HospitalInspections.org

The Hospital was out of compliance with the Condition of Participation of Patient Rights.

Findings included:

The Hospital failed for three (Patients #1, #5 and #11) patients in a total sample of thirteen sampled patients to protect and promote patient rights when the Hospital failed to obtain properly executed informed consents prior to planned procedures.

Refer to TAG A131.

Based on records reviewed and interviews, the Hospital failed for three (Patients #1, #5 and #11) patients in a total sample of thirteen sampled patients to protect and promote patient rights when the Hospital failed to obtain properly executed informed consents prior to planned procedures.

Findings included:

The Hospital policy titled Patient Bill of Rights and Patient Responsibilities, undated, indicated that patients have the right to make informed decisions regarding their care.

The Hospital Policy titled Informed Consent, dated 8/15/16, indicated that the informed consent will identify the full procedure and a description of the proposed procedure in plain language that the patient could readily understand.

1.) The Radiology Oncology Consultation, dated 2/1/19, indicated Patient #1 was previously treated for metastatic lung cancer. Patient #1 complained of back pain and had a low back bone metastasis which would be treated with palliative (pain relieving) radiation.

Patient #1's Consent for Radiation Therapy, dated 2/1/19, indicated that Patient #1 consented to have radiation therapy. The Physician did not document on, Patient #1's Consent form, the location (site) to be treated.

The Diagnosis, Staging and Course Form, dated 2/4/19, indicated Patient #1 had metastatic cancer that involved the lower back. The Diagnosis, Staging and Course Form indicated the palliative radiation treatment to be administered at a total dose of 3,000 centiGray (cGy - a radiation dose described in units) for ten treatments.

The Radiation Treatment Log, dated 2/2019, indicated Patient #1 received seven palliative radiation treatments on 2/7/19, 2/11/19, 2/12/19, 2/13/19, 2/14/19, 2/15/19 and 2/20/19 (that was 2100 cGy doses) to the incorrect treatment site, the lung, instead of to the lower back.

2.) Patient #11's Consent for Radiation Therapy, dated 4/3/19, indicated that Patient #11 consented to have radiation palliative therapy. Patient #11's consent for radiation palliative treatment did not specify the location (site) for the radiation therapy.

The Surveyor interviewed Radiation Therapist #2 at 9:00 A.M. on 4/11/19. Radiation Therapist #2 said the patient Consent forms for palliative radiation treatment did not include the specific site for radiation treatment. (This was approximately two months after wrong site radiation therapy was administered for seven treatments to Patient #1).

The Surveyor interviewed the Chief Operating Officer at 1:30 P.M. on 4/11/19. The Chief Operating Officer said Patient #1's and Patient #11's consent forms for palliative radiation treatment were incomplete and did not indicate the location or site to be treated.

The Surveyor interviewed the Quality Manager at 8:15 A.M. on 4/12/19 regarding Patients #1 and Patient #11. The Quality Patient Manager said, Radiation Oncology was not using the correct Bedside Office Procedure Checklist to ensure correct patient, procedure and site. The Quality Manager said that the Bedside/Office Procedure Checklist for correct patient, procedure and site and consent forms were different in the outpatient departments of Radiology and the Pain Clinic. The Quality Manager said the Hospital would need to implement a consistent consent form and time out form to prevent wrong site procedures.

3.) The Consent for Repeated Office Based Procedure, dated 2/14/18, indicated Patient #5 consented for the Pain Clinic to administer Botox injection(s) (a pain medication and muscle relaxant). The Consent for Repeated Office Based Procedure indicated no documentation of site location for the injection.

The Physician History and Physical Examination, dated 7/25/18, indicated Patient #5 had multiple complaints of pain that included migraine headaches, face and neck pain that were adequately controlled with Botox injection(s).

The Hospital Investigation, dated 8/2/18, indicated the Pain Clinic treated Patient #5 with the incorrect medication for the treatment of Patient #5's pain. Patient #5 did not receive the Botox injection that Patient #5 consented to receive.

The Surveyor interviewed the Quality Manager at 8:15 A.M. on 4/12/19. The Quality Manager said at the visit of 7/25/18, Patient #5 received incorrect medications to treat the painful areas. The Quality Manager said that Patient #5's Consent for Repeated Office Based Procedure Form for the Botox injections did not indicate the site for the analgesic treatment.

The Hospital was out of compliance with the Condition of Participation of Quality Assessment & Performance Improvement (QAPI) Program.

Findings included:

Hospital Quality Assessment & Performance Improvement (QAPI) activities failed for three (Patients #1, #5 and #11) of thirteen sampled patients to ensure thorough investigations, review and analysis, of adverse patient events in accordance with Hospital policies, the Safety Program Director Job Description and Hospital Standards of Care regarding informed consent for radiological treatments.

Refer to TAG: A-0273.

Hospital Quality Assessment & Performance Improvement (QAPI) activities failed for one patient (Patient #2) of 13 sampled patients, to identify an opportunity for improvement regarding Emergency Medical Treatment And Labor Act (EMTALA) education.

