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Based on interviews and document review, the hospital failed to collect, measure, analyze, and track data to monitor the safety and effectiveness related to bar code medication administration (BCMA) and Pyxis (automated drug dispensing cabinet) overrides (when an authorized user removes a medication for patient use before the pharmacist reviews the order for appropriateness). The failure resulted in unmonitored and ineffective medication use process in the hospital.

Findings:

a. BCMA is a technology that reduces medication errors by electronically verifying the '5 rights' of medication administration - right patient, right dose, right drug, right time, right route - at the patient's bedside. This is achieved when a nurse scans a bar code on the patient's wristband, and on the medication to be administered, the data are delivered to a computer software system where algorithms check various databases and generate real-time warnings or approvals. (https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5085324, accessed 5/16/19)

During a group meeting on 5/9/19 at 1:45 p.m. with the QA Coordinator (QAC), the Chief Nursing Officer (CNO), the Assistant CNO (ACNO), and the Pharmacist-in-Charge (PIC), they said the hospital had been implementing BCMA since May of 2018 (one year ago). They agreed the use of BCMA was for reducing or preventing medication administration errors in the hospital. When asked if the hospital had set a benchmark (point of reference for evaluating performance or level of quality) for BMCA compliance, they said no. When asked whether the hospital had been collecting, measuring, and tracking the BCMA compliance (e.g., percentage of staff scanning the medication bar codes and patients' wristbands) since implementation, they said no.

During the interview, QAC said she recently ran the BCMA report for First Quarter 2019 "to discuss at the QA Committee, but no decisions made yet."

A review of the "MedVerify Compliance Report By Employee," date range 1/1/19 - 3/3/19, with QAC revealed:
- 25,119 administrations.
- Total MedVerify (those that were scanned): 10,316 (41%)
- Armband Scanned: 4,709 (19%)
- Total not scanned: 10,094 (40%)

QAC said she interpreted the report as: the compliance level for BCMA for First Quarter 2019 was 41%.

b. During the survey from 5/7/19 to 5/9/19, it was identified:

- Medication orders were not evaluated by a pharmacist for appropriateness such as appropriate dose, indication, contraindication, duplication, etc. before use of the first dose, as required;

- All medications (664 medications) in four Pyxis Medstations in the patient care units were available to the nursing staff by override. There were no designated list of override-able medications;

- The amount of Pyxis overrides was excessive: 204 override transactions in a 7-day period for 31 patients;

- A review of 9 patients (Patients 3, 8, 10, 14, 15, 16, 17, 18, and 19) showed multiple concerns such as nursing staff overriding medications even after the pharmacist reviewed and verified the medication orders, wrong medication was pulled, etc. (refer to A500 for more information).

During the group interview with QA staff members above, PIC said the number of Pyxis override was "voluminous" and had been ongoing. The staff said it had been going for years but more so since the Winter of this year due to increased census. When asked if the hospital had been monitoring and tracking Pyxis override rate and for compliance with hospital policy and procedures, they said no.

The hospital's "Automated Dispensing Machine Policy," dated 4/2019, indicated the following under Quality Assurance:

"- Audit discrepancy results from each nursing unit
- Override audit results from each nursing unit
- Override reason audit results from each nursing unit..
- DOP [director of pharmacy] and Quality Management Department head are responsible for tracking these audits."

On 5/9/19, a review of the January 2018 to April 2019 meeting minutes of hospital's Pharmacy and Therapeutics Committee (the multidisciplinary body of the hospital responsible for the safe and effective systems for procurement, storage, distribution, dispensing, and use of medications) revealed there were neither discussion nor presentation of BCMA compliance or Pyxis override data and monitoring.

The hospital's "Quality Management Plan," dated 4/5/19, indicated the organizational management plan included assuring the "... monitoring, assessing, and evaluating the quality and appropriateness of patient care, patient safety practices and clinical performance to resolve identified problems and improve performance..." and "[t]racking the status of identified problems and action plans to assure improvement or problem resolution."

Based on observation, interview, and record review, the hospital failed to:

1. administer heparin (a blood thinner to prevent blood clots) in accordance with the prescriber's order for one of two patients (Patient 6) receiving heparin infusion. The failure had the potential to result in an increased risk of adverse effects, e.g., blood clot or bleeding, for the patient;

2. validate the competence of three of six Registered Nurses (Licensed Nurses F, M and N), in sterile compounding (preparing a medication in an environment free from viruses, bacteria, or any other potentially infectious microorganisms) for medications in intravenous (administered within a vein) solutions. This failure had the potential for patients to receive intravenous medications contaminated by viruses, bacteria or microorganisms, resulting in the potential for contracting an infection.

Findings:

1. The hospital's "Dual Signature for Specific Medications and Dosing" policy, dated 9/1/17, identified heparin as one of the high risk medications, those that "have a higher degree of error than other medications due to their dosing parameters and their immediate pharmaco-dynamic [related to drug action on the body] effects."

On 5/7/19 at 3:10 p.m., a concurrent interview and record review of Patient 6's clinical record was conducted with licensed nurse F (LN F) in the presence of the Chief Nursing Officer (CNO). Patient 6 was admitted to the hospital with diagnoses including pulmonary embolism (a condition in which one or more arteries in the lungs become blocked by a blood clot).

The clinical record showed, on 5/6/19 at 5:30 p.m., Patient 6 had a prescriber order for heparin infusion (drip) per protocol (a formal set of rules and procedures to be followed during a particular course of treatment). The ordered initial infusion rate was 8.5 milliliters (ml, unit of measurement) per hour (hr). The protocol indicated to increase or decrease the heparin rate in response to the patient's PTT (partial thromboplastin time, a laboratory test to monitor clotting time during heparin therapy), which was obtained every 6 hours. The goal PTT was 46 to 70 seconds (unit of measurement).

The clinical record showed the nursing staff initiated the heparin infusion on 5/6/19 at 6:33 p.m., at the rate of 8.5 ml/hr, as ordered. However, less than an hour later, at 7:20 p.m., the Nurses Notes indicated the nursing staff ran the heparin at 8.3 ml/hr, instead of 8.5 ml/hr.

The laboratory record showed, on 5/7/19 at 8:14 a.m., the PTT was 50.9 seconds (within goal range). The protocol indicated "no change" in rate.

