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Based on interview and record review, the hospital failed to ensure an ongoing quality improvement (QI) program with measurable outcomes were implemented to identify and reduce a recurrence of the delay of administration of STAT (to be administered immediately) medications. This failure could lead to unmonitored incidents of delayed STAT medication administration.

Findings:

During an interview with the Director of Clinical Outcomes (DCO) on 6/8/17 at 8:25 a.m., she stated the immediate change implemented by the hospital was the revision of the computerized method of ordering bolus and drip medications. The DCO stated there are now screen locks that ask for dosage of the medication prior to the processing of the order. When asked if there were any QI monitoring or tracking for the administration of STAT medications in the emergency department or intensive care units since this adverse event occurred, she replied there were none.

Review of the hospital's Medication Administration policy dated 6/28/16 indicated a new entry which read, "Medication ordered as "STAT" "NOW" shall be administered to the patient within 30 minutes of the order entry and prior to transfer to receiving unit." This entry, according to the DCO, is set to go for approval by the Medical Executive Committee by the end of this month, June 2017, prior to its full implementation.

Based on interview, record and document review, the hospital failed to administer medications as ordered when two STAT (a directive to medical personnel during an emergency, which means immediately or instantly) medications for Patient 1 were not administered immediately or within 30 minutes as stipulated per hospital policy and procedure. Patient 1's heparin (an anticoagulant; a blood thinner to prevent blood clots) was given 4 hours 7 minutes after ordered, and his valproate sodium (a medication to prevent seizure) was given 2 hours 25 minutes after ordered. This failure may have contributed to a rapid decline in Patient 1's health status and may have resulted in significant physical impairment.

Findings:

Patient 1 was a 52 year old male brought in by ambulance with a cervical collar (neck brace, a medical device used to support a person's neck) to the hospital's emergency department (ED) on 3/22/17 at 7:03 a.m. with neck pain after sustaining a fall at home. According to the physical examination record documented by Physician 1 on 3/22/17, Patient 1 arrived at the ED awake, alert, and oriented with no motor or sensory deficits.

The consultation report by Physician 2 on 3/22/17 indicated Patient 1 had a history of meningioma (tumor that develops in the cells of the membrane that surrounds the brain and spinal cord) and the tumor was surgically removed in 2003. He was placed on Dilantin (medication to control seizure) for more than 9 years, and was discontinued for the last 5 to 6 years.

Patient 1's medical record, dated 3/22/17, revealed shortly after his arrival at the ED, he was taken to the radiology department for an initial computed tomography (CT) scan (a series of X-ray images taken from different angles using computer processing to create cross-sectional images of the bones, blood vessels, and soft tissues inside one's body) of the head and cervical spine to determine the extent of the injury and to determine whether surgery was needed.

Physician 2's Consultation Report, dated 3/22/17, indicated the CT scan showed evidence of the fracture of the 7th cervical vertebrae (C7; a spinal segment located near the base of the neck), and the CT angiogram (a CT imaging test that looks at the arteries and tissues in various parts of the body) showed "an injury to the vertebral artery [a major blood vessel of the neck] with potential clot in the vertebral artery as well."

The physical examination in Physician 2's Consultation Report showed Patient 1 was "alert and oriented x 3 [a person's awareness of three dimensions: person, time, and place]. Speech is fluent," and "[N]eurologically, [Patient 1] has no focal deficit. His fracture is generally considered stable. I will keep him in a cervical collar for now; however, I am more concerned about his vertebral artery injury. If this truly has a clot, he may need to be anticoagulated. I recommend we get IR involved. [Patient name] needs to have better imaging study like an MRI scan of his head just to make sure there is no sort of contusions or injury to his brain that would preclude him from having anticoagulation therapy..."

The CT angiogram results on the diagnostic imaging report, dated 3/22/17 at 9:45 a.m., revealed evidence of left vertebral artery dissection (a tear of the inner wall or lining of the vertebral artery) in addition to the C7 fracture.

During an interview on 6/6/17 at 12:50 p.m., Physician 1 said he was the physician who examined Patient 1 when he first arrived to the ED. He said Patient 1 came in as "trauma activation" due to the injury sustained at home. He said he did not recall any neurological findings; the patient was alert and oriented. The CT scans showed fracture of the neck and a report of vascular injury, so Neuro Interventional Radiology (IR - department specializing in minimally invasive image-based technologies and procedures used in diagnosis and treatment of diseases of the head, neck, and spine) was consulted.

