...04/26/10, CFU 48. 18 days.

Machine #60: 01/21/10, CFU 200...disinfect...01/22/10 neg. It was unclear how the culture results were obtained in 24 hours.

RO #59:
01/21/10, CFU 200...disinfect...01/22/10 neg. It was unclear how the culture results were obtained in 24 hours.
03/26/10, CFU 78...disinfect...03/31/10, CFU 12. 5 days.

The RN Director of Dialysis and the Biomedical Technician stated during interviews conducted on 06/18/10 at 0915, that they were not aware of, or provided documentation, related to machine testing and promptness of corrective action.

Based on hospital Anesthesia Rules and Regulations, medical records, and staff interview, it was determined the anesthesiologist did not document a preoperative assessment to include a notation of the patient's anesthesia risk according to established standards of practice ASA (American Society of Anesthesiologists); and a plan for the patient's anesthesia care in 2 of 2 endoscopy patients who received Propofol with monitored anesthesia care (MAC) (Patients #31 and 32).

Findings include:

The Rules and Regulations-Anesthesia require: Article Six. 6.0. "...The Anesthesia Section is responsible...shall participate in...describing comprehensive anesthesia care; preoperative...intraoperative...postoperative evaluation...with any/all levels of anesthesia privileges...Article Seven 7.1...All patients (both inpatients and outpatients) scheduled...examined pre-operatively...prior...surgery. The anesthesiologist...appropriate notes...record...."

Patient #31 had an endoscopy procedure on 06/22/10, with MAC. The anesthesiologist did not document a preoperative assessment to include the patient's anesthesia plan (general, regional, or MAC).

On 06/22/10, the Senior Clinical Manager of Surgical Services confirmed the anesthesiologist's preoperative assessment did not include the anesthesia plan.

Patient #32 had an endoscopy procedure on 06/22/10, with MAC. The anesthesiologist did not document a preoperative assessment to include the patient's anesthesia risk according to established standards of practice ASA.

On 06/22/10, the Senior Clinical Manager of Surgical Services confirmed the anesthesiologist's preoperative anesthesia assessment did not include the anesthesia risk according to established standards of practice ASA.

Based on review of hospital documents, medical records, and staff interviews, it was determined the anesthesiologist failed to document a post anesthesia assessment to include the patient's respiratory function, cardiovascular function, mental status, temperature, pain level, signs of nausea/vomiting, or the patient's hydration status, on 2 of 2 endoscopy patients who received Propofol with monitored anesthesia care (MAC) (Patients #31 and 32).

Findings include:

The Department of Surgery, Section of Anesthesia Rules and Regulations require: Article Six. 6.0."...The Anesthesia Section is responsible...shall participate in...describing comprehensive anesthesia care; preoperative...intraoperative...postoperative evaluation...with any/all levels of anesthesia privileges...Article Eight. 8.1...Whenever anesthesia...provided outside the operating room...care must be comparable to the care provided...operating room suite...8.2...Any patient...other than local anesthesia...is examined before discharge...The examination is performed by an anesthesiologist...They...will insure...patient is given adequate post anesthesia...."

Patient #31 had an endoscopy procedure on 06/22/10, with MAC. The anesthesiologist documented the patient's vital signs as stable, mental status awake, fluid totals, and checked the box, "no complications noted."

On 06/22/10, the Clinical Manager of Surgical Services confirmed the anesthesiologist's post anesthesia assessment did not include the patient's temperature, respiratory function, cardiovascular function, pain level, or signs of nausea/vomiting.

Patient #32 had an endoscopy procedure on 06/22/10, with MAC. The anesthesiologist documented the patient's respiratory function, cardiovascular function, mental status awake, fluid totals, and checked the box "no complications noted."

On 06/22/10, the Clinical Manager of Surgical Services confirmed the anesthesiologist's post anesthesia assessment did not include the patient's temperature, pain level, or signs of nausea/vomiting.