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Based on observation, interview and facility document review, the hospital failed to ensure adult code blue (cardiac or respiratory arrest) emergency cart medication inventory met current ACLS (advanced cardiac life support) standards of practice when Vecuronium (a neuromuscular blocking agent used as an adjunct during intubation, inserting a tube into the airway for mechanical breathing while the patient is unconscious; and during surgical procedures to relax and paralyze muscles) was available with other code blue medications.

This had the potential for error in use of a paralytic medication.

Findings:

During the initial tour of the hospital, accompanied by the DOP (Directory of Pharmacy) on 7/24/17 at approximately 12 pm, the medical-surgical unit adult code blue emergency cart was observed. During a concurrent interview, the DOP indicated that he had standardized the cart emergency medication tray contents (which included Vecuronium) throughout the hospital. The list of code blue medication tray contents posted on the outside of the cart, "[Name of Hospital] Adult Crash Cart Drugs (Above 36 kg [kilograms, a unit of weight])" indicated a revision date of September 2015.

Adult code blue emergency carts were also observed on 7/24/17 in the emergency department (at 12:08 pm) and post-anesthesia care patient areas (at 12:14 pm).

A back-up adult code blue emergency cart medication tray was inspected in the pharmacy on 7/24/17 at 3:20 pm. The tray was observed to contain a vial of Vecuronium 20 mg sterile powder and diluent (sterile water for reconstituting the powder) in a plastic bag with a cautionary label indicating "Paralytic Agent." During a concurrent interview, Pharm (Pharmacist) 1 indicated the Vecuronium was rarely used; and stated she had encouraged the DOP to remove it from the adult code blue cart emergency medication supply. Pharm 1 confirmed a separate supply of medications indicated for rapid sequence intubation (RSI) procedures was available in the emergency department refrigerator (that included neuromuscular blocking agents).

The American Heart Association, a nationally recognized expert on ACLS standards of practice, issued revised treatment guidelines in 2015 for the use of medications in cardiac and respiratory arrest. Primary medications include those used for cardiac emergencies:
https://eccguidelines.heart.org/index.php/circulation/cpr-ecc-guidelines-2/part-7-adult-advanced-cardiovascular-life-support/; and secondary medications included those indicated for intubation procedures: http://emedicine.medscape.com/article/109739-overview.

During an interview on 7/25/17 at 11:50 am, the Emergency Room Manager (ERM) indicated, that the RSI medication supply would be more appropriate for intubation a patient during a code blue emergency, as it contains agents to sedate the patient. The ERM acknowledged having a paralytic agent co-mingled with other code blue medications (in the crash cart emergency medication tray) may be a patient safety concern.

The Institute for Safe Medication Practices (ISMP), a national organization entirely dedicated to safe medication use and error prevention, included Vecuronium among its list of neuromuscular blocking agents which have a heightened risk of causing significant patient harm when used in error.

During an interview on 7/26/17 the DOP indicated Vecuronium had been available in the adult code blue emergency cart medication tray for 26 years; and it was not typically used. The DOP acknowledged RSI medication supplies have been available in the hospital for code blue emergencies for the past 5 to 6 years.

During an interview on 7/26/17 at 10 am, Emergency Room Physician (ERP) 1 stated he did not know Vecuronium was included among the medications in the adult code blue emergency cart; as the RSI medication supply was readily available. The ERP 1 stated, "I have not used it [Vecuronium]. I don't think there is any reason to keep it."

Based on observation, interview, and record review, the facility failed to ensure the premises were kept clean when:

1. There was peeling paint and plaster in Room 714, located within the Speciality Clinic.

2. One ceiling vent in the kitchen was visibly dirty.

3. The facility's ice machines (located in the staff dining room directly across from the kitchen and on the medical/surgical unit) had drains that were not equipped with the required airgaps (as it relates to the plumbing trade, is the unobstructed vertical space between the water outlet and the flood level of a fixture).

