HospitalInspections.org

The Condition of Participation is NOT met as:

Based on observation, interview, and record review, the hospital's Governing Body (GB) failed to assume full legal responsibility for implementing, and monitoring policies governing the hospital's total operation, and providing the oversight for quality health care, in a safe environment as follows when:

1. The hospital failed to ensure that Patient 1's family had been notified about a medication error (which had occurred while Patient 1 had been receiving medical care in the hospital). This failure resulted in the hospital not being transparent with the patient's family regarding the patient's care. (Cross Reference A-0048).

2. The governing body failed to ensure that a contractor of furnished out-patient services complied with applicable Conditions of Participation (COP), when the hospital failed to provide for assessing the contracted service and identifying quality and performance of services, through the hospital's Quality Assurance and Performance Improvement (QAPI) program. (Cross Reference A-0083 and A-0308).

3. The hospital failed to ensure the QAPI department provided the required monitoring of the effectiveness, safety of services, and quality of care provided to their patients. The QAPI program had a process to determine areas of concern, but did not include pharmacy and therapeutics committee oversight of medication errors, and did not initiate a methodology for reassessing the performance improvement plan developed for concerns.(Cross Reference A-0286).

4. The hospital failed to ensure nursing services were provided in a safe manner, when hospital P&P and standards of practice were not followed (Cross Reference Condition of Participation- A-0385).

5. The hospital failed to ensure registered nurses (RNs) implemented hospital P&P, when patients were placed at risk of not receiving the appropriate medication administration, assessments, completed care plans and completed procedural informed consents, per facility P&P. (Cross Reference A-0398)

6. The hospital failed to follow P&P and standards of practice for medication administration, when a Patient (Patient 100) received two doses of Lovenox (an anticoagulant-blood thinner- medication that helps prevent formation of blood clots-side effects possible bleeding) within two hours, instead of the intended every 12 hours, per physician order. A second patient (Patient 201) received IV (intravenous-in the vein) Dopamine (medication used to treat low blood pressure) with increment changes greater than every two minutes, instead of the intended every two-minute increment change, per physician order. (Cross Reference A-0405).

7. The hospital failed to ensure that safe pharmaceutical services had been provided and meet the needs of each patient. (Cross Reference Condition of Participation- A-0489)

8. The hospital's pharmacy failed to ensure safe and appropriate dispensing or labeling of high alert medication (e.g., Lovenox) retrieved from a cassette (non-automated dispensing cabinet) from two inpatient units. (Cross Reference A-0491).

9. The hospital failed to ensure unit dosed oral medications (the ordered amount of a drug in a dosage form prepared for a one-time administration to an individual) had the correct expiration date or beyond use date (BUD), and that all of these medications had been checked/verified by a Pharmacist, prior to going to the hospital's floors for patient administration. This failure had the potential to put 32 out of 32 sampled patients at risk for receiving ineffective, incorrectly prepared, or outdated medications. (Cross Reference A-0501).

10.The hospital failed to ensure a single use topical antiseptic solution was discarded after use and was not accessible to the public. (Cross Reference A-0502).

11. The hospital failed to ensure that a preventable medication error did not occur with one of 32 sampled patients (Patient 1). Patient 1 received a second dose of a medication Lovenox (also known as Enoxaparin), within two hours of the first dose, which resulted in an excessive dose, based on the drug manufacturer's package insert, based on the patient's weight. The hospital's medication error may have led/contributed to Patient 1's death, which may have been averted. (Cross Reference A-0508)

12. The hospital failed to develop and evaluate its drug formulary (a drug formulary is a list of drugs covered under a hospital's health plan for the care and management of its patients). The hospital also failed to eliminate medications from this list that may not have been the most effective and latest treatments available, for 32 out of 32 sampled patients. This had the potential for the hospital to have medications on their drug formulary, which may not have been the most cost-effective medications for the hospital. (Cross Reference A-0511).

On 5/8/23 at 6:39 p.m., an Immediate Jeopardy (IJ), (a situation in which the facility's noncompliance had placed the health and safety of patients in its care at risk for serious injury, serious harm, serious impairment, or death), was declared. (Cross Reference A-0000 and A-0508).

The cumulative outcome of these failures resulted to the Governing Body not ensuring the safety and quality of care provided for patients in the hospital.

Based on interview with the Hospital's Chief Medical Officer (CMO), review of the hospital's Medical Staff Rules and Regulations, and the hospital's policies and procedures, the hospital failed to ensure that Patient 1's family had been notified about a medication error (which had occurred while Patient 1 had been receiving medical care in the hospital).

This failure resulted in the hospital not being transparent with the patient's family regarding the patient's care.

Findings:

Interview with the CMO on 5/9/2023 at 11:30 a.m. revealed that the hospital had not made contact with Patient 1's family as outlined in the hospital's Medical Staff Rules and Regulations, dated 7/21/2022. In the Medical Staff Rules and Regulations section XVI, which is entitled: "Disclosure of Unanticipated Outcomes", reads: "Patients are entitled to information related to unanticipated outcomes, whether positive or negative, and the disclosure of this information is part of the communication process that forms the context for trusting caregiver-patient relationship. For guidelines involving disclosure of unanticipated outcomes, please refer to the Hospital-Wide Administrative Policy and Procedure "Disclosure of Unanticipated Outcomes". Review of the hospital's Policy and Procedure entitled: "Disclosure of Adverse Events and Unanticipated Outcomes to Patients and their Families", under section D. reads: "The attending and/or consulting physician (in certain circumstances) is usually the responsible party for communicating with the patient, family or legally authorized representative about an unanticipated outcome or adverse event. In situations where a hospital employee may have committed an error, the physician and/or a hospital designee(s) can respond to questions from the patient and family. A. The physician should provide an explanation of the circumstances surrounding the event and, if appropriate, a treatment plan designed to correct or mitigate any medical injury." The hospital's policy and procedure entitled: "Adverse Event Reporting- California", reads: "The health care facility must inform the patient or the person responsible for the patient of the adverse event by the time the reports is made (Health and Safety Code section 1279.1 (c))" ...

Based on interview with the hospital's DOP on 5/8/2023 at 11:00 a.m., the facility was aware of this medication error during the first week of April 2023, yet during an interview with the hospital's CMO on 5/9/2023 at 11:30 a.m. the CMO was asked to provide a timeline of the hospital's attempts to reach out to this Patient's family. The provided timeline revealed that the facility had not tried to reach out to Patient 1's family until 5/3/2023 at 12:40 p.m., almost one month after the hospital knew that the medication error had occurred. Up until 5/12/2023, the hospital had only attempted to reach out to Patient 1's daughter, even though Patient 1 had two sons (a total of three children altogether). As of 5/11/2023, neither one of the sons had been attempted to be contacted. The hospital had failed to exhaust all attempts to reach out to Patient 1's family as outlined in the hospital's Rules and Regulations above and the hospital's policies and procedures. The hospital did not have any documentation that they had tried to reach out to the patient's family by mail until 5/9/2023, and again, this was only to the Patient's daughter.

Review of the hospital's Policy and Procedure entitled: "Disclosure of Adverse Events and Unanticipated Outcomes to Patients and their Families", under section F, reads: "1. Disclosure related to an unanticipated outcome or adverse event should be documented in the medical record as soon as possible. This information is documented in the medical record to demonstrate communication with the patient and family, and to provide for presentation of consistent information during subsequent discussions. Review of Patient 1's medical record on 5/11/2023 at 3:00 p.m. revealed that there was no documentation in the patient's medical record as of this time.

Based on interview with facility staff and review of records, the governing body failed to be responsible for all services performed under hospital contract, to ensure that a contractor of furnished services complied with applicable Conditions of Participation (COP), when the hospital had no process for assessing the contracted service, and identifying quality and performance evaluations of services, through the hospital's Quality Assurance and Performance Improvement (QAPI) program.

These failures placed patients at risk of not receiving quality-driven care.

Findings:

Review of facility's document titled, "Bylaws of Community Board of (name of facility)," dated "4/28/22," "pg 2 of 15" included, "(l) Requiring the development of a quality assurance program that includes a mechanism for review of the quality of patient care services provided by individuals who are not subject to staff privilege delineation process, reviewing the quality assurance program on an ongoing basis..."

Review of facility's document titled, "Quality Assessment, Performance Improvement Plan (QAPI)," dated "09/22/2022, "pg 1 of 6" included ... "1. The Community Board (GB) is responsible for assuring an on-going quality improvement plan for patient safety, quality of care, organization-wide quality assessment, and contracted services..."
Review of facility's document titled, "State of California Department of Public Health, License," included services, "Other Services," included, "Outpatient Services, Radiology or Imaging (address of outpatient service)."

During a concurrent interview and record review on 5/11/23, starting at 8:45 a.m., facility's QAPI document review was conducted with Chief Nursing Officer (CNO), and QAPI Manager (QAM1). QAPI documents indicated, no out-patient imaging center's participation in QAPI program. CNO and QAM 1 both acknowledged, out-patient service should be part of the QAPI program, and to date has not been, CNO stated, "opportunity for improvement."

Based on interview and record review, the hospital failed to ensure the Quality Assessment Performance Improvement (QAPI) department provided the required monitoring of the effectiveness, safety of services, and quality of care provided to their patients. The QAPI process did not include pharmacy and therapeutics committee oversight of medication errors and have no methodology for reassessing the performance improvement plan developed for concerns.

The failure resulted to the hospital having no process to determine if the plan for an identified issue was effective or needed revised.

Findings:

1. During a review of facility's document titled, "Medical Staff Rules and Regulations," dated, "7/21/22," included on pg."31 of 37,"... "The medication error team is a multidisciplinary subcommittee of the Quality Council and will be chaired by a physician appointed by the chief of staff. The medication error team will report its actions to the Quality Council and the Chair of the Quality Council will report to the Medical Executive Committee and the Governing Board.... Responsibilities are to:
a. assess and make recommendations for improving the medication use process.
b. analyze medication errors and adverse drug reactions to determine if trends exist."

