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Based on the manner and degree of standard level deficiencies referenced to the Condition, it was determined the Condition of Participation §485.627 ORGANIZATIONAL STRUCTURE was out of compliance.

C-0241 - Standard: Governing Body or Responsible Individual - The Governing Body failed to ensure the role and responsibility of mental health providers providing consultation and conducting assessments for hospital patients was clearly delineated by contract or through medical staff bylaws. This failure resulted in non-contracted and non-affiliated personnel to access patient's current status and medical history, assess patients while in the care of the facility and coordinate the transfer of patients requiring psychiatric hospitalization or outpatient services on behalf of the facility.

Based on interview and document review, the Governing Body failed to ensure the role and responsibility of mental health providers providing consultation and conducting assessments for hospital patients was clearly delineated by contract or through medical staff bylaws.

This failure resulted in non-contracted and non-affiliated personnel to access patient's current status and medical history, assess patients while in the care of the facility and coordinate the transfer of patients requiring psychiatric hospitalization or outpatient services on behalf of the facility.

POLICY

According to the policy, Management of Psychiatric Patients, (three identified external agencies) may be called to assist in appropriate referral and transfer or admit as indicated.

REFERENCE

According to the Bylaws of the Board of Directors (Board), the Board shall have full power and authority to adopt policies and procedures for the operation of the hospital. The Board shall have the following powers and duties: To review and approve the bylaws, rules and regulations, policies, procedures, plans and manuals of the Hospital Medical Staff; To determine which categories of healthcare practitioners are entitled to join the Hospital's Medical Staff and/or exercise clinical privileges.

The Board shall determine which categories of non-physicians shall be eligible to provide health care services and/or exercise clinical privileges at the Hospital. The rights and responsibilities of such non individuals and the procedures for credentialing such individuals shall be set forth in the Medical Staff Documents.

The Medical Staff Bylaws define the term "medical staff" as that group of healthcare professionals who have been granted appointment by the Board of Trustees. The medical staff is responsible for the quality of medical care in the hospital and is subject to the ultimate authority of the hospital's governing body. The cooperative efforts of the medical staff, the chief executive officer, and the governing body are necessary to fulfill the hospital's obligations to its patients.

FINDINGS

1. The Governing Body did not ensure the Medical Staff Bylaws addressed practitioners providing specialized mental health services at the facility and failed to evaluate the quality of care provided by these practitioners.

a) On 11/30/17, the current Bylaws of the Board of Directors, the Medical Staff Bylaws, and the Medical Staff Rules and Regulations were reviewed. The role, responsibility, oversight and review of the quality of care provided by the external mental health service provider entity was not addressed in any of these documents.

b) On 11/28/17, a list of contracted services utilized by the facility was provided. There was no contract included for the mental health service provider utilized by the facility.

On 11/28/17, an index of policies and procedures followed by the facility was provided. The policy, referenced above, which outlined the management of psychiatric patients, noted several provider entities who could be called for assistance; however, the authority and procedures for utilizing these services and an outline of how the services would be evaluated was not addressed.

c) During an interview with the Chief Executive Officer (CEO #3) on 11/28/17 at 4:24 p.m., s/he stated there was no contract with the external mental health provider entity. CEO #3 stated s/he needed to revise the policy which outlined the procedures for medical screening and planned to take that policy to the Board of Directors meeting in December. S/he stated s/he had not been aware until recently the Board of Directors needed to address the requirement of who was able to perform a medical screening.

During a subsequent interview on 11/29/17 at 10:57 a.m., CEO #3 stated the process for patients presenting to the facility with mental health issues was to call the external mental health provider entity and request a face to face person to provide the mental health component of care. S/he stated their role was to locate follow-up care and coordinate placement and transportation services.

