HospitalInspections.org

Based on interview and record review the hospital failed to ensure they immediately involved the Governing Body in the decisions related to a medication administration error that resulted in the death of a patient.

As a result, systems were not changed and staff were not reeducated to prevent this from reoccurring for at least 25 days.

Findings:

On the initial visit on 10/26/22, to investigate a complaint. The CNO and Quality Director informed the team there was a plan in place to educate staff, related to a medication administration error of administering an antibiotic to a patient (Patient 1) with a know allergy to the antibiotic. The medication was administered, and the patient expired on 10/20/22.

On 11/3/22, it was the determined the plan to educate staff related to the medication error, had not yet been presented to the Governing Body to be approved and implemented.

On 11/17/22, the Governing body admitted they were not presented the facts related to: the medication error, the changes made, and the education provided until 11/14/22. Twenty-Five days after the medication administration error which resulted in death.

Based on interview and record review, the hospital's Governing Body did not ensure they were involved in the development and implementation of needed safeguards ensuring medical, pharmacy, and nursing services were provided in a safe and efficient manner when they had no oversite into the policies and actions of a physician, a pharmacist, and a nurse who all discounted the systems in place to prevent the administration of a medication to a patient (Patient 1) with a documented known allergy.

As a result, this failure led to the administration of a medication to Patient 1 who suffered a severe was allergic reaction, resulting in death.

Findings:

Patient 1 had been seen in the hospital's Emergency Room (ER) on 10/19/22, at 11:31 P.M., for right shoulder pain, shortness of breath, end-stage Chronic Obstructive Pulmonary Disease (COPD), and cough. She was subsequently admitted to the hospital on 10/20/22, at 12:06 A.M., under the care of Physician 1 (MD 1).

On 10/20/22, at 3:45 P.M., MD 1 ordered an antibiotic Levofloxacin (Levaquin) 500mg daily for Patient 1.

On 10/20/2022, at 4:06 P.M, the Levaquin order was discontinued by Pharmacist 1 (PH 1) via text message. PH 1 and MD 1 continued to communicate regarding medication choices for Patient 1 via personal cellphones. Interview with the hospital's Chief Nursing Officer (CNO) and the Quality Director (QD) on 11/2/22, at 10:40 A.M., revealed that text messaging of any patient orders via personal cellphones is strictly prohibited by the hospital and this practice was not acceptable in this hospital. Via text message on 10/20/22, at 4:06 P.M., PH 1 advised MD 1 that Patient 1 did not have a "true" allergy to Ceftriaxone (Rocephin) and subsequently without a hospital protocol being in place for PH 1 to write medication orders, PH 1 changed Patient 1's previously ordered Levaquin antibiotic order to Ceftriaxone and Azithromycin (Zithromax). This change from Levaquin to Ceftriaxone, was made despite Patient 1's chart documented allergies (seizures) to Ceftriaxone.

Patient 1's medication Nurse (RN 1) had contacted MD 1 regarding Patient 1's documented allergic response (syncope and seizures) to Ceftriaxone, and she wrote the following in a Nursing note dated 10/20/2022, at 5:15 P.M.: " ... I noticed patient is allergic to Ceftriaxone with a reaction of seizures. I called MD 1 and alerted him that patient is allergic to Ceftriaxone. MD 1 confirmed he knew she was allergic to Ceftriaxone and that he confirmed with pharmacy that the Ceftriaxone was ok to give. I verbally confirmed on the phone with read back with MD 1 that he wanted me to give the Ceftriaxone and that it was confirmed by pharmacy. After confirmation, I gave Ceftriaxone by I.V. (intravenous) push. Patient stated that she felt weird and began to have a seizure. I suctioned the patient for 1 minute and then the patient stopped breathing. I called a code blue and began compressions 2 minutes later when her pulse stopped.". RN 1 had administered the Ceftriaxone into Patient 1's left arm at 4:21 P.M. and within less than 10 minutes, a Code Blue had been called by 4:30 P.M., and by 4:58 P.M., Patient 1 had been pronounced dead.

Review of the hospital's Rules and Regulations, dated 1/24/2022, confirmed that the Pharmacists were not allowed to write verbal orders via an established protocol: "Orders for treatment of patients must be entered into EPIC (EPIC is defined as a computerized physician order entry system). A telephone order taken directly from a practitioner may be received and entered via EPIC by a registered nurse or a licensed vocational nurse ...". The hospital Rules and Regulations do not allow for pharmacists to take telephone orders from a practitioner. Further review of the hospital's Rules and Regulations read: "If a nurse has any reason to doubt or question care provided to any patient or feels that appropriate consultation is needed and has not been obtained, (s)he shall call this to the attention of his/her superior who, in turn, may refer the matter to the CNO ...". RN 1's concern regarding Patient 1's allergy to Ceftriaxone was never escalated to the CNO, as outlined in the hospital's Rules and Regulations. PH 1 and MD 1 never spoke with Patient 1 regarding her allergy.

The hospital failed to meet the regulatory requirement under CFR 482.25 (b)(6) as evidence by the following:

As outlined in the acute hospital regulations: "Hospitals must establish policies and procedures for reporting of medication errors, Adverse Drug Reactions (ADRs), and incompatibilities, and ensure that staff are aware of the reporting process ...".