During an interview on 5/10/23, starting at 4:25 p.m., with QAPI manager (QAM1), while reviewing QAPI documents, QAM1 confirmed that medication error reportings are not one of organizations performance improvement projects, and are not part of hospital's QAPI program. QAM1 indicated, medication errors are managed within the Pharmacy and Therapeutics Committee.

During a concurrent facility document review and interview on 5/10/23, starting at 4:45 p.m., with Chief Nursing Officer (CNO), pharmacy and therapeutics committee minutes, dated, 12/31/21, included medication errors rates and trend reports with sections "recommendation/actions" indicated, "Discussed and noted as information."
Review of pharmacy and therapeutics committee minutes, dated, 5/23/22, included medication errors rates and trend reports with sections "recommendation/actions" section indicated, "Discussed and noted as information."
Review of pharmacy and therapeutics committee minutes, dated, 2/27/23, included medication errors rates and trend reports with sections "recommendation/actions" section indicated, "Discussed and noted as information."

All 3 sampled reports indicated opportunities for improvement with "bar code medication administration (inventory system that uses barcodes to prevent human errors in the distribution of medications in the hospital) and omnicell overrides (a single dose of medication that can be removed from decentralized automated medication system prior to pharmacist review)."

During an interview on 5/10/23, starting at 4:45 p.m., with CNO, CNO was asked if she could provide any evidence of implemented changes, such as staff education, training, or changes to policies and procedures surrounding pharmacy and therapeutic committee's medication error identified opportunity for improvement with barcode and Omnicell overrides, CNO acknowledging unable to locate stated, "It's an opportunity for improvement."

Based on interview and record review, the facility's Governing Body (GB) failed to have oversight of clinical contracted services in the out-patient imaging center, by integrating the evaluation of these services into the hospital's Quality Assessment and Performance Improvement (QAPI) program.

The failure has the potential to expose patients to ongoing substandard care, and for the GB to lack information relative to the quality of care being provided to patients in the facility.

Findings:

During a review of facility's document titled, "Bylaws of Community Board of (name of facility)," dated "4/28/22," "pg 2 of 15" included, "(l) Requiring the development of a quality assurance program that includes a mechanism for review of the quality of patient care services provided by individuals who are not subject to staff privilege delineation process, reviewing the quality assurance program on an ongoing basis..."

During a review of facility's document titled, "Quality Assessment, Performance Improvement Plan (QAPI)," dated "09/22/2022," "pg 1 of 6" included, ... "1. The Community Board (GB) is responsible for assuring an on-going quality improvement plan for patient safety, quality of care, organization-wide quality assessment, and contracted services..."

During a review of facility's document titled, "State of California Department of Public Health, License" included services, "Other Services," included, "Outpatient Services, Radiology or Imaging (address of outpatient service)."

During a concurrent interview and record review on 5/11/23, starting at 8:45 a.m., QAPI facility document review was conducted with Chief Nursing Officer (CNO), and QAPI Manager (QAM1). QAPI documents indicated, no out-patient imaging center's participation in QAPI program. CNO and QAM 1 both acknowledged, out-patient service should be part of the QAPI program, and to date has not been, CNO stated, "opportunity for improvement."

The Condition of Participation is not met as:

Based on observation, interview, and record review, the hospital failed to ensure nursing services were provided in a safe manner, when hospital policies and procedures (P&P) and standards of practice were not followed when:

1. Code Blue (cardiopulmonary arrest) report was not completed in the emergency department (ED) for one out of 32 sampled patients (Patient 200). (Cross Reference A-398).

2. Multiple medications: Tylenol (mild pain reliever), Epinephrine (used as temporary relief for mild symptoms of asthma) inhaler, Ativan (calming/sedating), Normal Saline (fluid replacement), Vasopressors (medications to increase blood pressure- Vasopressin, Norepinephrine, Phenylephrine) and sedation drips (Precedex) were not properly titrated, not properly administered, and/or documented for five out of 32 sampled patients (Patient 200, Patient 202, Patient 203, Patient 206, and Patient 207). (Cross Reference A-398).

3. Multiple consents in the ED, Cardiac Catheterization laboratory, and the ICU (Intensive Care Unit) were not completed for a Vena Cava filter (small device that can stop blood clots from going up into the lungs) procedure and Lumbar puncture procedure (taking fluid from the spine in the lower back through a hollow needle) for three out 32 sampled patients (Patient 200, Patient 207, and Patient 208). (Cross Reference A-398).

4. Post procedure Pain Assessments were not completed, and pain reassessments were not completed, after pain medication administration for two out of 32 sampled patients (Patient 101 and Patient 303 (Cross Reference A-398).

5. Pre-operative vital signs were not completed, prior to procedure, for one out of 32 sampled patients (Patient 303) (Cross Reference A-398).

6. Care plans were not completed for two out of 32 sampled patients (Patient 100 and Patient 101). (Cross Reference A-398).

7. Hand off communication was not completed, in the ED, for one out of 32 sampled patients (Patient 100). (Cross Reference A-398).

8. Autopsy release form was incomplete for one out of 32 sampled patients (Patient 100). (Cross Reference A-398).

9. Physician orders were not followed for medication administration, which lead to medication errors, for two out of 32 sampled patients (Patient 100 and Patient 201). Patient 100 received two doses of Lovenox (an anticoagulant-blood thinner- medication that helps prevent formation of blood clots-side effects possible bleeding) within two hours, instead of the intended every 12 hours per physician order. Patient 100 sustained a subdural hematoma (a pool of blood between the brain and its outer most covering) and intracranial hemorrhage (bleeding in the brain) within 24 hours of receiving the Lovenox doses and died 18 hours after the brain bleed. Patient 201 received IV (intravenous-in the vein) Dopamine (medication used to treat low blood pressure) with increment changes greater than every two minutes, instead of the intended every two-minute increment change, per physician order. Patient 201's blood pressure may have been adversely affected. (Cross Reference A-405)

The cumulative effects of the hospital's systematic failure to follow P&P and physician orders for medication administration, resulted in the hospital's inability to ensure safe medication administration practices and the provision of safe patient care.

Based on observation, interview and record review, the facility failed to ensure registered nurses (RNs) implemented their policy and procedure (P&P) when:

1. A) Patient 200's Code Blue (cardiopulmonary arrest) report was not complete.
B) Patient 200's Vasopressors (Vassopressin, Norepinephine, Phenylephrine-Medications to increase blood pressure) medication drips were not titrated and/or documented.
C) Patients 200, 207 and 208's procedure consents were not completed.
D) Patient 202's Tylenol (mild pain reliever) medication order was not clarified.
E) Patient 202's Epinephrine (used as temporary relief for mild symptoms of asthma) medication nebulizer order was not followed, documented and/or clarified.
F) Patient 203's Ativan (calming/sedating) medication was not administered and documented (STAT) immediately.
G) Patient 206's Normal Saline bolus (fluid replacement) was not administered (STAT).
H) Patient 207's Precedex (sedation medication) drip was administered.

2. I) Patient 100's autopsy release form was incomplete.
J) Patient 100's hand-off communication was not conducted.
K) Patients 100 and 101's care plans were not completed.
a) Patient 100 did not have a care plan when admitted with a DVT (deep vein thrombosis- blood clot) and being treated with Lovenox (an anticoagulant-blood thinner- medication that helps prevent formation of blood clots-side effects possible bleeding)
b) Patient 101 did not have a labor care plan for labor induction/augmentation
L) Patient 101's pain reassessments were not performed after pain medication administration.

3. M) Patient 303's Pre-op vital signs were not documented within one hour of surgery, and pain assessment post procedure was not documented.

These facility failures placed patients at risk of not receiving the appropriate medication administration, assessments, completed care plans, and lack of completed consents, all with the potential of resulting in negative patient outcomes, jeopardizing the quality and safety of patient care.

Findings:

1. A. Patient 200's medical record was reviewed on 5/9/23. The Emergency Department (ED) Physician note, dated 4/16/23, indicated, patient arrived at the ED unresponsive, no pulse and cardiac pulmonary resuscitation (CPR) was initiated. The Adult Cardiopulmonary Resuscitation Report, dated 4/16/23, at 8:00 a.m., was reviewed. The report was noted to have several areas that were blank.

During a concurrent record review and interview on 5/9/23, at 10:30 a.m., Patient 200's Adult CPR report was reviewed with the ED Manager (EDM). The CPR report indicated, not being complete, several areas had been left blank i.e., blood pressure, size of endotracheal tube, outcome ... The EDM acknowledged and agreed, the CPR report was not complete, and it should be.

The facility's P&P titled, "Code Blue/Code Silent," dated 9/16/21, indicated, "A CPR Report will be completed on all code blues."

B. A review of Patient 200's record indicated, patient had a cardiopulmonary arrest (dying) event in the ED on 4/16/23. Return of spontaneous circulation (ROSC) was achieved, then patient was placed on vasopressor medication drips to maintain mean arterial pressure (MAP-average blood pressure during heartbeat cycle) greater than 80. Review of Patient's 200's electronic medication administration record (eMAR) indicated, vasopressor medication drips were not initiated.

Review of Patient 200's ED blood pressure flow sheet indicated, MAP range from 52-68. A physician's order for norepinephrine and vasopressin medication drips, to increase blood pressure, was received on 4/16/23 at 9:00 a.m.

