HospitalInspections.org

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Based on observation, interview, record review, and review of hospital policies and procedures, the hospital's governing body failed to ensure adequate numbers of trained staff were available to provide for mental health therapy (Item #1) and failed to provide effective oversight of the hospital (Item #2).

Failure to provide effective oversight for patient rights, quality improvement, utilization review, and pharmacy services and failure to provide adequate staff for behavioral therapy, puts patients at risk of harm from inconsistent and inadequate treatment.

Findings included:

Item #1 - Adequate Staffing to Provide Mental Health Therapy

1. Document review of the hospital's policy titled, "Program Overview/Scope of Care-Inpatient," policy number 5441050, approved 07/19, showed that inpatient hospitalization services include group and individual therapy. Therapists provide counseling to each individual that addresses the individual's mental health or substance abuse disorder, motivation, and continuing care needs. Daily involvement in therapy groups and community meetings develops a sense of independence and mutual support that is important in the treatment of all patients in the program.

2. On 09/23/19 at 12:54 PM, Investigator # 5 and a Registered Nurse (Staff #512) reviewed the medical record for Patient #517 who was admitted to the Detoxification Unit on 08/27/19 and transferred to the Inpatient Mental Wellness Unit on 09/02/19 for the treatment of Suicidal Ideation. Documentation in the medical record showed that the patient did not receive group or individual therapy because of short staffing, on the following days:

-1 08/31/19, an Activity Group

-2 09/02/19 a Goal-Directed and Semi-Structured Therapy Group (CBT) and Activity Group

-3 09/12/19, an Activity Group

-4 09/15/19, 2 Activity Groups

-5 09/19/19 an Activity Group

-6 09/22/19, an Art Therapy Activity Group

-7 09/22/19, CBT

3. On 09/23/19 at 3:00 PM, a Registered Nurse (Staff #512) confirmed the finding and stated that the hospital was short on Therapy staff and they were unable to do all the therapy groups.

4. On 09/25/19 at 10:17 AM, Investigator #5 and the Corporate Quality Director (Staff #509) reviewed the medical record for Patient #518 who was admitted on 08/22/19 for the treatment of Unspecified Psychosis. The patient had a history of Schizophrenia, Paranoid Depression, and Type II Diabetes Mellitus. Documentation in the medical record showed that the patient did not receive group or individual therapy due to insufficient staff on the following days:

-1 09/12/19, an Activity Group

-2 09/15/19, 2 Activity Groups

-3 09/19/19 an Activity Group

-4 09/22/19, an Art Therapy Activity Group

-5 09/22/19, CBT

5. At the time of the observation, Staff #509 confirmed the finding and stated that the hospital has had Therapy Staff transitioning to other roles in the hospital.

Item #2 - Governing Body Oversight

1. Failure to appoint an administrator to direct and oversee all aspects of hospital treatment and policy implementation puts patients at risk of harm from substandard care.

Cross Reference: A-0057

2. Failure to protect and promote each patient's rights risks the patient's loss of personal freedom, privacy, dignity, and psychological harm.

Cross Reference: A-0115

3. Failure to systematically collect and analyze hospital-wide performance data limited the hospital's ability to identify problems and formulate action plans. This reduced the likelihood of sustained improvements in clinical care and patient outcomes.

Cross Reference: A-0263

4. Failure to provide nursing oversight for assessment, treatment, and evaluation of patient care needs and failed to ensure staff followed medication administration and assessment processes.

Cross Reference: A-0385

5. Failure to ensure controlled substance accountability standards, diversion-monitoring audits, pharmacist review of medication orders, and pharmacist review of unit-dosed medications risks patient safety, theft, and diversion of controlled substances.

Cross Reference: A-0489

6. Failure to ensure compliance with state and federal laws and regulations, failure to accurately perform monthly unit inspections, failure to develop and implement Pharmacy policies and procedures to minimize drug errors, failure to ensure quality control activities of Pharmacy Services are monitored, assessed, and evaluated, failure to ensure medication orders were written as directed by hospital policy, and failure to ensure medication unit dosed by the hospital were appropriately labeled.

Cross Reference: A-0489

7. Failure to develop and implement a plan for review of care provided to patients limits the hospital's ability to improve healthcare services and risks poor patient outcomes.

Cross Reference: A-0652

8. Failure to ensure adequate numbers of trained staff is available to provide for mental health therapy in a psychiatric specialized hospital risks patient harm.

Cross Reference: A-0043

Due to the scope and severity of deficiencies detailed under § 42 CFR 482.13 Condition of Participation for Patient Rights, § 42 CFR 482.21 Condition of Participation for Quality Assessment and Performance Improvement, § 42 CFR 482.23 Condition of Participation for Nursing Services, §42 CFR 482.25 the Condition of Participation for Pharmacy Services, and §42 CFR 482.30 the Condition of Participation for Utilization Review, the Condition of Participation for Governing Body was NOT MET.
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Based on interview and review of hospital documents, the hospital's Governing Body failed to appoint an administrator to be responsible for implementing the policies adopted by the Governing Body and be accountable for all aspects of patient care.

Failure to have an administrator to direct and oversee all aspects of hospital treatment and policy implementation puts patients at risk of harm from substandard care.

1. On 10/01/19 at 11:10 AM, Investigator #5, Investigator #4, and Investigator #3 interviewed available members of the hospital's Governing Body (both present and attending via teleconference). Members included the hospital's Chief Executive Officer (Staff #412) and 3 members of the hospital's parent corporation: the Medical Director (Staff #413), The Chief Operating Officer (Staff #414) and the Vice President of Nursing (Staff #415). The investigators also reviewed the Governing Body meeting minutes. Review of the Governing Body meeting minutes showed no evidence the Governing Body had documented approval for the appointment of the current administrator.

2. On 10/01/19 at 11:10 AM, the investigators asked the members of the Governing Body if there were meeting minutes to document the appointment of the Current Chief Executive Officer (Staff #412) as administrator for the hospital.

After the conclusion of the Governing Body meeting, Staff #412 produced a 1- page document titled, "Minutes of Special Meeting of the Governing Board of Rainier Springs, LLC," dated 10/01/19. The document indicated that two members of the hospital's Governing Board (The parent company's Chief Operating Officer and Chief Medical Officer) held a special meeting via telephone, which resulted in nomination and appointment of Staff #412 as the hospital's administrator.
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Based on interview, document review, review of the hospital's quality and performance improvement program, and review of Governing Body documents, the Governing Body failed to ensure that the hospital had an effective system in place to evaluate the quality of care provided by contracted services for 6 of 6 contracts reviewed.

Failure to determine whether patient care contractors meet all Medicare Conditions of Participation and standards risks provision of ineffective and unsafe healthcare to patients.

Findings included:

1. Document review of the hospital's policy titled, "Governing Board Bylaws," policy number 6313788, approved 07/19, showed that the Governing Body is responsible to ensure that all contractors providing contracted services for the hospital, including shared services and joint ventures, furnish such services in a safe and effective manner that permits the hospital to comply with all applicable rules, regulations, and standards for contracted services.

Document review of the hospital's document titled, "Organizational Quality Improvement Plan," policy number 6366314, approved 07/19, showed that the hospital's Organizational Quality Improvement Committee, with the support of the Governing Board, has the responsibility for monitoring every aspect of patient care and service (including contracted services), from the time the patient enters the hospital through diagnosis, treatment, recovery, and discharge, to identify and resolve any breakdowns that may result in suboptimal care and safety.

2. On 09/27/19, Investigator #5 and Investigator #4 reviewed 4 patient care contracts eligible for review. The review showed:

a. The contracted service with a dietary/nutritional services organization showed that the annual contract evaluation form was blank. Additionally, the section of the review form listing the quality indicators and specific measurables was blank. Investigator #5 found no evidence the hospital collected quality data or monitored the established measurables.

b. A contracted service for a Blood Center/Tissue Recovery Center showed that the hospital's Chief Executive Officer signed and dated the contract review form on 08/11/19. Document review showed that the annual contract evaluation form was blank; including the section of the review form listing the quality indicators and specific measurables. Investigator #5 found no evidence the hospital collected quality data or monitored the established measurables.

c. A contracted service for eye procurement services showed that the hospital's Chief Executive Officer signed and dated the contract review form on 08/11/19. Document review showed that the annual contract evaluation form was blank; including the section of the review form listing the quality indicators and specific measurables. Investigator #5 found no evidence the hospital collected quality data or monitored the established measurables.

d. A contracted service for staffing showed that the annual contract evaluation form was blank. Additionally, the section of the review form listing the quality indicators and specific measurables was blank. Investigator #5 found no evidence the hospital collected quality data or monitored the established measurables.

3. On 09/27/19, Investigator #5 and Investigator #4 reviewed 2 professional service agreements. The contracts identified the contractee hospital as, "Brentwood Springs, LLC," and not Rainier Springs Behavioral Health hospital.

4. On 10/01/19 at 11:10 AM, Investigator #5, Investigator #4, and Investigator #3 interviewed the hospital's Governing Body and reviewed the Governing Body meeting minutes. Investigator #4 and Investigator #5 found no evidence in the meeting minutes that the Governing Body had reviewed the contracts as directed in their bylaws. During the interview, the Vice President of Nursing (Staff #518) stated that the Governing Body reviewed a scorecard for contracts that listed the measurables. She stated that the hospital maintained the scorecard.
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Based on observation, interviews, document review, and review of hospital policies and procedures, the hospital failed to provide for patient safety and protection of patient rights.

Failure to protect and promote each patient's rights risks the patient's loss of personal freedom, privacy, dignity, and psychological harm.

Findings included:

1. Failure to provide written notice of the outcome of the grievance investigation.

Cross Reference: A0123

2. Failure to provide patients with limited English proficiency and sensory deficits access to interpretive services.

Cross Reference: A0129

3. Failure to provide an appropriate assessment, document ongoing care, provide for patient transfer to another facility and failure to implement appropriate precautions for patients exhibiting unsafe behaviors.

Cross Reference: A0144

4. Failure to ensure that a provider writes an appropriate order for seclusion and restraint.

Cross Reference: A0168

5. Failure to ensure that providers did not write orders for restraints on a standing order or as-needed basis.

Cross Reference: A0169

Due to the scope and severity of deficiencies cited under 42 CFR 482.13, the Condition of Participation for Patient Rights was NOT MET.
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Based on document review, interview, and review of hospital policy and procedures, the hospital failed to follow its procedure for provision of written response to complainants for filed grievances for 1 of 4 grievances reviewed (Patient #305).

Failure to provide written notice of the outcome of the grievance investigation and steps taken on behalf of the patient to investigate the grievance violates their right to be informed about how the hospital investigated and resolved the grievance.

Findings included:

1. Document review of the hospital policy and procedure titled, "General Grievances and Patient Advocacy (IP, PHP & IOP), " PolicyStatID # 6451484, last revised 09/19, showed that when the complaint issue has been resolved, the patient will receive written notification of the results within 15 business days. The Patient Advocate will respond in writing to the complainant and address the following areas:

(1) The name of the Hospital contact
(2) The steps taken on behalf of the individual to investigate the complaint
(3) The results of the process
(4) The date of completion of the complaint process
(5) The steps to take if dissatisfied with the outcome

2. On 09/27/19 at 11:25 AM, Investigator #3 reviewed the hospital's grievance log. The review showed that on 05/29/19, Patient #305 filed a grievance with the hospital concerning the quality of care with an outpatient program. On 06/29/19, the patient sent a follow-up letter with additional information about her concerns. The grievance log showed that the hospital sent a letter to the complainant summarizing a conversation with the Director of Assessment (Staff #306). The "notes column" showed that resolution was done verbally and that a date was needed when the letter was sent. In the grievance file, the investigator reviewed a copy of an undated and unsigned letter from the hospital indicating resolution of Patient #305's grievance. The letter did not include information on steps the complainant could take if dissatisfied with the outcome.

3. At the time of review, Investigator #3 asked the Director of Nursing (Staff #301) if she knew when the hospital sent the letter to the complainant. Staff #301 stated that she could not determine when the hospital sent the letter. She indicated that the hospital had recent turnover of staff responsible for handling complaints.
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Based on interview, document review, and review of hospital policy and procedures, the hospital failed to provide interpretative services for a patient with deafness for 11 of 17 days of involuntary hospitalization.

Failure to provide patients with limited English proficiency and sensory deficits access to interpretive services risks patient's loss of personal dignity and respect and limits the patient ability to participate in their plan of care.

Findings included:

1. Document review of the hospital's policy titled, "Communication with Persons with Limited English Proficiency (LEP) and Sensory Disabilities," policy number 5182826, showed that the hospital will promptly identify the language and communication needs of the LEP person. The hospital will obtain an outside interpreter, use a staff member who is qualified to interpret, or use a language services line. In the event that a patient requires a scope of service beyond the hospital capabilities, the hospital will provide referral to the needed service and support in the coordination of care.

2. On 09/27/19, Investigator #5 reviewed the medical record for Patient #512 who was admitted involuntarily on 07/26/19 for the treatment of psychosis and violent behavior. The patient was discharged on 08/12/19. The record review showed:

a. A History and Physical completed on 07/26/19 at 7:55 PM showed that the patient was deaf and communicating with the provider by hand signals, reading the provider's lips, and some sounds.

b. The Psychosocial Assessment completed on 07/27/19 at 1:00 PM showed that the patient was deaf and needed an interpreter.

c. The Comprehensive Psychiatric evaluation completed on 07/27/19 at 2:00 PM showed the patient is deaf and did not speak.

d. On 07/28/19, a day shift nursing assessment showed that "there was no interpreter on the unit at this time to facilitate communication."

e. A psychiatric progress note on 07/29/19 showed the patient is "mute" and there was an interpreter present.

f. An inpatient therapy note dated 08/03/19 at 5:11 PM, showed the patient did not attend group and was unavailable for treatment as no interpreter was present.

g. On 08/03/19, a psychiatric progress note stated that an interpreter could not be located and the day shift nursing assessment stated that the patient communicated with the nurse on paper.

h. On 08/04/19, a psychiatric progress note stated that an interpreter could not be located.

i. On 08/05/19, a psychiatric progress note stated that the patient was easily frustrated which may be due to his language deficit. The provider stated, "Thought content unable to be assessed fully as interpreter is not present again at this session."

j. On 08/06/19, a night shift nursing assessment showed that the nurse was unable to complete the shift assessment related to the communication barrier and due to a sign language barrier.

k. O 08/07/19, a psychiatric progress note stated that an interpreter could not be located.

l. On 08/08/19, a night shift nursing assessment stated, "Patient is deaf and as a result very little communication."

m. On 08/10/19, a psychiatric inpatient progress note showed that there was no interpreter present for the evaluation and that staff communicated with the patient via notes. The provider was unable to assess orientation and thought processes.

n. On 08/11/19, a psychiatric inpatient progress note showed that there was not an interpreter available, but a staff member with knowledge of ASL (American Sign Language) interpreted for the patient.

o. On 08/11/19, a day shift nursing assessment stated, "Patient is deaf and hard to communicate needs or interact with others." "Patient is deaf but no interpreter available."

p. On 08/11/19, a night shift nursing assessment stated, "Communicated with nurse through writing."