CEO #3 stated the facility did not bill for the services provided by the external mental health provider entity and was unaware whether the entity billed the patients for the services provided in the hospital.

d) On 11/28/17 at 4:03 p.m., an interview was conducted with the Chief of Staff (Physician #7) who stated for patients who presented with a mental health issue, once the patient was medically cleared, the external mental health provider was contacted and asked to come assess the patient and provide recommendations for care and treatment. S/he stated she was not sure of the credentials of the "emergency responder" who came from the external mental health provider entity but assumed they were social workers or therapists. Physician #7 stated his/her responsibility with the patient ended once the care was turned over to the external mental health provider unless the Physician's assistance was needed with acute medications.

e) On 11/30/17 at 8:28 a.m., an interview was conducted with the Trauma and Emergency Department Director (Director #6) who stated the external mental health facility entity's staff performed the mental health part of the patient's exam and an assessment of risk once a patient who presented with mental health needs was medically cleared. The unaffiliated entity then made recommendations regarding whether inpatient placement was needed or the patient could be sent home with a safety contract. Director #6 stated in both situations the external mental health provider entity typically arranged the follow-up care. Director #6 stated recommendations were provided verbally in discussion, and the written documentation was provided later. Director #6 stated s/he assumed the staff of the external mental health provider entity were qualified and had been vetted by their employer, but the facility did not have a process for vetting or evaluating the mental health provider entity's staff.

f) Record review showed multiple instances where the unaffiliated mental health entity evaluated and decided treatment plans for patients who were currently receiving emergency services at the hospital. As example:

On 09/08/17 at 5:35 p.m., Patient #31 was brought to the Emergency Department by ambulance after a suicide attempt. The patient's Medical Record revealed the external mental health provider staff performed an assessment on the patient at 8:34 p.m.

On 07/30/17 at 6:56 p.m., Patient #29 was brought to the Emergency Department by ambulance after a psychotic event with self-harm thoughts. The patient's Medical Record revealed the external mental health provider staff performed an assessment on the patient at 10:44 p.m.

On 08/08/17 at 6:54 p.m., Patient #28 was brought to the Emergency Department by ambulance for suicidal ideation. The patient's Medical Record revealed the external mental health provider staff performed an assessment on the patient at 8:16 p.m. and again before discharge on 08/09/17 at 12:00 p.m.

Medical record review revealed six additional patients were assessed by the external mental health provider staff in the Emergency Department, as follows:

Patient #22 was assessed on 11/28/17 at 2:50 p.m.

Patient #23 was assessed on 11/01/17 at 5:48 p.m.

Patient #25 was assessed by telephone on 04/29/17 at 0:32 a.m.

Patient #26 was assessed on 08/27/17 at 9:35 p.m.

Patient #27 was assessed on 10/18/17 at 10:23 p.m. A second staff person from the external mental health provider arrived at 10:36 p.m.

Patient #30 was assessed on 07/29/17 at 10:10 p.m.

In addition, a review of the Medical Record for Patient #12, a Swing Bed patient, revealed the staff from the external mental health provider was involved in coordinating transfer of care for the patient.

Cross Reference Tag 0275.

Based on the manner and degree of standard level deficiencies referenced to the Condition, it was determined the Condition of Participation §485.635 PROVISION OF SERVICES was out of compliance.

C-0273 - A description of the services the CAH furnishes, including those furnished through agreement or arrangement. The facility failed to establish a contract with the entity providing mental health services at the facility. This failure allowed personnel who were not affiliated or credentialed by the facility to examine patients and determine treatments which were relied on by the practitioners at the facility.

C-0275 - Guidelines for the medical management of health problems that include the conditions requiring medical consultation and/or patient referral, the maintenance of health care records, and procedures for the periodic review and evaluation of the services furnished by the CAH. The facility failed to establish guidelines for the management of behavioral and psychiatric conditions which required consultation and referral for behavioral or psychiatric services. Additionally, the facility failed to establish guidelines for the maintenance of health records and failed to review services provided by unaffiliated entities on behalf of the facility. This failure resulted in personnel not affiliated with the CAH, and whose credentials, qualifications, background and experience were unknown to the facility, providing mental health evaluations and determining the course of treatments for patients with behavioral and psychiatric conditions.