Refer to TAG: A-0283.

Hospital Quality Assessment & Performance Improvement (QAPI) activities failed for six (Patients #1, #2, #5, #8, #9 and #11) of thirteen sampled patients to ensure thorough investigations, analysis and implementation of preventive actions of adverse patient events in accordance with Hospital policies, the Safety Program Director Job Description and Hospital standard of care.

Refer to TAG: A-0286.

Hospital Executives failed for six (Patients #1, #2, #5, #8, #9 & 11) of thirteen sampled patients to ensure effective and preventative Quality Assessment & Performance Program activities after adverse patient events.

Refer to TAG: A-0309.

Based on records reviewed and interviews Hospital Quality Assessment & Performance Improvement (QAPI) activities failed for six (Patients #1, #2, #5,#8, #9, & 11) of thirteen sampled patients to ensure thorough investigations analysis, monitoring and implementation of corrective action plans, of adverse patient events in accordance with Hospital policies, the Safety Program Director Job Description and Hospital Standards of Care regarding informed consent for radiological treatments, a delayed interactive transfer, site verification prior to treatments and a head injury event.

Findings included:

The Surveyor interviewed the Chief Operating Officer at 1:30 P.M. on 4/11/19. The Chief Operating Officer said that Hospital Quality Assessment & Performance Improvement activities needed a clinical (related to the actual medical, scientific aspects of patient care) focus.

Regarding Patient #1:

Radiological Services failed to ensure: 1.) that Patient #1's physician order for radiation was followed for seven radiation treatments; 2.) that the treatment site for radiation therapy was verified before each visit and; 3.) Patient #1's consent for palliative radiation therapy specified the location (site) for the radiation therapy.

The Physician History and Physical Examination, dated 11/7/18, indicated Patient #1 was recently diagnosed with metastatic lung cancer.

The Neurosurgery Consultation Note, dated 1/22/19, indicated Patient #1 presented to the Emergency Department on 1/21/19 with complaints of worsening back pain. Patient #1 was admitted with severe low back pain. A Computerized Tomography (CT) scan showed a mass in Patient #1's lower back. The Neurosurgery Consultation Note indicated the neurosurgeon recommended that Patient #1 should have a consultation regarding palliative radiation treatment (to treat the symptom of pain).

The Hospital Policy titled Informed Consent, dated 8/15/16, indicated that the informed consent should include the full procedure and a description of the proposed procedure in plain language that the patient could readily understand.

The Hospital policy, Bedside Office Procedure Universal Protocol Checklist, Correct Patient, Procedure and Site, dated 10/2016, indicated that, prior to the procedure, the site for the procedure would be marked by the provider (physician) with his/her initials, a time out would be performed before the start of the procedure, the provider would confirm the correct procedure by reading plain language description from the consent, the patient and team would verify the procedure and the correct site would be confirmed by pointing to the site marked and viewing the X-rays if displayed.

Patient #1's Consent for Radiation Therapy, dated 2/1/19, indicated that Patient #1 consented to have radiation therapy. The Physician did not document on Patient #1's consent form for palliative radiation therapy the location (site) for radiation therapy.

The Radiation Treatment Log, dated 2/2019, indicated Patient #1 received seven palliative radiation treatments on 2/7/19, 2/11/19, 2/12/19, 2/13/19, 2/14/19, 2/15/19 and 2/20/19 (that was 2100 cGy doses) to the incorrect treatment site, the lung, instead of to the lower back.

The Hospital Investigation, dated 2/21/19, did not indicate corrective actions regarding the verification of the radiological treatment site during the time out procedure and the Hospital Investigation did not indicate corrective actions regarding formal identification of radiological treatment sites documented on the patient informed consent form. There was no documentation to indicate that the Hospital identified corrective actions that were effective and preventative for future wrong site radiological treatment errors.

The Surveyor interviewed Radiation Therapist #2 at 9:00 A.M. on 4/11/19. Radiation Therapist #2 said the patient consents forms for palliative radiation treatment did not include the specific site for radiation treatment. (This was approximately two months after wrong site radiation therapy was administered for seven treatments to Patient #1).

Regarding Patient #2:

Hospital QAPI activities failed to conduct a clear and thorough investigation of events regarding Patient #2's delayed interfacility transfer and implement timely and effective corrective actions and monitor those corrective actions.

A.) The Discharge Summary indicated Patient #2 had a discharge diagnosis of subacute left hemispheric subdural collection (brain bleed, head injury) with complications of presumed status epilepticus (seizures) after a fall. The Discharge Summary indicated the cause of Patient #2's delayed interfacility transfer. The Discharge Summary indicated a Critical Care Unit Physician intubated (inserted a breathing tube) Patient #2 in the Critical Care Unit due to concerns for airway protection by the Emergency Medical Services (EMS) team to protect Patient #2's airway prior to transfer to a higher level of care hospital.