3. On 09/27/19 at 11:00 AM, the Chief Nursing Officer (Staff #506) verified the observation and stated that the hospital had trouble getting an American Sign Language (ASL) interpreter to come to the facility and were only able to provide an interpreter for 3 days.

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Based on document review and interview, the hospital failed to ensure that patients presenting to the hospital received a medical screening to determine if they have an emergency medical condition, failed to document continued monitoring until the patient was stabilized or transferred, failed to follow the hospital's policy for transferring a patient to another medical facility (Item #1), and failed to place a patient exhibiting "sexually acting out" behaviors on safety precautions, including monitoring, as directed in the hospital's policy (Item #2).

Failure to provide an appropriate assessment, document ongoing care, provide for patient transfer to another facility as directed by hospital policy and failure to implement appropriate precautions for patients exhibiting unsafe behaviors risks physical and emotional patient harm.

Findings included:

Item #1 Assessment and Transfer

1. Document review of the hospital's policy titled, "Emergency Medical Treatment and Active Labor Act (EMTALA)," policy number 6229033, approved 07/19, showed that all persons presenting to the hospital will receive a medical screening examination to determine if they have an emergency medical condition including a psychiatric emergency. The chart should document continued monitoring until the patient is stabilized or transferred. When a patient transfers to another medical facility, staff are to call an emergency department able to provide appropriate care, and discuss the transfer with the patient. If the patient consents, call emergency medical services, and complete and send a copy of the EMTALA Physicians Assessment and Certification to transfer form to the receiving hospital. If the patient refuses to be transferred and is not at imminent risk, complete a copy of the EMTALA Physician Assessment and Certification Consent to transfer, noting the patient's refusal and complete the assessment process.

2. On 10/01/19 at 11:00 AM, Investigator #5 reviewed screening documents for Patient #513 who presented for a psychiatric crisis and treatment for psychosis, 3 times in 24 hours: On 01/04/19 at 7:04 AM, on 01/04/19 at 7:30 PM and on 01/05/19 at 12:05 AM. The review showed the following:

a. On 01/04/19 at 7:04 AM, The EMTALA log showed the patient was "Deflected."

b. On 01/04/19 at 7:40 AM, the completed Safety Assessment Form showed the patient was hearing voices telling him to harm others and was having current thoughts of harming himself "to a certain extent."

c. Review of the form showed the Screening Assessment was incomplete past page 4 as the patient was unable to stay awake. The section of the document titled "Clinician Assessment" stated that the patient may meet criteria for inpatient or outpatient care. The remainder of the clinician assessment was left blank.

d. The Personalized Treatment Recommendation completed by a Licensed Mental Health Counselor (Staff # 515) showed that the staff member recommended that the patient go home, sleep, and return later in the day to complete the assessment.

Investigator #5 found no evidence that staff consulted a provider or informed them of the patient's condition as required by hospital policy. Investigator #5 found no evidence the patient received an assessment by a Registered Nurse prior to being sent home.

e. On 01/04/19 at 6:02 PM, the EMTALA log showed that staff referred the patient to an Emergency Room for further evaluation.

f. On 01/04/19 at 6:20 PM, the completed Safety Assessment Form showed the patient was having current thoughts of harming himself and the patient stated, "I want to die."

g. Document review of the Screening Assessment showed "The patient returns from a previous deflection due to patient being so sleepy he could not engage in answering questions ...patient endorses suicide ideation with no plans or intent, ..upon return this young man is still lethargic, with difficulty keeping his eyes open, unable to articulate answers."

Documentation in the section of the form titled "Clinician Assessment" showed "Patient is unable to complete assessment for 2nd time due to lethargy." The Screening Assessment was incomplete.

h. Document review of the Personalized Treatment Recommendation showed that the provider requested the patient seek medical evaluation at an Emergency Room for clearance. Investigator #5 found no evidence staff discussed a transfer option with the patient or completed the EMTALA Physicians Assessment and Certification to transfer form.

i. Investigator #5 reviewed the Emergency Room notes for 01/04/19 that showed the patient's mother transported the patient to the Emergency Department.

j. On 01/05/19 at 12:05 AM, the EMTALA log showed the patient was admitted to inpatient care for the treatment of a psychiatric condition.

3. On 10/01/19 at 12:00 PM, the Interim Quality Director (Staff #508) confirmed the finding and stated that a transfer form should have been completed and a copy placed in the record. She stated that the intake department now has Registered Nurses and that there are Nursing Supervisors available to provide nursing assessments for medical concerns

4. On 10/01/19 at 12:00 PM, Investigator #5 and the Interim Quality Director (Staff #508) reviewed the medical records for 3 patients (#514, #515, and #516) who presented to the hospital for emergency psychiatric conditions and received referrals to another facility. The review showed:

a. On 06/24/19 at 10:56 AM, Patient #514 presented for Alcohol Detoxification. Documentation in the EMTALA log showed that the "Patient blood alcohol too high, to return with support for treatment." The patient's medical record showed he had a blood alcohol level of .401. Investigator #5 found no evidence the patient received a medical screening; no evidence staff discussed transfer options with the patient or that staff completed the EMTALA Physicians Assessment and Certification to transfer form. There was no documentation of a safe discharge.

b. On 06/30/19 at 2:51 PM, Patient #515 presented to the hospital. The EMTALA log showed the patient was sent to an Emergency Department. Investigator #5 found no evidence the patient received a medical screening; no evidence staff discussed transfer options with the patient; and no evidence that staff completed the EMTALA Physicians Assessment and Certification to transfer form as directed by hospital policy.

On 06/30/19 at 11:53 PM, the EMTALA log showed a second entry for Patient #515 that documented the patient's inpatient admission and showed the patient was admitted for "Suicidal Ideation with a Specific Plan."

c. On 06/25/19 at 12:28 PM, Patient #516 presented to the hospital. The EMTALA log showed the patient was to return in the afternoon/evening of 06/29/19 for detoxification. Staff #508 was unable to locate any documentation for this patient's presentation for emergency care.

Investigator#5 found no evidence the patient received a medical screening, no evidence staff discussed transfer options with the patient; and no evidence that staff completed the EMTALA Physicians Assessment and Certification to transfer form as directed by hospital policy. Investigator #5 also found no evidence the patient was safely discharged.

3. At the time of the observations, Staff #508 confirmed the findings and stated that she had provided "just in time" education for the staff in triage regarding documentation requirements.

Item #2- Safety Precautions

1. Document review of the hospital's policy titled, "Sexual Acting Out (SAO)," policy number 6005832, approved 02/19, showed that sexual behaviors of any kind are prohibited by the facility. Reports of sexual acting out between patients will be investigated. All allegations of observations of sexual behavior will be investigated by the facility. Patients with alleged or observed sexual acting out behaviors will be assessed daily by the physician to ensure appropriate levels of care. Staff will obtain an order for SAO precautions and the Registered Nurse will note SAO precautions on the daily Shift Nursing Assessment Form. The RN addresses the patient's status, SAO precautions, and level of observation in daily treatment teams and documents in the Nursing Assessment every 24 hours. A physician order is required to decrease or discontinue SAO precautions. An incident report will be filed.

2. On 09/23/19 at 12:54 PM, Investigator # 5, a Registered Nurse (Staff #512), and the Director of Ancillary and Outpatient Services (Staff #516) reviewed the medical record for Patient #517. The review showed that on 09/21/19, the patient engaged in an occurrence of Sexually Acting Out (SAO) with a roommate and the roommate was moved to a different room.

Investigator #5 found no evidence staff placed Patient #517 on SAO precautions. Investigator #5 found no evidence a provider assessed the patient consistent with the hospital's policy.

3. At the time of the review, Staff #512 stated that she did not know if the hospital had SAO precautions. Staff #512 showed the investigator an admission document, which showed different types of precautions. The document did not list SAO precautions as an option. Staff #512 stated that staff would not file an incident report unless there was patient harm. Staff #516 stated that the hospital did have a policy on SAO.

4. On 09/25/19, (two days later) Investigator #5 completed the medical record review of Patient #517. The review showed staff had not yet placed the patient on SAO precautions.
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Based on record review and review of hospital policy and procedures, hospital staff failed to ensure that a licensed provider wrote a complete order for seclusion or restraint for 4 of 5 patient records reviewed (Patient #306, #307, #308, #309).

Failure to ensure that a provider writes an appropriate order for seclusion and restraint puts patients at risks for psychological harm, loss of dignity, and personal freedom.

Findings included:

1. Document review of the hospital's policy and procedures titled, "Seclusion and Restraint," PolicyStat ID # 6516123, last revised 07/19, showed that, in an emergency, the qualified trained Registered Nurse (QRN) can initiate an order for seclusion or restraint as a protective measure provided they obtain a physician's order as soon as possible. The QRN will contact the appropriate licensed independent provider responsible for the care of the patient and write an order for the restraint or seclusion. Providers are not to write "Standing" or "As needed" orders for seclusion and restraint orders.

2. On 09/25/19 at 9:20 AM, Investigator #3 reviewed the medical records of five patients who were placed in seclusion or restraint during their hospital stay. The review showed the following:

a. Patient #309 was a 28 year-old who became severely agitated and began spitting, hitting patient lockers, and banging on the nurse's station. On 04/02/19, staff placed the patient in seclusion between 10:45 AM and 11:15 AM (a 30-minute period). The provider order did not include the maximum length of time that the patient could remain in seclusion without a new order.

b. Patient #308 was a 20 year-old who began shouting and hitting the nurse's station. The patient was physically restrained for administration of an intramuscular injection. On 06/20/19, following the physical hold, staff placed the patient in seclusion between 1:19 PM and 2:04 PM (a 45-minute period). The provider order did not include the maximum length of time the patient could remain in seclusion without a new order.

c. Patient #307 was a 45-year-old who was physically restrained after assaulting hospital staff and attempting to break windows to elope from the hospital. On 08/07/19, staff placed the patient in a physical hold between 11:05 PM and 11:45 PM (a 40-minute period). Following the hold, emergency medical personnel transported the patient to a local hospital for evaluation of delirium. The provider order for physical restraint failed to include the length of time the patient could remain held without a new order.

d. Patient #306 was a 28-year-old who had an order for "forced medications" if he refused voluntary oral medications. The patient was physically restrained for administration of three intramuscular injections. On 08/22/19, following the physical hold, staff placed the patient in seclusion between 2:03 PM and 2:38 PM (a 35-minute period). The provider order did not include the maximum length of time the patient could remain in seclusion without a new order.
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Based on record review and review of hospital policy and procedures, the hospital failed to ensure that providers did not write orders for restraints as a standing order and failed to ensure that orders for patient restraint were not used on an as-needed basis as demonstrated by 1 of 1 patients reviewed (Patient #512).

Failure to follow approved policies and procedures for restraint use puts patients at risk for physical and psychological harm, loss of dignity, and personal freedom.

Findings included:

1. Document review of the hospital's policy and procedures titled, "Seclusion and Restraint," PolicyStat ID # 6516123, last revised 07/19, showed that, in an emergency, the qualified trained Registered Nurse (QRN) can initiate an order for seclusion or restraint as a protective measure provided they obtain a physician's order as soon as possible. The QRN will contact the appropriate licensed independent provider responsible for the care of the patient and write an order for the restraint or seclusion. Providers are not to write "Standing" or "As needed" orders for seclusion and restraint.

2. On 09/27/19, Investigator #5 reviewed the medical record of Patient #512 who was admitted involuntarily on 07/26/19 for the treatment of Psychosis and violent behavior. The review showed that on 07/26/19 at 4:45 AM, a provider wrote an order for "restraint as necessary." The provider listed "agitation" as the rationale for the order.
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Based on observation, interview, and review of quality documents, the hospital failed to develop a hospital-wide quality assessment and performance improvement (QAPI) plan to monitor, evaluate, and improve the quality of patient care services through systematic data collection, analysis, and implementation and monitoring of quality activities.

Failure to systematically collect and analyze hospital-wide performance data limited the hospital's ability to identify problems and formulate action plans. This reduced the likelihood of sustained improvements in clinical care and patient outcomes.

Findings included:

Interview, record review, and review of hospital policies and procedures showed the following:

1. Failure to collect, aggregate and analyze data to improve patient outcomes.

Cross Reference: A-0273

2. Failure to systematically collect, aggregate, and analyze data regarding medication errors and adverse patient events.

Cross Reference: A-0286

3. Failure to develop projects and action plans based on results of data collection and aimed at improving patient outcomes.

Cross Reference: A-0297

4. Failure to ensure that the hospital's Quality Program reflects the complexities of services provided by the hospital.

Cross Reference: A-308

5. Failure to provide oversight of the Quality Assessment and Performance Improvement program to ensure full implementation of the Performance Improvement Plan.

Cross Reference: A-309

Due to the scope of the deficiencies cited under 42 CFR 482.21; the Condition of Participation for Quality was NOT MET.

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Based on interview, review of the hospital's quality program, and review of quality documentation, the hospital failed to analyze data regarding Medication Errors, Medication Management, Pharmacy and Therapeutics Function, Safety Management, Risk Management, Infection Control, Utilization Management, Clinical Laboratory Services, Nursing Services, Nutritional Services, Pharmacy Services, Therapeutic and Discharge Planning for patterns, trends, and common factors through the hospital's quality program.

