January 2019: Getting Ready for the New Year: Cleaning Up Your Coagulation Lab

by Donna Castellone, MS, MT (ASCP) SH • January 10, 2019

The coagulation community has lost a renowned expert J. Evan Sadler, MD, PhD on December 13, 2018. Dr. Sadler was the director of the division of hematology at Washington University School of Medicine in St. Louis. He made major contributions and discoveries in the study of von Willebrand factor and ADAMTS13 structure and function. He was 67 years old, and he will be missed.

Out with the old and in with the new! This also applies to the coagulation laboratory. While people are out shopping at post-holiday sales, the laboratory has to close out and prepare for the new year. Paper in the laboratory is supposed to be a thing of the past, but the reality is, unless you have a full-time person who can scan documents and back up everything, paper is still a reality. What to keep, what to discard, what to store, what needs to be done to have all your ducks in a row and keep that inspection- ready environment. Rule of thumb, follow the most stringent guidelines that apply to your institution. This includes internal hospital policies, regulatory (CAP, CLIA, JCAHO) as well as any state policies. Records may be stored electronically or off-site as long as they can be retrieved within 24 hours. This chart is an example of record retention times- and I know it is hard to discard things but, space is usually limited in most labs, so clear out what you don't need. If possible, it is best to keep 2 years on site, which just happens to be the inspection window for laboratories. It is easier to provide documents during a tracer audit, and have all the information regarding procedures, quality control, proficiency testing, and competency. Having all this information accessible makes an audit much easier than having to hunt for information. Many laboratories have uploaded all procedures, personal files, proficiency test results and checklists, instrument records and any regulatory documents making retrieval easier and inspections can then occur all from one place- the computer.




Test Request

7 years

Accession records

7 years

Test reports from reference laboratories

7 years

Quality Control Records

2 years (on site)

Preventive maintenance, service and repair records

Life of instrument

Instrument/Method Validation; product recalls for instrument parts

Life of instrument/method plus 2 years after discontinued use

Instrument printouts

2 years

Manual procedures worksheets

2 years

Retired policies, test procedures and procedure manuals

2 years after retirement; must have the dates of initial use and the date it was discontinued

*This is taken from the CAP general checklist and NYS regulations- your institution and state may require more, or less stringent requirements.

Next, make sure that all of your instrument correlations, formula validations, and proficiency testing are completed for the year. That means if your computer calculates things like your ELISA HIT assay for % inhibition, or your DRVV ratios, or hexagonal phospholipid formula is calculated, you have verified that it correlates with a manual calculation. Don't forget to define acceptability criteria.

Also, it is a good time to review your refrigerator inventory for expiration dates. In particular, reagents that you may not use frequently may be expired- and need to be reordered. This may include reptilase, some platelet agonists, and check the back of the shelf as there may be a stray box of expired controls. If you still make some reagents, such as buffers for inhibitor testing, first try to purchase as many reagents as possible to ensure consistency (remember you do need to demonstrate that the results with a new reagent correlate), but check to see if the reagents are within date.

Next, make sure that your iQCP documents in coagulation have undergone an annual quality assessment review. Some examples in the coagulation laboratory would include testing for PFA, platelet aggregation, Verify Now and Reptilase (unless you are able to run 2 levels of controls). There needs to be a purposeful review of these documents that are signed off by the director. Also, quality indicators should be decided for the upcoming year including turn around times for factor assays, review of rejection logs and follow ups, as well as monitoring of platelet function testing and time of draw to completion of testing.

Delegation letters should be updated to note responsibilities given to supervisors, and managers by directors.

One of the most complicated and time-consuming annual activities in the coagulation laboratory is the implementation of new coagulation reagents. Reagents need to be evaluated for factor sensitivity- meaning at what level of factor will your routine tests of the PT and aPTT be prolonged? This is important to understand when screening patients for bleeding. It is also important to establish or to verify your heparin therapeutic range for the reagent. Your reference range should also be verified. Additionally, all analyzers need to be correlated and results must span the reportable range. That is a lot of activity, but it will ensure that you understand how your reagents perform for your patient population.

Make sure that all competencies for staff are up to date. Let's say you have a new employee being trained on von Willebrand testing. You will need to have training documents, then initial competency should be evaluated BEFORE any patient results are reported out- and don't forget to give an unknown (such as a proficiency testing, or just previous patients- with acceptability criteria) as well as problem solving. The easiest way to fulfill that directive is to give a quiz on von Willebrand testing that includes pre-analytical, analytical and post analytical questions. Competency will then need to be repeated at 6 months from the initial competency, then at one year, and annually after that. I am often asked, if you run multiple testing on an analyzer, do all tests need to be competency assessed. I usually competency methodologies, such as a clotting assay, a chromogenic assay and an immunologic assay, unless there are specific algorithms required for testing outcomes, then I will also include that test to ensure all technologists are performing tests correctly.

So, that is a lot of end of year / beginning of the new year housekeeping. I have learned over the years, that the more organized and the more engaged and involved I can keep staff in the laboratory processes, the easier this all falls into place. Thank you for your dedication to patient care and for providing quality coagulation results and continued successes in 2019!