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Hello- I work for a 300 bed hospital that is transitioning from Hemochron Signature Elites to the GH 100 ACT meter. Does every one that uses this instrument run on a IQCP? and if you do- why do you have one? I looked in archieves and saw a robust conversation in Jan- feb 2025. While looking thru the manual for the GH 100 it states 2 levels of QC must be ran every 8 hours. It also states that EQC can be used to comply with this requirement. Manuafacture requires 2 levels of LQC to be ran every 30 days and with new shipment/new lot. So why would we need an IQCP? Set meter to run EQC (2 levels) every 8hours, Operators run LQC every 30 days with QC lock out, Put in procedure that facility will follow manufactures recommendation, and call it a day. What am I missing? Newer to this role and still learning. image.png
Hi Tara, I'm not sure if you are CAP accredited or not, but I believe the GH100s still need an IQCP due to this CAP standard (see **** section below). My facilities have an IQCP for the GH100s that state we follow those same manufacturer guidelines. We also did a 30 day QC study upon implementing the devices to show QC is stable over 30 days. If you'd like me to share our IQCP, I am happy to do that.
POC.07300 Daily QC - Nonwaived Tests The laboratory must define the number and type of quality control used and the frequency of testing in its quality control procedures. Control testing is not required on days when patient testing is not performed.
Controls must be run prior to resuming patient testing when changes occur that may impact patient results, including after a change of analytically critical reagents, major preventive maintenance, change of a critical instrument component, or with software changes, as appropriate.
Daily quality control must be run as follows: 1. Quantitative tests - two controls at different concentrations at least daily, except for coagulation tests (two controls every eight hours), or unless otherwise required elsewhere in this checklist 2. Qualitative tests - a negative control and a positive control (when applicable) at least daily
Controls should verify assay performance at relevant decision points. The selection of these points may be based on clinical or analytical criteria.
*****If an internal quality control process (eg, electronic/procedural/built-in) is used instead of an external control material to meet daily quality control requirements, the laboratory must have an individualized quality control plan (IQCP) approved by the laboratory director defining the control process, including the frequency and use of external and internal controls. At a minimum, external control materials must be analyzed with new lots and shipments of reagents or more frequently if indicated in the manufacturer's instructions. Please refer to the IQCP section of the All Common Checklist for the eligibility of tests for IQCP and requirements for implementation and ongoing monitoring of an IQCP.
Not only does CAP require an IQCP, but CLIA (Joint Commission) does as well. CLIA states that for a moderately complex analyzer that does not run the minimal CLIA QC requirement (2 levels of external controls once a day) then they must have an IQCP.
For the 30 days of QC to validate your IQCP, did you run it on every meter, just one, or a certain subset? I just received 16 Hemochron GEM 100s. Did you run your external QC daily or every 8 hours that first 30 days?
I ran liquid QC on 1 meter 1x per day for 30 days. I did not do every 8 hours for 30 days. Our facility only brought on 3 meters. We have another facility that just purchased 5 meters and we intend on doing the 30 day QC study only on one device.
Leigh- can you tell me the WHY for you did 2 levels of QC once a day for 30days and NOT 2 levels of QC every 8 hours for 30 days. I'm getting mixed guidance on this aspect of the IQCP.
We just ran the liquids 1x per day due to cost and feasibility. You can also show with the study that EQC is stable every 8 hours over that 30 days too....I guess running liquid QC every 8 hours for 30 days would probably be best...it is just very costly and time consuming to do so for a POC setting?
I think it is up to the medical director, or policy on this particular item. We don't perform all levels all days either. We do both/all liquid levels once a week - day 1, day 7, day 14, day 21, day 28 and day 32. The electronic was documented every day for 32 days.
I'm not sure if you are CAP accredited or not, but I believe the GH100s still need an IQCP due to this CAP standard (see **** section below). My facilities have an IQCP for the GH100s that state we follow those same manufacturer guidelines. We also did a 30 day QC study upon implementing the devices to show QC is stable over 30 days. If you'd like me to share our IQCP, I am happy to do that.
POC.07300 Daily QC - Nonwaived Tests
The laboratory must define the number and type of quality control used and the frequency of testing in its quality control procedures. Control testing is not required on days when patient testing is not performed.
Controls must be run prior to resuming patient testing when changes occur that may impact patient results, including after a change of analytically critical reagents, major preventive maintenance, change of a critical instrument component, or with software changes, as appropriate.
Daily quality control must be run as follows:
1. Quantitative tests - two controls at different concentrations at least daily, except for coagulation tests (two controls every eight hours), or unless otherwise required elsewhere in this checklist
2. Qualitative tests - a negative control and a positive control (when applicable) at least daily
Controls should verify assay performance at relevant decision points. The selection of these points may be based on clinical or analytical criteria.
*****If an internal quality control process (eg, electronic/procedural/built-in) is used instead of an external control material to meet daily quality control requirements, the laboratory must have an individualized quality control plan (IQCP) approved by the laboratory director defining the control process, including the frequency and use of external and internal controls. At a minimum, external control materials must be analyzed with new lots and shipments of reagents or more frequently if indicated in the manufacturer's instructions. Please refer to the IQCP section of the All Common Checklist for the eligibility of tests for IQCP and requirements for implementation and ongoing monitoring of an IQCP.
Hope this helps!
Would you please share your IQCP to my email?
norahabhab@yahoo.com
Appreciate it!
Did you run your external QC daily or every 8 hours that first 30 days?