During an interview on 5/7/19 at 3:35 p.m., Patient 6's primary nurse (LN G) said the heparin rate remained unchanged due to the morning's PTT within goal range. When asked at what rate it was run, he said it was run as before (meaning 8.3 ml/hour) but he did not have a chance to document yet. He led the surveyor to Patient 6's bedside. The heparin infusion was observed running at 8.3 ml/hour at this time (on 5/7/19 at 3:40 p.m.)

Shortly after this observation, LN F and LN G explained the heparin (concentration of 100 units/ml) was run based on the patient's weight (at 15 units per kilogram per hour x patient's weight of 55 kilogram = 8.3 ml/hr) instead of the ordered rate of 8.5 ml/hr. Thus, the heparin was run at lower than prescribed rate from 7:20 p.m. on 5/6/19 to 3:40 p.m. on 5/7/19 (a period of approximately 20 hours).

The resultant PTT, obtained on 5/7/19 at 3 p.m., was 44.6 (lower than goal range). This required the heparin infusion rate to be increased to 9.5 ml/hour at the time of review.

During the review, LN F, LN G, and CNO acknowledged the heparin infusion was not carried out as ordered for Patient 6.



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2. A review of the facility policy titled "Immediate Use (IV Admixture)," dated 12/1/2017, indicated USP (United States Pharmacopeial) 797 Guidelines (describe conditions and practices to prevent harm, including death, to patients resulting from a contaminated or improperly made compounded sterile preparations) for immediate use (situations where there is a need for emergency or immediate administration) compounded sterile preparations are strictly followed. The policy did not indicate the validation of licensed nurse competency requirements prior to immediate use sterile compounding of medications for administration to patients.

During an interview and concurrent record review on 5/8/2019 at 1:45 pm with Director of Nurses B (DON), the employee files for six Registered Nurses (RNs) were reviewed. DON B confirmed that three of the six files (LN F, M and N) did not indicate validation of competence for immediate use sterile compounding.

During an interview on 5/9/2019 at 10:27 am with DON B, she stated that immediate use sterile compounding was included in the orientation of new RNs and would be included in the facility's Annual Nursing skills Fair (a place where staff demonstrate competence with nursing skills at stations designed to address specific topics).

During an interview on 5/9/2019 at 11:25 am with Pharmacist In Charge (PIC), PIC stated that education and evaluation of competency should be completed by all RNs working clinically. PIC stated he tries to catch all RNs coming through orientation to provide the education and validate their competence. PIC confirmed the facility policy did not address requirements for competence assessment and validation of RNs performing immediate use sterile compounding.

According to USP 797 Guidelines for Pharmaceutical Compounding, qualified licensed healthcare professionals who supervise compounding and dispensing of CSPs shall ensure that compounding personnel are adequately skilled, educated, instructed, and trained to correctly perform and document sterile compounding duties.

Based on interview and record review, the facility failed to ensure authentication (provider review and signature) of verbal orders for three of nine patient (Patients 4, 10 and 13) clinical records containing verbal orders, in accordance with regulations and facility policy.

This failure had the potential for Patients 4, 10, 13 and other facility patients to receive medications in error, resulting in patient adverse outcomes.

Findings:

A review of facility policy titled "Verbal and Telephone Order," dated 8/2018, indicated a verbal order must be authenticated by the person who issued it at the earliest opportunity, but no more than 48 hours after issued. Authentication consists of the prescriber initialing, dating and timing the transcribed order.

During an interview and concurrent record review on 5/8/2019 at 8:50 am with DON B, the clinical record for Patient 4 was reviewed. DON B confirmed a verbal order was taken on 4/14/19 at 9:34 pm by LN H with the following order detail:

Guaifen/DM (Robitussin DM - cough medicine) Syrup 5 ml (milliliters) PO (by mouth) TID (three times per day)
Received on 4/14/2019 at 9:34 pm from Family Nurse Practitioner (FNP)
Taken/entered on 4/14/2019 at 9:34 pm by LN H
Authenticated on 4/28/2019 at 8:42 pm by FNP

A review of the Medication Administration Record (MAR) for Patient 4 with DON B, indicated the first dose of Robitussin DM was administered on 4/14/2019 at 10:09 pm by LN H.

DON B confirmed the verbal order for Patient 4 should have been authenticated by the provider within 48 hours according to the facility policy.

During an interview and concurrent record review on 5/8/2019 at 11:34 am with DON B, the clinical record for Patient 13 was reviewed. DON B confirmed a verbal order was taken on 4/27/2019 at 12:09 pm by LN F with the following order detail:

Insulin Lispro (a rapid-acting form of insulin used for the treatment of high blood sugar caused by diabetes) Injectable 20 units subcutaneous (injected under the skin) x1 (one time)
Received on 4/27/2019 at 12:09 pm from Medical Doctor (MD)
Taken/entered on 4/27/2019 at 12:09 pm by LN F
Nursing verified on 4/27/2019 at 1:29 pm by LN E
Authenticated - signature pending as of 5/8/2019 at 11:34 am.

DON B confirmed the verbal order for Patient 13 should have been authenticated by the provider within 48 hours according to the facility policy.

During an interview and concurrent record review on 5/8/2019 at 11:45 am with DON B, the clinical record for Patient 10 was reviewed. DON B confirmed a verbal order was taken on 4/24/209 at 11:42 by LN O with the following order detail:

Heparin Sodium Injectable 5000 units/ml subcutaneous BID (twice per day)
Received on 4/24/2019 at 11:42 pm from FNP
Taken/entered on 4/24/2019 at 11:42 pm by LN O
Nursing verified on 4/24/2019 at 3:51 am by LN I
Pharmacy verified on 4/25/2019 at 6:51 am by PIC
Authenticated on 4/28/2019 at 8:42 pm by FNP

A review of the Medication Administration Record (MAR) for Patient 10 with DON B, indicated the first dose of Heparin 5000 units was administered on 4/25/2019 at 9:30 am by LN J.

DON B confirmed the verbal order for Patient 10 should have been authenticated by the provider within 48 hours according to the facility policy.

During an interview on 5/9/2019 at 10:01 am, LN L stated that verbal or telephone orders are entered into the patient's electronic medical record and then the order is verified by another licensed nurse. LN L stated a pharmacist reviews the order prior to medication administration. LN L was unable to state the time frame in which a verbal or telephone order must be authenticated by the provider.

