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Based on interview and record review, the hospital failed to ensure the GB assumed full responsibility for determining, implementing, and monitoring policies governing all hospital functions as evidenced by:

1. Failure to ensure the QAPI program's quality processes were designed and implemented to ensure the improvement of patient health outcomes and reduction of medical errors. As a result, the Condition of Participation for QAPI (482.21) was not met. Cross reference to A263.

2. Failure to ensure the the pharmaceutical services were provided to meet the needs of the patients. As a result, the Condition of Participation for Pharmaceutical Services (482.85) was not met. Cross reference to A489.

3. Failure to ensure the MS was accountable for the quality of the medical care provided to the patients. Cross references to A049 and A347.

4. Failure to ensure the contracted pharmacy and dietary services were provided in a safe and effective manner. Cross reference to A084.

5. Failure to ensure there was a complete list of contracted services that included the contracted dietitian. Cross reference to A085.

The cumulative effect of these systemic failures resulted in the hospital's inability to provide quality healthcare to the patients in a safe environment.

Based on interview and record review, the hospital failed to have a system in place to ensure the MS was accountable to the GB for the quality of care provided, creating the risk of substandard patient care.

Findings:

Review of the hospital's P&P titled Newport Bay Hospital Performance Improvement Plan 2017 showed in part: "...Assessment / analysis involves the identification of unexpected patterns of structure, process or outcomes such as differences in patterns among subgroups; the range of "acceptable" patterns and those patterns above and below the "acceptable" range. This function also includes requesting explanations where patterns or trends vary from acceptable ranges, determining where improvement is needed and recommending appropriate change in design...The Governing Body exercises oversight responsibility for the effectiveness and the efficiency of patient care..."

Review of the Medical Staff Bylaws Rules and Regulations dated 10/15 showed in part: "....4.6-3. Standards and procedure for review. When a staff member submits the first application for reappointment, and every two years thereafter, or when the member submits an application for modification of staff status or clinical privileges, the member shall be subject to an in-depth review..."

Review of the Governance Board Bylaws dated 3/17 showed in part: "...7.2. Medical Care Evaluation Reports. The Governing Board shall be required to review Medical Staff reports of medical care evaluation, utilization review, risk management, and other matters relating to the quality of care rendered at the Hospital...shall present such reports to the Governing Board at regular Governing Board meetings or at such other times as may be requested by the Governing Board..."

1. Patient 22's medical record was reviewed on 7/24/17. The Order Summary Report dated 5/26/17 at 1554 hours, showed "...Pacemaker use: Monitor heart rate for pacemaker efficiency Q (every) shift. Notify MD if < 60 beats / min..."

Review of the nursing progress note dated 5/28/17 at 0530 hours, showed the nurse heard a loud sound coming from the lounge. Patient 22 was observed slumped over while sitting in the wheelchair with a seatbelt on. The patient had been awake, restless, and up in the wheelchair prior to the fall. At 0530 hours, a CNA found the patient on the floor and asked another CNA to assist the patient. At 0555 hours, the staff informed the charge RN the patient had fallen. Documentation in the nursing progress note showed Patient 22 had swelling and bruising on her forehead from the fall; continue with vital signs and neurochecks per fall protocol; and the MD, DON, ADON, family, and psychiatrist were to be notified.

Continued review of the Patient 22's medical record failed to show documented evidence the physician or anyone listed in the above nursing note were notified of the patient's fall.

Review of the Fall Incident Report dated 5/28/17 at 0530 hours, showed in part: "...Treatment. Other. Offered Tylenol for pain. cold pack applied to forehead...Post Fall Report. Was the incident, a: Found on the floor (unwitnessed)..." The box next to this statement was checked.

The Progress Note dated 5/28/17 at 2022 hours, showed "...The patient had a fall yesterday and was offered an intramuscular injection for acute agitation..."

Review of the H&P dated 5/29/17 at 1155 hours, showed "...Admit Date 5/26/17...On seeing the patient this afternoon, she had no acute complaints but the staff reported that over the weekend she fell out of her wheelchair and hit her forehead. She has been on neuro checks since then...Physical Examination...Left eyebrow with bruising and hematoma, mildly tender to palpation..."

Review of the Neurology consultation dated 6/5/17 at 1506 hours, showed "...Admit Date 5/26/17...Conclusion: At this time, her neurological examination seems relatively stable. I do not know if the patient has had any radiological studies of the brain in the past or not and if she has not had one done in the past 1-2 years, I recommend that upon discharge she undergo at least a CAT scan of the brain to look at the anatomy..."

Review of the Physician's Order Sheet dated 5/29/17 at 1200 hours, showed "Left spine XR (x-ray). Neck pain after fall. R/O fx (rule out a fracture of a bone)..." No physician's orders were found for further patient evaluation.

Review of the Discharge Summary dated 6/12/17 at 1037 hours, showed "...Admit date 5/26/17. Discharge Date 6/12/17...nursing notices in the early morning a sudden change in condition. She was less responsive. 9-1-1 was called...she was transferred to ...[Hospital A's name] for acute medical management..."

Review of the Peer Review document dated 6/13/17, showed "...From chart review, it seems like a sudden episode. There was no decline over period of time or vs. changes over (period of time) hours or days." Review of the facility committee meeting minutes for the QAPI, Medical Staff, and GB for the last 12 months, showed no documented evidence the Peer Review information or analysis of the event were discussed. Patient 22 died the day after she was transferred via 9-1-1 to an acute facility.

During an interview with the Treatment Coordinator on 7/26/17 at 1100 hours, she reviewed Patient 22's medical record. The Coordinator acknowledged the above findings and lack of documented evidence. The Treatment Coordinator was unable to find documented evidence the MD was notified of the patient's fall. Following review of the neurologist note, which recommended a CT of the brain, the Treatment Coordinator stated she "expected the staff to get a brain CT after the patient's fall." The Treatment Coordinator acknowledged there was no documented evidence the patient received a brain CT or was sent to an acute hospital for further evaluation after the fall.

2. Five practitioner credential files were randomly selected for review. Review of MD 4's file did not show documented evidence of an evaluation prior to reappointment. The Evaluation portion of the Reappointment Recommendation form was left blank and at the bottom of the Reappointment Recommendation form was signed and dated.

Further review of MD 4's credential file showed the MD had a higher rate of patient readmissions less than 30 days after discharge than was expected. However, there was no documented evidence to show the multiple readmissions were considered during MD 4's reappointment.

The Medical Staff Coordinator was interviewed on 7/25/17 at 0935 hours, and acknowledged the above findings.

During an interview with the Director of Performance Improvement on 7/25/17 at 1425 hours, she was asked how the QAPI program tracked the medical errors and adverse events. The Director stated the QAPI program only checked on drug errors; they did not track the medical errors because they "haven't had any."

Based on interview and record review, the GB failed to evaluate the contracted services (Pharmacy, Dietician, and Medical Records) for quality and effectiveness, creating a risk of patients receiving substandard pharmacy, dietary, and general medical care.

Findings:

1. Review of the hospital's P&P titled Contract Services dated 3/5/17, showed in part: "...The Governing Body of Newport Bay Hospital is responsible for services furnished in the hospital whether or not they are furnished under contract. All contracted services are evaluated/monitored, on an ongoing basis, to ensure that quality is maintained and that services are delivered in a competent and safe manner."

Review of the GB meeting minutes dated 3/30/17, under the column "contract service," showed "No issues to report this quarter."

Review of the GB meeting minutes for the last 12 months showed no documented evidence the GB evaluated the pharmacy, dietary, or medical record contract services.

On 7/25/17 at 0935 hours, the Medical Staff Coordinator was interviewed. When asked regarding the contracted services, the Medical Staff Coordinator referred to the GB minutes for the first quarter of 2017, in the area that indicated "...contract service. No issues to report this quarter..." typed underneath. The Medical Staff Coordinator stated this indicated the GB evaluated the contract services; "If there are any issues, (we) report."


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2. An interview and concurrent document review was conducted with the Director of Performance Improvement and DOP on 7/26/17 at 1013 hours. The Director of Performance Improvement stated the services were evaluated once a year, and a standardized evaluation form was to be completed for each service evaluated. The document provided was the "Self-Assessment" form from the Board of Pharmacy, last completed 6/30/17. The "Self-Assessment" form was not the same as the standardized form used by the hospital. The prior "Self-Assessment" form was completed in 2015. The DOP acknowledged the form was inadequate to evaluate the quality of pharmaceutical services provided, as required by the hospital's GB. In addition, the evaluation was not performed annually.


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3. On 7/24/17 at 0830 hours, an interview was conducted with the Food Service Manager. The Manager stated the current Registered Dietician (RD 1) was an independent contractor.

On 7/24/17 at 1100 hours, a contract review was conducted with the HR Director who stated she was unable to find a contract for RD 1. The Director further stated she was unaware of RD 1 working at the facility and did not have a copy of RD 1's credentials, employee health screening, contract or license verification.

When asked what process was in place for the contracted service providers, the HR Director stated the contractor must be approved by the GB prior to working in the facility.

Review of the payroll records showed RD 1 first worked in the facility on 11/18/16.

Cross reference to A085 and A621.


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4. During an interview with the Director of Performance Improvement and HR Director on 7/26/17 at 0810 hours, the Director of Performance Improvement confirmed the Director of Medical Records was a contracted employee. The HR Director provided the AHIMA proof of RHIT certification for the Director of Medical Records, but stated, "We don't keep this in his employee file."

The CEO was interviewed on 7/26/17 at 1020 hours. When asked for evidence of the GB's annual review of the Director of Medical Record's contract, the CEO stated, "We run the business by exception...if there is no change, its ok....There is no evidence of it...we don't do it."

Based on interview and record review, the GB failed to ensure the hospital maintained a complete list of contracted services, creating the risk of poor management of the hospital's contracted services.

Findings:

The hospital's P&P titled Contract Services dated 3/5/15, showed in part: "...The Governing Body of Newport Bay Hospital is responsible for services furnished in the hospital whether or not they are furnished under contract. All contracted services are evaluated/monitored, on an ongoing basis, to ensure that quality is maintained and that services are delivered in a competent and safe manner."


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On 7/24/17 at 0800 hours, a review of the contracted services was discussed with the Director of Performance Improvement. Review of the list of contracted services presented to the GB and approved in March 2017 included RD 2, who was not the primary RD working in the facility. The Director of Performance Improvement was not aware the list of contracted services did not include the current RD (RD 1).

On 7/24/17 at 0830 hours, an interview was conducted with the Food Service Manager. The Manager stated the current Registered Dietician (RD 1) was an independent contractor.

On 7/24/17 at 1100 hours, a contract review was conducted with the HR Director. The Director was unable to find a contract for RD 1. The Director further stated she was unaware of RD 1 working at the facility and did not have a copy of RD 1's credentials, employee health screening, contract or license verification.

When asked what process was in place for contracted service providers, the HR Director stated the contractor must be approved by the GB prior to working in the facility and "unfortunately we did not go through the proper channels when hiring her."

Review of the payroll records showed RD 1 first worked in the facility on 11/18/16.

Based on observation, interview, and record review, the hospital failed to ensure a P&P was developed as guidance for the staff when obtaining the informed consents for admissions, treatments, and medications from the cognitively impaired patients with no designated legal responsible parties. Four of 30 sampled patients (Patients 3, 18, 23, and 24) were asked to give verbal or signed consents for treatments and/or medications when the psychiatric and nursing evaluations showed impaired judgement and thinking. There was no documentation to show the family members listed on the medical records were contacted to speak for the patients. This had the potential for the patients to receive treatments and/or medications with side effects not understood by the patients or family members.

Findings:

Review of the hospital's P&P titled Informed Consent last revised 2/14/13, showed the purpose of the policy is to safeguard and protect the rights of the patient and to ensure patient understanding of the planned treatment. The policy defines a surrogate decision-maker as a person appointed to act on behalf of another including court appointed guardians to make decisions when an individual is without capacity...

The P&P showed nursing is to obtain written consent from the patient or legal guardian at the time of admission and to ensure a patient admitted on an involuntary legal hold will have their rights upheld regarding medications. The physician is to inform patient who are to receive mood-altering medications of the side effects of the medications, risks, benefits, and alternatives to medication therapy. Social Services Department is to provide a translator if the patient does not speak or understand English. The physician signs the medication consent form indicating the patient is aware of the medication(s) recommended indicating that the patient is aware of the medications recommended and the patient signs the consent to take the medications.

Nursing witnesses the patient's signature for consent to take the medication by signing the form with first initial/last name, title, time and date, and provides a copy of written material pertaining to the medication ordered to educate the patient and/or significant other.

Further review of the P&P did not show guidance for the staff to obtain informed consent from patients who are unable to make their own decisions and who did not have legally designated responsible parties.

1. According to Lexicomp, an online professional drug resource, the drugs Latuda and Zyprexa showed a US Boxed Warning of increased mortality in elderly patients with dementia-related psychosis.

For Latuda (antipsychotic medication), the documentation showed "based on the American Psychiatric Association practice guideline on the use of antipsychotics to treat agitation or psychosis in patients with dementia, antipsychotics, such as lurasidone (Latuda) may be considered for the treatment of agitation and psychosis in certain patients with dementia; however, evidence for efficacy is modest and use should be limited to patients whose symptoms are dangerous, severe, or cause significant patient distress due to safety risks associated with antipsychotic use.

