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I. Based on document review, observation, and staff interviews, the hospital's administrative staff failed to ensure 2 of 2 observed anesthesia providers (Certified Registered Nurse Anesthetist (CRNA) B and Anesthesiologist A) cleansed the stopper on medication vials prior to removing the medication from the vial for 2 of 2 observed patients (Patient #1 and Patient #2). The hospital staff performed an average of 24 surgical procedures per day.

Failure to cleanse the stopper could potentially result in the staff introducing bacteria, viruses, or fungi into the medication and then administering the contaminated medication to the patient. Administering contaminated medication could potentially result in the patient developing a life threatening infection.

Findings included:

1) Review of the policy "Sterile Product Preparation," effective 11/2008, revealed in part, "The surfaces of ... vials ... closures (i.e. vial stoppers) will be disinfected by swabbing ... with an appropriate disinfectant solution (i.e. 70% isopropyl alcohol) prior to entry."

2) Observations during a tour of the operating rooms revealed the following on 10/31/2017:

a. At 06:30 AM, CRNA B (a nurse with specialized training to administer the medications used during surgery to ensure patients do not feel pain during surgery) removed the plastic cover on the top of the medication vial and removed 8 mg (milligrams) of Decadron (a steroid) with a needle attached to a syringe. CRNA B failed to cleanse the vial stopper with 70% isopropyl alcohol prior to removing the medication from the vial.

b. At 06:30 AM, CRNA B removed the plastic cover on the top of the medication vial and removed 4 mg of Zofran (a medication to control nausea) with a needle attached to a syringe. CRNA B failed to cleanse the vial stopper with 70% isopropyl alcohol prior to removing the medication from the vial.

c. At 06:30 AM, CRNA B removed the plastic cover on the top of the medication vial and removed 100 mcg (micrograms) of Fentanyl (a powerful pain relieving medication) with a needle attached to a syringe. CRNA B failed to cleanse the vial stopper with 70% isopropyl alcohol prior to removing the medication from the vial.

d. At 06:30 AM, CRNA B removed the plastic cover on the top of the medication vial and removed 2 mg of Versed (a medication to relax patients prior to surgery) with a needle attached to a syringe. CRNA B failed to cleanse the vial stopper with 70% isopropyl alcohol prior to removing the medication from the vial.

e. At 06:30 AM, CRNA B removed the plastic cover on the top of the medication vial and removed 10 mg of Ketamine (a medication to relax patients prior to surgery) with a needle attached to a syringe. CRNA B failed to cleanse the vial stopper with 70% isopropyl alcohol prior to removing the medication from the vial.

f. At 06:30 AM, CRNA B removed the plastic cover on the top of the medication vial and removed 100 mg of Succinylcholine (a medication to relax a patient's muscles prior to surgery) with a needle attached to a syringe. CRNA B failed to cleanse the vial stopper with 70% isopropyl alcohol prior to removing the medication from the vial.

g. At 07:15 AM, CRNA B removed the plastic cover on the top of the medication vial and removed 40 mg of Rocuronium (a medication to relax a patient's muscles during surgery) with a needle attached to a syringe. CRNA B failed to cleanse the vial stopper with 70% isopropyl alcohol prior to removing the medication from the vial.

h. At 8:58 AM, Anesthesiologist A (a physician with specialized training in administering the medications used during surgery so patients do not feel pain during surgery) removed the plastic cover on the top of the medication vial and removed 10 mg of Reglan (a medication to control nausea) with a needle attached to a syringe. Anesthesiologist A failed to cleanse the vial stopper with 70% isopropyl alcohol prior to removing the medication from the vial.

i. At 8:58 AM, Anesthesiologist A removed the plastic cover on the top of the mediation vial and removed 4 mg of Zofran with a needle attached to a syringe. Anesthesiologist A failed to cleanse the vial stopper with 70% isopropyl alcohol prior to removing the medication from the vial.

3. During an interview at the time of the tour, the Director of Accreditation acknowledged CRNA B and Anesthesiologist A should have cleansed the stopper in the vial with 70% isopropyl alcohol prior to removing the medication from the vial.


II. Based on document review, observation, and staff interviews, the hospital's administrative staff failed to ensure 2 of 2 observed anesthesia providers (Anesthesiologist A) cleansed the IV access port prior to administering medications to 2 of 2 observed patients (Patient #1 and Patient #2). The hospital staff performed an average of 24 surgical procedures per day.

Failure to cleanse the IV access port could potentially result in the staff introducing bacteria, viruses, or fungi into the IV access port and flush them into the patient's blood stream, which could potentially result in the patient developing a life threatening infection.

Findings included:

1. Review of the policy "Intravenous Therapy, Peripheral," effective 3/10/16, revealed in part, "Administering IV (intravenous, directly into the patient's vein) medications through an intermittent infusion device (saline lock): Refer to Lippincott Procedures; Intermittent infusion device drug administration ..."