These failures had the potential to spread germs and result in hospital acquired infections.

Findings:

1. During the initial tour of the facility starting at 9:30 am on 7/24/17 with the Chief Nursing Officer (CNO), Room 714 was observed. This room was located within the hospital's Specialty Clinic and was used by the provider to perform electrodiagnosis procedures (a method of medical diagnosis that obtains information about diseases by recording the electrical activity of body parts or by measuring their response to external electrical stimuli).

Two portions of the wall in Room 714 were noted to have peeling paint and plaster present. One area beneath the sink measured approximately 12 inches (length) by 12 inches (width). The second area was above the sink, where the wall joined the ceiling, and measured approximately 24 inches (length) by 24 inches (width).

During a concurrent observation and interview, the above wall damage was acknowledged by the CNO, who stated that this needed to be repaired.

2. During a tour of the facility's kitchen starting at 11:15 am on 7/24/17 with the Dietary Director (DD), one ceiling vent above the food preparation area was observed to be dirty with visible fuzz and debris present.

During a concurrent observation and interview, the above finding was acknowledged by the DD, who stated that the vent looked like it had not been cleaned in awhile. The DD reported that she thought the vent was cleaned by maintenance, as it was part of the ventilation system.

A review of an undated document titled, "Dietary Department Monthly Cleaning Schedule," revealed that the vent was not currently an item that was cleaned by the dietary department.

During an interview on 7/25/17 at 10:30 pm, with the Maintenance Supervisor (MS), he reported that the dietary department normally cleaned all of their own equipment, but he had since learned that they thought that his department cleaned the vent, and so the vent was overlooked.

3. On 7/25/17 at 2:40 pm, the facility's two ice machines were observed with the MS. One large ice machine was located in the staff dining room directly across from the kitchen and the other smaller ice machine was located on the medical/surgical unit. Both ice machines drained directly into pipes that went directly into the floor with no visible airgap present. The MS confirmed that the two ice machines appeared to be plumbed directly into the drain with no airgaps to prevent possible contamination in the event the drains were to back up into the machines.

According to the California Retail Food Code, effective 1/1/17, all plumbing and plumbing features shall be installed in compliance with applicable local plumbing ordinances and shall be maintained so as to prevent any contamination. All ice machines that discharge liquid waste shall be drained by means of indirect waste pipes, and all wastes drained by them shall be discharged through an airgap into a floor sink or other approved type of receptor.

Based on observation, interview, clinical record and facility document review, the hospital failed to ensure development and implementation of policies and procedures for the storage, handling, labeling, dispensation and administration of medication in accordance with accepted professional principles when:

1. Four of seven RSI (Rapid Sequence Intubation, emergency insertion of a tube into the trachea after administration of a potent sedative then neuromuscular blocking agent) injectable emergency medications stored in the refrigerator were labeled to be maintained at room temperature and therefore were not stored in accordance with manufacturer specifications, with the risk for potential medication degradation.

2. A repackaged (into a clear plastic oral syringe) dose of ferrous sulfate liquid located in the pharmacy was not protected from light in accordance with manufacturer specifications, with the risk for potential medication degradation.

3. An immediate use intravenous (injected into the vein) insulin CSP (compounded sterile product), admixed by licensed nursing staff outside of a sterile compounding clean room environment, was not labeled in accordance with facility policy, with the risk for administration of a potentially contaminated product.

These failures had the potential for medication degradation and administration of a potentially contaminated product.