Failure to collect, aggregate and analyze data to improve patient outcomes puts patients at risk of substandard care.

Findings included:

1. Document review of the hospital's document titled, "Organizational Quality Improvement Plan," policy number 6366314, approved 07/19, showed that the hospital's Organizational Quality Improvement plan is to ensure the Governing Board, medical staff, and professional service staff demonstrate a consistent endeavor to deliver safe, effective, optimal patient care and services in an environment of minimal risk. As a patient is a coordinated and collaborative effort, the approach to improving performance involves multiple departments and disciplines establishing the plans, processes, and mechanisms that comprise the performance improvement of the hospital. The program consists of focus components including quality improvement, patient safety, and quality assessment, and quality control activities. The status of identified problems and action plans is tracked to assure improvement or problem resolution.

The scope of the organizational quality improvement program includes performance monitoring, assessment, and evaluation of all individuals with clinical privileges. The continuous quality improvement activities of the medical staff and all appropriate departments and services and disciplines that affect patient care and safety and medical staff services within the medical staff service committee will be reviewed including:

a. Medication Management
b. Pharmacy and Therapeutics Function
c. Safety Management
d. Risk Management
e. Infection Control
f. Utilization Management

Patient Care and Quality Control Activities are monitored, assessed, and evaluated including:

a. Clinical Laboratory Services
b. Nursing Services
c. Nutritional Services
d. Pharmacy Services
e. Therapeutic and Discharge Planning

A Patient Safety Committees will operate as an independent committee dedicated to implementation and monitoring of the effectiveness of the Patient Safety Program and will report committee findings, determinations, and actions to the Quality Improvement Committee. Information reporting will contain concurrent data related to ongoing patient safety and medical error issues as well as information related to the proactive risk assessment.

Undesirable patterns or trends in performance are analyzed for performance measures related to:

a. Management of hazardous conditions

b. Medication management

c. Restraint use and seclusion use

d. Behavior management and treatment

e. Appropriateness of pain management

f. Care, treatment or services to high-risk populations

g. National patient safety goals.

In-depth analysis is conducted for levels of performance, patterns, or trends for:

a. All serious adverse drug events

b. All significant medication errors

c. Hazardous conditions

Data on all action plans will be collected and reported to the Quality/Safety Committee on a monthly basis. Results of outcomes of quality improvement and patient safety activities identified through data collection and analysis, performed by the medical staff service committees, ancillary, nursing, Safety Committees, and the Continuous Quality Improvement team will be reported to Quality Improvement Committee on a monthly/bimonthly or quarterly basis as designated by the committee.

2. On 09/30/19 at 2:50 PM, Investigator #5, Investigator #4, the Chief Nursing Officer (Staff #506) and the Interim Director of Quality (Staff #508) reviewed the hospital's Quality Improvement Program. Investigator #5 observed that data for quality indicators identified in the Hospital's Quality Plan were not reported to the Quality Committee. Investigator #5 observed only line item data for medication-missed doses, discharge summaries, and contraband reported in the meeting minutes. Investigator #5 found no evidence of analysis of the line-itemed data.

3. At the time of the review, Staff #506 and #508 confirmed the finding and stated that medication missed doses, discharge summaries, and contraband were the indicators reported as part of the parent corporation's quality metrics and that the hospital did track other quality measures that were not reported to the Quality Committee. Staff #506 stated that there could be improvement in meeting minutes to capture information shared in the committee.
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Based on interview and review of the hospital's quality improvement program and performance data, the hospital failed to aggregate data regarding patient medication errors, patient injuries, and other adverse events and failed to analyze the aggregated data for patterns, trends, and common factors through the hospital's quality program.

Failure to systematically collect, aggregate, and analyze data regarding medication errors, patient injuries, and adverse patient events limits the hospital's ability to develop action plans to prevent medical errors and patient injuries.

Findings included:

1. Document review of the hospital's quality document titled, "Organizational Quality Improvement Plan," policy number 6366314, approved 07/19, showed that the hospital's Organizational Quality Improvement plan is to ensure the Governing Board, medical staff, and professional service staff demonstrate a consistent endeavor to deliver safe, effective, optimal patient care and services in an environment of minimal risk. As a patient is a coordinated and collaborative effort, the approach to improving performance involves multiple departments and disciplines establishing the plans, processes, and mechanisms that comprise the performance improvement of the hospital. The program consists of focus components including quality improvement, patient safety, and quality assessment, and quality control activities.

A Patient Safety Committees will operate as an independent committee dedicated to implementation and monitoring of the effectiveness of the Patient Safety Program and will report committee findings, determinations, and actions to the Quality Improvement Committee. Information reporting will contain concurrent data related to ongoing patient safety and medical error issues as well as information related to the proactive risk assessment.

Undesirable patterns or trends in performance are analyzed for performance measures related to:

a. Management of hazardous conditions

b. Medication management

c. Restraint use and seclusion use

d. Behavior management and treatment

e. Appropriateness of pain management

f. Care, treatment or services to high-risk populations

g. National patient safety goals.

In-depth analysis is conducted for levels of performance, patterns, or trends for:

a. All serious adverse drug events

b. All significant medication errors

c. Hazardous conditions

Data on all action plans will be collected and reported to the Quality/Safety Committee on a monthly basis. Results of outcomes of quality improvement and patient safety activities identified through data collection and analysis, performed by the medical staff service committees, ancillary, nursing, Safety Committees, and the Continuous Quality Improvement team will be reported to Quality Improvement Committee on a monthly/bimonthly or quarterly basis as designated by the committee.

2. On 09/30/19 at 2:50 PM, Investigator #5, Investigator #4, the Chief Nursing Officer (Staff #506) and the Interim Director of Quality (Staff #508) reviewed the hospital's Quality Improvement Program. Investigator #5 found no evidence that quality staff measured, analyzed, or tracked patient safety activities identified in the hospital's quality Improvement Plan including patient medication errors, patient injuries, and other adverse events to demonstrate measurable improvement in indicators.

3. At the time of the observation, Staff #506 and #508 confirmed the finding and stated that hospital did track other quality measures in the Patient Safety Committee, but that the indicators were not reported to the Quality Committee.
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Based on interview, document review, and review of quality data, the hospital failed to develop and implement performance improvement activities that supported hospital quality indicators related to patient safety and quality of care and failed to develop action plans to address identified areas of concern.

Failure to develop projects and action plans based on results of data collection and aimed at improving patient outcomes puts patients at risk from harm from substandard care.

Findings included:

1. Document review of the hospital's document titled, "Organizational Quality Improvement Plan," policy number 6366314, approved 07/19, showed that the program consists of focus components including quality improvement, patient safety, and quality assessment, and quality control activities. The hospital tracks the status of identified problems and action plans to assure improvement or problem resolution.

Data on all action plans will be collected and reported to the Quality/Safety Committee on a monthly basis. Results of outcomes of quality improvement and patient safety activities identified through data collection and analysis, performed by the medical staff service committees, ancillary, nursing, Safety Committees, and the Continuous Quality Improvement team will be reported to Quality Improvement Committee on a monthly/bimonthly or quarterly basis as designated by the committee.

2. On 09/30/19 at 2:50 PM, Investigator #5, Investigator #4, the Chief Nursing Officer (Staff #506) and the Interim Director of Quality (Staff #508) reviewed the hospital's Quality Improvement Program. The review showed:

a. Hospital staff did not report data for quality indicators identified in the Hospital's Quality Plan to the Quality Committee.

b. There was line item data for medication-missed doses, discharge summaries, and contraband reported in the meeting minutes. The data reported for January, February, March, April, May, June, July, and August 2019 showed the hospital did not meet goals established by the Quality Committee for medication missed doses, discharge summaries, and contraband. There was no evidence that the Quality Committee developed, reported, or tracked Process Improvement Plans for indicators not meeting their goals.

c. Investigator #5 found no evidence the hospital integrated Clinical Laboratory Services, Nutritional Services, Pharmacy and Therapeutic Services, Discharge Planning or Infection Control into the Quality Improvement Program.

3. At the time of the review, Staff #506 confirmed the finding and stated that the hospital had workgroups addressing the issues but that the information was not reported in the Quality Committee. The staff member also stated that the hospital could improve the meeting minutes to capture information that was shared in the committee.
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Based on interview, document review, and review of the hospital's Quality Improvement Program, the Governing Body failed to ensure that the program reflected the complexity of the hospital's organization and services, and involved all hospital departments including those services furnished under contract.

Failure to ensure that the hospital's Quality Program reflected the complexities of services provided, limits the hospital's ability to identify areas of concern related to quality and safety, and limits the hospital's ability to implement process improvement actions to improve care outcomes and patient safety.

1. Document review of the hospital's quality document titled, "Organizational Quality Improvement Plan," policy number 6366314, approved 07/19, showed the scope of the organizational quality improvement program includes performance monitoring, assessment, and evaluation of all individuals with clinical privileges. The continuous quality improvement activities of the medical staff and all appropriate departments and services and disciplines that impact patient care and safety and medical staff services within the medical staff service committee will be reviewed including:

a. Medication Management
b. Pharmacy and Therapeutics Function
c. Safety Management
d. Risk Management
e. Infection Control
f. Utilization Management

Patient Care and Quality Control Activities are monitored, assessed, and evaluated including:

a. Clinical Laboratory Services
b. Nursing Services
c. Nutritional Services
d. Pharmacy Services
e. Therapeutic and Discharge Planning

A Patient Safety Committees will operate as an independent committee dedicated to implementation and monitoring of the effectiveness of the Patient Safety Program and will report committee findings, determinations, and actions to the Quality Improvement Committee. Information reporting will contain concurrent data related to ongoing patient safety and medical error issues and well as information related to the proactive risk assessment.

Undesirable patterns or trends in performance are analyzed for performance measures related to:

a. Management of hazardous conditions
b. Medication management
c. Restraint use and seclusion use
d. Behavior management and treatment
e. Appropriateness of pain management
f. Care, treatment or services to high-risk populations
g. National patient safety goals.

In-depth analysis is conducted for levels of performance, patterns, or trends for:

a. All serious adverse drug events
b. All significant medication errors
c. Hazardous conditions

Data on all action plans will be collected and reported to the Quality/Safety Committee on a monthly basis. Results of outcomes of quality improvement and patient safety activities identified through data collection and analysis, performed by the medical staff service committees, ancillary, nursing, Safety Committees, and the Continuous Quality Improvement team will be reported to Quality Improvement Committee on a monthly/bimonthly or quarterly basis as designated by the committee.

2. On 09/30/19 at 2:50 PM, Investigator #5, Investigator #4, the Chief Nursing Officer (Staff #506) and the Interim Director of Quality (Staff #508) reviewed the hospital's Quality Improvement Plan and Program. Investigator #5 observed that the hospital's Quality Plan listed indicators for Patient Care and Quality Control Activities as "Services" for example, "Pharmacy Services" or by management such as "Safety Management" but did not identify the specific quality indicators to be measured within that service or program management. Investigator #5 observed only line item data for medication-missed doses, discharge summaries, and contraband reported in the meeting minutes, which did not reflect the complexities of services provided by the hospital.

3. At the time of the review, Staff #506 and #508 confirmed the finding and stated that medication missed doses, discharge summaries, and contraband were the indicators the hospital reported as part of their parent company's quality metrics and that the hospital did track other quality measures that were not reported to the Quality Committee. Staff #506 also stated that there could be improvement in meeting minutes to capture information shared in the committee.

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Based on interview and review of the hospital's performance improvement plan, the hospital's Governing Body failed to provide oversight to ensure full implementation of the quality assessment and performance improvement (QAPI) plan.

Failure to provide oversight of the Quality Assessment and Performance Improvement program to ensure full implementation of the Performance Improvement Plan limited the hospital's ability to identify systemic problems and develop action plans to improve patient care and ensure safety.

Findings included:

1. Document review of the hospital's quality document titled, "Organizational Quality Improvement Plan," policy number 6366314, approved 07/19, showed that the hospital's Organizational Quality Improvement plan is to ensure the Governing Board, medical staff, and professional service staff demonstrate a consistent endeavor to deliver safe, effective, optimal patient care and services in an environment of minimal risk. The Governing Board is responsible for the quality of care provided. The Governing Board has a responsibility to evaluate the effectiveness of the quality improvement activities performed throughout the hospital and the organizational quality improvement program as a whole. The Governing Board requires a detail and frequency of data collection for all indicators and performance processes outlined in the Quality Plan including reporting of all patient care and service indicators to the Patient Safety Committee on a monthly basis.

Document review of the hospital's policy titled, "Governing Bylaws," policy number 6313788, approved 07/19, showed that the Governing Body has the ultimate responsibility for performance improvement, risk management, and outcomes. The Governing Board oversees performance functions through its appointment and reappointment responsibilities, receiving and acting on reports that summarize activities of performance improvement, risk management, safety, human resources, budget, and other hospital based functions.

2. On 09/30/19 at 2:50 PM, Investigator #5, Investigator #4, the Chief Nursing Officer (Staff #506) and the Interim Director of Quality (Staff #508) reviewed the hospital's Quality Improvement Program. The review showed:

a. Hospital staff did not report data for quality indicators identified in the Hospital's Quality Plan to the Quality Committee.

b. There was line item data for medication-missed doses, discharge summaries, and contraband reported in the meeting minutes.

c. The data reported for January, February, March, April, May, June, July, and August 2019 showed the hospital did not meet goals established by the Quality Committee for medication missed doses, discharge summaries, and contraband. There was no evidence that the Quality Committee developed, reported, or tracked Process Improvement Plans for indicators not meeting.

d. Investigator #5 found no evidence that the hospital integrated Clinical Laboratory Services, Nutritional Services, Pharmacy and Therapeutic Services, Discharge Planning or Infection Control into the Quality Improvement Program.

3. On 10/01/19 at 11:10 AM, Investigator #5, Investigator #4, and Investigator #3 interviewed the hospital's Governing Body and reviewed the Governing Body meeting minutes. Review of the Governing Body meeting minutes showed no evidence the Governing Body ensured that the hospital tracked or analyzed all quality assessment and performance improvement quality indicators identified in the hospital's Quality Improvement Plan. The review also showed no evidence that the hospital developed process improvement activities to address the 3 indicators (medication missed doses, contraband, and Discharge Summaries) that showed consistent non-compliance with the hospital's established goals.