During a concurrent record review and interview on 5/10/23, at 10:08 a.m., Patient 200's record was reviewed with Registered Nurse (LN 2). LN 2 reported that on 4/16/23, the ED called the ICU to have an ICU RN come down to the ED to assist the ED nurse to manage the care of this critical care patient. LN 2 came to the ED that morning to assist with the care of this patient, but the ED RN was still responsible for the care and documentation for this patient. According to LN 2, the norepinephrine and vasopressin medication drips were initiated in the ED, the medication administration documentation was on the titration block charting in the record. The titration block charting was reviewed but observed to be blank except for a date and time.

During a concurrent record review and interview on 5/10/23, at 10:39 a.m., Patient 200's titration block charting was reviewed with the Intensive Care Unit Manager (ICUM). The charting indicated, no titration block charting was in the record. The ICUM acknowledged and agreed, the titration block charting for the vasopressor medication drips was missing and was not according to their policy.

A review of the facility's P&P titled, "Titratable Medication Infusion Administration," dated 9/2/21 indicated, "Documenting each individual rate change during an urgent/emergency can potentially create undue burden. In these situations, block charting can be instituted. a. Block charting is a method of documenting rapid titrations. b. Documentation of block charting must be completed in the electronic health record EHR. c. Block charting includes the initial rate, ending rate, and max rate of medication infusions ...d. A single block charting episode cannot extend beyond a 4-hour time frame. f. The minimum elements that must be documented in each block charting episodes are: i. Time of initiation and completion of the charting block. ii. Name (s) of medications administered during the block. iii. Initial rate and ending rate of medication infusions administered during the charting block. iv. Maximum rate (dose) of medications administered during the charting block.

C. A review of facility's P&P titled, "Consent and Informed Consent," dated 5/4/22, indicated, "The consent form should include the name of the patient, the medical terminology for the procedure, name or names of the practitioners who will perform important parts of the procedure ... the patient's legal representative. If an adult lacks the capacity to make medical decisions, representative must be identified ... the nursing staff should be responsible for verifying that the documentation has been included in the chart prior to the surgery/procedure.

During a concurrent record review and interview on 5/11/23, at 2:27 p.m., Patient 200's Vena Cava filter (small device that can stop blood clots from going up into the lungs) procedure consent, dated 5/6/23 was reviewed with the Catheterization Lab Manager (CLM). The consent indicated, there was a blank in the area indicating the relationship of the person signing the consent. The CLM confirmed, the witness for this consent was one of the Cath-lab nurses, acknowledged the observation and agreed, this area should not have been left blank because the relationship of the person signing the consent was not established or identified.

During a concurrent record review and interview on 5/11/23, at 10:28 a.m., Patient 207's Lumbar puncture (taking fluid from the spine in the lower back through a hollow needle) procedure, was reviewed with ICUM. The consent indicated, the form was left blank on the area where the procedure name and the name of the practitioner would have been written. The ICUM acknowledged and confirmed, the consent must have the name of the procedure and the name of the practitioner, and this consent is missing both.

During a concurrent record review and interview on 5/11/23, at 2:25 p.m., Patient 208's Lumbar puncture procedure, dated 5/10/23, was reviewed with EDM. The consent form indicated, missing the patient's name and the patient's relationship with the person who signed the consent. The EDM acknowledged and confirmed, the nurse who witnessed this consent is one of the ED nurses, the relationship of the person signing the consent was not identified, and the name of the patient is missing.

D. During a concurrent record review and interview on 5/10/23, at 5:17 p.m., Patient 202's record was reviewed with EDM. The eMAR indicated, a STAT Tylenol medication had not been administered, yet at 5:24 p.m., a physician's order for Tylenol, STAT priority, and every 6 hours was ordered on 5/10/23 at 11:17 a.m. The EDM explained, that a Tylenol medication would not be ordered as STAT, this medication was ordered for every 6 hours, as needed for pain. This is the reason the Tylenol medication was not given immediately. The EDM was asked to locate the Tylenol order clarification to determine if the medication needed to be given STAT and then every 6 hours, or the Tylenol was to be given only every 6 hours, as needed for the pain. The EDM was not able to locate documentation indicating the Tylenol medication order was clarified with the physician by the nurse. The EDM acknowledged and agreed, the Tylenol medication order should have been clarified.

A review of the facility's P&P titled, "Medication Administration," dated 9/28/22, indicated, "Both nursing and pharmacy verify appropriateness of the order and the accuracy of transcription. Nursing and pharmacy to collaborate on ambiguous or incomplete orders and upon resolution, the nurse or pharmacist that contacted prescriber will write clarification of order."

E. Further review of Patient 202's record indicated, a physician's order for epinephrine nebulizer was ordered on 5/10/23, at 10:12 a.m. The eMAR indicated, the epinephrine medication nebulizer was not administered while patient was in the ED. A nurse documented, "Not done" in the eMAR on 5/10/23 at 1:54 p.m. but failed to clarify if this medication had been administered while the patient was in the ED, or if the patient should still get this medication.

During a concurrent record review and interview on 5/10/23, at 6:08 p.m., Patient 202's eMAR was reviewed with the Respiratory Therapy Director (RTD). The RTD reported, the respiratory therapists in the ED did not give the epinephrine medication nebulizer, because the ED physician did not want this medication dose to be given. The RTD acknowledged and agreed, that the respiratory therapist and the nurse should have collaborated and clarified, with the physician, if the patient should still receive the epinephrine medication nebulizer.

A review of the facility's P&P titled, "Medication Administration," dated 9/28/22, indicated, "Medication will be administered by ... registered nurse ... respiratory therapist ... Both nursing and pharmacy verify appropriateness of the order and the accuracy of transcription. Nursing and pharmacy to collaborate on ambiguous or incomplete orders and upon resolution, the nurse or pharmacist that contacted prescriber will write clarification of order."

F. During a concurrent record review and interview on 5/10/23, at 4:31 p.m., Patient 203's eMAR was reviewed with the ED Manager (EDM). The patient's eMAR indicated, the STAT Ativan (sedative) medication had not been administered. A physician's order for Ativan one milligram IM (intramuscular) STAT was received on 5/10/23, at 3:33 p.m. The EDM acknowledged and agreed, that according to the eMAR, the Ativan medication had not been administered and documented, within 30 minutes of receipt of the order.

A review of the facility's P&P titled, "Medication Administration," dated 9/28/22, indicated, "STAT means within 30 minutes of receipt of the order. Review the medical record at regular intervals to identify orders requiring immediate attention. Process STAT orders immediately ..."
G. During a concurrent record review and interview on 5/10/23, at 4:00 p.m., Patient 206's eMAR was reviewed with the EDM. The eMAR indicated, Normal Saline bolus order had not been administered yet. A physician's order for normal saline 500 milliliters bolus, to be administered STAT, was received on 5/10/23, at 2:44 p.m.. The EDM acknowledged and confirmed, the normal saline bolus had not been administered, within 30 minutes of receipt of order.

A review of the facility's P&P titled, "Medication Administration," dated 9/28/22, indicated, "STAT means within 30 minutes of receipt of the order. Review the medical record at regular intervals to identify orders requiring immediate attention. Process STAT orders immediately ..."

H. During a concurrent record review and interview on 5/10/23, at 11:25 a.m., Patient 207's eMAR was reviewed with ICUM. The eMar indicated, the Precedex (sedation) medication titration rate changes were correlated with the Richmond Agitation Sedation Scale (RASS) scale. RASS scale determines the sedation level, and it measures the severity of agitation and sedation with a score of +4 to -5: +4: combative, +3: very agitated, +2: agitated, +1: restless, 0: alert and calm, -1: drowsy, -2: light sedation, -3: moderate sedation, -4: deep sedation, and -5 ... For most patients a RASS of 0 to -2 is desirable. The Precedex medication rate change documentation indicated, on 5/9/23 patient was agitated with a RASS score of +2 at 12:30 p.m., medication was titrated up at 1:00 p.m., patient's RASS score remained +2, but there was no more medication titration and RASS scores documentation until 5/10/23 at 1:05 a.m., with RASS score +2. The ICUM acknowledged and confirmed, the patient was agitated and the nurse did not continue to titrate medication until patient's RASS score was 0 to -2.

A review of the facility's P&P titled, "IV Administration Drug List," dated 9/28/22, indicated, "Start at 0.2mcg/kg/hr., titrate by 0.1 mcg/kg/hr. every 10 minutes up to a max of 1.4 mcg/kg/hr. to target RASS 0 to -2.

2. I) During a concurrent interview and record review on 5/12/23, at 11:15 a.m., with the Director of Quality (DOQ), Patient 100's "Autopsy Release Form," dated 3/29/23 was reviewed. The form indicated, the family wanted an autopsy; the box was checked "yes." The signature of the hospital representative was left blank and not dated. When asked if Patient 100 had an autopsy, DOQ verbalized the RP (daughter of Patient 100) wanted one, then changed her mind and wanted the body released to the mortuary. DOQ further verbalized, there was a clinical nursing note in the medical record. The Autopsy Release Form was further reviewed, and the release of body section was not signed by the hospital representative and or dated, it was blank. The form further indicated to assess all cases and call the coroner if meets criteria and to select one: does not meet criteria-coroner not notified, or coroner notified-case released, or coroner notified-case accepted. All the boxes were blank, and the hospital representative did not sign and or date the form. DOQ acknowledged, the Autopsy release form was incomplete. DOQ verbalized, the form should have been signed by the hospital representative/witness and further verbalized, this is a nursing responsibility to witness and sign the form. DOQ further acknowledged nursing did not follow policy and procedure.

During a review of Patient 100's "Clinical Nursing Note," dated 3/29/23, at 11:00 a.m., the note indicated, the mortuary was called to notify them they can come pick up Patient 100. The documentation in the nursing note did not specifically say the autopsy was to be cancelled.