Elderly patients with dementia-related psychosis treated with antipsychotics are at an increased risk of death compared to placebo. Most deaths appeared to be either cardiovascular (e.g., heart failure, sudden death) or infectious (e.g, pneumonia) in nature. Lurasidone is not approved for the treatment of dementia-related psychosis."

For Zyprexa (antipsychotic medication), the documentation in the Lexicomp showed elderly patients with dementia-related psychosis treated with antipsychotics are at an increased risk of death compared with placebo. Most deaths appeared to be either cardiovascular (e.g., heart failure, sudden death) or infectious (e.g., pneumonia) in nature. In addition, an increased incidence of cerebrovascular effects (e.g., transient ischemic attack, stroke) has been reported in studies of placebo-controlled trials of olanzapine (Zyprexa) in elderly patients with dementia-related psychosis.

Under Special Geriatric Considerations, the documentation showed "Elderly patients have an increased risk of adverse effects to antipsychotics. In light of this risk, and relative to their small beneficial effect in the treatment of dementia-related psychosis and behavioral disorders, patients should be evaluated for possible reversible causes before being started on an antipsychotic. Nonpharmacologic interventions should be tried before initiating an antipsychotic."

Patient 24's medical record was reviewed on 7/2/17. The patient was admitted to the hospital on 7/9/17, on an involuntary legal hold. The patient was over 65 years old.

Review of the initial nursing assessment dated 7/9/17 at 2100 hours, showed documentation the patient refused to sign the paperwork on admission stating, "I'll have my husband read it first." The RN documented the patient's thought process was "disoriented."

Review of the Informed Patient Consent to Receive Psychiatric Medications form dated 7/11/17, for the use of Latuda 80 mg, and the Informed Patient Consent to Receive Psychiatric Medications form dated 7/21/17, for the use of Zyprexa 20 mg, showed the patient signed both forms on the signature line under which was printed "I have read this form, I understand it, and I consent to take the medications prescribed by the doctor." Further review of the forms showed printed documentation that by signing, the patient acknowledged the doctor discussed the medications, probable side effects, including the increased risk of death in elderly patients with the patient, the reason for taking the medications, and discussed whether or not reasonable alternative treatments were available.

Review of Patient 24's admission Psychiatric Evaluation dated 7/10/17, showed the physician documented a diagnosis of psychotic disorder unspecified, rule out dementia. Documentation showed the patient lived at home with her family but had been increasingly agitated, aggressive, confused, and combative for the last two weeks. Documentation showed the patient thought she was in the hospital to try and conduct a business venture.

Review of Patient 24's Psychiatric Evaluation dated 7/11/17, showed the physician documented the patient was confused, delusional, and was misidentifying her surrounding and situation; and the patient had poor insight and judgement.

Review of Patient 24's Psychiatric Evaluation dated 7/21/17, showed the physician documented delusions and auditory hallucinations were present and the patient had poor insight and judgement.

RN 3 and CN 1 were interviewed on 7/25/17 at 1030 hours. RN 3 stated if a patient was on an involuntary legal hold, such as Patient 24, the hospital did not need the patient's consent for admission; however, the hospital required consent from the patient for medications. RN 3 stated the physician obtained informed consent for Patient 24 for the Latuda and Zyprexa.

RN 3 and CN 1 were asked to review the physician's assessments for Patient 24 dated 7/11 and 7/21/17, which showed the patient had poor insight and judgement both days informed consents were obtained. When asked why the patient's next of kin was not contacted and asked to review the medications and give consent, CN 1 stated they did not ask the family because these were psychiatric patients who required a legally designated responsible party. The CN stated even if the family member was legally designated as the power of attorney for medical care, this would not apply as psychiatric issues were separate. When pointed out the patient's diagnosis was not a psychiatric diagnosis, but probable dementia with psychosis, the staff was unable to answer.


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2. Patient 3's medical record review was initiated on 7/24/17 at 0924 hours. Patient 3 was admitted to the hospital on 7/22/17, with a diagnosis of unspecified psychosis not due to a substance or known physiological condition.

Review of the Interdisciplinary Patient Admission Assessment completed by the RN on 7/22/17 at 2100 hours, showed when prompted to answer why he was admitted, Patient 3 stated, "I don't know." The RN documented Patient 3 was alert to person and time but not to the place and situation and had short term and long term memory deficits.

Review of the Psychiatric Evaluation dated 7/23/17 at 2158 hours, showed Patient 3 was increasingly aggressive with yelling, disruptive behavior, and anxiety. Patient 3 was evaluated to have poor insight, judgement, impulse control, and safety awareness. Patient 3 was assessed as oriented to himself only and with a compromised fund of knowledge.

However, review of the patient's medical record showed Patient 3 gave a verbal consent to the following documents:
* Conditions of Admission (undated).
* County of Orange, California Health Care Agency Behavioral Health Services Patients' Rights Advocacy Services, dated 7/22/17.
* Notification of Patient's Admission, Medications, and Special Procedures dated 7/22/17 at 2030 hours. The next-of-kin to be notified showed "sister;" however, it did not list the name or phone number.
* Notice and Acknowledgement of Privacy Practices, dated 7/22/17.
* Seclusion/Restraint Advisement, dated 7/22/17.
* Advance Directive Acknowledgement, dated 7/22/17 at 2030 hours.

In addition, review of the Informed Patient Consent to Receive Psychiatric Medications dated 7/22/17 at 0020 hours, showed Patient 3 gave a verbal consent to take the following medications:
* Abilify (antipsychotic medication)
* melatonin (helps regulate sleep and wakefulness)
* Nuedexta (treats involuntary outbursts of crying or laughing)
* Ativan (antianxiety medication)
* clonazepam (sedative medication)

3. Patient 23's medical record review was initiated on 7/25/17 at 0900 hours. Patient 23 was admitted to the hospital on 7/17/17, with a diagnosis of dementia with behavioral disturbance.

On 7/26/17 at 0912 hours, Patient 23 was observed sitting in a wheelchair in the Activities Room. With the translation assistance of CNA 1, Patient 23 stated, "I don't know why I am here." When prompted, Patient 23 stated her name incorrectly. When asked what she had eaten for breakfast, CNA 1 stated she was not able to understand Patient 23's mumbling. CNA 1 stated Patient 23 was mostly confused and did not make much sense when she spoke.

Review of the Interdisciplinary Patient Admission Assessment completed by the RN on 7/17/17 at 2100 hours, showed the RN assessed Patient 23 as alert to person only and had short term and long term memory deficits.

Review of the Psychiatric Evaluation dated 7/18/17 at 1808 hours, showed Patient 23 was not thoroughly assessed for thought content, mood or memory because of the patient's disengagement. Documentation showed the patient was alert to self only, with severe cognitive impairment.

However, review of the medical record showed Patient 23 gave a verbal consent to the following documents:
* Conditions of Admission (undated).
* County of Orange, California Health Care Agency Behavioral Health Services Patients' Rights Advocacy Services, dated 7/17/17.
* Consent to Release Information, dated 7/17/17 at 1930 hours.
* Request for Voluntary Admission and Authorized for Treatment, dated 7/17/17 at 1930 hours.
* Notification of Patient's Admission, Medications, and Special Procedures dated 7/17/17 at 1930 hours. The next-of-kin to be notified listed Patient 23's daughter.
* Patient Orientation, dated 7/17/17.
* Notice and Acknowledgement of Privacy Practices, dated 7/17/17.
* Seclusion/Restraint Advisement, dated 7/17/17 at 1930 hours.
* Advance Directive Acknowledgement, dated 7/17/17 at 1930 hours.

In addition, review of the Informed Patient Consent to Receive Psychiatric Medications dated 7/18/17 at 1600 hours, showed Patient 23 gave a verbal consent to take Risperdal (antipsychotic medication).

During an interview with RN 2 on 7/26/17 ay 0946 hours, she stated the patients were often very confused on admission. RN 2 stated she would ask a general question, such as "Do you consent to have us care for you?" If the patient agreed, RN 2 stated she would finish signing all the consents with "VC" for verbal consent.

The above findings were verified with the Director of Performance Improvement on 7/26/17 at 0950 hours.


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4. Patient 18's medical record was reviewed on 7/25/17. The patient was admitted to the hospital from a skilled nursing facility on 7/13/17, on a voluntary status.

Review of a physician's H&P examination from the skilled nursing facility dated 7/6/17, showed Patient 18 did not have the capacity to understand or make decisions.

Review of the Patient Transfer Record dated 7/13/17, showed Patient 18 was confused prior to the transfer to the hospital.

Review of Patient 18's consent for admission dated 7/13/17, showed "v/c" (verbal consent) on the patient signature line. The form was witnessed by two licensed nurses.

Review of the Short Portable Mental Status Questionnaire dated 7/13/17, showed Patient 18 refused to answer the questions and stated "No! I want to go home."

Review of the Interdisciplinary Patient Admission Assessment for Patient 18 dated 7/13/17 at 1900 hours, showed when asked why she was admitted to the hospital she stated, "I don't know why, damn it!"

Review of the Social Services admit note dated 7/14/17 at 0745 hours, showed Patient 18 was admitted to the hospital on a voluntary status and would receive one-to-one interventions, group therapy, and medications to stabilize mood and behavior. The note did not include documentation of family notification.

Review of the Psychiatric Evaluation dated 7/14/17 at 0859 hours, showed Patient 18 had slow and illogical thought processes, poor insight and judgement, and impaired attention span and concentration.

Review of the H&P dated 7/14/17 at 1826 hours, showed Patient 18 was disoriented to person, place, and time.

Review of the Informed Patient Consent to Receive Psychiatric Medications form dated 7/14/17, showed the physician received informed consent from Patient 18 to receive the Lexapro and Remeron (antidepressant medications), melatonin (hypnotic medication), Aricept (memory enhancement medication), and Ativan (antianxiety medication). Patient 18 signed on the patient signature line under which was printed "I have read this form, I understand it, and I consent to take the medications prescribed by the doctor."

On 7/25/17 at 1030 hours, an interview and concurrent record review was conducted with CN 1 regarding consent for admission and treatment for Patient 18. CN 1 stated the hospital preferred to have a signature from the patient, but will accept verbal consent if the patient was unable to sign. CN 1 further stated he usually asked patients if they wanted to be at the hospital. If they said yes, he considered this as an adequate consent. CN 1 was asked to review Patient 18's medical record. After reviewing the record, including the form which showed Patient 18 told staff she wanted to go home, CN 1 stated he did not know what happened in Patient 18's case, as it was unusual to see contradictory statements related to the verbal consent for admission to the hospital.

On 7/26/17 at 0930 hours, an interview and document review was conducted with the Director of Social Services. The Director was asked to review the hospital's P&P for informed consent. When asked why the P&P did not address notification of the patient's next-of-kin in cases when an incapacitated patient is admitted to the hospital, the Director stated she talked to the families of the patients daily about their treatment plans; however, the Director stated social services was not involved with obtaining consent. The Director further stated she was not aware family members could be designated to make decisions for incapacitated patients and acknowledged changes should be made to the hospital's informed consent P&P.

Based on interview and record review, the hospital failed to ensure their QAPI program's quality processes were designed and implemented to ensure improvement of patient health outcomes and reduction of medical errors as evidenced by:

1. Failure to ensure the QAPI program incorporated quality indicators which showed measurable improvement and included all areas in the hospital. Cross reference to A273.

2. Failure to ensure the QAPI program identified and prioritized opportunities for improvement to patient care including the care provided in high volume, high risk, and problem prone areas. Cross reference to A283.

3. Failure to ensure the QAPI program had a comprehensive system for tracking and trending medical errors and adverse events. Cross reference to A286.

4. Failure to ensure the QAPI program was ongoing and focused on the quality improvement of patient care and safety, as well as the reduction of medical errors and adverse events. Cross reference to A309.

5. Failure to ensure the MS was accountable for the quality of care provided. Cross references to A049 and A347.

The cumulative effect of these systemic failures resulted in the hospital's inability to provide an efficient QAPI program and quality healthcare to the patients in the hospital.

Based on interview and record review, the hospital failed to ensure the QAPI program incorporated quality indicators which showed measurable improvement and included the analyzing of medication errors and the provision of dietary services, creating the risk of substandard patient care in an unsafe setting.

Findings:

Review of the hospital's P&P titled Newport Bay Hospital Performance Improvement Plan 2017 showed in part: "...Information Gathering. The task of conducting, coordinating and/or supervising information gathering, aggregation, display, reporting, maintenance, and storage is centralized in the PI Department. The information gathered is based on criteria and/or measures that identify important aspects of care...reflect hospital practice patterns, professional performance and patient outcomes..."

1. Review of the QAPI reports submitted to the GB for the last 12 months, showed the facility was collecting data on medication errors; however, there was no documented evidence the medication errors decreased over time and there was no documented evidence of an attempt to analyze the medication error data to plan a prevention strategy for the future.

During an interview with the Director of Performance Improvement on 7/25/17 at 1330 hours, she was unable to state which quality indicators showed measurable improvement or showed a decrease in medical errors. The Director stated the QAPI collected data on medication errors as a quality indicator. The Director of Performance Improvement stated the quality plan was to post the data on the bulletin board.


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2. Review of the Position Description titled Clinical Dietician approved 4/98 showed one of the duties of the RD was to attend the quarterly Quality Assurance committee meetings to present clinical findings.

However, review of the Quality Assurance meeting minutes for 2016 and 2017 showed no documented evidence the RD had attended the meetings.

During an interview with the Director of Performance Improvement on 7/25/17 at 0930 hours, the Director stated the Dietary Supervisor attended and reported at the Quality Assurance meetings but the RD did not. When asked if there were any quality indicators related to dietary, the Director stated no.