Findings:

1. On 7/24/17, at approximately 3:20 pm, inspection of the RSI injectable emergency medication supply stored in the pharmacy refrigerator (with a digital thermometer indicating a temperature of 37 º Fahrenheit) indicated the following seven agents were stocked within the supply box:

- Three ampules of Fentanyl (potent narcotic) 100 mcg (micrograms)/ 2 mL (milliliters)
- Two vials of Etomidate (general anesthetic) 40 mg/20 mL
- One vial of Ketamine (general anesthetic) 500 mg/10 mL
- Two vials of Midazolam (anti-anxiety/sedative) 2 mg/2 mL
- Two vials of Lorazepam (anti-anxiety/sedative) 2 mg/mL
- Five vials of Rocuronium (neuromuscular blocking agent used to relax and paralyze muscles) 50 mg/5 mL
- Two vials of Succinylcholine (neuromuscular blocking agent) 200 mg/10 mL

During a concurrent interview, Pharmacist (Pharm) 1 confirmed an identical RSI supply box was also stored in the emergency room medication refrigerator. Pharm 1 further confirmed Lorazepam, Rocuronium and Succinylcholine required refrigeration; but Fentanyl, Etomidate, Ketamine and Midazolam were usually stored at room temperature.

Review of DailyMed, a nationally recognized online compendium of manufacturer labeling (package insert) information, indicated Fentanyl, Etomidate, Ketamine and Midazolam should be stored at controlled room temperature; specifically, 68º - 77 º F.

Review of the hospital policy "Inspection of Medication Storage Areas," formulated 09/2011 and reviewed 2/12/16, indicated: "(6) Drugs shall be stored at appropriate temperatures."

Review of the hospital policy "Pharmaceutical Services," formulated 3/13/14 and reviewed 7/14/15, indicated under Storage and Handling: " ...drugs ...used to prepare or administer sterile products will be stored in accordance with manufacturer or USP [United States Pharmacopeia, a national organization that sets standards for the quality and purity of medicines] requirements."

During a continued interview on 7/24/17 at approximately 3:20 pm, Pharm 1 indicated she was unable to provide manufacturer information indicating Fentanyl, Etomidate, Ketamine and Midazolam could be safely stored under refrigeration, below the labeled storage temperature range.

2. During an inspection of the pharmacy on 7/24/17 at approximately 11:40 am, one 16 ounce bottle of ferrous sulfate liquid (in the original white plastic manufacturer's container) was observed in a storage bin on a top shelf in an alcove room adjacent to the main pharmacy. A clear oral plastic syringe containing 7.5 mL of clear yellow fluid was observed inside the storage bin adjacent to the stock bottle of ferrous sulfate; and the syringe label indicated contents consisted of ferrous sulfate liquid. During a concurrent interview the DOP (Director of Pharmacy) confirmed the observation.

Further inspection of the stock bottle of ferrous sulfate elixir indicated the manufacturer's labeling indicated the medication should be stored in a light-resistant container.

Review of the facility policy "Unit Dose Medication Repackaging," formulated 9/2011, indicated: "Packaging Materials should possess the physical characteristics required to protect the contents from light ..."

During a continued interview on 7/24/17 at approximately 11:40 am, the DOP confirmed the oral syringe containing ferrous sulfate liquid was not light-resistant, and should be stored in an amber plastic bag to ensure optimal medication stability.

3. On 7/24/17 at 2:44 pm, an intravenous minibag (100 mL 0.9% saline), labeled for Patient 21 (an emergency room patient treated on 7/24/17), was observed on the work counter in an alcove room adjacent to the main pharmacy. The tubing port had the original manufacturer's seal, meaning the minibag had not been infused. The red handwritten label affixed to the product indicated "Insulin 100 units" had been added to the minibag on 7/24; and initialed by staff. During a concurrent interview, the Pharmacy Technician (Pharm Tech), stated the emergency room (ER) nursing staff, who had placed the minibag in the pharmacy return bin, had compounded the insulin minibag prior to transferring the patient out to another hospital; Pharm 1 confirmed the minibag labeling, which did not identify the time of compounding, was an immediate use CSP, and had been admixed by ER licensed nursing staff outside of a sterile compounding clean room environment.

