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Based on interview and record review, the facility failed to provide another copy of the "Important Message from Medicare" (IM) prior to discharge in a timely manner for one of 41 sampled patients (Patient 5). This failure had the potential for the facility not to provide the patient guidance for rights to appeal Medicare.

Findings:

A review of the Admitting face sheet for Patient 5, indicated the patient was admitted on February 16, 2015, at 8:43 PM, with diagnoses which included intracranial hemorrhage (bleeding in the brain). Patient 5 was discharged on March 3, 2015, at 12:30 PM.

A review of the "An Important Message From Medicare About Your Rights" (IM) for Patient 5, indicated the patient gave a verbal acknowledgement of receipt of the notice, and understanding of the rights provided on February 16, 2015, at 5:40 PM. This was also signed by two (2) hospital staff to verify verbal consent from Patient 5. However, there was no second notice provided to the patient or the family member before discharge in the medical record.

During an interview with the Clinical Nurse Educator (CNE) on March 5, 2015, at 10:01 AM, the CNE confirmed there was no second IM in the medical record.

During an interview with the Director of Health Information Manager (DHIM) on March 5, 2015 at 10:08 AM, the DHIM stated the IM is offered on admission and within 48 hours before discharge. The DHIM stated the case manager of the unit is responsible for the process of providing a copy of the IM to the patient or the family members on admission and discharge.

During an interview with the Intensive Care Unit/Telemetry Unit Case Manager (CM 1) on March 5, 2015, at 1:55 PM, the CM 1 stated Patient 5 was a Medicare Advantage beneficiary. The CM 1 said Patient 1 or the family member should have received the second notice of the IM, and the unit secretary failed to provide the IM to Patient 5, or the family member. The CM 1 stated Patient 5 did not have the IM in the patient's medical records.

The facility policy and procedure titled, "Medicare Appeal Rights" revised May 2014, indicated under "Unit Secretaries: 1. Unit Secretaries will access a daily Medicare and Medicare Advantage census and will issue the second copy of the Important Message to the patient within 48 hours of discharge. Note the original form stays with the Medical Record." Under the "Case Management/Nursing: 1... For unplanned discharges, the Important Message will be given on day of discharge but the patient must be allowed at least four (4) hours to consider their rights to request a Quality Improvement Organization (QIO) review."

Based on interview and record review, the facility failed to renew the use of restraints with a physician's order as indicated on the facility policy and procedure for one (1) of 41 sampled patients (Patient 5). This failure had the potential for unauthorized use of restraints to a non-violent/non-combative patient.

Findings:

A review of the Admitting face sheet for Patient 5, indicated the patient was admitted on February 16, 2015, at 8:43 PM with diagnoses which included intracranial hemorrhage (bleeding in the brain). Patient 5 was discharged on March 3, 2015 at 12:30 PM.

A review of the Consent to Surgery/Medical Procedure on February 17, 2015 at 12:45 PM, indicated Patient 5 had a peripheral central catheter (a large bore catheter inserted through the left or right upper arm used for longer fluid management) placed.

A review of the Non-Combative/Non-Violent Restraint Order (initial order for restraint) for Patient 5 on February 18, 2015 at 8:15 PM, signed by the physician, indicated the restraint was initially used for "attempts to pull out tubes and lines" (peripherally inserted central catheter). The Non-Combative/Non-Violent Restraint Order further indicated a "soft limb restraint" (soft cloth wrapped around both wrists to prevent pulling out lines) was used.

A review of the Emergency Adult Intubation (placement of a tube through the mouth down to the lungs to aid in breathing) Procedure Note on February 19, 2015 at 9:00 PM, indicated Patient 5 had an endotracheal tube (a tube inserted through the mouth down to the lungs) placed.

A review of the Medical Restraint Orders indicated the initial restraint order was renewed on February 19, 2015 at 1000 [10:00 AM]. The February 19, 2015 restraint order was renewed on February 20, 2015 at 2000 [8:00 PM], which is 32 hours after the previous order.

A review of the Medical Restraint Orders on February 23, 2015, at 7:03 PM, indicated the restraint order was renewed 59 hours after the previous renewal order of the restraint.

A review of the restraint documentation by different nurses from February 18, 2015 at 8:15 PM until February 23, 2015 at 10:00 PM, indicated the soft limb restraints were used and documented every 2 hours continuously.

During an interview with the Clinical Nurse Educator (CNE) on March 5, 2015 at 10:14 AM, the CNE confirmed the restraints were continuously used even during the period when the restraints orders were not renewed by the physician in a timely manner on February 20, 21, and 22, 2015.

During an interview with the Intensive Care Unit Nurse Manager (ICUNM) on March 5, 2015 at 2:00 PM, the ICUNM confirmed the restraint orders were not renewed in a timely manner on February 21 and 22, 2015.

