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Based on the manner and degree of the standard level deficiencies referenced to the Condition, it was determined the Condition of Participation §482.13, PATIENT RIGHTS, was out of compliance.

A-0117 A hospital must inform each patient, or when appropriate, the patient's representative (as allowed under State law), of the patient's rights, in advance of furnishing or discontinuing patient care whenever possible. Based on interviews and document review, the facility failed to ensure patients were advised of their legal status and accompanying rights regarding continued treatment. Specifically, the facility failed to ensure patients were advised of their right to voluntary admission for continued treatment or the need for a short-term certification for involuntary treatment, once the patients' 72-Hour involuntary mental health (M-1) holds expired. This affected two of three patients (#13 and #14) whose records were reviewed.

A-0143 The patient has the right to personal privacy. Based on interviews and document review, the facility failed to ensure the personal privacy of patients quarantined on a designated cohort unit for COVID-19, a highly infectious disease. This affected four of four patients (Patients #1, #2, #3 and #4) in shared rooms on the cohort unit.

Based on the manner and degree of standard level deficiencies referenced to the Condition, it was determined the Condition of Participation §482.23 NURSING SERVICES was out of compliance.

A-0395 A registered nurse must supervise and evaluate the nursing care for each patient. Based on document reviews and interviews, the facility failed to supervise nursing care for patients on the inpatient psychiatric unit and the outpatient partial hospitalization program (PHP) as expected per policy and/or as ordered. Specifically, record review revealed the facility failed to maintain observation rounds on patients per provider orders and/or policy, failed to obtain provider orders to alter observation frequency, and failed to supervise the care of patients in the PHP. This affected six (#10, #17, #3, #11, #22 and #23) of eight patients whose records were reviewed.

A-0398 All licensed nurses who provide services in the hospital must adhere to the policies and procedures of the hospital. The director of nursing service must provide for the adequate supervision and evaluation of all nursing personnel which occur within the responsibility of the nursing service, regardless of the mechanism through which those personnel are providing services (that is, hospital employee, contract, lease, other agreement, or volunteer). Based on document review and interviews, the facility failed to ensure agency staff working at the facility met the qualifications and expectations of facility nursing staff. Specifically, the facility failed to verify agency personnel were trained in The Non-Violent Crisis Prevention Intervention (CPI) Plan outlined in the facility policy.

Based on the nature of the standard level deficiency referenced to the Condition, it was determined the Condition of Participation §482.42, INFECTION CONTROL, was out of compliance.

A-0749 The hospital infection prevention and control program, as documented in its policies and procedures, employs methods for preventing and controlling the transmission of infections within the hospital and between the hospital and other institutions and settings. Based on observation and interviews, the facility failed to have procedures in place to prevent and control the spread of infection within the hospital when staff responded to emergencies on and off the isolation unit designated for patients suspected of having Coronavirus (COVID-19), a highly infectious disease.

A- 0750 The infection prevention and control program includes surveillance, prevention, and control of HAIs, including maintaining a clean and sanitary environment to avoid sources and transmission of infection, and addresses any infection control issues identified by public health authorities. Based on observations, video, document review, and interviews, the facility failed to follow infection control standards, facility policy and directives from the local public health department (LPHD) to prevent possible transmission of the infectious disease, COVID-19. Specifically, the facility failed to test, cohort, quarantine, surveil, and properly care for patients suspected of exposure to COVID-19, following the discovery of staff testing positive for the virus.

Observations, interviews and document review, which included video review, conducted from 9/21/20 through 9/28/20 revealed, although the facility attempted to create a designated COVID-19 patient care unit, staff were not provided Center for Disease Control (CDC) recommended personal protective equipment (PPE), patients were not quarantined to their rooms, staff were not cohorted to the same shifts, units, and patients, and signs on the designated COVID-19 unit to advise staff of the recommended PPE for the unit were not posted. In addition, the facility staff failed to enforce social distancing and prevent co-mingling of exposed and non-exposed patients. Further, the facility continued to admit new patients and placed them in the COVID-19 unit, even though the new patients had not been exposed and had not received positive test results for COVID-19.

The local public health department (LPHD) notified the facility on 9/18/20, a registered nurse (RN #3) reported symptoms which met clinical criteria for a probable case of COVID-19, given her exposure. Because she was a probable case, RN #3 was issued isolation orders through 9/27/20 and instructed not to work until 9/28/20. Interviews and documentation review revealed the RN worked on 9/19/20 and 9/21/20 in multiple patient care areas in direct violation of the isolation orders she received.

Finally, observations revealed the infection control RN provided non-medical face masks to staff who were providing direct patient care, failed to ensure patients exposed to COVID-19 received follow-up instructions at discharge, and failed to ensure staff had processes and training in responding to emergency situations on the isolation unit. (Cross-reference A0749)

The facility's multiple failures created the likelihood, if not immediately corrected, of serious harm affecting all facility patients.

Based on interviews and document review, the governing body failed to ensure the medical staff operated according to the facility's approved bylaws, rules and policies. Specifically, the facility failed to ensure inpatients were not admitted to the hospital under the order of a mid-level provider (nurse practitioner).

This affected three patients (Patient #1, #8, and #19) out of 21 patients whose inpatient records were reviewed.

Findings include:

Facility policy:

The facility's 2020 Medical Staff Bylaws, Rules, and Regulations (Med Staff Bylaws) defined clinical privileges as the specific permission granted to practitioners by the Board based on specific standards, to include patient care. A practitioner shall be entitled to exercise only those clinical privileges specifically granted by the Board. Nurse Practitioners (NPs) and Physician Assistants (PAs) may, under a collaborative practice agreement, serve under the supervision of a physician member of the Medical Staff but they are not allowed to admit or discharge patients. Active medical staff physicians have the primary duties and responsibilities for patient care, including admission and discharge of patients.

The policy, Pre-Admission Screening, applies to all Admissions Department staff and/or all other personnel performing functions relative to this process. The purpose of the policy was to ensure all assessments were appropriately processed for admission or assessed for an appropriate determination for level of care. According to the policy, a clinical assessment of a potential patient is completed by an admissions assessor. If admission criteria appear to be met, the assessor will proceed with consulting with the on call psychiatric provider.

The policy, Admission of Patient, reads, patients will be admitted to any level of care in the continuum only on the order of a physician with admitting privileges.

1. The governing board failed to ensure inpatients were admitted only under the order of an active physician according to approved bylaws, rules and policies.

Interviews and record reviews conducted identified evidence NPs were independently placing inpatient orders to admit and discharge patients.

Interviews

a. On 9/23/20 at 3:08 p.m., an interview was conducted with a psychiatric mental health nurse practitioner (NP #6). NP #6 stated NPs were allowed to admit inpatients independently under their own order, and would not require involvement or oversight from an active psychiatrist. NP #6 admitting orders placed by the NPs would also include inpatient admitting medications and providing verbal phone orders for staff to admit patients as well.

The interview conflicted with the governing board's approved medical staff bylaws, rules and policies.

b. On 9/27/29 at 10:54 a.m. an interview was conducted with the chief executive officer (CEO #1) who also served as a governing board member for the facility. CEO #1 stated she was aware NPs were admitting inpatients to the hospital, but was unaware the Medical Staff Bylaws stated only active physicians could place orders to admit patients.

CEO#1 stated the governing body was responsible to ensure facility bylaws were followed, and that all providers were expected to comply with the documents as approved. However, CEO #1 was unable to provide evidence that system-wide processes were implemented to ensure patients were admitted by physician-level practitioners as outlined in the facility's policies and Medical Staff Bylaws.

Medical Records

Review of medical records revealed evidence mid-level providers were admitting patients under the order of the NPs.

c. Review of Patient #1's medical record found the patient was ordered voluntary admission to the hospital on 9/18/20 at 8:30 p.m. under the order of the nurse practitioner (NP #24). The order was entered as a telephone order by the registered nurse, and then electronically signed by NP #24 on 9/19/20 at 12:27 p.m.

d. Review of Patient #8's medical record revealed on 9/7/20 at 6:00 p.m., the patient was ordered involuntary admission to the hospital by NP #6. The order was entered as a telephone order by the registered nurse, and then electronically signed by NP #6 on 9/8/20 at 7:59 a.m.

e. Review of Patient #19's medical record revealed the patient was admitted under the order of NP #6 on 9/19/20 at 8:10 p.m. This order was entered as a telephone order by the registered nurse, and then electronically signed by NP #6 on 9/21/20 at 9:58 a.m.

Review of the medical records for Patients #1, #8, and #19 also found no evidence the intake staff of the Admissions Department consulted with a psychiatrist prior to receiving orders to admit patients. According to the Initial record, the NPs providing the admission orders also were providing the sole psychiatric consultation prior to admitting patients.

Based on interviews and document review, the facility failed to ensure patients were advised of their legal status and accompanying rights regarding continued treatment. Specifically, the facility failed to ensure patients were advised of their right to voluntary admission for continued treatment or the need for a short-term certification for involuntary treatment, once the patients' 72-Hour involuntary mental health (M-1) holds expired.