During an interview on 6/6/17 starting at 10:25 a.m., physician's assistant (PA) 1 said she was working in the Neuro IR when she was contacted to consult on Patient 1 in the ED around noon on 3/22/17. Patient 1 had a fall at home after a seizure and was identified to have a fracture of the cervical vertebrae. She said Patient 1 had a history of a brain lesion removed in the past, therefore a brain MRI (a non-invasive imaging technology that produces three dimensional detailed anatomical images without the use of damaging radiation) was ordered. After the MRI results showed no evidence of bleeding, and after consulting with the Neuro IR attending physician and the neurosurgeon, the decision was to put Patient 1 on heparin. PA 1 said she placed the orders for a STAT heparin bolus dose and the heparin infusion (a maintenance dose to be given over time) per protocol (a set of orders for adjusting doses based on patient response and laboratory results), to be administered immediately. PA 1 said the CT angiogram showed a vertebral artery dissection so she was concerned about a clot; therefore, she wanted the heparin to be given immediately. PA 1 stated she expected the heparin to be given "STAT."

During the above interview, PA 1 said she approached the ED nurse (RN 1) regarding the heparin orders and RN 1 told her he wanted to see the coagulation lab results before giving heparin. Coagulation lab refers to the PTT (partial thromboplastin time - blood test that measures the time it takes your blood to clot). PA 1 said she did not know the heparin protocol required PTT before the administration of heparin. PA 1 said she even went to the inpatient pharmacy and informed one of the pharmacists about her new heparin orders.

The Adult General Consultation report by PA1, dated 3/22/17, indicated PA 1 discussed the findings with Physician 3 (neurologist) who agreed with the heparin treatment. The report also indicated PA 1 communicated the treatment plan with Physician 1 (ED physician), Physician 2 (neurosurgeon) and Physician 4 (ED Trauma physician).

According to Patient 1's medical record, PA 1 entered the STAT heparin bolus and heparin drip orders, to be given intravenously (IV-directly through the vein), at 1:53 p.m. on 3/22/17. However, neither of the heparin orders was administered by nursing staff to Patient 1 until 6:00 p.m., or 4 hours 7 minutes after the medication had been first ordered.

The prescribing information for heparin indicates it is an anticoagulant to prevent blood clot formation and thus can help prevent a stroke. It's onset of action (time for a medication to take effect) is immediate if given intravenously.

A concurrent interview and review of Patient 1's medical record was conducted on 6/5/17 at 3:20 p.m. with the director of pharmacy (DOP), pharmacist (Pharm) 1, and the quality project manager (QPM). They said PA 1, on 3/22/17 at 1:53 p.m., entered the heparin bolus and infusion orders in Meditech (an electronic health record system) for Patient 1, but PA 1 did not include a dosage for the bolus. The computer system allowed this order to go through even without the bolus dose. They said Pharm 2 was on duty on that day and was responsible for verifying the heparin orders. Pharm 2 had to clarify the bolus dose since none was indicated. Pharm 2 had difficulty locating PA 1 on that day and finally found her after calling different departments in the hospital. Pharm 2 did not look up PA 1's contact information in the physician's directory (available online). Once PA 1 clarified the bolus dose, Meditech did not allow Pharm 2 to input the bolus order for PA 1 because PA 1 had locked the patient's Meditech order entry screen (the system was set up such that only one user can access the order entry screen at a time). After several attempts, Pharm 2 was able to get into the Meditech order screen and verified the bolus dose.

During an interview on 6/7/17 at 10:10 a.m., Pharm 2 stated she saw PA 1's heparin orders for Patient 1 a minute after they were ordered, but she needed to clarify the heparin bolus because it lacked a dosage. She called the ED first, then ICU, and finally was told to call Interventional Radiology (IR) to reach PA 1. She said she did not look up PA 1's contact information in the physician directory. She stated, looking back, it would have saved her a few minutes had she used the directory. She continued to explain that, after she finally reached PA 1 and clarified the bolus dosage, she could not get into the Meditech order screen to clarify the bolus order, as it was locked by PA 1. Pharm 2 said she tried at least three times between other tasks and activities, and was finally able to get into Meditech.

The medical record showed the heparin bolus order was clarified and completed at 2:51 p.m. on 3/22/17, 58 minutes after the initial order entry by PA 1. At this time, Patient 1 was still in the ED and was about to be transferred to the intensive care unit (ICU).