During a review of the facility's P&P titled, "Autopsy Procedure," revised 12/9/21, the P&P indicated in part, ... "It is the policy of the medical staff (including the Pathology Department) to encourage the seeking of autopsy permission in every inpatient hospital death that occurs in the hospital ...no autopsy shall be performed without written consent of the next of kin or a legally authorized agent ...the nurse should obtain the written authorization for the autopsy, if one is requested by the physician/and or family ...if there is to be an autopsy: 1. Copy of the authorization form is placed on the medical record ...2. The primary nurse is responsible for notifying the nursing house supervisor of the need for an autopsy ...6. The nursing supervisor will verify the autopsy status before releasing the body to the mortuary..."

J) During an interview on 5/10/23, at 6:14 p.m., with the ED Nurse (LN 3), LN 3 verbalized caring for Patient 100 when relieving another nurse (LN 4) for lunch. LN 3 verbalized seeing the order, to give Patient 100, 60 mg of Lovenox as a STAT one-time dose, and further verbalized giving the medication. LN 3 verbalized, after the medication was given it is documented in the e-MAR. When asked if a report (hand off-communication) was given to the Nurse (LN 4), when returning from lunch, about giving the 60 mg of Lovenox, LN 3 verbalized could not remember and stated, "It is my usual practice to give report to the oncoming nurse about what was done for the patient and what medications were given." LN 3 further verbalized, documents hand off communication in the medical record.

During a review of Patient 100's "Clinical ED Notes," dated 3/27/23, there was no documentation about hand-off communication (report) to LN 4. The clinical ED note documentation only indicated that LN 4 assumed care of Patient 100 at 7:47 p.m.

During an interview on 5/11/23, at 10:03 a.m., with LN 4, LN 4 verbalized caring for Patient 100 in the ED. LN 4 verbalized, Patient 100 had a DVT. LN 4 verbalized, Patient 100 was going to be admitted to the hospital and saw the order for Lovenox 40 mg every 12 hours. When asked about receiving report from the previous nurse, LN 4 verbalized, it's our standard of practice to receive report from the previous nurse. When asked if you were told Patient 100 received a 60 mg dose of Lovenox at 7:19 p.m., LN 4 stated, "If I knew about the previous 60 mg dose of Lovenox then I would not have given another 40 mg dose of Lovenox" and further stated, "It would have been too soon." LN 4 acknowledged, the second dose of Lovenox was given to soon and was a medication error.

During a review of the facility's P&P titled, "Hand-Off Communication," revised 9/28/22, the P&P indicated in part, ... "It is the policy for all clinical staff to practice "hand-off communication whenever there is a change in the patient's caregivers and when communicating amongst members of the interdisciplinary health care team ...A. "Hand -off" communication shall include ...1. Accurate patient information regarding care, treatment, and services ...2. Current patient's condition ...3. Recent or anticipated changes in the patient's/client's/resident's condition ...E. Methods ...1. Care givers will perform "hand-off" communication using a verbal report, bedside hand-off communication is preferred ...2. Caregivers will give each other the opportunity to ask questions, answer questions and read-back, or repeat-back information, as needed ...3. Information provided during hand-off communication will include the following information, as appropriate: a. Patient's name and location ...b. Patient's physician ...c. date of admission ...d. diagnosis ...e. Plan of care/problem list ...f. summary of the patient's/client's/resident's current physical and mental health condition such as: i. Pertinent physical assessment findings ...ii. Current medications and when they were last given ..."

K) a) During a review of Patient 100's "ED Physician Notes," dated 3/27/2023, the physician notes indicated, Patient 100 was an 81-year-old, brought into the ED complaining of left lower leg swelling that started in the morning. Medical Decision Making: Patient 100 was given IV (intravenous-in the vein) fluids and started on Lovenox for an extensive DVT found on ultrasound. Patient 100 will be admitted due to age and new onset of DVT.

During a concurrent interview and record review on 5/11/23, at 2:28 p.m., with the Computer Information Specialist (CIS 2), Patient 100's "Nursing Flowsheet" under orders and plans, dated 3/28/23-3/29/23, were reviewed. CIS 2 acknowledged, there was no care plan initiated or documented in Patient 100's medical record about DVT management, when Patient 100 was admitted with a DVT and being treated with Lovenox. CIS 2 acknowledged, there should be a care plan and further acknowledged, Patient 100 was at risk for bleeding.

K) b) During a concurrent interview and record review on 5/11/23, at 11:42 a.m., with the Labor and Delivery Nurse (LN 5), Patient 101's "Labor Nursing flowsheet" under assessments, orders, and plans, dated 5/2/23-5/5/23, were reviewed. The admission assessment indicated, Patient 101 was admitted for spontaneous rupture of membranes (SROM-water broke) and admitted for labor induction/augmentation (using medications to bring on labor). Under orders and plans, LN 5 acknowledged, there was no care plan initiated or documented in Patient 101's medical record about labor management and induction/augmentation. LN 5 acknowledged, there should be a labor care plan for Patient 101.

During a review of the facility's P&P titled, "Assessments of Patients-Interdisciplinary," revised 3/31/22, the P&P indicated in part, ... "Patients receiving care will have an assessment performed of their needs, condition, and goals by a licensed member of the healthcare team utilizing the following principles: A. Initial data will be gathered within a specific time frame according to the policy as it relates to the individual patient and care setting ...B. Care decisions will be based upon the information gathered in assessments and reassessments. This data will be utilized in selecting appropriate interventions in an effective manner ...T. Plan of care: 1. The plan of care will be reviewed regularly in consultation with the appropriate members of the healthcare team and the patient/family. The plan of care will be revised as appropriate to the patient's condition and ongoing assessment process ..."

L) During a review of Patient 101's "Physician Orders," dated 5/2/2023, the orders indicated, give Ketorolac (medication used to treat moderate to severe pain) 30 mg (milligrams) IV every 6 hours as needed for moderate pain (4-6/10 on pain scale).

During a concurrent interview and record review on 5/11/23, at 11:50 a.m., with the LN 5, Patient 101's "Pain assessment flowsheet" and eMAR, dated 5/3/23 were reviewed. The pain assessment flow sheet indicated, Patient 101 had a pain of 6 out of 10 at 1:46 a.m., and the eMAR indicated, Patient 101 received 30 mg of Ketorolac. When reviewing the pain assessment flowsheet an hour after Patient 101 received the Ketorolac, LN 5 acknowledged, there was no pain re-assessment documented in the medical record. LN 5 further acknowledged, there should be. Further review of Patient 101's pain assessment flow sheet and eMAR indicated, Patient 101 had a pain of 6 out of 10 at 8:31 a.m. and received 30 mg Ketorolac and had a pain of 6 out of 10 at 2:36 p.m. and received 30 mg of Ketorolac. LN 5 acknowledged, there were no pain re-assessments documented in the medical record after the last two pain medications that were given, and there should have been.

During a review of the facility's P&P titled, "Pain Management," revised 12/9/21, the P&P indicated in part, ... "It is the policy to deliver prompt and effective assessment, diagnosis, and treatment of pain using collaborative interdisciplinary approach with participation of the patient and the patient's family/significant others. The scope of pain assessment and treatment is based on the care setting and services provided ...A. Initial/First Patient Assessment: 1. Screen patient for pain-is patient in pain now?... 2. If yes to above, assess for the following, and document and appropriately. Accept the patient's description of his/her: a. intensity/level of pain ...b. location of pain ...c. duration/frequency of pain ...d. quality of pain ...e. onset of pain ...f. aggravating/alleviating factors ...g. relief measures used/interventions ...B. Reassessment: 1. Pain reassessment will occur once a shift, after pain management interventions, and according to the patient's clinical condition ...2. Reassess pain within 30 minutes to 1 hour after pain medication administration ...4. Document the reassessment ..."

3. M) During a concurrent record review and interview on 5/11/23, at 10:40 a.m., with Licensed Nurse (LN 1) and CIS 1, Patient 303's medical chart was reviewed. LN 1 and CIS 1 were asked to provide documentation indicating Patient 303's preoperative vital signs were taken within one hour of surgery, on 4/26/23, and also to provide documentation indicating Patient 303's pain level was assessed after the surgical procedure, in the post operative care unit (PACU). Both LN 1 and CIS 1 were unable to provide the documentation. The LN 1 acknowledged, Patient 303's vital signs should have been taken within an hour before the surgical procedure, but it was not documented. The LN 1 verbalized, Patient 303 should have been assessed for pain, following the surgery on 4/26/23, and acknowledged it was not documented in the medical record.

During a review of the facility's P&P titled, "Perioperative Plan of Care - Standards of Care," dated 2/15/22, the P&P indicated in part, "This policy outlines the nursing management of any patient undergoing an operative/invasive procedure in the surgical services during the preoperative, intraoperative, and postoperative phases. Patient assessment and reassessment is performed throughout the perioperative process ...pre-operative physical status especially most recent BP (blood pressure) pulse, temp (temperature) and Resp (respirations) rate (within 1 hour prior to surgery) and airway/lung status."

During a review of the facility's P&P titled, "Assessment of Patients - Interdisciplinary," dated 3/31/22, the P&P indicated in part, "Post Anesthesia Care Unit a. A full set of vital signs will be measured upon admission and discharge which will include blood pressure, pulse, respiratory rate, temperature (f), pulse oximetry, and pain level. b. Repeat vital signs will be measured every 15 minutes or as patient's condition warrants until discharged from the Post Anesthesia Care Unit. Repeat vital signs are defined as blood pressure, pulse, respiratory rate, pulse oximetry, and pain."

Based on interview and record review, the facility failed to follow policy and procedures (P&P) and standards of practice for medication administration for two out of 32 sampled patients (Patient 100 and 201), when:

1. Patient 100 received two doses of Lovenox (an anticoagulant-blood thinner- medication that helps prevent formation of blood clots-side effects possible bleeding) within two hours, instead of the intended every 12 hours, per physician order.