Based on interview and record review, the hospital failed to ensure the QAPI Program identified and prioritized opportunities for improvement to patient care including care provided in high volume, high risk, and problem prone areas. This created the risk for the hospital to not be able to improve patient care and safety.

Findings:

Review of the hospital's P&P titled Newport Bay Hospital Performance Improvement Plan 2017 showed in part: "...The performance Improvement (PI) program objectives...To assure the continuous monitoring, evaluation and improvement of patient care and professional performance. The results of evaluation activities are recorded, reported and improved upon..."

On 7/25/17 at 1330 hours, the Director of Performance Improvement was interviewed. When asked which of the Quality Indicators the QAPI program used to gain measurable improvement and decrease medical errors, the Director was unable to provide an answer.

When asked about QAPI surveillance of the facility, the Director of Performance Improvement stated the QAPI program did not do surveillance to identify opportunities for improvement; instead, the nurses brought data and incident information to the Director of Performance Improvement for evaluation.

When asked to list the problems that posed the greatest risk to the patients, the Director of Performance Improvement stated the following:

a. patients who leave the facility,
b. medication errors,
c. falls, and
d. the number of times IM medication was used to calm a patient.

The Director of Performance Improvement stated after the data was collected on medication errors, her QAPI action plan was to collect data on medication errors and to "post the results on the bulletin board."

Based on interview and record review, the hospital failed to ensure the QAPI Program had a comprehensive system for tracking and trending medical errors and adverse events, creating the risk of decreased patient safety due to the potential for similar medical errors or adverse events in the future.

Findings:

Review of the hospital's P&P titled Newport Bay Hospital Performance Improvement Plan 2017 showed in part: "...Assessment/analysis involves the identification of unexpected patterns of structure, process or outcomes such as differences in patterns among subgroups; the range of acceptable patterns and those patterns above and below the acceptable range. This function also includes requesting explanations where patterns or trends vary from acceptable ranges, determining where improvement is needed and recommending appropriate change in design..."

1. Patient 22's medical record was reviewed on 7/24/17. The Order Summary Report dated 5/26/17 at 1554 hours, showed "...Pacemaker use: monitor heart rate for pacemaker efficiency Q shift. Notify MD if < 60 beats / min..."

Review of the nursing progress note dated 5/28/17 at 0530 hours, showed the nurse heard a loud sound coming from the lounge. Patient 22 was observed slumped over while sitting in the wheelchair with a seatbelt on. The patient had been awake, restless, and up in the wheelchair prior to the fall. At 0530 hours, a CNA found the patient on the floor and asked another CNA to assist the patient. At 0555 hours, the staff informed the charge RN the patient had fallen. Documentation in the nursing progress note showed Patient 22 had swelling and bruising on her forehead from the fall; continue with vital signs and neurochecks per fall protocol; and the MD, DON, ADON, family, and psychiatrist were to be notified.

Review of the Fall Incident Report dated 5/28/17 at 0530 hours, showed in part: "...Treatment. Other. Offered Tylenol for pain. cold pack applied to forehead...Post Fall Report. Was the incident a: Found on the floor (unwitnessed)..." The box next to this statement was checked.

Review of the nursing progress note dated 5/28/17 at 2022 hours, showed the patient had a fall yesterday and was offered an intramuscular injection for acute agitation.

Review of the H&P dated 5/29/2017 at 1155 hours, showed in part: "...Admit Date 5/26/17...On seeing the patient this afternoon, she had no acute complaints but the staff reported that over the weekend she fell out of her wheelchair and hit her forehead. She has been on neuro checks since then...Physical Examination...Left eyebrow with bruising and hematoma, mildly tender to palpation..."

Review of the Neurology consultation dated 6/5/17 at 1506 hours, showed in part: "...Admit Date 5/26/17...Conclusion: At this time, her neurological examination seems relatively stable. I do not know if the patient has had any radiological studies of the brain in the past or not and if she has not had one done in the past 1-2 years, I recommend that upon discharge she undergo at least a CAT scan of the brain to look at the anatomy..."

Review of the Physician's Order Sheet dated 5/29/17 at 1200 hours, showed "Left spine XR (xray). Neck pain after fall. R/O fx (rule out a fracture of a bone)..." No physician orders were found for further patient evaluation.

Review of the Discharge Summary dated 6/12/17 at 1037 hours, showed the nursing staff noticed the patient was less responsive in the early morning, 9-1-1 was called, and the patient was transferred to Hospital A for acute medical management.

Review of the Peer Review document dated 6/13/17, showed in part: "...From chart review, it seems like a sudden episode. There were no decline over period of time or vs. changes over (period of time) hours or days."

Review of the facility's committee meeting minutes for the QAPI, Medical Staff, and GB, for the last 12 months, did not show documented evidence of Peer Review information or analysis of the event were discussed. Patient 22 died the day after she was transferred via 9-1-1 to an acute facility.

During an interview with the Treatment Coordinator on 7/26/17 at 1100 hours, she reviewed Patient 22's medical record. The Coordinator acknowledged all of the above findings. The Coordinator was unable to find documented evidence the MD was notified of the patient's fall. After reviewing the neurologist note dated 6/5/17, which recommended a CT of the brain, the Coordinator stated she "expected the staff to get a brain CT after the patient's fall." The Coordinator acknowledged there was no documented evidence the patient received a brain CT or was sent to an acute hospital for further evaluation after the fall.

On 7/25/17 at 1425 hours, the Director of Performance Improvement was interviewed. When asked how their QAPI program tracked medical errors and adverse events, the Director stated the QAPI program only checked on drug errors; they did not track medical errors because they "haven't had any."

2. On 7/25/17, five physician credential files were randomly selected for review. The following was identified:

a. Review of Psychologist 1's file showed no documented evidence he was evaluated at the time of reappointment. The Evaluation portion of the Reappointment Recommendation form was left blank.

Review of the credential file for Psychologist 1 showed during a specific time period, Psychologist 1 had a higher rate of patient readmissions, less than 30 days after discharge, than was expected. However, there was no documented evidence to show the multiple readmissions were considered during Psychologist 1's reappointment.

b. Review of Physician 3's credential file showed during the reappointment, Physician 3 was evaluated by a physician not in his discipline to evaluate and grant Physician 3 the continued privileges. There was no documented evidence to show Physician 3 was evaluated by a physician in another discipline (specialty).

During an interview with the Medical Staff Coordinator on 7/25/17 at 0935 hours, she acknowledged the above findings.

Based on interview and record review, the hospital failed to ensure the QAPI program was ongoing and focused on the improvement of patient care and safety as well as the reduction of medical errors and adverse events. This created the risk of the hospital not being able to prevent adverse events in the future.

Findings:

Review of the hospital's P&P titled Newport Bay Hospital Performance Improvement Plan 2017 showed in part: "...The performance Improvement (PI) program objectives...To assure the continuous monitoring, evaluation and improvement of patient care and professional performance. The results of evaluation activities are recorded, reported and improved upon....Assessment/analysis involves the identification of unexpected patterns of structure, process or outcomes such as differences in patterns among subgroups; the range of "acceptable" patterns and those patterns above and below the "acceptable range. This function also includes requesting explanations where patterns or trends vary from acceptable ranges, determining where improvement is needed and recommending appropriate change in design...The Governing Body exercises oversight responsibility for the effectiveness and the efficiency of patient care services and the outcomes..."

Review of the QAPI reports submitted to the GB for the last 12 months, showed the facility collected data on medication errors; however, there was no documented evidence to show medication errors decreased over time and no documented evidence the medication error data collected was analyzed and a prevention strategy was developed for the future. In addition, there was no documented evidence to show medical error and adverse event data was analyzed, tracked, and a plan was put into place to prevent a recurrence of similar events in the future.

During an interview with the Director of Performance Improvement on 7/25/17 at 1330 hours, the Director was unable to state which quality indicators showed measurable improvement or showed a decrease in medical errors. The Director stated QAPI was collecting data on medication errors as a quality indicator. The Director of Performance Improvement stated the quality plan was to post the data on the bulletin board.

Based on interview and record review, the hospital failed to ensure the MS was accountable for the quality of care provided, creating the risk of substandard patient care.

Findings:

Review of the hospital's P&P titled Newport Bay Hospital Performance Improvement Plan 2017 showed in part: "...The task of conducting, coordinating and/or supervising information gathering, aggregation, display, reporting, maintenance and storage is centralized in the PI Department. The information gathered is based on criteria and/or measures that identify important aspects of care...reflect hospital practice patterns, professional performance and patient outcomes... Assessment/analysis involves the identification of unexpected patterns of structure, process or outcomes such as differences in patterns among subgroups; the range of "acceptable" patterns and those patterns above and below the "acceptable" range. This function also includes requesting explanations where patterns or trends vary from acceptable ranges, determining where improvement is needed and recommending appropriate change in design...The Governing Body exercises oversight responsibility for the effectiveness and the efficiency of patient care services and the outcomes..."

Review of the Medical Staff Bylaws Rules and Regulations dated 10/15 showed in part: "....4.6-3. Standards and procedure for review. When a staff member submits the first application for reappointment, and every two years thereafter, or when the member submits an application for modification of staff status or clinical privileges, the member shall be subject to an in-depth review..."

Review of the Governance Board Bylaws dated 3/17 showed in part: "...7.2. Medical Care Evaluation Reports. The Governing Board shall be required to review Medical Staff reports of medical care evaluation, utilization review, risk management, and other matters relating to the quality of care rendered at the Hospital...shall present such reports to the Governing Board at regular Governing Board meetings or at such other times as may be requested by the Governing Board..."

1. Patient 22's medical record was reviewed on 7/24/17. The Order Summary Report dated 5/26/17 at 1554 hours, showed "...Pacemaker use: Monitor heart rate for pacemaker efficiency Q shift. Notify MD if < 60 beats / min..."

Review of the nursing progress note dated 5/28/17 at 0530 hours, showed the patient was found on the floor by the CNA at 0530 hours, and at 0555 hours, the charge RN was informed of the patient's fall. The licensed nurse documented Patient 22 had swelling and bruising on her forehead; will continue with vital signs and neurochecks per fall protocol; and the MD, DON, ADON, family, and psychiatrist were to be notified.

Continued review of Patient 22's medical record failed to show documented evidence the physician or anyone listed in the above nursing note were notified of the patient's fall.

Review of the Fall Incident Report dated 5/28/17 at 0530 hours, showed "...Treatment. Other. Offered Tylenol for pain. cold pack applied to forehead...Post Fall Report. Was the incident a: Found on the floor (unwitnessed)..." The box next to this statement was checked.

The Progress Note dated 5/28/17 at 2022 hours, showed "...The patient had a fall yesterday and was offered an intramuscular injection for acute agitation..."

Review of the H&P dated 5/29/17 at 1155 hours, showed "...Admit Date 5/26/17...On seeing the patient this afternoon, she had no acute complaints but the staff reported that over the weekend she fell out of her wheelchair and hit her forehead. She has been on neuro checks since then...Physical Examination...Left eyebrow with bruising and hematoma, mildly tender to palpation..."

Review of the Neurology consultation dated 6/5/17 at 1506 hours, showed "...Admit Date 5/26/17...Conclusion: At this time, her neurological examination seems relatively stable. I do not know if the patient has had any radiological studies of the brain in the past or not and if she has not had one done in the past 1-2 years, I recommend that upon discharge she undergo at least a CAT scan of the brain to look at the anatomy..."

Review of the Physician's Order Sheet dated 5/29/17 at 1200 hours, showed "Left spine XR (x-ray). Neck pain after fall. R/O fx (rule out a fracture of a bone)..." No physician orders were found for further patient evaluation.

Review of the Discharge Summary dated 6/12/17 at 1037 hours, showed "...Admit date 5/26/17. Discharge Date 6/12/17...nursing notices in the early morning a sudden change in condition. She was less responsive. 9-1-1 was called...she was transferred to Hoag Hospital for acute medical management..."

Review of the Peer Review document dated 6/13/17, showed in part: "...From chart review, it seems like a sudden episode. There were no decline over period of time or vs. changes over (period of time) hours or days."

Review of the facility's committee meeting minutes for the QAPI, Medical Staff, and GB, for the last 12 months showed no documented evidence the Peer Review information or analysis of the event were discussed. Patient 22 died the day after she was transferred via 9-1-1 to an acute facility.

During an interview with the Treatment Coordinator on 7/26/17 at 1100 hours, the Coordinator reviewed the clinical record and acknowledged all of the above findings and lack of documented evidence. The Coordinator was unable to find documented evidence the MD was notified of the patient's fall. Following the review of the neurologist note, which recommended a CT of the brain, the Coordinator stated she "expected the staff to get a brain CT after the patient's fall". The Coordinator acknowledged there was no documented evidence the patient received a brain CT or was sent to an acute hospital for further evaluation after the fall.

2. Five practitioner credential files were randomly selected for review. The following was identified:

a. One of the five practitioner credential files reviewed (Psychologist 1) did not contain documented evidence he was evaluated at the time of reappointment. The Evaluation portion of the Reappointment Recommendation form was left blank. Further review of the credential file showed Psychologist 1 had a higher rate of patient readmissions, less than 30 days after discharge, than was expected. There was no documented evidence to show the multiple readmissions were considered during Psychologist 1's reappointment.

b. Physician 3's credential files showed during the reappointment, Physician 3 was evaluated by a physician not in his discipline to evaluate and grant him continued privileges.

