Back in high school, I had several substitute teachers. In order to get out early, I sometimes set the clock ahead 10 minutes fast. It seldom worked. When it did, the teacher saw the clock, didn’t realize it was set fast, and let the class leave early. I always enjoyed this mischievous act.
After weeks of working and planning for a pharmacy inspection, I wondered what would happen if I set the department clocks ahead eight minutes. I chose eight minutes because I thought ten minutes would be more readily noticed. I figured I had nothing to lose.
On the day of the inspection, all the clocks in the Pharmacy were set eight minutes fast. When the inspector arrived in the department at 1:00 pm, he took a ten minute tour of the Pharmacy. He then sat with my boss and me in the Director’s Office. The clock on the wall read 1:20 pm, when in actuality it was only 1:12 pm.
Knowing that he had to be in another department at 1:30 pm, the inspector rushed through the inspection, even skipping over certain portions, because he didn’t have the time. He thanked us for our time and quickly left us at 1:28 pm (or so he thought).
In my many years of departmental inspections, this was the most abbreviated inspection that I’ve ever participated in. I totally enjoyed taking part in it.
Over the years, I have become aware that the inspector’s requests are only part of the inspection process. Whereas knowledge and producing requested materials are important, there are practices that I’ve always performed that result in a successful inspection.
But I wondered. What if I were not there for the inspection. What if I were on vacation or unavailable that day. I needed to prepare my pharmacy staff to conduct a successful inspection.
1. Develop enjoyable learning.
When it comes to teaching and training my staff, I’ve never used a classroom setting. I don’t believe in providing large amount of handouts, which I find that nobody reads. Instead I use pictures and posters to get my message across. I developed question and answer games to make learning fun. I quizzed my pharmacy staff on a daily basis in order to teach them what they needed to know.
But knowledge is only part of what makes a successful inspection.
2. Determine the format
Pharmacy inspections follow different formats. With some inspections, I had to provide information based on a list of rules. With others, I produced policies to demonstrate departmental procedures.
A tracer method is another type of inspection. In a tracer method, an inspector chose a patient’s chart and followed the experiences that the patient had while at the hospital. The tracer method assessed whether certain standards were met in providing patient care. It also allows the inspector to see if the practices performed were consistent between staff members.
It’s an important practice to know the format of a pharmacy inspection.
3. Make materials available
I had a boss who was very well prepared for pharmacy inspections. My boss made certain that he had all licenses and documents in notebook binders. He had past records in color-coded file folders. He had various documents stored in alphabetized folders in the file cabinet. My boss also used a program in the hospitals computer system to compile, store, and update the Pharmacy Policy and Procedure Manual.
I often marveled at how well organized my boss was for an inspection. Until I realized that he was the only one who knew where everything was. If he were not available, neither I nor my staff would know where to find anything. Everything would be lost amongst the file folders, notebook binders, and computer programs.
In addition, there was another problem. Even if my boss had previously shared where everything was, if he were not available, his office would be locked. Furthermore, his file cabinet would be locked. In addition, access to his computer would be denied because it was password protected.
I’m sure the information was there, since my boss was very thorough. But what good are records, files, and computer programs if no one has access to them.
I needed to make certain that there were duplicate copies of all documents and files. Furthermore, I had to ensure that there was an up-to-date hard copy of the computerized Policy and Procedure Manual available to the staff.
4. Answer the question
The inspector hosted a round table discussion as part of the inspection. He invited several departmental managers and supervisors to attend. At one point, the inspector turned to my Director and said, “Does the Pharmacy have a procedure to make sterile IV products?”
My Director responded, “Yes, we do.” He said nothing more. The inspector looked at my Director, but said nothing. My Director said nothing in response. Finally, after about fifteen seconds of silence, the inspector said, “How many products do you make a day?”
“About 300-350 products,” said my Director.
“Could you elaborate on one or two of them,” asked the inspector.
“Sure,” answered my Director. And he proceeded to describe one or two preparations. After which he stopped again. Then, he waited for the inspector to continue the conversation.
My Director was not being difficult. He knew how to answer questions. He also knew not to say anything else.
I’ve always taught my staff to answer the question and stop. Do not ramble on. Do not include other topics which the inspector hasn’t asked about. Just answer the question that the inspector has asked. Let the inspector ask additional questions if he’s seeking more information.
5. Use a “show” and “tell” procedure
When it comes to answering an inspector questions, I encouraged my staff to “show” the answer, rather than “tell” the answer.
In a given scenario, an inspector asked a pharmacist about insulin. Normally the pharmacist would than stand there and tell about insulin. However, a better method would be for the pharmacist to bring the inspector to the insulin. The pharmacist could answer the insulin questions while standing right in front of the product. They could describe the packaging and even point out parts of the label. In addition, if the pharmacist forgot certain things, hopefully by standing by the insulin, it would jog their memory.
In general, people like visuals. They like the “show” procedure, rather than the “tell” procedure. This is an effective method of answering an inspector’s questions.
6. Utilize mock surveyors
Even the most seasoned individual can find an inspection quite nerve racking. An inspector, wearing a three piece suit and carrying a clipboard, can be very intimidating.
I’ve been a big proponent of having mock surveyors speak with and question my staff. Just knowing the answers wasn’t enough. Pharmacy staff members had to get their message accross. I used outside people to portray these mock surveyors. My staff became very comfortable as they answered the mock surveyor’s questions.
The inspector came into the Pharmacy. He approached a pharmacy technician and asked a question. The pharmacy technician froze at first. She did not immediately answer. When my boss tried to help her, the inspection said, “ Excuse me, I’m asking her the question.”
The inspector focused on the pharmacy technician and repeated the question. Shortly after, the pharmacy technician correctly answered the question.
By becoming knowledge and learning key practices, any pharmacy staff member can conduct a successful pharmacy inspection.
About the Author:
Alex is the Founder of The Happy PharmD. He loves anime, his family, and video games, but not in that order.