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Better Cars = Better Healthcare?

Better Cars = Better Healthcare?
August 17, 2018 Seth DePasquale

The medical industry could take a page or two from a certain car manufacturer.Click To Tweet But not all car companies are created equal though; it’s important to know which I’m referring to. This particular manufacturer actually has a assembly plant near where I live here in Kentucky and I recently was able to tour the factory. After reading several books about how they operate and their philosophy, I have to say I didn’t fully appreciate many of the concepts until I saw them first hand in action.

Toyota has a whole philosophy, the Toyota Production System, that is weaved into every aspect of their operation from management down to their suppliers. In a few words: an efficient process is one that eliminates all waste leading to higher productivity with few errors. Waste in Toyota terms means any part of a process that doesn’t actually contribute to the overall value of the final product. There are 14 principles that make up Toyota’s philosophy, I’m just going to focus on one, Kaizen (or continuous improvement). However, I encourage the reader to learn all 14 (CLICK HERE).

Data collection is key

Process improvement is extremely important to the way Toyota functions on a daily basis; the company never stops learning. By having a culture that truly rewards learning, innovation and improvement, they’re able to continuously improve their processes to make them more efficient. This kind of environment though needs a lot of inputs; Data. Data points are absolutely key to learning where in a process you may need improvement. There are two broad categories for collecting data: internal sources or external sources.

Internal sources may include training records, inspection data, process control data and out of specification reports. Examples of external data sources would be customer complaints, service repairs, adverse event reports or even the FDA. Any reports of something gone wrong is really an opportunity for improvement. This data feeds into your Corrective Action, Preventative Action program (CAPA). Once you have some piece of data that warrants improvement how do you go about figuring out the problem and implementing a solution? Lucky for you it’s a simple five step process called DMAIC (pronounced Duh-May-Ick).

DMAIC: A Six Sigma Tool

If you’re unfamiliar with Six Sigma, it is a set of tools for process improvement. Six Sigma itself refers to a process that is well controlled with little variation and comes from statistics meaning six standard deviations from the mean and the specification limits. In plain English: a process that has less than 3.4 defects per million opportunities (very little error). Anyone and everyone involved in health care should make themselves familiar with the improvement concepts and thought processes that Six Sigma has to offer as it will lead to higher productivity with less chance for error and variation; which in turn will increase efficiency and margins.

Recently, I had to opportunity to share the DMAIC approach with a pharmacy and it had great results: it lead to improvements in their contamination control protocols and the FDA closing out their open inspection. DMAIC stands for Define, Measure, Analyze, Improve and Control. These are the steps for improving a process when a problem or variation has been identified. In the case of this pharmacy they had a contamination issue on the surface of their ISO 5 environment in which they compound. Any contamination that has been isolated from an ISO 5 area should be identified and remediated based on their own SOPs and standards within USP chapter <797> as this is the highest risk area for actually contaminating a preparation.

FREE Six Sigma Webinar!

“A Compounder’s Guide to Lean Six Sigma Process Improvement”

In this webinar I’ll be talking about what Six Sigma is and using it to make improvements in your pharmacy. A real-life case of using six sigma will be discussed; how it was used to “close out” further investigation by the FDA.

PLEASE SIGN UP HERE (click)

Below is the actual DMAIC response that was sent to the FDA:

Summary of Investigation and Corrective Actions for Environmental Excursions:

DEFINE: USP <797> lists all molds and yeasts as “highly pathogenic mircroorganisms” and requires investigation and corrective action regardless of colony forming unit counts.  Environmental excursions (fungi) occurred on (DATE REMOVED), on the surface of the ISO 5 laminar flow hood and on the left fingertip of the compounding pharmacist during routine environmental monitoring (EM).  The following goals were identified in this investigation and improvement process:

  • The environment where compounded sterile products (CSPs) are produced and personnel should remain in a state of control.
  • The CSPs must be safe.
  • The process for evaluating a state of control should be designed to protect patients receiving CSPs.
  • The EM program should be designed to properly evaluate environmental control.
  • Personnel and processes should be designed to maintain environmental control.  This includes gowning, cleaning, aseptic technique, and EM technique.

MEASURE:  Defect – The cleanroom environment is not in a constant state of control.  Opportunity – Each time the cleanroom is used to make CSPs.  Unit of Measure – EM results.

ANALYZE: The following areas were evaluated in the investigation and improvement process:

Storage and staging of products into the cleanroom

  1. High traffic area.
  2. Plastic bags used to store and stage materials into cleanroom are stored in corrugated cardboard.
  3. Bioburden of process not evaluated.