The facility policy and procedure titled, "Restraints for Non-Combative, Non-Violent Patients" revised June 2014, indicated: "...6. Patients will be placed in restraint only on the order of a physician or nurse practitioner (NP). An order will be obtained for each medical restraint episode, which is no longer than a 24 hour period."

The facility failed to ensure the Quality Assessment and Performance Improvement Condition of Participation was met by failing to:

1. Ensure the Radiology Safety Questionnaire contained patient allergy screening questions. (Refer to A-273)

2. Ensure the Radiologic Safety Questionnaire was integrated into the Quality Assessment and Performance Improvement (QAPI) program and approved by facility leadership before utilization. (Refer to A-273)

The cummulative effect of these practices resulted in an increased risk of a poor health outcome for all Radiology patients.

Based on interview and record review, the facility Quality Assessment and Performance Improvement (QAPI) committee failed to ensure:

1. The Radiology Safety Questionnaire contained questions regarding patient allergies.

2. The Radiology Safety Questionnaire was reviewed and approved by all levels of hospital leadership before being utilized.

This practice increased the risk of an adverse reaction for all Radiology patients in the hospital utilizing the service.

Finding:

On September 22, 2014, Patient 42 had a magnetic resonance imaging procedure (MRI- imaging using magnetic field and pulses to make pictures of organs) "with and without" contrast (a media used to improve the visibility of body structures) of the head/brain. After the MRI technician injected the contrast, Patient 42 developed an itchy throat, felt nauseated, and was short of breath and eventually passed out.

The hospital's Rapid Response Team intervened and immediately transferred Patient 42 to the Emergency Department (ED). A review of the MRI procedure notes documented Patient 42 complained of dizziness, a sharp shooting pain in her left cheek, shortness of breath and exhibited a possible seizure within three minutes of the contrast injection.

A review of the MRI/Radiology Department's policy and procedure noted a "Safety Questionnaire" must be discussed with every patient, before the procedure, to screen for possible allergies/allergic reactions to Intravenous (in the vein) contrast prior to all procedures. This procedure was not done in this case, which was confirmed by the MRI Director. This failure resulted in Patient 42 developing an allergic reaction manifested by a seizure and asthmatic attack (shortness of breath), resulting in the need for ED intervention.

A review of the current Imaging Department MRI History and Screening Form (the MRI Safety Questionnaire), undated, indicated, "Are you allergic to, or have you had a previous reaction to gadolinium-based contrast (gadolinium is a metal ion that moves differently in a magnetic field, useful for MRI) agents?" The form also indicated, "List Allergies." Review of the form indicated there was no documented evidence that the form had been approved for use by the facility.

During an interview with the Imaging Services Director (ISD), on March 3, 2015 at 9:40 AM, when asked which committees approved the updated MRI Safety Questionnaire, the ISD stated that they "Rely on the Radiation Safety Committee to address many of the issues addressed in the MRI Questionnaire." He stated the Radiology "Medical Director sits on that committee." He stated the form is "only used by the Radiology Department." At that time, the ISD was unable to provide documented evidence to show a meeting was conducted regarding changes made to the MRI Safety Questionnaire or facility approval of the form.

During a group QAPI interview, on March 5, 2015 at 11:30 AM, the DPS was asked if there was documentation of facility leadership approval of the changes made to the MRI Safety Questionnaire. The DPS stated, "The Department of Radiology approved the form." He said the form was kept in the department, only the Radiology Department completes that form. He acknowledged the approval process "didn't go further." The DQMSS stated, 99% of forms go to the Medical Executive Committee (MEC-represents the medical staff), and they are usually attached to a hospital policy. That is how the process is supposed to work, but it didn't happen in this case."

During an interview with the ISD, on March 5, 2015 at 3:20 PM, he stated the revised, unapproved, MRI Safety Questionnaire was being used at that time. The electronic medical record was reviewed during the interview and it was verified the MRI Safety Questionnaire was already being used and was incorporated into patient medical records.

The facility policy and procedure titled, "Policy Formulation, Revision and Approval Process", Revised May 10, 2013, indicated, "Purpose. To provide a consistent structure for implementing and achieving hospital goals and providing patient care. To assure that the same standards apply in all areas of the hospital. to establish a mechanism that ensures appropriate review and approval of policies...Patient Care policies will be approved by Administration, the Medical Executive Committee, and the Board of Directors of the hospital...Policies should be reviewed by the appropriate Director, Medical Director (if appropriate), and Administration at least annually."

The facility failed to ensure the Radiologic Services Condition of Participation was met by failing to:

1. Maintain compliance with facility policy and accepted standards of practice regarding patient allergy screening. (Refer to A-529)

2. Ensure that the Radiology Safety Questionnaire was integrated into the Quality Assessment and Performance Improvement (QAPI) program and approved by facility leadership before utilization. (Refer to A-273)

The cumulative effect of these practices resulted in an increased risk of a poor health outcome for all Radiology patients in the hospital utilizing the service.