According to Patient 1's medical record, a baseline PTT was obtained on 3/22/17 at 7:15 a.m. shortly after the patient arrived in the ED. This PTT result would have been available in the computer by the time the heparin orders were made at 1:53 p.m. The medical record showed another PTT test was ordered on 3/22/17 at 2:09 p.m. as part of the heparin infusion protocol; this result was available at 2:40 p.m. At this time, Patient 1 was still in the ED.

During an interview on 6/6/17 at 11:25 a.m., Administrative Staff 1 (Admin 1) said RN 1 did not know of the existing PTT in the medical record at the time PA 1 was telling him of her heparin orders.

During an interview on 6/7/17 at 1:50 p.m., the ED director said interview with RN 1 revealed RN 1 had to verify the coagulation labs before he could give the heparin, and there was also a problem with the heparin bolus order that the pharmacy needed to clarify.

RN 1 was no longer employed by the hospital and not available for interview during the survey.

While still in the ED on 3/22/17 at 2:20 p.m., Patient 1's medical record showed Physician 3 was called and notified of the patient's complaint of nausea. Physician 3 ordered to hold the patient in the ED until he assessed the patient.

Patient 1 was transferred to the ICU on 3/22/17 at 3 p.m. and that was about the time for the next shift change in the ICU.

During an interview on 6/6/17 starting at 1:20 p.m., RN 2 said she received Patient 3 from the ED around 3 p.m. on 3/22/17. The patient was alert and oriented x 4 (patient's awareness of person, time, place, and circumstances) and was conversant. She said she conducted the neuro hand-off (checked the patient's neurological status, asked a series of questions, checked pupil size, strength of extremities, etc.) with RN 1 and Patient 1 had no neurological deficit. RN 2 said she was told by RN 1 there was a heparin order but it was not finalized. At this time, RN 2 was about to go off her shift, and she was to transfer Patient 1's care to the on-coming ICU nurse (RN 3). RN 2 said, during the hand-off with RN 3, she told RN 3 there was heparin to be administered. RN 2 said she did not recall whether RN 1 told her the heparin was a STAT order.

The medical record showed the second PTT result was available at 2:40 p.m. and the heparin bolus order was clarified and completed at 2:51 p.m. (before patient transfer).

RN 2's nurses note, dated 3/22/17 at 3 p.m., indicated, "Received pt [patient] from ED. Neuro handoff completed at bedside with [QNUR mnemonic for RN 1]." However, the notes did not document what information was exchanged between the two nurses, whether communication regarding the heparin was relayed, what the patient's neurological status was at the time, and whether medication orders were discussed and reviewed.

Review of Patient 1's medical record did not find any hand-off documentation between RN 2 and RN 3 during the shift change at around 3:00 p.m. on 3/22/17.

During an interview on 6/8/17 at 8:20 a.m., the ICU director said she expected the ICU nursing staff to document the following hand-off information in the patient's medical record: the patient's Glascow Coma Scale (common scoring system used to describe the level of consciousness in a person following a traumatic brain injury), the NIHSS (NIH Stroke Scale, stroke assessment tool to evaluate and document neurological status in acute stroke patients), and how the patient was at the time.

The hospital Intensive Care Unit Standards of Care, revision date 4/2015, indicated, "When admitting or transferring a patient with neurological deficits/injury, the ICU nurse will do a brief, bedside neurologic assessment with the nurse handing off or receiving the patient. The ICU nurse will document this hand off assessment in the nursing narrative notes... Change of shift hand-off will include on-coming and off-going RN doing a bedside double-check of patient status to include: review of all IV infusions/rates, assessment of skin, verification of relevant assessment findings (IE: neurological status, IABP settings, etc.)"

During an interview on 6/7/17 at 2:10 p.m., RN 3 said he remembered Patient 1 got sick and had a large vomit in bed shortly after arriving in the ICU on 3/22/17. The patient was given a dose of Zofran for the vomiting. The patient began to get sick again after he was cleaned up. After two episodes of vomiting, which were about 20 to 30 minutes apart, the patient experienced an episode of seizure. The trauma physician (Physician 4) from the ED was called to the ICU for emergent treatment. Patient 1 stopped seizing after a second dose of Ativan (IV medication for seizure). The medical record showed Ativan was given at 4:43 p.m. and 4:44 p.m. The patient was intubated (placement of flexible plastic tube into the windpipe to maintain an open airway) and was sedated with propofol (medication for induction and maintenance of anesthesia or sedation). RN 3 said he did not remember if he and RN 2 completed the hand-off before the patient got sick. He did not recall being told about the heparin order by RN 2.