Review of Patient 21's clinical record he was admitted to the ER on 7/24/17 at 4:28 am, with diagnoses including diabetes mellitus, uncontrolled elevated blood sugar and diabetic ketoacidosis (a complex disordered metabolic state that can lead to diabetic coma). Review of Patient 21's physician orders indicated no intravenous insulin infusion was prescribed prior to his transfer to another hospital at 8 am.

Review of the facility policy, "Immediate Use Compounded Sterile Products - Nursing Sterile IV Admixture," formulated 09/03/15 and reviewed 06/18/16, indicated with regard to immediate use CSP's: "Dose must be discarded if administration has not begun within 1 hour after the start of the the preparation ...Label with the required information ...initial and date/time the label."

During an interview on 7/25/17 at 11:35 am, the Emergency Room Manager (ERM) confirmed that Patient 21's immediate use CSP (minibag containing insulin 100 units dated 7/24) was not adequately labeled. The ERM indicated the minibag should have been more accurately labeled, "Regular Insulin" and, to be in compliance with hospital policy, included the specific time of compounding.

Based on observation, interview, and facility document review, the hospital failed to ensure infection control policies and procedures were implemented for controlling infections when one licensed nurse failed to perform hand hygiene prior to medication administration in accordance with hospital policy.

This failure had the risk for potential spread of infection.

Findings:

During observation of medication administration preparation on 7/25/17 at 8:25 am, Registered Nurse (RN) 1 was observed to log in to a computer to withdraw Patient 17's medications from the medication room automated dispensing device (electronically controlled cabinet containing medications). After withdrawing Patient 17's medications from the device and Patient 17's plastic medication bin, RN 1 placed them on the mobile workstation on wheels (computer with keyboard on a rolling cart) and entered Patient 17's room. RN 1 was not observed to perform hand hygiene prior to preparing Patient 17's medications or entering his room. RN 1 was then observed to hold Patient 17's wrist to scan his armband, followed by donning clean medical gloves prior to administering Patient 17's medications. RN 1 was not observed to perform hand hygiene prior to donning gloves.

Review of the hospital policy "Hand Hygiene," dated 09/01/06 and reviewed 02/22/17, indicated: "Waterless, alcohol-based hand rubs will be provided throughout the facility ....Sanitize hands before having direct contact with patients ...Sanitize hands before donning sterile gloves ...Sanitize hands before preparing or handling medications."

During an interview on 7/25/17 at 10:55 am, RN 1 confirmed she had not performed hand hygiene prior to preparing Patient 17's medications; prior to having direct contact with Patient 17; or prior to donning clean medical gloves.

Based on observation, interview, clinical record and facility document review, the hospital failed to ensure medications were administered in accordance with physician orders, facility policy and accepted standards of practice for two of 34 sampled patients (Patients 17 and 20) when:

1. A licensed nurse did not perform a blood pressure or pulse assessment prior to administering a blood pressure lowering medication (Diltiazem CD, an extended release formulation) for Patient 17 in accordance with the physician's order.

This failure had the potential Patient 17 to have hypotension (low blood pressure), dizziness and falls.

2. A licensed nurse did not document Patient 18's pain assessment after administration of a narcotic pain relieving medication (Oxycodone/acetaminophen); and a licensed nurse did not document Patient 18's post-narcotic pain assessment (for Hydromorphone) within one hour, in accordance with hospital policy.

This failure had the potential for lack of consistency in pain management for Patient 18.

Findings:

1. During observation of medication administration on 7/25/17 at approximately 8:40 am, Registered Nurse (RN) 1 was observed to administer one capsule each of Diltiazem CD 120 mg (milligrams) and 180 mg (totaling 300 mg) by mouth to Patient 17 along with his other morning medications. RN 1 was not observed to assess Patient 17's blood pressure or pulse prior to administering the medications.