Gowning process

  1. Donning of sterile gown is performed after handwashing and prior to donning sterile gloves; bioburden may be transferred to gowning via clean bare hands.

Environmental monitoring process

  1. Monthly cleaning occurs after 3rd party validation of cleanroom; it was discovered that routine validation was cancelled and rescheduled on (DATE REMOVED) after a significant amount of testing equipment had been staged into the cleanroom and monthly cleaning did not take place.
  2. Previous growth had been recovered the week before, on (DATE REMOVED).  It is possible that bioburden was on specific testing plates (SabDex plates) that were only used on a weekly basis (DATES REMOVED) and were generally stored in the ante room.
  3. Monitoring of staged bags does not occur.
  4. Surface samples in ISO 7 areas on not performed on a weekly basis.

Cleaning process

  1. Documentation of weekly and monthly cleaning is not well documented on logs.
  2. Sporicidal agents are rotated on a monthly basis.

Primary and Secondary controls

  1. Validated every 6 months, no current issues.

Aseptic/compounding process

  1. Review of media fills and smoke visualization studies performed every 6 months did not reveal deficiencies.

Patient safety

  1. Use of USP 797 dating and storage conditions reduces the chance of microbial growth if contamination of a CSP occurred.
  2. Variances in environmental monitoring procedures do not define the circumstances that would require a product recall.

IMPROVE:  The following improvements were made:

Storage and staging of products into the cleanroom

  1. Staging area was repositioned to reduce traffic.
  2. Plastic bags used to store and stage materials into cleanroom were changed to Ziplock bags that had not been exposed to corrugated cardboard.
  3. Procedure for EM was updated to include a weekly surface sample of a staged bag.

Gowning process

  1. Procedure for gowning was updated for operator to don a pair of sterile gloves after handwashing and prior to donning sterile gown (followed by an additional pair of sterile gloves after completion of gowning).

Environmental monitoring process

  1. Monthly and weekly cleaning logs were improved to properly show documentation of monthly and weekly cleaning.
  2. Use of SabDex plates was discontinued, plates will no longer be stored in the cleanroom for long periods of time.
  3. Monitoring of staged bags shall occur on a weekly basis.
  4. Surface samples in ISO 7 areas shall be performed on a weekly basis.

Cleaning process

  1. Retraining and updating of logs for the documentation of weekly and monthly cleaning occurred, with increased frequency of reviewing the documentation of this cleaning.
  2. Procedures for cleaning were updated to require that sporicidal agents are rotated on a weekly basis.

Primary and Secondary controls

  1. Validated every 6 months, no current issues.  Ensure monthly cleaning occurs after validation process, including if a cancellation part way into the process occurs, in order to prevent increased bioburden.

Aseptic/compounding process

  1. Continue current policies and procedures.

Patient safety

  1. Policy for environmental excursions was updated to require a recall of products compounded on a date when an environmental excursion occurred.

CONTROL PHASE: To be determined if and when sterile compounding resumes.

Conclusion

If you already have some kind of process improvement program in place, is it working? Being a true learning organization involves constantly re-visiting your processes and procedures when an error or adverse event takes place to figure out how to improve. While examining the process using DMAIC, be sure to include all team members involved in that process; brainstorming solutions for preventing future failures is a key.

There are many points to discuss further and I encourage the reader to educate themselves on using these process improvement tools. The main point that I would like to leave you with is that in order to make improvements in any process you must first be collecting data. In the case of preventing and controlling contamination of your clean room that data is in the form of environmental monitoring. However, data collection isn’t enough; using this data to improve using DMAIC is a systematic way for getting your processes under a state of control.

Additional Reading:

The FDA has a systematic way for how they operate and we can learn a lot from each other starting with their thought process in how they inspect and correct sterile compounding operations. (LINK HERE TO ARTICLE ABOUT HOW FDA DOES INSPECTIONS)

FREE Six Sigma Webinar!

“A Compounder’s Guide to Lean Six Sigma Process Improvement”

In this webinar I’ll be talking about what Six Sigma is and using it to make improvements in your pharmacy. A real-life case of using six sigma will be discussed; how it was used to “close out” further investigation by the FDA.

PLEASE SIGN UP HERE (click)

 

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About the author:

Seth DePasquale is a pharmacist and co-owner of BET Pharm, LLC in Lexington, KY; a compounding pharmacy specializing in long-acting injectable hormone formulations for equine reproduction. Seth is a 2002 graduate of Albany College of Pharmacy in Albany, NY and is a Registered Pharmacist in New York, Kentucky, Michigan, Oklahoma, Texas, West Virginia, Virginia, Alabama, Tennessee, Mississippi, Arkansas, Nebraska, Louisiana and Oregon.

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