Based on interview with the Hospital's CNO on 11/21/22, at 4:15 P.M., the hospital had failed to develop policies and procedures around medication errors and ADRs. Interview with the hospital's CNO on 11/21/22, at 4:15 P.M., confirmed that the hospital did not have nor had the hospital implemented a policy and procedure, which addressed "Medication errors". The National Coordinating Council Medication Error Reporting and Prevention (NCCMERP) is a national 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., a medication actually is administered to a patient when it should not be ...". The following represents a clear example of what NCCMERP defines as a "Medication Error":

On 11/4/22, at 4:00 P.M., the hospital administrative staff provided a Plan of Action (POA), which included the following summarized actions:
a) Education module was created to instruct clinical staff that only RN's and LVN's can receive orders from physician's and enter them into the hospital's electronic medical record (called EPIC).
b) Education modules were created for Nursing, Pharmacy, and Medical staff.
c) Competency evaluations (with 10 questions on the training material) were to be completed for Nursing and Pharmacy staff.
d) The Director of Pharmacy (DOP) will be responsible for running EPIC reports to check to see if Pharmacists are writing orders. These reports will be sent to various medical staff committees.
e) The Chief Nursing Officer (CNO) and the Chief Medical Officer (CMO) will the responsible for their staff completing their respective educational pieces.
f) Corporate Information Technology (IT) had been asked to remove the "intravenous" route of administration entirely or require administration instructions, as a hard stop, to be entered before the order can be pushed through. The goal is to remove the ambiguity present with using "intravenous" as a route which does not accurately depict how an intravenous medication should be administered. EPIC already has IVP (Intravenous Push) and IVPB (Intravenous Piggyback) routes that automatically populate administration instructions based off of drug (IV push drugs) and require a rate (IVPB drugs).
g) Corporate Information Technology (IT) had been asked to change how the override functionality works to include a "STOP", which would require a clinical rationale be provided before a provider can move forward.

This original POA was revised (to include a requirement that all healthcare practitioners be required to put a note in each patient's chart when an allergy override has been done) and on 11/16/22, at 4:22 P.M., 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 Quality Director (QD).

On 11/9/22 at 9:25 A.M., the hospital provided a demonstration by a pharmacist ordering a medication using their EMR. Even after the improvements the hospital made for the immediate plan of action, the pharmacist was able to order a medication for a current patient with a known allergy.

The facility's systems allowed for a simple override by any staff member for any medication to be ordered and administered to a patient with a known medication allergy. The system did not require a justification or consultation from any staff member prior to administering the medication they were allergic to.

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 had a process to determine areas of concern, but did not have a methodology for reassessing the performance improvement plan developed for concerns.
As a result, there was no way to determine if the plan for an identified issue was effective or needed revision.

In addition, the hospital failed to ensure that key opportunities for improvement were identified and preventative actions were immediately implemented, pertaining to medication ordering and administration for patients with an identified medication allergy. The hospital's Quality program further failed to revise their policies for Override Medication List and Medication Orders - Administration, to include language necessary to prevent an override of a medication for patients with a known medication allergy.

Findings:

The Quality Director (QD) was interviewed on 11/16/22. The Quality Director stated there was no QAPI committee meeting that included the other committee's members. The concerns identified by QAPI were addressed and the QD was responsible for developing an action plan to resolve the concern. The Quality Director said the Committee did not have QAPI meetings to discuss the effectiveness of the action plan once it was implemented.

The only policy the hospital was able to provide that included any language specific to an allergy was the the policy and procedure entitled Latex Allergy, Care of the Patient.

Based on interview and record review the hospital failed to follow the hospitals bylaws when they did nor escalate identified issues within the committee structure. The hospital Medical Staff Executive was not aware of and had not seen the 2022 hospital safety plan until they were presented it during the survey QAPI interview.

As a result, there was the potential for issues to not be identified and resolved using the hospitals existing committees.

Findings:

On 11/17/22 at 10:35 AM, a meeting and interview was conducted with the Quality Council Committee and the Governing Body. During the interview MD 3, a Medical Staff Executive, stated he had not seen the hospital's Safety Plan for 2022.

Based on interview and record review, the Hospital failed to ensure:

A. Registered Nurse (RN) 1 conducted an accurate assessment on Patient 1 who had a known allergy to an antibiotic (medication for infection) Ceftriaxone. As a result, Patient 1 was administered Ceftriaxone 1 gram intravenous (IV) push and had an allergic reaction resulting in an untimely death.

B. Nursing staff followed the reeducation training (provided 10/26/22) regarding identification of patient's allergies prior to administering the medication. As a result, Patient 17 with a known allergy to Penicillin was administered piperacillin-tazobactam (a similar antibiotic to penicillin) from 11/1/22 to 11/8/22, a total of seven days.

Findings:

A. Patient 1 was admitted to the hospital on 10/20/2022 at 12:26 A.M. per undated Admission Registration.
A review of History and Physical dated 10/20/2022 indicated treatment plans that included " ...1. Acute on chronic respiratory failure ... secondary to Chronic Obstructive Pulmonary disease (COPD) exacerbation ... 2. Community acquired pneumonia ..."

RN 1 administered the Ceftriaxone to Patient 1 at 4:21 P.M., 1 gram IV push. Patient 1 experience an allergic reaction (seizure), cardiac arrest, and died.

On 10/26/2022 at 12:03 P.M., an interview was conducted with the Chief Nursing Officer (CNO). The CNO stated Patient 1's medical records indicated a medication allergy to Ceftriaxone and allergic reactions that included seizure, anxiety, and syncope.

Per the CNO, Physician 1 was aware of Patient 1's allergy and allergic reactions to Ceftriaxone. The CNO stated, the antibiotic Levofloxacin was initially ordered and was discontinued and replaced with Ceftriaxone after Pharmacist 1 spoke to Physician 1.

Per the CNO, Pharmacist 1 was aware of Patient 1's allergy and allergic reactions to Ceftriaxone and stated it was "not a true allergy". The CNO stated there was no documentation that Pharmacist 1 and Patient 1 discussed Patient 1's allergy to Ceftriaxone and allergic reactions.

Per the CNO, RN 1 was aware of Patient 1's allergy and allergic reactions to Ceftriaxone. The CNO stated RN 1 clarified and discussed with Physician 1 Patient 1's allergy, allergic reaction, and order for Ceftriaxone. The CNO further stated Physician 1 clarified with RN 1 that Ceftriaxone was discussed with Pharmacist 1 and could be administered.

Per the CNO, RN 1 did not escalate her concerns to the Charge Nurse and administered "Ceftriaxone 1 g [gram] diluted in 10 cc [cubic centimeter] via IV push" in "about 5 minutes". The CNO stated, Patient 1 immediately had seizures, swelled up, and coded (patient stopped breathing and had no pulse). Code Blue (someone is experiencing a life-threatening medical emergency) was activated and the patient was not revived.