During this interview, RN 3 said right after the patient was intubated, Physician 3 (neurologist) asked him about the heparin order, and that was the first time he was informed about it. The medical record indicated the patient was intubated at 4:50 p.m. on 3/22/17. When asked why he did not give the STAT heparin after he was informed by the physician, RN 3 said he could not remember what happened after that. He was busy cleaning up the patient (after the second vomiting episode).

Patient 1's medication administration record (MAR) indicated the heparin "STAT" order was not administered until 6:00 p.m. on 3/22/17, 4 hours 7 minutes after ordered.

Review of the hospital policy, dated 6/28/16, entitled, "Medication Administration", on page 4 under procedure, it read, "2. b. Medication ordered as "STAT" "NOW" shall be administered to the patient within 30 minutes of the order entry."

During an interview on 6/7/17 at 10:32 a.m., Physician 4 (ED trauma physician) said he was in communication with PA 1 regarding the course of treatment for Patient 1, and PA 1 told him she felt she could write the orders for heparin. Physician 4 said, because of the vertebral artery dissection, Patient 1 was at high risk for an occlusion (blockage or closing of a blood vessel), so the proactive approach was to place the patient on heparin to prevent an occlusion. When he was called to the ICU after the patient started seizing, he asked the ICU nurse if heparin was given and was told no. (Physician 4 was the one who told RN 3 about the heparin order, not Physician 3 as per interview with RN 3 above.) Physician 4 said he told the ICU nurse to give the heparin right away, but the ICU nurse said, "I'm too busy" and that he did not have time.

Review of Patient 1's clinical notes, dated 3/22/17, by Physician 4 indicated, "Called at 1630 for pt seizing, had recently vomited and maintained in Cspine precautions. Seizure continuing and gave Ativan 2 mg times 2 doses without resolution of seizure ... Pat [patient] post ictal [after a seizure] and not responsive... Anesth called and intubated at 1650 with glidescope and maintained in C collar. [Physician 3] called and recommended Propofol and EEG [electroencephalogram; a test that measures and records the electrical activity of the brain]."

An interview was conducted with Physician 3 (neurologist) on 6/7/17 starting at 8:55 a.m. He recalled assessing Patient 1 in the ED and found the patient to be alert and oriented and neurologically intact. Through communication with PA 1 and other physicians, the decision was to put Patient 1 on heparin infusion because there was a clot in vertebral artery. He said the idea was to prevent a new clot from forming and the existing clot to get larger. Physician 3 stated the goal was to prevent further clotting, to prevent a stroke; and that before Patient 1 was transferred to the ICU, he was called about the patient complaining of nausea and vomiting, so he told the nurse to hold the patient until he could assess the patient again. He said his examination found Patient 1 to be neurologically intact and allowed for patient transfer to the ICU.

During this interview, Physician 3 said he was called to the ICU after Patient 1 had an episode of seizure and Physician 4 had already been there. He ordered the valproate sodium STAT to prevent further seizure. He said he expected the medication to be given STAT. Physician 3 said he was later told that he incorrectly input the valproate sodium order in Meditech but he was unsure what happened.

Patient 1's medical record indicated Physician 3 had ordered valproate sodium 1,500 mg IV STAT at 4:44 p.m. on 3/22/17. However, review of the record indicated the valproate sodium order was not verified by pharmacy until 6:23 p.m. or about one and one half hour after it was first ordered by Physician 3. The medication administration record (MAR) showed the valproate sodium was administered at 7:09 p.m., or 2 hours 25 minutes after ordered.

During an interview on 6/7/17 at 1:05 p.m., Pharm 1 explained the valproate sodium ordered by Physician 3 did not include a carrier (the base solution). The medication order required mixing valproate sodium concentrated solution with a base solution (sodium chloride 0.9%), to be infused intravenously over time. Since the order was written without the carrier, it had to be re-entered to add the carrier while discontinuing the old one. When a medication order was made, the pharmacy sig (sig means directions on a prescription) automatically included "ASDIR" (as directed) as a default sig. When Pharm 4 re-entered the valproate sodium order, she did not change the default sig to "STAT." Pharm 1 further explained that, the way the computer was set up, when no sig change happened, the pharmacy label would not come out unless the user input a "1" in another field for the label to print. Because this did not happen, no pharmacy label was printed, and no valproate sodium solution was prepared. This resulted in the delay in the verification of order, preparation, and delivery of the medication to the ICU. Pharm 1 said the hospital policy stipulated verification and processing for STAT medication orders to be done within 15 minutes.