C-0276 - Rules for the storage, handling, dispensation, and administration of drugs and biologicals. These rules must provide that there is a drug storage area that is administered in accordance with accepted professional principles that current and accurate records are kept of the receipt and disposition of all scheduled drugs, and that outdated, mislabeled, or otherwise unusable drugs are not available for patient use. The facility failed to ensure all mobile carts containing drugs, biologicals, and medication injection supplies remained locked in a secure area when not in use. This failure created the potential for harm by allowing access by unauthorized persons.

C-0278 - A system for identifying, reporting, investigating and controlling infections and communicable diseases of patients and personnel. The facility failed to ensure disinfection of transvaginal probes was performed according to manufacturer instructions and facility policy. The failure created the potential for the transmission of bacteria or cross contamination, creating negative patient outcomes.

C-0291 - The CAH maintains a list of all services furnished under arrangements or agreements. The list describes the nature and scope of the services provided. The facility failed to maintain an agreement with the external mental health provider entity conducting mental health assessments and other services on behalf of the facility. This failure resulted in the facility having no control of the nature and scope of services provided by the mental health entity and potentially resulted in negative patient outcomes.

Based on interviews and document review the facility failed to establish a contract with the entity providing mental health services at the facility.

This failure allowed personnel who were not affiliated or credentialed by the facility to examine patients and determine treatments which were relied on by the practitioners at the facility.

POLICY

According to the policy, Management of Psychiatric Patients, (three identified external agencies) may be called to assist in appropriate referral and transfer or admit as indicated.

FINDINGS

1. The facility did not have a contract or policies that described the healthcare service provided by the external mental health service provider entity.

a) On 11/28/17, a list of contracted services utilized by the facility was provided. There was no contract included for the mental health service provider utilized by the facility.

On 11/28/17, an index of policies and procedures followed by the facility was provided. The policy, referenced above, which outlined the management of psychiatric patients, noted several provider entities who could be called for assistance; however, the authority and procedures for utilizing these services was not addressed.

b) During an interview with the Chief Executive Officer (CEO #3) on 11/28/17 at 4:24 p.m., s/he stated there was no contract with the external mental health provider entity.

During a subsequent interview on 11/29/17 at 10:57 a.m., CEO #3 stated the process for patients presenting to the facility with mental health issues was to call the external mental health provider entity and request a face to face person to provide the mental health component of care. S/he stated their role was to locate follow-up care and coordinate placement and transportation services.

c) On 11/28/17 at 4:03 p.m., an interview was conducted with the Chief of Staff (Physician #7) who stated for patients who presented with a mental health issue, once the patient was medically cleared, the external mental health provider was contacted and asked to come assess the patient and provide recommendations for care and treatment. S/he stated she was not sure of the credentials of the "emergency responder" who came from the external mental health provider entity but assumed they were social workers or therapists. Physician #7 stated his/her responsibility with the patient ended once the care was turned over to the external mental health provider unless the Physician's assistance was needed with acute medications.

d) Nine medical records reviewed indicated the external mental health service provider entity had conducted the evaluations of the patients at the facility (Patients #22, 23, 25, 26, 27, 28, 29, 30 and 31). Seven patient records (Patients # 22, 23, 26, 27, 28, 29, and 30) contained some documentation from the mental health service provider entity, such as summary notes, assessments, or safety plans. Two patient records (Patients #25 and 31) contained no documentation from the mental health service provider entity, even though the facility's practitioner notes indicated the mental health service provider had evaluated the patients. Only one record (Patient #22) contained the full psychiatric assessment.

Cross Reference tag 0275.

Based on interview and document review the facility failed to establish guidelines for the management of behavioral and psychiatric conditions which required consultation and referral for behavioral or psychiatric services. Additionally, the facility failed to establish guidelines for the maintenance of health records and failed to review services provided by unaffiliated entities on behalf of the facility.

This failure resulted in personnel not affiliated with the CAH, and whose credentials, qualifications, background and experience were unknown to the facility, providing mental health evaluations and determining the course of treatments for patients with behavioral and psychiatric conditions.