Per the CNO, the facility practice for administering Ceftriaxone was by intravenous piggy back (adding a medication to a solution) however there was a time period when the piggy back supply was not available, and the facility administered the medication by intravenous push. This practice had not been updated.

A review of Patient 1's medication orders indicated " ...Ceftriaxone injection 1 g ... Dose: 1 g ...Route: Intravenous ... Frequency: Daily ... Entered by: Pharmacist 1 ... Dispense User: Pharmacist 1 ... Administration User: RN 1 ... Time: 10/20/2022 at 4:21 P.M ... Total number of overridden warnings: 1"

A review of Patient 1's computer screen allergy warning indicated "Allergies: Ceftriaxone ... Reaction: Anxiety, Syncope, Seizure ... Severity: High ..."

A review of Patient 1's Nursing Note documented by RN 1, dated 10/20/2022 at 5:15 P.M., indicated " ...I noticed pt. [Patient 1] is allergic to Ceftriaxone with reaction of syncope and seizure ... called Dr. [Physician's name/Physician 1] and alerted ... pt. is allergic to Ceftriaxone. Dr. [Physician's name] confirmed he knew she was allergic to Ceftriaxone and that he confirmed with pharmacy ... Ceftriaxone was okay to give. I verbally confirmed on the phone with readback ... to give the Ceftriaxone and that it was confirmed by pharmacy ... I gave the Ceftriaxone by IV push. Pt. stated she felt weird and began to have seizure. I suctioned the pt. for 1 minute and then the pt. stopped breathing. I called a code blue and began compressions 2 minutes later when her pulse stopped."

A review of Patient 1's Discharge Summary, dated 10/20/2022 at 4:58 P.M. indicated " ... After patient received the Rocephin [Brand Name of Ceftriaxone], it was reported by nursing staff that she did not feel well afterwards. Subsequent [sic] after that patient started having a seizure. She then became unresponsive. CODE BLUE was called immediately ... attempt to resuscitate patient unsuccessful and patient pronounced deceased."

On 11/17/22 at 9:16 A.M., the Chief Nursing Officer (CNO) was interviewed her follow-up regarding with RN 1 following the death of Patient 1. The CNO stated she had interviewed RN 1 after she became aware of Patient 1's death. The CNO stated that RN 1 was upset she had made the mistake. The CNO stated RN 1 admitted she should have asked her Charge Nurse about giving Patient 1 the medication she was allergic to prior to administering the medication, but she trusted Patient 1's physician was doing the right thing. The CNO stated RN 1 admitted she knew better and had "ignored her gut." The CNO stated RN 1 stated she should have followed the chain of command and questioned this medication order. The CNO stated RN 1 stated she felt bad when she talked to Patient 1 about this medication as Patient 1 had concerns about taking the medication. The CNO stated RN 1 stated she told Patient 1 the benefits outweighed the risks and Patient 1's physician said "it would be okay."

A review of hospital policy and procedure titled Administrative Chain of Command, reviewed 9/2020. " ...Policy: ... Initiating Chain of Command for IMMEDIATE Patient care clinical concern. 1. Immediate patient care clinical concern 1.1 Any member of the healthcare team who observes potentially unsafe ... reports the situation to the charge nurse/nurse manager."

A review of hospital policy and procedure titled Interdisciplinary Patient Assessment, Screening and Reassessment dated 10/20, " ...Policy ...F. Interdisciplinary Variables: ... The following variables influence and direct the process of patient assessment ...2. Allergies ..."


B. Patient 17 was admitted to the facility on 11/1/22 with diagnoses which included multifocal pneumonia (infection of the lung) per the hospital Admission Registration.

A review of the Allergy Review History for Patient 17 was conducted. On 11/1/22 at 4:17 P.M., RN 20 documented, "No Active Allergies". On 11/8/22 at 10:33 P.M., RN 11 documented, Patient 17 had an allergy to penicillin (an antibiotic).

On 11/9/22 at 12:32 P.M., a joint interview and review of Patient 17's records was conducted with Registered Nurse (RN) 17. The physician's order dated 11/1/22 indicated to administer piperacillin-tazobactam (a similar antibiotic to penicillin) to Patient 17. Per the Medication Administration Record (MAR), Patient 17 was administered this medication from 11/1/22 to 11/8/22.

On 11/9/22 at 1:20 P.M., an interview with RN 18 was conducted. RN 18 stated the staff should have verified Patient 17's allergies. RN 18 stated the piperacillin-tazobactam had the "same component as penicillin." RN 18 stated she would not have administered it to Patient 17.

On 11/9/22 at 1:41 P.M., an interview with RN 19 was conducted. RN 19 stated if the information on Patient 17's allergy to penicillin was known from the beginning of admission, RN 19 stated she would not have given the antibiotic to Patient 17 but it was a "hard question" to answer.

On 11/10/22 at 1:38 P.M., an interview with RN 11 was conducted. RN 11 stated she was the primary nurse for Patient 17 on 11/8/22. RN 11 stated she reviewed Patient 17 for allergies. RN 11 stated Patient 17 had an "allergy band" but the allergy was not documented in the EMR. RN 11 stated Patient 17 informed her she had a reaction to penicillin in the past.

On 11/14/22 at 1:55 P.M., an interview with Charge Nurse (CN) 12 was conducted. CN 12 stated if the nurse had verified with the physician and pharmacist to administer a medication a patient is allergic to and was told to administer it, "She did what she was supposed to do. If you don't give it then it's a missed dose. The only way you cannot give it was if the patient said no. It's very hard."

A review of hospital policy and procedure titled Interdisciplinary Patient Assessment, Screening and Reassessment dated 10/20, " ...Policy ...F. Interdisciplinary Variables: ... The following variables influence and direct the process of patient assessment ...2. Allergies ..."

Based on hospital staff interview and medical record, the hospital failed to ensure a Physicians and a Pharmacist did not communicate medication orders and other personal health information via test message on their personal cell phones.

As a result, Pharmacist 1 (PH 1) and Physician 1 (MD 1) communicated confidential information and medication orders regarding Patient 1 via personal cell phone texts.