This failure was identified in two of three medical records reviewed for patients who admitted to the facility under a M-1 hold and subsequently had a second M-1 hold initiated at the facility (Patients #13 and #14).

Findings include:

Facility policies:

The 72-Hour Hold policy read, Purpose: To provide guidelines to ensure compliance with the legal requirements in the event a patient requires a 72-Hour Hold for evaluation and treatment. A patient meets the criteria for a 72-Hour Hold if he or she is considered to be, because of mental illness, an imminent danger to self or others or gravely disabled. If hospitalization is indicated but involuntary hold criteria are not present, the physician must write an order for the patient to sign voluntary admission forms or be discharged.

At the end of the 72-Hour Hold, one of the following must occur: Patient released, patient referred for further treatment on a voluntary basis (patient signs Request for Voluntary Admission and Authorization for Treatment Form), or patient certified for not more than three months of short-term treatment pursuant to CRS 27-10-107.

The Short Term Certification policy read, an individual who is detained for 72-hour evaluation and treatment may be certified for short-term treatment. Prior to the expiration of the 72-hour period, certification for short-term treatment must be filed.

In order to provide involuntary treatment to a mentally ill person who meets legal criteria, the rules and regulations of CRS 27-65 allow a physician to certify the patient for short-term involuntary treatment. Criteria must be met including: The physician had analyzed the person's condition and found the person is, as a result of mental illness, a danger to others or self, or gravely disabled; the individual had been advised of the availability of but has not accepted voluntary treatment.

The Admissions Patient Rights and Organization Ethics policy read, patients have the right to voluntary consents or to refuse to consent to admission to the facility. Only the administrator or the patient's physician may commit a patient to the hospital and only if they meet criteria for involuntary commitment.

1. The facility failed to ensure patients were advised of their legal status, either their right to voluntary admission for continued treatment or the need for a short-term certification for involuntary treatment, once the patients' 72-Hour involuntary mental health (M-1) holds expired.

A. Interviews

Interviews with staff revealed facility policy required one of three actions to occur when a patient's M-1 hold expired: to discharge the patient, to admit the patient for voluntary treatment, or to initiate a short-term certification for involuntary treatment. Interviews further revealed a second M-1 hold could not be initiated, as this would not be in alignment with facility policies and procedures and patient rights.

1. On 9/23/20 at 12:45 p.m., Court Liaison (Liaison) #22 was interviewed. Liaison #22 stated she assisted the provider to complete legal documents, including short-term certifications for involuntary treatment and voluntary admissions for treatment. She stated she was responsible to notify patients of their legal status with regard to continued treatment, to obtain signatures on legal documents, and to ensure patients understood the terms of voluntary admission if the patient consented to voluntary treatment.

Liaison #22 stated if a patient needed a short-term certification for continued involuntary treatment, she and the provider would initiate the certification on the same day the M-1 hold expired. She stated only a physician was able to initiate a short-term certification, and stated that typically, the psychiatrist at the facility was responsible to initiate the certification. Liaison #22 stated a short-term certification was initiated if a patient remained a danger to self or others, or remained gravely disabled.

Liaison #22 stated most patients admitted to the facility with an M-1 hold in place. She stated she would monitor a patient's legal status so she knew when the hold would expire. Liaison #22 stated when a patient's hold was close to expiring, the provider and treatment team were responsible for determining whether the patient would be offered voluntary admission, would discharge from the facility, or would require a short-term certification. She stated if the provider felt a patient was able to understand their rights and the concept of voluntary treatment, then the patient would be offered the opportunity to consent to voluntary treatment. Liaison #22 stated if the patient was not able to make this decision or remained at risk to self or others, the provider would initiate the short-term certification.

Liaison #22 stated when she assisted a patient who chose to consent to voluntary treatment, she would have the patient sign a document to verify the patient understood their rights. She stated she was responsible to ensure patients understood their rights when they consented to voluntary treatment.

Liaison #22 stated it was not standard practice at the facility to initiate consecutive M-1 holds for a patient, and stated facility staff avoided initiating multiple M-1 holds in a single admission.

2. On 9/22/20 at 4:45 p.m., Director of Clinical Services (Director) #16 was interviewed. Director #16 stated she regularly was assigned to oversee the initiation of M-1 holds for patients hospitalized at the facility. She stated the treatment team assessed a patient to determine whether the patient met criteria for involuntary treatment, which included suicidal ideation, homicidal ideation, and grave disability. She stated a patient who was gravely disabled could be out of contact with reality, hallucinating, experiencing intense delusions, or unable to care for themselves.

Director #16 stated the physician determined whether a patient met the criteria for initiation of a short-term certification. She stated when a short-term certification was warranted, paperwork would be completed and sent to the courts for approval. Director #16 stated Liaison #22 would notify the patient if a short-term certification was initiated. She stated a short-term certification was initiated if the patient's M-1 hold expired and the patient remained a risk to themselves or others, or if the patient remained gravely disabled.

Director #16 stated a short-term certification could not be initiated on a weekend as the courts were closed. She stated for this reason, it was important to monitor a patient's legal disposition well before a patient's M-1 hold expired. She stated if facility staff were aware a patient's M-1 hold would expire on a weekend, and the physician did not plan to discharge the patient, the physician needed to prepare for either voluntary admission of the patient or the initiation of a short-term certification prior to the weekend.

B. Document Review

Review of medical records for Patients #13 and #14 revealed both patients admitted to the facility on M-1 holds. There was no evidence in the medical records that Patient #13 or Patient #14 consented to continued voluntary treatment or were certified for short-term involuntary treatment when the M-1 holds expired as required.

1. Patient #13's medical record was reviewed. On 8/19/20 an Emergency Mental Illness Report and Application (M-1) hold was initiated at an outside facility prior to Patient #13's admission. The M-1 hold read Patient #13 was gravely disabled.

a. On 8/20/20 at 4:49 a.m., Physician #23 entered an order which read, admit to involuntary. Physician #23 placed an additional order which read Patient #13's M-1 hold would expire on Saturday, 8/22/20.

b. On 8/21/20 Physician #23 completed an Advisement to Person on 72-Hour Hold for Evaluation or Certified for Treatment which read, if at any time during the 72-hour evaluation or treatment the provider requested the person to sign in voluntarily and he elected to do so, the following advisement was given orally and in writing.

i. On the same day, the Consent to Admission and Medical Treatment and the Rights of Patients document were partially completed. Patient #13's name and the date were entered on the documents; however the documents were not signed by the patient or by a facility staff member.

ii. On the same day at 4:03 p.m., Liaison #22 entered a Communication Log note. Liaison #22 documented she was unable to get intake consents signed by Patient #13 because the patient was nonsensical and disoriented. Liaison #22 documented the patient made bizarre statements and was off topic, and she was unable to have a conversation with the patient.

c. On Monday, 8/24/20 at 11:30 a.m., a second M-1 Hold was completed by Nurse Practitioner (NP) #6. The M-1 Hold read Patient #13 continued to be gravely disabled as manifested by his lack of ability to provide for his basic needs.

d. There was no evidence facility staff initiated a short-term certification for involuntary treatment on 8/21/20, when Liaison #22 documented Patient #13 was unable to consent to voluntary admission. Furthermore, there was no evidence in the medical record to demonstrate Patient #13 signed a consent for voluntary admission between 8/22/20 when the initial M-1 hold expired and 8/24/20 when the second M-1 hold was initiated. This was in conflict with facility policy and patient rights, which required either voluntary admission or a short-term certification to occur when the patient's M-1 hold expired.

2. Patient #14's medical record was reviewed. On 8/20/20 at 12:59 p.m., an M-1 hold was initiated at an outside facility prior to Patient #14's admission. The M-1 hold read Patient #14 was gravely disabled.

a. On 8/20/20 at 7:46 p.m., a High-Risk High Alert Handoff document was completed by facility intake staff which read Patient #14's legal status was involuntary. On the same day at 8:08 p.m., Physician #23 entered an order which read Patient #14's M-1 Hold would expire on Sunday, 8/23/20 at 12:59 p.m.

b. The medical record included multiple consent forms, including the Consent to Admission and Treatment. However, the consents were signed by the patient on 8/20/20 when she was admitted to the facility with involuntary legal status.

c. The medical record revealed on Monday, 8/24/20 at 11:45 a.m., NP #6 initiated a new M-1 hold. The M-1 hold read Patient #14 remained gravely disabled as manifested by her inability to provide for her basic needs.

d. There was no evidence in the medical record Patient #14 was advised of and signed a consent for voluntary admission and treatment between 8/23/20 when the initial M-1 hold expired and 8/24/20 when the second M-1 hold was initiated. Furthermore, the medical record did not include documentation a short-term certification for involuntary treatment was initiated during this time period. This was in conflict with facility policy and patient rights, which require one of these actions to occur when the patient's M-1 hold expired.

