How prepared is your lab for an inspection? As the old saying goes, an ounce of prevention is worth a pound of cure. It takes a fair amount of time to maintain thorough organization of the POLs records, especially if you're preparing in the days just before the inspection is to occur. Having organizational systems already in place when you receive the notice of an approaching inspection will make the process much simpler and less stressful.
The first step in organizing the POL is gathering and maintaining the required documents:
Preparing for an Inspection
- Personnel files – including a job application form, a training checklist, copies of diplomas or certifications, performance evaluations and continuing education for each lab employee.
- Procedure manual – including procedures for every test performed in the office, including the pre-analytical, analytical and post-analytical phases of testing.
- Instrument maintenance logs – including documentation of daily, weekly, monthly, etc. maintenance performed. Instrument manufacturers provide a maintenance schedule and often provide a master form to use.
- Temperature logs – including daily logs of the room temperature and incubator temperature logs if cultures are performed.
- Quality control logs – including documentation of all quality control for all tests performed in the lab.
- PT records – including ordering information, copies of results and evaluations and all other PT related documentation (e.g., corrective actions, correspondence with the PT provider)
- Patient test management – including requisitions and reporting mechanisms.
- Calibration verification logs
- Method verification logs
- Quality assurance plan
How these documents are stored is a matter of the responsible person's preferences. Labs have typically used three-ring binders and dividers for recordkeeping; binders can be easily updated and transported for one room to another. File cabinets with hanging folders work also. Just be sure that the information is easily accessible and keep in mind that a minimum of two years worth of documentation must be available.
The organization of the documents is also a matter of preference. While the personnel files, the procedure manual, proficiency testing records and quality assurance plan tend to be "independent" of each other, some of the logs could be combined. For example, you may decide to maintain one binder for each instrument or lab specialty, such as hematology records in one log with chemistry in another. Then all the pertinent information (QC, instrument maintenance, calibration verification and method verification logs) could be stored by instrument or specialty instead of all QC in one binder, maintenance in another, and so on.
While the inspector will want to do a walk through of the lab, it is not necessary to use this space for the record review. Prepare a quiet space, perhaps an office or area with a table and chair for the inspector to use. Some inspectors use a laptop computer so try to have accommodations for this too. The day before the inspection, place all the lab's documentation in the area you've prepared for the inspector.
Final preparations include:
The organization of the documents is also a matter of preference. While the personnel files, the procedure manual, proficiency testing records and quality assurance plan tend to be "independent" of each other, some of the logs could be combined. For example, you may decide to maintain one binder for each instrument or lab specialty, such as hematology records in one log with chemistry in another. Then all the pertinent information (QC, instrument maintenance, calibration verification and method verification logs) could be stored by instrument or specialty instead of all QC in one binder, maintenance in another, and so on.
While the inspector will want to do a walk through of the lab, it is not necessary to use this space for the record review. Prepare a quiet space, perhaps an office or area with a table and chair for the inspector to use. Some inspectors use a laptop computer so try to have accommodations for this too. The day before the inspection, place all the lab's documentation in the area you've prepared for the inspector.
Final preparations include:
- Make sure that everything that needs to be signed, is signed.
- Make sure all the quality control records are maintained and up to date.
- Double check supplies for expiration dates and proper storage.
- Make sure that all laboratory personnel are capable of answering the inspector's questions and that they are comfortable with having someone observe them performing tests.
- The day before the inspector comes, run through things once again, and then, as you would clean house before a guest arrives, make sure everything in the lab is wiped off and clean.
- Make sure, at the very last minute, that no one on the staff has decided to store their food and drink in the lab.
- Do not argue with the inspector. Politely probe his or her comments so that you understand his or her perspective.
- Seek as much information from the inspector as possible.
- Smile – it should be over in a few hours.
- Begin planning responses to deficiencies if any were mentioned by the inspector.
- Within a day or two of the inspection, consider what, if anything went wrong. Then start planning how to avoid that problem on the next time around.
Tips
- Many POLs have just one lab person in the lab. If this is the case in your lab, someone should serve as a backup and be knowledgeable about the lab policies, procedures and documentation.
- Maintain a "calendar of events" for the POL. Items to be scheduled could include: when the procedure manual should be reviewed, when PT kits are shipped, and when results and evaluations are due, along with when it is time to re-enroll, instrument maintenance schedules, purchasing and service contract schedules, and when to expect the next inspection.
- Consider having regular staff meetings to keep all staff informed about lab-related issues.
Some states and all private accrediting agencies have checklists to help you prepare for an inspection. Check to see if checklists are available.