During an interview on 5/9/2019 at 12:13 pm, LN K stated that according to the facility policy/procedure for verbal or telephone orders, two licensed nurses must verify the verbal or telephone order upon entry into the patient's electronic medical record. LN K was unable to state the time frame in which a verbal or telephone order must be authenticated by the provider.

Based on observations, interviews, and document and record reviews, the hospital failed to ensure the provision of pharmaceutical services and care met the needs of patients when:

1. One of one patient (Patient 20) receiving fentanyl transdermal patch (a potent narcotic applied to the skin for moderate to severe pain) did not have demonstrated opioid tolerance (patient must have used opioids, like morphine, previously in sufficient quantities to develop a tolerance to opioid effects), a requirement by the manufacturer for the use of fentanyl patch. This failure had the potential patient to suffer severe effects such as respiratory depression (slowed breathing, which can lead to decreased oxygenation and possibly death). (Refer to A-500)

2a. The medication orders were not evaluated by a pharmacist for appropriateness such as appropriate dose, indication, contraindication, duplication, etc. before use of the first dose. All medications (664 medications) in four Pyxis Medstations (automated drug dispensing cabinet) in the patient care units were available to the nursing staff for override (when an authorized user removes a medication for patient use before the pharmacist reviews the order for appropriateness). There was no designated list of override-able medications (medications approved by a multidisciplinary committee as having clinically urgent need for the medication that outweighs the potential risk of medication error). (Refer to A-500)

2b. The amount of Pyxis overrides was excessive. There were 204 override transactions by the nursing staff in a 7-day period from 5/1 to 5/7/19 for 31 patients. (Refer to A-500)

2c. A review of the override transactions for 9 patients (Patients 3, 8, 10, 14, 15, 16, 17, 18, and 19) showed:

- Medication orders were not reviewed by the pharmacist for appropriateness before the first dose was administered for 9 out of 9 patients;

- There were medication orders that did not get reviewed by the pharmacist for as long as 55 hours from the time the order was placed to the time of pharmacist review, necessitating nursing staff to override the medication repeatedly;

- The nursing staff removed medications from the Pyxis on override even after the orders had been reviewed and verified by the pharmacist for 7 out of 9 patients (8, 10, 14, 15, 16, 18, and 19)

- Two medication orders for Patient 8 did not have a pharmacist review 6 days after they were placed; and

- For Patient 15, the nursing staff overrode and gave oral morphine liquid while the order was for morphine extended release capsule. There was no written order for oral morphine liquid.

2d. Although the practice of Pyxis overrides had been ongoing and high in volume, the hospital did not collect, measure, analyze, and track Pyxis override data to ensure the appropriate and safe use of medications through this practice (Refer to A-0273)

These failures resulted in unsafe and ineffective medication-use process (such as medication errors not being caught and intervened by the pharmacist before they were administered to the patients) in the hospital. (Refer to A-500)

3. The medication refrigerator in the pharmacy was not set at the specified refrigerator temperature range of 2 to 8 degrees Celsius (ºC). Storing medications outside of the specified temperature range may affect the medications' potency and efficacy, and therefore would affect the patient's therapeutic outcome. (Refer to A-491)

4. The hospital had not been monitoring the temperature for the medication refrigerator in the Operating Room (OR) for more than a month. This failure may result in out-of-range temperature to go undetected, which may affect the potency and efficacy of the medications within the refrigerator. (Refer to A-491)

5. The hospital failed to ensure outdated medications were not available for patient use. The failure had the potential for patients to be given expired medications, which would be ineffective in treating their medical conditions (Refer to A-505).

The cumulative effects of these systemic problems resulted in the hospital's inability to provide pharmaceutical services and care in a safe and effective manner in accordance with the statutory-mandated Conditions of Participation for Pharmaceutical Services.

Based on observation, interview, and document review, the hospital failed to ensure medication storage was maintained as in accordance with the hospital policy and procedures (P&P) in two of six observed medication refrigerators when:

1. The medication refrigerator in the pharmacy was not set at the specified refrigerator temperature range of 2 to 8 degrees Celsius (ºC). Storing medications outside of the specified temperature range may affect the medications' potency and efficacy, and therefore would affect the patient's therapeutic outcome; and

2. The hospital had not been monitoring the temperature for the medication refrigerator in the Operating Room (OR) for more than a month. This failure may result in out-of-range temperature to go undetected, which may affect the potency and efficacy of the medications within the refrigerator.

Findings:

1. During a visit to the pharmacy on 5/7/19 at 11:37 a.m., a large medication refrigerator was identified. It contained various types of refrigerated medications such as prefilled insulin pens (for high blood sugar), lorazepam injection solution (for anxiety/seizure), various types vaccines (e.g., Pneumococcal 23 vaccine - a vaccine to protect patients from the pneumococcal disease), succinylcholine (a muscle relaxant used during surgery), etc.

A review of the temperature setting in the electronic temperature monitoring system (ETMS) was conducted with the pharmacist-in-charge (PIC). It reflected the temperature range was set from 1.8 (lower limit) to 9.5ºC (upper limit), instead of 2 to 8 ºC. The PIC said when the temperature was out of range, the ETMS would trigger an alert, which would be sent to his phone to notify him of the out-of-range temperature.

A review of the history of temperature readings, from 4/1 to 5/7/19, for this medication refrigerator reflected they were within the 2 to 8 ºC range. However, the PIC acknowledged, because of the wider temperature range setting (from 1.8 to 9.5ºC), temperature excursions such as 1.8ºC or 9ºC would not trigger an alert to notify him of the out-of-range temperature. The PIC said he did not know how long the temperature range was set this way.

To date, the manufacturer for Pneumococcal 23 vaccine indicated to store at 2°C to 8°C.

The manufacturer for succinylcholine indicated to refrigerate at 2°C to 8°C and may be stored at room temperature for 14 days.

The manufacturer for the prefilled insulin pens indicated to store them under refrigeration between 2°C and 8°C.

The hospital's "Drug Storage Refrigerators and Freezer" P&P, dated 9/1/17, defined the refrigerator temperature range as "2 to 8 degrees C."