The Hospital Action Plan, dated 2/23/19, indicated there were delays in Patient #2's transfer from the Hospital to a higher level of care hospital due to Patient #1's need for intubation. The Hospital Action Plan indicated updating the Interfacility Transfer Policy with the Interfacility Transfer Form and nursing and provider education as corrective actions.

The Surveyor interviewed the Patient Safety Director at 2:00 P.M. on 4/10/19. The Patient Safety Director said the Hospital conducted an investigation regarding Patient #2's delayed interfacility transfer. The Patient Safety Director said the Hospital investigation identified corrective actions as follows. The Patient Safety Director said when EMS arrived in the Critical Care Unit, EMS asked Critical Care Registered Nurse #1 about intubating Patient #2 prior to transfer and Critical Care Registered Nurse #1 told EMS that there was no indication that Patient #2 needed to be intubated (there was no doctor's order for intubation).

The Patient Safety Director said the Interfacility Transfer Policy and Interfacility Transfer Form were updated; however, the Interfacility Transfer Packet included an outdated form which indicated the Hospital did not thoroughly implement the action plan.

The Hospital provided no documentation to indicate nursing or provider education.

B.) The Patient Safety Director said, while EMS was transporting Patient #2 through the Emergency Department (ED) to the ambulance, online medical control (EMS contact to a physician for medical instructions) was contacted for further instructions and an ED physician evaluated Patient #2 and agreed to intubate Patient #2 for a Glasgow Coma Score of 4 (a GCS of 8 or less indicated Patient #2 had severe head injury).

The Action Plan indicated Crew Resource Team Education for the ED and acute care as the corrective action.

The Patient Safety Director said the Hospital did not implement the Crew Resource Team Education in the ED and acute care.

The Hospital investigation failed to identify that ED Physician #1 did not document a Medical Screening Examination when ED Physician #1 agreed that Patient #2 required intubation prior to transport.

C.) The Surveyor interviewed the Nurse Supervisor at 2:20 P.M. on 4/11/19. The Nurse Supervisor said that he thought it was an Emergency Medical Treatment and Labor Act (EMTALA) violation to intubate Patient #2 in the ED.

The Surveyor interviewed ED Physician #1 at 3:40 P.M. on 4/11/19. ED Physician #1 said he requested staff to register Patient #2 into the ED. ED Physician #1 evaluated Patient #2 as needing intubation prior to transport and prepared to intubate Patient #2. ED Physician #1 said the Nurse Supervisor said it was "illegal" to intubate Patient #2 in the ED and the Nurse Supervisor canceled the Patient #2's discharge and the Charge Nurse transferred Patient #2 back to the Critical Care Unit without his knowledge or transfer order. ED Physician #1 said he did not write a note because the he was instructed not to document in Patient #2's medical record and was instructed to document the event in a Hospital event report.

The Surveyor interviewed Critical Care Nurse #1 at 5:30 P.M. on 4/11/19. Critical Care Nurse #1 said EMS did not mention anything about intubating Patient #2.

The Hospital investigation failed to identify why the Nurse Supervisor and the ED Charge Nurse thought it was "illegal" to intubate Patient #2 in the ED and implement corrective action(s).

Regarding Patient #5:

Hospital QAPI activities failed to conduct a thorough analysis regarding Patient #5's incorrect injection treatment that identified site documentation on informed consents. Hospital QAPI activities failed to implement timely and effective corrective actions and to monitor corrective actions.

The Physician History and Physical Examination, dated 7/25/18, indicated Patient #5 had multiple complaints of pain that included, migraines headaches, face and neck pain that were adequately controlled with Botox injection(s).

The Consent for Repeated Office Based Procedure Form, dated 2/14/18, indicated Patient #5 consented for the Pain Clinic to administer Botox injection(s) (a pain medication and muscle relaxant). The Consent for Repeated Office Based Procedure Form indicated no documentation of site location for the injection.

The Surveyor interviewed the Quality Manager at 8:15 A.M. on 4/12/19. The Quality Manager said at the visit of 7/25/18, Patient #5 received incorrect medications to treat the painful areas. The Quality Manager said that Patient #5's Consent for Repeated Office Based Procedure Form for the Botox injections did not indicate the site for the analgesic treatment.

The Hospital Investigation, dated 8/2/18, indicated the Pain Clinic treated Patient #5 with the incorrect medication for the treatment of Patient #5's pain. Patient #5 did not receive the Botox injection that Patient #5 consented to receive. The Hospital investigation indicated no clinically effective corrective actions to ensure correct medication administration.

Regarding Patient #8:

Hospital QAPI activities failed to correct the problem as previously identified with Patient #1 in 2/2019, with the specific site verification prior to treatments for planned radiation treatment for Patient #8 on 4/11/19, during Survey, creating the potential for further wrong site radiation therapy, and the time out did not occur in the treatment room with the Patient #8.

Patient #8's Consent for Radiation Therapy, dated 2/22/19, indicated Patient #8 consented to have radiation therapy for cancer of the left breast.

The Surveyor observed, at 8:05 A.M. on 4/11/19, Patient #8's radiological treatment. The Surveyor observed that none of the three radiation therapists conducted a time out and did not verify Patient #8's site and side for radiation therapy at Patient #8's bedside with Patient #8.