During an interview on 6/7/17 at 4:05 p.m., Pharm 4 said when she re-entered the valproate sodium order for Patient 1, she did not change the sig to STAT and did not know the pharmacy label did not come out. She said a physician and the ICU nurse called later that day inquiring about the status of Patient 1's STAT valproate sodium, and that was when she realized what had happened.

Review of the hospital policy, dated 2/23/16, entitled, "Prescribing, Verification and Clarification of Medication Orders", indicated the turn-around time for processing of STAT medication orders was 15 minutes.

Patient 1's medical record indicated PA 1 entered the STAT heparin orders on 3/22/17 at 1:53 p.m. The orders were not acknowledged by a nursing staff until 5:56 p.m., more than 4 hours later.

Patient 1's medical record also indicated an order for an NIHSS to be done every 8 hours, ordered by PA 1 on 3/22/17 at 11:40 a.m. This order was not acknowledged by a nursing staff until 9:02 p.m. (more than 9 hours later).

During an interview on 6/7/17 at 8:30 a.m., Admin 1 said she was not sure if there was a policy and procedure addressing a timeframe by which the nurse had to acknowledge the orders.

During an interview on 6/7/17 at 2:25 p.m., the ICU director said the STAT medication orders had to be acknowledged by nursing within 15 minutes, and the routine orders by the end of the shift.

The medical record showed, while in the ED on 3/22/17 at 9:30 a.m., Patient 1 had a NIHSS score of 0 (no neurologic deficit). At midnight on 3/22/17, RN 4 conducted the neurological assessment and documented the NIHSS score of 29 (based on scale from 0 to 42; score of 21 to 42 = severe stroke). However, there was no documented evidence RN 4 called and reported the changed NIHSS score of 29 to the physician or the PA of this change.

RN 4 was no longer employed by the hospital and was not available for interview during the survey.

During an interview on 6/6/17 at 2:15 p.m., the ICU manager verified RN 4 did not call and report the NIHSS of 29 to a physician or a PA. She said according to nursing procedures, a physician should be called when the patient had a change in the NIHSS score of 4 or greater. The patient's previous NIHSS documented on 3/22/17 at 9:30 a.m. was zero (0), and at midnight the patient had a score of 29, so there was a significant change in the patient's neurological condition.

During an interview on 6/6/17 starting at 10:25 a.m., PA 1 said she examined Patient 1 the next morning (3/23/17) and found significant neurological change as compared to the day before. She said Patient 1 was only blinking without facial expression, not following any commands, and had no response to stimuli. She immediately notified Physician 3 and a STAT magnetic resonance angiogram-provides pictures of blood vessels using a magnetic field and pulses of radio wave energy (MRA) of the head was ordered.

Review of the neurological assessment, dated 3/23/17, indicated "Neuro exam is very limited today, despite propofol off since 8:15 a.m. Pt. opens eyes spontaneously, but does not track. Gaze in midline."

The MRA findings, dated 3/23/17, revealed large pons (area of the brain that serves as a message station between several areas of the brain; helps relay messages from the cortex and the cerebellum) infarct (a localized area of dead tissue resulting from failure of blood supply) and "progression of left vertebral artery dissection with complete occlusion from the origin."

Subsequent consultation, dated 3/23/17, concluded the patient had locked-in syndrome (a condition in which a patient is aware but cannot move or communicate verbally due to complete paralysis of nearly all voluntary muscles in the body except for vertical eye movements and blinking) with poor prognosis for functional recovery.

The Trauma Progress Notes, dated 3/24/17, indicated, "He [Patient 1] was intubated and placed on a heparin drip in an effort to keep the L [left] dissected vertebral artery open. His mental status also declined overnight, and he underwent MRA brain this morning, which showed complete occlusion of the L vertebral artery and a large ischemic pontine [related to the pons] stroke. [Physician 3] diagnosed him with locked-in syndrome... He may improve over the next few months to years, but will likely not be fully independent and will never reach his former functional status."