In summary, review of the medical records for Patients #13 and #14 revealed the M-1 holds for both patients expired during a weekend. The M-1 hold for Patient #13 expired on Saturday 8/22/20, and the M-1 hold for Patient #14 expired on Sunday 8/23/20. The facility was unable to provide evidence Patient #13 or Patient #14 signed the "Request for Voluntary Admission and Authorization for Treatment Form" once the M-1 holds expired. Likewise, the patients' medical records did not reveal evidence staff initiated a short-term certification for involuntary treatment for either patient prior to the weekend. These findings conflict with Director #16's interview, as Director #16 stated if a patient's M-1 hold expired on a weekend, staff were responsible to ensure either voluntary admission or a short-term certification were in place prior to the weekend.

C. Provider Interviews

Interviews with facility providers revealed if a M-1 hold expired and either voluntary admission or a short-term certification were not in place, the patient no longer had legal status to remain hospitalized for continued treatment. Provider interviews further revealed continued hospitalization of a patient without legal status amounted to a violation of the patient's rights.

1. On 09/23/20 at 3:08 p.m., NP #6 was interviewed. NP #6 stated although he was able to initiate M-1 holds, he did not do so often and believed he had only initiated five in the last year. NP #6 stated a patient met the criteria for a M-1 hold if the patient presented a danger to self or others, or was gravely disabled. He stated he considered this criteria seriously before initiating a hold because he believed a hold represented taking somebody's freedom away from them.

NP #6 stated a short-term certification for involuntary treatment needed to be in place before an M-1 hold expired. NP #6 stated only a psychiatrist could initiate a short-term certification when a patient's M-1 hold expired. NP #6 stated for example, on the Monday prior to the interview, he attended to four or five patients who had M-1 holds which were near expiration. He stated he suggested the psychiatrist see the patients on that day in order to ensure the psychiatrist was able to initiate a short-term certification if needed prior to the expiration of the M-1 holds.

NP #6 stated before a patient's M-1 hold expired, either the patient consented to voluntary treatment or the physician initiated a short-term certification. He stated, if the patient did not need continued hospitalization, the treatment team would plan to discharge the patient when the M-1 expired. NP #6 stated if one of these actions did not occur, the patient had no legal status to remain in the hospital because the patient was neither there voluntarily nor certified for a short-term involuntary treatment.

NP #6 stated at the end of August he had observed problems with staff's monitoring of patients' M-1 holds. He stated he was aware of one or two patients whose M-1 holds expired and the holds were not addressed in a timely manner, but he could not recall who these patients were.

NP #6 reviewed the M-1 hold which he initiated for Patient #14 on 8/24/20. He stated the facility should have initiated a short-term certification for Patient #14 if she remained gravely disabled. He stated it was possible Patient #14's M-1 hold had expired over a weekend and it was overlooked.

NP #6 stated a patient could only be hospitalized voluntarily or if an involuntary hold was in place. He stated the patient's legal status could only be determined under one of these two conditions. He stated it was a problem if a patient's M-1 hold expired and the patient remained at the hospital without legal status. NP #6 stated all patients had the right to understand why they were hospitalized, and stated it was important to ensure a patient either consented to remain at the hospital, or understood why they were kept against their will.

2. On 9/23/20 at 2:06 p.m., Psychiatrist (MD) #8 was interviewed. MD #8 stated when a patient was admitted to the facility with an M-1 hold in place, patients often were placed on short-term certifications at the end of the M-1 hold. He stated the criteria for short-term certification was grave disability, danger to self or danger to others. MD #8 stated when an M-1 hold expired, a patient could also sign in voluntarily and remain at the hospital, or could discharge. He stated if a patient consented to voluntary treatment, the patient would sign a form to verify their voluntary status. MD #8 stated the treatment team monitored the status of the M-1 hold and assessed the patient's condition to determine the patient's disposition when the M-1 expired.

MD #8 stated it was not ideal to initiate a second M-1 hold during a patient's hospitalization and he did not believe it was standard practice for consecutive M-1 holds to be initiated for a patient. He stated the treatment team was responsible for reviewing a patient's hold and legal status in order to ensure there was no confusion regarding the patient's anticipated disposition when the M-1 hold expired.

MD #8 stated no time could elapse between the expiration of an M-1 hold and initiation of a short-term certification if the certification was warranted. He stated if this occurred and the patient did not alternatively consent to voluntary admission, the patient was considered to be "in limbo" with no legal status. He stated this could not happen because patients had rights. He stated either a patient consented to voluntary treatment or the patient received involuntary treatment under a hold, and there was no other option. MD #8 stated if a patient did not have legal status for continued hospitalization, it was similar to kidnapping and was an infringement on a patient's right to freedom and choice.

3. On 9/27/20 at 3:00 p.m., Chief Medical Officer (CMO) #7 was interviewed. CMO #7 stated he was the acting medical director for the facility, and stated he was responsible to oversee the psychiatric and medical care provided to patients.

CMO #7 stated patients had a right to know their legal status for hospitalization. He stated all patients were advised of their legal rights while at the hospital.

CMO #7 stated if a patient was able and desired to leave at the end of the M-1 hold, the patient would be released. However, CMO #7 stated if a patient was still demonstrating signs of psychosis, or posed a danger if released and needed further treatment, a short-term certification would be initiated for the patient.

CMO #7 stated when a patient's M-1 hold expired, the facility was required to immediately initiate either the patient's voluntary admission or a short-term certification. CMO #7 stated if a patient was held at the hospital for continued treatment, the patient had the right to understand their legal status and the basis for their continued hospitalization.

Based on interviews and document review, the facility failed to ensure the personal privacy of patients quarantined on a designated cohort unit for COVID-19, a highly infectious disease. This affected four of four patients (Patients #1, #2, #3 and #4) in shared rooms on the cohort unit.

Findings include:

Facility policies:

The Care, Treatment and Privacy policy read, every effort should be made to protect each patient's right to confidentiality and privacy. Staff will not discuss patients or events with any person not authorized to receive patient information. Patient privacy shall be maintained during treatment. Other patients should not be able to hear discussions regarding patient treatment, including medications, assessments, discharge and individual discussions regarding patient care.

References:

The facility Patient Bill of Rights read, Patients have the right to be treated with respect and dignity. Patients have the right to personal privacy to the extent possible during their stay.

1. The facility failed to ensure the personal privacy of Patients #1, #2, #3 and #4 during medication and therapy sessions conducted by the psychiatric provider.

A. Provider Interview

An interview revealed a facility provider conducted treatment and discussed patient health information with other patients present, specifically patients in shared rooms on the designated COVID-19 cohort unit.

1. On 9/21/20 at 10:45 a.m., Nurse Practitioner (NP) #6 was interviewed on the 300 Unit. NP #6 confirmed the 300 Unit was a designated cohort unit for patients suspected of exposure to COVID-19 and said he had conducted psychiatric treatment for multiple patients on the unit today.

a. NP #6 stated that today, he provided treatment for Patients #1, #2, #3 and #4. He stated the patients' roommates were present at the time of the treatment sessions. NP #6 stated before he provided treatment to a patient, he instructed the patient's roommate to turn on the shower so the roommate would not overhear his discussion with the patient. NP #6 stated this practice was "not ideal."

B. Patient Interviews

Interviews with Patients #1, #2, #3 and #4 confirmed NP #6 instructed the patients to put their heads in the shower while he conducted treatment with their roommates. Interviews further revealed one patient was able to overhear the content of NP #6's discussion with his roommate.

1. On 9/21/20 at 11:30 a.m., Patients #1, #2, #3 and #4, all quarantined in their rooms due to potential exposure to COVID-19, were interviewed. Patients #1 and #2 were interviewed in the room they shared on the 300 Unit. Patients #3 and #4 were interviewed in the room they shared.

a. Patient #1 stated he was present in the room when NP #6 conducted treatment with Patient #2. He stated he put his head in the shower while NP #6 spoke with Patient #2; however, he stated he was still able to hear what was discussed.

b. Patient #2 stated he put his head in the shower while NP #6 spoke with Patient #1, and stated he, too, was able to hear their voices as they spoke.

c. Patient #4 stated she was present in the room when NP #6 conducted treatment with Patient #3. She stated she did not go into the shower, but she and Patient #3 remained in their beds when NP #6 spoke with them. She stated during her discussion with NP #6 she discussed "how she was doing."

C. Document Review

Review of medical records for Patients #1, #2, #3 and #4 confirmed on 9/21/20, when NP #6 conducted medication and therapy sessions in the patients' rooms with their roommates present, the NP discussed multiple aspects of the patients' care plan and treatment. This included discussion of medications, symptoms, plans for discharge and the patients' current thought content and mood.

This conflicted with facility policy which read patient privacy must be maintained during treatment, and other patients should not hear discussions regarding treatment, medications, assessments, discharge or other discussions regarding patient care.

1. Patient #1's medical record was reviewed. The medical record revealed on 9/21/20, NP #6 entered a Psychiatric Progress Note. The date of service on the note was 9/21/20 at 10:20 a.m. NP #6 documented he saw Patient #1 for a medication and therapy session and he examined the patient during this session.

a. The progress note read, NP #6 met with Patient #1 in the patient's room. NP #6 documented Patient #1 reported high levels of depression, anxiety, and agitation, and the patient was able to describe the reason for his hospitalization and discuss the treatment regimen. He further documented Patient #1 endorsed occasional auditory and visual hallucinations, as well as occasional ideations of self-harm. NP #6 documented Patient #1's thought content included ideas of guilt, hopelessness and worthlessness.

