Paperless inspections no longer a dream

INTRODUCTION

In the US, all laboratories must be accredited every two years. Usually, preparations for an inspection require complete instrument calibration, QC, and maintenance files dating back from the previous accreditation. Files may need to be copied, and the result is often carts full of paper - and many hours of valuable staff time used in the process.

For some labs, though, the paper hassle associated with accreditation is now history. Audrey Angelella (Respiratory Care Manager at the Community Medical Center in Scranton, Pennsylvania), Timothy Ruffin (Assistant Director of the University of Iowa's Department of Respiratory Care), and Susan Holcomb (Respiratory Supervisor at the Belleville Memorial Hospital in Belleville, Illinois) are living proof that paperless inspections are no longer a dream.

Instead of accumulating piles of paper reports, they are letting their data management systems do all the work. The result? During the past three years, all three hospitals have been accredited through a paperless inspection.

What is a paperless inspection?

A paperless inspection means using your data management system to file all inspection relevant data electronically.

The inspection process is still the same. The inspector begins by checking CAP (College of American Pathologists) surveys. Random test results are then pulled out, and lab personnel must prove that calibrations before and after the test were ok, and that quality control and maintenance on the analyzer were properly performed. If problems arose, the lab must be able to document how the problem was solved.

Furthermore, there must be documentation that the lab follows its own standard operating procedures while meeting all legal testing requirements.

Previously all this information had to be printed out and filed in binders. Nowadays all information can be filed electronically and available on the computer screen within seconds.

Timesaving for staff and inspectors

As Susan Holcomb, Respiratory Supervisor at the Belleville Memorial Hospital in Belleville, Illinois puts it: "Before going paperless, every month somebody in our staff had to print out all the monthly reports. Printing out all those reports and organizing them in folders was extremely time consuming. Now all the information is already there and ready to be used."

Paperless inspection not only saves staff time used in preparing for an inspection; it saves the time of inspectors as well. "I consider it a benefit that we don't have to download all this paper and have five, three-inch binders for inspectors to look through," admits Audrey Angelella, Respiratory Care Manager at the Community Medical Center in Scranton, PA.

"It's much more convenient for them to go into the computer and look for a specific piece of information. It's just so much faster. All it takes is a few mouse clicks."

Decrease in documentation errors

Filing data electronically also reduces documentation failure. Once information has been recorded in the data management system, there is never any question about it being altered or a signature missing.

Because the data management system requires a user name and password from each person in order to proceed with an operation, operators and procedures can be tracked in the smallest detail (e.g. who has changed the reagent on a particular day!).

"Inspectors can pick a date within the previous two years and say: Show me the QC errors, show me the equipment malfunctioning that you dealt with, and how you dealt with it, and how you communicated that," says Timothy Ruffin, Assistant Director of the University of Iowa's Department of Respiratory Care.

"I go to my computer and all steps have been recorded." According to him, documentation failures have decreased tenfold since his unit began filing data electronically.

Positive reaction from inspectors

The inspectors who have surveyed the three labs were all very positive about electronic data filing. One inspector was so impressed by what he saw that he actually took notes to bring back to his own lab. According to Audrey Angelella, Susan Holcomb, and Timothy Ruffin, a problem could arise if a lab came across an inspector who insisted on paper documentation.

In that case, all three recommend labs to print out examples of files in order to convince the inspector that the rest of the documentation is in place.

Benefits outweigh the costs

Not everything can be made paperless. CAP surveys are still on paper, and it may be a good idea to print out some files should an inspector insist on some form of paper documentation. But the point is, that the vast majority of data can be filed electronically - basically at no extra cost.

All three hospitals have stored information in the data management systems they already had. Some adaptations were made, but according to the three healthcare professionals, vendors were more than willing to work with hospitals in order to accommodate their needs.

Staff training had to be arranged, but as Timothy Ruffin explains: "Going paperless basically requires that the same individual who was previously responsible for the paper logs to now verify that all the daily, weekly, monthly entries are being made and that all necessary information is in place.

Before, I was responsible for our paper logs. Now I utilize less time to verify that our electronic files are kept current on our data management system than I did when they were paper-only."

All three professionals recommend other labs to store their inspection relevant data electronically. The benefits speak for themselves. Saving files electronically is easier and faster than printing out and filing two-years' worth of files. Not to mention that physical space that is freed up once binders no longer are necessary.

Electronic filing is also timesaving for both laboratory staff and inspectors. As Audrey Angelella so wisely puts is: "It is silly to have all that paper when you have a data management system to keep all the data in." According to Tim, "having electronic filing has played a key role in reducing documentation errors."

Preparing for your first paperless inspection

Going paperless implies of course that you have to (1) have a data management system and (2) which can store the information you need. Therefore, you may want to talk to your vendor about what your options are.

Provided that your data management system is up and running and storing the information you need, the next step is preparing for a paperless inspection. First, make sure that all records are in place and can indeed be easily retrieved by whoever is responsible for presenting them during an inspection.

That requires checking up on all entries, as well as having familiarity with the system. Ideally your lab should always be ready for an inspection.

Anticipating inspection questions is also a good way to prepare for an accreditation survey. "What I do is compile the questions I believe the surveyor will ask. Those include very simple questions, but also very tough ones. Then, we have our pathology department do a mock survey.

We are a respiratory care unit, a "special function" lab, so we work with the pathology department, which is CAP surveyed, to come up and grill us, " says Timothy Ruffin with a smile. "If we can pass their muster, then we feel pretty safe that we can pass the surveyor's questions."

Interviewees

Audrey Angelella, Respiratory Care Manager
Community Medical Center
Scranton, Pennsylvania
USA

Timothy Ruffin, Assistant Director
University of Iowa's Department of Respiratory Care
Iowa City, Iowa
USA

Susan Holcomb, Respiratory Supervisor 
Belleville Memorial Hospital
Belleville, Illinois
USA

Interviewer

Pia Lorenzen
Radiometer Medical A/S
Åkandevej 21
DK-2700 Brønshøj
Denmark