This failure probably caused Patient 100 to sustain a subdural hematoma (a pool of blood between the brain and its outer most covering) and intracranial hemorrhage (bleeding in the brain) within 24 hours of receiving the Lovenox doses, and died 18 hours after the brain bleed.

2. Patient 201 received IV (intravenous-in the vein) Dopamine (medication used to treat low blood pressure) with increment changes greater than every two minutes, instead of the intended every two-minute increment change, per physician order.

This failure placed Patient 201 at risk for an altered either high or low blood pressure reading.

Findings:

1. During a review of Patient 100's "ED (emergency department) Physician Notes," dated 3/27/2023, the physician notes indicated, Patient 100, an 81-year-old, was brought into the ED complaining of left lower leg swelling that started in the morning. The patient had a steady gait alert at baseline, reports mild pain, aching, constant pressure for unknown duration. The ED Physician Notes further indicated Patient 100 had swelling of moderate severity, was not on aspirin medication or other blood thinners with notes -Medical Decision Making: Patient 100 was given IV (intravenous -via vein) fluids and started on Lovenox (anti-coagulant-medication for an extensive DVT- deep vein thrombosis-blood clot) and will be admitted due to age and new onset of DVT.

During a review of the manufacturer's instructions for use (MIFUs) for Lovenox, revised 4/22, the "MIFU" indicated in part, ... "Indications and Usage ...Inpatient treatment of acute DVT with or without pulmonary embolism (blood clot in the lung) ...WARNINGS AND PRECAUTIONS ... Increased Risk of Hemorrhage: Monitor for signs of bleeding ...Treatment of Deep Vein Thrombosis with or without Pulmonary Embolism ... the recommended dose of Lovenox is 1 mg/kg every 12 hours administered subcutaneously or 1.5 mg/kg once a day administered subcutaneously at the same time every day for inpatient (hospital) treatment of patients ..."

During an interview on 5/10/23, at 5:00 p.m., with the ED Physician (MD 1), MD 1 verbalized, Patient 100 came into the ED with leg swelling and was diagnosed with a DVT. MD 1 further verbalized having Patient 100 admitted in the hospital because of age, dementia (memory loss), and to treat the DVT with Lovenox (the most preferred medication treatments for DVT's- dose for Lovenox depends on the weight of the patient). According to MD 1, the patient weighed about 40 kilograms (kg) and the standard of practice for Lovenox is to give 1 mg (milligram) /kg every 12 hours. MD 1 ordered 80 mg initial dose of Lovenox.

During further interview with MD 1 on 5/10/23 at 5:00 p.m., MD 1 indicated, putting the wrong order and Pharmacy (PX -tele pharmacy) called informing MD 1 the order for Lovenox 80 mg, for initial dose was too much, the 1mg/kg every 12 hours, calculated to 40 mg, was the standard for this patient but MD 1 was told by PX-tele Pharmacy, " You can also give 1.5 mg/kg which would calculate as 60 mg for this patient as a one-time dose. MD 1 then ordered to cancel the Lovenox 80 mg. one time initial dose and changed it to the 60 mg. one time initial dose.MD 1 contacted MD 2 (Hospitalist Physician) to admit Patient 100 to the hospital. When MD1 was asked if it was typical to give a hand off communication to the next physician taking over the patient, MD 1 stated, "It depends on the Admitting Physician (AP). MD 2 usually just wants to know the patient's name, age, why being admitted and diagnosis. The AP will be able to see what had been done for the patient, and what orders and medications were given.

During a review of Patient 100's "ED Physician Orders," dated 3/27/23, the orders indicated, give 60 mg of Lovenox subcutaneous (SUBQ-in the fatty tissue just under the skin) injection STAT (immediately) for DVT.

During an interview on 5/10/23, at 6:14 p.m., with the ED nurse (LN 3), LN 3 verbalized caring for Patient 100 when relieving another nurse (LN 4) for lunch. LN 3 verbalized seeing the order, to give Patient 100, 60 mg of Lovenox as a STAT, one-time dose and further verbalized, giving the medication. LN 3 verbalized, after the medication was given it is documented in the electronic medication administration record (eMAR). When asked if a report (hand off-communication) was given to the nurse (LN 4), when returning from lunch, about giving the 60 mg of Lovenox, LN 3 verbalized could not remember and stated, "It is my usual practice to give report to the oncoming nurse about what was done for the patient and what medications were given." LN 3 further verbalized, documenting hand off communication in the medical record.

During a review of Patient 100's "eMAR Summary," dated 3/27/23, the summary indicated, 60 mg of Lovenox was given at 7:19 p.m.

During a review of Patient 100's "Clinical ED Notes," dated 3/27/23, there was no documentation about a report to LN 4. The clinical ED note documentation only indicated that LN 4 assumed care of Patient 100 at 7:47 p.m.

During an interview on 5/11/23, at 9:04 a.m., with the MD 2, MD 2 verbalized receiving Patient 100 for admission and further verbalized, receiving report. MD 2 verbalized being informed that Patient 100 was being admitted for a DVT. MD 2 verbalized, there was no discussion of Patient 100 receiving a dose of Lovenox in the ED. MD 2 verbalized Patient 100 was to be admitted and put on Lovenox and ordered for pharmacy to adjust dose and timing of the medication. MD 2 stated, "I did not know about the first dose of Lovenox." MD 2 verbalized, did not get an alert from pharmacy about a duplication of order. MD 2 verbalized the standard of practice for Lovenox should be given 12 hours after the first dose and further verbalized, pharmacy and nursing should be aware of giving Lovenox every 12 hours, its standard of care. MD 2 was informed that the first dose of the Lovenox (60mg) was verified by a tele pharmacy and not the in-house pharmacy. Once the first dose was given, it dropped off the pharmacy screen as a discontinued medication. The in-house pharmacy did not see the first dose of Lovenox and the tele pharmacy did not communicate to in-house pharmacy that a 60 mg dose of Lovenox had been given. MD 2 was further informed when she entered the order for the 40 mg dose of Lovenox, the in-house pharmacy verified it was ok to give, and the in-house pharmacy did not get an alert that there was a duplicate medication order. MD 2 acknowledged, there should have been a system in place where the in-house pharmacy should have known about the first dose of Lovenox that had been given. MD 2 stated, "I should have looked at Patient 100's eMAR and further stated, "I don't think anybody knew about the first dose of Lovenox that was given."

During a review of Patient 100's "Physician Orders," dated 3/27/23, at 9:00 p.m., the orders indicated, give 40 mg of Lovenox SUBQ injection every 12 hours for DVT.

During an interview on 5/11/23, at 10:03 a.m., with the ED nurse (LN 4), LN 4 verbalized caring for Patient 100 in the ED. LN 4 verbalized, Patient 100 had a DVT. LN 4 verbalized, Patient 100 was going to be admitted to the hospital and saw the order for Lovenox 40 mg every 12 hours. LN 4 verbalized wanting to help the nurse on the floor and give the Lovenox medication before transferring Patient 100. When asked about one-time stat medication orders, LN 4 verbalized, once a one-time stat medication order is given, then the order is discontinued and drops down to the bottom of the screen. When asked if the discontinued medication at the bottom of the screen was reviewed for Patient 100, prior to giving the Lovenox, LN 4 stated, "It did not occur to me to look down at the discontinued medication box at the bottom of the screen." LN 4 further verbalized, only looking at the bottom of the screen when handing off a patient to another nurse, to inform the nurse what medications had been given. LN 4 verbalized, before giving a medication, would review the order. LN 4 verbalized, once an order is reviewed it creates a task list that will show when medication orders are due. LN 4 verbalized, after order review, the medication is pulled from the Omnicell (automated drug dispenser), the patient's arm band is scanned, the medication is scanned, then the check mark is clicked, indicating good to give the medication to the patient. LN 4 verbalized, scanning Patient 100's arm band and scanning the 40 mg Lovenox medication. LN 4 verbalized, during the scanning, there were no alerts or red flags for the medication order. When asked if he received report from the previous nurse, LN 4 verbalized it's our standard of practice to receive report from the previous nurse. When asked if LN 4 was told Patient 100 received a 60 mg dose of Lovenox at 7:19 p.m., LN 4 stated, "If I knew about the previous 60 mg dose of Lovenox then I would not have given another 40 mg dose of Lovenox" and further stated, "It would have been too soon." LN 4 acknowledged, the second dose of Lovenox was given too soon and was a medication error. When asked if duplicate orders occur in the ED, LN 4 verbalized, they do happen every now and then.

During a review of Patient 100's "eMAR Summary," dated 3/27/23, the summary indicated, 40 mg of Lovenox was given at 9:22 p.m.

During a review of Patient 100's "Nursing Flowsheet," dated 3/28/23, at 2:49 p.m., the flowsheet indicated, Patient 100 had head pain 3/10. At 3:11 p.m. Patient 100 had head pain 9/10.

During a review of Patient 100's "Rapid Response Team Care Record," dated 3/28/23, at 4:12 p.m., the record indicated, Patient 100 became unresponsive to painful stimuli, right pupil fixed/dilated, left eye non-reactive, and a code stroke was called.

During a review of Patient 100's "Consultation Report," dated 3/28/23, at 5:12 p.m., the report indicated in part, ...Patient 100 chief complaint: ... right cerebral (brain) bleed hemisphere bleed ...left leg DVT on Lovenox ...altered mental status ...decreased level of consciousness of sudden onset ...History of present illness: ...Patient 100 admitted yesterday work-up revealing left leg DVT ...Patient 100 on Lovenox treatment and this afternoon poorly responsive ...rapid response team code was called and Patient 100 was taken for CT of brain revealing large right sided-bleed ....Lovenox was stopped Patient 100 is obtunded with flaccid extremities ...Patient 100 went to ICU for further neurological care.