Findings:

Patient 1 had been seen in the hospital's Emergency Room (ER) on 10/19/22, at 11:31 P.M., for right shoulder pain, shortness of breath, end-stage Chronic Obstructive Pulmonary Disease (COPD), and cough. She was subsequently admitted to the hospital on 10/20/22, at 12:06 A.M., under the care of Physician 1 (MD 1).

On 10/20/22, at 3:45 P.M., MD 1 ordered an antibiotic Levofloxacin (Levaquin) 500mg daily for Patient 1.

On 10/20/2022, at 4:06 P.M, the Levaquin order was discontinued by Pharmacist 1 (PH 1) via text message. PH 1 and MD 1 continued to communicate regarding medication choices for Patient 1 via personal cellphones. Interview with the hospital's Chief Nursing Officer (CNO) and the Quality Director (QD) on 11/2/22, at 10:40 A.M., revealed that text messaging of any patient orders via personal cellphones is strictly prohibited by the hospital and this practice was not acceptable in this hospital. Via text message on 10/20/22, at 4:06 P.M., PH 1 advised MD 1 that Patient 1 did not have a "true" allergy to Ceftriaxone (Rocephin) and subsequently without a hospital protocol being in place for PH 1 to write medication orders, PH 1 changed Patient 1's previously ordered Levaquin antibiotic order to Ceftriaxone and Azithromycin (Zithromax). This change from Levaquin to Ceftriaxone, was made despite Patient 1's chart documented allergies (seizures) to Ceftriaxone.

Patient 1's medication Nurse (RN 1) had contacted MD 1 regarding Patient 1's documented allergic response (syncope and seizures) to Ceftriaxone, and she wrote the following in a Nursing note dated 10/20/2022, at 5:15 P.M.: " ... I noticed patient is allergic to Ceftriaxone with a reaction of seizures. I called MD 1 and alerted him that patient is allergic to Ceftriaxone. MD 1 confirmed he knew she was allergic to Ceftriaxone and that he confirmed with pharmacy that the Ceftriaxone was ok to give. I verbally confirmed on the phone with read back with MD 1 that he wanted me to give the Ceftriaxone and that it was confirmed by pharmacy. After confirmation, I gave Ceftriaxone by I.V. (intravenous) push. Patient stated that she felt weird and began to have a seizure. I suctioned the patient for 1 minute and then the patient stopped breathing. I called a code blue and began compressions 2 minutes later when her pulse stopped.". RN 1 had administered the Ceftriaxone into Patient 1's left arm at 4:21 P.M. and within less than 10 minutes, a Code Blue had been called by 4:30 P.M., and by 4:58 P.M., Patient 1 had been pronounced dead.

Review of the hospital's Rules and Regulations, dated 1/24/2022, confirmed that the Pharmacists were not allowed to write verbal orders via an established protocol: "Orders for treatment of patients must be entered into EPIC (EPIC is defined as a computerized physician order entry system). A telephone order taken directly from a practitioner may be received and entered via EPIC by a registered nurse or a licensed vocational nurse ...". The hospital Rules and Regulations do not allow for pharmacists to take telephone orders from a practitioner. Further review of the hospital's Rules and Regulations read: "If a nurse has any reason to doubt or question care provided to any patient or feels that appropriate consultation is needed and has not been obtained, (s)he shall call this to the attention of his/her superior who, in turn, may refer the matter to the CNO ...". RN 1's concern regarding Patient 1's allergy to Ceftriaxone was never escalated to the CNO, as outlined in the hospital's Rules and Regulations. PH 1 and MD 1 never spoke with Patient 1 regarding her allergy.

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 developed and implemented policies and procedures along with a system to evaluate medication error and near-misses (potential medication errors which did not reach the patients but had the potential to reach the hospital's patients) which had occurred within the hospital. The hospital also failed to evaluate their collected medication error data in such a manner that it would have allowed the hospital to improve upon the care for 30 out of 30 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 drug lot numbers and expiration dates for medications (which had been prepared into oral syringes) and ensuring that the hospital-maintained records/logs of what had been prepared by hospital staff as outlined in the hospital's policies and procedures. This deficiency had the potential to affect 30 out of 30 sampled patients. (Refer to A 501).

3. The hospital failed to ensure that all controlled drugs or scheduled medications (which included Tylenol # 3, with Codeine), which is a narcotic and subject to the potential for abuse or misuse, had been locked inside the hospital's CII-Safe (CII cabinets are electronic storage cabinets used in all pharmacies to keep the Schedule II narcotics locked away), for the purpose of storage, tracking and monitoring, as outlined in the hospital's policies and procedures. This deficiency had the potential to affect 30 out of 30 sampled patients. (Refer to A 502).

4. The hospital failed to ensure that medications such as Lidocaine 2 % jelly tubes, Neostigmine (a muscle relaxant) vials, Normal Saline, and Sterile Water for irrigation bottles had not expired and that these medications had not been available for patient use. This deficiency had the potential to affect 30 out of 30 sampled patients. (Refer to A 505).

5. The hospital failed to ensure that patients who had severe drug allergies (which included severe reactions such as seizures) to antibiotics which included drugs like Ceftriaxone (Rocephin), which had been documented in a patient's clinical records, that these patients did not receive these medications during the course of the patient's hospital stay. This deficiency had the potential to affect 30 out of 30 sampled patients. (Refer to A508).

6. The hospital failed to ensure that the hospital had developed a 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), which included a system for the hospital to evaluate 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 which the hospital may have deemed as "non-formulary" (not on the hospital's list of pre-approved drugs). This deficiency had the potential to affect 30 out of 30 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.

The medical staff is responsible for developing policies and procedures that minimize drug errors. This function may be delegated to the hospital's organized pharmaceutical service.] §482.25(a) Standard: Pharmacy Management and Administration The pharmacy or drug storage area must be administered in accordance with accepted professional principles.
Based on interview with hospital administrative staff and review of the hospital's policy and procedures the hospital failed to ensure that the medication error data which had been gathered had been used to affect changes in the hospital's processes for patient care. This failure had the potential to jeopardize patient care for 30 out of 30 sampled patients.