The Medical Staff Coordinator was interviewed on 7/25/17 and acknowledged the above findings.

Based on observation, interview, and record review, the hospital failed to ensure the nursing staff performed consistent comprehensive assessments for one of one patient (Patient 16) with an indwelling urinary catheter (IUC). This failure posed the risk of Patient 16 not receiving the appropriate care and treatment specific to his individual medical and nursing needs.

Findings:

Review of the hospital's P&P titled Nursing Standards of Care dated 11/13/14, showed the following:

* The RN supervises the direct and indirect patient care services to insure the safety, comfort, personal hygiene, and protection of patients, and the performance of disease prevention and restorative measures.
* The RN begins the initial assessment of a patient's physical and emotional needs within two hours of admission.
* The RN completes the comprehensive nursing assessment within eight hours of admission.
* The RN collaborates with other health professionals in the assessment, planning, and implementation of patient care.
* The RN reassesses each patient at a minimum every shift.
* The licensed nurse implements the treatment plan interventions that promote, restore, and maintain functioning and effect rehabilitation.

Review of the hospital's P&P titled Daily Licensed Nurse Progress Notes dated 2/8/17, showed the following:

* It is the responsibility of the licensed nurse to document every eight hours, data collection, the treatment received, nursing interventions, and patient responses. The daily notes will relate to the problems, goals, patient progress, and treatment methods outlined in the Master Treatment Plan.
* An RN documents at a minimum, once every 24 hours on the patient.
* The licensed nurse documents observations on every shift based on the problems identified in the Master Treatment Plan or Treatment Updates.
* The licensed nurse documents the medical management of identified medical problems.

Medical record review for Patient 16 was initiated on 7/24/17. Patient 16 was admitted to the hospital on 7/13/17.

Review of the Interdisciplinary Patient Admission Assessment dated 7/13/17 at 1230 hours, showed Patient 16 had an IUC in place when he was admitted to the hospital. Further review of the Assessment showed the Nursing Admitting Notes to address the patient's condition on admission to the hospital; however, the notes did not include documentation to address the indication for the IUC, or when or where it was inserted.

Review of a physician's order dated 7/13/17 at 1254 hours, showed to perform IUC care every shift.

Review of a nurse practitioner's H&P dated 7/14/17 at 1757 hours, showed Patient 16 was to begin Augmentin (an antibiotic) 875/125 mg by mouth every 12 hours for seven days for an acute urinary tract infection (UTI).

However, continued review of the medical record did not show documentation the RN clarified the indication for the ongoing use of the IUC.

Review of Patient 16's Medical Treatment Plan Problem 1 dated 7/13/17, showed the following:

* Problem: UTI.
* Goals: patient will respond to medication regimen and experience symptom reduction within 7-10 days.
* Interventions: Administer antibiotic therapy...to eliminate symptoms and provide relief. Encourage patient to drink fluids...to promote urinary output. Assess patient for signs and symptoms of UTI: burning, frequency, foul smell, flank pain, hematuria, temperature...to communicate the need for treatment or effectiveness of treatment.

Review of the Licensed Nursing Notes for Patient 16 for each eight hour shift dated between 7/13 and 7/24/17, showed the following:

* Patient 16 was admitted to the hospital with an IUC on 7/13/17 at 1230 hours; however, the IUC was not addressed in the nursing notes until 7/14/17 at 2200 hours (nearly 36 hours later).
* Patient 16 was diagnosed with a UTI on 7/14/17; however, the UTI was not addressed in the nursing notes until 7/18/17 at 0700 hours (four days later).
* There was no documented evidence of a complete bladder/IUC assessment in the nurses' notes until 7/19/17 at 0700 hours (six days after admission to the hospital, and five days after the diagnosis of a UTI).
* Only two of six RN's documented a complete bladder/IUC assessment in the nursing notes between the dates of 7/13 and 7/24/17.
* On 7/19/17, a nursing note showed an assessment for signs and symptoms of a UTI as per the treatment plan; however, no other assessments of the signs and symptoms of a UTI were found in the nursing notes between 7/13 and 7/24/17.

On 7/25/17 at 1350 hours, an interview was conducted with CN 1. When asked what was expected of the nursing staff when a patient was admitted with an IUC, CN 1 stated first, the physician was made aware the patient had an IUC and he or she would determine whether to discontinue the IUC. CN 1 further stated the standard of care for a patient with an IUC was to perform catheter care every shift. When asked how a patient with an IUC should be assessed, CN 1 stated the IUC should be included in the treatment plan and the nurse should document the IUC in the nursing assessment. CN 1 asked to review Patient 16's medical record to find documentation to show where an assessment of the IUC/bladder was included. After review of Patient 16's record the CN stated the assessment should have been documented every shift in the nursing notes or progress notes. CN 1 verified the IUC and bladder assessment was not done every shift for Patient 16.

On 7/26/17, Patient 16 was observed in the dining room wearing street clothes and sitting in a wheelchair. No IUC was observed. CN 2 was asked if Patient 16 still had an IUC. CN 2 palpated Patient 16's leg and stated he had a leg bag (a small bag to collect urine from the IUC) under his clothing. CN 2 was asked what should be assessed for in a patient with an IUC, and whether or not there was a policy addressing IUC's in the hospital. CN 2 stated there is not policy; however, she would assess the patency (openness) of the catheter, the color and clarity of the urine, and if the patient's abdomen was soft and non-tender.

On 7/26/17 at 1000 hours, the Infection Preventionist stated the hospital had no P&P to address the IUCs. Cross reference to A748.

Based on interview and record review, the hospital failed to ensure an individualized care plan was developed and completed to address the medical and psychiatric needs of four of 30 sampled patients (Patients 1, 2, 3, and 23). The lack of a comprehensive care plan may result in the interventions not developed which could further compromise the patients' medical status.

Findings:

Review of the hospital's P&P titled Individual Treatment Plan revised 4/16 showed the purpose is to ensure the development of an individualized interdisciplinary treatment plan for each patient based on a multi-disciplinary team assessment. The P&P also showed the following:

* The treatment team includes the psychiatrist, psychologist, nursing, social services, activity therapy, and dietary.

* The Physician, Social Worker, Treatment Coordinator, and RN develop the Master Treatment Plan within 72 hours of the admission. The plan will include at least the following information:

- identified safety risk factors such as suicidality/self harm, homicidal or assaultive behaviors.
- identified problems, behavioral manifestations of the problem, short and long term goals, interventions, responsible clinical staff, education to be performed, and criteria for discharge.
- patient strengths and limitations.

* The treatment team reviews the current status of the patient in meeting the goals on a weekly basis, to support the patient's continued stay.

* An RN updates the treatment plan based on assessment/re-assessments, and adds necessary problems or interventions.

1. Patient 2's medical record review was initiated on 7/24/17. Patient 2 was admitted to the hospital on 7/18/17.

Review of the Interdisciplinary Progress Notes dated 7/20/17 at 0045 hours, showed Patient 2 stated he used his fist to punch the bathroom wall.

Review of the Interdisciplinary Progress Notes dated 7/23/17 at 2000 hours, showed Patient 2 was hypersexual towards certain nursing staff.

Review of the Master Interdisciplinary Treatment Plan showed the Treatment Plan was initiated on 7/18/17. However, further review of the Treatment Plan failed to show any update to address Patient 2's assaultive behaviors. In addition, there was no physician's signature to show the physician was involved in the development of the master treatment plan.

On 7/24/17 at 1400 hours, an interview and concurrent medical record review was conducted with the Director of Clinical Services. When asked what kind of precautions were put into place for a patient with assaultive behaviors, the Director stated usually 1:1 monitoring would be implemented. When asked if Patient 2 was on 1:1 monitoring, the Director stated no.

The Director of Clinical Services verified the above findings.

2. Patient 1's medical record review was initiated on 7/24/17. Patient 1 was admitted to the hospital on 7/13/17.

Review of the Master Interdisciplinary Treatment Plan dated 7/17/17, showed the following areas to identify for the patient were left blank:

* Preferred leaning method
* Communication aids
* Strengths
* Barriers/liabilities
* Soothers
* Triggers

On 7/24/17 at 1410 hours, the Director of Clinical Services verified the Master Interdisciplinary Treatment Plan was not complete for Patient 1.


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3. Patient 3's medical record review was initiated on 7/24/17 at 0924 hours. Patient 3 was admitted to the hospital on 7/22/17, with a diagnosis of unspecified psychosis, not due to a substance or known physiological condition.

On 7/24/17 at 1049 hours, Patient 3 was observed in the Activity Room. Patient 3 was in a semi-prone position in a gerichair (a large, padded, reclining chair with casters designed to allow patients recovering from illness and surgery, or the elderly and infirm to get out of a bed and sit comfortably while being fully supported and transported to adjoining areas within a facility). Patient 3 stated in a low-toned and garbled speech he was forced to be in the activity. At 1100 hours, Patient 3 was still sitting in the gerichair; no restless movements or signs of agitation were observed. At 1105 hours, Patient 3 was asleep in the gerichair during the activity.

Review of the Psychiatric Evaluation dated 7/23/17 at 2158 hours, showed Patient 3 was increasingly aggressive with yelling, disruptive behavior, and anxiety. Patient 3 was evaluated to have poor insight, judgement, impulse control and safety awareness.

Review of the Interdisciplinary Patient Admission Assessment dated 7/22/17 at 2000 hours, showed Patient 3 was increasingly agitated, rolling out of bed, and throwing items. Patient 3 had a speech deficit and needed total assistance with his ADLs.

Review of the Initial Psychiatric Treatment Plan showed Patient 3 had an active behavioral problem of poor impulse control as evidenced by striking out and throwing items. The long term goal was for Patient 3 to reduce all impulsive acts that created unsafe conditions. Short term goals developed showed Patient 3 would have two or less episodes of interrupting behaviors due to impulsivity and Patient 3 would take all the medications ordered to lessen impulsivity from day three with 100 percent compliance. However, further review of the document failed to show a care plan was developed for Patient 3 specific to identifying the triggers for his impulsivity and aggressive behavior. The interventions documented showed to mitigate his impulsive actions when they occurred and how to treat his impulsive actions with medication therapy, redirection, and a predictable routine. In addition, the physician did not sign and date the treatment plan.

The above findings were verified with the Director of Clinical Services on 7/24/17 at 1030 hours. The Director stated the care plan should address interventions tailored to Patient 3's pre-existing condition as a factor to identify possible behavioral triggers, such as his decreased mobility or his inability to clearly verbalize his needs.

4. Patient 23's medical record review was initiated on 7/25/17 at 0900 hours. Patient 23 was admitted to the hospital on 7/17/17, with a diagnosis of dementia with behavioral disturbance.

On 7/26/17 at 0912 hours, Patient 23 was observed sitting in a wheelchair in the Activities Room. With the translation assistance of CNA 1, Patient 23 stated, "I don't know why I am here." When asked what she ate for breakfast, Patient 23 mumbled. CNA 1 stated Patient 23 was not making any sense. CNA 1 stated Patient 23 communicated only in her primary language.

Review of the Psychiatric Evaluation dated 7/18/17 at 1808 hours, showed Patient 23 was agitated, aggressive, and posed an imminent danger to herself and others given her poor insight and judgement.

Review of the Interdisciplinary Patient Admission Assessment dated 7/17/17 at 1930 hours, showed Patient 23 identified her primary language to be other than English. Patient 23 was incontinent of urine and required moderate to total care in her ADLs. The patient was agitated and restless upon admission.

Review of the Initial Psychiatric Treatment Plan dated 7/17/17 at 2030 hours, showed Patient 23 had an active behavioral problem of poor impulse control. The active nursing problem documented was for the risk of falls. Further review of the document failed to show the documentation Patient 23's language barrier was addressed in her care plan. In addition, the physician did not sign and date the treatment plan.

The above findings were verified with CN 1 on 7/25/17 at 1003 hours. CN 1 stated many of the hospital staff was able to speak in Patient 23's primary language and a translation line via telephone was used if needed. However, when asked how the care plan addressed and evaluated Patient 23's active problem of impulse control, he stated the care plan failed to address the problem and also did not include her language barrier.

Based on interview and medical record review, the hospital failed to ensure the Informed Patient Consent to Receive Psychiatric Medications was complete for three of 30 sampled patients (Patients 18, 24 and 29). This failure had the potential for patients to make important healthcare decisions without the complete information and understanding of the planned treatment.

Findings:

Review of the hospital's P&P titled Informed Consent last revised 2/14/13, showed the hospital must secure written consents from the patient or legal guardian for admission, medications, applicable treatments, and operative/other procedures. The purpose of the policy was to safeguard and protect the rights of the patient and to ensure patient understanding of planned treatment.

The P&P showed the nursing staff is to obtain written consent from the patient or legal guardian at the time of admission and to ensure a patient admitted on a involuntary legal hold will have their rights upheld regarding medications. The nursing staff witnesses the patient's signature for consent to take the medication by signing the form with first initial/last name, title, time and date, and provides a copy of the written material pertaining to the medication ordered to educate the patient and/or significant other.

The P&P showed the physician is to inform the patients who are to receive mood-altering medications of the side effects of the medication, risks, benefits, and alternative to the medication therapy. The physician signs the medication consent form indicating the patient is aware of the medication(s) recommended and the patient signs the consent to take the medications.

1. Patient 29's medical record was reviewed on 7/26/17 at 0845 hours. The Informed Patient Consent to Receive Psychiatric Medications form dated 7/25/17 at 1700 hours, showed no signature by the patient. The box next to line "Unable to sign, but provides verbal permission" was checked; and two witness signatures were entered. Three medications, Melatonin, Trazodone, and Ativan, were listed on the consent form.