2. During a visit to the OR on 5/7/19 at 2:30 p.m. with PIC and the Chief Nursing Officer (CNO), a medication refrigerator was identified in a room. It contained medications such as succinylcholine, insulin, sodium chloride 0.9% solution (for fluid replacement), Zemuron (for relaxing muscles during surgery and medical procedures), and Precedex (a sedative to keep patient asleep during surgery or other medical procedures). There was no temperature log that could be found. PIC and CNO said they did not know if there was a temperature log for this refrigerator.

On 5/9/19 at 8:30 a.m. accompanied by a nursing manager (Manager C) and an anesthesia technician, the OR medication refrigerator was again observed. Posted outside the refrigerator was the 5/2019 temperature log, which had the temperature recording for 5/8/19. The entries from 5/1 to 5/7/19 were left blank. This was verified with Manager C and the anesthesia technician.

During an interview on 5/9/19 at 10:35 a.m., nurse manager D (Manager D) stated the OR refrigerator had been managed by an anesthesia provider until recently; only that provider had the key to the room. Manager D said she only had access to this room for about a month and a half, and knew the refrigerator did not have a temperature log. She said the temperature logging "was not done until yesterday." She acknowledged there was no documented evidence the hospital staff monitored the temperature for this refrigerator until 5/8/19, after brought up by the surveyor.

The hospital's "Drug Storage Refrigerators and Freezer" P&P, dated 9/1/17, indicated,"Drug storage areas (refrigerators and freezers) shall be inspected daily by the Pharmacy staff. A daily record log of temperature readings shall be maintained electronically" and "[i]nspection of drug storage refrigerators on patient care units and non-nursing units (i.e., Respiratory Therapy) shall be inspected daily and logged according to the above procedure by individuals designated by the area supervisor."

Based on interviews and record and document reviews, the hospital failed to ensure the safe and effective administration and distribution of medications according to manufacturer's specifications, hospital policy and procedures (P&P), and/or accepted professional standards of practice when:

1. One of one patient (Patient 20) receiving fentanyl transdermal patch (a potent narcotic applied to the skin for moderate to severe pain) did not have demonstrated opioid tolerance (patient must have used opioids, like morphine, previously in sufficient quantities to develop a tolerance to opioid effects), a requirement by the manufacturer for the use of fentanyl patch. This failure had the potential patient to suffer severe effects such as respiratory depression (slowed breathing, which can lead to decreased oxygenation and possibly death);

2. The medication orders were not evaluated by a pharmacist for appropriateness such as appropriate dose, indication, contraindication, duplication, etc. before use of the first dose. All medications (664 medications) in four Pyxis Medstations (automated drug dispensing cabinet) in the patient care units were available to the nursing staff by override (when an authorized user removes a medication for patient use before the pharmacist reviews the order for appropriateness). There was no designated list of override-able medications (medications approved by a multidisciplinary committee as having clinically urgent need for the medication that outweighs the potential risk of medication error).

3. The amount of Pyxis overrides was excessive. There were 204 override transactions by the nursing staff in a 7-day period from 5/1 to 5/7/19 for 31 patients.

4. A review of the Pyxis override transactions for 9 patients (Patients 3, 8, 10, 14, 15, 16, 17, 18, and 19) showed:

- Medication orders were not reviewed by the pharmacist for appropriateness before the first dose was administered for 9 out of 9 patients;

- There were medication orders that did not get reviewed by the pharmacist for as long as 55 hours from the time order was placed to the time of pharmacist review, necessitating nursing staff to override the medication repeatedly;

- The nursing staff removed medications from the Pyxis by override even after the orders had been reviewed and verified by the pharmacist for 7 out of 9 patients (8, 10, 14, 15, 16, 18, and 19);

- Two medication orders for Patient 8 did not have a pharmacist review 6 days after they were placed; and

- For Patient 15, the nursing staff overrode and gave oral morphine liquid while the order was for morphine extended release capsule. There was no written order for oral morphine liquid.

These failures resulted in unsafe and ineffective medication-use process (such as medication errors not being caught and intervened by the pharmacist before they were administered to the patients) in the hospital.

Findings:

1. Fentanyl transdermal patch (brand name: Duragesic) is a potent synthetic opioid pain reliever, applied to the skin to treat moderate to severe pain. It is designed to release the drug in a slow, steady manner over 72 hours.

The Food and Drug Administration (FDA) required pharmaceutical companies who manufacture fentanyl patches to place a boxed warning (black box warning- BBW - the strongest warning) on the labeling. The BBW for fentanyl patch indicates that "serious, life-threatening, or fatal respiratory depression may occur" with its use; and "[b]ecause of the risk of respiratory depression, DURAGESIC is contraindicated [not advised as a course of treatment] for use... in non-opioid tolerant patients."

The full prescribing information (PI) for fentanyl patch indicates it is "indicated for the
management of pain in opioid-tolerant patients, severe enough to require daily, around-the-clock, long-term opioid treatment and for which alternative treatment options are inadequate."

According to the fentanyl patch PI, "Patients considered opioid-tolerant are those taking, for one week or longer, at least 60 mg [milligram, unit of measurement] oral morphine per day, 25 mcg [micrograms] transdermal fentanyl per hour, 30 mg oral oxycodone per day, 8 mg oral hydromorphone per day, 25 mg oral oxymorphone per day, 60 mg oral hydrocodone per day, or an equianalgesic [same level of pain control] dose of another opioid." (www.duragesic.com, accessed 5/14/19)

On 5/8/19 at 9 a.m., a concurrent interview and record review of Patient 20's electronic clinical record was conducted with licensed nurse E (LN E). Patient 20 was an 83 year old patient admitted to the hospital for diagnoses including generalized weakness and chronic pain syndrome (long term pain).

The clinical record showed the patient was admitted on 2/20/19 and was discharged on 3/9/19. The home medications did not include a fentanyl patch use, but included Norco 10/325 mg (hydrocodone 10 mg with Tylenol 325 mg, an opioid medication for pain) 10/325 mg every 6 hours as-needed. LN E confirmed the record did not have evidence how long and how often the patient was receiving Norco prior to admission to the hospital.

During the hospital stay, the clinical record showed Patient 20 had physician orders for the following opioid medications:

- Norco 10/325 mg 1 tablet every 6 hours as needed for pain, dated 2/20/19.

