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Based on observation, interviews and document review, the pharmacy department does not have proper ventilation and airflow in the laminar flow hood being used for the preparation of chemotherapeutic agents in the clean room of the pharmacy.

This deficient practice could affect the patients receiving medication compounded in the pharmacy if the medications become contaminated during preparation. Additionally, the staff in the pharmacy may be affected by contact with chemotherapeutic agents being prepared.


Findings include:

On 8/18/2015 observation in the pharmacy revealed that the clean room did not have a door and the room opened directly into a medication storage area.

The laminar flow hood for preparing chemotherapeutic agents was contained in the same room as the hood for preparing vaccines and other medications, and was not located in a separate negative pressure room.

During an interview with Staff #11, Pharmacy Director and Staff #12, Assistant Pharmacy Director, both stated that the chemotherapy hood was not vented to the outside.

A review of the ventilation test results, conducted by a third party contractor, showed that the laminar flow hood in the clean room did not pass inspection and was not certified by this contractor.

On 8/19/2015, during a second interview with the Pharmacy Director and Assistant Pharmacy Director, the Assistant Director stated that he was aware that the laminar flow hood in the clean room did not pass inspection and could not be certified. Both stated that the facility has future plans to renovate the pharmacy to include a separate clean room for preparing chemotherapy which will have negative pressure and an anteroom. They further stated that in the interim, the facility would construct a door to the clean room and vent the chemotherapy laminar flow hood to the outside.

These findings could affect both patient and staff health if the medications being prepared become contaminated during preparation and are delivered to patients, or if staff are exposed to chemotherapeutic agents in the clean room of the pharmacy.

These findings were verified by the Assistant Pharmacy Director and Pharmacy Director during the interviews on 8/18/2015 and 8/19/2015. They were further verified by the Assistant Pharmacy Director at the exit conference on 8/20/2015.

Based on document review and staff interview, the facility did not identify the presence of an infectious condition in a neonate, and to take infection control measures when providing care and transfer of this neonate.

This lapse in the infection control system, may have placed patients and staff (including the transferring staff) at risk for health care associated infections.

Findings include:

Review of Patient A's medical record identified: This 19 year old female pregnant with twins, presented to the facility on 5/13/15. She was 35 weeks into her first pregnancy when it was determined that there was no heartbeat from one of the fetuses. At triage, the patient, an Arabic speaking immigrant from Yemen, denied rash or recent travel (last 30 days) outside of the country. The patient had her first pre-natal visit to the Obstetrics clinic on 2/05/15. Vital signs were; temperature 36.8 C, Pulse 96, Respiration 18, Blood Pressure 118/79. Physical exam revealed no abnormalities. Consents were signed and witnessed. She delivered the same day by emergency Caesarian section. One of the infants (twin A) was still born and the other (twin B) was born at 35 weeks and two days gestation.

This female neonate (twin B), had a low birth weight of 1.92 kg (4 lbs 4 oz) and severe cardiac and respiratory challenges which required mechanical ventilation. Examination by the pediatric cardiologist on 6/11/15 indicated the pericardial effusion and patent ductus arteriosus (PDA," hole in the heart") were resolving. The patient also had a right cleft lip and palate. She received seven days of antibiotic therapy, she was on total parenteral nutrition via central umbilicus venous catheter and later transitioned to full oral/enteral feeding. The patient was kept on constant cardio-pulmonary monitoring with pulse oximetry, she required frequent oropharyngeal suctioning due to her facial deformities.
The retinal specialist examined the patient on 6/25/15 and discovered the patient had bilateral cataracts that would need surgical repair in the future. She remained in the NICU for almost two months, however, she required additional treatment for bilateral cataracts, cleft lip and cleft palate. The patient was transferred to a receiving facility for further treatment. After transfer, the receiving facility discovered the patient had positive antibodies for Rubella IgM and determined that this was an active case of Congenital Rubella Syndrome (CRS) and the CRS was the reason for her birth defects.

Staff #2 (Infection Control Officer), was interviewed on 8/18/15 at 11:00 am regarding the issue of possible disease transmission in the ICU. Staff #2 informed us that there is no contact between infants in isolettes; each isolette is an enclosed unit and are separated from each other by a distance of four feet. Staff attending to these patients use standard precautions. Regarding patients who present with possible infectious status, Staff #2 stated that all mothers presenting for delivery are screened for infectious diseases and newborns are also tested. When asked the reason why the facility did not identify twin B as having CRS, Staff #2 stated that the mother of the neonate tested positive for Rubella antibodies as part of her pre-natal screen. The IgG test result is interpreted that one has had Rubella and is now immune to further infection. A more definitive test for IgM antibodies would indicate active or recent infection. This test was not done.

This facility did not identify the presence of CRS in the surviving twin B although the neonate displayed two of the symptoms of the disease. The Centers for Disease Control and Prevention (CDC) lists cataracts and congenital heart disease among the suspected and probable symptoms of CRS case definition and recommends contact isolation for infants with CRS.