Further review of the consent form showed the following check boxes and lines on the form were left blank:

* "Evidence of tardive dyskinesia: yes or no." No box was checked. "If yes, specify:" This line was left blank.

* "I have received written information regarding the medication(s) I am taking:- yes, no, or refused documents." No box was checked to show the patient received information regarding the medications.

Further review of Patient 29's medical record showed three entries by the nurses on 7/25/17, documenting the patient was appropriate and oriented to person, place, and time. There was no notation in the above mentioned notes as to why Patient 29 was unable to sign the Informed Patient Consent To Receive Psychiatric Medications form.

During an interview with CN 2 on 7/26/17 at 0910 hours, CN 2 stated, "I would put an explanation next to the checked box...it's not in the policy to explain inability to sign."

During an interview with Patient 29 on 7/26/17 at 0940 hours, Patient 29 stated, "I didn't refuse to sign anything...nobody gave me written medication information."

On 7/26/17 at 1005 hours, the DPCS was interviewed. When asked about the lack of explanation for the unable to sign entry, she stated, "there should be an explanation in the progress note or daily charting...there is no explanation."


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2. Review of the Informed Consent to Receive Psychiatric Medications form dated 7/14/17 at 1030 hours, showed Patient 18 signed the form indicating she read the form, understood it, and consented to take the medications prescribed by the doctor; however, the following check boxes and lines on the form were left blank:

* "Evidence of tardive dyskinesia: yes or no." No box was checked. "If yes, specify:" This line was left blank.
* "I have received written information regarding the medication(s) I am taking: yes, no, or refused documents."
No box was checked to show the patient received information regarding medications.


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3. Patient 24's medical record was reviewed on 7/2/17. The patient was admitted to the hospital on 7/9/17.

Review of the Informed Patient Consent to Receive Psychiatric Medications forms dated 7/11 and 7/21/17, showed Patient 24 signed the form indicating she read the form, understood it, and consented to take the medications prescribed by the doctor; however, the following check boxes and lines on the form were left blank:

* "Evidence of tardive dyskinesia: yes or no." No box was checked. "If yes, specify:" This line was left blank.

* "I have received written information regarding the medication(s I am taking:- yes, no, or refused documents. No box was checked to show the patient received information regarding the medications.

The DOP was interviewed on 7/26/17 at 1055 hours. The DOP was asked to review the area of the Informed Consent for Medications form for documentation of written information given to the patients. The DOP stated this area should be completed by the nurse. The DOP stated written information for medications was available at the nurses' station.

On 7/26/17 at 1100 hours, RN 4 was asked about information provided to patients regarding the medications they were taking. RN 4 stated, "We ask the doctor to explain the medications...we ask the pharmacist for printouts." When the drawer containing the printed drug information handouts was pointed out by another staff member, he stated, "Oh, that's where it is."

Based on interview and record review, the hospital failed to ensure the H&P was completed timely after admission to the hospital for one of 30 sampled patients (Patient 3). This failure posed an increased risk for Patient 3's medical needs to not be addressed.

Findings:

Patient 3's medical record review was initiated on 7/24/17. Patient 3 was admitted to the hospital on 7/22/17 at 2000 hours. Review of the medical record showed no H&P was completed for Patient 3.

During an interview with the Infection Preventionist on 7/24/17 at 1021 hours, she was able to verify an H&P was not completed for Patient 3 at this time.

Based on observation, interview, and document review, the hospital failed to ensure pharmaceutical services were provided to meet the needs of the patients. The hospital failed to:

1. Provide pharmaceutical services to meet the needs of the patients. Cross reference to A490.

2. Ensure the drug storage areas were administered in accordance with accepted standards. Cross reference to A491.

3. Ensure the medication cart was secured at all times. Cross reference to A502.

4. Ensure expired medications were not available for use. Cross reference to A505.

5. Ensure the medications accessible to the nurses when the pharmacist was not available (night locker) was correctly stocked. In addition, the hospital had no process to determine the appropriateness of the medications stocked in the night locker. Cross reference to A506.

6. Ensure the medication errors and adverse drug reactions (medication events) were analyzed to identify the improvement opportunities to prevent reoccurrences. In addition, identified medication incompatibilities (when prescribed medications interfere with each other) were not addressed and documented. Cross reference to A508.

7. Establish or implement an auditing and monitoring system to prevent and detect misuse or abuse of controlled substances. Cross reference to A509.

8. Ensure an up-to-date drug information source was available to the professional staff involved in the medication use process. Cross reference to A510.

9. Ensure written criteria for determining which medications were available for dispensing and administration (the formulary) were developed and implemented. Cross reference to A511.

The cumulative effect of these systemic issues resulted in the failure of the hospital to deliver pharmaceutical services in a safe manner.

Based on interview and document review, the hospital failed to ensure the pharmaceutical services was provided to meet the needs of the patients as evidenced by:

1. The hospital did not have a process in place to ensure the appropriate use of medications, potential medication interactions, and contraindications were managed during the hours the pharmacy was closed. Medication interactions can range from mild to severe, where death can occur if certain medications are administered together. Medication contraindications mean certain medications should not be administered to certain patients.

2. A medication order did not include the time it was written.

As a result, the hospital could not ensure medications were safely used.

Findings:

1. On 7/24/17 at 1250 hours, Pharmacist 1 was interviewed regarding the pharmacy's hours. The hours were as follows:

- 0700 hours to 1430 hours, Monday through Friday;
- 0700 hours to 1300 hours on Saturday; and
- Closed on Sunday.

The DOP was interviewed on 7/25/17 at 1145 hours. The DOP stated when the pharmacy was closed, new medication orders were not be reviewed by the pharmacist. This meant from 1430 hours to 0700 hours on the weekdays, and from 1300 hours on Saturday to 0700 hours on Monday every week, new medications were administered without the pharmacist's review for potential interactions and contraindications. The DOP acknowledged the hospital did not have any other process in place to ensure medications were reviewed for appropriateness and medication interactions, as well as contraindications.

2. According to the hospital's P&P titled Medication Orders last approved 10/24/12, "Orders must be written, timed, dated...."

On 7/25/17 at 1015 hours, Patient 17's medical record was reviewed with LVN 2. Documentation in the medical record showed on 7/24/17, Patient 17 was prescribed Zyprexa (a medication to treat mood disorder). LVN 2 acknowledged the medication order did not include the time it was written.

Based on observation, interview, and document review, the hospital failed to ensure the drug storage areas were administered in accordance with accepted standards as evidenced by:

1. Multiple strengths of the medication, fentanyl patch (Duragesic, a potent medication to treat pain, which can cause death if not used appropriately or used in error), were stored together. This could lead to the selection and administration of an incorrect dosage, an error that could potentially cause death.

2. The hospital had no P&P in place to ensure medications that were either look-alike, or sound-alike (LASA) were used safely. This could lead to preventable medication errors.

3. The hospital had no P&P in place to ensure medications that were considered high-risk (medications that can cause significant patient harm when used in error) were used safely. This could lead to preventable medication errors.

4. The hospital had no P&P in place to ensure medications with boxed warnings (a box around the warning, designed to call attention to serious or life-threatening risks) were used safely. This could lead to preventable medication errors.

5. Medications requiring refrigeration in the pharmacy were not appropriately refrigerated when the out-of-range temperatures in the refrigerator were not addressed to ensure the medications were safe for administration. Therefore, the hospital could not ensure the potency and purity of the medications.

6. Medications were not labeled with the appropriate beyond-use-date (BUD, a date after which a medication should not be stored or used) as specified by the manufacturers. Therefore, the hospital could not ensure the potency and purity of the medications.

7. Medications brought in by admitted patients were not managed and tracked to prevent misuse and abuse. In addition, when these medications were administered to admitted patients, the pharmacist did not ensure the medications were safe prior to the administration. This could lead to misuse and abuse of medications stored by the hospitals, and the medications were not safely administered to the patients.

8. A medication was not stored under the appropriate conditions as specified by the manufacturer's specifications. Therefore, the hospital could not ensure the potency and purity of the medication.

9. Medications were not stored under sanitary conditions. Therefore, the hospital could not ensure the purity of the medications.

Findings:

1. According to the hospital's P&P titled Storage of Medications last approved 10/24/12, the DOP was to "[e]nsure that standards for the storage of medication(s) ... are inviolate."

The medication storage was inspected with the DOP on 7/24/17 at 1435 hours. Fentanyl patches with different dosages (25 mcg, 50 mcg, and 100 mcg) were stored in the same storage bin labeled as "Duragesic 25 mg." The DOP stated it was "an accident waiting to happen," because the nurse could administer the 100 mcg patch instead of the 25 mcg patch. The DOP added this error "could cause death."

2. On 7/25/17 at 1405 hours, the DOP was interviewed regarding LASA medications.

The DOP provided a list of LASA medications, last updated 6/14/16. The DOP acknowledged the hospital did not have a policy, procedures, or guidance to prevent the medication errors associated with LASA, other than having a list available. The prescribers, pharmacists, and nurses would not know what they should have done to prevent medication errors associated with LASA.

3. On 7/25/17 at 1405 hours, the DOP was interviewed regarding high-risk medications.

The DOP provided a list from the ISMP (Institute for Safe Medication Practices, a nonprofit organization devoted to medication error prevention and safe medication use) from 2012. According to the ISMP's List of High-Alert Medications, "Although mistakes may or may not be more common with these drugs, the consequences of an error are clearly more devastating to patients. We hope you will use this list to determine which medications require special safeguards to reduce the risk of errors."

During the same interview, the DOP acknowledged the hospital did not have its own list to determine which medications required special safeguards and what safeguards were to be used to reduce or prevent errors. In addition, most medications listed in the ISMP's list were not used at the hospital.

4. On 7/26/17 at 0840 hours, the DOP was interviewed regarding medications with boxed warnings.

The DOP acknowledged the hospital had no policy, procedures, or guidance for the safe use of medications with boxed warnings. The prescribers, pharmacists, and nurses would not know what they should have done to ensure the safe use of medications with boxed warnings.

5. According to the hospital's P&P titled Storage of Medications last approved 10/24/12, medications requiring refrigeration were to be stored in refrigerators, and the temperature was to be maintained between 36 to 46 degrees Fahrenheit (F). In addition, the DOP was to "[e]nsure that standards for the storage of medication(s) ... are inviolate."

On 7/25/17 at 1145 hours, the temperature logs for the medication refrigerator in the Pharmacy were reviewed with the DOP and Special Project Manager. The following was identified:

- In 10/2016, the temperatures were out of range for approximately seven hours, from 10/24/16 at 1246 hours to 10/25/16 at 0946 hours.

- In 4/2017, the temperatures were out of range for approximately 21 hours, from 4/26/17 at 1052 hours to 4/27/17 at 0548 hours.

The Manager stated she was responsible for the temperature monitoring by reviewing the temperature logs generated by the electronic temperature monitoring system. The Manager indicated the temperature monitoring was not in real-time. The Manager stated she would review the logs for temperatures that were out of range for more than four hours.

The DOP stated the medication refrigerator contained PPD (a testing agent to detect tuberculosis, a lung infection that can spread from person to person), influenza vaccine (vaccine to prevent the flu), insulins (medications to treat high blood sugar), and lorazepam injection (medication to treat anxiety or seizure). The DOP stated he was not aware these medications were potentially deteriorated. The DOP was not aware if the medications were replaced, and indicated the staff did not take any action other than closing the refrigerator door.

The DOP was again interviewed on 7/25/17 at 1405 hours. The DOP stated the hospital had no P&P specifically for the monitoring of the medication refrigerator temperatures. According to the current procedures, "If [temperature] out of normal range... Adjust temperature and recheck within 4 hours... If out of range after second check, take action: A. Notify charge nurse. B. Work order to Engineering to check the refrigerator/freezer and thermometer. C. Notify pharmacy for instruction of medicine storage... E. Refrigerator/freezer taken out of service."

6. According to the hospital's P&P titled Storage of Medications last approved 10/24/12, the DOP was to "[e]nsure that standards for the storage of medication(s) ... are inviolate."

a. On 7/24/17 at 1300 hours, a tour of the Pharmacy was conducted with the DOP.

Three units of levalbuterol (medication to treat breathing difficulty) 1.25 mg in 3 ml were stored in an open container, without the BUD or open date.

The DOP stated the medication would be used until the manufacturer's expiration date of "2/2018."

According to the manufacturer's specifications, once opened, the medication should be used within two weeks.

The DOP stated, he was "not aware of that."

b. On 7/24/17 at 1450 hours, the medication room was inspected with the DOP.

One vial of Humulin R (regular insulin, to treat high blood sugar) was opened and labeled with the open date of 7/7/17, and the BUD of 8/25/17.

The DOP stated the BUD should have been 28 days after the vial was opened, and the current labeled BUD was beyond 28 days.

c. Medication Cart 1 was inspected with LVN 3 on 7/25/17 at 1100 hours. The following was observed:

- Patient 27's medication, latanoprost eye drop (Xalatan, medication to reduce pressure in the eye) 0.005% bottle was opened and had no open date or BUD. LVN 3 stated the medication could be used until the manufacturer's expiration date of "9/2018." According to the manufacturer's specifications, once opened, the medication could be used up to 6 weeks [and discarded].