- Tramadol 50 mg 1 tablet every 6 hours as needed for breakthrough pain, dated 2/23/19.

The clinical record also indicated, on 3/6/19, Patient 20 had a physician order for fentanyl 25 mcg per hour (patch delivers 25 mcg per hour) patch every 72 hours. The medication administration record (MAR) showed the nursing staff administered it on 3/6/19 and 3/9/19.

Prior to receiving the fentanyl patch on 3/6/19, the MAR showed Patient 20 received the following within the week prior to fentanyl patch:

Norco 10/325:
Date Dose (# of times per day)
2/27 3x (30 mg of hydrocodone)
2/28 3x
3/1 2x (20 mg of hydrocodone)
3/2 3x
3/3 3x
3/4 2x
3/5 1x (10 mg of hydrocodone)

For Tramadol 50 mg:
Date: Number of times:
2/28 1x
3/1 1x
3/2 none
3/3 4x
3/4 1x
3/5 Discontinued

Tramadol 50 mg is approximately equivalent of 5 mg hydromorphone (https://www.cms.gov/Medicare/Prescription-Drug-Coverage/PrescriptionDrugCovContra/Downloads/Opioid-Morphine-EQ-Conversion-Factors-Aug-2017.pdf)

Thus, from the 7-day usage above, Patient 20 did not have demonstrated opioid tolerance, as required. Opioid tolerance meant at least 60 mg oral hydrocodone per day for a week or longer (as mentioned above). The maximum Patient 20 had per day, such as on 3/3/19, was 3 tablets of hydromorphone 10 mg (30 mg total) in addition to 4 tablets of of Tramadol 50 mg (which was approximately equivalent to 20 mg of hydromorphone), totaling 50 mg per day. This was for only one day. On 3/5/19, Patient 20 only received one time of hydromorphone 10 mg and no tramadol.

During an interview on 5/8/19 at 9:45 a.m. in the presence of LN E, the pharmacist-in-charge (PIC) said he verified the fentanyl patch order for Patient 20. He said he and the prescriber discussed and knew Patient 20 did not meet the opioid tolerance requirement, and that it "went out of the parameters required by the [hospital] policy," but the prescriber wanted to try the fentanyl patch. PIC said he did not document this conversation.

On 5/8/19 at 9:50 a.m., further review of Patient 20's clinical record with LN E revealed no documented evidence the prescriber documented that alternative treatment options had failed.

The hospital's "Fentanyl Patch Prescribing Guidelines" P&P, dated 9/1/17, indicated:

"The following strategies are set to reduce the risk of inappropriate prescribing and administration of Fentanyl patches

Patients that are opioid tolerant - taking one of the following for one week or longer

Hydromorphone 8 mg po [by mouth]/day
Oxymorphone 25 mg po/day
Oxycodone 30 mg/ day
Morphine 60 mg/day
Fentanyl 25 mcg/hr patch
Or equi-analgesic dose of an opioid...

Nursing and pharmacy have a responsibility to question the prescriber for patients that do not fit the above indications or dosing parameters."

2. The hospital utilized the automated dispensing cabinet (Pyxis) from which nursing staff could retrieve medications to administer to patients. After the pharmacist reviewed and verified the prescriber's orders, the pharmacy system is interfaced (a program enabling communication between two systems) with the Pyxis to allow authorized staff to access the medications, under the patient's specific profile, for patient administration. This is called "profiled mode." Bypassing the pharmacist review process is referred to as an "override."

According to the 2019 Guidelines for the Safe Use of Automated Dispensing Cabinets, the Institute for Safe Medication Practices (ISMP), a nationally known nonprofit patient safety organization with recognized national expertise in medication error prevention, indicated, "The use of an ADC [automated dispensing cabinet] in 'PROFILED mode' is considered an important safety feature throughout the healthcare industry as it directs PRACTITIONERS [users] to a patient-specific medication profile and limits access to only medications that have been reviewed and verified by a pharmacist as appropriate for the patient."

In the 2013 ASHP Guidelines: Minimum Standard for Pharmacies in Hospitals by the American Society for Health-System Pharmacist (ASHP), a nationally recognized professional organization that represents pharmacists who serve as patient care providers in acute and ambulatory care settings, it indicated:

"All medication orders shall be prospectively [in advance] reviewed by a pharmacist and assessed in relation to pertinent patient and clinical information before the first dose is administered or made available in an automated dispensing device, except in emergent situations in which the treatment of the patient would be significantly compromised by the delay that would result from pharmacist review of the order...

Medication therapy monitoring shall be conducted by pharmacists. Medication therapy monitoring includes a proactive assessment of patient problems and an assessment of

a. The therapeutic appropriateness of the patient's medication regimen.

b. Therapeutic duplication or omissions in the patient's medication regimen.

c. The appropriateness of the dose of the medication, as well as the route, method, and frequency of administration of the medication.

d. Patient adherence to the prescribed medication regimen.

e. Medication-medication, medication-food, medication-dietary supplement, medication-laboratory test, and medication-disease interactions.

f. Adverse drug reactions and other undesired effects.

g. Patient medication allergies and sensitivities.

h. Clinical and pharmacokinetic [related to movement of drugs within the body]laboratory data to evaluate the efficacy and safety of medication therapy and to anticipate toxicity and adverse effects.

i. Physical signs and clinical symptoms relevant to the patient's medication therapy.

j. Assessment of the effectiveness of the patient's medication therapy."

The hospital's "Automated Dispensing Machine Policy," dated 4/2019, indicated:

"Med-stations on all units will be Profile mode...

Overriding Medications
- Conditions for override should be for urgent patient care or in the presence of a practitioner..."

The hospital's "Pharmacist Order Verification" P&P, dated 9/1/17, indicated, "The pharmacist shall review each prescription or order for medication before administration.

Exception shall be made for situations in which a licensed independent practitioner... controls ordering, preparation and administration of medication, as in... surgery, during cardiorespiratory [relating to heart and lungs] arrest or in the Emergency Department.

Exceptions shall include urgent situations when the resulting delay would harm the patient, including situations in which the patient experiences a sudden change in clinical status."