Based on interview and record review, the facility failed to follow accepted standards of practice and facility policy regarding allergy screening of Radiology patients. The facility failed to ensure the Radiology Safety Questionnaire was reviewed and approved by the Quality Assessment and Performance Improvement (QAPI) program and facility leadership before utilization. This practice increased the risk of an adverse reaction for all Radiology patients.

Finding:

On September 22, 2014, Patient 42 had a magnetic resonance imaging procedure (MRI- imaging using magnetic field and pulses to make pictures of organs) "with and without" contrast (a media used to improve the visibility of body structures) of the head/brain. After the MRI technician injected the contrast, Patient 42 developed an itchy throat, felt nauseated, and was short of breath and eventually passed out. The hospital's Rapid Response Team intervened and immediately transferred Patient 42 to the Emergency Department (ED). A review of the MRI procedure notes documented Patient 42 complained of dizziness, a sharp shooting pain in her left cheek, shortness of breath and exhibited a possible seizure within three minutes of the contrast injection. A review of the MRI/Radiology Department's policy and procedure noted a "Safety Questionnaire" must be discussed with every patient, before the procedure, to screen for possible allergies/allergic reactions to Intravenous (in the vein) contrast prior to all procedures. this procedure was not done in this case, which was confirmed by the MRI Director.

This failure resulted in Patient 42 developing an allergic reaction manifested by a seizure and asthmatic attack (shortness of breath), resulting in the need for ED intervention.

During a review of the current Imaging Department MRI History and Screening Form (the MRI Safety Questionnaire), undated, indicated, "Are you allergic to, or have you had a previous reaction to gadolinium-based contrast (gadolinium is a metal ion which moves differently in a magnetic field, useful for MRI agents?" The form also indicated, "List Allergies." Review of the form indicated there was no documented evidence to show the form had been approved for use by the facility.

During an interview with the Imaging Services Director (ISD), on March 3, 2015 at 9:40 AM, when asked which committees approved the updated MRI Safety Questionnaire, he stated they "Rely on the Radiation Safety Committee to address many of the issues addressed in the MRI Questionnaire." He stated the Radiology "Medical Director sits on that committee." He further stated the form is "only used by the Radiology Department." At that time the ISD was unable to provide documented evidence of a meeting conducted regarding changes made to the MRI Safety Questionnaire or facility approval of the form.

During a group QAPI interview, on March 5, 2015 at 11:30 AM, the DPS was asked if there was documentation of facility leadership approval of the changes made to the MRI Safety Questionnaire. The DPS stated, "The Department of Radiology approved the form." He said the form was kept in the department, only the Radiology Department completes that form. He acknowledged the approval process "didn't go further." the DQMSS stated, 99% of forms go to the Medical Executive Committee (MEC-represents the medical staff), and they are usually attached to a hospital policy. That is how the process is supposed to work, but it didn't happen in this case."

During an interview with the ISD, on March 5, 2015 at 3:20 PM, he stated the revised MRI Safety Questionnaire was being used for patients at that time. The electronic medical record was reviewed during the interview and it was verified that the MRI Safety Questionnaire was being used and was incorporated into patient medical records.

A review of the facility Imaging Department Policy No. 024, revised June 2013, indicated, "Technologist Review and Documentation of Risk Factors Prior to I.V. Contrast Injection...The information will be reviewed by the technologist and documented on the History and Screening Form for Iodine Injection or the MRI Questionnaire Form (MRI Safety Questionnaire)...All contrast administered under "direct supervision" will follow ACR (American College of Radiology) guidelines, department protocols, and be documented in the patient record by the technologist."

A review of the American College of Radiology (ACR) Manual on Contrast Media, Version 9, authored by the ACR Committee on Drugs and Contrast Media, dated 2013, indicated, "Adverse side effects from the administration of contrast media vary from minor physiological disturbances to rare severe life-threatening situation...Risk Factors for Adverse Intravenous Contrast Material Reactions. Allergy: With regard to specific risk factors, a history of prior allergy-like reaction to contrast media is associated with an up to five fold increased likelihood of the patient experiencing a subsequent reaction. Additionally, any allergic diathesis (hereditary tendency) predisposes (to make vulnerable) individuals to reactions...Any patient who describes an "allergy" to a food or contrast media should be questioned further to clarify the type and severity of the "allergy" or reaction...The frequency of acute adverse reactions to gadolinium contrast media is about eight (8) times higher inpatients with a previous reaction to gadolinium-based contrast media...Persons with asthma and various other allergies, including to other medications or foods are also at greater risk..."

The facility policy and procedure titled, "Policy Formulation, Revision and Approval Process," Revised May 10, 2013, indicated, "Purpose. To provide a consistent structure for implementing and achieving hospital goals and providing patient care. To assure that the same standards apply in all areas of the hospital. To establish a mechanism that ensures appropriate review and approval of policies...Patient Care policies will be approved by Administration, the Medical Executive Committee, and the Board of Directors...Policies should be reviewed by the appropriate Director, Medical Director (if applicable), and Administration at least annually."