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The Condition of Participation: Quality Assessment and Performance Improvement Program (QAPI) was out of compliance.

Findings included:

Based on records reviewed and interviews, for two of 10 sampled patients (Patient #1 & Patient #2), the Hospital failed to ensure the Quality Assessment and Improvement Program (QAPI) implemented and maintained an effective, ongoing, hospital-wide, data-driven quality assessment, and performance improvement program to ensure safe and effective patient care outcome in response to preventable adverse patient events.

Refer to TAG: A-0286.

Based on records reviewed and interviews, for two of 10 sampled patients (Patient #1 & Patient #2), the Hospital failed to ensure the Quality Assessment and Improvement Program (QAPI) implemented and maintained an effective, ongoing, hospital-wide, data-driven quality assessment, and performance improvement program to implement preventative actions in response to preventable adverse patient events.

Finding include:

1. Review of Patient #1's medical records, indicated he/she presented to the Emergency Department (ED) in April 2023, from an outpatient oncology clinic with progressive bilateral lower extremity numbness, paralysis, and pain. Patient #1, who had a recent diagnosis of B-cell lymphoma was pre-medicated in the ED with morphine and a Magnetic Resonance Imaging (MRI) scan was ordered to evaluate for a possible spinal cord compression. Patient #1 was unable to tolerate the MRI due to pain and discomfort. Patient #1 was admitted to the medical surgical unit with orders for an urgent spine MRI scan, with pre-medication as Patient #1 was unable to tolerate lying flat due to pain, and to consult anesthesia services to assist, if needed.

Review of the Department of Public Health's (DPH) Health Care Facility Reporting System (HCFRS), indicated that the Hospital submitted a Report, dated 5/11/23, indicating that on 4/4/23, Nurse #1 administered combination of medications (later identified as 1 milligram (mg) of Hydromorphone and 2 mg of Lorazepam in 0.9% sodium chloride) intravenously (IV) on the medical surgical unit to treat Patient #1's pain and anxiety, 30 minutes prior to leaving the unit unmonitored and with a messenger escort (non-clinical) staff member for an MRI scan. Patient #1 returned to the unit three hours later and was found obtunded (a state similar to lethargy in which the patient has a lessened interest in the environment, slowed responses to stimulation, and drowsiness) by nursing staff; therefore, a medication emergency team response was called, Patient #1 received two doses of Narcan 0.4 mg/milliliter, and transferred to a higher level of care. The Report indicated the level of sedation (moderate/conscious) that resulted from the combination of the medications administered to Patient #1 prior to the MRI fell within the scope of the Hospital's Moderate Sedation and Analgesia Policy.

The Hospital failed to ensure staff followed the Moderate Sedation Policy, when on 4/4/23, Patient #1's Physician ordered Patient #1 to be premedicated to complete a procedure. The Physician failed to consult anesthesia services for assistance, resulting in Patient #1 having received a combination of medications ordered by a Physician who was not educated or trained in sedation practices, administered by a nurse not trained in sedation practices, and in an unapproved setting of the hospital when Patient #1 reached a state of conscious sedation without any clinical staff monitoring/assessing Patient #1 during the three hours he/she was off the unit for a MRI scan. Patient #1 returned to the unit and found to be obtunded, requiring emergent medical response, two doses of Narcan to reverse the effects of the medications, and required a transfer to a higher level of care.

Further review of the Hospital's Internal Investigation indicated there was no documentation to support the Hospital implemented and monitored any system wide corrective actions to prevent future potential of similar adverse incidents.

During an interview on 7/17/23 at 10:00 A.M. and throughout the Survey, the Director of Risk Management and Patient Safety said the Hospital had a root cause analysis meeting on 6/5/23 to discuss Patient #1's adverse event on 4/4/23. The Director said the Hospital was still reviewing the event and corrective action plan options; therefore, no system wide corrective actions had been developed or implemented in response to the event on 4/4/23.


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2. Patient #2 presented to the Hospital on 5/2/23, for the second of three intravitreal injections for treatment of wet-age related macular degeneration (a condition when abnormal blood vessels grow in the back of the eye and can cause vision loss) of his/her right eye.

Review of Patient #2 ' s Ophthalmology Office Visit Note, dated 5/2/23, indicated Patient #2 was there for the second of three injections of Avastin (a medication injected into the eye to help slow vision loss from macular degeneration) into his/her right eye (OD). The Surgeon injected Patient #2 ' s left eye (OS) with the Avastin, rather than the right eye as scheduled.

Review of the Hospital ' s Internal Investigation into Patient #2 ' s incident on 5/2/23, indicated that Patient #2 required interpreter services which was provided via an iPad. The Surgeon marked Patient #2 ' s laterality and completed a time-out process to validate the correct patient, correct procedure, and correct site with uncertain participation from Patient #2. At the conclusion of the procedure, Patient #2 questioned the Surgeon about the injection site. The Surgeon then realized he had incorrectly marked and administered the intravitreal injection into Patient #2 ' s left eye, rather than the scheduled procedure for the right eye. The Investigation further indicated that Patient #2 ' s incorrect eye was marked by staff during timeout and the site was not marked by staff in accordance with Hospital Policy. The hospital failed to produce any evidence that the staff was re-educated or implemented any corrective actions.