During an interview on 5/7/19 at 10:45 a.m., PIC said the hospital utilized the Pyxis for storage and distribution of the medications. He said the pharmacy was opened from 7 a.m. to 3:30 p.m. from Monday through Friday, and closed on the weekend. He stated he reviewed new medication orders via remote access after pharmacy hours. He said all patient care areas, except Emergency Department (ED) and Operating Room, were on profiled mode. When asked about the Pyxis overrides, he said, "Every med could be overridden except fentanyl patches." He added, "It's up to the nurse what to override."

During an interview on 5/8/19 starting at 8:55 a.m., the CNO and LN F demonstrated the Pyxis override process. LN F explained, during the pharmacy operational hours (7 a.m. to 3:30 p.m. on weekdays), a new medication order entered into the computerized system by the providers (e.g., doctors, nurse practitioners) would trigger an "unverified order." This unverified order would appear on the MAR but would be grayed out, so the nursing staff could not proceed with order verification (acknowledgement of the order) until the pharmacist reviewed and verified the order. Once the pharmacist reviewed and verified the order, then the nurse could do the nursing verification, and the medication order became available on the MAR. From there he/she could proceed with medication administration and documentation (after administered). LN F further explained, during the non-pharmacy hours (after 3:30 p.m. on weekdays or on weekends), the system was set up to bypass the pharmacist review requirement. Once a medication order was put in, the nursing staff would get an alert of an "unverified clinical order." He/she would click on this alert, verify the order(s), and it would become available for nursing to proceed with administration and documentation. LN F said, after the nursing order verification, the nurse would retrieve the medication(s) from the Pyxis on override. She said the nurses "usually call [pharmacist's name] before they override the medications."

During an interview on 5/8/19 at 11:10 a.m. in the presence of the CNO, PIC said the the system was set up automatically for nurses to verify orders during non-pharmacy hours, and they could override whatever medications "whenever they deem necessary." He said there were 623 medications available in the four Pyxis Medstations in the patient care areas. He said nurses could override medications from any of the four Pyxis Medications, even when they were not assigned to care for the patients in the unit. For example, a nurse assigned to the Medical/Surgical Unit could override medications from the ED Pyxis. He said this practice has been in place for years.

Review of the "All Locations" Inventory Report, provided by PIC on 5/9/19, reflected there were 664 medications.

The hospital's "Automated Dispensing Machine Policy," dated 4/2019, indicated "[a]ll medications" could be overridden.

Thus, the hospital system was set up to bypass the pharmacist review for appropriateness before the first dose was administered during non-pharmacy hours; and all medications available in the Pyxis Medstations could be overridden. This practice was inconsistent with the hospital's Pharmacist Order Verification P&P (indicated above).

In the 2010 ASHP Guidelines on the Safe Use of Automated Dispensing Devices, it indicated, "Clearly stated organizational policies and criteria for system overrides should be developed that limit access to medications before orders have been reviewed and approved by a pharmacist. Override access to medications should be limited to cases in which the drug product has been approved by a multidisciplinary committee of physicians, pharmacists, and nurses as having a clinically urgent need for the medication that outweighs the potential risk of medication error."

3. During a visit to the pharmacy on 5/7/19 at 3 p.m. in the presence of CNO, the Pyxis override activity report (POAR) for one month was requested from the PIC. He said the report would be too many to print out. He said it would be a huge stack of pages. A 7-day report was then requested.

On 5/7/19, PIC provided the POAR for 5/1 to 5/7/19 (seven days) consisting of 26 pages.

On 5/7/19, a review of the POAR showed that the nursing staff removed medications by override 204 times (excluding those obtained by the ED nurses for ED patients, where the Pyxis was not on profiled mode) during the 7-day period for 31 patients.

During an interview on 5/8/19 at 11:48 a.m., PIC stated the number of Pyxis of overrides was "voluminous," that "nurses can override whatever they want," and whenever they wanted even after he had already verified the medication orders, making them available for selection from the Pyxis patient profile.

On 5/9/19, a review of the "All Locations" Pyxis Inventory Report showed it contained medications identified by the ISMP as high-alert medications, those that bear a heightened risk of causing significant patient harm when they are used in error. These medications included: digoxin (to treat heart rhythm problems) 500 mcg/2 ml, epinephrine (to treat severe allergic reactions) 1 mg/10 ml, heparin (blood thinner to prevent blood clots) drip 25000 units/250 ml, magnesium sulfate (for replacement or severe heart problems) injection, ketamine injection (a sedative used in surgery), intravenous (IV) opioids such as morphine, fentanyl, etc.

4. On 5/8/19 starting at 10:45 a.m., the override transactions for six patients (Patients 8, 10, 14, 15, 16 and 17) from the 7-day POAR were selected for review with CNO. They reflected to following:

a. Patient 14, four override transactions were reviewed:

- Citalopram (an antidepressant) 10 mg once daily:
* Order was made on 4/13/19 at 9 a.m.
* Pharmacist verified the order on 4/15/19 at 7:08 a.m. (46 hours after ordered)
* Staff removed it on override on 5/2/19 at 8:25 a.m. (7 days after the pharmacist verified the order.)

- Norco 10/325 mg 1 tablet every 6 hours as need:
* Order was entered on 4/13/19 at 00:49 a.m.
* Pharmacist verified: 4/15/19 at 7:08 a.m. (55 hours after order entered)
* Nursing overrode med on 5/2/19 at 2:24 p.m. (7 days after pharmacist verification)

- Ketorolac (pain medication) 60 mg x 1:
* Order was made on 5/1/19 at 6:40 p.m.
* Nursing verified and gave medication on 5/1/19 at 7:13 p.m.
* Pharmacist verified on 5/2/19 at 6:40 a.m. (12 hours after ordered)

- Furosemide (for high blood pressure) 40 mg by mouth x 1:
* Order was entered on 5/4/19 at 11:35 a.m.
* Nursing verified and gave medication: 5/4/19 at 12:39 p.m.
* Pharmacist verified: 5/5/19 at 8:37 a.m. (20 hours after ordered)

During the clinical record review for Patient 14, CNO said she could not explain why the Norco and citalopram were overridden as the pharmacist had already reviewed and verified the orders 7 days prior. She also acknowledged the pharmacist did not review the order before the first dose was administered for 4 out of 4 medications, and one took as long as 55 hours between time ordered to time of pharmacist review.

b. For Patient 10, the nursing staff overrode medications 25 times from 5/1 to 5/6/19 for 13 medications: docusate (for bowel movement), metochlopramide (for nausea/vomiting), loratadine (for allergies), doxycycline (antibiotic for infection), heparin (a blood thinner to prevent blood clot), gabapentin (for nerve pain), magnesium oxide (for supplement), fenofibrate (for high cholesterol), metoprolol (for high blood pressure), montelukast (for allergies), atorvastatin (for high cholesterol), and two types of insulin (for high blood sugar).