At the time of the interview, the Springstone Sr. Vice-President of Operations (Staff #517) stated that the Governing Body reviewed a scorecard maintained by the hospital. Staff #517 also stated that when the Governing Board finds that the hospital is "falling short" they take action by using "platform" staff to work with hospital staff to meet expectations or make staff changes, adding that this was not necessarily something that would be found in the minutes.

4. Investigator #5 asked the Governing Body about its involvement in quality tracking, monitoring, and process improvement for the hospital's pharmacy services, based on the issues identified during the investigation. The Springstone Vice President of Nursing (Staff #518) stated that they have "a lot of interaction with the pharmacist and complete an annual review," and that they (the parent company) did not "see issues across the platform (hospital system)."

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Based on interview and review of medical staff documents, the hospital failed to ensure that a majority of members of the Medical Executive Committee were either doctors of medicine or osteopathy (Item #1) and failed to ensure that members of the Medical Executive Committee performed duties related to quality management and utilization review as outlined the the Medical Staff Bylaws (Item #2).

Failure to maintain the Medical Executive Committee with a majority of members who are either doctors of medicine or osteopathy and failure to have members of the Medical Executive Committee oversee quality improvement and utilization review, puts patients at risk of harm from inadequate oversight of medical practitioners and substandard care.

Findings included:

Item #1- Composition of the Medical Executive Committee

1. Document review of the hospital document titled, "Hospital Medical Staff Bylaws", last revised 11/18, showed that the Medical Executive Committee shall consist of a majority of members who are fully licensed physician members of the active staff.

Document review of the meeting minutes of the hospital's Medical Executive Committee showed that between January and April 2019, the attendants of each meeting included the hospital's Medical Director, the Chief Executive Officer, and the Director of Nursing.

2. On 09/25/19 at 5:00 PM, Investigator #4 interviewed the hospital's administrative assistant (Staff #401) about the composition of the Medical Executive Committee. Staff #401 provided the investigator with a list of members of the Medical Executive Committee and confirmed that the Medical Director is sole physician member of the Medical Executive Committee.

Item #2- Duties of the Medical Executive Committee

1. Document review of the hospital document titled, "Hospital Medical Staff Bylaws", last revised 11/18, showed that primary duties of the Medical Executive Committee include overseeing quality assessment and improvement activities and ensuring compliance with the hospital's utilization review plan.

2. On 09/30/19 at 10:30 AM, Investigator #5 and the Director of Utilization review (Staff #501) reviewed the hospital's Utilization Review Committee program and the Utilization Review Committee Minutes.

a. Document review of the Utilization Review Committee minutes showed the committee had only met twice, once on 10/16/18 to discuss data for the time span of 10/01/18-10/16/18, and then on 01/22/19 for 4th Quarter 2018 admissions data and the 12/18 monthly report. Investigator #5 found no evidence the committee met and reviewed 2019 data.

b. Review of the UR Committee minutes dated 10/16/18 showed one medical doctor in attendance (Staff #502).

c. Review of the UR Committee minutes dated 01/22/19 showed no medical doctor in attendance.

Cross Reference: Tags 0286, 0297 and 0654
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Based on observation, interview, and document review, the hospital failed to failed to provide nursing oversight for the assessment, treatment, and evaluation of patient care needs, and failed to ensure hospital staff members followed hospital policy for medication administration and assessment processes .

Failure to follow hospital policy and procedure and recognized standards of care for nursing oversight for patient assessments, evaluation and treatment and failure to follow medication administration and assessment processes puts patients at risk for errors, inappropriate treatment, or patient harm.

Findings included:

1. Failure to provide appropriate safety assessments and reassessment after a patient experiences a change in condition.

Cross Reference: A0395

2. Failure to develop an individualized plan of care which meets patient care needs.

Cross Reference: A0396

3. Failure to follow the hospital's medication administration and medication assessment processes.

Cross Reference: A0405

Due to the scope and severity of deficiency cited under 42 CFR 482.23 the Condition of Participation for Nursing Services was NOT MET.

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Based on interview, document review, and review of hospital policy and procedures, the hospital failed to ensure an RN evaluated patients with abnormal vital signs consistent with the provider's order for 2 of 2 patients reviewed (Patient #307, #512).

Failure to have a Registered Nurse evaluate and review patient vital signs and failure to contact an independent practitioner if a patient's vital signs are outside of appropriate parameters risks patient harm and poor patient outcomes.

Findings included:

1. Document review of the hospital's Vital Signs Flow sheet, document number IP-FSW-101-06, updated 01/15/16, showed that a Registered Nurse (RN) is to review patient blood pressures below 90 mm/Hg systolic and below 60 mm/Hg diastolic.

Document review of the hospital's Alcohol and/or Benzodiazepine CIWA Symptom Triggered Detox Protocol, document number IP-POW-062-03, updated 03/29/17, showed that staff are to measure vital signs every six hours. If the systolic blood pressure is greater than 180 mm/Hg and or diastolic blood pressure greater than 120 mm/Hg, the licensed independent practitioner is to be contacted.

2. On 09/25/19 at 9:20 AM, Investigator #3 reviewed the medical record of Patient #307 who was admitted on 08/05/19 for alcohol dependence. The Clinical Institute Withdrawal Assessment (CIWA) sheet showed:

a. On 08/06/19 at 06:00 AM, the patient's blood pressure was 181/116 mm/Hg.

b. Although CIWA scores were assessed at 09:00 AM and 12:30 PM, the patient's record showed no documented vital sign measurements despite a Registered Nurse's initials at those times indicating they performed the CIWA assessment.

c. On 08/06/19 at 6:00 PM, the patient's blood pressure was 170/90 mm/ Hg.

3. Investigator #3 found no evidence in the medical record to indicate the Registered Nurse had contacted the provider as required by the standing protocol for elevated blood pressure obtained at 6:00 AM. Further, the investigator found no evidence that the blood pressure was checked or rechecked for a period of twelve hours despite the order for vital sign measurements every six hours.

4. On 09/26/19, Investigator #5 and the Chief Nursing Officer (Staff #506) reviewed the medical record for Patient #520 who was admitted on 09/03/19 for Unspecified Schizophrenia. On 09/03/19, the review showed a provider wrote an order for daily vital signs. The vital signs flow sheet showed:

a. On 09/12/19, the patient's blood pressure was 101/49 mm/Hg

b. 09/18/19, the patient's blood pressure was 91/57 mm/Hg

c. On 09/21/19, the patient's morning blood pressures were below parameters identified on the hospital document. The column of the document titled "RN Signature" was blank. Investigator #5 found no evidence an RN reviewed the abnormal vital signs.

5. At the time of the review, Staff #506 confirmed the finding and stated that the nurse should review the vital signs when they fall out of parameter.

6. On 09/26/19, Investigator #5 reviewed the medical record for Patient #524. The review showed that on 01/25/19, the patient's blood pressure was 97/57 mm/Hg. Investigator #5 found no evidence that an RN reviewed the abnormal vital signs.

7. At 2:00 PM, during interview with Investigator #5, the Chief Nursing Officer (Staff #506) confirmed the finding and stated that the nurse should have reviewed the abnormal vital signs.
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Based on interview, record review, and review of policies and procedures, the hospital failed to develop an individualized plan for patient care for 6 of 6 patient plans of care reviewed (Patient #509, #512, #517, #520, #521, and #524) [Item #1] and failed to ensure a Registered Nurse (RN) reassessed patients after a change in condition that required transfer to a higher level of care for 3 of 3 patients reviewed (Patient #517, #519, and #520) [Item #2].

Failure to develop an individualized plan of care and reassess patients when transferring to a different level of care can result in the inappropriate, inconsistent, or delayed treatment of patient's needs and may lead to patient harm and lack of appropriate treatment for a medical condition.

Findings included:

ITEM #1 - Development of Individualized Plans for Patient Care

1. Document review of the hospital's policy and procedure titled, "Treatment Planning-Philosophy and Purpose," policy number 5063622, approved 01/19, showed that every patient admitted to the hospital will have an individualized plan specific to his or her assessed needs. Care planning includes the development of measurable treatment goals. Care, treatment, and services will be planned, which include patient objectives, staff interventions, services, and treatments necessary to assist the patient in meeting the identified goal. The plan of care, treatment, and services includes:

a. Defined Problems

b. Measurable goals

c. Frequency of care, treatment, and services

d. A description of facilitating factors and possible barriers to care

e. Criteria for transition

f. A plan for discharge

g. Documentation of the course of treatment

h. Treatment plan review that evaluates patient response to goals and interventions.

Document review of the hospital's policy titled, "Program Overview/Scope of Care-Inpatient," policy number 5441050, approved 07/19, showed that Treatment Plans will address lack of participation and interventions will be developed to encourage active participation in treatment.

2. On 09/23/19 at 12:54 PM, Investigator #5 and a Registered Nurse (Staff #512) reviewed the medical record for Patient #517. The review showed:

a. The patient had a history of chronic low back pain and lower extremity muscle cramps. The patient utilized a wheelchair for mobility.

b. On 09/02/19, the patient was transferred from Alcohol Detoxification to the inpatient unit for Suicidal Ideation.

c. Group Therapy notes showed the patient was not attending group therapy.

d. On 09/21/19, the patient engaged in an occurrence of Sexually Acting Out (SAO) with a roommate.

e. On 09/22/19, the patient became violent and threw a chair at staff.

Investigator #5 found no evidence the patient care plan included defined problems, measurable goals, frequency of care, treatment, and services, a description of facilitating factors and possible barriers to care, or criteria for transition for the problems of altered mobility, substance use disorder treatment, non-compliance, SAO, violent behaviors or pain.

3. At the time of the review, Staff #512 confirmed the care plan was missing the elements.

4. On 09/25/19 at 11:10 AM, during interview with Investigator #5, an Outpatient Therapist (Staff #519) stated that if patients were not attending groups, they would address it at the treatment team meeting and it should be added to the patient's treatment plan.

5. On 09/25/19 at 11:00 AM, Investigator #5 and the Corporate Quality Director (Staff #509) reviewed the medical record for Patient #509. The review showed the patient had:

a. head lice

b. was HIV positive

c. had incontinent bloody stool episodes

d. was non-compliant with isolation precautions

e. had violent behavior episodes

f. was non-compliant with therapy group attendance

Investigator #5 found no evidence the patient's treatment plan addressed the problems related to isolation precautions, treatment non-compliance, violent behaviors and non-compliance with therapy groups.

6. At the time of the review, Staff #509 confirmed the the treatment plan was missing the required elements.

7. On 09/26/19 at 12:00 PM, Investigator #5 and the Chief Nursing Officer (Staff #506), reviewed the medical record for Patient #524 who was admitted on 08/25/19 for the treatment of Psychosis, Heroin Detoxification, Schizo-Affective Disorder, Cellulitis, and Pain. The review showed the patient was non-compliant with group attendance.

Investigator #5 found no evidence the treatment plan addressed therapy non-compliance.

8. At the time of the review, Staff #506 confirmed the treatment plan failed to address therapy non-compliance.

9. On 09/26/19 at 1:03 PM, Investigator #5 reviewed the Medical Record for Patient #520 who was admitted for Opioid Detoxification on 09/03/19. On 09/10/19, the patient was admitted to the Inpatient Mental Health Unit directly after Opioid Detoxification for the treatment of Suicidal Ideation. The patient had a history of Major Depressive Disorder and Unspecified Schizophrenia. The review showed:

a. The patient had open wounds (from cutting) to his left wrist. On 09/06/19, a provider order directed staff to perform daily wound care that included daily wound cleaning, application of antibiotic cream, and application of a non-adherent dressing.

Investigator #5 found no evidence that the patient's treatment plan addressed the alteration in their skin with daily wound care.

10. On 09/27/19, Investigator #5 and the Chief Nursing Officer reviewed the medical records for Patient #512 and #521. The record reviews showed:

a. Patient #512 was admitted involuntarily on 07/26/19 for the treatment of Psychosis and violent behavior. The patient was deaf and mute. Review of the Group Therapy notes showed the patient was significantly non-compliant with group therapy attendance.

Investigator #5 found no evidence the patient's treatment plan addressed the communication barrier or non-compliance with treatment.

b. Patient #521 was admitted 09/16/19 for the treatment of Major Depressive Disorder, anxiety and Post Traumatic Stress Syndrome. Review of Group Therapy notes showed the Patient was significantly non-compliant with Therapy Group attendance.

Investigator #5 found no evidence the patient's treatment plan addressed Group Therapy attendance non-compliance.

11. At the time of the review, the Chief Nursing Officer (Staff #506) confirmed the treatment plan failed to address therapy non-compliance.

ITEM #2 - Registered Nurse Assessment

1. Document review of the hospital's policy titled, "Admission Process Inpatient," policy number 5127934, approved 10/18, showed that a Registered Nurse would complete the admission nursing assessment within 8 hours of admission.

2. On 09/23/19 at 12:54 PM, Investigator #5 and a Registered Nurse (Staff #512) reviewed the medical record for Patient #517 who transferred from the hospital's Detoxification Unit to the Inpatient Mental Wellness Unit for the treatment of Suicidal Ideation. Upon discharge from the Detoxification Unit, the patient became suicidal and transferred to the Mental Wellness Unit. Investigator #5 found no evidence that a Registered Nurse completed an admission assessment of the patient related to the change in the patient's status.

3. On 09/23/19 at 2:46 PM, Investigator #5 asked the nurse about reassessment for a change in a patient's medical or mental health condition that requires transfer to another unit or higher level of care. Staff #512 stated that nursing does not reassess the patients when they are transferred from the Sober Living Unit, following detoxification from Drugs or Alcohol.

4. On 09/23/19 at 3:00 PM, Investigator #5 requested hospital policies related to nursing reassessment after change in condition or transfer. Investigator #5 received a policy titled, "Program Overview/Scope of Care," policy number 5441050, approved 07/19, a policy titled, "Admission Process Inpatient," policy number 5127934, approved 10/18, and a policy titled "Shift Nursing Assessment/Reassessment," policy number 6219317, approved 07/19. The policies did not address assessment by a nurse when patients transferred to a higher level of care or patients experienced a substantial change in medical or mental health condition.