2. Patient #2's medical record was reviewed. The medical record revealed NP #6 entered a Psychiatric Progress Note with the same date of service as Patient #1, 9/21/20 at 10:20 a.m. NP #6 documented he saw Patient #2 for a medication and therapy session and examined the patient.

a. NP #6 documented Patient #2 denied suicidal and homicidal ideation, paranoia, or hallucinations. He further documented Patient #2 was open to discussing the treatment regimen and plan, and was stable on medications with no adverse effects. NP #6 documented the plan was to await the result from a Lithium level (a measurement of the chemical Lithium, used to treat psychiatric conditions, in an individual's blood) prior to the patient's discharge, and he reviewed this plan with Patient #2.

3. Patient #3's medical record was reviewed. The medical record revealed NP #6 entered a Psychiatric Progress Note with a date of service 9/21/20 at 10:30 a.m. NP #6 documented he saw Patient #3 for a medication and therapy session and examined the patient.

a. NP #6 documented Patient #3 refused to complete a CORE assessment (a self-reported questionnaire used to determine an individual's level of psychological distress). NP #6 documented when questioned regarding levels of depression, anxiety and agitation, Patient #3 responded she was "OK." He documented Patient #3 was open to discussing her treatment regimen and plan and was able to describe the situation and reason for her hospitalization.

4. Patient #4's medical record was reviewed. The medical record revealed NP #6 entered a Psychiatric Progress Note with a date of service of 9/21/20 at 10:35 a.m. NP #6 documented he saw Patient #4 for a medication and therapy session and examined the patient.

a. NP #6 documented Patient #4 reported low levels of depression, anxiety and agitation. He further documented Patient #4 denied suicidal or homicidal ideation and hallucinations. NP #6 documented Patient #4's Lexapro (a medication used to treat depression and anxiety) would be increased to 15 milligrams to treat mood, and this plan was reviewed with the patient.

D. Staff and Leadership Interviews

Interviews with facility staff and leadership revealed the facility had not implemented processes to maintain personal privacy for patients quarantined in their rooms on the COVID-19 cohort unit. Interviews further revealed when treatment was conducted in the presence of another patient, this constituted a potential breach of patient privacy.

1. On 9/23/20 at 3:08 p.m., NP #6 was interviewed. NP #6 stated when he conducted patient treatment sessions on a unit not designated as a COVID-19 cohort unit, he would speak with patients in an area which was not in proximity to other patients. He stated he often met with patients outside in the courtyard or in the unit day room to ensure distance from other patients. NP #6 stated until recently, he was also able to speak with patients in their rooms because the unit had not previously housed two patients in the same room.

NP #6 stated that ever since the 300 Unit was designated as a COVID-19 cohort unit, he had to conduct conversations with patients while another patient was in the room because patients on the cohort unit were restricted to their rooms. NP #6 repeated that when he conducted treatment with a patient while the patient's roommate was in the room, he asked the roommate to go into the bathroom and turn the shower on so they would not overhear the conversation.

NP #6 stated he was unsure whether a breach of patient privacy occurred when he conducted treatment with a patient's roommate in the bathroom. He stated it "may not have been the best thing to do" because it was possible the patient's roommate overheard his conversations.

NP #6 stated he had not received any guidance regarding how to conduct treatment with patients in shared rooms on the COVID-19 cohort unit. He stated his guidance for treating patients on the COVID-19 unit was limited to the personal protective equipment (PPE) required to be worn on the unit.

NP #6 stated he had significant concerns regarding conducting patient treatment while a patient's roommate was present. He stated patients had a right to as much privacy as possible. He further stated patients were not as forthcoming with information if they did not have privacy, and it was more difficult to evaluate a patient if they did wish to share information in front of their roommate. NP #6 stated he did not know how to maintain privacy effectively if patients on the COVID-19 cohort unit were not allowed out of their rooms.

2. On 9/27/20 at 3:00 p.m., Chief Medical Officer (CMO) #7 was interviewed. CMO #7 stated it was important to respect patient privacy. He stated if patient privacy was not ensured, staff could get in trouble due to "HIPAA (the Health Insurance Portability and Accountability Act, which regulates the protection and confidentiality of health information) rules and all that nonsense."

CMO #7 stated it was important to keep patient information confidential and private to avoid embarrassing a patient. He further stated if patient privacy was not maintained, patients might not share important information with a provider, which could impact their care, such as whether the patient was suicidal.

3. On 9/27/20 at 10:54 a.m., CEO #1 was interviewed. CEO #1 stated she was aware NP #6 had instructed patients' roommates to go into the shower when PHI (protected health information) was discussed with the other patient in the room. She stated NP #6 should not have done so. She stated NP #6 was allowed to bring one patient at a time out of the room to conduct conversations and treatment.

CEO #1 stated protection of patient health information was part of the initial training staff received regarding HIPAA and she stated she expected staff to follow these practices to maintain patient privacy. She agreed, however, that staff including NP #6 had not received specific education on how to maintain patient privacy on the COVID-19 cohort unit.

Based on document reviews and interviews, the facility failed to supervise nursing care for patients on the inpatient psychiatric unit and the outpatient partial hospitalization program (PHP) as expected per policy and/or as ordered. Specifically, record review revealed the facility failed to maintain observation rounds on patients per provider orders and/or policy, failed to obtain provider orders to alter observation frequency, and failed to supervise the care of patients in the PHP. This affected six (#10, #17, #3, #11, #22 and #23) of eight patients whose records were reviewed.

Findings include:

Facility policy:

According to the facility policy, Precautions and Level of Observations, the physician orders the level of observation with the minimum interval for all patients to be observed every 15 minutes. The policy further states the observations are to be at random intervals not to exceed 15 minutes between any two observations. This interval can be increased to every five minutes or to one on one observation depending on the safety needs of the patient. The registered nurse may initiate the increase to five minute checks, then must obtain a physician order to both continue the increased observations and to discontinue the order to return to 15 minute observations.

According to the facility policy, Outpatient Treatment Team Responsibility, an interdisciplinary treatment team involving a nurse, therapists and mental health technician, work together to provide care and reach goals of the treatment plan on behalf of the patient in the PHP. It is the role of the nurse specifically to coordinate the admission to the program including but not limited to: completing the nursing assessment, admission note, a comprehensive mental status note, document and perform interventions as indicated, encourage client participation in the program, communicate with staff and attending providers, provide group activities and distribute prescribed medication and patient education.

1. Nursing staff failed to supervise nursing care for patients on the inpatient psychiatric unit as expected and/or as ordered. Specifically, record review revealed nursing failed to maintain documented observation rounds on patients per provider orders and failed to obtain provider orders to alter observation frequency.

A. Failure to maintain documented observation rounds

(1) Interviews with staff regarding observation rounds for patients on the inpatient psychiatric unit revealed their purpose and importance.

On 09/25/2020 at 2:29 p.m., an interview was conducted with Mental Health Technician (MHT) #25. MHT #25 stated rounds were performed to verify patient safety, location, behavior, and overall status. Patient data collected through rounds helped to identify when behavior changed in a patient. MHT #25 stated most patients were observed every 15 minutes, but the observations were increased if staff were concerned for a patient's safety due to changed behavior. Conducted rounds were also important to monitor patient acuity; more acute patients were noted to be at greater safety risk of self-harm or escalation of emotion which put others at risk. MHT #25 stated it was important to have observations of patients who showed these signs so staff could intervene and prevent harm to the patient or others in the area.

On 9/25/20 at 3:17 p.m., an interview was conducted with RN #26. RN #26 stated observation rounds were important to staff so nothing was missed and patients were not in distress. Most patients were on standard 15 minute observation rounds; she said on occasion, a patient who had become violent towards others or had harmed his or herself was placed on 5 minute observation rounds. RN #26 further stated the time intervals were specified for a reason, no patient should be a danger to self or others. If 5 minute observation rounds were not performed an issue could arise with patient safety, eyes must be kept on patients at the frequency ordered to prevent any negative outcomes happening to patients.

(2) Documentation of Patient #10, Patient #17 and Patient #3's observation rounds records found gaps in charting of patient rounds ordered by the physician, which was in conflict to the facility policy standard that all patients to be observed at a minimum of 15 minute intervals.

On 9/22/20, review of Patient #3's medical record revealed the patient was on 15 minute observation rounds on admission. Review revealed observations were missed on two occasions. The documentation for observation rounds were missed on 9/16/20 at 7:15 p.m. and on 9/18/20 at 6:30 p.m..

On 9/24/20, review of Patient #10's medical record revealed the patient was to be observed at five minute intervals for the patient's safety. Observations rounds were missed in the chart for the patient on 8/14/29 at 2055.

On 9/24/20, review of Patient #17's medical record, revealed the patient was to be observed at 15 minute intervals. Observation rounds with an interval greater than 15 minute was noted between two observations on one of two forms dated 9/19/20. The observation times were recorded at 1:20 a.m. and 1:45 a.m. Further, review of Patient #17's observation rounds sheet noted missed observation rounds on 9/12/20 at 12:15 p.m.