The clinical record review showed 22 out of 25 times the medication orders had already been reviewed and verified by the pharmacist; some medications were overridden 10 - 11 days after the pharmacist verification.

For examples:
- Heparin 5,000 units by injection twice daily:
* Order was entered on 4/24/19 at 11:42 p.m.
* The pharmacist verified: on 4/25/19 at 6:51 a.m.
* Nursing staff overrode heparin on: 5/2/19 at 8:18 p.m.; 5/4/19 at 10 p.m., and 5/5/19 at 8:32 a.m. (11 days after pharmacist reviewed order)

- Metoprolol 25 mg at each bedtime:
* Order was placed on 5/1/19
* Pharmacist verified on 5/2/19 at 6:47 a.m.
* Nursing staff overrode: on 5/2/19 at 8:22 p.m., 5/4/19 at 9:59 p.m., and 5/6/19 at 9:16 p.m. (5 days after pharmacist review)

On 5/8/19 at 11:48 a.m. with the presence of PIC, CNO acknowledged the above findings. PIC said the nurses overrode whatever they wanted, and some overrode "out of habit" even though the orders had already been reviewed by the pharmacist and were available in the patient's Pyxis profile for selection.

c. For Patient 16, five override transactions were selected for review. It reflected 2 out of 5 medication overrides took place after the pharmacist reviewed the orders:

- Magnesium sulfate (a high-risk medication) 2 grams IV:
* Order was made: 5/3/19 at 7:33 a.m.
* Pharmacist verified: 5/3/19 at 8:59 a.m.
* Nursing staff override and gave: 5/3/19 at 9:18 a.m. (after pharmacist review)

- Metoprolol 50 mg daily:
* Order was made: 5/5/19 at 12:35 p.m.
* Pharmacist verified: 5/6/19 at 6:45 a.m.
* Nursing overrode on 5/6/19 at 8:35 a.m. and gave at 8:38 a.m. (after pharmacist review)

The POAR review for Patient 16 also showed: 4 out 5 override transactions the pharmacist review took place after the first doses were given. For examples:

- Insulin lispro (for high blood sugar) per protocol:
* Order was made: 5/3/19 at 5:29 p.m.
* Pharmacist verified: 5/4/19 at 6:21 a.m. (13 hours after order made)
* Nursing gave first dose on 5/3/19 at 8:52 p.m. (before pharmacist review)

- Pneumococcal 23 Vaccine (to guard against pneumococcal diseases) x1:
*Order was made: 5/3/19 at 2:48 p.m.
*Pharmacist verified: 5/4/19 at 6:21 a.m. (15 hours after order made)
*Nursing gave medication: 5/3/19 at 5:45 p.m.

During the review on 5/7/19 at 1:35 p.m., CNO acknowledged these findings and agreed that the nursing staff could have waited for pharmacist review before giving pneumococcal vaccine.

d. For Patient 8, three override transactions were selected for review, which reflected the following:

- Potassium (for replacement) 40 milliEquivalent x 1:
* Order was made: 5/2/19 at 10:12 p.m.
* Nursing verification: 5/2/19 at 10:12 p.m.;
* Nursing override: 5/2/19 at 10:13 p.m. and gave at 10:15 p.m.
* No pharmacy review yet as of 5/8/19 at 2:10 p.m. (6 days after orders made)

- Multivitamin 1 tablet daily:
* Order was made: 5/2/19 at 10:04 p.m.
* Nursing verified: 5/3/19 at 10:22;
* Nursing override: 5/3/19 at 8:05 a.m. and gave at 8:07 a.m.
* No pharmacy review yet as of 5/8/19 at 2:10 p.m. (6 days after orders made)

- Prozac (for depression) 20 mg once daily:
* Order was made 5/3/19 at 1:55 p.m.
* Pharmacy review 5/3/19 at 2:06 p.m.
* Nursing override: 5/3/19 at 2:08 and gave at 2:09 p.m. (after pharmacy review)

During the review on 5/7/19 at 2:15 p.m., CNO acknowledged: two out of three medication orders had no pharmacist review; and a nursing staff overrode the medication after the pharmacist verified the medication order.

e. For Patient 15, four override transactions were selected for review. It reflected the nursing staff removed on override: morphine oral liquid 20 mg on 5/3/19 at 8:28 p.m.

A review of Patient 15's clinical record with CNO on 5/7/19 at 2:25 p.m. revealed there was no prescriber's order for oral morphine liquid. Instead, there was a physician order for "Morphine sulfate ER [extended release] 20 mg" 1 capsule every 6 hours, on 5/3/19 at 2:42 p.m.

Review of the patient's MAR revealed the nursing staff documented a dose of morphine ER 20 mg capsule was given on 5/3/19 at 8:30 p.m. (2 minutes after the morphine liquid was overridden).

During a follow-up interview on 5/7/19 at 4:15 p.m., CNO said she could not find the prescriber's order for the oral morphine liquid. She said the nursing staff overrode and gave the oral morphine and documented they gave the oral morphine ER capsule. She acknowledged they were not the same.

The review also showed an insulin Lispro was overridden after the pharmacist review; and first dose ibuprofen (medication for pain/fever) 400 mg given to the patient before the pharmacist review.

f. For Patient 17, four override transactions were chosen for review. Four out of four the pharmacist reviewed the medication orders at least 20 hours after ordered and after the nursing staff gave the first doses. For examples:

- Protonix (for stomach protection) 40 mg daily:
* Order was made: 5/5/19 at 10:33 a.m.
* Nurse overrode: 5/5/19 at 11 a.m. and gave at 11:05 a.m.
* Pharmacist verified: 5/6/19 at 7 a.m. (20.5 hours after order was made)

- Losartan (blood pressure medication) 50 mg daily:
* Order was made: 5/5/19 at 10:36 a.m.
* Nursing overrode: 5/5/19 at 11 a.m. and gave at 11:01 a.m.
* Pharmacist verified: 5/6/19 at 7 a.m. (20.5 hours after order was made)

Two other medications: heparin injection and duloxetine (antipressant) also were reviewed by the pharmacist 20.5 hours after they were made and after the nursing staff gave the first doses. The CNO acknowledged the finding.

g. On 5/9/19, the Pyxis override report for controlled substance medications (those with high potential for abuse and dependency) were requested for review. Override transactions for three patients were selected for review with CNO on 5/9/19 starting at 11:05 a.m.