5. On 09/26/19 at 12:00 PM, Investigator #5 and the Chief Nursing Officer (Staff #506), reviewed the medical record for Patient #519 for the 09/03/19 admission for the treatment of Heroin Detoxification. On 09/10/19, the patient was transferred to Inpatient Mental Health Unit for increased depression and suicidal ideation.

Investigator #5 found no evidence a Registered Nurse completed an assessment of the patient upon admission to the Inpatient Mental Health Unit related to the change in the patient's status.

6. On 09/26/19 at 12:50 PM, a Licensed Clinical Social Worker (Staff #520) stated that when a patient transfers from the substance abuse unit to the mental health unit, a therapist reassesses them. Staff #520 confirmed that the medical record did not show a nursing reassessment, or any documentation in a nursing progress note that showed that the patient was transferred to the mental health unit for suicidal ideation.
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Based on observation, interview, and review of hospital policy and procedures, hospital staff failed to follow safe medication practice for medication administration (Item #1), failed to ensure staff members completed and documented an initial pain assessment and pain reassessments after each pain management intervention for 2 of 3 patient records reviewed (Patient #517 and #518) (Item #2), and failed to ensure nursing staff monitored a patient's glucose and administered insulin as directed by the provider order for 1 of 1 patients reviewed (Patient #526) (Item #3).

Failure to follow the hospital's medication administration process places patients at risk for medication errors and patient harm.

Findings included:

Item #1 - Pre-pouring of Medications

1. Document review of the hospital's policy and procedure titled, "Medication Administration -General Guidelines," PolicyStat ID #4985266, approved 10/18, showed that prior to administration, the medication and dosage schedule on the patient's medication administration record is compared with the medication label.

2. On 09/26/19 at 8:45 AM, Investigator #3 observed a Registered Nurse (Staff #303) open a cabinet door in the medication room and retrieve a white basket with four patient-labeled cups containing medications. The investigator observed that two of the patient-labeled cups had some medications out of their original packaging.

3. At the time of the observation, Investigator #3 interviewed the Registered Nurse (Staff #303) about the observation. Staff #303 stated that she had to prepare the medications ahead of time and then provide them to the patients. She stated that this was her practice.

4. On 09/26/19 between 8:45 AM and 09:00 AM, Investigator #3 interviewed the Director of Nursing (Staff #301) about the observation. Staff #301 stated that it was not their policy to pre-pour medications or remove medications out of their packaging prior to administration.

Item # 2 - Pain Medication Assessment and Reassessment

1. Document review of the hospital's policy titled, "Medication Administration-General Guidelines," policy number 4985266, approved on 10/18, showed that when a patient receives an "As Needed" (PRN) medication for complaints of pain, the clinical staff must re-evaluate the patient's pain and rate it as 1-10 for effectiveness within an hour of the PRN medication administration.

2. On 09/23/19 at 12:54 PM, Investigator # 5 and a Registered Nurse (Staff #512) reviewed the medical record for Patient #517. The patient had a history of chronic low back pain and lower extremity muscle cramps. The patient utilized a wheelchair for mobility.

The review showed:

a. On 08/30/19 at 6:35 PM, nursing staff administered Ibuprofen 600 mg by mouth. Investigator #5 found no evidence nursing staff reassessed the patient after administering the PRN medication.

3. On 09/25/19 at 10:17 AM, Investigator #5 and Corporate Quality Director (Staff #509) reviewed the medical record for Patient #518 who was admitted on 08/22/19 for the treatment of Unspecified Psychosis. The patient had a history of Schizophrenia, Paranoid Depression, and Type II Diabetes Mellitus. The review showed:

a. On 09/14/19 at 10:43 PM, nursing staff administered Ibuprofen 600 mg by mouth. Investigator #5 found no evidence nursing staff assessed an initial pain score or reassessed the patient after administering the PRN medication.

b. On 09/14/19 at 9:10 PM, nursing staff administered Ibuprofen 600 mg by mouth. Investigator #5 found no evidence nursing staff assessed an initial pain score or reassessed the patient after administering the PRN medication.

4. At the time of the observation, Staff #509 confirmed the finding.

Item #3- Insulin Coverage for high blood glucose levels

1. On 09/25/19 at 10:17 AM, Investigator #5 and Corporate Quality Director (Staff #509) reviewed the medical record for Patient #518 who was admitted on 08/22/19 for the treatment of Unspecified Psychosis. The patient had a history of Schizophrenia, Paranoid Depression, and Type II Diabetes Mellitus. The review showed the following:

a. On 08/23/19, a provider ordered blood sugars prior to every meal and at bedtime. The provider ordered Low dose Sliding Scale Correctional Insulin Protocol with no nighttime insulin coverage. The protocol showed that for a blood glucose level of110 mg/dl to 150 mg/dl nursing staff were to administer 1 unit of Lispro insulin subcutaneously.

b. On 08/26/19 at 5:00 PM, Investigator #5 found no evidence staff monitored the patient's blood glucose level or that the patient received coverage. The prior blood glucose level at 12:00 PM showed a blood glucose of 171 mg/dl and the patient received 2 units of Lispro subcutaneously per the provider order. The subsequent blood sugar at 9:00 PM was 214 mg/dl.

c. On 09/10/19 at 12:00 PM, the patient's blood sugar was 140 mg/dl. The provider order showed nursing staff should have administered 1 unit of Lispro insulin subcutaneously. Investigator #5 found no evidence the patient received the insulin.

d. On 09/12/19 at 7:00 AM, the patient's blood sugar was 120 mg/dl. The provider order showed nursing staff should have administered 1 unit of Lispro insulin subcutaneously. Investigator #5 found no evidence the patient received the insulin.

e. On 09/12/19 at 12:00 PM, the patient's blood sugar was 115 mg/dl. The provider order showed nursing staff should have administered 1 unit of Lispro insulin subcutaneously. Investigator #5 found no evidence the patient received the insulin.

2. At the time of the observation, Staff #509 confirmed the finding.

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Based on document review and review of the hospital's medical staff rules and regulations, the hospital failed to ensure that healthcare providers authenticated orders for care and treatment of patients according to the hospital's medical staff rules and regulations.

Failure to write and authenticate orders for medications and treatment risks provision of incorrect and/or inadequate patient care.

Findings included:

1. Document review of the hospital's policy titled, "Medical Staff Rules and Regulations," policy number 5612049, approved 03/19, showed that all orders must be authenticated, dated, and timed by the Physician or Allied Health Professional issuing the order. The attending Physician will co-sign, as soon as possible and in accordance with Hospital policy. All verbal orders will be read back to the provider and so noted in the medical record. All verbal orders will be authenticated by the ordering Provider within the State specified time frame.

Document review of the hospital's policy titled, "Provider Orders," policy number 5253244, approved 10/18, showed that written orders would be signed by the physician within 48 hours.

2. On 09/23/19 at 12:54 PM, Investigator #5, a Registered Nurse (Staff #512), and the Director of Ancillary and Outpatient Services (Staff #516) reviewed the medical record for Patient #517 who was admitted on 08/27/19. The review showed that provider had not authenticated their telephone orders within 48 hours on the following dates and times:

a. 08/28/19 at 1:43 PM

b. 08/29/19 no time

c. 08/30/19 at 10:50 AM

d. 08/31/19 at 11:10 AM

e. 09/02/19 no time

f. 09/02/19 at 2:11 PM

g. 09/02/19 no time

h. 09/03/19 at 2:16 PM

i. 09/06/19 at10:24 AM

j. 09/10/19 at 2:15 PM

k. 09/10/19 at 4:50 PM

l. 09/11/19 at 3:50 PM

3. On 09/25/19 at 9:20 AM, Investigator #3 reviewed the medical records of five patients who were placed in seclusion or restraint during their hospital stay (period of 03/19 to 08/19). The review showed the that the provider had not authenticated telephone orders given to the nursing staff for restraint or seclusion for Patient's #306, #307, #308, #309, and #310.

4. On 10/01/19 at 8:15 AM, Investigator #3 reviewed the medical record of Patient #311 who was admitted on 03/15/19. The review showed that the provider had not authenticated telephone orders given to the nursing staff on admission given for Admission Medication Reconciliation/Admission Medication Orders and the Subcutaneous and Correctional (Sliding Scale) Insulin Orders.

5. On 10/01/19 at 1:10 PM, Investigator #3 interviewed the Health Information Manager (Staff #307) about delinquent records. Staff #307 stated getting records signed is especially problematic with providers who provide care via telemedicine since they are not often in the hospital on-site.
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Based on observation, interview, and document review, the hospital failed to deliver pharmaceutical services according to regulatory requirements and accepted standards of practice.

Failure to implement controlled substance accountability standards, diversion-monitoring audits, and pharmacist review of medication orders risks patient safety, theft, and diversion of controlled substances.

Findings included:

Observations, interviews, record reviews, and review of hospital policies and procedures, showed the following:

1. Failure to ensure compliance with state and federal laws and regulations, failure to accurately perform monthly unit inspections, failure to develop and implement Pharmacy policies and procedures to minimize drug errors, failure to monitor, assess and evaluate quality control activities of Pharmacy Services, failure to write medication orders consistent with hospital policy, and failure to appropriately label medication dispensed in unit-doses by the hospital.

Cross-reference: A0491

2. Failure to maintain an accurate controlled substance inventory, failure to account for and resolve discrepancies in controlled substances .

Cross-reference: A0494

3. Failure to ensure that pharmaceuticals were acquired, controlled, distributed, inspected, and labeled according to applicable standards of practice and hospital policy.

Cross-reference: A0500

4. Failure to provide Pharmacist oversight during the process of unit-dosing from bulk medications.

Cross-reference: A0501

5. Failure to ensure that medications have labels with an expiration date.

Cross-reference: A0505

Due to the scope of the deficiencies cited under 42 CFR 482.25; the Condition of Participation for Pharmaceutical Services was NOT MET.

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Based on observation, interview, document review, and review of the hospital's Pharmacy and Therapeutics and Quality Programs, the hospital failed to ensure compliance with state and federal laws (Item #1), failed to accurately perform monthly unit inspections (Item #2), failed to develop and implement Pharmacy policies and procedures to minimize drug errors (Item #3), failed to monitor, assess and evaluate quality control activities of Pharmacy Services (Item #4), failed to ensure that practitioners wrote medication orders as directed by hospital policy (Item #5), and failed to ensure appropriate labeling for medications dispensed as unit doses (Item #6).

Failure to follow state and federal laws and regulations, develop and implement safe medication practice policies, and monitor for quality care, limits the hospital's ability to improve outcomes and puts patients at risk of harm from medication errors and inadequate oversight.

Findings included:

Item #1- Compliance with State Law Utilization Plan for Pharmacy Technicians

References: RCW 18.64A.060 Pharmacy's application for ancillary personnel-Fee-Approval or rejection by commission-Hearing-Appeal
No pharmacy licensed in this state shall utilize the services of pharmacy ancillary personnel without approval of the commission.

WAC 246-901-100 (2) (a) Board approval of pharmacies utilizing pharmacy ancillary personnel and specialized functions
(1) Application. All licensed pharmacies may apply on a form supplied by the board for permission to utilize the services of pharmacy ancillary personnel. (2) Utilization plan for pharmacy technicians.

1. On 09/24/19 at 11:30 AM, Investigator #5, Investigator #12, a Pharmacy Technician (Staff #504) and the Pharmacy Director (Staff #503) inspected the hospital's main pharmacy. The observation showed that the hospital did not have an approved Ancillary Staff Utilization Plan (AUP) as required by Revised Code of Washington (RCW) 18.64A.060 and Washington Administrative Code (RCW) 246-901-100 (2) (a).

2. At the time of the observation, the Pharmacy Director (Staff #503) confirmed the hospital did not have an approved AUP and stated that he was not familiar with the Washington State requirements.

Item #2- Compliance with State Law Unit Inspections

Reference: WAC 246-873-080 (1) (b) A monthly inspection of all nursing care units or other areas of the hospital where medications are dispensed, administered or stored. Inspection reports shall be maintained for one year.

1. On 09/24/19 at 11:20 AM, Investigator #5 and a Registered Nurse (RN) (Staff #505) inspected the Automated Medication Dispensing Cabinet located in the inpatient Cedar Unit. Investigator #5 observed 8 patient-owned medications belonging to 5 patients (Patient #506, #507, #508, #509, and #510) that did not contain a hospital pharmacy label or show they had been verified by a pharmacist prior to administration to the patient as a patient-owned medication. Investigator #5 asked Staff #505 to describe the hospital policy for verification of patient-owned medications. Staff #505 stated that she did not know.

2. On 09/24/19 at 11:58 AM, Investigator #5 interviewed the hospital's Director of Pharmacy (Staff #503) about pharmacy verification of patient-owned medications. Staff #503 stated that he checked every patient-owned medication. Investigator #5 then asked Staff #503 about the unverified medications located on the Cedars and Meadow Units. Staff #503 stated that it was a "work in progress" and that he was not "100% at checking."

3. On 09/26/19 at 9:50 AM, Investigator #5 and the Pharmacy Director (Staff #503) inspected the hospital's Nursing Care Unit inspection reports, located in the main pharmacy. The inspection reports for all 3 inpatient units from 11/18 to current (a period of 11 months) contained documentation to indicate that the pharmacist checked to ensure that a patient-owned medication was clearly labeled, verified, and within date. Investigator #5 asked if staff correctly completed the unit's inspection logs, as the investigator had already observed on the inpatient units, that Pharmacy verification of medication prior to administration to the patient was not the hospital's current process. Staff #503 stated that they were, but that he was not 100% compliant with completion of the verification. He was not able to answer why the documentation on the Unit inspection reports showed 100% compliance.

Item #3- Pharmacy Policies and Procedures to Minimize Drug Errors

1. On 09/24/19, Investigator #5 requested the hospital's policy for "Override Medications." Investigator #5 received a typewritten list titled "Addendum A-Medication Override List," no date provided.