During this interview on 6/7/17 at 9:25 a.m., Physician 3 said he was informed of the delay of heparin the next day. He said the patient's seizure (while in the ICU) may have caused the stroke; or it could have happened during the intubation. Physician 3 was asked if heparin was given immediately after ordered, would it have prevented the stroke from happening. He said he was not 100 percent sure as his research did not yield a lot of data, but "it [heparin] would have decreased the chance of further clotting." He stated if heparin was given "as expected," it would "more likely than not" have prevented the stroke from happening. When asked what percentage of assurance he could give for this likelihood, he said 51 percent.

During an interview on 6/7/17 at 10:48 a.m., Physician 4 said the goal for the heparin treatment was to prevent occlusion in the blood vessel as the CT angiogram showed narrowing of the vertebral artery due to the injury. When asked could a stroke have happened if heparin was given immediately after ordered, Physician 4 said, "Not giving it made it more likely to occlude [close up or block]."

Based on observation, interview, and document review, the hospital failed to ensure safe dispensing of compounded (mixed) sterile preparations (CSPs) when:

1. Compounded intravenous (IV, given directly through the vein) antibiotic medications (to treat or prevent infections) were used as stock solutions for multiple pediatric patients and given a beyond-use-date (BUD, date after which a compounded preparation should not be used) longer than specified by hospital policy and procedure and current professional standards; and

2. Seven out of seven new pharmacy staff members did not have gloved fingertip sampling (GFS) conducted three times before initially being allowed to compound CSPs for human use, as in accordance with the hospital policy and procedure.

These failures had the potential to expose patients to preventable infections.

Findings:

1. During a visit to the pharmacy on 6/5/17 at 10:35 a.m., the director of pharmacy said the hospital followed the standards in United States Pharmacopoeia (USP) <797> for CSPs.

USP 797 refers to chapter 797 "Pharmaceutical Compounding - Sterile Preparations" in the USP National Formulary. USP <797> establishes best practices and regulations for the production of CSPs.

On 6/5/17 at 11:20 a.m. in the presence of Pharmacist (Pharm) 3, an inspection of the pass-through medication refrigerator between the ante-room (a staging area where hand-hygiene and garbing procedures take place) and the clean room (where compounding of CSPs occurs) identified two syringes of compounded IV antibiotic (to treat infections) solutions. One was clindamycin 18 milligrams (mg) per milliliter (ml); the other was ceftriaxone 40 mg/ml. The label on the syringes indicated each was assigned a 9-day beyond-use-date (BUD). For example, one was prepared on 6/2/17 and had the expiration date of 6/11/17 (9 days). Upon interview, Pharm 3 said they were compounded antibiotics (antibiotic medication mixed with a diluent) as stock solution for pediatric patients. He explained the stock solution syringes were prepared by the pharmacy so individual doses for pediatric patients could be drawn from the syringe at a later time within the 9-day period. Each syringe was attached with a dispensing pin (an access device for withdrawal of solution from the syringe).

The compounding formula indicated clindamycin 300 mg/2ml and sodium chloride 0.9% solution (as a diluent) were used to make the clindamycin 18 mg/ml solution; and ceftriaxone 1 gram vial and sodium chloride 0.9% solution were used to make ceftriaxone 40 mg/ml solution.

During this visit, Pharm 3 was requested to provide the individual components that make up the above stock solutions. A vial each of clindamycin 300 mg/2ml, ceftriaxone 1 gm, and a vial containing 25 ml of sodium chloride 0.9% injection solution were presented. The manufacturer's label on each vial indicated "single use vial" or "single dose container."

A review of the manufacturer's prescribing information for the above two antibiotics and sodium chloride 0.9% indicated that all these products did not contain any bacteriostatic or antimicrobial agents for the inhibition of microbial replication. Each final product (after mixed together) contained no bacteriostatic or antimicrobial agent to prevent bacterial growth.