Regarding Patient #9:

Hospital QAPI activities failed to conduct a clear and thorough investigation regarding Patient #9's head injury events, implement corrective actions and monitor those actions for effectiveness.

The Newborn Admission and Discharge Examination, dated 1/3/19, indicated Patient #9 had a diagnosis of Neonatal Abstinence Syndrome (are conditions in newborns exposed to addictive opiate drugs while in the womb).

The Surveyor interviewed the Maternal Health Director at 1:45 P.M. on 4/10/19. The Maternal Health Director said the Hospital conducted an investigation regarding the events of Patient #9.

Head Event #1.) The Maternal Health Director said as Registered Nurse #1 stood up from a seated position while holding Patient #9 (a newborn), Patient #9's head hit the side of a table. The Maternal Health Director said Registered Nurse #1 notified a pediatrician and the pediatrician examined Patient #9; however, the Pediatrician did not document Patient #9's examination in Patient #9's medical record.

The Surveyor interviewed Registered Nurse #1 at 10:40 A.M. on 4/12/19. Registered Nurse #1 said a pediatrician examined Patient #9 within 30 minutes of the event and approximately one hour after the event. Patient #9 had swelling and a bruise where the head was hit on the table.

The Hospital provided no documentation or interview for clarification if Registered Nurse #1 contacted a Pediatrician after noting the new head bruise on the evening of 1/8/19.

Registered Nurse #1 said she performed one neurological assessment by checking Patient #1's pupils with a flash light and she did not perform subsequent neurological monitoring. Registered Nurse #1 said ongoing neurological assessment was not performed for early detection of an internal head injury (such as a brain bleed) as would be the standard of practice after an injury to the head. Registered Nurse #1 said she did not document an event note in Patient #9's medical record.

The Hospital provided no documentation to indicate corrective action was taken regarding the medical record containing no documentation of a pediatrician note after Patient #9's head even, no nursing note of the event and no ongoing neurological evaluations.

Hospital QAPI activities failed to identify that neurological assessment was the standard of practice after an injury to the head.

Head Event #2.) The Maternal Health Director said a registered nurse noted a new bump and bruise on Patient #9's head at approximately 2:30 A.M. on 1/20/19; however, the registered nurse did not notify a pediatrician to examine Patient #9.

A pediatrician documented an examination of Patient #9's bump and head bruise on Patient #9's discharge examination on 1/21/19 at 9:30 A.M., approximately 31 hours after the new head bump and bruise of the early morning of 1/20/19.

The Maternal Health Director said Hospital QAPI activities did not investigate why a pediatrician was not notified after a registered nurse noted the new bump and bruise on Patient #9's head at 2:30 A.M. on 1/20/19 and did not know why Patient #9 was not evaluated by a pediatrician until discharge. The Maternal Health Director said the discharging pediatrician ordered an x-ray and CT scan that showed a concern that Patient #9 had a skull fracture.

Hospital QAPI activities failed to investigate why a pediatrician was not notified after a registered nurse noted the new bump and bruise on Patient #9's head at 2:30 A.M. on 1/20/19 and why Patient #9 was not evaluated by a pediatrician until discharge, and therefore no corrective action plan was implemented.

Regarding Patient #11:

Hospital QAPI activities failed to correct the problem as previously identified with Patient #1 in 2/2019, with the specific site verification prior to treatments for planned radiation treatment for Patient #11 on 4/11/19, during Survey, creating the potential for further wrong site radiation therapy. Additionally, Patient #11's consent forms for palliative radiation therapy did not specify the location (site) for this therapy and the time out did not occur in the treatment room with the patient.

Patient #11's Consent for Radiation Therapy, dated 4/3/19, indicated that Patient #11 consented to have palliative radiation therapy. Patient #11's consent for radiation treatment did not specify the location (site) for the radiation therapy.

The Surveyor observed Patient #11, at 9:00 A.M. on 4/11/19, for a radiation treatment to the chest for metastatic colon (bowel) cancer. The Surveyor observed that Radiation Therapist #2 did not verify the radiation treatment site or side. The Surveyor observed no time out with site and side verification was performed in the treatment room with Patient #11.

The Radiation Treatment Log, dated 4/11/19, indicated a Radiation Therapist performed Patient #11's time out procedure. This was not consistent with the Surveyors observations. The Radiation Treatment Log indicated no documentation that a physician performed the time out procedure according to Hospital policy.

The Surveyor interviewed Radiation Therapist #2 at 9:00 A.M. on 4/11/19. Radiation Therapist #2 said that site and side verification for radiation treatments were only performed for the first radiation therapy and performed by the Radiation Therapists. Radiation Therapist #2 said this was not Patient #11's first radiation treatment.

The Surveyor interviewed the Quality Manager at 8:15 A.M. on 4/12/19. The Quality Manager said that the Bedside Office Procedure Checklist for correct patient, procedure and site should be utilized in Radiology and Oncology and include a physician to ensure verification of site and treatment before treatments..