- Patient 6's medication, Advair (medication to treat breathing difficulty) 250/50 (strength) was opened and had no open date or BUD. Patient 26's medication, Advair 250/50 was opened and had no open date or BUD. LVN 3 stated the medication should have been labeled with the open date. According to the manufacturer's specifications, once opened, the medication should have been discarded after one month. Without the open date, staff would not know when to discard the medication.

According to the hospital's P&P titled Expiration Dates of Medications last revised 11/12, "The pharmacy ensures that all medication(s) dispensed are properly labeled with the expiration date and removes all expired medication from the inventory. Licensed Nurses are educated as to the required time frame for use of products once opened... Give Advair an expiration date of thirty (30) days after opening... Give Xalatan an expiration date of six (6) weeks after opening...."

- Eight units of ipratropium (medication to treat breathing difficulty) 0.02% (strength) were not stored in the foil pouch. LVN 3 acknowledged the medication should have been stored in the foil pouch as specified by the manufacturer.

Six units of ipratropium/albuterol (medication to treat breathing difficulty) 0.5 mg/3 mg in 3 ml were not stored in the foil pouch and had no open date or BUD. LVN 3 acknowledged the medication should have been stored in the foil pouch as specified by the manufacturer, or once removed from the foil pouch, they should have been used within one week. Without the open date or BUD, staff would not know when to discard the medication.

d. Medication Cart 2 was inspected with LVN 3 on 7/25/17 at 1100 hours. The following was observed:

- Patient 25's medication, Symbicort (medication to treat breathing difficulty) 160/4.5 was opened and had no open date or BUD. LVN 3 stated the medication should have been labeled with the open date. According to the manufacturer's specifications, once opened, the medication should have been discarded after three months. Without the open date or BUD, staff would not know when to discard the medication.

- Two units of ipratropium/albuterol (medication to treat breathing difficulty) 0.5 mg/3 mg in 3 ml were not stored in the foil pouch and had no open date or BUD. LVN 3 acknowledged the medication should have been stored in the foil pouch as specified by the manufacturer, or once removed from the foil pouch, they should have been used within one week. Without the open date or BUD, staff would not know when to discard the medication.

- Three units of ipratropium (medication to treat breathing difficulty) 0.02% (strength) were not stored in the foil pouch. LVN 3 acknowledged the medication should have been stored in the foil pouch as specified by the manufacturer.

7. According to the hospital's P&P titled Medication Brought to Hospital by Patient last approved 11/9/16, "Ensure patient safety and the appropriate use of patients' own medications while hospitalized... allow use of the patient's own medication with a physician's order and re-labeling by pharmacist... Pharmacist... Before dispensing medication, verifies medication and visually inspects for deterioration."

a. The medication room was inspected with the DOP on 7/24/17 at 1410 hours.

Medications brought by patients from outside pharmacies were stored in the medication room, including controlled substances (medications with high abuse potential). The DOP stated the hospital had no tracking system in place to ensure medications were not missing or misused. The DOP stated he was "surprised this many [medications were] in here."

b. Medication Cart 1 was inspected with LVN3 on 7/25/17 at 1100 hours.

Four prescription medications for Patient 4 contained label s from two different pharmacies (not the hospital's pharmacy). LVN 3, a nurse responsible for the medication administration, stated she used these for administration earlier. LVN 3 stated she would not "have access" to these medications until they were verified by the pharmacist; however, there were no labels to indicate the medications were verified by a pharmacist.

The DOP was interviewed on 7/25/17 at 1145 hours. The DOP stated an order from a physician was required to use the patient's medications from outside pharmacies. The medications would have been sent to the pharmacy for verification by a pharmacist, and the hospital's pharmacy label would be applied to the medication container.

Patient 4's medications were inspected with the DOP on 7/25/17 at 1255 hours. The DOP acknowledged these four medications were not verified by a pharmacist, and stated they should not have been available for the nurse to administer. The DOP also acknowledged Patient 4's medical record did not contain the physician's order to use the patient's medications from outside pharmacies.

8. According to the hospital's P&P titled Storage of Medications last approved 10/24/12, the DOP was to "[e]nsure that standards for the storage of medication(s) ... are inviolate."

The medication refrigerator in the medication room was inspected with the DOP on 7/24/17 at 1450 hours. Patient 14's medication, Toujeo Solostar (an insulin injection to treat high blood sugar), was opened and stored in the refrigerator. The DOP was unsure if the storage was appropriate.

The DOP was interviewed on 7/25/17 at 1405 hours. The DOP stated the medication should not have been stored in the refrigerator after it was opened.

According to the manufacturer's specification, the medication should have been stored at room temperature after it was opened.

9. According to the hospital's P&P titled Storage of Medications last approved 10/24/12, the DOP was to "[e]nsure that standards for the storage of medication(s) ... are inviolate."

Medication Cart 2 was inspected with LVN 3 on 7/25/17 at 1100 hours. The medication storage bin for respiratory medications (medications administered via inhalation to treat breathing difficulty) had debris at the bottom. LVN 3 stated it was dirty.

Based on observation and interview, the hospital failed to ensure the medication cart was secured at all times. This posed the risk of injury from access to needles and medications by the psychiatric patients.

Findings:

On 7/24/17 at 0905 hours, an unattended medication cart was observed in the hallway in front of a patient room. The medication cart was not locked. Inspection of the cart showed it contained insulin needles in the first drawer and medications in the second drawer. LVN 1 was observed coming out of the patient room. When asked, LVN 1 stated the medication cart should be locked all the time. LVN 1 verified the medication cart was not locked and unattended.

Based on observation, interview, and document review, the hospital failed to ensure expired medications were not available for use. This had the potential for the patients to receive medications that might be no longer effective to provide the intended benefits.

Findings:

Review of the hospital's P&P titled Expiration Dates of Medication dated 11/29/12, showed the pharmacy ensures that all medication(s) dispensed are properly labeled with the expiration date and removes all expired medication from the inventory. The manufacturer's expiration is defined as the date provided on the original container and identifies the time during which prescription drug may be expected to meet the requirements of the pharmacopia monograph, provided the drug is kept under prescribed storage conditions.

1. A tour of the Pharmacy was conducted with the DOP on 7/24/17 at 1300 hours. The following was observed:

- Twenty-four doses of Bronava (an inhalation medication to treat breathing difficulty), stored in the medication refrigerator, had the expiration date of "5/2017." The DOP stated the medication expired at the end of May 2017 and should not have been stored in the refrigerator.

- Ten doses of influenza vaccine (vaccine to prevent the flu), stored in the medication refrigerator, had the expiration date of "6/30/17." The DOP stated the vaccine had expired and should not have been stored in the refrigerator.

2. A tour of the medication room was conducted with the DOP on 7/24/17 at 1435 hours.

One fentanyl patch (Duragesic, a medication to treat pain) 25 microgram had the expiration date of 6/2017. The Director acknowledged the medication had expired.


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3. On 7/24/17 at 0900 hours, the emergency cart was observed with the Infection Preventionist. Two vials of flumazenil (reverses sedative effects of benzodiazepines used in general anesthesia or conscious sedation management of benzodiazepine overdose) was observed with an expiration date of 6/17. The Infection Preventionist stated, "Yes, the flumazenil is expired, it shouldn't be there."

Based on observation, interview, and document review, the hospital failed to ensure medications accessible to the nurses when the pharmacist was not available (night locker) were correctly stocked. In addition, the hospital did not have a process to determine the appropriateness of the medications stocked in the night locker. As a result, the hospital failed to ensure medications were safely used, and this practice potentially could lead to preventable medication errors.

Findings:

1. According to the hospital P&P titled Pharmacy Night Locker last approved 4/22/15, "The availability of medication in the night locker ensures that a patient receives the first dose of a newly ordered medication in a timely manner... Pharmacist... Maintains an adequate supply of medications in the night locker for use during the hours the pharmacy is closed... Posts a list of medications available in the night locker...."

The night locker was inspected with the DOP on 7/24/17 at 1410 hours.

Five tablets of clozapine (a medication to treat mood disorders) 25 mg were observed stocked in the night locker. The list posted outside the night locker showed 10 tablets should have been stocked.

2. According to the hospital's P&P titled Clozapine [medication to treat mood disorders] (Clozaril, FazaClo) Administration last approved 2/8/17, "Outline the procedures for the safe prescribing, administering, and monitoring of Clozaril/FazaClo... Pharmacist... completes the Patient Registration Form to register the patient on the Clozaril REMS [Risk Evaluation and Mitigation Strategy, required by the Food and Drug Administration to ensure the medication was safely used when there was a high risk of harm, even though the benefits existed] Website... Orders baseline [blood test] before starting medication. To initiate or continue treatment, the [blood level] is [level determined by the hospital]... Fills the medication after receiving the requested lab results, monitor [blood level]... before dispensing the medication."

Pharmacist 1 was interviewed on 7/24/17 at 1250 hours, regarding the Pharmacy's hours. The hours were as follows:

0700 hours to 1430 hours Monday through Friday;
0700 hours to 1300 hours on Saturday; and
Closed on Sunday.

The night locker was inspected with the Director of Pharmacy on 7/24/17 at 1410 hours. The night locker contained clozapine 25 mg and 100 mg.

The DOP was interviewed on 7/25/17 at 1145 hours. The DOP stated new medication orders after the pharmacy's business hours were not reviewed by the pharmacist for safety issues prior to administration. The DOP also stated the nurses had access to the medications in the night locker, and could administer to the patients without the pharmacist's review.

The DOP was interviewed on 7/25/17 at 1405 hours. The DOP stated clozapine had a REMS program, requiring the [blood level] prior to administration; however, the nurses were not responsible for the [blood level] calculation. The DOP also stated clozapine was in the night locker because if the risk of not getting the medication was high, then the nurse could remove the drug without the review required of the pharmacist. However, the DOP could not recall if the hospital had discussed the risks and benefits of having clozapine in the night locker.

Based on interview and document review, the hospital failed to ensure medication errors and adverse drug reactions (medication events) were analyzed to identify the improvement opportunities to prevent reoccurrences. In addition, identified medication incompatibilities (when prescribed medications interfere with each other) were not addressed and documented. As a result, the hospital failed to ensure patients would be free of preventable medication events.

Findings:

1. According to the hospital's P&P titled Medication Dispensing/Administration Errors last revised 11/29/12, "The data collected is reviewed and analyzed for trends and common denominators."

The meeting minutes for the P&T committee were reviewed with the DOP on 7/26/17 at 0840 hours. The DOP acknowledged the committee did not analyze the data related to the medication errors and adverse drug reactions, and did not identify the corrective actions to prevent reoccurrences.

Record review and interview were conducted with the Director of Performance Improvement and DOP on 7/25/17 at 1013 hours. They acknowledged the hospital did not identify improvement opportunities for the medication errors reported in 2016.

2. Patient 12's medical record was reviewed on 7/25/17 at 1020 hours. The record showed documents dated 7/14 and 7/24/17 were placed in Patient 12's medical record regarding incompatibilities between:

NSAID (a group of medication to treat pain or inflammation) and ACE-I (a group of medication to treat high blood pressure); and

SSRI (a group of medication to treat mood disorders) and aspirin.

The DOP was interviewed on 7/25/17 at 1405 hours. The DOP stated he was not sure if the incompatibilities were seen by Patient 12's physician. The DOP added, "physician tends to ignore it [the document regarding medication incompatibilities]."

Based on observation, interview, and document review, the hospital failed to establish or implement an auditing and monitoring system to prevent and detect misuse or abuse of controlled substances. As a result, the hospital was not able to effectively detect and prevent abuses and losses to protect the patients, staff, and the surrounding community from misuse and abuse of controlled substances.

Findings:

According to the DEA, medications with abuse potentials are placed in schedules II to V. Schedule II medications have the highest abuse potential, while schedule V medications have the lowest abuse potential. Medications in schedules II to V are controlled substances.

According to the hospital's P&P titled Controlled Drug Monitoring last revised 11/29/12, showed "The [hospital name] Pharmacy is responsible for the purchasing, storing, distributing and overall control of everything involved with drugs classified as controlled substances by the DEA."

1. On 7/24/17 at 1300 hours, the hospital's Narcotic Sales Report was reviewed with the DOP.

The report was generated monthly by the wholesaler for the Pharmacy, listing the controlled substance purchases made for that month. Review and reconciliation of such report with the receiving records in the Pharmacy on a regular basis would ensure ordered controlled substances were received and recorded in the Pharmacy's inventory. This would detect and prevent abuses and losses of controlled substances.

The DOP stated the reports for 5/2017 and 6/2017 were not reviewed because the signature and review date were not on the report.

Additional Narcotic Sales Reports were reviewed with the DOP on 7/25/17 at 1145 hours. The DOP acknowledged the reports were not reviewed from 8/2016 to 6/2017 (11 consecutive months).

2. The Controlled Substance Administration Record was reviewed with LVN 4 on 7/24/17 at 1618 hours. The record was in the medication room and used to record activities related to each controlled substance.

LVN 4 was the current medication nurse. LVN 4 stated she completed a shift change count at 1500 hours. A shift change count was to be performed when the outgoing and incoming nurses would count the controlled substances together to ensure the count accuracy for each controlled substance.

The record showed there was one fentanyl patch (a schedule II medication) 100 microgram, but zero was present. LVN 4 was not able to account for the medication.

LVN 4 then stated she was supposed to count together with the outgoing nurse at shift change, but did not.

The DOP was interviewed at 7/24/17 at 1800 hours. The DOP stated he removed the fentanyl patch because it was expired, and should have documented the activity on the record, but did not.