B. Failure to obtain provider orders to alter observation frequency.

(1) Interviews conducted with nursing and leadership revealed the expectation for changes in observation round frequency.

On 9/25/20 at 3:17 p.m., an interview was conducted with RN #26. RN #26 stated the psychiatrist would order changes to the level (frequency) of patient observations; it was not the nurse's role to make this change. The physician order to change the observation frequency must be put into action immediately and the order must be recorded in the medical record.

On 09/27/2020 at 9:01 a.m., an interview was conducted with chief nursing officer (CNO) #2. CNO #2 stated patient's behavior determines the level of observation ordered for a patient. When a patient has improved behavior, the frequency can be reduced only by physician order.

(2) Document review of patient medical records found interval changes in patient observation rounds without a corresponding physician order. This was in conflict with facility policy that a physician order must be given for staff to increase observation rounds to 5 minute intervals and to return observation rounds to the standard 15 minute observation rounds.

Review of Patient #10's medical record on 9/24/20, found the interval of observation rounds changed from 5 minute observation rounds to 15 minutes rounds without a physician order in the medical record for the change in observation level.

Review of Patient #11's medical record on 9/23/20 t found the observation rounds had been changed on 9/13/20 at 0945 from 5 minute observation rounds to 15 observation rounds. A physician order for this change was not found in the medical record.

2. The facility failed to assign staff to supervise nursing care for patients in the outpatient PHP.
A. Medical record review of patients admitted to the PHP revealed lack of nursing involvement in the patient planning and treatment.

(1) On 9/25/20, a focused medical record review was conducted for Patient #22. The record revealed documentation completed by other members of the interdisciplinary team but no documentation was found to be completed by nursing.

(2) On 9/25/20, a focused medical review was conducted for Patient #23 on 9/25/20. The record review revealed nursing did not participate in the treatment plan, documentation or assessments outlined in the facility policy (see above).

B. Interview

(1). On 9/27/2020 at 9:01 a.m., an interview was conducted with CNO #2. CNO#2 stated a nurse's role in the PHP was to perform a weekly assessment; this was in contrast to facility policy that stated the nurse had a more defined role in the PHP which involved multiple steps including, but not limited to, admission, assessment, medication administration.

In regards to Patient #23, CNO #2 stated nursing had been trying to do an assessment through a video chat as nurses need to perform medication checks for adverse drug reactions and mental health status of the patient. However, the nurses had all been assigned to work on the inpatient units; inpatient staffing did not allow for PHP coverage and the nursing assessment of Patient #23 CNO #2 stated she was unaware a patient had been admitted to the PHP until the admission day. CNO #2 stated the PHP had a designated nurse when the PHP opened; however, the patient load was inconsistent and the nurse was sent to cover other areas and resigned. The position had not been refilled.

(2) An interview was conducted with Chief Executive Officer (CEO) #1 at 10:54 a.m. on 9/27/20. CEO #1 stated the PHP had one patient in August and one current patient. CEO #1 stated nursing does have a role in the PHP, there are pieces they have to complete. It was expected early in the program the house supervisor would assist the PHP until the program increased in patient size.

Based on document review and interviews, the facility failed to ensure agency staff working at the facility met the qualifications and expectations of facility nursing staff. Specifically, the facility failed to verify agency personnel were trained in The Non-Violent Crisis Prevention Intervention (CPI) Plan outlined in the facility policy.

Findings include:

Facility Policy:

According to facility policy, Non-Violent Crisis Prevention Intervention (CPI) - "APR-Acute Psychiatric Response," staff are trained on CPI training, a less restrictive alternative to restraints, to be used when all other methods have been ineffective. The person-centered approach allows staff to use decision making, problem solving principles to prevent, defuse or manage high-risk behaviors. The policy read staff may not intervene when alone. If a situation escalates to need hands on intervention, staff will be assigned a limb to be restrained, or to remove the patient's shoes for the safety of those involved.

1. The facility failed to ensure agency staff working on the inpatient psychiatric unit were trained in CPI, a training requirement of all facility staff that worked on the unit.

A. Documentation

The facility provided documentation of all agency staff who have worked at the facility. The documentation revealed four registered nurses (RN) and a combination of 11 licensed practical nurses (LPN) and certified nurse aides (CNAs) acting as Mental Health Technicians (MHTs), had worked at the facility.

The facility provided documentation of employee job descriptions of RN's and MHT's, stating CPI Certification was a requirement of employment.

B. Interviews

Staff interviews revealed different training requirement for facility staff and agency staff assigned to the care of inpatient psychiatric patients.

On 9/25/20 at 2:29 p.m., an interview was conducted with MHT #25, a facility staff member. MHT #25 stated he had been trained on CPI, an approach with methods to address patient needs, keep everyone safe and if needed, assist with patient holds or restraint of a patient who was acting out. MHT #25 stated new trainees were not able to participate in holds or complete training days shadowing their trainer on the inpatient psychiatric unit if they had not completed the CPI training. The importance of all staff being trained was to ensure staff were not in an unsafe situation with untrained staff, waiting for trained staff to arrive. He stated he did not know if agency staff had the same requirement.

On 9/24/20 at 10:02 a.m., an interview was conducted with RN #12. RN #12 stated her only concern with staffing was every person in the building not having CPI training. She had worked with an agency staff who was not trained in CPI. RN #12 stated she had emailed the facility management, due to facility policy stating CPI was a requirement for staff working on the inpatient psychiatric unit. RN #12 stated agency staff had denied having the CPI training when she inquired.

On 9/24/20 at 12:09 a.m., an interview was conducted with Supervisor #3. Supervisor #3 stated as house supervisor, she had to trust her leadership had vetted and sent appropriate people from agency staff to cover shifts at the facility. Supervisor #3 further stated she had little control over who was sent to cover shifts; she said she recently had a nurse arrive without any experience in psychiatric nursing. She said agency MHTs were mostly CNAs and it is her understanding most agency staff working as MHTs were not CPI trained. Supervisor #3 stated it is important to have all staff trained in order to have extra help available if a safety issue arises. Supervisor #3 stated not having agency staff trained in CPI put facility and agency staff at risk.

On 9/25/20 at 2:27 p.m., an interview was conducted with Supervisor #5. Supervisor #5 stated Chief Nursing Officer (CNO) #2 scheduled agency staff. Supervisor #5 stated she was unsure if agency nurses had CPI training but knew agency MHT staff were not trained in CPI.

On 9/27/20 at 9:03 a.m., an interview was conducted with CNO #2. CNO #2 stated agency staff were not CPI trained; however, it was a requirement for facility staff to have CPI training to work on the inpatient psychiatric units. CNO #2 was unable to report whether two agency staff had been placed to work on the same unit without a CPI trained staff member on the inpatient psychiatric unit, but stated it was a possibility.

An interview was conducted on 9/27/20 at 10:54 a.m. with Chief Executive Officer (CEO) #1. CEO#1 stated she was not able to report what CPI training agency nursing staff had received and said she would follow up with the CPI trainer.

Based on observation and interviews, the facility failed to have procedures in place to prevent and control the spread of infection within the hospital when staff responded to emergencies on and off the isolation unit designated for patients suspected of having Coronavirus (COVID-19), a highly infectious disease.

Specifically, staff responding to a behavioral emergency on the isolation unit failed to follow social distancing guidelines as outlined by the CDC in 1 of 1 observation of an emergency staff response alert to the designated COVID-19 unit. Interviews further revealed a lack of staff training on measures to prevent and control the virus.

Findings include:

Facility Policy:

According to facility policy, Coronavirus (COVID-19) Protocol-Social Distancing read, CDC recommends that everyone can do their part to help us respond to this emerging public health threat by following CDC recommendations: CDC continues to recommend that people try keep about 6 feet (2 arms length) between themselves and others, do not gather in groups, stay out of crowded places and avoid mass gatherings.

References:

The CDC Interim Infection Prevention and Control Recommendations for Patients with Suspected or Confirmed Coronavirus Disease 2019 (COVID-19) in Health Care Settings, updated 07/15/20 read, Encourage Physical Distancing Healthcare delivery requires close physical contact between patients and HCP (health care providers). However, when possible, physical distancing (maintaining 6 feet between people) is an important strategy to prevent SARS-CoV-2 transmission.

The CDC Interim Infection Prevention and Control Recommendations for Patients with Suspected or Confirmed Coronavirus Disease 2019 (COVID-19) in Health Care Settings, updated 07/15/20 read, employers should select appropriate PPE (personal protective equipment) and provide it to HCP in accordance with OSHA PPE standards (29 CFR 1910 Subpart I). HCP must receive training on and demonstrate an understanding of: when to use PPE, what PPE is necessary, how to properly don, use, and doff PPE in a manner to prevent self-contamination, how to properly dispose of or disinfect and maintain PPE, the limitations of PPE.

1. Observations revealed staff responding to a behavioral emergency on the COVID-19 isolation unit failed to follow social distancing guidelines as outlined by the CDC.