Medical record reviews indicated that The Bedside Office Procedure Universal Protocol Checklist, Correct Patient, Procedure and Site forms were not contained in Patient #1's, Patient #8's or Patient #11's medical record to document correct patient, procedure and site.

The Hospital provided no documentation or interview to indicate that Hospital QAPI activities identified that physicians were not conducting complete bedside time out procedures, including site and side verification, immediately prior to the procedure, including appropriate documentation.

Based on records reviewed and interviews, Hospital Quality Assessment & Performance Improvement (QAPI) activities failed to identify an opportunity for improvement regarding Emergency Medical Treatment And Labor Act (EMTALA) education.

Findings included:

The Surveyor interviewed the Patient Safety Director at 2:00 P.M. on 4/10/19. The Patient Safety Director said Emergency Department Physician #1 planned to intubate Patient #2. The Patient Safety Director said the Nurse Supervisor thought intubation in the Emergency Department was a violation of the Emergency Medical Transfer and Labor Act (EMTALA), sent Patient #2 back to the Critical Care Unit, and a Critical Care Unit Physician intubated Patient #2 for transfer and discharge to a higher level of care hospital.

The Surveyor interviewed the Nurse Supervisor at 2:20 P.M. on 4/11/19. The Nurse Supervisor said that he thought it was an EMTALA violation to intubate Patient #2 in the Emergency Department.

The Hospital investigation failed to identify an opportunity for learning regarding EMTALA regulation education and documentation of EMTALA requirements.

Based on records reviewed and interviews Hospital Quality Assessment & Performance Improvement (QAPI) activities failed for six (Patients #1, #2, #5, #8, #9 & 11) of thirteen sampled patients to ensure thorough investigations, analyze causes and implement corrective action of adverse patient events in accordance with Hospital policies, the Safety Program Director Job Description and Hospital standard of care regarding informed consent for Radiological Treatments, wrong site radiological treatments, incorrect pain treatment, no immediate physician evaluation and the lack neurological assessments.

Findings included:

Hospital policy titled Notification and Response to Sentinel Events (Adverse Patient Event), dated 3/15/19, indicated an adverse patient event investigation was a process for identifying the most basic causes of an adverse patient event through a comprehensive analysis of the event. The adverse patient event process focused on Hospital systems and Hospital processes rather than individual performance and the process identified changes in Hospital systems that may improve patient care.

The job description titled Patient Safety Program Director, dated 11/29/17, indicated the Patient Safety Program Director coordinated analytical review of clinical contents of medical records and associated documents for adherence to safe patient care standards.
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Review of the Patient Safety Program Director personnel records indicated no documentation of experience or education regarding analytical review of clinical contents of medical records and associated documents for adherence to safe patient care standards.

Regarding Patient #1:

The Hospital investigation, regarding Patient #1's wrong site radiological treatments, dated 2/21/19, did not indicate corrective actions regarding the verification of the radiological treatment site during the time out procedure and the Hospital investigation did not indicate corrective actions regarding identification of radiological treatment sites documented on the patient's informed consent form. There was no documentation or interventions to indicated the Hospital implemented corrective actions that were effective and preventative for future wrong site radiological treatment errors.

Regarding Patient #2:

The Action Plan, dated 2/23/19, indicated updating the Interfacility Transfer Policy with the Interfacility Transfer Form and nursing and provider education as corrective actions.

The Hospital provided no documentation to indicate nursing or provider education.

The Hospital investigation failed to identify that the Emergency Department (ED) Physician #1 did not document a Medical Screening Examination when ED Physician #1 agreed that Patient #1 required intubation prior to transport

Regarding Patient #5:

The Hospital Investigation, dated 8/2/18, indicated the Pain Clinic treated Patient #5 with the incorrect medication for the treatment of Patient #5's pain. Patient #5 did not receive the Botox injection that Patient #5 consented to receive. The Hospital Investigation indicated no clinically effective corrective actions.

Regarding Patient #8:

Hospital QAPI activities failed to correct the problem with the specific site verification prior to treatments for planned radiation treatment for Patient #8 on 4/11/19, during Survey, creating the potential for further wrong site radiation therapy and the time out did not occur in the treatment room with the patient.

Regarding Patient #9:

The Hospital provided no documentation to indicate corrective actions regarding the lack of a pediatrician note following Patient #9's first head event.

Hospital QAPI activities failed to identify that neurological assessment was be the standard of practice after an injury to the head.

Hospital QAPI activities failed to investigate why a pediatrician was not notified after a registered nurse noted the bump on Patient #9's head at 2:30 A.M. on 1/20/19 and why Patient #9 was not evaluated by a pediatrician until discharge.

Regarding Patient #11:

Hospital QAPI activities failed to correct the problem with the specific site verification prior to treatments for planned radiation treatment for Patient #11 on 4/11/19, during Survey, creating the potential for further wrong site radiation therapy. Additionally, Patient #11's consent forms for palliative radiation therapy did not specify the location (site) for this therapy and the time out did not occur in the treatment room with the patient.