The Centers for Disease Control and Prevention (CDC) indicated vials labeled by the manufacturer as "single dose" or "single use" should only be used for a single patient. These medications typically lack antimicrobial preservatives and can become contaminated and serve as a source of infection when they are used inappropriately. The CDC further guided that, in time of critical need, contents from unopened single-dose/single-use vials can be repackaged for multiple patients. However, this should be performed by qualified healthcare personnel in accordance with the standards in USP <797>. It further indicated that following the USP standards is imperative, as medication contamination and patient harm can occur when repackaging (e.g. splitting doses) is not done properly. (www.cdc.gov; accessed 6/12/17)

According to the current USP <797>, opened or needle-punctured single-dose containers... shall be used within 1 hour if opened in worse than ISO Class 5 air quality (ISO Class 5 air quality is that provided inside an IV hood), and any remaining contents must be discarded. Single-dose vials exposed to ISO Class 5 or cleaner air may be used up to 6 hours after initial needle puncture.

During an interview on 6/5/17 at 11:30 a.m., Pharm 3 acknowledged that multiple entries (multiple withdrawals at various times over a 9-day period) to the stock solution without antimicrobial agent increased the risk of accidental microbial contamination of the product. He agreed the IV antibiotic stock solution for pediatric patients should be treated as single-use/single-dose containers, and when prepared in accordance with the standards in USP <797>, should not be used beyond 6 hours if prepared, and the stock solution remained in an ISO Class 5 environment.

The hospital policy and procedure entitled "Compounded Sterile Preparations (CSPs): Environmental Control," revision date 2/2016, indicated the following for single-dose containers:

"1) 6 hours, unless specified otherwise by the manufacturer, for closure sealed single-dose containers in ISO Class 5 or cleaner air after initial opening or entry

2) 1 hour for closure sealed single-dose containers after being opened or entered in worse than ISO Class 5 air."

2. Gloved fingertip sampling (GFS) is a procedure that measures the ability of compounding personnel to perform hand hygiene and garbing without contaminating gloved hands.

The hospital's policy and procedure entitled "Compounded Sterile Preparations (CSPs): Quality Assurance," reviewed and revised 7/2016, indicated, "All pharmacy staff must successfully complete 3 (three) Gloved fingertip sampling occurrences prior to compounding CSPs for human use. For new pharmacy employees, each of these three occurrences will occur prior to beginning of three days of Media-Fill verification." (Media-fill verification is a procedure to test whether aseptic procedures are adequate to prevent contamination during the production of a CSP.)

On 6/8/17, the initial training and competency evaluation for seven new pharmacy staff members (four pharmacists and three pharmacy technicians) were requested for review.

On 6/8/17 at 12:18 p.m., Pharm 1 said all pharmacy staff members were required to be evaluated for competency initially after hire and annually; part of the competency evaluation was the GFS, whether or not the staff was assigned compounding responsibilities.

On 6/8/17 at 12:40 p.m., a review of seven new pharmacy staff members' personnel records with Pharm 1 and Pharm 3 revealed each member had completed the initial GFS only once, with two different reported results - one for before and one after the media-fill test. In other words, each staff member had only one occurrence of GFS during one media-fill verification. Pharm 1 and Pharm 3 verified the new pharmacy staff members did not have GFS conducted three times as stipulated by the hospital policy and procedure. Pharm 1 stated all but one (one technician) had been involved in the compounding of CSPs.

Based on observation, interview, and document review, the hospital failed to ensure expired medications were removed and not available for patient use. The failure had the potential for patients to be given expired or ineffective medications.

Findings:

A visit to the Medical/Surgical Oncology Unit was conducted on 6/6/17 at 9:15 a.m. with several hospital staff members including Pharmacist (Pharm) 3. A random inspection of medications in the Pyxis (an automated dispensing cabinet) identified Rapid Sequence Intubation kit (a kit containing medications for endotracheal intubation that is used where the patient is at a high risk of pulmonary aspiration or impending airway compromise, to maintain the airway) in the medication refrigerator. One of one vial of succinylcholine (drug to induce skeletal muscle relaxation to facilitate tracheal intubation) inside the kit had an expiration date of 5/1/17. The label outside the kit indicated the kit would expire on 5/1/18 (wrong year). Pharm 3 confirmed the succinylcholine vial had expired, and that the kit was mislabeled with the wrong expiration date.

During this visit, a bag containing 1-liter of normal saline with 20 milliEquivalent potassium (a solution for fluid and potassium replenishment) was identified in the Pyxis. It had an expiration date of 3/1/17. Pharm 3 verified it had expired and should be removed from the Pyxis.

The hospital's "Medication Storage and Inspections" policy and procedure, reviewed 2/2016, indicated, "All expired... medications are segregated until they are removed from the hospital."