Based on observation, interview, and document review, the hospital failed to ensure an up-to-date drug information source was available to the professional staff involved in the medication use process. As a result, the hospital could not ensure medications were used safely.

Findings:

Medication Cart 1 was inspected with LVN 3 on 7/25/17 at 1100 hours.

Patient 27's medication, latanoprost eye drop (Xalatan, medication to reduce pressure in the eye) 0.005% bottle was observed opened and did not have an open date or the beyond-use-date (BUD, a date after which a medication should not be used or stored). LVN 3 stated the medication could be used until the manufacturer's expiration date of "9/2018."

According to the manufacturer's specifications, once opened, the medication could be used up to 6 weeks [and discarded].

LVN 3 stated she was "not familiar with the medication." LVN 3 added she was not aware of any drug information reference she could use to learn more about the medication.

The DOP was interview on 7/25/17 at 1520 hours. The DOP provided the Nursing Drug Guide from 2005. The DOP stated, "that's outdated," referring to the reference from 2005, and "that's a deficit."

Based on interview and document review, the hospital failed to ensure written criteria for determining which medications were available for dispensing and administration (the formulary) were developed and implemented. As a result, the hospital could not ensure quality pharmaceuticals were provided to the patients.

Findings:

The DOP was interviewed on 7/26/17 at 0840 hours. The DOP stated the formulary was approved three months ago by the hospital.

The meeting minutes were reviewed with the DOP. The minutes showed the medications were either added or deleted from the formulary. However, the DOP was unable to provide, and the minutes did not reflect, the criteria when determining which medications were added or deleted.

Based on interview and document review, the hospital failed to ensure the qualifications of a Registered Dietician (RD 1) was verified. This created the risk of substandard healthcare outcomes to the patients in the hospital.

Findings:

On 7/24/17 at 0930 hours, a review of all current diet menus was conducted with the Food Service Manager. All menus were approved and contained a signature by RD 1.

On 7/24/17 at 1100 hours, a contract review was conducted with the HR Director who was unable to find a contract for RD 1. The Director further stated she was unaware of RD 1 working at the facility and did not have a copy of RD 1's credentials, employee health screening, contract or license verification. Review of the payroll records showed RD 1 first worked in the facility on 11/18/16.

On 7/25/17, review of the nutritional screenings for 30 of the 30 sampled patients showed RD 1 completed 100% of the assessments.

Based on observation and interview, the hospital failed to ensure the physical environment was maintained in a manner that assured safety and well-being of the patients and protected the patients from self-injury. This created the risk of substandard healthcare outcomes to the patients in the hospital.

Findings:

1. On 7/24/17 at 0910 hours, a tour of the hospital was conducted with the DPCS. The following was observed:

a. Observation of Room B showed the room was occupied by two patients. Two sprinkler heads were observed projecting approximately three inches from the ceiling. The sprinkler assembly included a gap which allowed for the looping of any long material with the potential for self-injury to a patient by hanging.

b. The window blind wands were observed broken and sharp to touch in Rooms A and B.

The DPCS verified the above findings.


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2. On 7/24/17 at 0900 hours, a tour of Room 1 was conducted with the Activities Director. Room 1 was a two bed room. Each of the two beds had a power cord connected to an outlet. The power cord for each bed was wrapped around the bed frame and zip tied; however, there was still a long section of the cord unsecured before connecting to the wall outlet. Each bed also had a bed positioning control connected by a coiled cord from the bed to the control. With tension, the cord was able to be uncoiled to a substantial length.

On 7/25/17 at 1445 hours, an observation and concurrent interview was conducted with Engineer 1 in Room 9. Room 9 had four patient beds. Engineer 1 measured the length of the power cord from the point it was no longer wrapped around the bed frame to the outlet. The length was four feet and six inches. Engineer 1 also measured the uncoiled length of the bed positioning control and it measured five feet long.

During an interview with the Director of Plant Operations on 7/25/17 at 0930 hours, he stated all the bed cords in the hospital were set up in a similar configuration. The Director stated this was a known issue and that was why the power cords were zip-tied. However, the Director stated he would work on correcting the issue.

Based on observation, interview, and record review, the hospital failed to ensure the nursing staff consistently performed a quality test for two of the two glucometers in the facility. This failure posed the risk of the patients being tested with a potentially malfunctioning and/or inaccurate glucometer.

Findings:

On 7/24/17 at 0930 hours, an interview was conducted with LVN 3 and the DPCS. LVN 3 stated there were two glucometers in the facility; and the nursing staff performed a control test every night to ensure the meter and test strips were working properly.

Review of the Sure Step Quality Control Record form showed the two glucometers were not consistently tested. For example:

* For Glucometer #1, there was no documented evidence a quality control test was performed on 6/1, 6/15, 6/29, 7/22, and 7/23/17.

* For Glucometer #2, there was no documented evidence a quality control test was performed on 5/11, 5/25, 6/8, 6/15, 6/23, 6/29, 7/22, and 7/23/17.

The DPCS verified the two glucometers were not consistently tested.

Based on observation, interview, and record review, the hospital failed to ensure the IP developed and implemented P&Ps to control infections and communicable diseases as evidenced by:

1. Lack of P&P related to infection control practices in the dietary department and lack of handwashing surveillance in the dietary department.
2. Incomplete P&P for the cleaning and disinfecting of patient equipment.
3. Lack of P&P to address the use of IUC's in the hospital.

These failures had the potential for the spread of infections; and the potential for non-indicated IUC use, development of CAUTI, and increased antibiotic use.

Findings:

1. On 7/24/17 at 0830 hours, Dietary Aide 1 was observed cleaning soiled dishes in the dishwashing area. After scraping the food particles into the sink the Aide opened the dishwasher and removed the clean rack of dishes. During an interview with Dietary Aide 1 and the Dietary Supervisor, they both stated handwashing should have been done prior to touching the clean dishes.

On 7/24/17, the Infection Control P&P manual was reviewed. There were no P&P's related to dietary services.

During an interview with the Infection Control Practitioner on 7/25/17 at 0900 hours, the IP stated there were no P&Ps written by the IP related to dietary services. When asked who conducted observations to assess hand hygiene of the kitchen staff, the IP stated she did not include handwashing observations in the kitchen as part of infection control rounds.


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2. On 7/24/17 at 0935 hours, an interview with CNA 1 was conducted. CNA 1 stated she cleaned the blood pressure cuff with alcohol wipes after each use. In addition, three staff did not know the correct way to disinfect the equipment and floor (cross reference to A749, example #2).

Review of the hospital's P&P titled Patient Equipment: Cleaning, Disinfection, and Disposal revised 1/16 showed the systematic process for the rotation and cleaning of equipment by Environmental Services and direct patient care staff is identified in the attached chart. The chart showed the cleaning method, frequency, and responsibility for patient care equipment. However, the chart failed to show a complete and specific instruction addressing the cleaning process and type of sanitizing solution for each equipment. For example:

* The method to clean pumps, IV poles, bedside commodes, and pulse oximeter is "wiped down and disinfected."
* The method to clean wheelchairs, walkers, EKG machine, glucometers, plastic restraints, lap buddies, safety belts, and wedges is "wiped down."

During an interview and concurrent record review with the Infection Preventionist on 7/25/17 at 0855 hours, she verified the P&P was not specific and complete as a guideline for the staff.


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3. Review of the CDC's HICPAC Guidelines for Prevention of CAUTIs updated 2/15/17, showed the following:
I. Appropriate Urinary Catheter Use:
A. Insert catheters only for appropriate indications, and leave in place only as long as needed.
B. Consider alternatives to indwelling urethral catheter use when appropriate.

On 7/26/17 at 0900 hours, an interview was conducted with the IP. When asked how she was notified of patients in the hospital with IUC's, the IP stated she was not notified when a patient was admitted to the hospital with an IUC. The IP stated if a patient had a UTI, she would check to see if the patient had an IUC. When asked if the hospital had a P&P to address catheter use, including indication and the prevention of CAUTI's, the IP stated no, but she would speak with the DPCS to come up with a plan to educate the nursing staff regarding IUC use.

Based on observation, interview, and record review, the hospital failed to ensure the IC program developed an effective system to implement and evaluate measures for identification, investigation, reporting, and preventing infections within the hospital as evidenced by:

1. A brown foul-smelling substance was smeared on the toilet seat of the single unit restroom in the short hallway.

2. Three of three staff (RN 3, LVN 3, and Housekeeping 1) interviewed regarding disinfectants did not know the correct dwell time for the disinfectants used to clean the equipment and floors.

3. The hospital's housekeeping staff did not dilute the bleach sanitizing solution per the hospital's instructions, which in turn did not reflect the manufacturer's guidelines.

4. One kitchen staff did not perform hand hygiene after washing soiled dishes prior to handling clean dishes.

These failures had the potential to result in the increased risk of spreading infection to the patients in the hospital.

Findings:

1. On 7/24/17 at 0900 hours, a tour was conducted with the Activities Director. The restroom next to the nurse's station in the short hallway was observed. The toilet seat frame was smeared with a foul-smelling brown substance all along the top of the frame. The Activities Director stated the toilet needed to be cleaned right away.


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2. Review of the manufacturer's guidelines for the CaviWipe (disinfectant wipe) showed the disinfected area should remain visibly wet for three minutes for complete disinfection.

Review of the manufacturer's guidelines for the Quat-128 (disinfectant) showed the disinfected area should remain wet for ten minutes for complete disinfection.

a. On 7/24/17 at 0930 hours, an interview with LVN 3 was conducted. LVN 3 stated she cleaned the glucometer with CaviWipes. When asked for the CaviWipe's dwell time, LVN 3 stated about 30 seconds. This was not per the manufacturer's guidelines of three minutes.

b. On 7/24/17 at 1007 hours, Housekeeping 1 was interviewed. Housekeeping 1 stated she used Quat-128 to clean the floors. Housekeeping 1 stated the process was to mop the floor and let it dry. When asked for the Quat-128's dwell time, Housekeeping 1 was not able to answer.

c. On 7/24/17 at 1050 hours, RN 3 was observed cleaning a blood pressure cuff with a CaviWipe. The blood pressure cuff was visibly dry before three minutes. When asked for the dwell time of the CaviWipe, RN 3 stated it dried instantly.

On 7/25/17 at 0855 hours, the Infection Preventionist acknowledged the above findings.

3. On 7/25/17 at 0840 hours, an interview with Housekeeping 1 was conducted in the presence of the Special Projects Manager. Housekeeping 1 stated she diluted six oz of bleach to one gallon of water. The diluted bleach was used to clean only isolation rooms. When asked if the test strip was used to validate the concentration, Housekeeping 1 stated no. Housekeeping 1 stated there were no patients requiring isolation rooms at this time, so bleach was not used today.

Review of the manufacturer's guideline for the Germicidal Ultra Bleach showed the following:

* For 200 ppm, add half oz of the Bleach per one gallon of water.
* For 2500 ppm, add 3/4 cup of the Bleach per one gallon of water.
* For 5000 ppm, add 12 oz of the Beach per one gallon of water.
* Check the chlorine concentration with standard test strip.
* To clean infectious material, use one part Bleach to 10 parts water to achieve a 1:10 dilution (about 5,000 ppm available chlorine).

Review of the instruction, posted in the laundry room where sanitizing solutions were stored showed the following:

* Add six oz of bleach per one gallon of water for shower room cleaning.
* Add one tablespoon per one gallon of water for common surfaces.

On 7/25/17 at 0855 hours, the Infection Preventionist acknowledged the above findings and verified the instructions for the housekeeping staff did not reflect the hospital's cleaning process.

On 7/25/17 at 0855 hours, the Infection Preventionist verified the hospital's housekeeping staff did not dilute the bleach sanitizing solution per the hospital's instructions, which in turn did not reflect the manufacturer's guidelines.


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4. Review of the hospital's P&P titled Handwashing revised 10/10 showed hands should be washed after touching anything that might contaminate the hands, such as unsanitized equipment, work surfaces or washcloths.

On 7/24/17 at 0830 hours, Dietary Aide 1 was observed cleaning soiled dishes in the dishwashing area. After scraping the food particles into the sink the Aide opened the dishwasher and removed the clean rack of dishes. During an interview with Dietary Aide 1 and the Dietary Supervisor, they both stated handwashing should have been done prior to touching the clean dishes.

During an interview with the Infection Preventionist on 7/25/17 at 0900 hours, the IP was asked who conducted observations to assess hand hygiene of the kitchen staff. The IP stated she did not include observations of handwashing in the kitchen as part of her infection control rounds.

Based on record review and staff interview, it was determined that for eight (8) of eight (8) active sample patients (Patients A1, A2, A3, A4, B1, B2, B3, and B4), the Psychosocial Assessment failed to include the anticipated role of the social service staff in discharge planning. This failure results in no information being made available to other members of the multidisciplinary treatment team about what efforts the social service staff may pursue.

Findings include:

A. Record Review

1. For patients A2 (admitted 7/17/2017) and A4 (admitted 7/13/2017) there were no Psychosocial Assessments in their charts.

2. For the following patients (date of Psychosocial Assessment in parenthesis) there was no description of the role of the social service staff in discharge planning. Patient A1 (7/13/2017), A3 (7/17/2017), B1 (7/14/2017), B2 (7/17/2017), B3 (7/15/2017), and B4 (7/20/2017).

3. Facility Policy Review

The Social Service Policy for "Patient Assessment, Number SS-300, dated 4/22/2015" stated in Section IV "Procedure" that, "The Social Worker assesses and completes the social service component of the Interdisciplinary Assessment Form within seventy-two (72) hours of admission..." Thus, the findings of absent Psychosocial Assessments violated facility policy.

