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Based on observations, interviews and document review, the facility failed to maintain appropriate infection control processes and follow infection control standards in the areas of medication storage, preparation, and administration.

These failures created the potential for the transmission of healthcare associated infections to patients receiving care in the facility.

FINDINGS

POLICY

According to policy, Common MDI Canister Application (CCA), the following patient populations will be excluded from the application of this policy. These patients will receive MDIs dispensed from the pharmacy with a patient-specific label: NICU, Pediatrics, Oncology, Isolation, ICU, and Tracheostomy patients.

REFERENCE

According to the Clinical Services Group's Common/Shared Metered Dose Inhaler (MDI) Canister Minimum Guidance Statement, CMS's intent in stating that a multi-dose vial being used for more than one patient should not enter the patient treatment area is to prevent inadvertent contamination of the medication container that could then lead to infections in subsequent patients This process results in the MDI entering multiple treatment areas with a potential risk of contamination and subsequent hospital acquired infections.

Gains from employing a common/shared MDI canister will be quickly lost if cross contamination occurs resulting in healthcare associated infections. If staff is not always compliant with hand hygiene between patients, how compliant will they be with cleaning the MDI after every patient use?

The following high-risk populations should be excluded: patients in isolation, ICU, BMT patients, oncology, pediatrics, neonates and all other immunologically compromised patients.

According to the APIC Position Paper, Safe Injection, Infusion, and Medication Vial Practices in Health Care (2016), aseptic technique includes, in part, to disinfect the rubber stopper of medication vials and the neck of glass ampoules with sterile 70% alcohol before inserting a needle or breaking the ampoule.

1. The facility utilized a practice where Metered Dose Inhaler (MDI) canisters entered immediate patient treatment areas and were then used for more than one patient in 4 of 4 patient care unit medication rooms observed (a telemetry, orthopedic, neurology and oncology unit).

a) A tour of the facility was conducted on multiple occasions during the survey. On 08/14/17 at 11:35 a.m., a tour of the 4th floor telemetry unit medication room revealed a green plastic bin with 7 MDIs including 1 Asmanex canister, 1 Atrovent canister, and 5 Dulera canisters.

At 4:05 p.m., in the medication room on the 4th floor Orthopedic Unit, a green bin was observed and contained 6 MDIs; specifically, 3 Dulera canisters, 1 Atrovent canister, 1 Proventil, and 1 Asmanex canister.

At 4:28 p.m., observation of the 4th floor Neurology Unit front medication room revealed a common canister respiratory bin which contained 1 Asmanex canister.

At 4:43 p.m., an interview with the Charge Respiratory Therapist (RRT #1) was conducted. S/he stated the facility employed a common canister Metered Dose Inhaler (MDI) program. S/he stated the MDIs were stored in a common bin in the unit's medication room. In order to administer the medication to a patient, the MDI was taken into the patient's room and used with a patient-specific spacer. After the administration of the MDI, the spacer was returned to a plastic bag which stayed in the patient's room, and the MDI was wiped down and returned to the common bin in the medication room.

RRT #1 stated common canisters were typically used for Dulera 100, Dulera 200, Proventil, Symbicort, and Spiriva medications. S/he stated the canisters were typically cleaned after, but not before they were used by patients. RRT #1 stated this practice was appropriate because the MDI had been cleaned by the Respiratory Therapist who last used the MDI. RRT #1 stated the common canister MDIs were used, instead of patient-specific inhalers, to minimize waste of the medications.

On 08/16/17 at 9:34 a.m., an observation was conducted of a respiratory therapy treatment for Patient #14. RRT #1 looked in the green common respiratory bin located in the back medication room of the Oncology Unit on the 5th floor. S/he stated the correct medication was not in the bin, so s/he had to go to another floor to get the inhaler. S/he then checked the automated medication dispensing system (Pyxis) in the same medication room, but the correct medication was not available in the Pyxis.