Findings:

Review of the written standards for ASHP's (American Society of Hospital Pharmacists), (an organization who sets hospital standards), which had been published with a copyright of 2018, entitled: "Guidelines on Preventing Medication Errors in Hospitals", which is a standard of practice for hospitals reads: " ...A system for reporting and reviewing errors is an essential component of a medication safety system; the goal is to enhance patient safety and prevent patient harm. Errors and close calls should be reported and analyzed e.g., (for example) root cause analysis [RCA] to identify the causes and develop measures to prevent similar occurrences ... the organization must evaluate and adopt technologies that will help reduce the risk of medication errors and help prevent patient harm ... Regardless of how medication errors are discovered, the information should be used to prevent future errors. A multidisciplinary group should evaluate error information where feasible to develop risk reduction strategies. While it is important to focus on errors that have caused harm to the patient, close calls (or near misses) should also be reviewed.
During an interview with several hospital administrative staff, which included the hospital's (Chief Nursing Officer) CNO and PH 5 (Regional Director of Pharmacy), on 11/15/22 at 4:30 P.M., the surveyor asked the hospital administrative staff, if the hospital had a medication error policy and procedure and what has been the hospital's highest medication error category? The hospital administrative staff stated that the hospital did not have a policy and procedure on medication errors and that the hospital's highest medication error category had been "medication administration errors". The surveyor then asked the hospital how they had used this data on "medication administration errors" to change or improve the hospital's "medication administration errors"? Hospital administrative staff replied: "I have not seen a plan, but it has been discussed in the Medication Safety Meeting." Hospital administrative staff proceeded to explain that we have lots of new Nurses and "we have had to fix scanners". The surveyor then proceeded to ask the hospital administrative staff, by the hospital "fixing their scanners", would this prevent or reduce medication administration errors involving the wrong dose or the wrong rate? Administrative hospital staff replied: "no we need a plan. We have the data, but we need a plan about what to do with it (this data)." The surveyor then asked: what has the hospital done regarding the correction of wrong rate medication errors? What action is the hospital planning on taking regarding wrong rate administration errors? Hospital administrative staff replied: "we didn't do the background to find out what went wrong. There is no action. There was no researching on the back end. What should have happened is if the directors (nursing directors on the floor) are not responding, there should have been some type of escalation. These conversations (among the Nurse Directors) did not happen, so the use of this data (wrong rate and wrong dose) was left without any action whatsoever". The surveyor asked: "It looks like medication administration errors are your highest medication error, what has the hospital done regarding medication administration errors, besides education to help reduce these types of errors?" The hospital administrative staff replied: "we had some failures that we did not follow up on. First, we need to find out and identify if this problem is a system issue versus a human, or a unit issue. Then start looking at processes when we have made that determination. What has been happening is that people (everyone in the hospital) have not been following up and that we will fix ...we (everyone in the hospital) have to look for pattern of behavior (regarding these types of medication administration errors) and address these issues with personnel to fix the problem. We need more information on the report if we are going to attach any accountability (to these types of medication administration errors)".
A second interview had been conducted on 11/16/22 with the CNO and PH 7 (the hospital's Corporate Clinical Pharmacist), at 9:22 A.M. The surveyor asked: "Did you see any potential medication errors (near misses) on the hospital's medication error data sheets? Several hospital administrative staff replied: "Potential medication errors or near misses? No, we don't have any, but they should be on the report ...".

Based on observation, interview and record review, the facility failed to ensure unit dosed medications (the ordered amount of a drug in a dosage form prepared for a one-time administration to an individual) had been labeled with the lot number (an identification number assigned to a particular quantity or lot of medication from a single manufacturer) and expiration date or beyond use date (BUD). This failure had the potential to put 30 out of 30 sampled patients at risk for receiving ineffective or outdated medications.

Findings:

During an observation on 11/9/22, at 2:05 P.M., in the pharmacy, located on a shelf, there were four unit dosed oral syringes filled with Amantadine (medication used for involuntary muscle movements) which were not labeled with a lot number and expiration date, and two unit dosed oral syringes filled with fluoxetine (an antidepressant) which were not labeled with a lot number.

During an interview on 11/9/22, at 2:14 P.M., with Pharmacy Technician 1 (PT 1), when asked by a surveyor if the facility had a process to track oral syringes, PT 1 stated there is no binder to keep track when medications are drawn into a syringe for oral use.

During an interview on 11/9/22, at 2:17 P.M., with Pharmacy Technician 2 (PT 2), when asked by a surveyor if the facility has a process to track oral syringes, PT 2 said oral syringes are tracked by a lot number and expiration date in EPIC (the facility's electronic medical record system). However, PT 2 could not locate the lot number and expiration date for the unit dosed oral syringes filled with Amantadine in EPIC.

During an interview on 11/9/22, at 2:44 P.M., with Pharmacist 2 (PH 2), PH 2 stated she could not locate the lot number and expiration date for the unit dosed oral syringes filled with Amantadine in EPIC and PH 2 was unable to find a log of when the Amantadine oral syringes were drawn up.

During an interview on 11/9/22, at 4:07 P.M., with the Director of Pharmacy (DOP), the DOP stated, there is no report in EPIC for logging oral syringes made for specific patients. During an interview on 11/16/22, at 10:25 A.M., with Pharmacist 7 (PH 7), when asked by a surveyor if there is a process for logging oral syringes, PH 7 stated, "There was not a process (for logging oral syringes) in Epic before but they (the facility pharmacy staff) are doing a paper log now."

During a review of the facility's draft policy and procedure (P&P) titled, "Medication Dispensing" (undated), the P&P read, " ...For oral medication compounding pursuant to a specific order, a paper log will be used for every order with the following information...Lot # (number), beyond use date ...". During an interview on 11/21/22, at 4:09 P.M., with the Chief Nursing Officer (CNO) and the Quality Director (QD), the CNO confirmed the P&P titled "Medication Dispensing" was new to the facility, had been developed from the facility's processes but had not been approved or implemented. The QD also confirmed that the P&P titled "Medication Dispensing" was new to the facility. American Society of Health System Pharmacists (ASHP), a nationally recognized pharmacy organization, represents pharmacists who serve as patient care providers in acute and ambulatory settings and is at the forefront of efforts to improve medication use and enhance patient safety. According to "ASHP Guidelines: Minimum Standard for Pharmacies in Hospitals,": "There shall be a policy and procedures manual governing pharmacy functions (e.g., administrative, operational, and clinical), and all pharmacy personnel shall follow those policies and procedures.".
?