During a review of Patient 100's "Clinical Nursing Note," dated 3/29/23, the note indicated in part, ...Patient 100 found not breathing, two registered nurses verified that there was no pulse or breath sounds at 10:33 a.m., house supervisor was called ...Hospitalist Physician (MD 3) notified.

During an interview on 5/8/23, at 10:19 a.m., with the Director of Pharmacy (DOPH) and the Pharmacy Clinical Coordinator (PCC), DOPH verbalized Patient 100 came to the ED with a DVT. DOPH verbalized when the ED Physician (MD 1) ordered the first dose of 60 mg of Lovenox, the medication was verified by tele pharmacy. DOPH verbalized, tele pharmacy verifies one-time STAT orders for the ED. DOPH verbalized, once the order is reviewed by the nurse and the medication is given, the order drops down to the bottom the pharmacy screen and is discontinued. DOPH verbalized, Patient 100 was then admitted to the medical floor. DOPH further verbalized, the Hospitalist (MD 2) then ordered the second dose of Lovenox, 40 mg every 12 hours. DOPH verbalized, the in-house pharmacy verifies the routine scheduled medications. DOPH verbalized, MD 2 did not get an alert for a duplicate order, and the in-house pharmacy did not get an alert for the duplicate order, when the first dose of Lovenox was just given two hours prior. DOPH verbalized, the in-house pharmacy and ordering physician should be able to see what medications had been given to Patient 100 and stated, "They did not see it." DOPH verbalized, the ED nurse (LN 4) had reviewed the first and second order for Lovenox. LN 4 went on lunch break and ED nurse (LN 3) gave the first dose at 7:19 p.m. When LN 4 came back to care for Patient 100, LN 4 did not see that the first 60 mg dose of Lovenox was given, was not told the first dose was given, and LN 4 gave the second 40 mg dose of Lovenox at 9:22 p.m. DOPH verbalized, the second dose was given to Patient 100, two hours after receiving the first dose. DOPH verbalized, LN 4 did not receive an alert or red flag when administering the second dose of Lovenox. DOPH and PCC both acknowledged, this was a medication error.

During a review of the facility's P&P titled, "Medication Administration, "revised 9/28/22, the P&P indicated in part, ... "Medications will be administered only upon the order of members of the medical staff, an authorized prescriber, of the house staff, or other individuals who have been granted clinical privileges by the medical staff and the State of California to write such orders ...Pharmacists may initiate and adjust the drug regimen of a patient pursuant to an order or authorization made by the patient's prescriber in accordance with policies, procedures, or protocols developed by physicians, pharmacists, and registered nurses ...interpretation and dispensing of all prescribed medication orders shall be done from a direct or faxed copy of the written order or order entered electronically into the computer system ...A. Scope of service ...1. Nursing ...a. registered nurses may administer all parenteral (subcutaneous, intramuscular, intravenous, and intrathecal) oral, rectal, and topical medications including blood and blood products if not specifically excluded elsewhere ...C. Administration of Medications ...12. Utilize the seven rights in administering medication: a. Right Dose ...b. Right Time ...c. Right Route ...d. Right Drug ...e. Right Patient ...f. Right to Refuse ...g. Right to Educate ..."

2. During a concurrent record review and interview on 5/8/23, at 12:39 p.m., Patient 201's medical record was reviewed with the ED manager (EDM). The record indicated, patient was seen in the ED due to alter level of consciousness. According to the vital signs flow sheet, patient's blood pressure decreased significantly requiring a vaso-suppressor (medication that increases blood pressure). A physician's order for a Dopamine (treatment for low blood pressure) medication drip was received on 5/7/23 at 2:02 p.m. The order indicated, "Initial rate of infusion: 2 mcg/kg/minute. Increment of change: 2mcg/kg/min. Frequency of increment of change: 2 minutes. Maximum dose: 20 mcg/kg/min. The eMAR indicated, the medication frequency of increment change was more than 2 minutes. The EDM acknowledged and confirmed, the Dopamine drip was not administered as per the physician's order.

Based on observation, interview, and record review the hospital failed to ensure that safe pharmaceutical services had been provided and meet the needs of each patient as evidenced by:

1. The hospital failed to ensure that the hospital had implemented all of its policies and procedures regarding the labeling of high alert medications. The hospital also failed to ensure that patient home medication had been destroyed as outlined in the hospital's policy and procedures for 32 out of 32 sampled patients in the hospital's care systems (Refer to A 491).

2. The hospital failed to ensure that the hospital was following their policies and procedures for documenting expiration dates for medications (which had been prepared into oral syringes) and ensuring that all medications had been checked by a Pharmacist, before being sent to patient care areas. This deficiency had the potential to affect 32 out of 32 sampled patients. (Refer to A 501).

3. The hospital failed to ensure that one single use bottle of Povidone/Iodine had been secured and discarded as outlined in the hospital's policies and procedures. This deficiency had the potential to affect 32 out of 32 sampled patients. (Refer to A 502).

4. The hospital failed to ensure that patients had been protected from medication errors and that these medication errors did not contribute to a patient's death, while under care of the hospital, during the course of the patient's stay. This deficiency had the potential to affect 32 out of 32 sampled patients. (Refer to A508).

5. The hospital failed to ensure that the hospital's drug formulary (a drug formulary is a list of drugs covered under a hospital's health plan for the care and management of its patients), had been evaluated for each medication's effectiveness, risk, and the costs of the medications, which had been used by the hospital, for patient care. This included evaluating the risks, effectiveness, and costs of medications. This deficiency had the potential to affect 32 out of 32 sampled patients. (Refer to A 511).

The cumulative effect of these systemic problems resulted in the facility's inability to ensure the provision of quality health care, in compliance with the Condition of Pharmaceutical Services.

Based on observation, interview and record review, the hospital's pharmacy failed to ensure:

1. Safe and appropriate dispensing or labeling of high alert medication (e.g., Lovenox-used to treat or prevent a type of blood clot) retrieved from a cassette (non-automated dispensing cabinet) from two in-patient units:
a. For one of 22 cassettes inspected in Telemetry 1 (1 South - where patients undergo continuous cardiac monitoring) unit.
b. for one of 16 cassettes inspected in Medical - Surgical (3 North - where patients are prepared for or recovering from a surgical procedure) unit.

This failure had a potential to affect all patients receiving high alert medications and result in medication errors which are a substantial source of morbidity and mortality risk in the hospitalized setting.

2. The policy and procedure (P&P) for home medication storage was implemented for 32 out of 32 sampled residents.

This failure resulted in hospital storing home medications over the three month limit per their P&P, and the overcrowding of these medications.

Findings:

1. a. The hospital's document titled, "Description of Initiative: High Severity High Alert Medication Safety," dated 09/2022, included the immediate actions to be completed on 5/9/2023 indicating " ...A revised process has been developed for high severity, high alert medications in the emergency department and Inpatient units ... Nursing Alerts: High severity high alert medications stored in medication carts will have high alert sticker (to verify the right dose, right time, indication, last dose given, any interactions and document RN double check) placed by pharmacy, prompting nurse for verification ..."

During a concurrent tour and interview on 5/10/23, starting at 10:21 a.m., Telemetry 1 (T1) was viewed with the T1 Manager (T1M) and Registered Nurse Informatics (RNI). On observation, starting inside the medication room, a total of 22 unlocked cassettes were inspected to determine what high alert sticker is expected to be seen on a high-risk medication. The cassette for room 1171 revealed, a pre-filled Lovenox syringe was without a precautionary label to alert the nurse that certain verifications are needed before medication can be administered. T1M and RNI, both confirmed the pre-filed Lovenox syringe did not have a high alert sticker, and it should have been labeled with a high alert sticker.

1. b. During a tour of 3 North on 5/10/23, at 10:00 a.m. with the 3N Manager (3NM), in the medication room, 16 patient cassettes where inspected. On cassette number 305, a prefilled syringe of Lovenox was observed to have no warning sticker attached to it.

During an interview on 5/10/23 at 10:03 AM, the 3NM acknowledged, there was no sticker attached to the prefilled syringe of Lovenox.

The hospital's document titled, "Description of Initiative: High Severity High Alert Medication Safety," dated 09/2022, included the immediate actions to be completed on 5/9/2023 indicating " ...A revised process has been developed for high severity, high alert medications in the emergency department and Inpatient units ... Nursing Alerts: High severity high alert medications stored in medication carts will have high alert sticker (to verify the right dose, right time, indication, last dose given, any interactions and document RN double check) placed by pharmacy, prompting nurse for verification ..."


2. During a concurrent observation, record review, and interview on 5/12/23, at 3:45 p.m., an inspection of the pharmacy's home medication storage area and review of patients' own medication storage logs were reviewed with the Director of Pharmacy (DOP). The following were observed:
a. One patient's bag of home medications had been left in the Pharmacy and not destroyed since 3/19/2022 (over 1 year).
b. One patient's bag of home medications had been left in the Pharmacy and not destroyed since 11/01/2021 (almost 2 years).
c. One patient's bag of home medications had been left in the Pharmacy and not destroyed since 11/06/2021 (almost 2 years).
d. One patient's bag of home medications had been left in the Pharmacy's refrigerator and not destroyed since 7/22/2022 (almost 1 year).
e. One patient's bag of home medications had been left in the Pharmacy and not destroyed since 9/02/2022 (less than 1 year).
f. One patient's bag of home medications had been left in the Pharmacy and not destroyed since 11/03/2021 (almost 2 years).
g. One patient's bag of home medications had been left in the Pharmacy and not destroyed since 1/4/2022 (over 1 year).
h. One patient's bag of home medications had been left in the Pharmacy and not destroyed since 4/26/2022 (over 1 year).
i. One patient's bag of home medications had been left in the Pharmacy and not destroyed since 8/11/2022 (less than 1 year).
j. One patient's bag of home medications had been left in the Pharmacy and not destroyed since 8/11/2022 (less than 1 year).
k. One patient's bag of home medications had been left in the Pharmacy and not destroyed since 12/12/2021 (more than 1 year).
l. One patient's bag of home medications had been left in the Pharmacy and not destroyed since 10/26/2022 (less than 1 year).

