The information below comes from the statement of deficiencies compiled by health inspectors and provided to AHCJ by the Centers for Medicare and Medicaid Services. It does not include the steps the hospital plans to take to fix the problem, known as a plan of correction. For that information, you should contact the hospital, your state health department or CMS. Accessing the document may require you to file a Freedom of Information Request. Information on doing so is available here.

WOMEN & INFANTS HOSPITAL OF RHODE ISLAND 101 DUDLEY STREET PROVIDENCE, RI 02905 July 26, 2016
VIOLATION: SECURE STORAGE Tag No: A0502
Based upon observation and staff interview, it has been determined that the pharmacy has failed to store hazardous drugs (HDs) in a secure area, and locked when appropriate.

Findings are as follows:

Surveyor observation of the pharmacy on 7/26/2016 from 8:40 to approximately 10:00 AM, revealed the entrance door was open to the corridor. The compounding technicians were observed at their compounding stations in the compounding room with no direct line of sight to the door. The pharmacist was observed entering and exiting the compounding room. At times, no staff member had direct line of sight into the office, which contained the drug refrigerator.

No cameras were observed in the pharmacy.

When interviewed on 7/26/2016 at 9:30 AM, the Director of Pharmacy Services stated that there was no alarm in the pharmacy. She was unable to produce evidence that the HDs were properly secured.
VIOLATION: FACILITIES, SUPPLIES, EQUIPMENT MAINTENANCE Tag No: A0724
Based upon observation and staff interview, it has been determined that the hospital has failed to maintain facilities and supplies that ensure a acceptable level of safety and quality relative to hazardous drugs.

Findings are as follows:

The USP (United States Pharmacopeia) 797 guidelines for Pharmaceutical Compounding, under Hazardous drugs as CSPs (compounded sterile preparations), states, in part:

1) HDs shall be prepared for administration only under conditions that protect the healthcare workers and other personnel in the preparation and storage areas. HDs shall be stored separately from other inventory in a manner to prevent contamination and personnel exposure".

2) Many HDs have sufficient vapor pressures that allow volatilization at room temperature; thus storage is preferably with a containment area such as a negative pressure room. The storage area should have sufficient general exhaust ventilation, at least 12 air changes per hour to dilute and remove any airborne contaminants.

Surveyor observation of the Infusion pharmacy on 7/26/2016 at 8:40 AM revealed Category 1 drugs (according to the National Institute of Occupational Safety and Health, hazardous drug list, 2014) stored in plastic containers on shelving in the pharmacy compounding area. Examples of these hazardous drugs (HDs) observed were: Azacitidine, Cabazitaxel, Carboplatin, Cixplatin, Abraxane, Cylophosamide, Gemcitabine, and Pemetraxel. These HDs are considered hazardous due to being carcinogenic and their ability to vaporize at room temperature. Pharmacy staff were observed in the room compounding medications while the pharmacist was observed entering and exiting the room.

There was no evidence of negative pressure (a situation in which an enclosed volume has lower pressure than its surroundings) or of an exhaust ventilation system in the compounding room.

When interviewed on 7/26/2016 at 10:25 AM, the Director of Pharmacy Services was unable to produce evidence that the pharmacy and hazardous drugs were maintained to ensure an acceptable level of safety and quality.
VIOLATION: PHARMACY ADMINISTRATION Tag No: A0491
Based upon observation and staff interview, it has been determined that the hospital has failed to store hazardous drugs (HDs) in accordance with applicable standards of practice consistent with Federal and State law.

Findings are as follows:

The USP (United States Pharmacopeia) 797 guidelines for Pharmaceutical Compounding, under Hazardous drugs as CSPs (compounded sterile preparations), states, in part:

1) HDs shall be prepared for administration only under conditions that protect the healthcare workers and other personnel in the preparation and storage areas. HDs shall be stored separately from other inventory in a manner to prevent contamination and personnel exposure".

2) Many HDs have sufficient vapor pressures that allow volatilization at room temperature; thus storage is preferably with a containment area such as a negative pressure room (a situation in which an enclosed volume has lower pressure than its surroundings). The storage area should have sufficient general exhaust ventilation, at least 12 air changes per hour to dilute and remove any airborne contaminants.

Surveyor observation of the Infusion pharmacy on 7/26/2016 at 8:40 AM revealed Category 1 drugs (according to the National Institute of Occupational Safety and Health, hazardous drug list, 2014) stored in plastic containers on shelving in the pharmacy compounding area. Examples of these hazardous drugs (HDs) observed were: Azacitidine, Cabazitaxel, Carboplatin, Cixplatin, Abraxane, Cylophosamide, Gemcitabine, and Pemetraxel. These HDs are considered hazardous due to being carcinogenic and their ability to vaporize at room temperature. Pharmacy staff were observed in the room compounding medications while the pharmacist was observed entering and exiting the room.

There was no evidence of negative pressure (a situation in which an enclosed volume has lower pressure than its surroundings) or of an exhaust ventilation system in the compounding room.

3) " Appropriate personnel protective equipment (PPE) shall be worn when compounding ...closed-system via-transfer device. PPE should include...shoe covers ...double gloving with sterile chemo-type gloves ... " .

Surveyor observation on 7/26/2016 at 8:40 to 10:00 AM revealed the pharmacy technician compounding non-hazardous drugs was not wearing shoe covers nor a beard cover. Additionally, pharmacy technician compounding HDs was wearing a pair of sterile gloves and a pair of chemo-type gloves instead of the double gloved with sterile chemo-type gloves as required.

When interviewed on 7/26/2016 at 10:25 AM, the Director of Pharmacy Services was unable to produce evidence that the HDs were properly secured or stored under negative pressure and ventilated or that the technicians wore appropriate PPE.