Based on observation, interview and record review, the facility failed to ensure that one Controlled Substance (A drug or other substance that is tightly controlled by the government because it may be abused or cause addiction) medication brought in from home by one of 30 sampled patients (Patient 2) had been stored locked. This failure increased the risk for loss and/or diversion (the illegal distribution or abuse of prescription drugs or their use for purposes not intended by the prescriber) of a Controlled Substance.

Findings:

During a concurrent observation and interview on 11/8/22, at 6:05 P.M., with Pharmacist 2 (PH 2) and the Director of Pharmacy (DOP), in the pharmacy, there was one medication bottle brought in from home by Patient 2 which contained 61 tablets of acetaminophen and codeine. This medication is an opioid pain medication that is classified by the Drug Enforcement Administration (DEA) as a Controlled Substance Schedule III (defined as drugs with a moderate to low potential for physical and psychological dependence). The medication bottle was stored in an unlocked storage cabinet with Non-Controlled Substance medications brought in from home by different patients. Both PH 2 and the DOP stated that this medication is a Controlled Substance, which should remain locked at all times.

During a review of the facility's policy and procedure (P&P) titled, " ...Control of Medications Throughout the Hospital" dated 4/25/22, the P&P read: " ...Medications should remain in their secure storage area (locked cabinet ...". During a review of the facility's P&P titled, "Storage of Medications" dated 7/25/22, the P&P read: "Controlled Substances are stored to prevent diversion, pilferage, and theft...". During a review of the facility's P&P titled, "Controlled Substances" dated 2/28/20, the P&P read: " ...C. Storage and Pharmacy Perpetual Inventory: All Controlled Substances are stored in the CII- Safe in the pharmacy ...". According to the CII Safe manufacturer, a CII Safe stores, tracks and monitors the management of Controlled Substances.

Based on observation, interview and record review, the facility failed to ensure outdated and unusable medications were not available for patient use. These failures had the potential to put 30 out of 30 sampled patients at risk for receiving ineffective or outdated medications.

Findings:

1) During an interview on 11/9/22, at 2:14 P.M., with Pharmacy Technician 1 (PT 1), when asked by a surveyor if the facility had a process to track oral syringes, PT 1 stated there is no binder to keep track when medications are drawn into a syringe for oral use.

During a concurrent observation and interview on 11/9/22, at 2:56 P.M., with Pharmacist 2 (PH 2), in the pharmacy, there were two unit dosed (the ordered amount of a drug in a dosage form prepared for a one-time administration to an individual) 5 milliliter (mL) oral syringes filled with fluoxetine (an antidepressant) oral solution which expired on 8/21/22. The expired fluoxetine oral syringes were located on a shelf with other medications that were not expired. PH 2 stated the oral syringes were expired and should have been thrown away.

During an interview on 11/9/22, at 4:07 P.M., with the Director of Pharmacy (DOP), the DOP stated, "There is no report in EPIC (the facility's electronic medical record system) for logging oral syringes ..." and when a surveyor showed the fluoxetine oral syringes to the DOP, the DOP stated, the syringes were expired and will be thrown away. During an interview on 11/16/22, at 10:25 A.M., with Pharmacist 7 (PH 7), when asked by a surveyor if there is a process for logging oral syringes, PH 7 stated, "There was not a process (for logging oral syringes) in Epic before but they (the facility pharmacy staff) are doing a paper log now."

During a review of the facility's draft policy and procedure (P&P) titled, "Medication Dispensing" (undated), the P&P read, " ...For oral medication compounding pursuant to a specific order, a paper log will be used for every order with the following information: Date, order number, drug name and volume, quantity, Lot # (number), beyond use date, technician and pharmacist initials ...". During an interview on 11/21/22, at 4:09 P.M., with the Chief Nursing Officer (CNO) and the Quality Director (QD), the CNO confirmed the P&P titled "Medication Dispensing" was new to the facility, had been developed from the facility's processes but had not been approved or implemented. The QD also verified that the P&P titled "Medication Dispensing" was new to the facility. American Society of Health System Pharmacists (ASHP), a nationally recognized pharmacy organization, represents pharmacists who serve as patient care providers in acute and ambulatory settings and is at the forefront of efforts to improve medication use and enhance patient safety. According to "ASHP Guidelines: Minimum Standard for Pharmacies in Hospitals,": "There shall be a policy and procedures manual governing pharmacy functions (e.g., administrative, operational, and clinical), and all pharmacy personnel shall follow those policies and procedures.".

2) During a concurrent observation and interview on 11/15/22, at 10:30 A.M., with Registered Nurse 2 (RN 2) and the CNO, in the operating room number 6 (OR 6), there was one opened and unusable 5 milliliter (mL) tube of Lidocaine 2% Jelly (medication used on the skin for pain) located inside an unlocked anesthesia (medical treatment that prevents patients from feeling pain during procedures such as surgery) supply cart. RN 2 said medications are not supposed to be stored in this cart. The CNO stated there should not be any drugs found in that cart. RN 2 stated anesthesiologists (a doctor who gives patients medication so they do not feel pain when they are undergoing surgery) will be reminded not to store medications in the supply cart.

3) During a concurrent observation and interview on 11/15/22, at 11:10 A.M., with Pharmacy Technician 3 (PT 3) and the CNO, in the operating room number 6 (OR 6), there were two opened and undated 10 milliliter (mL) multiple dose vials of neostigmine (medication used to reverse the effects of muscle relaxants after surgery) located in the supply drawer of the Anesthesiologist Workstation (AWS). PT 3 stated this drawer should not have medications and opened multiple dose vials are only used one time. The CNO verified that the medication vials were not supposed to be in the AWS supply drawer. The CNO gave the opened and undated multiple dose vials to RN 2 to discard.