On 7/25/17 at 10:34 am, reconciliation of the medication administration observation with Patient 17's electronic clinical record Quality Coordinator (QC) indicated physician orders (dated 7/17/17) for Diltiazem ER (extended release) 180 mg, to be given with Diltiazem ER 120 mg daily; the order indicated the following parameters: "Hold for SBP [systolic blood pressure, the top number of a BP assessment] < [less than] 110; DBP [diastolic blood pressure, the bottom number of a BP assessment] < 60; HR [heart rate] < 55." The clinical record indicated nursing assistant assessed Patient 17's blood pressure (135/68) and heart rate (62 beats per minute) at 7:10 am, on 7/25/17. During a concurrent interview, the QC confirmed Patient 17's clinical record findings.

Review of the facility policy, "Medication Management: Administration of Medication, formulated 07/01/16, and reviewed 08/11/16, indicated under item 5: "'Parameters' for drug administration as ordered by the physician will be documented on the Medication Administration Record (MAR)."

During an interview on 7/25/17 at 10:55 am, RN 1 confirmed a nursing assistant had assessed Patient 17's blood pressure approximately 90-minutes prior to administration of Diltiazem CD earlier that morning. RN 1 stated she thought that she had assessed Patient 17's blood pressure and heart rate prior to the morning medication administration; then acknowledged she had not documented the assessments in Patient 17's clinical record.

2. a. During observation of medication administration on 7/25/17 at approximately 9:03 am RN 2 was observed to administer one tablet Morphine Sulfate ER (extended release morphine, a potent narcotic medication) and one tablet Oxycodone 10 mg/Acetaminophen (APAP) 325 mg to Patient 18, along with her other scheduled morning medications.

On 7/25/17 at 10:40 am, reconciliation of the medication administration observation with Patient 18's electronic clinical record with the QC, indicated orders for Morphine SR (sustained release) 30 mg twice daily; Oxycodone /APAP 10-325 mg tablet every 4 hours as needed for pain level 4 to 10 (zero to 10 scale, zero meaning no pain and 10 meaning excruciating pain); and Hydromorphine 1 mg tablet every 6 hours as needed if Oxycodone/APAP 10-325 mg not effective. Patient 18's eMAR (electronic medication administration record) indicated RN 2 had documented a baseline pain level of 8 prior to administering the morning medications. During a concurrent interview, QC confirmed Patient 18's clinical record findings.

Further clinical record review with the Chief Nursing Officer (CNO), on 7/25/17 at 1:55 pm, indicated the night shift licensed nurse had administered a dose of Oxycodone/APAP 10-325 mg dose to Patient 18 on 7/25/17 at 4:43 am. The eMAR indicated no post-narcotic pain assessment was documented. During a concurrent interview, the CNO confirmed Patient 18's clinical record finding and stated the nurse who administered the medication was a contracted registry nurse.

2. b. Continued clinical record review with the CNO on 7/25/17 at 10:40 am, indicated RN 2 had administered a tablet of Hydromorphone 1 mg to Patient 18 on 7/25/17 at 8:09 am. Patient 18's eMAR indicated RN 2 documented a post-narcotic pain assessment of 8 at 9:45 am. Therefore, RN 2 documented Patient 18's post-narcotic pain assessment more than 90-minutes after the Hydromorphone was administered; and 42 minutes after the dose of Oxycodone/APAP 10-325 mg was observed administered the same morning. During a concurrent interview, the CNO confirmed Patient 18's clinical record findings and acknowledged RN 2 had not documented Patient 18's Hydromorphone post-narcotic pain assessment timely.

The CNO provided a hospital policy (formulated May 2017 and not yet approved), entitled "Pain, Hospital Management and Control," indicating: "Pain re-assessment will occur within 60 minutes of administration of pain medications and recorded on the eMAR."

During an interview on 7/26/17 at approximately 10:35 am, the CNO provided a memo copy (dated September 2016) indicating he had provided licensed nursing staff with an in-service on pain management and documentation; the memo included guidance related to timely post-intervention pain documentation. The CNO had provided unit huddles that included the same topic on 2/8/17 and 3/2/17; the provided documentation indicated RN 2 was present at both huddles, as evidenced by her signature.