An observation on 9/22/20 at approximately 3:15 p.m. of a behavioral emergency on the COVID-19 isolation unit revealed 15 staff not working the COVID-19 unit responded to the behavioral emergency and congregated outside the unit. Staff were not observed maintaining distances of at least 6 feet. After approximately 10 minutes, another staff member arrived and directed the staff not working the COVID-19 unit to disperse.

The facility was unable to provide evidence that any guidance or training was provided to staff regarding the COVID-19 isolation unit and the infection control measures to prevent and control the spread of COVID-19.

2. Interviews confirmed a lack of methods to prevent and control the spread COVID-19 in emergencies.

On 9/22/20 at 11:16 a.m., an interview was conducted with a Mental Health Technician (MHT #14) assigned to the COVID-19 isolation unit, however, MHT #14 stated she was still required to respond to behavioral emergencies on other units. MHT #14 stated she was not cohorted to the isolation unit because she was the most senior staff and had to respond to emergencies on other units.

On 9/22/20 at 12:00 p.m., an interview was conducted with a registered nurse (RN #15). RN #15 stated she could not remember any training regarding donning and doffing, and said no one at the facility explained how to don or doff personal protective equipment (PPE).

On 9/27/20 at 10:54 a.m. an interview was conducted with CEO #1. CEO #1 stated that she was unaware of any training for staff regarding responding to emergencies on the isolation unit.

As of the exit of the survey, the facility was unable to provide any training or education to staff related to how to respond to emergencies on the 300 isolation unit to prevent the spread of COVID-19.

Based on observations, video, document review, and interviews, the facility failed to follow infection control standards, facility policy and directives from the local public health department (LPHD) to prevent possible transmission of the infectious disease, COVID-19. Specifically, the facility failed to test, cohort, quarantine, surveil, and properly care for patients suspected of exposure to COVID-19, following the discovery of staff testing positive for the virus.

Observations, interviews and document review, which included video review, conducted from 9/21/20 through 9/28/20 revealed, although the facility attempted to create a designated COVID-19 patient care unit, staff were not provided Center for Disease Control (CDC) recommended personal protective equipment (PPE), patients were not quarantined to their rooms, staff were not cohorted to the same shifts, units, and patients, and signs on the designated COVID-19 unit to advise staff of the recommended PPE for the unit were not posted. In addition, the facility staff failed to enforce social distancing and prevent co-mingling of exposed and non-exposed patients. Further, the facility continued to admit new patients and placed them in the COVID-19 unit, even though the new patients had not been exposed and had not received positive test results for COVID-19.

The local public health department (LPHD) notified the facility on 9/18/20, a registered nurse (RN #3) reported symptoms which met clinical criteria for a probable case of COVID-19, given her exposure. Because she was a probable case, RN #3 was issued isolation orders through 9/27/20 and instructed not to work until 9/28/20. Interviews and documentation review revealed the RN worked on 9/19/20 and 9/21/20 in multiple patient care areas in direct violation of the isolation orders she received.

Finally, observations revealed the infection control RN provided non-medical face masks to staff who were providing direct patient care, failed to ensure patients exposed to COVID-19 received follow-up instructions at discharge, and failed to ensure staff had processes and training in responding to emergency situations on the isolation unit. (Cross-reference A0749)

The facility's multiple failures created the likelihood, if not immediately corrected, of serious harm affecting all facility patients.

Findings include:

I. Facility policies and professional references in managing COVID-19

Facility policies and professional references outlined the immediate and continuing steps the facility should have taken to limit the spread of COVID-19.

A. Policies

1. The Department Responsibility for Infection Control policy read:

Nursing is responsible for the following: assisting in the Infection Control Surveillance aspect of the Infection Control Program. Knowing and abiding by the Infection Control Program and all policies and procedures relating to Infection Control. Performing nursing functions essential in the prevention, recognition, and management of infection. Nursing Administration educates employees to report personal exposure or incidents of infectious or communicable diseases to (the) Department Head.

Directors and Managers of all programs, departments and services are responsible for: developing policies and procedures addressing Infection Control issues in their respective areas.

Infection Control Practitioner is responsible for: Developing Infection Control Orientation Program for new employees. Providing annual and as needed departmental in-service programs on Infection Control. Maintaining Infection Control Program.

2. The Management of Coronavirus (2019n-CoV) policy revised 3/31/20 read:

The facility shall implement infection control procedures including administrative and engineering controls, correct work practices, environmental hygiene and appropriate use of personal protective equipment to minimize the chance of exposure and to prevent spread of coronavirus to patients, healthcare personnel and visitors during healthcare delivery. All reasonably suspected cases of coronavirus shall be immediately reported to CDPHE (Colorado Department of Public Health and Environment).

Purpose of the policy is to quickly identify HCP (health care providers), patients, visitors and vendors reasonably suspected of being infected with coronavirus and to follow CDC guidelines for containing the infection thereby minimizing exposure and preventing transmission of coronavirus within the facility and community, and to ensure facility policies and practices are in place to minimize exposures to respiratory pathogens.

Employees will be screened on a daily basis and as needed per CDC recommendations. Screenings shall include the following clinical features and epidemiology risks: fever, signs/symptoms of lower respiratory illness (e.g., cough, shortness of breath), close contact with a laboratory confirmed COVID-19 patient within 14 days of symptoms onset.

Any patient, visitor or employee reasonably suspected of coronavirus infection based on their responses to the assessment questions will immediately be donned with a surgical mask over the mouth and nose, and isolated in a designated isolation space with the door closed. Any post-admission patient reasonably suspected of coronavirus infection based on signs and symptoms will immediately be donned with a surgical mask over the mouth and nose, and isolated in a designated isolation space with the door closed. Entry and exit to this room should be limited and should occur only when absolutely necessary. Only the number of staff required to maintain patient safety should be allowed in the room. Staff shall immediately don personal protective equipment including gowns, gloves, eye protection/face shield and surgical mask. Housekeeping staff shall wear full PPE while cleaning and disinfecting.

Management of exposed healthcare employees: movement and monitoring decisions for health care provider potentially exposed to COVID-19 should be made in consultation with public health authorities (e.g.. CDPHE). Non-punitive and flexible sick leave policies for health care providers should be implemented that are consistent with public health guidance.

3. Guidance for patient with suspected Coronavirus read:

1. Isolate patients in a designated isolation room or unit.
2. Patient should wear a mask.
3. Staff: gloves, gown, mask, eye protection (glasses or face shield)

B. Directives

Local Public Health Department (LPHD) directives dated 9/18/20 outlined specific steps the facility should take upon discovery of staff infected with COVID-19. The directives read:

Test all patients and staff for COVID-19, create a separate COVID-19 unit and quarantine any patients who had been possibly exposed to COVID-19 by the infected [staff]. Patients who were exposed were to be individually isolated in separate rooms on the COVID-19 unit and cohort potentially exposed staff to work the same shifts, on the same unit, and with the same patients to prevent further exposure and spread of infection to other staff and patients.

Conduct surveillance. The facility was unable to provide evidence of COVID-19 surveillance. Multiple requests were made for the surveillance, including the contact tracing done, reconciliation of patient and staff testing completed and any past testing of patient and staff. As of the exit of the survey, none was provided.

Seek additional guidance from infection prevention subject matter experts at CDPHE. Plan for and implement recommendations from Larimer County Department of Health and Environment (LCDHE). Testing is mandatory for all employees. You must ensure social distancing to prevent potential exposure. Please maintain a distance of 6 feet or greater with patients and peers, unless you are providing direct care and you cannot maintain this distance.

C. References

References set out detailed recommendations for healthcare providers during the COVID-19 pandemic, including use of personal protective equipment, testing, health risks, surveillance, and screening.

1. According to the CDC, Interim Infection Prevention and Control Recommendations for Healthcare Personnel During the Coronavirus Disease 2019 (COVID-19) Pandemic, updated 7/15/20:

Implement mechanisms and policies that promote situational awareness for facility staff including infection control, healthcare epidemiology, facility leadership, and frontline staff about patients with suspected or confirmed SARS-CoV-2 infection and facility plans for response.

Recommended infection prevention and control (IPC) practices when caring for a patient with suspected or confirmed SARS-CoV-2 infection read: Patient placement: for patients with COVID-19 or other respiratory infections, if admitted, place a patient with suspected or confirmed SARS-CoV-2 infection in a single-person room with the door closed. The patient should have a dedicated bathroom. Airborne Infection Isolation Rooms (AIIRs) should be reserved for patients who will be undergoing aerosol generating procedures (See Aerosol Generating Procedures Section). Personnel entering the room should use PPE: gown, gloves, mask and face shield.