During a review of the hospital policy and procedure (P&P) titled, "Compounding Sterile Preparations Beyond Use Dates" dated 10/2020, the P&P read, " ...Multiple dose vials (MDV) once opened ...should be labeled with BUD (beyond use date, date and time); if it lacks a BUD it should not be used and discarded ...".

4) During a concurrent observation and interview on 11/15/22, at 12:08 P.M., with RN 2, in front of a procedure room in the Operating Room (OR), there was one refrigerated 1-liter Normal Saline (NS) 0.9% bag for the Malignant Hyperthermia (a severe reaction to certain drugs used to prevent pain during surgery) Kit which was expired on April 2021. RN 2 acknowledged the NS bag was expired and discarded the bag.

5) During a concurrent observation and interview on 11/15/22, at 12:08 P.M., with Registered Nurse 4 (RN 4) and RN 2, in the Post Anesthesia Care Unit (PACU), there was one opened and undated 10 milliliter (mL) multiple dose vial of Regular Insulin (Insulin R, a medication used in the treatment of diabetes) at room temperature in the automated drug delivery system (Omnicell) in the PACU. RN 4 did not know the expiration date for the opened and unrefrigerated Insulin R vial. RN 4 stated she needed to look at the policy (for dating opened vials) but was unable to locate the policy. RN 2 was asked by a surveyor "How long can you keep an open vial of insulin?". RN 2 did not know and called the pharmacy. RN 2 was informed by the pharmacy of the 30-day expiration date of the opened and unrefrigerated Insulin R vial.

6) During a concurrent observation and interview on 11/15/22, at 12:50 P.M., with Registered Nurse 3 (RN 3) and RN 2, in the OR, there was one opened 1-liter bottle of Sterile Water located on the bottom of a supply cart. When asked by a surveyor what the bottle expiration date should be when opened, RN 3 stated "It should be disposed of." and RN 2 stated "As soon as it is opened." Both RNs read the label on the front of the bottle and acknowledged the manufacturer's instructions stated: "Discard unused portion".

Based on interview and record review, the hospital failed to ensure that a preventable medication error did not occur with one of 30 sampled patients (Patient 1). Patient 1 received a medication she was allergic to. This medication error led to Patient 1's death, which could 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 10/19/22, at 11:31 P.M., for right shoulder pain, shortness of breath, end stage Chronic Obstructive Pulmonary Disease (COPD, a group of diseases that cause airflow blockage and breathing-related problems), and cough. She was subsequently admitted to the hospital on 10/20/22, at 12:06 A.M., under the care of Physician 1 (MD 1).

During a review of Patient 1's medical record, dated 10/20/22, at 3:45 P.M., the medical record indicated, MD 1 ordered an antibiotic (a medication used to treat infections) Levofloxacin (Levaquin) 500mg daily for Patient 1.

During a review of Patient 1's medical record, dated 10/20/22, at 4:06 P.M, the medical record indicated, the Levaquin order was discontinued by Pharmacist 1 (PH 1) via text message. PH 1 and MD 1 continued to communicate regarding medication choices for Patient 1 via personal cellphones. Interview with the hospital's Chief Nursing Officer (CNO) and the Quality Director (QD) on 11/2/22, at 10:40 A.M., revealed that text messaging of any patient orders via personal cellphones is strictly prohibited by the hospital and this practice was not acceptable in this hospital. Via text message on 10/20/22, at 4:06 P.M., PH 1 advised MD 1 that Patient 1 did not have a "true" allergy to Ceftriaxone (Rocephin, an antibiotic medication used to treat infections) and subsequently without a hospital protocol being in place for PH 1 to write or discontinue medication orders, PH 1 changed Patient 1's previously ordered Levaquin antibiotic order to Ceftriaxone and Azithromycin (Zithromax). This change from Levaquin to Ceftriaxone, was made despite Patient 1's chart documented allergies (seizures, a sudden, uncontrolled electrical disturbance in the brain that can cause changes in behavior, movements, and in levels of consciousness) to Ceftriaxone.

During an interview on 11/3/22, at 11:05 A.M, with Patient 1's Registered Nurse (RN 1), RN 1 had contacted MD 1 regarding Patient 1's documented allergic response (syncope, fainting or passing out and seizures) to Ceftriaxone, and she wrote the following in a Nursing note dated 10/20/22, at 5:15 P.M.: " ... I noticed patient is allergic to Ceftriaxone with a reaction of seizures. I called MD 1 and alerted him that patient is allergic to Ceftriaxone. MD 1 confirmed he knew she was allergic to Ceftriaxone and that he confirmed with pharmacy that the Ceftriaxone was ok to give. I verbally confirmed on the phone with read back with MD 1 that he wanted me to give the Ceftriaxone and that it was confirmed by pharmacy. After confirmation, I gave Ceftriaxone by I.V. (intravenous, medication administered into the vein) push. Patient stated that she felt weird and began to have a seizure. I suctioned the patient for 1 minute and then the patient stopped breathing. I called a code blue (a hospital emergency code used to describe the critical status of a patient, usually cardiac or respiratory arrest) and began compressions 2 minutes later when her pulse stopped.". RN 1 had administered the Ceftriaxone into Patient 1's left arm on 10/20/22, at 4:21 P.M., and within less than 10 minutes, a Code Blue had been called by 4:30 P.M., and Patient 1 had been pronounced dead on 10/20/22, at 4:58 PM.

Review of the hospital's Rules and Regulations, dated 1/24/2022, confirmed that the Pharmacists were not allowed to write verbal orders via an established protocol: "Orders for treatment of patients must be entered into EPIC (EPIC is defined as a computerized physician order entry system). A telephone order taken directly from a practitioner may be received and entered via EPIC by a registered nurse or a licensed vocational nurse ...". The hospital Rules and Regulations do not allow for pharmacists to take telephone orders from a practitioner. Further review of the hospital's Rules and Regulations read: "If a nurse has any reason to doubt or question care provided to any patient or feels that appropriate consultation is needed and has not been obtained, (s)he shall call this to the attention of his/her superior who, in turn, may refer the matter to the CNO ...".