POLICY

According to the policy, Management of Psychiatric Patients, (three identified external agencies) may be called to assist in appropriate referral and transfer or admit as indicated.

FINDINGS

1. The facility failed to establish a process for providing, documenting and evaluating mental health consultative services provided at the facility.

a) During an interview with the Chief Executive Officer (CEO #3) on 11/28/17 at 4:24 p.m., s/he stated there was no contract with the external mental health provider entity.

During a subsequent interview on 11/29/17 at 10:57 a.m., CEO #3 stated the process for patients presenting to the facility with mental health issues was to call the external mental health provider entity and request a face to face person to provide the mental health component of care. S/he stated their role was to locate follow-up care and coordinate placement and transportation services.

b) On 11/28/17 at 4:03 p.m., an interview was conducted with the Chief of Staff (Physician #7) who stated for patients who presented with a mental health issue, once the patient was medically cleared, the external mental health provider was contacted and asked to come assess the patient and provide recommendations for care and treatment. S/he stated she was not sure of the credentials of the "emergency responder" who came from the external mental health provider entity but assumed they were social workers or therapists. Physician #7 stated physician responsibility with the patient ended once the care was turned over to the external mental health provider unless the physician's assistance was needed with acute medications.

c) On 11/30/17 at 8:28 a.m., an interview was conducted with the Trauma and Emergency Department Director (Director #6) who stated the external mental health facility entity's staff performed the mental health part of the patient's exam and an assessment of risk once a patient who presented with mental health needs was medically cleared. The unaffiliated entity then made recommendations regarding whether inpatient placement was needed or the patient could be sent home with a safety contract. Director #6 stated in both situations the external mental health provider entity typically arranged the follow-up care. Director #6 stated recommendations were provided verbally in discussion, and the written documentation was provided later. Director #6 stated s/he assumed the staff of the external mental health provider entity were qualified and had been vetted by their employer, but the facility did not have a process for vetting or evaluating the mental health provider entity's staff.

d) On 11/29/17 at 4:22 p.m., an interview was conducted with a House Coordinator, Registered Nurse (RN #4). S/he stated the facility's process for providing care to patients presenting to the Emergency Department with mental health concerns was to call the physician who would come in, order lab work, and then provide a medical clearance. RN #4 stated the external mental health provider entity was then called and came in and performed a mental health evaluation. The mental health provider entity staff then decided whether the patient was able to go home or qualified for a hold. RN #4 stated this decision was made the mental health provider entity but the doctor tried to interject his/her thoughts.

e) Medical record review revealed Patient #31 was brought to the Emergency Department (ED) on 09/18/17 after a suicide attempt with cutting lacerations. The patient continued to make statements of suicidal ideation while in the ED. The medical record indicated a representative from the external mental health provider entity evaluated Patient #31 and had arranged for admission to a behavioral health facility. However, there was not documentation in the medical record from the mental health entity who conducted the mental health assessment and clinical decision making.

f) Medical record review revealed Patient #25 was brought to the Emergency Department (ED) on 04/28/17 for depression with suicidal ideation and cutting lacerations. The patient continued to state s/he did not feel safe after s/he was admitted to the Emergency Department. Physician #8 assessed the patient, and then stated in his note the external mental health provider entity would "evaluate and manage disposition of this patient. S/he is cleared from a medical standpoint." The medical record indicated a representative from the external mental health had spoken to the patient by telephone only, and then advised the patient should be released to a family member. The facility followed this direction. However, there was no documentation in the medical record from the mental health entity who conducted the telephone mental health assessment and provided clinical decision making.

g) Medical record review showed Patient #23 was brought to the Emergency Department by the police for a suspected suicide attempt. The patient had been seen earlier in the day and had a CT scan to investigate his/her chronic pain. The medical record indicated a representative from the external mental health entity had evaluated the patient and advised the patient could go home with a safety plan in place. However, the mental health assessment completed by the external mental health entity was not in the patient's medical record.

h) The facility documentation for 5 additional medical records reviewed (Patient #s 26, 27, 28, 29, and 30) indicated the external mental health provider entity had conducted mental health assessments for these patients. However, none of these records contained documentation of the mental health assessment conducted.