DOP acknowledged the above findings, and confirmed, the drawers which were being used to keep patient's own medications were overflowing.

Review of the hospital's policy and procedure (P&P) titled, "Medications from Home," dated 7/9/21, the P&P indicated, "5. if the patient goes home without the medications, the pharmacy will attempt to contact the patient by telephone or in writing. The Pharmacy will store the medications until three (3) months after discharge, at which time they (the medications) will be destroyed."


39912

Based on observation, interview and record review, the facility failed to ensure unit dosed oral medications (the ordered amount of a drug in a dosage form prepared for a one-time administration to an individual) had the correct expiration date or beyond use date (BUD) and that all of these medications had been checked/verified by a Pharmacist prior to going to the hospitals floors for patient administration. This failure had the potential to put 32 out of 32 sampled patients at risk for receiving ineffective, incorrectly prepared, or outdated medications.

Findings:

During a review of the hospital's oral compounding logs on 05/12/2023, at 10:30 am and interview with the hospital's Director of Pharmacy who indicated that the Pharmacy adhere' s to USP 797, revealed the following concerns:

a) One Azithromycin (antibiotic) 200 mg/ 5 ml oral syringe which had been compounded on 4/7/2023 by one of the Pharmacy's Pharmacy Technician's but this medication had not been checked by a Pharmacist prior to this medication leaving the Pharmacy and being sent up to the patient floor.
b) One Amoxicillin (antibiotic) 250 mg/5 ml oral syringe which had been made on 4/9/2023, but the label did not contain a time when this medication had been prepared. This time of day was critical in making sure that the Pharmacist had assigned the correct Beyond Use Date (BUD) time to this product.
c) One Amoxicillin (antibiotic) 250 mg/5 ml oral syringe which had been made on 4/28/2023, but the label did not contain a time when this medication had been prepared. This time of day was critical in making sure that the Pharmacist had assigned the correct Beyond Use Date (BUD) time to this product.
d) One Amoxicillin (antibiotic) 250 mg/5 ml oral syringe which had been made on 4/29/2023, but the label did not contain a time when this medication had been prepared. This time of day was critical in making sure that the Pharmacist had assigned the correct Beyond Use Date (BUD) time to this product.
e) One Azithromycin (antibiotic) 200 mg/ 5 ml oral syringe which had been made on 4/29/2023, but the label did not contain a time when this medication had been prepared. This time of day was critical in making sure that the Pharmacist had assigned the correct Beyond Use Date (BUD) time to this product.
f) One bottle of Acetic Acid 0.25%, 1000 ml irrigation solution had been compounded on 5/4/2023 by the hospital pharmacy staff and given a 6-hour expiration date contrary to USP 797 (which indicates that these compounded products should only be given a one-hour BUD, before being discarded.
g) One mouthwash for Antifungal/Pain 120 ml had been compounded on 5/4/2023 and no BUD had been assigned to this medication.
h) One Lactulose sterile water for injection had been compounded on 5/8/2023 by the hospital's pharmacy staff and this medication had been given a BUD date of 12-hour contrary to USP 797.
i) One Lactulose sterile water for injection had been compounded on 5/9/2023 by the hospital's pharmacy staff and this medication had been given a BUD date of 12-hour contrary to USP 797.
j) One Omerazole (Prilosec a medication used to treat heartburn), 2 mg/ml 10ml oral syringe had been compounded on 5/10/2023 at 8:58 pm, but no BUD had been assigned to this medication.
k) One Gabapentin (seizure medication) 250 mg/5 ml oral syringe had been made in the Pharmacy on 5/3/2023 by a Pharmacy Technician but had not been signed off by a Pharmacist prior to being sent up to the patient care floor.
l) One Glycerin Adult Suppository had been made on 5/3/2023 and given a BUD of 10/28/2022. This drug was expired before it left the Pharmacy.

Based on observation, interview and record review, the facility failed to ensure a single use bottle of Povidine-Iodine topical antiseptic solution was discarded after use and not accessible to the public, patient, and staff.

The failure had the potential for the Povidine solution to be accessible and used for what it was not ordered or intended for.

Finding:

During a tour of the emergency department (ED) on 5/10/23 at 11:50 a.m., a bottle of Povidine-Iodine single use solution was observed on top of a plastic cart, parked next to room 18, where a visitor was sitting approximately four (4) feet away from the cart.

During a concurrent observation and interview on 5/10/23, at 11:52 a.m., the Povidine-Iodine bottle solution was observed with the ED charge nurse (EDCN). The bottle was observed on top of a cart, parked next to room 18. The EDCN acknowledged and confirmed, the single use bottle of Povidine should not be on top of the cart. EDCN stated, "Single use only once used medication to be discarded."

A review of the facility policy and procedure (P&P) titled, "Safe Injection Practices," dated 4/21/21, indicated, "Use a single-dose/single-use vial for a single patient ...Discard the vial after this single use ..."

Based on interview and record review, the hospital failed to ensure that a preventable medication error did not occur with one of 32 sampled patients (Patient 1). Patient 1 received a second dose of a medication Lovenox (also known as Enoxaparin, a blood thinning medication), within two hours of the first dose, which resulted in an excessive dose based on the drug manufacturer's package insert based on the patient's weight. The hospital's medication error may have led/contributed to Patient 1's death, which may have been averted.

Findings:

During record review of Patient 1's medical record, Patient 1 had been seen in the hospital's Emergency Room (ER) on 3/27/2023, at 4:39 pm, for Acute bilateral deep vein thrombosis of the femoral veins. She was subsequently admitted to the hospital and discharged (passed away) on 3/29/2023, at 4:20 pm, under a Physician's care.

During a review of Patient 1's medical record, dated 5/8/2023, at 11:00 am, the medical record indicated, MD 1 ordered Lovenox (Enoxaparin, an anticoagulant medication which helps to prevent the formation of blood clots). This Lovenox had been ordered as a "one time dose" of 60 mg, and then a second order by MD 2, had been written for the patient to receive Lovenox 40 mg every 12 hours, but. The following information was taken directly from the drug's manufacturer's 2022 sanofi-aventis U.S. LLC package insert:
"For the treatment of Deep Vein Thrombosis with or without Pulmonary Embolism, the recommended dose of Lovenox is 1 mg/kg every 12 hours administered subcutaneously in patients with acute deep vein thrombosis without pulmonary embolism, who can be treated at home in an outpatient setting. The recommended dose of Lovenox is 1 mg/kg every 12 hours administered subcutaneously or 1.5 mg/kg once a day administered subcutaneously at the same time every day for inpatient (hospital) treatment of patients with acute deep vein thrombosis with pulmonary embolism or patients with acute deep vein thrombosis without pulmonary embolism (who are not candidates for outpatient treatment)." Patient 1 had a weight of 35.8 Kilograms (kg) on admission to the Emergency Room. Based on this patient's weight and drug manufacturer's specifications above, this patient should have only received a maximum dose of 52.5 mg in a 24-hour period. Review of patient 1's medical record on 5/8/2023 revealed that this patient had received a total dose of 140 mg of Lovenox (more than double the manufacturer's specifications, within the 24-hour period, contrary to the drug manufacturer's specifications.

The following information was taken directly from the drug's manufacturer's 2022 sanofi-aventis U.S. LLC package insert: "Renal Impairment: In patients with renal impairment, there is an increase in exposure of Enoxaparin sodium. All such patients should be observed carefully for signs and symptoms of bleeding. Because exposure of Enoxaparin sodium is significantly increased in patients with severe renal impairment (creatinine clearance <30 ml/min), a dosage adjustment is recommended for therapeutic and prophylactic dosage ranges." On 3/27/2023, Patient 1 had a laboratory blood draw and this patient's Blood Urea Nitrogen (BUN) and Creatine level came back at 28.9 mg (milligrams) per dl (deciliter). As identified in the drug manufacturer's literature above, when the BUN/Creatine level is below 30 ml/min, the Lovenox dose needs to be reduced from the "normal dose".
Again, the normal dose according to this drug's manufacturer for this patient, based on the patient's actual weight would have been 52.5 mg (if the dose was based on 1.5 mg/kg) and 35 mg (if the dose was based on 1 mg/kg). Based on this patient's impaired renal clearance, neither one of these doses would have been correct, as hospital's Physician and the hospital's Pharmacy should have reduced/adjusted these doses, rather than rounding these doses up, as was done.

