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Tag No.: A0084
Based on staff interview and record reviews, the hospital failed to ensure seven hospital vendor contracts had quality assessment and performance improvement (QAPI) evaluations. This failure may result in vendor contractors not providing services in a safe and effective manner.
Findings:
Seven binders of administrative vendor contracts were reviewed with the Administrative Director for Support Services (ADSS). Each vendor contract had the contract approval form, product specifications and description of services to be provided. Each binder did not have any documentation of a QAPI evaluation.
During an interview with the ADSS on 4/8/15 at 8:15 a.m., he was asked to show evidence of QAPI evaluation for these seven administrative hospital vendor contracts. The ADSS could not show any evidence or documentation of a QAPI evaluation. He referred to the contract approval form as the QAPI evaluation.
Tag No.: A0500
Based on observation, interview, and document review, the facility failed to implement procedures for safe preparation of hazardous injectable compounded drugs in accordance with the hospital's policy and procedure. This can result in exposure of staff for unsafe preparation of these drugs.
Findings:
During an inspection of the pharmacy's Intravenous (IV) Room, on 4/6/15 at 11:30 a.m., there were four IV hoods, three horizontal air flow hoods for mixing and compounding regular non-hazardous IVs and TPNs (Total Parenteral Nutrition bags) and one vertical air flow hood for mixing and compounding hazardous medications. Three Pharmacy Technicians were observed in the IV Room each wearing a yellow gown, mask, and booties.
Vertical and horizontal hoods are biological safety cabinets that create sterile environment to prevent contamination from micro-organisms. Vertical hoods create airflow inward into the prep area of the hood so harmful cytotoxic (cell killing) agents (by way of evaporated and aerosolized air) would not reach the person working in front of it. Horizontal hoods create sterile environment but the air flow is toward the person working in front of the cabinet. This type of hood is used to compound regular IV (non-cytotoxic and non-hazardous).
During an interview on 4/6/15 at 11:45 a.m., Pharmacist (Pharm) 3, the IV Room supervising pharmacist, stated the staff were protected from from exposure to hazardous drugs using the vertical hood. He stated unlike horizontal hoods, air is blown toward the person compounding non-hazardous IV medications, and thus kept small particles such as micro-organisms from contaminating the objects inside the hood. Pharm 3 stated staff use the same Personal Protective Equipment (PPE) such as the gowns, gloves, and booties when preparing drugs under the vertical or horizontal hoods.
The facility's policy and procedure dated 8/2013 titled, "Antineoplastic and Hazardous Drug Handling" indicated "this policy establishes safety guidelines for handling and disposal of antineoplastics and other hazardous drugs (HD) in order to prevent occupational related exposures, engineering controls and proper use of protective equipment...
Hazardous Drug (HD) - A HD is any drug that is identified by at least one of the following six criteria: carcinogenicity; teratogenicity or developmental toxicity; reproductive toxicity in humans; organ toxicity; at low doses in humans or animals; genotoxicity; or new drugs that mimic existing hazardous drugs in structure or toxicity. Examples include antineoplastics, antivirals, biologicals, immunosuppressive and potentially investigative drugs or agents...
Disposable long sleeve chemotherapy gloves and gowns should be worn for all procedures involving the preparation, administration, and disposal of antineoplastics and HD materials...
Disposable long sleeve chemotherapy gloves will be used in handling antineoplastic and HD materials. The Kimberly-Clark Safeskin Purple Nitrile-Xtra glove is used in patient care areas...The Kendall Chemo Bloc glove is used in pharmacy drug prep areas...
Gowns should be disposable, low-lint non-permeable polyethylene coated materials, long sleeves with closed cuff at the wrist and in the front."
Tag No.: A0749
Based on observation, interview and document review, the hospital failed to ensure isolation precaution for visitors was implemented as part of the hospital-wide infection control program. This had the potential to promote transmission of infections.
Findings:
During a medication observation with RN 100 on 4/7/15 at 9 a.m., a sign posted on the door of Patient 25's room read, "Contact/Droplet Isolation Precaution". Patient 25's family member was observed inside the room without protective gown, gloves, or mask.
During an interview with Patient 25's family member on 4/7/15 at 9:15 a.m., she stated the hospital staff did not inform her about the isolation precaution.
During a concurrent interview, RN 100 stated visitors were usually educated on the importance of observing isolation precautions and if visitors refused it, the non-compliance would be documented in the patient's medical record.
RN 100 was not able to produce documentation that Patient 25's family member was informed about the isolation precautions and consented to being in the patient's room without wearing gown, gloves, and mask.
On 4/7/15 at 9:40 a.m., three visitors were observed by the nursing station and proceeded to enter Patient 36's room without wearing gown, gloves, and a mask.
During a concurrent interview, RN 101 stated family members and visitors did not need to wear the protective equipment because they did not go from one patient's room to another.
During an interview on 4/7/15 at 12 p.m., the Director of Patient Safety and Infection Control (DPSIC), stated visitors needed to observe isolation precaution and handwashing and acknowledged there was an opportunity for educating the nurses about the importance of visitors to observe the isolation precaution.
Review of the hospital's policy and procedure titled, "Isolation - Transmission Based Precautions and Standard Precautions" indicated "the isolation sign informs visitor to check with the nurse before entering the room. Droplet/Contact isolation - Visitors shall wear a surgical mask that is secured and close fitting while visiting the patient. Gowns and gloves are required for close contact with the patient. Nursing staff will teach family/visitors to perform hand hygiene after contact with patient or contact with immediate patient environment."