Facilities could consider designating entire units within the facility with dedicated HCP, to care for patients with suspected or confirmed SARS-CoV-2 infection. Dedicated means that HCP are assigned to care only for these patients during their shift. Determine how staffing needs will be met as the number of patients with suspected or confirmed SARS-CoV-2 infection increases and if HCP become ill and are excluded from work.
-It might not be possible to distinguish patients who have COVID-19 from patients with other respiratory viruses. As such, patients with different respiratory pathogens might be cohorted on the same unit. However, only patients with the same respiratory pathogen may be housed in the same room. For example, a patient with COVID-19 should ideally not be housed in the same room as a patient with an undiagnosed respiratory infection or a respiratory infection caused by a different pathogen.
-To the extent possible, patients with suspected or confirmed SARS-CoV-2 infection should be housed in the same room for the duration of their stay in the facility (e.g., minimize room transfers).Once the patient has been discharged or transferred, HCP, including environmental services personnel, should refrain from entering the vacated room until sufficient time has elapsed for enough air changes to remove potentially infectious particles (more information on clearance rates under differing ventilation conditions is available). After this time has elapsed, the room should undergo appropriate cleaning and surface disinfection before it is returned to routine use.

Personal Protective Equipment. HCP who enter the room of a patient with suspected or confirmed SARS-CoV-2 infection should adhere to Standard Precautions and use a NIOSH-approved N95 or equivalent or higher-level respirator (or facemask if a respirator is not available), gown, gloves, and eye protection. When available, respirators (instead of facemasks) are preferred; they should be prioritized for situations where respiratory protection is most important and the care of patients with pathogens requiring Airborne Precautions (e.g., tuberculosis, measles, varicella).

-Personal Protective Equipment Training: employers should select appropriate PPE and provide it to HCP in accordance with OSHA (Occupational Safety and Health Administration) PPE standards. HCP must receive training on and demonstrate an understanding of: when to use PPE, what PPE is necessary, how to properly don, use, and doff PPE in a manner to prevent self-contamination, how to properly dispose of or disinfect and maintain PPE, the limitations of PPE. Any reusable PPE must be properly cleaned, decontaminated, and maintained after and between uses. Facilities should have policies and procedures describing a recommended sequence for safely donning and doffing PPE.

-The PPE recommended when caring for a patient with suspected or confirmed COVID-19 includes the following:

--Respirator or Facemask (Cloth face coverings are NOT PPE and should not be worn for the care of patients with suspected or confirmed COVID-19 or other situations where use of a respirator or facemask is recommended.) Put on an N95 respirator (or equivalent or higher-level respirator) or facemask (if a respirator is not available) before entry into the patient room or care area, if not already wearing one as part of extended use strategies to optimize PPE supply. Other respirators include other disposable filtering facepiece respirators, powered air purifying respirators (PAPRs), or elastomeric respirators. N95 respirators or respirators that offer a higher level of protection should be used instead of a facemask when performing or present for an aerosol generating procedure. Disposable respirators and facemasks should be removed and discarded after exiting the patient ' s room or care area and closing the door unless implementing extended use or reuse. Perform hand hygiene after removing the respirator or facemask. If reusable respirators (e.g., powered air-purifying respirators [PAPRs] or elastomeric respirators) are used, they should also be removed after exiting the patient ' s room or care area. They must be cleaned and disinfected according to manufacturer ' s reprocessing instructions prior to re-use. Those that do not currently have a respiratory protection program, but care for patients with pathogens for which a respirator is recommended, should implement a respiratory protection program.

--Eye Protection (i.e., goggles or a face shield that covers the front and sides of the face) gloves, gowns. Facilities should work with their health department and healthcare coalition to address shortages of PPE.

-Aerosol Generating Procedures (AGPs): Some procedures performed on patients with suspected or confirmed SARS-CoV-2 infection could generate infectious aerosols. Procedures that pose such risk should be performed cautiously and avoided if possible. If performed, the following should occur: HCP in the room should wear an N95 or equivalent or higher-level respirator, eye protection, gloves, and a gown. The number of HCP present during the procedure should be limited to only those essential for patient care and procedure support. Visitors should not be present for the procedure. AGPs should ideally take place in an AIIR. Clean and disinfect procedure room surfaces promptly as described in the section on environmental infection control below.

2. According to the CDC's Overview of Testing for SARS - CoV-2 (COVID-19), if a person has been in close contact, such as within 6 feet of a person with documented SARS-CoV-2 infection for at least 15 minutes and do not have symptoms, the person needs to receive a COVID test. A person should consult with their health care provider or public health official. Testing is recommended for all close contacts of persons with SARS-CoV-2 infection. This is important because of the potential for asymptomatic and pre-symptomatic transmission. A single negative test does not mean you will remain negative at any time point after that test. Even if you have a negative test, you should still self-isolate for 14 days.

3. The CDC's Clinical Questions about COVID-19: Questions and Answers, updated August 4 2020 read: Some procedures performed on patients are more likely to generate higher concentrations of infectious respiratory aerosols than coughing, sneezing, talking or breathing. These aerosol generating procedures (AGPs) potentially put healthcare personnel and others at an increased risk for pathogen exposure and infection. Commonly performed medical procedures that are often considered AGPs, or that create uncontrolled respiratory secretions, include: non-invasive ventilation (e.g., BiPAP, CPAP). Facilities that do not have sufficient supplies of N95s and other respirators for all patient care should prioritize their use for activities and procedures that pose high risks of generating infectious aerosols.

4. The CDC's People with Certain Medical Conditions, updated September 11 2020, read: People of any age with certain underlying medical conditions are at increased risk for severe illness from COVID-19: cancer, chronic kidney disease, COPD (chronic obstructive pulmonary disease), immunocompromised state, obesity, serious heart conditions such as heart failure, coronary artery disease or cardiomyopathies, sickle cell disease, Type 2 diabetes mellitus. People with the following conditions might be at an increased risk for severe illness from COVID-19: asthma, cerebrovascular disease, cystic fibrosis, hypertension or high blood pressure, neurologic conditions such as dementia, liver disease, pregnancy, pulmonary fibrosis, smoking, thalassemia, Type 1 diabetes mellitus. The list of underlying conditions is meant to inform clinicians to help them provide the best care possible for patients, and to inform individuals as to what their level of risk may be so they can make individual decisions about illness prevention.
Currently, those at greatest risk of infection are persons who have had prolonged, unprotected close contact (i.e., within 6 feet for 15 minutes or longer) with a patient with confirmed SARS-CoV-2 infection, regardless of whether the patient has symptoms. Persons frequently in congregate settings (e.g., homeless shelters, assisted living facilities, college or university dormitories) are at increased risk of acquiring infection because of the increased likelihood of close contact. Among adults, the risk for severe illness from COVID-19 increases with age, with older adults at highest risk. Severe illness means that the person with COVID-19 may require hospitalization, intensive care, or a ventilator to help them breathe, or they may even die. People of any age with certain underlying medical conditions are also at increased risk for severe illness from SARS-CoV-2 infection.
5. According to the CDC's Strategies for Optimizing the Supply of N95 Respirators, proper use of respiratory protection by HCP must be used in the context of a comprehensive respiratory protection program. The program must include fit testing, which complies with OSHA's Respiratory Protection Standard.
6. According to the CDC's Performing Broad-Based Testing for SARS-CoV-2 in Congregate Settings, updated June 27, 2020, PPE to be worn includes N95 respirator/mask (or a facemask if a respirator is not available), gloves, gowns, and eye protection. HCP remaining six feet away during the specimen collection process must wear gloves and a face mask. The HCP performing the specimen collection or within six feet of the patient during the collection must wear a gown, and N95 or higher level respirator/mask (or a facemask if a respirator is not available), gloves and eye protection.
7. According to OSHA's Respiratory Protection standard, the employer is to develop and implement a respiratory program with elements for required respirator use. In any workplace where respirators are necessary to protect the health of the employee, a respiratory protection program must be established.
8. According to the CMS Memo QSO-20-20-All, issued on March 23 2020, the Focused Infection Control Survey is available to every provider in the country to make them aware of Infection Control priorities during this time of crisis.
Facilities should utilize the COVID-19 Focused Survey as a self-assessment tool. Priority areas for self-assessment include: Standard Precautions (hand hygiene, use of PPE, Transmission-Based Precautions), Patient Care (including patient placement), Infection prevention and control standards, policies and procedures (PPE, surveillance), Education, monitoring and screening of staff, and Emergency preparedness (staffing in emergencies).
For infection surveillance, the facility has established a surveillance plan for identifying, tracking, monitoring and/or reporting of signs/symptoms of COVID-19. The plan includes early detection, management of potentially infectious symptomatic patients, and the implementation of appropriate transmission-based precautions and PPE.
For employee screening, if staff develop symptoms at work, does the facility have a process for staff to report their illness or developing symptoms, place them in a facemask and have them return home, inform the facility's infection Preventionist and include information on individuals and locations the person came into contact with, and follow current guidance about returning to work (e.g. local health department and CDC guidance)?
For policy development, does the facility have a policy and procedure for ensuring staffing to meet the needs of the patients when needed during an emergency, such as a COVID-19 outbreak?
For patient care, is the facility restricting patients to the extent possible to their rooms except for medically necessary purposes? If patients have to leave their room, are they wearing a facemask, limiting their movement in the facility and performing social distancing (stay at least six feet away from others)? Has the facility isolated residents with known or suspected COVID-19 in a private room if available, or taken other actions based on national (e.g. CDC), state, or local public health authority recommendations?
9. Strategies to Mitigate Healthcare Personnel Staffing Shortages Mitigating Staff Shortages read, Maintaining appropriate staffing in healthcare facilities is essential to providing a safe work environment for healthcare personnel (HCP) and safe patient care. As the COVID-19 pandemic progresses, staffing shortages will likely occur due to HCP exposures, illness, or need to care for family members at home. Healthcare facilities must be prepared for potential staffing shortages and have plans and processes in place to mitigate these, including communicating with HCP about actions the facility is taking to address shortages and maintain patient and HCP safety
There are Contingency and Crisis Capacity Strategies that healthcare facilities should consider in these situations.
Contingency Capacity Strategies to Mitigate Staffing Shortages: When staffing shortages are anticipated, healthcare facilities and employers, in collaboration with human resources and occupational health services, should use contingency capacity strategies to plan and prepare for mitigating this problem. At baseline, healthcare facilities must: Understand their staffing needs and the minimum number of staff needed to provide a safe work environment and safe patient care. Be in communication with local healthcare coalitions, federal, state, and local public health partners (e.g., public health emergency preparedness and response staff) to identify additional HCP (e.., hiring additional HCP, recruiting retired HCP, using students or volunteers), when needed.
Contingency capacity strategies for healthcare facilities include:
Adjusting staff schedules, hiring additional HCP, and rotating HCP to positions that support patient care activities. Developing regional plans to identify designated healthcare facilities or alternate care sites with adequate staffing to care for patients with COVID-19.
Crisis Capacity Strategies to Mitigate Staffing Shortages:
When staffing shortages are occurring, healthcare facilities and employers (in collaboration with human resources and occupational health services) may need to implement crisis capacity strategies to continue to provide patient care.
When there are no longer enough staff to provide safe patient care: Implement regional plans to transfer patients with COVID-19 to designated healthcare facilities, or alternate care sites with adequate staffing. If not already done, implement plans (see contingency capacity strategies above) to allow asymptomatic HCP who have had an unprotected exposure to SARS-CoV-2 but are not known to be infected to continue to work. If HCP are tested and found to be infected with SARS-CoV-2, they should be excluded from work until they meet all Return to Work Criteria.