During an interview with the CNO on 11/2/22, at 10:51 A.M., CNO stated the RN 1's concern regarding Patient 1's allergy to Ceftriaxone was never escalated to her supervisor, as outlined in the hospital's Rules and Regulations. PH 1 and MD 1 never spoke with Patient 1 regarding her allergy.

As outlined in the acute hospital regulations: "Hospitals must establish policies and procedures for reporting of medication errors, Adverse Drug Reactions (ADRs), and incompatibilities, and ensure that staff are aware of the reporting process ...". Based on interview with the Hospital's CNO on 11/21/22, at 4:15 P.M., the hospital had failed to develop policies and procedures around medication errors and Adverse Drug Reactions (ADRs). Interview with the hospital's CNO on 11/21/22, at 4:15 P.M., the CNO stated that the hospital did not have nor had the hospital implemented a policy and procedure, which addressed "Medication errors". 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 ...". The following represents a clear example of what NCCMERP defines as a "Medication Error":

On 11/4/22, at 11:37 A.M., 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 administered on 10/20/22, at 4:21 P.M., an antibiotic medication (Ceftriaxone, also known as Rocephin) to Patient 1 via I.V. push. Patient 1 had a documented allergy in her clinical record to Ceftriaxone (documented as causing seizures for this patient), yet the patient's Physician, a hospital Pharmacist, and a Nurse all allowed this patient to receive this medication intravenously, despite the clearly documented allergic reaction (seizures) which had been documented in the patient's medical record, which resulted in this patient seizing, having a code (cardiac arrest), which subsequently led to this this patient's death.

On 11/4/22, at 4:00 P.M., the hospital administrative staff provided a Plan of Action (POA), which included the following summarized actions:
a) Education module was created to instruct clinical staff that only RN's and LVN's can receive orders from physician's and enter them into the hospital's electronic medical record (called EPIC).
b) Education modules were created for Nursing, Pharmacy, and Medical staff.
c) Competency evaluations (with 10 questions on the training material) were to be completed for Nursing and Pharmacy staff.
d) The Director of Pharmacy (DOP) will be responsible for running EPIC reports to check to see if Pharmacists are writing orders. These reports will be sent to various medical staff committees.
e) The Chief Nursing Officer (CNO) and the Chief Medical Officer (CMO) will the responsible for their staff completing their respective educational pieces.
f) Corporate Information Technology (IT) had been asked to remove the "intravenous" route of administration entirely or require administration instructions, as a hard stop, to be entered before the order can be pushed through. The goal is to remove the ambiguity present with using "intravenous" as a route which does not accurately depict how an intravenous medication should be administered. EPIC already has IVP (Intravenous Push) and IVPB (Intravenous Piggyback) routes that automatically populate administration instructions based off of drug (IV push drugs) and require a rate (IVPB drugs).
g) Corporate Information Technology (IT) had been asked to change how the override functionality works to include a "STOP", which would require a clinical rationale be provided before a provider can move forward.

This original POA was revised (to include a requirement that all healthcare practitioners be required to put a note in each patient's chart when an allergy override has been done) and on 11/16/22, at 4:22 P.M., 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 Quality Director (QD).

Based on interview with facility hospital staff and review of the hospital's policy and procedures, the hospital failed to implement 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), policy and procedure. The hospital also failed to develop a hospital specific non-formulary drug list (drugs which have not been included in the hospital's drug formulary), which may have contributed to the hospital's inability to evaluate each medication for the medication's effectiveness in treatment, any potential risks for harm to each patient, and the cost of each drug to other medications which may be on the hospital's drug formulary, for 30 of 30 sampled patients.

Findings:

During an interview with Pharmacist 7 (PH 7) on 11/16/22 at 9:00 A.M. he stated that the hospital had failed to develop a local drug formulary for this hospital. The hospital was also unable to provide, a copy of any type of drug formulary which had been developed and approved by the hospital's Pharmacy and Therapeutics (P & T) Committee, the hospital's Medical Executive Committee, or the hospital's Governing Body Committee. Based on review of the hospital's Pharmacy and Therapeutics Meeting minutes and a list of non-formulary drugs which had been provided to the surveyor by PH 7. These minutes and lists showed that the hospital's physicians had been able to order more than 10 different non formulary drugs (these drugs included: Aranesp (darbepoetin alfa), which is used to treat anemia (which is the lack of red blood cells in the body), Alfentanil (alfentanil hydrochloride), which is used as an pain medication used during a surgery, and Dalteparin (Fragmin), which is used to treat Deep Vein Thrombosis (DVT), which occurs when a clot is found deep in a vein. These drugs had been used by the hospital over the past 6-month period, without going through the hospital's established approval process based on the hospital's documents and concurrent interview with PH 7. Review of the hospital's policy and procedure entitled: "Formulary Selection process", dated: 2/26/18, reads: "It is the responsibility of the hospital's Pharmacy Director ... to ensure the availability of formulary request forms, the timely evaluation of formulary requests, and the reporting, and implementation of formulary decisions by the P&T Committee to physicians requesting additions/deletions to formulary .... The Pharmacy shall utilize a formulary system whereby the Pharmacy, working with the Medical staff through the Pharmacy and Therapeutics Committee and Anesthesia (Anesthesia is a state of controlled, temporary loss of sensation or awareness that is induced for medical purposes) Supervisory for all anesthesia medications, evaluates, and selects drug products that are considered most useful for patient care ... Upon receiving an order for a Non formulary drug, the pharmacist will inform the requesting physician of formulary alternatives, availability of the Non formulary drug, asses the need and document on the Non formulary Drug Request Form." Concurrent interview with PH 7, who confirmed that the hospital had been using Non formulary drugs without going through the hospital's approval process. Concurrent review of the hospital's Non formulary drug forms revealed that the facility only had one "Non formulary drug request form" since 2017. The only Non-formulary drug request form found, had been dated 4/30/21. No other Non formulary request forms had been kept by the facility for the previous 4 years (2017 to 2021) and the hospital had been unable to provide any Non formulary drug request forms for the last 6 months prior to 4/30/21, as confirmed in a concurrent interview with PH7. The hospital was unable to provide any evidence that any of the many Non formulary drug request had, gone through the hospital's P & T approval process.