2. On 09/27/19 at 12:30 PM, Investigator#5, the Chief Nursing Officer (Staff #506), and a Registered Nurse (Staff #507) reviewed all medications available for removal from the automated drug dispensing cabinet (ADC) and compared those medications to both the list provided to the investigator and to a list posted on the wall behind the ADC. Investigator #5 observed the ADC contained 16 additional medications available for removal that were not on the list provided to the investigator. The additional drugs included:

a. Alprazolam 0.5 mg tablet (a controlled medication used to treat anxiety)

b. Clonazepam 0.5 mg tablet (a medication used to prevent and control seizures)

c. Clonazepam 1.0 mg tablet

d. Haldol 1 mg tablet (an antipsychotic medication used to treat psychotic disorders)

e. Haldol 5mg tablet

f. Ibuprofen 400 mg tablet

g. Losartan 25 mg tablet (a medication used to treat high blood pressure and to help protect the kidneys from damage due to diabetes)

h. Seroquel 50 mg tablet (an anti-psychotic medication used to treat mental and mood disorders)

i. Temazepam 50 mg tablet (a benzodiazepine medication used to treat insomnia)

j. Temazepam 30 mg tablet

k Tramadol 50 mg tablet (a narcotic-like pain reliever used to treat moderate to severe pain in adults)

l. Trazadone 100 mg tablet (an antidepressant medication)

m. Ziprasidone 50 mg tablet (an atypical antipsychotic used to treat mental and mood disorders)

n. Ziprasidone 100 mg tablet

o. Ziprasidone 20 mg tablet

p. Zolpidem 10 mg tablet (a sedative used to treat insomnia)

3. At the time of the observation, Staff #507 confirmed the discrepancy and verified that she could remove all 16 medications from the ADC without first obtaining a physician order.

4. On 09/27/19 at 1:00 PM, the Chief Nursing Officer (Staff #506) confirmed that the hospital did not have an Override Medication Policy that defined the medications approved for override and that the Override List provided to the investigator had not received approval from the hospital's Pharmacy and Therapeutics committee.

Item #4-Quality Improvement

1. Document review of the hospital's policy titled, "Organizational Quality Improvement Plan," policy number 6366314, revised 07/19, showed that patient care and quality control activities of Pharmacy Services are monitored, assessed, and evaluated. The Quality Improvement Program will assess the performance of patient care and organizational functions including Medication Management.

Document review of the hospital's policy titled, "Pharmacy and Therapeutics Committee," policy number 6219309, approved 07/19, showed that the Pharmacy and Therapeutics (P&T) Committee oversees and evaluates pharmaceutical services and recommends policies and procedures related to medication use and evaluation, appraisal, selection, procurement, storage, distribution and safe use. The committee reviews data on drug delivery systems, monitors implementation of policy and procedure, reviews reports submitted by the pharmacy, regulatory agencies, nursing, and medical staff related to mediation use process.

2. On 09/26/19 at 9:50 AM, Investigator #5 and the Pharmacy Director (Staff #503) inspected the hospital's main pharmacy. Investigator #5 requested the P&T Committee minutes and asked Staff #503 for his medication variance data (wrong medication administration, wrong dose, wrong time, wrong patient etc.). Staff #503 stated that he did not collect this information and that the hospital collected data only on missed medication doses.

3. On 09/29/19, Investigator #5 reviewed the hospital's P&T Committee minutes for 09/13/18, 10/19/18, 12/05/18, 04/02/19, 07/19/19, and 09/18/19. In the section titled, "P&T Quality Monitors," and in the section titled, "Medication Management Processes," the review showed that the documentation stated, "Ongoing" in both sections.

4. On 09/29/19, at 9:50 AM, Investigator #5 asked the Director of Pharmacy (Staff #503) what "ongoing" meant and if he reported medication use and process quality data to the P&T Committee or Quality Committee. Staff #503 stated that he did not because it was an "ongoing process".

5. On 09/30/19 at 2:50 PM, Investigator #5, the Interim Director of Quality (Staff #508) and the Chief Nursing Officer (Staff #506) reviewed the hospital's Quality Program and meeting minutes. Investigator #5 observed missed medication dosages reported for 07/19 and 08/19 that contained data from 01/19-06/19. Investigator #5 found no other evidence that "P&T Quality Monitors," or "Medication Management Processes included collection, aggregation, and analysis of medication use variances, or that results from the analyses were reported to the Quality committee.

6. Document review of the hospital's Quality Minutes, showed no recorded pharmacy activities included in the reports. Instead, the reports contained a repeated placeholder statement that indicated the department would report "next month."

7. At the time of the review, Staff #506 stated that she collected medication errors from incident reports filed by staff and that the hospital had identified that there were areas for significant improvement with their Pharmacy Department processes.

Item #5-Physician Orders

1. Document review of the hospital's policy titled, "Provider Orders," policy number 5253244, approved 10/18, showed that a medication order will contain the medication name, the dose, the route of administration, the frequency of administration, the medication status, the indication or diagnosis, and the date and time of the order.

2. On 09/25/19 at 11:00 AM, Investigator #5 and the Corporate Quality Director (Staff #509) reviewed the medical record for Patient #509 who was admitted on 08/26/19 for the treatment of Unspecified Psychosis and Stimulant Abuse. The review showed that on 08/30/19 at 2:30 PM, a provider ordered an intramuscular (IM) injection of "B52" (A drug cocktail named for "Benadryl", "5 mg haloperidol" and "2 mg of lorazepam", or consisting of 50 mg of an anticholinergic, either haloperidol or droperidol, plus 2 mg of a benzodiazepine) for either "agitation" or "if the patient refused (their other) medication by mouth".

Document review of the medication administration records showed "B52" handwritten in the "as needed" (PRN) order section. Investigator #5 found no evidence the provider clarified the order to determine the specific medications and medication doses the patient should receive.

3. At the time of the observation, Staff #509 stated that the provider should have clarified the order.

4. On 09/25/19 at 9:20 PM, Investigator #3 reviewed the medical record of Patient #306 who was admitted on 08/17/19 for the treatment of Unspecified Psychosis. The review showed that on 08/22/19 at 2:00 PM, a Registered Nurse wrote a telephone order for a provider to "Give B52 IM now". Investigator #3 found no evidence the provider order was clarified to determine the specific medications and medication dosages the patient should receive.

Item #6- Misbranding of Repackaged Medication

Reference:

21 US Code §352 Misbranded drugs and devices: A drug or device shall be deemed to be misbranded-(a) False or misleading label ...(g) Representations as recognized drug; packing and labeling; inconsistent requirements for designation of drug (i) Drug; misleading container; imitation; offer for sale under another name

WAC 246-873-080(5) (a) (5) Labeling: (a) Inpatient. All drug containers in the hospital shall be labeled clearly, legibly and adequately to show the drug's name (generic and/or trade) and strength when applicable. Accessory or cautionary statements and the expiration date shall be applied to containers as appropriate.

1. On 09/24/19 at 11:50 AM, Investigator #5 observed pharmacy re-packaged unit-dose medications containing both the generic and trade names of the product. Bulk bottles in the bins with the unit-dose medications showed generic medications. The observation showed:

a. Unit-dosed medication labeled as both Estradiol and Estrace 0.5 mg tablet. The corresponding bottle located with the medication contained the generic Estradiol.

b. Unit-dosed medication labeled as both Prazosin HCL and Minipress 1 mg capsule. The corresponding bottle located with the medication contained the generic Prazosin HCL.

c. Unit-dosed medication labeled as both Prazosin HCL and Minipress 1 mg capsule. The corresponding bottle located with the medication contained the generic Prazosin HCL.

d. Unit-dosed medication labeled as both Metoprolol Succinate and Toprol XL 50 mg tablet. The corresponding bottle located with the medication contained the generic Metoprolol Succinate.

2. At the time of the observation, Staff #503 stated that the hospital only purchased generic drugs and that it was easier for the nurses to have both the generic and a trade name. He stated that he was unaware that he could not use both the generic and the trade name when repackaging medications.
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Based on document review, interview, and review of hospital policies and procedures, the hospital failed to ensure pharmacy kept an accurate controlled substance inventory (Item #1), failed to follow its policies involving discrepancies in controlled substances accounting (Item #2), failed to develop and implement a policy and procedure to identify and ensure suspected staff diversion behaviors prompt necessary investigation and communication to assess patient risk (Item #3), and failed to ensure that two nurses completed a daily count of all patient home medication narcotics (Item #4).

Failure to account for and resolve discrepancies in controlled substances accountability risks medication errors and potential diversion for patients and staff jeopardizing patient's health and safety.

Findings included:

Item #1-Controlled Substance Inventory

1. Document review of the hospital's policy titled, "Controlled Substance Administration and Record Keeping," policy number 5253234, approved 10/18, showed that the Director of Nursing and the Pharmacy are responsible for complying with all state and federal regulations dealing with controlled substances. Medications listed in Schedules III, IV, V, and I are dispensed by the Pharmacy. The policy does not address accountability procedures to ensure control of the distribution, use, and disposition of all scheduled drugs stored in the Pharmacy.

2. On 09/26/19 at 10:15 AM, Investigator #5, a Pharmacist (Staff #510), the Community Liaison (Staff #511), and the Chief Nursing Officer (Staff #506) conducted a count of 4 random medications in the Scheduled Drug Inventory located in the hospital's main Pharmacy. The review showed 3 of 4 medications counted resulted in discrepancies as follows:

a. The Oxycodone 5 mg tablets (a narcotic pain medication) inventory showed that there should have been 270 tablets. A double count by the Pharmacist (Staff #510) and verified by Staff #511 showed 281 tablets, an excess of 11 tablets. Staff #510, #511, and the investigator reviewed the addition and subtraction for the entire Oxycodone log sheet and found no addition or subtraction discrepancies. Staff were unable to determine how the count was in excess of the amount documented in the log.

b. The Amphetamine 20 mg tablets (a controlled medication used to treat attention-deficit hyperactivity disorder (ADHD) and narcolepsy) showed there should have been 75 tablets. A double count by the Pharmacist (Staff #510) and verified by Staff #511 showed 74 tablets, leaving a deficit of 1 tablet. Staff #510, #511, and the investigator reviewed the addition and subtraction for the entire Amphetamine log sheet and found no addition or subtraction discrepancies. Staff were unable to determine the whereabouts of the missing tablet.

c. The Oxycodone 5 mg/ Acetaminophen 325 mg tablets (a narcotic pain reliever with acetaminophen) showed there should have been 45 tablets. A double count by the Pharmacist (Staff #510) and verified by Staff #511 showed 65 tablets, an excess of 20 tablets. Staff # 510, #511, and the investigator reviewed the addition and subtraction for the entire log sheet and found no addition or subtraction discrepancies. Staff were unable to determine how the count was in excess of amount documented in the log.

3. At 10:30 AM, the Director of Pharmacy (Staff #503) verified the discrepancies and stated that he was the only person to access, dispense, and return medications to the controlled medication cabinet. He stated he did not know why the counts were not correct unless he returned some controlled medications and forgot to enter it into the log.

Item #2-Controlled Substance Discrepancies

1. Document review of the hospital's policy titled, "Controlled Substance Administration and Record Keeping," policy number 5253234, approved 10/18, showed that a physical inventory of all controlled medications shall be conducted by two licensed nurses and documented on the inventory record. All controlled substances in Classes II-V shall be dispensed to the Pyxis Medication Station (Automated drug dispensing cabinet) via an inventory control record (count sheet). If a discrepancy is noted, the nurse will investigate the discrepancy. No nurse is to leave the premises if there is a narcotic discrepancy. If a discrepancy cannot be resolved, the nurse fills out a medication variance report and reports the discrepancy to the Directors of Nursing and Pharmacy for proper investigation. The Pharmacy will audit the inventory periodically during site inspection for accuracy and completeness.

2. On 09/23/19 at 11:30 AM, Investigator #5 and a Registered Nurse (RN) (Staff #512) inspected the medication room on an inpatient unit. Investigator #5 observed the Automated Drug Dispensing Cabinet showed 3 narcotic discrepancies including:

a. Methadone 10 mg 1 tablet occurring on 09/16/19 (7 days prior)

b. Lorazepam injectable 2 mg/ml occurring on 09/23/19 (1 day prior)

c. Lorazepam injectable 2 mg/ml occurring on 09/23/19 (1 day prior)

3. At the time of the observation, Staff #512 stated that the nurse responsible for the discrepancy is supposed to "fix" it.

Item #3-Drug Diversion Program

Reference:

WAC 246-873-080 (7) Controlled substance accountability. The director of pharmacy shall establish effective procedures and maintain adequate records regarding use and accountability of controlled substances, and such other drugs as appropriate, in compliance with state and federal laws and regulations.

1. On 09/25/19 at 2:00 PM, Investigator #5 and a Registered Nurse (RN) (Staff #514) inspected the medication room on an inpatient unit. During the inspection, Investigator #5 observed a Registered Nurse (RN) (Staff #513) remove half of a Hydromorphone 4 mg tablet (a narcotic pain reliever) for Patient #507 from the Patient-Owned Medication section of the Pyxis. Staff #513 failed to document the narcotic removal on the inventory sheet and left the room.

2. At the time of the observation, Staff #512 stated that the nurse was probably nervous with so many people in the room and should have documented the removal at the time.

3. At this time, further review of the narcotic inventory record showed 22 tablets but a count performed at 3:50 AM showed 22.5 tablets. A physical count performed at the time of the finding by Staff #514 showed only 21.5 tablets.

4. On 09/25/19 at 3:00 PM, the Pharmacy Director (Staff #503) and the Chief Nursing Officer (Staff #506) stated that the 3:50 AM count reflected an undocumented removal of a medication. They also stated that the form in use was flawed, as it did not have a space to write removals. Staff #503 stated that the RN had documented the 2:00 PM removal and the count was now correct.

5. On 09/26/19 at 11:00 AM, Investigator #5 interviewed the Director of Pharmacy (Staff #503) about the hospital's diversion control program. Staff #503 stated that the hospital did not have an official diversion control program or policy and that neither pharmacy nor nursing conducted audits of controlled substance administration to verify patients received their medications. During the interview, the Chief Nursing Officer (Staff #506) confirmed that the hospital did not conduct audits related to diversion control.