For Patient 18, two override transactions were selected. It reflected the following:

- Morphine sulfate 2 mg IV every 4 hours as need:
* Order was made: 4/9/19 at 4:41 p.m.
* Pharmacist verified: 4/9/19 at 8:26 p.m.
* Nursing overrode: 4/11/19 at 2:37 p.m. and gave at 2:55 p.m. (almost 2 days after pharmacist verified the order)

- Morphine sulfate 4 mg IV every 6 hours:
* Order was made: 4/9/19 at 9:43 p.m.
* Pharmacist review: 4/10/19 at 6:43 a.m. (11 hours after order was placed)
* Nursing overrode: 4/11/19 at 4:31 a.m. and gave at 4:36 a.m. (more than 1 day after pharmacist verified the order)

During the review, CNO confirmed the nursing staff should not have overridden the morphine for patient administration because the pharmacist had already verified the order. Also, the pharmacist review took 11 hours after the order was placed.

h. For Patient 3, four override transactions were selected for review: one lorazepam (for anxiety/agitation) oral tablet 0.5 mg; two transactions for lorazepam injection 2 mg, and one transaction for zolpidem (for insomnia) 5 mg tablet. All four were ordered on 4/10/19 at around 11:14 p.m.; and the pharmacist verified them the next morning on 4/11/19 at 6:46 a.m. (approximately 7 hours later). The nursing staff gave the first doses, at various times, for all four medications before the pharmacist review. This was confirmed with CNO on 5/9/19 at 11:45 a.m.

i. For Patient 19, three medication orders were selected for review, which reflected the following:

- Norco 5/325 mg 1 to 2 tablets every 6 hours as needed for pain:
*Order was made: 4/11/19 at 10:08 p.m.
*Nursing verified on 4/11/19 at 10:11 p.m. and gave first dose at 10:14 p.m.
*Pharmacist verified: 4/12/19 at 7:06 a.m. (9 hours after order was placed)

- Norco 10/325 mg 1 tablet every 6 hours as needed for pain:
*Order was placed: 4/13/19 at 1:54 a.m.
*Nursing verified: 4/13/19 at 2:26 a.m.
*Nursing overrode: 4/13/19 at 5:36 a.m., at 12:03 p.m., at 7:25 p.m.; 4/14/19 at 1:22 a.m., at 8:34 a.m.; and 4/15/19 at 2:44 a.m.
*Pharmacist reviewed: 4/15/19 at 7:19 a.m. (53 hours after order was placed)

- Percocet (potent narcotic for pain) 10/325 mg 1 tablet every 6 hours as needed for pain:
* Order was placed: 4/20/19 at 3:04 p.m.
* Pharmacist verified: 4/21/19 at 8:34 a.m. (17 hours after order was placed)
* Nursing overrode: 4/23/19 at 12:40 p.m. and gave at 12:34 p.m. (2 days after pharmacist verified the order).

During the review on 5/9/19 at 12:05 p.m., CNO acknowledged the nursing staff overrode the Percocet after the pharmacist had verified the order; the pharmacist review took place after the first Norco doses given; and the pharmacist review for Norco took place 53 hours after the order was entered, necessitating the staff to override the medications repeatedly.

Based on observation, interview, and document review, the hospital failed to ensure outdated medications were not available for patient use; and that sodium chloride 0.9% injection solution bags (intravenous [IV] solution for dilution with medication) remained in the overwrap until ready to use. These failure had the potential for patients to be given expired or deteriorated medications, which would be ineffective in treating their medical conditions.

Findings:

a. During a visit to Station A (a Medical/Surgical Unit) on 5/7/19 at 11:55 a.m. with the Pharmacist-in-Charge (PIC), 21 bags of dextrose 5% in water (D5W, a form of glucose solution given through intravenous (IV) route for fluid and carbohydrate replacement) were identified in the Supply Room. All 21 bags had the expiration date of 4/2019. The PIC verified this finding.

b. On 5/7/19 at 12:15 p.m. accompanied by PIC in the Emergency Department (ED), an inspection in the medication refrigerator identified a 30-milliliter (ml, unit of measurement) vial of diltiazem (IV medication to treat chest pain) 125 milligrams (mg, unit of measurement) per 25 ml. It had the expiration date of 7/2018. PIC verified it had expired and said it should not have been in the refrigerator.

During the same visit to the ED, an inspection of medications stored in a closet revealed 3 out of 3 bags of gentamycin injection solution (IV antibiotic to treat various infections) 80 mg with the expiration date of 2/2019. The PIC verified they had expired.

Also in the ED's medication closet were eight 100-ml sodium chloride 0.9% injection solution in Viaflex plastic bags which were outside of the overwrap (a thick protective covering which came with the bags). The PIC said they were supposed to be stored in the overwrap until ready for use.

To date, the Prescribing Information from the manufacturer for the sodium chloride 0.9% solution indicates, "Do not remove unit from overwrap until ready for use. The overwrap is a moisture barrier."

c. During a visit to the Station B (a Medical/Surgical Unit) on 5/7/19 at 12:35 p.m. with PIC and the Chief Nursing Officer (CNO), two opened bottles of Lorazepam Intensol Oral Concentrate (controlled substance medication to treat anxiety/agitation) 2 mg/ml were identified in the medication refrigerator. One did not have the opened date; the other had the opened date of 2/1/19. The manufacturer's label on these bottles indicated, "Discard opened bottle after 90 days." Both the PIC and CNO acknowledged one bottle was not labeled with an opened date, and the one opened on 2/1/19 would have expired on 5/1/19.

The hospital's "Drug Storage Areas Inspection" policy and procedures, dated 9/1/17, indicated, "Drugs shall not be kept in stock after the expiration date on the label and no contaminated or deteriorated drugs shall be available for use."