The Hospital provided no documentation or interview to indicate that Hospital QAPI activities discovered that physicians were not conducting complete bedside time out procedures, including site and side verification, immediately prior to the procedure, including appropriate documentation.

Based on records reviewed and interviews Hospital Executives failed for six (Patients #1, #2, #5, #8, #9 & 11) of thirteen sampled patients to ensure an effective and preventative Quality Assessment & Performance Program activities after adverse patient events.

Findings included:

1.) Hospital policy titled Notification and Response to Sentinel Events (Adverse Patient Event), dated 3/15/19, indicated the adverse patient event process focused on Hospital systems and Hospital processes rather than individual performance and the process identified changes in Hospital systems that may improve patient care.

The Job Description titled Patient Safety Program Director, dated 11/29/17, indicated the Patient Safety Program Director coordinated analytical review of clinical contents of medical records and associated documents for adherence to safe patient care standards.

Review of the Patient Safety Program Director personnel records indicated no documentation of experience or education regarding analytical review of clinical contents of medical records and associated documents for adherence to safe patient care standards.

2.) The Hospital investigation regarding Patient #1 who received radiation therapy to the wrong site for 7 treatments, dated 2/21/19, did not indicate corrective actions regarding the verification of radiological treatment site during the time out procedure and the Hospital investigation did not indicate corrective actions regarding identification of radiological treatment sites documented on the patient informed consent form. There was no documentation or interviews to indicate the Hospital identified corrective actions that were effective and preventative for future wrong site radiological treatment errors.

3.) The Hospital Action Plan, dated 2/23/19 regarding Patient #2 whose discharge was delayed related to failure to intubate prior to leaving the Critical Care Unit, indicated updating the Interfacility Transfer Policy with the Interfacility Transfer Form and nursing and provider education as corrective actions. The Hospital provided no documentation to indicate nursing or provider education. The Hospital investigation failed to identify that Emergency Department (ED) Physician #1 did not document a Medical Screening Examination when ED Physician #1 agreed that Patient #2 required intubation prior to transport

4.) The Hospital Investigation, dated 8/2/18 regarding Patient #5, indicated the Pain Clinic treated Patient #5 with the incorrect medication for the treatment of Patient #5's pain. Patient #5 did not receive the Botox injection that Patient #5 consented to receive. The Hospital investigation indicated no clinically effective corrective actions.

5.) Hospital QAPI activities, regarding Patient #8, failed to correct the problem with the specific site verification prior to treatments for planned radiation treatment for Patient #8 on 4/11/19, during Survey, creating the potential for further wrong site radiation therapy and the time out did not occur in the treatment room with the patient.

6.) The Hospital provided no documentation, regarding Patient #9, to indicate corrective actions regarding the lack of a pediatrician note following Patient #9's first head injury event. Hospital QAPI activities failed to identify that neurological assessment was be the standard of practice after an injury to the head. Hospital QAPI activities failed to investigate why a pediatrician was not notified after a registered nurse noted a new bump and bruise on Patient #9's head at 2:30 A.M. on 1/20/19 and why Patient #9 was not evaluated by a pediatrician until discharge.

7.) Hospital QAPI activities, regarding Patient #11, failed to correct the problem with the specific site verification prior to treatments for planned radiation treatment for Patient #11 on 4/11/19, during Survey, creating the potential for further wrong site radiation therapy. Additionally, Patient #11's consent forms for palliative radiation therapy did not specify the location (site) for this therapy, and the time out did not occur in the treatment room with the patient. The Hospital provided no documentation or interview to indicate that Hospital QAPI activities discovered that physicians were not conducting complete bedside time out procedures, including site and side verification, immediately prior to the procedure, including appropriate documentation.

The Hospital was out of compliance with the Condition of Participation of Radiological Services.

Findings included:

Based on records reviewed and interviews, Hospital Radiological Services failed for three oncology patients (Patient #1, #8 and #11) of thirteen sampled patients to ensure the accurate site(s) for radiation therapy.

Refer to TAG: 0535.

Based on records reviewed and interviews, Hospital Radiological Services failed for three oncology patients (Patient #1, #8 and #11) of thirteen sampled patients to ensure the accurate site(s) for radiation therapy.

Findings included:

Regarding Patient #1:

Radiological Services failed to ensure: 1.) that Patient #1's physician order for radiation were followed for seven radiation treatments, 2.) the site for radiation therapy was verified before each treatment and 3.) Patient #11's consent for palliative radiation therapy specified the location (site) for the radiation therapy.

The Surveyor interviewed Radiation Oncologist #1 at 3:03 P.M. on 4/11/19. Radiation Oncologist #1 said the Standard of Practice followed by the Hospital was from the American Society for Radiation Oncology. Version 1.4, dated 2/1/16.