Item #4-Complete and Accurate Narcotic Counts

1. Document review of the hospital's policy titled, "Controlled Substance Administration and Record Keeping," policy number 5253234, approved 10/18, showed that a physical inventory of all controlled medications shall be conducted by two licensed nurses and is documented on the inventory record. All controlled substances in Classes II-V shall be dispensed to the Pyxis Medication Station (Automated drug dispensing cabinet) via an inventory control record (count sheet). If a discrepancy is noted, the nurse will investigate the discrepancy. No nurse is to leave the premises if there is a narcotic discrepancy. If a discrepancy cannot be resolved, the nurse fills out a medication variance report and reports the discrepancy to the Directors of Nursing and Pharmacy for proper investigation. The Pharmacy will audit the inventory periodically during site inspection to accuracy and completeness.

2. On 09/23/19 at 12:45 PM, during interview with Investigator #5, a Registered Nurse (Staff #505) stated that nursing staff are responsible to complete the narcotic counts for patient-owned medications each shift.

3. On 09/24/19 at 11:30 AM, Investigator #5 and a Registered Nurse (RN) (Staff #512) inspected the medication room on an inpatient unit. Investigator #5 reviewed the paper "Home Narcotic Log," for 3 narcotic medications brought to the hospital by 2 patients (Patient #507 and #511). The review showed:

a. The narcotic log for Patient # 507 for Klonopin 1 mg tablets (potentially habit-forming benzodiazepine used to treat seizures and anxiety) showed that narcotic inventory counts were missing for 5 of 9 shifts including:

-09/20/19 night shift

-09/21/19 day shift and night shift

-09/22/19 day shift

-09/24/19 day shift

b. The narcotic log for Patient # 507 for Hydromorphone 4 mg tablets (a narcotic pain reliever) showed that narcotic inventory counts were missing for 5 of 9 shifts including:

-09/20/19 night shift

-09/21/19 day shift and night shift

-09/22/19 night shift

-09/24/19 day shift

c. The narcotic log for Patient # 511 for Lorazepam 0.5 mg tablets (a benzodiazepines used to treat anxiety disorders) showed that narcotic inventory counts were missing for 22 of 29 shifts including:

-09/10/19 night shift

-09/11/19 day shift and night shift

-09/12/19 day shift and night shift

-09/13/19 day shift and night shift

-09/14/19 day shift and night shift

-09/15/19 day shift and night shift

-09/16/19 night shift

-09/17/19 day shift and night shift

-09/18/19 day shift and night shift

-09/19/19 night shift

-09/21/19 day shift and night shift

-09/22/19 day shift and night shift

-09/24/19 day shift

4. At the time of the review, Staff #512 verified the missing narcotic inventories and stated that the Registered Nurses were to conduct a narcotic count each shift.

5. At the time of the review, the investigator observed that the narcotic bottles were packaged in a clear plastic package with a security tape across the top.

At the time of the observation, Investigator #5 interviewed Staff #512 about the security of the medication packages. Staff #512 stated that the nurses accounted for the bottle on the narcotic count; they did not count the medication inside the bottle. Investigator #5 also asked the staff member how the nurse could be sure the package had not been tampered with or that the seal had not been broken and the bag replaced. Staff #512 stated that she did not know but that it had not been a problem.
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Based on observation, interview, and review of hospital policy and procedure, the hospital failed to ensure that a pharmacist verified patient-owned medications to identify and verify integrity of the medication for 9 of 9 patients with patient-owned medications (Patient #301, #302, #303, #304, #506, #507, #508, #509, and #510).

Failure to verify patient medication brought from home puts patients at risk of harm or death from medication errors.

Findings included:

1. Document review of the hospital's policy and procedure titled, "Administration of Own/Personal Medications," policy number 4890035, approved 05/18, showed that medications brought to the hospital by the patient will not be administered until a Pharmacist identifies the medication, verifies its integrity via visual inspection, and adds a label that includes the patient's name, one other identifier, and the patient location. The pharmacist will attach a supplemental label to the container to verify that the medication is approved for administration. During hours when the Pharmacy is closed, the attending physician, another responsible practitioner, or Nurse Supervisor may make the approval.

Document review of the hospital's policy and procedure titled, "Medical Staff Rules and Regulations," PolicyStatID # 5612049, approved 03/19, showed that the attending Physician may order a home medication to be used; however, it must be verified by the Pharmacy according to the hospital policy.

2. On 09/23/19 at 12:30 PM, Investigator #3 inspected the "Meadows" inpatient nursing unit medication room with the Director of Nursing (Staff #301). The observation showed the following non-verified patient-owned medications stored in the Pyxis (automated medication dispensing machine) cabinet:

a. Olanzapine ODT 20 mg tablets in a pharmacy blister package card with a non-hospital prescription label for Patient #301.

b. Fluphenazine 1 mg tablets in a non-hospital pharmacy blister package card with a prescription label for Patient #301.

c. Eliquis 5 mg tablets in a non-hospital pharmacy blister package card with a prescription label for Patient #301.

d. Fluphenazine 1 mg tablets in a bottle with a non-hospital prescription label for Patient #301.

e. Latuda 80 mg tablets in a bottle with a non-hospital prescription label for Patient #302.

f. Advair Diskus inhaler with a non-hospital prescription label for Patient #303

g. Proair HFA inhaler with a non-hospital prescription label for Patient #303.

3. On 09/23/19 at 1:00 PM, Investigator #3 interviewed a registered nurse (Staff #302) about patient-owned medications. Staff #302 stated that patient-owned medications could be administered if the provider writes an order authorizing their usage. Nursing or Pharmacy staff visually verified patient-owned medications and placed them in the Pyxis machine. Investigator #3 asked the nurse if they require any supplemental label or marking to document visual verification. Staff #302 stated that they didn't, but explained patient-owned medications may only be placed in the Pyxis storage cabinet if there has been a visual verification.

4. On 09/24/19 at 11:00 AM, Investigator #3 inspected the "Sunrise" inpatient nursing unit with Staff #301. The observation showed the following non-verified patient-owned medications stored in the Pyxis (automated medication dispensing machine) cabinet:

a. Atazanavir 30 mg capsules in a bottle with a non-hospital prescription label for Patient #304

b. Ritonavir 100mg tablets in a bottle with a non-hospital prescription label for Patient #304.

c. Emtricitabine 200 mg and Tenofovir 300mg tablets with a non-hospital prescription label for Patient #304.

5. On 09/24/19 at 11:20 AM, Investigator #5 and a Registered Nurse (RN) (Staff #505) inspected the Automated Medication Dispensing Cabinet located in the inpatient Cedar Unit. The observation showed 8 patient-owned medications belonging to 5 patients (Patient #506, #507, #508, #509, and #510) that did not contain a hospital pharmacy label or evidence of verification by a pharmacist prior to administration to the patient.
At the time of the observation, Investigator #5 asked Staff #505 to describe the hospital policy for verifying patient-owned medications. Staff #505 stated that she did not know.

6. On 09/24/19 at 11:58 AM, Investigator #5 interviewed the hospital's Director of Pharmacy (Staff #503) about pharmacy verification of patient-owned medications. Staff #503 stated that he checked every patient-owned medication. Investigator #5 asked Staff #503 about the unverified medications located on the Cedars Unit drug-dispensing machine. Staff #503 stated that he checked patient-owned medications but that it was a "work in progress" and that he was not "100% at checking."
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Based on observation, interview, and review of policy and procedure, the hospital failed to ensure that a registered pharmacist supervised the activities of the pharmacy technician during unit dosing of bulk medications in the main pharmacy.

Failure to provide Pharmacist oversight during the unit dosing process creates risk that patients will receive a medication error resulting in patient harm.

Findings included:

1. Document review of the hospital's policy titled, "Restocking the Automatic Dispensing Machine (ADM)," policy number 6219312, approved 07/19, showed that a Licensed Pharmacist or a Registered Technician working under the direct supervision of a Licensed Pharmacist will be responsible for restocking the ADM.

Document review of the hospital's policy titled, "Pharmaceutical Services," policy number 6659301, approved 08/19, showed that the Pharmacy is responsible for rendering services in accordance with local, state, and federal laws and regulations, hospital policies and procedures and accreditation standards.

2. On 09/24/19 at 11:50 AM, Investigator #5, the Director of Pharmacy (Staff #503) and a Pharmacy Technician (Staff #504) reviewed the Pharmacy's unit-dose packaging process. Investigator #5 reviewed the unit dose log and 4 bins containing medication repackaged by the pharmacy Technician from a bulk container to a unit dose package. Investigator #5 found no written evidence a Pharmacist had reviewed the medication after repackaging.

3. At the time of the review, during interview with Investigator #5, Staff #504 confirmed that a Pharmacist did not check the medications she repackaged prior to placing them back into the pharmacy stock bins. The Director of Pharmacy confirmed that prior to this date, the Pharmacist failed to check the repackaged medications, and failed to verify repackaged medication both in the Pharmacy and in the Automated Drug Dispensing Cabinets.

4. Further discussion regarding the Automated Drug Dispensing Machine cart fills showed that a Pharmacist did not supervise the Pharmacy Technician during the medication pull and cart fill process.

5. At the time of the finding, during interview with Investigator #5, Staff #504 confirmed that a Pharmacist did not check the medications needed for cart fill. The Director of Pharmacy confirmed that he did not supervise the Technician during this process. He stated that checks were only performed for the narcotics.
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Based on observation and interview, the hospital failed to ensure that staff labeled patient inhalers with the beyond use date after removing the medication from the foil packaging, as directed by the manufacturer for 3 of 3 inhaled medications observed.

Failure to ensure that staff label inhaled medications with an expiration date risks that expired medications are available for patient administration and creates a risk of harm to the patient.

References:

GlaxoSmithKline, Advair HFA package insert, 01/09: Safely discard ADVAIR HFA 12 months after you remove it from the foil pouch, or after the dose indicator reads "0," whichever comes first.

GlaxoSmithKline, Ventolin HFA (Albuterol Sulfate Inhalation Aerosol) package insert, 2017: Throw the inhaler away when the counter reads 000 or 12 months after you opened the foil pouch, whichever comes first.

Findings included:

1. On 09/24/19 at 11:20 AM, Investigator #5 and a Registered Nurse (Staff #505) inspected the patient-owned medication section of the automated drug dispensing cabinet. The observation showed 2 opened albuterol inhalers and 1 opened Advair inhaler that did not contain the beyond use date (BUD) as directed on the drug labels.

2. At the time of the observation, Staff #505 verified the finding and stated that nursing is responsible to put a date on the inhalers when opened.
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Based on observation, interview and document review, the hospital failed to ensure the dietary department enacted policies and procedures for dietary practice (Item #1) and failed to ensure that dietary staff maintained compliance with the Washington State Retail Food Code (Washington Administrative Code (WAC) 246-215) (Item #2).

Failure to ensure that the dietary department has policies and procedures in place to maintain quality in their dietary practice and failure to ensure that staff comply with the Washington State Retail Food Code puts patients, visitors and staff at risk from food-borne illness and puts patients at risk of harm from substandard nutrition.

Findings included:

Item #1- Policies and Procedures

On 09/24/19 at 9:50 AM, Investigator #4 interviewed the Dietary Manager (Staff #406) about policies and procedures available to staff in the department. Staff #406 stated that she did not have current policies and procedures for the dietary department, despite having requested them from the hospital's corporate office. She also stated that she received menus from another hospital in the corporation's system, as none were developed by the previous dietary manager.

Item #2- Safe Food Handling

1. Document review of the hospital's policy titled,"Dietary Services- Health and Hygiene Standards," last reviewed 09/19 showed that employees shall thoroughly wash hands and the exposed portions of their arms with soap and warm water during work, as often as necessary to keep them clean.

2. On 09/24/19 at 10:15 AM, Investigator #4 observed a member of the dietary staff (Staff #408) as he carried out multiple tasks in the kitchen, including food preparation and stocking of incoming products. The observation showed that the staff member failed to change gloves and perform hand hygiene between tasks.

Reference: WAC 246-215-02310 (6)

3. On 09/24/19 at 10:00 AM, Investigator #4 toured the hospital kitchen. While inspecting the walk-in refrigerator, the investigator observed several cooked items including turkey filets and meat chili. The observation showed that the cooked items were in the walk-in refrigerator cooling in pans greater than 2 inches deep.

4. At the time of the observation, the investigator asked Staff #406 if she had a cooling log to document that the items cooling in the pans had reached an internal temperature of 41 degrees Fahrenheit or less within six hours of placement in the walk-in, since the items were in pans of greater than two inches of depth. Staff #406 stated that she did not maintain a cooling log for the items.

Reference: WAC 246-215-03515

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Based on interview, the hospital failed to provide a current therapeutic diet manual to clinical and food service staff that had been approved by the dietician and physicians.

Failure to provide a current therapeutic diet manual to staff in order to guide patient nutritional services puts patients at risk of harm from improper or substandard diets.

Findings included:

On 09/24/19 at 10:00 AM, Investigator #4 interviewed the Dietary Manager (Staff #406) and requested to see the current therapeutic diet manual. Staff #406 stated she did not have a therapeutic diet manual for the hospital and had received patient menus from another hospital in the hospital's corporate system.

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Based on interview, document review, and review of hospital policy and procedures, the hospital failed to develop and implement a utilization review plan for services provided to hospital patients.

Failure to develop and implement a plan for review of care provided to patients limits the hospital's ability to improve healthcare services and risks poor patient outcomes.

Findings included:

Interview, record review, and review of hospital policies and procedures showed the following:

1. Failure to ensure that the Utilization Review Committee membership included at least 2 physicians.

Cross Reference: A0654

2. Failure to ensure that the Utilization Review Plan addressed review of outlier cases based on extended length of stay and professional services review.

Cross Reference: A0655

3. Failure to notify patients in writing when the hospital determined the patient did not meet medical necessity.

Cross Reference: A0656

4. Failure to review extended stays as defined in CFR: 412.80 (a) (1) (i).

Cross Reference: A0657

5. Failure to review professional services as required by 42 CFR 482.30(f).

Cross Reference: A0658

Due to the scope of the deficiencies cited under 42 CFR 482.30, the Condition of Participation for Utilization Review was NOT MET.
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Based on interview, document review, review of Utilization Review Committee Minutes, and review of the hospital's Utilization Review (UR) Committee Program, the hospital failed to ensure that at least 2 members of the committee were Doctors of Medicine or Osteopathy.