B. Staff Interview

1. On 7/24/17 at 10:30 a.m., Social Worker #1 (SW#1) was asked to determine if the Psychosocial Assessment of Patient A3 included a description of the anticipated role of the social service staff toward discharge planning. SW#1 concurred that the information was absent.

2. On 7/25/17 at 8:30 a.m., the Director of Social Work was interviewed. A partial focus of the interview was a discussion of the findings described in Section A above. The Director agreed that the anticipated role of the social service staff toward discharge planning was absent and was a necessary component of a Psychosocial Assessment.

Based on record review and interview, it was determined that the Psychiatric Evaluations for eight (8) of eight (8) active sample patients (Patients A1, A2, A3, A4, B1, B2, B3, and B4) did not contain an assessment of patient assets in a descriptive, not interpretive fashion. This failure results in no information for the other members of the multidisciplinary treatment team to consider in the selection of treatment modalities.
Findings include:

A. Record Review

1. Patient A1: The Psychiatric Evaluation, dated 7/12/17, stated as the sole patient asset "Engaged in psychiatric care, engaged in medical care."

2. Patient A2: The Psychiatric Evaluation, dated 7/18/17, stated as the sole asset "The patient has stable housing."

3. Patient A3: The Psychiatric Evaluation, dated 7/15/17, stated as the sole patient asset "Engaged in psychiatric care, engaged in medical care."

4. Patient A4: The Psychiatric Evaluation, dated 7/13/17, stated as the sole patient asset "Engaged in psychiatric care, engaged in medical care."

5. Patient B1: The Psychiatric Evaluation, dated 7/13/17, stated as the sole patient asset "Engaged in psychiatric care, engaged in medical care."

6. Patient B2: The Psychiatric Evaluation, dated 7/15/17, stated as the sole patient asset
"Engaged in psychiatric care, engaged in medical care."

7. Patient B3: The Psychiatric Evaluation, dated 7/14/17, stated as the sole patient asset "Engaged in psychiatric care, engaged in medical care."

8. Patient B4: The Psychiatric Evaluation, dated 7/19/17, stated as the sole patient asset "Engaged in psychiatric care, engaged in medical care."

B. Interview

On 7/25/17 at 1:30 p.m., the Clinical Director was interviewed. A partial focus of the interview was a discussion of the findings described in Section A, above. He agreed that these evaluations were not patient specific and were not patient attributes, interests, past accomplishments or information that might aid other members of the treatment team in the selection of treatment modalities.

Based on record review and interview, the facility failed to include the identified strengths on the Master Treatment Plans (MTPs) for five (5) of eight (8) active sample patients (A1, A2, B1, B2, and B3). Failure to include the patients' strengths hinders the staff's ability to utilize them in providing active treatment measures to promote a quicker movement toward discharge.
Findings include:

A. Record Review

1. The following patients' Master Treatment Plans (MTPs), dates of MTP in parenthesis, did not identify any patients' strengths that could be used in treatment: A1 (7/14/17), A2 (7/24/17), B1 (7/18/17), B2 (7/20/17), and B3 (7/13/17).

2. The Facility policy, titled "Individual Treatment Plans" last revised 4/20/16, stated, "The Master Treatment Plan treatment team psychiatrist, psychologist, nursing, social services, activity therapist, and dietary."

B. Interviews

1. In an interview on 7/23/17 around 9:04 a.m., the lack of identified strengths on the MTPs for five active sample patients was discussed with the Nursing Director. She acknowledged the omission.

2. On 7/25/17 at 1:30 p.m., the clinical director was interviewed. A partial focus was the absence of patient strengths on the MTP. The clinical director agreed that this was a necessary component and that the inclusion was a future goal of the facility staff.

Based on record review and interview, the facility failed to provide measurable and/or patient, not staff goals (what the staff wanted patients to accomplish) on the Master Treatment plans (MTPs) for seven (7) of eight (8) active sample patients (A1, A2, A3, A4, B1, B2, and B4). This failure results in treatment plans that do not identify individualized expected patient outcomes in a manner that can be utilized by the treatment team to measure the effectiveness of treatment and/or progress towards discharge.

Findings include:

A. Record Review

1. In patient A1's Master Treatment Plan (MTP), dated 7/14/17, the difficult to measure long-term goal for the problem "Agitation related to ineffective coping AEB [as evidenced by] unmanageable agitation, anxiety, and hyperactivity, pt. is hyper verbal and difficult maintaining focus, can be intrusive and easily triggered when {his/her] needs are not met right away" was, "Patient will discharge with an ability to manage agitation at a level acceptable to next level of care and/or care provider(s)." The staff did not define the "ability" to be achieved.

The short-term goal for the problem listed above was, "Patient will attend a minimum of 2 groups or activities per day which will stimulate patient and provide support relating to [his/her] symptoms." This goal statement was written to reflect what the staff wanted the patient to achieve not as a patient outcome based on his/her presenting psychiatric symptoms or problems.

2. In patient A2's MTP, dated 7/24/17, the difficult to measure short-term goals for the problem "Anxious mood AEB excessive worrying, restlessness, need to ask questions frequently" were, "Patient will respond appropriately to necessary communications from staff by days. Patient will calm [sic] and respond to reassurance offered by staff daily."

3. In patient A3's MTP, dated 7/18/17, the difficult to measure long-term goal for the problem "Agitation - psychomotor related to ineffective coping AEB pt. becoming verbally hostile toward family and staff, asking many questions, demanding staff do things, stating false accusations," was, "Patient will discharge with an ability to manage agitation at a level acceptable to next level of care and/or care provider(s)."

4. In patient A4's MTP, dated 7/22/17, the difficult to measure long-term goal for the problem, "Poor impulse control AEB on 1:1 at SNF [skilled nursing facility] due to repeated incidents of agitation and verbal aggression towards roommates. Also threatening roommate with a fork, easily triggered and is difficult to redirect and reassure" was, "patient will reduce all of impulsive acts that create unsafe conditions."

The difficult to measure short-term goals were: "Patient will respond appropriately to necessary communication from staff." "Patient will have 50% decrease with impulsivity and maintain for LOS [length of stay]."

5. In patient B1's MTP, dated 7/18/17, the difficult to measure long-term goal for the problem "Anxious mood AEB excessive worrying, inability to focus at times, occasional panic," was, "Patient will obtain ability to manage anxiety with coping skills and medications at a level acceptable to the patient, that also allows for the patient to return to life demands and role expectation AEB assessment and/or patient self-report."

The non-measurable short-term goal was, "Patient will respond appropriately to necessary communication from staff by days." The following staff goal was included instead of a patient outcome statement based on this patient's presenting psychiatric symptoms: "Patient will attend or meet 1:1 (one to one) with staff to explore false beliefs through the introduction of CBT [Cognitive Behavior Therapy] by day 10 AEB pt. [patient] attendance."

6. In patient B2's MTP, dated 7/20/17, the difficult to measure long-term goal for the problem "Agitation - psychomotor related to ineffective coping AEB restlessness, irritable, fidgeting, verbal hostility, poor safety awareness," was, "Patient will discharge with an ability to manage agitation at a level acceptable to next level of care and/or care provider(s)."

The difficult to measure short-term goal was, "Patient will calm and respond to reassurance offered by staff by day 5."

7. In patient B3's MTP, dated 7/13/17, the difficult to measure long-term goal for the problem "Agitation - psychomotor related to ineffective coping AEB related to resistive behavior and noncoorporative [sic] with staff during assistance with care" was, "Patient will discharge with an ability to manage agitation at a level acceptable to next level of care and/or care provider(s)."

8. In patient B4's MTP, dated 7/21/17, the difficult to measure long-term goal for the problem, "Poor impulse control AEB speaks out and interrupt others, intrusive" was, "Patient will be able to recognize the onset of anxiety and take action before panic sets in, measured by observation and/or patient reports." The staff did not include observable behaviors to tell them the patient knows s/he is anxious."

B. Interview

In an interview on 7/25/17 around 11:01 a.m., the non-measurable short and long-term goals were discussed withRN2. He did not dispute the findings.

Based on record review and interview, the facility failed to:

I. Develop Master Treatment Plans (MTPs) for six (6) of eight (8) active sample patients (A1, A2, A3, A4, B1, and B3) that included individualized nursing treatment interventions. Most of the nursing interventions were generic discipline functions or tasks that would be carried out for any patient regardless of their individual problems. Failure to clearly describe specific nursing modalities on patients' MTPs can hamper staff's ability to provide treatment based on individual patient needs.

II. Include physician interventions on the MTPs for eight (8) of eight (8) active sample patients (A1, A2, A3, A4, B1, B2, B3, and B4). This failure to include physician interventions compromises the multidisciplinary approach to patient care, especially since the physicians are the leaders of the treatment team.

Findings include:

I. Generic Nursing Interventions

A. Record Review

1. Active sample patient A1, MTP dated 7/14/17, had the following generic Nursing Intervention for the problem "Agitation, psychomotor related to ineffective coping AEB [as evidenced by] unmanageable agitation, anxiety, and hyperactivity, pt. is hyper verbal and difficult [sic] maintaining focus, can be intrusive and easily triggered when [his/her] needs are not met right away": "Medicare patient as ordered and adverse side effect to MD [doctor]. Rationale: medication potentiated the effectiveness of talk and behavioral intervention."

2. Active sample patient A2, MTP dated 7/24/17, had the following generic Nursing Intervention for the problem "Anxious mood AEB excessive worrying, restlessness, need to ask questions frequently": "Administer anti-anxiety medications as prescribed routinely and upon request encourage use of diversional activities and coping skills with medication administration."

3. Active sample patient A3, MTP dated 7/18/17, had the following generic Nursing Intervention for the problem "Agitation - psychomotor related to ineffective coping AEB pt. becoming verbally hostile toward family and staff, asking many questions, demanding staff do things, stating false accusations": "Staff will assist with ADL's [activities of daily living] and give positive reinforcement for accepted care."

4. Active sample patient A4, MTP dated 7/22/17, had the following generic Nursing Interventions for the problem, "Poor impulse control AEB on 1:1 at SNF [skilled nursing facility] due to repeated incidents of agitation and verbal aggression towards roommates. Also threatening roommate with a fork, easily triggered and is difficult to redirect and reassure." The generic Nursing Interventions were, "Educate patient and [his/her] family on onset of actions, risks and benefits of prescribed medications," and "Medicate patient as ordered and report adverse side effects to MD."

5. Active sample patient B1, MTP dated 7/18/17, had the following generic Nursing Intervention for the problem "Anxious mood AEB excessive worrying, inability to focus at times, occasional panic": "Administer anti-anxiety medications as prescribed routinely and upon request. Encourage use of diversional activities and coping skills with medication administration."

6. Active sample patient B3, MTP dated 7/13/17, had the following generic Nursing Intervention for the problem "Agitation - psychomotor related to ineffective coping AEB related to resistive behavior and noncoorporative [sic] with staff during assistance with care": "Assess for potential underlying causes of agitation such as pain, signs of infection and psychological stress."

B. Interview

In an interview on 7/25/17 at 9:04 a.m., the generic Nursing Interventions on the MTPs were discussed with the Nursing Director. She did not dispute the findings.

II. No Interventions by Psychiatrist on Master Treatment Plans

A. Record Review

1. The Facility's policy titled, "Individual Treatment Plans," last revised 4/21/16, stated, "The Master Treatment Plan treatment team stated - [sic] psychiatrist, psychologist, nursing, social services, activity therapy and dietary."

2. For eight (8) of eight (8) active sample patients' MTPs (dates of MTPs in parenthesis) did not include a physician intervention: A1 (7/4/17), A2 (7/24/17), A3 (7/17/17), A4 (7/22/17), B1 (7/18/17), B2 (7/20/17), B3 (7/13/17), and B4 (7/21/17).

B. Interview

On 7/25/17 at 1:30 p.m., the Clinical Director was interviewed. A partial focus was the absence of psychiatrist interventions on the MTPs. The Clinical Director acknowledged this was a deficiency and an issue that needed correction.

Based on medical record review, hospital policy review and staff interview it was determined that for eight (8) of eight (8) patients (Patients A1, A2, A3, A4, B1, B2, B3, and B4) the Clinical Director failed to ensure that:

1. Psychiatric Evaluations contained an assessment of patient assets in descriptive, not interpretive fashion. (Refer to B117 for details)

2. Master Treatment Plans --

a. Included patient strengths. (Refer to B119 for details)

b. Included goals in behaviorally measurable terms. (Refer to B121 for details)

c. Included interventions by the attending psychiatrist. (Refer to B122 for details)

Based on record review and interview, the facility failed to develop Master Treatment Plans (MTPs) for six (6) of eight (8) active sample patients (A1, A2, A3, A4, B1, and B3) that included individualized nursing treatment interventions. Most of the nursing interventions were generic discipline functions or tasks that would be carried out for any patient regardless of their individual problems. Failure to clearly describe specific nursing modalities on patients' MTPs can hamper staff's ability to provide treatment based on individual patient needs. (Refer to B122)

Based on medical record review and staff interview, the Director of Social Work failed to ensure that the Psychosocial Assessments for eighth (8) of eight (8) patients (Patients A1, A2, A3, A4, B1, B2, B3, and B4) contained information about what the anticipated role of the social service would be in discharge planning. This failure results in no information available to other members of the treatment team about what efforts the social service staff might pursue. (Refer to B108 for details)