The facility's standard practice to rely on unaffiliated mental health provider's evaluations and treatment recommendations for patients presenting to the emergency department resulted in patients discharged from the facility without evidence of complete and comprehensive psychiatric evaluation.

Based on observation and interview, the facility failed to ensure all mobile carts containing drugs, biologicals, and medication injection supplies remained locked in a secure area when not in use.

This failure created the potential for harm by allowing access by unauthorized persons.

FINDINGS

1. The facility failed to ensure the mobile emergency code cart was secured at all times while not in use.

a) During a tour of the facility, on 11/27/17 at 4:06 p.m., a code cart was observed unlocked in the Cardiac Services Room, which was also unlocked.

The top drawer of the emergency code cart contained the following medications:
- 2 prefilled syringes 1mg Epinephrine
- 1 prefilled syringe 1mg Atropine
- 2 vials 2% 5 ml Lidocaine
- 1 vial 500 mg Aminophylline
- 3 vials 2.5 mg Albuterol Sulfate
- 1 bottle Nitroglycerin Lingual spray
- 2 vials 150 mg Amiodarone
- 3 tablets 4 mg Ondansetron disintegrating tablets
- 1 opened bottle 81 mg Chewable Aspirin tablets (36 tablets per bottle)

The second drawer contained the following biologicals and injection supplies:
-1 bag 250 ml 0.9% Sodium Chloride solution
-1 bag 500 ml 0.9% Sodium Chloride solution
-13 19 gauge needles
-13 22.5 gauge needles

b) During the tour, The Rehabilitation Department Receptionist (Receptionist #10) stated there was no key available to lock the cart. S/he stated this area was locked after hours; however, the facility's housekeeping staff entered the area to mop each evening.

Based on observation, interviews and document review the facility failed to ensure disinfection of transvaginal probes was performed according to manufacturer instructions and facility policy.

The failure created the potential for the transmission of bacteria or cross contamination, creating negative patient outcomes.

POLICY

According to the Emergency Room policy, Transvaginal Probe Sterilization Protocol for the SonoSite Portable Ultrasound Machine, its purpose was to ensure the proper cleaning/sterilization of the SonoSite transvaginal probe according to the manufacturer's recommendations. The Transvag Probe Sterilization Protocol stated the recommended sterilizing solution is Cidex OPA Solution. Test this solution for effectiveness with a Cidex OPA test strip.

REFERENCE

Cidex OPA Solution Test Strips instruction booklet stated the Cidex OPA Solution Test Strips are semi-quantitative chemical indicators for use in determining whether the concentration of the active ingredient in Cidex OPA Solution is above or below the minimum effective concentration established for Cidex OPA solution. Cidex OPA Solution Test Strips are developed exclusively for monitoring the minimum effective concentration (MEC) of Cidex OPA Solution. It is recommended that Cidex OPA Solution be tested before each usage with the Cidex OPA Solution test strips in order to guard against solution below its MEC of 0.3%.

FINDINGS

1. The facility failed to ensure transvaginal probes were properly disinfected.

a) During a tour of the facility's Radiology Department, on 11/28/17 at 10:49 a.m., observations were made of the disinfection equipment and supplies for transvaginal probes used in the examination of female patients. Observation of the Cidex OPA Solution Test Strips had a Do Not Use After date of 10/24/17. Review of the Ultra Sound Intravaginal Wand Log revealed a transvaginal probe had been processed 3 times using the expired Chemical Indicator (on 11/03/17, 11/16/17, and 11/27/17). On 11/16/17, the probe was processed using the expired Chemical Indicator prior to and after use of the probe on a patient.