The Hospital Patient -Specific Safety Interventions and Safe Practices in Treatment Preparation and Delivery indicated an American Society for Radiation Oncology Standard of Care (dated 2/1/16). The Standard of Care indicated that the Radiation Oncology team followed standard operating procedures to ensure safety and consistent high-quality care prior to and during radiation therapy. The Standard of Care indicated the radiation oncology team, for each patient, perform a time out procedure prior to all procedures, including all treatments to conduct patient-specific quality and safety checks as evidenced by documentation of: verification of patient treatment site, verification of correct patient positioning for external beam radiation therapy and verification of treatment delivery, parameters consistent with the approved prescription and plan.

The Hospital policy Bedside Office Procedure Universal Protocol Checklist, Correct Patient, Procedure and Site, dated 10/2016, indicated that. prior to the procedure, the site for the procedure would be marked by the provider (physician) with his/her initials, time out procedure would be performed before the start of the procedure, the provider would confirm the correct procedure by reading plain language description from the consent, the patient and team would verify the procedure and the correct site was confirmed by pointing to the site marked and viewing the X-rays if displayed.

The Hospital Policy titled Informed Consent, dated 8/15/16, indicated that the informed consent include the full procedure and a description of the proposed procedure in plain language that the patient could readily understand.

The Physician History and Physical Examination, dated 11/7/18, indicated Patient #1 was recently diagnosed with metastatic lung cancer.

The Neurosurgery Consultation Note, dated 1/22/19, indicated Patient #1 presented to the Emergency Department on 1/21/19 with complaints of worsening back pain. Patient #1 was admitted with severe low back pain. A Computerized Tomography (CT) scan showed a mass in Patient #1's lower back. Neurosurgery Consultation Note indicated the Neurosurgeon recommended that Patient #1 should have a consultation regarding palliative radiation treatment (to treat the symptom of pain).

The Radiology Oncology Consultation, dated 2/1/19, indicated Patient #1 was previously treated for metastatic lung cancer. Patient #1 complained of back pain and had a lumbar vertebral metastasis and would be treated with palliative radiation treatment to this area.

Patient #1's Consent for Radiation Therapy, dated 2/1/19, indicated that Patient #1 consented to have radiation therapy. The Physician did not document on Patient #1's consent form for palliative radiation therapy the location (site) for the radiation therapy.

The Diagnosis, Staging and Course Form, dated 2/4/19, indicated Patient #1 had metastatic cancer that involved the lower back. The Diagnosis, Staging and Course Form indicated the palliative radiation treatment to be administered at a total dose of 3,000 centiGray (cGy - a radiation dose described in units) for 10 treatments.

The Radiation Treatment Log, dated 2/2019, indicated Patient #1 received seven palliative radiation treatments on 2/7/19, 2/11/19, 2/12/19, 2/13/19, 2/14/19, 2/15/19 and 2/20/19 (that was 2100 cGy doses) to the incorrect treatment site, the lung, instead of to the lower back.

The Patient Setup Note dated 2/23/19, indicated that, on 2/13/19 the Radiation Therapist noticed that the laser (from the radiation machine) position was not consistent (lining-up) with Patient #1's treatment plan (radiation oncologist medical orders). The Patient Setup Note indicated no documentation that correct site verification for Patient #1's treatment was performed despite the laser position was not consistent with medical orders.

The Surveyor interviewed Radiation Therapist #1 at 9:20 A.M. on 4/11/19. Radiation Therapist #1 said that he was one of the radiation therapists present when Patient #1 received radiation treatments on 2/7/19, 2/12/19, 2/13/19 and 2/14/19 in which the wrong site radiation was administered to the lungs instead of the back. Radiation Therapist #1 said the incorrect tattoos (site marking to identify accurate radiation treatment site) on the chest were used instead of the tattoos on the abdomen, which the radiation therapists did not see prior to starting the treatments. Radiation Therapist #1 said the attending radiology oncologist was notified and the measurements for the lasers and the treatment table position were not consistent with the original physician's order dated 2/4/19. The radiation oncologist was notified and said to change the table position (to meet the laser measurements for the radiation treatment). There was no re-evaluation of the treatment site (time out) with the physician to verify if the incorrect tattoo markers were used or if Patient #1 had additional tattoo makers on his/her body, subsequently wrong site radiation treatments continued.

Radiation Therapist #1 said before the initial time out occurred on 2/7/19, the radiation therapists positioned Patient #1 on the treatment table in the treatment room, used the predetermined laser measurements for the new radiation site, performed the X-ray to verify the treatment site, and then the radiation oncologist was called to view the X-ray in the radiation control room (the room next to the Patient #1), but the time out was not performed to visualize Patient #1's new tattoos in the treatment room.

Regarding Patient #8:

Patient #8's Consent for Radiation Therapy, dated 2/22/19, indicated Patient #8 consented to have radiation therapy for cancer of the left breast.