2. Review of the Lippincott Procedures "Intermittent infusion device drug administration," revised 5/12/17, revealed in part, "Perform a vigorous mechanical scrub of the needleless connector for at least 5 seconds using an antiseptic pad. Allow it to dry completely."

3. Observations during a tour of the operating rooms on 10/31/17 revealed:

a. At 7:24 AM, CRNA B administered 100 mg of Phenylephrine (a medication to raise Patient #1's blood pressure) to Patient #1. CRNA B failed to scrub the connector to the access port on Patient #1's intravenous (IV) access prior to administering the medication.

b. At 9:20 AM, Anesthesiologist A administered 4 mg of Zofran to Patient #2. Anesthesiologist A failed to scrub the connector to the access port on Patient #2's IV access prior to administering the medication.

c. At 9:20 AM, Anesthesiologist A administered 10 mg of Reglan to Patient #2. Anesthesiologist A failed to scrub the connector to the access port on Patient #2's IV access prior to administering the medication.

3. During an interview at the time of the tour, the Director of Accreditation acknowledged CRNA B and Anesthesiologist A should have cleansed the IV access port prior to administering the medications.


III. Based on document review, observation, and staff interview, the hospital's administrative staff failed to ensure 1 of 2 observed anesthesia providers (Anesthesiologist A) did not withdraw medication from the vial prior to a scheduled surgery. The hospital's administrative staff also failed to ensure the nursing staff labeled 3 of 3 observed syringes in the endoscopy procedure room. The hospital performed an average of 24 surgical and 11 endoscopic procedures per day.

Failure to document when the staff removed medication from a vial or withdraw a medication prior to the surgery could potentially result in the medication preventing bacteria from growing in the liquid and potentially causing the patient to develop a life threatening infection.

Findings included:

1. During an interview on 11/1/17 at 1:30 PM, the Director of Pharmacy stated they expected the staff to follow USP <797> (United States Pharmacopoeia) when the staff members withdrew medications from a vial.

2. Review of the "November 2017 / USP Compounding Compendium" revealed in part, "Opened or needle-punctured single-dose containers, such as ... vials of sterile products ... shall be used within 1 hour ..."

3. Observations during a tour of the operating rooms on 10/31/17 at 8:45 AM revealed Anesthesiologist A removed a syringe containing 200 mg of Propofol (a medication to sedate patients prior to surgery) and a syringe containing 100 mcg of Fentanyl from the bottom drawer of the cart containing anesthesia medications.

4. During an interview at the time of the observations, Anesthesiologist A stated he removed the medication from the vials in the morning, before he provided anesthesia to his first patient of the day. Anesthesiologist A removed the medication for the first patient and second patient at the same time, prior to providing care to the first patient. Anesthesiologist A stored the medication for the second patient's procedure in the anesthesia medication cart during the first patient's procedure.

5. During an interview on 11/1/1 7 at 1:30 PM, the Director of Pharmacy acknowledged Anesthesiologist A should not have drawn up the medication for the second patient's procedure before the start of the first patient's procedure. Drawing up the medication prior to another patient's procedure risked contaminating the medication and potentially spreading infections between patients.

6. Observations during a tour of the endoscopy (where a doctor inserts a flexible camera into a patient) procedure room #2 revealed three syringes. Two syringes had a label indicating they contained 2 mg of Versed. One syringe had a label indicating it contained Fentanyl. All three syringes lacked documentation of the date or time the staff removed the medication from the vial and placed the medication in the syringe.

7. During an interview on 11/1/17 at 1:30 PM, the Director of Pharmacy acknowledged if the syringes lacked evidence of the date or time a staff member removed the medication from the vial, the staff could not know if the medication was removed within the 1 hour window as allowed by USP <797>.


IV. Based on observation and staff interview, the hospital's administrative staff failed to ensure 1 of 1 observed CRNA's (CRNA B) opened sterile packaging for needles in a way to ensure the sterility of the needle. The hospital's administrative staff identified an average of 24 surgical procedures per day.

Failure to open sterile packages appropriately could potentially result in contamination of the sterile fluid pathway, and potentially result in the patient developing a life threatening infection.

Findings included:

1. Observations during a tour of the operating rooms on 10/31/17 at 06:30 AM revealed CRNA B preparing medication to administer to Patient #1. CRNA B removed 5 syringes and 5 needles from her anesthesia medication storage cart. The packaging for the syringes and needles consisted of a plastic side and a paper side. CRNA B pushed against the plastic side of the packaging for the syringes and needles and pushed the syringes and needles through the paper side of the packaging.

2. During an interview at the time of the observations, the Director of Accreditation acknowledged the findings and acknowledged CRNA B could have contaminated the needles and syringes when pushing the needles and syringes through the paper packaging.