Accreditation

Hear what surveyors look for in hospital clean rooms

Accreditation Connection, August 13, 2004

JCAHO surveyors are looking at hospital clean rooms during surveys, and one of their questions caught a Boston pharmacy director off-guard. Surveyors will look for compliance with the U.S. Pharmacopeia (USP) Chapter 797 requirements on compounding sterile preparations in a clean environment.

While the survey team toured the clean room at Brigham and Women's Hospital during its February survey, "They asked me whether this is something they should look for in every hospital," says Bill Churchill, MS, RPh. "I said I didn't know how to answer the question. I would be concerned that many small hospitals would not have the capability, space, or financial resources to do this."

For your information only
Although surveyors wanted to see Brigham and Women's clean room, they did not survey for compliance with compounding sterile preparations and related JCAHO standards, such as safely preparing and dispensing medications, Churchill says.


Brigham and Women's put itself in place to comply with the new USP requirements when it built its clean room for nearly $340,000 in 1999. The hospital built Class 100, 1,000, and 10,000 environments to compound sterile high-risk medications. The numbers represent the maximum particles per cubic meter of air that exist in that environment.

The hospital is also developing new procedures to increase compliance with Chapter 797, including new pyrogen testing for harmful microbes, Churchill says.


"We were one of the first large academic medical centers to be surveyed," Churchill says. "They focused in on this in an informational way. They didn't go after the crosswalk at all."

Check your sterile products
Surveyors also checked how the pharmacy prepares and dispenses sterile product orders, Churchill says. One of the patient tracers was an oncology patient, and surveyors followed the order from the nursing unit back to the sterile products suite.

Surveyors asked the pharmacist in the oncology unit to walk them through how the pharmacy reviews a medication order and what double-checks exist to prevent an overdose, Churchill says. Brigham and Women's has a chemotherapy order entry system with multiple safety checks to alert prescribers and pharmacists about a possible overdose. The alerts are linked to certain protocols programmed into the system, he says.

The tracer continued to the pharmacy and the central sterile products room. Surveyors wanted to speak with the pharmacist about how the department prepared the order, filled it, and ensured it was for the correct patient, Churchill says.

Pharmacy staff pointed out their department's policy for sterile product preparation, the new pharmacy bar-code system, and the IV label printing units, Churchill says.

Watch your policies
Expect surveyors to be meticulous when reviewing policies and procedures. Surveyors returned to the pharmacy to speak about drug samples after watching a patient receive a sample medication in the ambulatory unit, Churchill says.


Brigham and Women's allows the use of drug samples. However, the pharmacy and therapeutics (P&T) committee must review the samples, and only the practices that request the samples may use them.

Surveyors asked the physician and nurse in the ambulatory unit about the hospital's policy. After they explained the policy, surveyors went to the pharmacy to check for proof that the P&T committee approved the sample in question, Churchill says.


"That was very thorough," Churchill says. "Fortunately, we had that documentation."

Reinforcing lessons
Brigham and Women's made a concerted effort to educate staff about key points surveyors might touch upon during their visit, Churchill says.

For example, he wanted staff to know that surveyors might ask them about the hospital's policy on reviewing medication orders or what safety measures exist for high-risk medications.

Prior to survey, staff received daily or weekly e-mails on hot survey or JCAHO topics, Churchill says. He also shared any JCAHO-related articles from journals or newsletters with staff.

The survey preparation process was more about reminding staff about policies than educating them because anything could occur during the tracer portion of the survey, Churchill says.

"It was preparing them so in the context of any particular question, they would feel confident and comfortable giving an answer," Churchill says.

 

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