During an interview on 7/21/23 at 8:19 A.M., the Chair of Ophthalmology said that procedures in the Operating Room (OR) and procedure areas always have a nurse present, but a nurse is not required to be present for in office procedures. The Chair of Ophthalmology said that patients are generally awake and alert during office visit procedures, so they participate in the timeouts and confirm the correct site with Hospital staff. The Chair of Ophthalmology said there was no documentation to support the Hospital developed and/or implemented any corrective actions in response to Patient #2 ' s wrong site procedure on 5/2/23.

The Condition of Participation: Nursing Services

Findings included:

Based on records reviewed and interviews, for one of 10 sampled patients (Patient #1), the Hospital failed to ensure staff ordered and administered intravenous drugs and biologicals (Hydromorphone and Lorazepam) in accordance with the approved Hospital Policies and Procedures.

Refer to TAG: A-0405.

Based on records reviewed and interviews, for one of 10 sampled patients (Patient #1), the Hospital failed to ensure staff ordered and administered intravenous drugs and biologicals (Hydromorphone and Lorazepam) in accordance with the approved Hospital Policies and Procedures.

Finding include:

The Hospital's Policy titled, Safety Report Patient Visitors and Colleagues, dated 4/7/22, indicated that all events or occurrences that had an actual, potential, or perceived adverse impact on a patient would be reported through the Hospital's web-based Safety Reporting System. The System would include documentation on the investigation/follow-up/recommendations for a plan of action to prevent reoccurrence, if applicable.

The Hospital's Policy titled, Moderate Sedation and Analgesia (used for Procedures) by Non-Anesthesiologists, dated 11/3/22, indicated the Policy was designed to provide for the safe administration of intravenous sedation and analgesia by non-anesthesiologists to patients undergoing diagnostic or therapeutic procedures.

The Policy indicated intravenous sedation and analgesia may only be administered in approved locations, not including a medical surgical unit, and by staff who have received moderate sedation is competency-based education, training, and experience in performing moderate sedation including methods and techniques required to rescue those patients who entered into a deeper-than-desired level of sedation or analgesia, either intentionally or unintentionally.
The Policy indicated the medications approved for moderate sedation use included hydromorphone, usually administered 0.25 mg - 0.5 mg, every three minutes, up to a total dose of 2 mg in 70 kg patient (consider reducing dose for elderly and reducing dose when given with a sedative). The doses are intended to serve as a guideline in administering the medications; in addition, the medications, when used in combination may have additive or synergistic effects. Lorazepam was not approved for use or recommended because of the prolonged duration of action and unpredictable nature of inducing sedation.

Review of Patient #1's medical records, indicated he/she presented to the Emergency Department in April 2023, from an outpatient oncology clinic with progressive bilateral lower extremity numbness, paralysis, and pain. Patient #1, who had a recent diagnosis of B-cell lymphoma was pre-medicated with morphine and attempted to Magnetic Resonance Imaging (MRI) scan to evaluate for spinal cord compression; however, Patient #1 was unable to tolerate the MRI due to pain and anxiety. Patient #1 was admitted to the medical surgical unit with orders for an urgent spine MRI scan, with pre-medication as Patient #1 was unable to tolerate lying flat due to pain, and to consult anesthesia services to assist, if needed.

Review of the Department of Public Health's (DPH) Health Care Facility Reporting System (HCFRS), indicated that the Hospital submitted a Report, dated 5/11/23, indicating that on 4/4/23, Nurse #1 administered combination of medications (later identified as 1 milligram (mg) of Hydromorphone and 2 mg of Lorazepam in 0.9% sodium chloride) intravenously (IV) on the medical surgical unit to treat Patient #1's pain and anxiety, 30 minutes prior to leaving the unit unmonitored and with a messenger escort (non-clinical) staff member for an MRI scan. Patient #1 returned to the unit three hours later and was found obtunded (a state similar to lethargy in which the patient has a lessened interest in the environment, slowed responses to stimulation, and drowsiness) by nursing staff; therefore, a medication emergency team response was called, Patient #1 received two doses of Narcan (an opioid antagonist used for the complete or partial reversal of opioid overdose, including respiratory depression) 0.4 mg/milliliter, and transferred to a higher level of care. The Report indicated the level of sedation (moderate/conscious) that resulted from the combination of the medications administered to Patient #1 prior to the MRI fell within the scope of the Hospital's Moderate Sedation and Analgesia Policy.

During an interview on 7/18/23 at 8:00 A.M., the Physician said Patient #1's MRI scan was identified as urgent, so he informally spoke with anesthesia services about medication options and possible consult for anesthesia to assist with Patient #1's sedation, which was out of his scope of medical practice. The Physician said it can be time consuming when patients are added to the anesthesia services list. The Physician said he ordered the two IV medications (1 milligram (mg) of Hydromorphone and 2 mg of Lorazepam) prior to Patient #1's MRI to treat his/her pain and anxiety and did not consider consulting anesthesia services on 4/4/23, regarding the specific medications and/or dosages, or about the Hospital's Moderate Sedation Policy.

