Editor's Note: These are attendee-submitted questions from our popular webinar, Make POCT Work for You. Not all questions could be answered during the live event, but Bob Kaplanis, PBT, MT(ASCP), System Technical Specialist - POCT and AACC POCT Coordinator of the Year 2010, has continued to provide follow up. Read Part 1 of his Q&A here, and listen to a webcast about competency-related questions here.
Q: For sites with their own CLIA license, do they need to monitor and check all QC for all their POCT, or does that responsibility fall upon the laboratory?
A: We have several sites that have their own CLIA license, most are clinics or outpatient areas. For these sites we train the designee for the area on the requirements and allow them to do their own monitoring. Depending on the area, the POCT Coordinator at the facility may review QC and other aspects. Most of these locations have instruments that are interfaced and download to a computer in the POCT office. The POCT Coordinator prints out the monthly reports and sends them to the area with any comments for them to follow up on. The POCT personnel serve as a consultant in these circumstances.
Q: Equivalent QC (EQC)- CLIA Brochure #4 states for Option 1-"Test two levels of External Controls for 10 consecutive testing days." I do not see where we are instructed to test every 8 hours for 10 days for coagulation tests. Yes, internal QC must be performed every 8 hours. Where did the External validation every 8 hours come from?
A: This question leads me to believe my statements may not have been clear on this point. EQC is a protocol that can be followed to decrease the amount of external liquid material that must be performed every month for non-waived test systems and is different than external liquid QC. According to CAP regulation POC .07300 - QC for coagulation testing must be performed every 8 hours of testing. This can be an internal control in some cases. This same regulation states that the daily external controls must be compared to the built-in controls in order to limit daily QC. When we perform our EQC study for i-STAT we print the internal control that is programmed to be performed every 8 hours of testing. This is just another piece that can be easily generated to show the instrument is working. See more on this subject in the answer to the next question.
Q: There have been changes to the EQC requirements on the CAP checklist. Would you address those changes?
A: Note 2 for POC .07300 defines the validation study requirements for CAP. CLIA Brochure #4 for Option 1 states external controls must be performed for 10 consecutive days and compared to the internal controls. This brochure also defines the criteria for acceptability. The CAP regulation states that this validation must be for 20 consecutive days and takes effect as of 1/1/2012. When multiple identical devices are used, this validation applies to one device. The other similar devices will need to have the laboratory director approve what is acceptable testing to validate the other similar devices. I think this is a good process and documents the acceptability of performing a reduced amount of external QC per month for those test system that are eligible.
Q: Could you explain the best solution for QC with a very tight range? When are operators required to repeat the level of control other than when it is out of range?
A: Operators are required to repeat QC or perform troubleshooting steps to get QC within range when it fails. I would ask why you have a tight QC range. For example there should be some QC values every month that are just out of range. In determining your acceptable QC range, if you continually delete all points that are just outside the acceptable range, adjust the ranges so only points within the range are used, then the range will continue to tighten up until it becomes more difficult to get QC in.
Q: Are your occult blood patient results interfaced and if so, are the QC results included?
A: We have several ways that occult blood can be reported. Some of them are electronic. Those ask if the performance monitor was acceptable before the patient result can be reported. Those that are manually reported are more of a challenge to have the performance monitor result recorded. Because this is a waived test external QC is only required with new shipments or lot numbers. The POCT Coordinator arranges for the QC to be completed upon delivery of a new shipment so QC does not have to be recorded by nursing.
Q: New CAP regs require that every type of cartridge used in an area must be QC'd every month on each i-STAT instrument. How are you addressing this?
A: This became a requirement with the June 2010 CAP regulations. I tried to get a different interpretation than you describe from CAP and CMS, but to no avail. From communications I received from CAP it is required to perform two levels of external QC every month on every instrument for each different sensor type that can be used on that particular instrument. Some of our facilities have 40 or more i-STATs and this is very difficult. Most facilities with this many instruments will not have adequate POCT personnel to perform the QC. Many of our sites have decided to train the "super users" in the area that instrument is located to perform the external QC. A worksheet is setup to track which week each instrument's QC is due and POCT software documents when it was performed. I hope this will be looked at and change in the future.