Present during the tour was the Lead Ultrasound Tech (Tech #9) who confirmed the Clinical Indicators were expired and had been used during the disinfection process of a transvaginal probe. S/he was uncertain how the expired Chemical Indicator would affect the disinfection of the probes but believed they should not be used after the expiration date.

b) Chief Executive Officer (CEO #3), who also functions as the infection control officer, provided the logs for the vaginal probe cleaning on 11/28/17 at 2:00 p.m. S/he verified the expired test strips had been used to verify the disinfection of a vaginal probe used on a patient on 11/27/17. CEO #3 confirmed use of control test strips past the documented expiration date was not correct.

Based on interview and document review the facility failed to maintain an agreement with the external mental health provider entity conducting mental health assessments and other services on behalf of the facility.

This failure resulted in the facility having no control of the nature and scope of services provided by the mental health entity and potentially resulted in negative patient outcomes.

FINDINGS

1. The facility did not maintain an agreement with the unaffiliated mental health service provider entity that identified the services to be offered, the individuals providing the services or a process for evaluating the quality of services provided.

a) During an interview with the Chief Executive Officer (CEO #3) on 11/28/17 at 4:24 p.m., s/he stated there was no contract with the external mental health provider entity.

During a subsequent interview on 11/29/17 at 10:57 a.m., CEO #3 stated the process for patients presenting to the facility with mental health issues was to call the external mental health provider entity and request a face to face person to provide the mental health component of care. S/he stated their role was to locate follow-up care and coordinate placement and transportation services.

b) On 11/28/17 at 4:03 p.m., an interview was conducted with the Chief of Staff (Physician #7) who stated for patients who presented with a mental health issue, once the patient was medically cleared, the external mental health provider was contacted and asked to come assess the patient and provide recommendations for care and treatment. Physician #7 stated physician responsibility with the patient ended once the care was turned over to the external mental health provider unless the physician's assistance was needed with acute medications.

c) On 11/30/17 at 8:28 a.m., an interview was conducted with the Trauma and Emergency Department Director (Director #6) who stated the external mental health facility entity's staff performed the mental health part of the patient's exam and an assessment of risk once a patient who presented with mental health needs was medically cleared. The unaffiliated entity then made recommendations regarding whether inpatient placement was needed or the patient could be sent home with a safety contract. Director #6 stated in both situations the external mental health provider entity typically arranged the follow-up care.

Based on interviews and record review the facility failed to maintain complete medical records for patients who received care. Specifically, the facility failed to have a standard process to ensure services provided by an unaffiliated mental health provider entity on behalf of the CAH were complete and received in a timely manner.

This failure resulted in incomplete patient medical information available for continuity of care.

FINDINGS

1. The facility failed to ensure patient medical records were accurate and complete for services provided by an unaffiliated mental health provider entity at the request of the hospital.

a) On 11/30/17 at 8:28 a.m., an interview was conducted with the Trauma and Emergency Department Director (Director #6) who stated the unaffiliated mental health provider entity's staff performed the mental health part of the patient's exam and an assessment of risk once a patient who presented with mental health needs was medically cleared. The unaffiliated entity then made recommendations regarding whether inpatient placement was needed or the patient could be sent home with a safety contract. Director #6 stated in both situations the external mental health provider entity typically arranged the follow-up care. Director #6 stated recommendations were provided verbally in discussion, and the written documentation was often provided after the fact.

b) On 11/29/17 at 3:48 p.m., an interview was conducted with Physician #2 who saw patients in the facility's Emergency and Inpatient Departments, and at the community clinic. Physician #2 stated when s/he consulted with the unaffiliated mental health provider entity, s/he typically did not see their evaluations but, instead, wrote down what they told her. Physician #2 stated s/he expected there should be standardized documentation of mental health evaluations performed in the facility, but s/he was not sure how the facility accessed the unaffiliated mental health provider entity's documentation.

c) Nine medical records reviewed revealed the external mental health service provider entity had conducted evaluations of patients at the facility. Two patient records (Patients #25 and 31) contained no documentation from the mental health service provider, even though the facility's provider notes indicated the mental health provider had evaluated the patients. Six patient records (Patients #23, 26, 27, 28, 29, and 30) only contained partial documentation, such as a summary or a safety plan, but did not contain the psychiatric evaluation in the record.

Cross Reference Tag 0275.