Next, RRT #1 decided to look in the Pyxis located in the front medication room on the same oncology unit. At 9:38 a.m., s/he removed a canister of Dulera 100 from the front medication room Pyxis. S/he did not clean the MDI canister. The Dulera canister was then taken into Patient #14's room and set on the table next to the computer while RRT #1 conducted other patient care activities. At 9:42 a.m., the spacer was removed from a plastic bag, not cleaned, and attached to the Dulera canister. The canister was then handed to the patient who activated the inhaler with his/her bare hands, without performing any hand hygiene. RRT #1 then took the canister, removed the spacer, and returned the spacer to the plastic bag. The Dulera canister was placed on the patient's tray table while other patient care activities were performed. RRT #1 then picked up the Dulera canister, scanned it, and placed it again on the table next to the computer, without the cap. A nebulizer treatment was completed with Patient #14. After washing his/her hands, RRT #1 picked up the Dulera canister and returned to the back medication room, where s/he wiped the Dulera canister with an alcohol wipe and returned the canister to the green common respiratory bin.

On 08/16/17 at 9:54 a.m., a second interview was conducted with RRT #1. S/he stated the common canister was safe to use with multiple patients because it was used with the spacer which had a one way valve to prevent cross contamination. S/he confirmed Patient #14 had activated the MDI himself, touching the canister with his uncleaned bare hands.

b) A review of Patient #14's medical record indicated the patient had recently been diagnosed with stage 3 colon cancer. The use of a common canister MDI with the oncology patient was in contrast to facility policy.

c) On 08/16/17 at 2:11 p.m., an interview was conducted with the Respiratory Director (Director #2) who stated the reason for using a common canister program was to minimize cost. S/he was not able to speak to how the facility would have dispensed medication in common canister MDIs without having taken the inhalers into patient rooms. S/he thought this requirement may have applied only to patients in isolation or a circumstance where the canister was not cleaned properly. Director #2 stated as long as the canister was cleaned correctly before and after patient use, common canisters would have been safe for use by patients who were not specifically excluded.

A second interview was conducted on 08/17/17 at 9:45 a.m. with Director #2. S/he stated the Respiratory Department had not conducted any training regarding infection control practices when using common canister MDIs. Director #2 also stated no respiratory specific competencies had been established, and no audits of common canister MDI use had been conducted during the previous two years.

d) An interview was conducted with the Infection Prevention Manager (Manager #3) on 08/16/17 at 4:30 p.m. Manager #3 stated s/he was unaware there was regulatory guidance which required multi-dose vials for aerosolized medications used for more than one patient to not enter the immediate patient treatment areas. S/he stated s/he was aware of studies which concluded compliance with common canister MDIs implementation recommendations was important for infection control. Manager #3 stated it was not his/her responsibility to monitor medication management, and s/he did not conduct any training or auditing of common canister use. S/he was unaware whether any training or auditing had been done by the Respiratory Department. Manager #3 stated s/he did not like all the MDIs stored in a common bin because that may have presented a contamination risk. Manager #3 stated the facility had talked about changing to nebulizers as a best practice but no specific plans had been finalized.

2. The facility failed to ensure staff disinfected the rubber septums of IV medication vials prior to inserting the needle in 1 of 2 IV medication administration observations.

a) On 08/16/17 at 10:00 a.m., an IV medication administration observation was conducted on the 4th floor telemetry unit for Patient A. The Registered Nurse (RN #4) was observed removing the plastic cap from a 40 milligram (mg) vial of Lasix (used to treat fluid retention). RN #4 then inserted a needle through the rubber septum and removed the medication. RN #4 did not disinfect the top of the vial. This medication was then administered through Patient A's intravenous (IV) catheter.

b) An interview was conducted on 08/16/17 at 10:10 a.m. with RN #4. S/he stated the vial of Lasix was closed, not open; therefore, RN #4 understood s/he was not required to disinfect the rubber septum. RN #4 said s/he had been taught to disinfect the vial only if it was already open.

On 08/16/17 at 4:30 p.m., an interview was conducted with the Infection Prevention Manager #3 (Manager #3). S/he stated s/he was told by newly graduated nurses they had been taught in nursing school it was unnecessary to disinfect the rubber septum of single use vials after removing the plastic top. Manager #3 stated the facility did not have a policy which specified how to open a vial properly. S/he acknowledged there was a possible contamination risk if the staff did not perform hand hygiene or gloving properly.

On 08/17/17 at 8:58 a.m., Manager #3 returned for a second interview. S/he provided a 2016 guideline from APIC, referenced above, which recommended disinfecting the rubber stopper of medication vials with sterile 70% alcohol before inserting a needle. Manager #3 indicated the facility would have to change their practice.