II. Summary of immediate jeopardy for serious harm

A. The facility failed to follow infection control standards, facility policy and directives from the local public health department (LPHD) to prevent possible transmission of the infectious disease, COVID-19. Specifically, the facility failed to screen, test, cohort, quarantine, surveil, and properly care for patients suspected of exposure to COVID-19, following discovery of a staff testing positive for the virus.
1. Failure to implement facility policies and CDC guidelines, to take prompt steps upon discovery of COVID-19 in the facility to minimize exposure and prevent transmission of COVID-19.

On 9/11/20, a Mental Health Technician (MHT #10) experienced COVID-19 symptoms and was tested for the infectious disease. She failed to notify the facility of her symptoms and that she had been tested. MHT #10 reported to work on 9/12/20 and 9/13/20. On 9/14/20, MHT #10 reported to the facility she tested positive for COVID-19. As of 9/14/20, the facility knew of patient and staff exposure to COVID-19 and were required by facility policy and CDC guidelines to immediately implement infection control measures to contain the spread of the virus.

However, interviews and document review revealed the only action the facility took from 9/14/20 - 9/17/20, was to conduct their own contact tracing.

2. The facility held a meeting on 9/18/20 where the Local Public Health Department (LPHD) directives were reviewed. The LPHD directives (see above) included, consistent with related CDC guidelines and recommendations:

Testing all patients and staff for COVID-19, creating a separate COVID-19 unit, and quarantining any patients who had been possibly exposed to COVID-19 by the infected MHT individually isolating patients who were exposed in separate rooms on the COVID-19 unit. In addition, the facility should cohort potentially exposed staff to work the same shifts, on the same unit, and with the same patients to prevent further exposure and spread of infection to other staff and patients. Further, the facility was to conduct surveillance and reach out to the state ' s Disease Control and Environmental Epidemiology Division for further guidance.

However, the above directives and related CDC guidelines and recommendations were not followed.

Observations, interviews and document review, which included video review, conducted from 9/21/20 through 9/28/20 revealed:

Although the facility attempted to create a designated COVID-19 patient care unit, staff were not provided CDC recommended PPE, patients were not quarantined to their rooms, staff were not cohorted to the same shifts, units, and patients, and signs were not posted on the designated COVID-19 unit to advise staff of the recommended PPE for the unit. In addition, staff failed to enforce social distancing and prevent co-mingling of exposed and non-exposed patients. Finally, the facility continued to admit new patients and placed them in the COVID-19 unit, even though the new patients had not been exposed and had not received positive test results for COVID-19.

Further, the LPHD notified the facility on 9/18/20, that a registered nurse (RN #3) reported symptoms which met clinical criteria for a probable case of COVID-19, given her exposure. Because she was a probable case, RN #3 was issued isolation orders through 9/27/20 and instructed not to work until 9/28/20. Interviews and documentation review revealed the RN worked on 9/19/20 and 9/21/20 in multiple patient care areas in direct violation of the isolation orders she received.

Observations also revealed the infection control RN provided non-medical face masks to staff who were providing direct patient care, and failed to ensure patients exposed to COVID-19 were informed at discharge to consult with local public health providers regarding follow-up COVID-19 testing.

In addition, the facility was unable to provide evidence of COVID-19 surveillance; multiple requests were made for the surveillance, including the contact tracing done, reconciliation of patient and staff testing completed and any past testing of patient and staff. As of the exit of the survey (9/28/20), none was provided.

Finally, interviews revealed the facility failed to reach out to the state's Disease Control and Environmental Epidemiology Division for further guidance until after an Immediate Jeopardy was declared on 9/21/20.

B. An immediate jeopardy was called on 9/21/20 at 5:23 p.m. due to the infection concerns identified while on survey. The immediate jeopardy was not abated prior to exit of the survey.

III. Observations, interviews, video and document review of facility failures in infection control

A. Failure to follow LPHD directives and CDC recommendations

1. Failure to ensure all patients and staff had been tested for COVID-19.

See above; CDC recommendation and LPHD directives were to test all staff and patients following discovery of a staff's positive COVID-19 test.

The facility was unable to provide evidence of COVID-19 surveillance (testing data) for all staff and patients. Multiple requests for the surveillance data, including the reconciliation of patient and staff testing completed and any past testing of patient and staff was requested.

On 9/28/20 at 10:43 a.m., the Chief Executive Officer (CEO) #1 stated the facility was unsure which staff had been tested for COVID-19 and was unable to provide documentation that showed which patients and employees had been tested. CEO #1 stated it was important to know who had been tested and which had not, as test results will help prevent the spread of infection.

As of the exit of the survey (9/28/20), the facility was unable to provide evidence all staff and patients had been tested for COVID-19.

2. Failure to cohort and quarantine patients as directed. The facility transferred patients exposed to COVID-19 to an already occupied patient unit, failed to isolate the patients to their rooms and failed to place patients in individual rooms.

See above; CDC recommendations read to consider, and LPHD directed, that the facility create a separate COVID-19 unit with dedicated staff and if not possible to designate a unit, then to isolate the patients to their rooms.

a. Interview, record review and observations revealed patients who were exposed to a COVID-19 positive staff member were moved to the newly designated COVID-19 cohort unit (300 isolation unit), which was already occupied by patients who had not been exposed to COVID-19. Furthermore, the facility continued to admit new patients who were not previously suspected of exposure to COVID-19 and placed the new patients into shared rooms on the COVID-19 cohort unit. This was in conflict with the LPHD directive and CDC recommendations provided.

i. On 9/21/20 at 12:20 p.m., CNO #2 and CEO #1 were interviewed. CNO #2 stated patients who had been exposed to the COVID-19 positive staff member were moved to the 300 unit on 9/18/20, despite the unit being occupied by patients who had not been exposed to the staff member. CNO #2 then stated the facility continued to admit new patients, who had not been exposed, to the cohort unit because the unit had available beds and staff.

CEO #1 stated patients were admitted to the unit due to a lack of staffing at the facility.

CNO #2 and CEO #1 both stated the facility did not initiate any actions outside of conducting its own contact tracing from 9/14/20 until 9/18/20. This was in conflict with facility policy which read, any post-admission patient reasonably suspected of coronavirus infection based on signs and symptoms will immediately be donned with a surgical mask over the mouth and nose, and isolated in a designated isolation space with the door closed.

ii. Review of the facility contact tracing spreadsheet provided by CNO #2 revealed a list of 10 patients who had been exposed to the COVID-19 positive staff member. Five of the patients according to CNO #2 had been discharged, yet on 9/21/20 at 11:20 a.m., the 300 unit had 10 patients.

iii. On 9/21/20 at 11:20 a.m., an observation of the 300 unit revealed five patients (Patient #3, #4, #18, #19 and #20) on the unit who, according to the contact tracing spreadsheet, had not been exposed to the COVID-19 positive staff member.

Patient #18 was a 72 year old female with a history of hypertension which according to CDC guidelines made her an increased risk for severe illness from COVID-19.

Patient #3 was a 67 year old female with a history of hypertension which according to CDC guideline