Failure to ensure that the Utilization Review Committee membership includes appropriate physician membership limits the hospital's ability to determine if medical services are effective and necessary, improve healthcare services, and risks poor patient outcomes.

Findings included:

1. Document review of the hospital's policy titled, "Utilization Management Plan," policy number 5253241, reviewed 09/18, showed that the Medical Staff shall serve as an advisor to the Utilization Management Department and shall be available to assist the Assessment Department in reviewing those cases which do not meet criterion for danger to self, danger to others or grave disability. The policy did not address committee or medical staff membership.

2. On 09/30/19 at 10:30 AM, Investigator #5 and the Director of Utilization review (Staff #501) reviewed the hospital's Utilization Review Committee program and the Utilization Review Committee Minutes.

a. Document review of the Utilization Review Committee minutes showed the committee had only met twice, once on 10/16/18 to discuss data for the time span of 10/01/18-10/16/18, and then on 01/22/19 to review data for 4th Quarter 2018 admissions data and the 12/18 monthly report. Investigator #5 found no evidence the committee met to review 2019 data.

b. Review of the UR Committee minutes dated 10/16/18 showed one medical doctor in attendance (Staff #502).

c. Review of the UR Committee minutes dated 01/22/19 showed no medical doctor in attendance.

3. At the time of the review, Investigator #5 interviewed Staff #501 about the UR Committee. Staff #501 verified that the hospital utilized its own UR Committee and stated that there was only one medical doctor on the committee. She stated that she was unaware of the requirement for 2 medical doctors. Investigator #5 asked Staff #501 about the lack of committee meetings for UR data between 01/19 and 09/19 (9 months). Staff #501 stated that it was difficult to meet because the medical doctor on the committee was a tele medicine doctor and did not attend meetings as often as would be beneficial. She also stated that the UR committee was not a functioning committee and the hospital recently changed to have the meeting at the same time as quality to try to increase attendance.

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Based on interview, document review, and review of the hospital's Utilization Review (UR) Program, the hospital failed to ensure its UR policies and procedures addressed review of outlier cases based on extended length of stay and professional services review.

Failure to ensure that the Utilization Review policy addresses review of outlier cases based on extended length of stay or professional services limits the hospital's ability to determine if medical services are effective and necessary, improve healthcare services, and risks poor patient outcomes.

Findings included:

1. Document review of the hospital's policy titled, "Utilization Management Plan," policy number 5253241, reviewed 09/18, showed that the policy did not address review for Medicare and Medicaid patients with respect to the medical necessity of professional services furnished including drugs and biologicals. The policy did not define criteria for outlier cases based on extended length of stay or professional services.

2. On 09/30/19 at 10:30 AM, Investigator #5 and the Director of Utilization review (Staff #501) reviewed the hospital's Utilization Review Committee program and the hospital's UR Plan. The Director of Utilization Review (Staff #501) confirmed that the plan did not include a review of professional services. She stated that she was unaware of this requirement. Staff #501 confirmed the hospital's plan did not list criteria for or define outlier cases based on extended length of stay or professional services. Staff #501 stated that cases were not reviewed based on these outliers.
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Based on interview, document review, and review of the hospital's Utilization Review (UR) Program, the hospital failed to provide written notification to patients who it determined did not meet medical necessity for 5 of 5 patients reviewed (Patient #501, #502, #503, #504, and #505).

Failure to notify patients in writing when the hospital determines the patient does not meet medical necessity risks poor patient outcomes.

Findings included:

1. Document review of the hospital's policy titled, "Utilization Management Plan," policy number 5253241, reviewed 09/18, showed that it failed to address the need to notify patients no later than 2 days after the determination of denial of services.

2. On 09/30/19 at 10:30 AM, Investigator #5 and the Director of Utilization review (Staff #501) reviewed the hospital's Utilization Review Committee program,the Utilization Review Committee Meeting Minutes and then reviewed the medical records for 5 patients that the utilization review staff determined did not meet medical necessity for admission (Patient #501, #502, #503, #504, and #505). The review showed the following:

a. Patient #501 was admitted on 08/04/19 for treatment of Bipolar Disorder and Self-Harm. At the time of admission, the hospital's utilization review staff determined the patient did not meet admission criteria. Investigator #5 found no evidence the patient received written notification of the denial.

b. Patient #502 was admitted on 08/26/19 for the treatment of Psychosis, Major Depressive Disorder, and Opioid Use Disorder. At the time of admission, the hospital's utilization review staff determined the patient did not meet admission criteria. Investigator #5 found no evidence the patient received written notification of the denial.

c. Patient #503 was admitted on 04/14/19 for the treatment of Suicidal Ideation, Major Depressive Disorder, and Personality Disorder. At the time of admission, the hospital's utilization review staff determined the patient did not meet admission criteria. Investigator #5 found no evidence the patient received written notification of the denial.

d. Patient #504 was admitted on 05/10/19 for the treatment of Anxiety Skills. At the time of admission, the hospital's utilization review staff determined the patient did not meet admission criteria. Investigator #5 found no evidence the patient received written notification of the denial.

e. Patient #505 was admitted on 08/23/19 for the treatment of Alcohol Dependence and Alcohol Withdrawal. At the time of admission, the hospital's utilization review staff determined the patient did not meet admission criteria. Investigator #5 found no evidence the patient received written notification of the denial.

3. At the time of the review, the Director of Utilization Review confirmed the finding and stated that she was unaware of the requirement to provide the patient written notice of denial.

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Based on interview and document review, the hospital failed to review extended stays as part of the Utilization Review program.

Failure to review extended stays limits the hospital's ability to improve healthcare services.

Reference:

CFR: 412.80 (a) (1) (i)
(a) Basic rule - (1) Discharges occurring on or after October 1, 1994 and before October 1, 1997. For discharges occurring on or after October 1, 1994, and before October 1, 1997, except as provided in paragraph (b) of this section concerning transferring hospitals, CMS provides for additional payment, beyond standard DRG payments, to a hospital for covered inpatient hospital services furnished to a Medicare beneficiary if either of the following conditions is met: (i) The beneficiary's length-of-stay (including days at the SNF level of care if a SNF bed is not available in the area) exceeds the mean length-of-stay for the applicable DRG by the lesser of the following: (A) A fixed number of days, as specified by CMS; or (B) A fixed number of standard deviations, as specified by CMS.

Findings included:

1. Document review of the hospital's policy titled, "Utilization Management Plan," policy number 5253241, reviewed 09/18, showed that the policy did not define criteria for outlier cases that met the definition defined in CFR: 412.80 (a)(1)(i) or require review.

2. On 09/30/19 at 10:30 AM, Investigator #5 and the Director of Utilization review (Staff #501) reviewed the hospital's Utilization Review Committee program, and the Utilizations Review Committee Minutes. Investigator #5 found no evidence of extended stay review based on requirements defined in CFR: 412.80 (a) (1) (i).

3. At the time of the observation, the Director of Utilization Review (Staff #501) verified that the hospital's policy did not address extended stay review. She stated the hospital reviewed under-utilization and over-utilization based on insurance authorized days but not on extended stays based on Diagnosis Related Group (DRG).

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Based on interview and document review, the hospital failed to review professional services as part of the Utilization Review program.

Failure to review professional services limits the hospital's ability to determine if services provided are medically necessary and effective.

Findings included:

1. Document review of the hospital's policy titled, "Utilization Management Plan," policy number 5253241, reviewed 09/18, showed that the policy did not address professional services review based on the definition of review and evaluation of professional services as required by 42 CFR 482.30(f).

2. On 09/30/19 at 10:30 AM, Investigator #5 and the Director of Utilization review (Staff #501) reviewed the hospital's Utilization Review Committee program and the Utilization Review Committee Minutes. Investigator #5 found no evidence of professional service review.

3. At the time of the observation, the Director of Utilization Review (Staff #501) verified that the hospital's policy did not address professional service review. She stated that the UR committee had only 1 physician member who was a tele-medicine provider and who did not attend meetings as often as would be beneficial. She stated she was unaware of the professional service review requirement or that a physician cannot review his own services.
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Based on interview and document review, the hospital failed to complete an infection control risk assessment for construction prior to beginning a construction project in a patient care area (Item #1), and failed to complete its process for prevention of infection following an employee's exposure to blood-borne pathogens (Item #2).

Failure to assess infection risk to patients prior to beginning construction, and failure to assess and treat employee exposure to blood-borne pathogens puts patients, staff and visitors at risk for harm from infectious diseases.

Findings included:

Item #1- Construction Risk Assessment

1. Document review of the hospital policy titled, "Orientation Outside Personnel", no review date, showed that prior to construction in patient care areas, there should be discussion and planning for infection control concerns. It also showed that the planning should include plant operations and infection control.

2. On 09/30/19 at 1:30 PM, Investigator #3 and Investigator #4 interviewed the Infection Control Practitioner (Staff #403) and the Facilities Manager (Staff #404) about construction projects completed since the facility's opening. Staff #404 stated that there was one project from January 2019, to repair a cabinet and wall space from a leaking juice machine. The staff members stated that the area was closed off to patients, but they did not complete an infection control risk assessment as part of the construction project.

Item #2- Occupational Exposure to Blood-Borne Pathogens

1. Document review of hospital's policy and procedure titled, "Blood Borne Pathogen Exposure Control," PolicyStatID # 5128449, last revised 08/19, showed that following an exposure, the employee should complete an incident report and notify their supervisor. The supervisor will notify Human Resources and the Employee Health Nurse. The employee will be referred to the preferred provider clinic for appropriate treatment.

2. On 09/30/19 at 1:10 PM, Investigator #3 reviewed the employee records of three hospital staff who had a needle stick/blood borne pathogen exposure incident. A review of Staff #305's employee safety incident form showed the following items were left blank and not acknowledged on the report:

a. Was the employee examined by a physician
b. Examination Refused
c. Treatment Refused
d. Injury Status
e. Disposition
e. Is follow-up treatment indicated?
f. Signature of EHS

3. At the time of the review, Investigator #3 interviewed the Director Of Nursing (Staff #301) about the missing responses on the form. Staff #301 stated that the staff member had refused further treatment but acknowledged the report was not complete.

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Based on interview, document review, and review of hospital policies and procedures, the hospital failed to ensure that Therapists were designated as qualified personnel for discharge planning responsibilities.

Failure to designate which personnel are qualified to perform discharge planning risks patients receiving inadequate or unsafe discharge plans.

Findings included:

1. Document review of the hospital policy and procedure titled, "Discharge and Transition Planning -IP, PHP, IOP, OP," PolicyStat ID # 5586156, last revised 03/19, showed that the hospital engages in ongoing transition planning at the start of services, throughout the course of treatment, and at the time of discharge. Transition planning is documented by use of the Discharge Planning Form. The treating therapist will be responsible for completing the form in its entirety.

Document review of the hospital's job description titled, "Therapist," failed to include any elements of discharge planning as part of the position's job performance standards and responsibilities.

2. On 09/27/19 at 10:30 AM, Investigator #3 interviewed the Director of Clinical Services (Staff #304) about the discharge planning process. Staff #304 stated that approximately two weeks ago, the hospital stopped using their two designated discharge planners. The hospital reassigned those duties to the therapy staff. Staff #304 also stated that the Therapists are primarily responsible for the development and implementation of the discharge plan.

The investigator asked Staff #304 to review the current Therapist job description and identify the discharge planning activities. Staff #304 confirmed there was no specific mention of discharge planning responsibilities in the current Therapist job description.

The investigator also asked Staff #304 to review the hospital's current Therapist disclosure statement that lists the licensed therapists and certified counselors on staff. Seven of the twelve individuals identified as having primary responsibilities for supporting the hospital's three inpatient nursing units did not have a license, certification, or education background in social work consistent with training in discharge planning.

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Based on document review and interview, the hospital failed to develop and implement a process for collaboration with outside agencies as part of their disaster preparedness program.

Failure to collaborate with outside agencies, including Federal, State, Regional, Local and Tribal entities puts patients, staff and visitors at risk of harm from inadequate preparation and response in the event of an emergency.

Findings included:

1. Document review of the hospital's 2019 Emergency Plan showed no contact list for outside agencies, including Federal, State, Regional, Local and Tribal entities that would be included as part of the facility's emergency response.

2. On 09/25/19 between 10:10 AM and 11:10 AM, Investigator #4 reviewed the facility's Emergency Preparedness Program with the Facility Manager (Staff #404) and the Environment of Care Director for the hospital's Corporation (Staff #405). The staff members stated that they did not have a current contact list for outside entities.
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Based on document review and interview, the hospital failed to develop and implement a means of sharing patient information and medical documentation with other health providers for patient's under the hospital's care as a means of maintaining continuity of care in the event of an emergency.

Failure to provide a means of sharing patient information and medical documentation during emergency events puts patients at risk of harm from fragmented and inadequate care.

Findings included:

1. Document review of the hospital's 2019 Emergency Plan showed no documentation that included a means of sharing patient information and medical documentation with other health providers in the event of an emergency that involved either patient evacuation or shelter-in-place.

2. On 09/25/19 between 10:10 AM and 11:10 AM, Investigator #4 reviewed the facility's Emergency Preparedness Program with the Facility Manager (Staff #404) and the Environment of Care Director for the hospital's Corporation (Staff #405). The staff members confirmed that the plan did not provide a process for sharing of patient information.
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Based on document review and interview, the hospital failed to develop a means to provide information about the facility's occupancy needs and ability to provide assistance to the authority having jurisdiction, the Incident Command Center or designee.

Failure to provide information to the designated authorities about occupancy and emergency needs with identified shortages, in the event of a disaster or other emergency, puts patients and others at risk of harm from inadequate care and provision shortages in the facility.

Findings included:

1. Document review of the hospital's 2019 Emergency Plan showed no documentation that included a means of providing information about the hospital's occupancy and ability to provide assistance to the authority having jurisdiction, the Incident Command Center or designee.

2. On 09/25/19 between 10:10 AM and 11:10 AM, Investigator #4 reviewed the facility's Emergency Preparedness Program with the Facility Manager (Staff #404) and the Environment of Care Director for the hospital's Corporation (Staff #405). The staff members confirmed that the plan did not provide a process to share occupancy needs to the appropriate jurisdiction during a disaster event.
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