The Surveyor observed Patient #8 at 8:05 A.M. on 4/11/19, walk into the radiation control room (Patient #8 was scheduled for radiation to the left breast). The Surveyor observed that there were three Radiation Therapist in the room. The Surveyor observed Radiation Therapist #2 verify that Patient #8 was the correct patient; however, the Surveyor observed that none of the three radiation therapists verified Patient #8's site for radiation therapy. The Surveyor observed the three radiation therapists then prepare Patient #8 in the treatment room for his/her radiation treatment. The Surveyor observed the three radiation therapists later performed a time out in the radiation control room with the x-rays and electronic record, although no time out with site and side verification was performed in the treatment room with Patient #8.

The Radiation Treatment Log, dated 4/11/19, indicated that the radiation therapist checked off and initialed that the time out was performed for Patient #8. This was not consistent with the Surveyor's observations.

Regarding Patient #11:

Patient #11's Consent for Radiation Therapy, dated 4/3/19, indicated that Patient #11 consented to have radiation palliative therapy. Patient #11's consent for radiation palliative treatment did not specify the location (site) for the radiation therapy.

The Surveyor observed Patient #11 at 9:00 A.M. on 4/11/19, a radiation therapist transported Patient #11 in a wheelchair into the radiation control room, (Patient #11 was scheduled for radiation to the chest due to metastatic colon (bowel) cancer). The Surveyor observed Radiation Therapist #2 verify that Patient #11 was the correct patient, however the Surveyor observed that Radiation Therapist #2 did not verify the radiation treatment site or side. The Surveyor observed three radiation therapists prepare Patient #11 in the treatment room for the radiation treatment. The Surveyor observed three radiation therapists perform a time out in the radiation control room with the x-rays and electronic record, no time out with site and side verification was performed in the treatment room with Patient #11.

The Radiation Treatment Log, dated 4/11/19, indicated a radiation therapist checked off and initialed that the time out was performed for Patient #11. This was not consistent with the Surveyor's Observations.

The Surveyor interviewed Radiation Therapist #2 at 9:00 A.M. on 4/11/19. Radiation Therapist #2 said that site and side verification for radiation treatments were only performed for the first radiation therapy. The time out for the first radiation treatment was performed in the radiation control room with a check mark at the same time as visualizing the imaging of the site by the radiation oncologist and the radiation therapists. Radiation Therapist #2 said the radiation oncologist and the radiation therapist (the team) did not perform a time out in the treatment room with the patients, nor were the patients examined by the radiation oncologist immediately prior to the radiation treatment.

The Surveyor interviewed the Quality Manager at 8:15 A.M. on 4/12/19. The Quality Manager said that the Bedside/Office Procedure Checklist for correct patient, procedure and site should be utilized in radiology and oncology.

Medical record reviews indicated that the Bedside/Office Procedure Checklist were not contained in Patient #1's, Patient #8's or Patient #11's medical record to document correct patient, procedure and site.

Based on records reviewed and interviews the medical staff failed to revise policies and procedures governing medical care provided in the Emergency Department Quality Assessment & Performance Improvement activities.

Findings included:

The Discharge Summary indicated Patient #2 had a discharge diagnosis of subacute left hemispheric subdural collection (brain bleed, head injury) with complications of presumed status epilepticus (seizures) after a fall. The Discharge Summary indicated the cause of Patient #2's delayed interfacility transfer. The Discharge Summary indicated a Critical Care Unit Physician intubated (inserted a breathing tube) Patient #2 in the Critical Care Unit due to concerns for airway protection by the Emergency Medical Services (EMS) team to protect Patient #2's airway prior to transfer to a higher level of care hospital.

Hospital policy titled Emergency Department Scope of Care & Service, dated 11/30/16 and Hospital policy titled Emergency Department Visits, dated 2/28/17, provided by the Hospital as the Hospital's policy & procedures regarding Emergency Medical Treatment & Labor Act (EMTALA), indicated no indication for Hospital policy or procedures regarding EMTALA.

The Surveyor interviewed the Patient Safety Director at 2:00 P.M. on 4/10/19. The Patient Safety Director said while EMS was transporting Patient #2 through the Emergency Department to the Ambulance, Online Medical Control (EMS contact to a physician for medical instructions) was contacted for further instructions and an Emergency Department (ED) Physician evaluated Patient #2 agreeing to intubate Patient #2 for a Glasgow Coma Score of 4 (a GCS of 8 or less indicated Patient #2 had severe head injury).

The Surveyor interviewed the Nurse Supervisor at 2:20 P.M. on 4/11/19. The Nurse Supervisor said that he thought it was an EMTALA violation to intubate Patient #1 in the Emergency Department.

The Surveyor interviewed ED Physician #1 at 3:40 P.M. on 4/11/19. ED Physician #1 said he requested Emergency Department staff to register Patient #2 into the ED. ED Physician #1 evaluated Patient #2 as needing intubation prior to transport and prepared to intubate Patient #2. ED Physician #1 said the nurse supervisor said it was "illegal" to intubate Patient #2 in the ED and the nurse supervisor canceled the inpatient discharge and the charge nurse transferred Patient #2 back to the Critical Care Unit without his knowledge or transfer order. ED Physician #1 said he did not write a note because he was instructed by Medical Staff Leadership not to document in Patient #2's medical record and instructed to document in an event report.