Purpose

Meeting Reports

June 28, 2000

September 27, 2000

December 13, 2000

March 28, 2001

June 27, 2001

September 26, 2001

December 12, 2001

When:   Wednesday, June 28, 2000
Where:  Hershey Medical Center, Hershey, PA

The June 28th, 2000 KEYPOCC meeting was held at Hershey Medical Center and was hosted by Dawn Earnest and Jennifer Barkman of Pinnacle Health. The guest speaker was Rodney Stewart MT (ASCP) from the College of American Pathologists. Lunch was provided by Abbott and a brief presentation was given by Leslie Pratt, Account Representative for Abbott.

The morning began with a fun ice breaker game organized by Jennifer Barkman designed to have everyone meet new people and to get to know previous acquaintances a little bit better.

The meeting then progressed to the topic of the day - CAP regulations presented by Rodney Stewart, Inspection Specialist. Rodney began with an overview of what constitutes point of care testing and proceeded into what we need to expect when preparing for an inspection. There were quit a few topics that generated numerous questions from the members of KEYPOCC. Listed are these "hot topics."

1) Differentiating between linearity and calibration verification. Although these terms are often used interchangeably, they are two different subjects. Calibration verification is used to verify the reportable range. You are taking specimens with known values, running the specimens and determining if the results are within the allowable limits set by the manufacturer of the specimens. You must be sure to have a min, mid, and max specimen. When doing a linearity study you can take any elevated specimen and make dilutions of that specimen. You then run the specimen and the dilutions and determine if there is a linear relationship. This is not the same as calibration verification since the analyte concentration is unknown. Many of the kits that we use for calibration verification or also linearity kits. Calibration verification is required every 6 months on all instruments.

2) To the delight of many in the room, CAP is dropping weekly review of QC!!!

3) Electronic Simulators (EQC) can be used in lieu of liquid controls for waived or moderately complex analyzers. The frequency of liquid controls must, at a minimum, meet the manufacturer's requirements. Coordinators should use caution with these guidelines because the State has different requirements.

4) The following is a list of what we should look for when conducting an inspection at another institution:

1) Patient results are not reported if QC is out
2) QC is performed by the same individuals who perform the testing
3) All reagents are appropriately labeled.
4) Patient results are reported with reference or interpretive ranges
5) Maintenance checks and function checks are performed and documented.
6) Corrective action is implemented and recorded
7) Proficiency testing is rotated among all testing personnel
8) Supervisory review of QC and maintenance records
9) If supervisor is not on-site, review of patient results within 24 hrs of reporting.
10) Individuals performing the testing are identified on the report
11) Ongoing training and competency program.

5) Frequently seen Deficiencies were as follows:

1) When applicable, are all patient results reported with accompanying reference or interpretive ranges?
2) Are all reagents properly labeled?
3) In there a document defining the design and periodic evaluation of the QC and QI program for POCT, and are corrective improvements implemented? - A good QA indicator is to monitor reagent labeling.
4) Has the laboratory established criteria for the acceptability of new lots of reagents to ensure that patient reference range and QC ranges are similar to those from the previous lot and are parallel reagent checks performed and documented? Example: QC an old lot of reagents to a new lot. It is not a good idea to change QC lots at the same time the reagent lot is changed.

5) In the absence of on-site supervisors, are the results of tests performed by personnel reviewed by the laboratory director, general supervisor, or the person in charge of the POCT section on the next routine working shift? ( RN's qualify as general supervisors).

6) Are multiple instruments that perform the same assay checked at least twice a year for calibration agreement and correlation of patient results?

1) If you utilize in-house proficiency testing, this must be reviewed by the medical director of your laboratory.

If you have any questions regarding CAP requirements, you can call the CAP Technical Support Line at 1-800-323-4040 ext. 6065. Our speaker Rodney Stewart can be reached at ext. 7192. You can also email your questions to CAP at accred@cap.org.

Following Rodney's presentation we had a delicious lunch provided by Abbott. After lunch Leslie Pratt from Abbott gave a brief presentation on the i-STAT. Abbott has broadened the test cartridge menu of the i-STAT to include ACT levels. Future plans for the i-STAT include PT and PTT levels. Please contact your Abbott rep for additional information or contact Leslie at 1-800-243-1202 mailbox 535-7315.

After Leslie's presentation Rodney entertained more questions regarding the CAP checklist. Following the brief question and answer session Peter Garown announced that the "demerger" of Hershey and Geisinger would take place on June 30th, 2000. So stated, it was announced that our next meeting will be at Hershey Medical Center on September 27th. The guest speaker will be Marianne Porter who will give a presentation on the POC regulations for the state of PA. Vendor participation will be from HemoCue who is also trying to find a speaker for us. Additional meeting topics are always welcome and can be posted at KEYPOCC's website.

The consensus from those at the meeting was that everyone felt that the meeting went very well and was very informative. All are looking forward to the next meeting!!!

Respectfully submitted
Wendy Van Dyke