During an interview on 7/18/23 at 11:41 A.M., Nurse #1 said she was not educated/trained on the Hospital's sedation policy and practices in order safety administer/monitor sedation medications. Nurse #1 said that on 4/4/23, she was assigned to care for Patient #1, who was admitted to the medical surgical unit and in a great deal of pain. Nurse #1 said she administered 1 milligram (mg) of Hydromorphone and 2 mg of Lorazepam to Patient #1, approximately 30 minutes prior to the MRI scan. Nurse #1 said that she was aware of the synergistic interactions of the two medications she administered to Patient #1, but did not have any thoughts and/or discussions about the risks with other staff members when Patient #1 left the unit unmonitored for an MRI scan. Nurse #1 said that when Patient #1 returned to the unit, he/she was not responding to verbal cues or to a sternal rub, and his/her pupils were dilated, so oxygen support was applied the medical emergency team was called for assistance.

The Hospital failed to ensure staff followed the Moderate Sedation Policy, when on 4/4/23, Patient #1's Physician ordered Patient #1 to be premedicated to complete a procedure. The Physician failed to consult anesthesia services for assistance, resulting in Patient #1 having received a combination of medications ordered by a Physician not educated or trained in sedation practices, administered by a Nurse not educated or trained in sedation practices, in an unapproved setting of the hospital when Patient #1 reached a state of conscious sedation and without any clinical staff monitoring the Patient #1 during the three hours he/she was gone to a MRI scan. Patient #1 returned to the unit and found to be obtunded, requiring emergent medical response, two doses of Narcan to reverse the effects of the medications, and transferred to a higher level of care.

Further review of the Hospital's Internal Investigation indicated there was no documentation to support the Hospital implemented and monitored any system wide corrective actions to prevent future potential of similar adverse incidents.

During an interview on 7/17/23 at 10:00 A.M. and throughout the Survey, the Director of Risk Management and Patient Safety said the Hospital had a root cause analysis meeting on 6/5/23 to discuss Patient #1's adverse event on 4/4/23. The Director said the Hospital was still reviewing the event and corrective action plan options; therefore, no system wide corrective actions had been developed or implemented in response to the event on 4/4/23.

The Condition of Participation: Surgical Services was out of compliance.

Findings included:

Based on records reviewed, and interviews, for one of ten sampled patients (Patient #2), the hospital failed to ensure staff followed the Universal Protocol Policy related to site marking for a patient procedure. Patient #2 received an intravitreal injection (an injection into the eye) to his/her left eye, rather than the intended right eye.

Refer to TAG A-0951

Based on records reviewed, and interviews, for one of ten sampled patients (Patient #2), the hospital failed to ensure staff followed the Universal Protocol Policy related to site marking for a patient procedure. Patient #2 received an intravitreal injection (an injection into the eye) to his/her left eye, rather than the intended right eye.

Findings include:

Review of Hospital Policy titled, ' Universal Protocol ' , approved on 6/28/21, indicated the following:
-The Surgeon/ Proceduralist must mark the site using his/her first and last initials for procedures involving laterality (right/left distinction), a specific digit, lesion or spinal level.
-Minimum of a two-person time out is required in all operating room/ procedural areas.
-Site marking was required for procedures involving laterality (right/left distinction), specific digit, lesion, or spinal level.

Patient #2 presented to the Hospital on 5/2/23, for the second of three intravitreal injections for treatment of wet-age related macular degeneration (a condition when abnormal blood vessels grow in the back of the eye and can cause vision loss) of his/her right eye.

Review of Patient #2 ' s Ophthalmology Office Visit Note, dated 5/2/23, indicated Patient #2 was there for the second of three injections of Avastin (a medication injected into the eye to help slow vision loss from macular degeneration) into his/her right eye (OD). The Surgeon injected Patient #2 ' s left eye (OS) with the Avastin, rather than the right eye as scheduled.

Review of the Hospital ' s Internal Investigation into Patient #2 ' s incident on 5/2/23, indicated that Patient#2 required interpreter services which was provided via an iPad. The Surgeon marked Patient #2 ' s laterality and completed a time-out process to validate the correct patient, correct procedure, and correct site with uncertain participation from Patient #2. At the conclusion of the procedure, Patient #2 questioned the Surgeon about the injection site, which is when the Surgeon realized he had incorrectly marked and administered the intravitreal injection into Patient #2 ' s left eye, rather than the scheduled procedure for the right eye. The Investigation further indicated that Patient #2 ' s incorrect eye was marked by staff during timeout and the site was not marked by staff in accordance with Hospital Policy.

During an interview on 7/21/23 at 8:19 A.M., the Chair of Ophthalmology said that procedures in the Operating Room (OR) and procedure areas always have a nurse present, but a nurse is not required to be present for in office procedures. The Chair of Ophthalmology said that patients are generally awake and alert during office visit procedures, so they participate in the timeouts and confirm the correct site with Hospital staff. The Chair of Ophthalmology said there was no documentation to support the Hospital developed and/or implemented any corrective actions in response to Patient #2 ' s wrong site procedure on 5/2/23.