Again, the following information was taken directly from the drug's manufacturer's 2022 sanofi-aventis U.S. LLC package insert: "OVERDOSAGE: Accidental overdosage following administration of Lovenox may lead to hemorrhagic complications, Low-Weight Patients: An increase in exposure of Enoxaparin sodium with prophylactic dosages (non-weight adjusted) has been observed in low-weight women ... The incidence of bleeding complications was higher in geriatric patients as compared to younger patients when Lovenox was administered at doses of 1.5 mg/kg once a day or 1 mg/kg every 12 hours. The risk of Lovenox-associated bleeding increased with age. Serious adverse events increased with age for patients receiving Lovenox ...Careful attention to dosing intervals and concomitant medications (especially antiplatelet medications) is advised. Lovenox should be used with care in geriatric patients who may show delayed elimination of Enoxaparin. Monitoring of geriatric patients with low body weight ...Careful attention to dosing intervals and concomitant medications, (especially antiplatelet medications) is advised. Lovenox should be used with care in geriatric patients who may show delayed elimination of Enoxaparin. Monitoring of geriatric patients with low body weight (<45 kg) and those predisposed to decreased renal function should be considered ...ADVERSE REACTIONS: The following serious adverse reactions are also discussed in other sections of the labeling: " Spinal/epidural hematomas " Increased Risk of Hemorrhage ...Use Lovenox with extreme caution in conditions with increased risk of hemorrhage, such as bacterial endocarditis, congenital or acquired bleeding disorders, active ulcerative and angiodysplastic gastrointestinal disease, hemorrhagic stroke, or shortly after brain, spinal, or ophthalmological surgery, or in patients treated concomitantly with platelet inhibitors. Major hemorrhages including retroperitoneal and intracranial bleeding have been reported. Some of these cases have been fatal. Bleeding can occur at any site during therapy with Lovenox. An unexplained fall in hematocrit or blood pressure should lead to a search for a bleeding site..".

During an interview on 5/11/2023, at 10:05 am, with Patient 1's Registered Nurse (RN 1), RN 1 received an order from Patient 1's for 40 mg of Lovenox, which was administered to the patient only 2 hours after the first dose of 60 mg. During the interview, the Nurse stated: "I saw the medication order in the chart (for the Lovenox) and I wanted to be a good Nurse and help out the floor Nurse, so I gave the medication." After the third dose of Lovenox (40 mg), while the patient was in the hospital's Intensive Care Unit (ICU), the patient was later diagnosed with a "Large right hemispheric mixed attenuation collection compatible with acute subdural hematoma, (a solid swelling of clotted blood within the brain) as shown on a Brain CT (computed tomography) Scan (a computer linked x-ray machine).

The National Coordinating Council Medication Error Reporting and Prevention (NCCMERP) is a nationally recognized organization which sets the standards for the definition of medication errors. NCCMERP defines a medication error as: "Any preventable event that may cause or lead to inappropriate medication use or patient harm while the medication is in the control of the health care professional, patient, or consumer ..."drug administration error", is limited to those errors in administration that actually reach the patient, i.e. (for example), a medication actually is administered to a patient when it should not be ...".

On 5/8/2023, at 6:39 pm, an Immediate Jeopardy situation (a situation in which the facility's noncompliance had placed the health and safety of patients in its care at risk for serious injury, serious harm, serious impairment, or death) as the hospital had administered the first dose of Lovenox (Enoxaparin), had been ordered for Patient 1 on 3/27/2023, at 7:09 pm as a "Stat" (immediate) dose, via I.V. This order for Lovenox had been checked and verified by the hospital's corporate Pharmacy in Roseville California (via a telehealth Pharmacy system). Roseville is about 340 miles to the north of Simi Valley. A second dose of Lovenox 40 mg was given to Patient 1, approximately 2 hours after the first dose, but this dose had been approved and verified by the local Pharmacy in Simi Valley. The two Pharmacies never talked with each other after verifying each of these two doses. Approximately 12 hours after the second dose had been administered, a nurse administered a third dose of Lovenox 40 mg to this same patient. This patient received 140 mg of Lovenox within a 24-hour period (daily dose), contrary to the drug manufacturer's specifications that a once daily dose of 60 mg be given to someone with this patient's weight, age, and creatine clearance.

On 5/9/2023, at 3:54 pm, the hospital administrative staff provided a Plan of Action (POA), which included the following summarized actions:

a) Pharmacy will receive alerts for high alert medications, including therapeutic duplications.
b) Prescribers will be notified by the Pharmacist in the event of a therapeutic duplication of a high severity/high alert medication.
c) Nursing Director/designee will perform 5 random observations in each unit/per week, a total of 100 audits per month of high alert medications to verify right dose, right time, indication, last given and any interactions.
d) Nursing alerts when high severity high alert medication has been pulled from the Omnicell and all high alert medications will be reviewed by the hospital's on-site Pharmacy effective 5/10/2023.
e) Education: Pharmacy staff will receive education on high alert high severity medication alerts.
f) Audits will continue for at least six months until 100% compliance has been achieved and compliance data will be reported monthly to the QAPI committee and quarterly to the P&T committee.
g) Alerts for the hospital's contracted Physicians and Nursing staff are scheduled to have live high alert notifications to go live no later than 05/15/2023.
h) New-hire and on-going RN education and competency will be provided to staff.
i) The patient, family or legally authorized representative must be informed of a reportable adverse event by the time the report is made to the reporting agency. The patient must be informed that the event occurred ...

On 05/10/2023, at 7:52 pm, while onsite and after confirming the facility's implementation of the immediate corrective Plan of Action, the Immediate Jeopardy situation was removed in the presence of the Hospital's Administrative Staff.

Based on interview with facility hospital staff and review of the hospital's drug formulary, the hospital failed to develop and evaluate its drug formulary (a drug formulary is a list of drugs covered under a hospital's health plan for the care and management of its patients). The hospital also failed to eliminate medications from this list may not have been the most effective and latest treatments available, for 32 out of 32 sampled patients. This had the potential for the hospital to have medications on their drug formulary, which may not have been the most cost-effective medications for the hospital.

Findings:

During an interview with Director of Pharmacy (DOP) on 5/12/2023 at 2:45 pm, she stated that the hospital had developed a local drug formulary specific for this hospital, but that this drug formulary had not been reviewed in "quite some time". The hospital had failed to look at the current drug formulary based on the following criteria: medication effectiveness in treatment, potential risk for harm to patients, and the costs for the use of any medications (including duplication in therapy).


Review of the hospital's current drug formulary included drugs like Cocaine solution, Chloral Hydrate (a sedative), Tessalon Benzoate, and Vistaril, all of which are very old drugs and newer drugs are available which can be substituted, with safer drug profiles and with fewer side effects. For example, Cocaine has a very strong profile for "potential abuse", and other less abusive drugs are available and able to be used with similar results.

As for Choral Hydrate, Ventricular dysrhythmias and severe hypotension, which has led to some fatalities, from chloral hydrate toxicity have been reported. These effects were observed mostly after large doses or overdoses, as they are dose-dependent. Again, Chloral Hydrate is not a drug with the best safety profile.

Based on the package insert from the drug's manufacturer (Pfizer Inc 2015), Tessalon Benzoate (which has been used to treat coughs): "Hypersensitivity Severe hypersensitivity reactions (including bronchospasm, laryngospasm and cardiovascular collapse) have been reported which are possibly related to local anesthesia from sucking or chewing the capsule instead of swallowing it. Severe reactions have required intervention with vasopressor agents and supportive measures. Psychiatric Effects Isolated instances of bizarre behavior, including mental confusion and visual hallucinations, have also been reported in patients taking TESSALON in combination with other prescribed drugs ... CNS stimulation may cause restlessness and tremors which may proceed to clonic convulsions followed by profound CNS depression. Convulsions, coma, cerebral edema and cardiac arrest leading to death have been reported within 1 hour of ingestion." Indicating that Tessalon Benzoate may not have the safest profile.

Based on the manufacturer's (Pfizer Inc September 2019) package insert for Hydroxizine (also known as Vistaril and is used for the treatment of itching), reads: "Cases of QT prolongation and Torsade de Pointes have been reported during post-marketing use of hydroxyzine. The majority of reports occurred in patients with other risk factors for QT prolongation/TdP (pre-existing heart disease, electrolyte imbalances or concomitant arrhythmogenic drug use). Therefore, hydroxyzine should be used with caution in patients with risk factors for QT prolongation, congenital long QT syndrome, a family history of long QT syndrome, other conditions that predispose to QT prolongation and ventricular arrhythmia, as well as recent myocardial infarction, uncompensated heart failure, and bradyarrhythmias. Caution is recommended during the concomitant use of drugs known to prolong the QT interval. These include Class 1A (e.g., quinidine, procainamide) or Class III (e.g., amiodarone, sotalol) antiarrhythmics, certain antipsychotics (e.g., ziprasidone, iloperidone, clozapine, quetiapine, chlorpromazine), certain antidepressants (e.g., citalopram, fluoxetine), certain antibiotics (e.g., azithromycin, erythromycin, clarithromycin, gatifloxacin, moxifloxacin); and others (e.g., pentamidine, methadone, ondansetron, droperidol). In general, dose selection for an elderly patient should be cautious, usually starting at the low end of the dosing range, reflecting the greater frequency of decreased hepatic, renal or cardiac function and of concomitant disease or other drug therapy. The extent of renal excretion of VISTARIL has not been determined. Because elderly patients are more likely to have decreased renal function, care should be taken in dose selections. Sedating drugs may cause confusion and over sedation in the elderly; elderly patients generally should be started on low doses of VISTARIL and observed closely." Again, this is not the safest drug which can be used to treat this condition.


ASHP Guidelines on Preventing Medication Errors in Hospitals who also provides guidance on the National Standards for drug formularies, states, under their Formulary Assessment and Management section:

"A well-designed formulary system will guide clinicians to prescribe the safest and most cost-effective agent for treating a particular disease state or medical issue. Formularies limit the selection of medications available so that clinicians become proficient with the dosing, preparation, and administration practices of a selected number of medications. A streamlined formulary can also help to standardize the content of EHRs, pharmacy information systems, and infusion pump settings/medication libraries ... The "ASHP Guidelines on the Pharmacy and Therapeutics Committee and the Formulary System" provide detailed guidance on formularies and medication evaluation documents (i.e., monographs) and should be consulted for more information. In particular, when preparing an evidence-based formulary review document for a medication, a section should be devoted to medication safety assessment and recommendations. In short, the pharmacist/pharmacy should consider whether the medication being reviewed for addition to the formulary has potential safety issues ....".