iSTAT Validation and CAP COM.40300
6 followers
0 Likes
Hello everyone,
Wondering what you are doing for iSTAT validation to ensure you are meeting the CAP standard COM.40300? I am just asking for input as we are finding it to be VERY expensive and time consuming to do this process and wondering what others are doing.
CAP verbiage from Test Method Validation and Verification – Nonwaived Tests section/Definition portion:
Laboratories are required to perform analytical validation or verification of each nonwaived test, method, or instrument system before use in patient testing, regardless of when it was first introduced by the laboratory, including instruments of the same make and model and temporary replacement (loaner) instruments. There is no exception for analytical validation or verification of tests introduced prior to a specific date. The laboratory must have data for the validation or verification of the applicable method performance specifications and retain the records as long as the method is in use and for at least two years after discontinuation.
COM.40300:
**REVISED** 06/04/2020
COM.40300 | Verification of Test Performance Specifications - FDA-cleared/approved Tests | Phase II
| Prior to clinical use of each unmodified FDA-cleared or approved test, the laboratory has performed a verification study and prepared a written assessment of each of the following test method performance specifications, as applicable, using a sufficient number of characterized samples: Analytical accuracy Analytical precision Reportable range NOTE 1: Accuracy is verified by comparing results to a definitive or reference method, or an established comparative method. Use of matrix-appropriate reference materials, patient specimens (altered or unaltered), or other commutable materials with known concentrations or activities may be used to verify accuracy. The use of routine quality control materials or calibrators used to calibrate the method is not appropriate. NOTE 2: Precision is verified by repeat measurement of samples at varying concentrations/activities within run and between run over a period of time. NOTE 3: The reportable range of an assay is the range of values that the laboratory reports for that assay. NOTE 4: If multiple identical instruments or devices are in use, there must be records (data and written assessment) showing that the method performance specifications have been separately verified for each test and instrument or device. NOTE 5: If a method is verified by someone other than the laboratory's personnel (eg, manufacturer's representative), the laboratory must have records to show that the verification correlates with its in-house test performance by showing confirmation of performance specifications by the laboratory personnel testing known specimens. NOTE 6: The requirement for a written assessment applies to all tests implemented after June 15, 2009; however, all nonwaived tests must have records of completed analytical verification, regardless of the implementation date. The written assessment must include an evaluation of each component of the verification study, including the acceptability of the data. If data include discordant results, there must be a record of the discordance and investigation of any impact on the approval of the test for clinical use. Evidence of Compliance: Written procedure for verifying test method performance specifications AND Records of verification and written assessment of each component of the test method performance specifications for each test REFERENCES 1) | Department of Health and Human Services, Centers for Medicare and Medicaid Services. Clinical laboratory improvement amendments of 1988; final rule. Fed Register. 2003(Jan 24) [42CFR493.1253]
2) | Clinical and Laboratory Standards Institute. Preliminary Evaluation of Quantitative Clinical Laboratory Methods; Approved Guideline. 3rd ed. CLSI document EP10-A3-AMD. Clinical and Laboratory Standards Institute, Wayne, PA; 2014.
3) | Clinical and Laboratory Standards Institute. A Framework for Using CLSI documents to Evaluate Clinical Laboratory Measurement Procedures. 2nd ed. CLSI report EP19-ED2. Clinical and Laboratory Standards Institute, Wayne, PA; 2015.
4) | Clinical and Laboratory Standards Institute. Evaluation of Precision of Quantitative Measurement Procedures; Approved Guideline. 3rd ed. CLSI document EP05-A3. Clinical and Laboratory Standards Institute, Wayne, PA; 2014.
5) | Clinical and Laboratory Standards Institute. Evaluation of the Commutability of Processed Samples; Approved Guideline. 3rd ed. CLSI document EP14-A3. Clinical and Laboratory Standards Institute, Wayne, PA; 2014.
| Prior to clinical use of each unmodified FDA-cleared or approved test, the laboratory has performed a verification study and prepared a written assessment of each of the following test method performance specifications, as applicable, using a sufficient number of characterized samples: Analytical accuracy Analytical precision Reportable range NOTE 1: Accuracy is verified by comparing results to a definitive or reference method, or an established comparative method. Use of matrix-appropriate reference materials, patient specimens (altered or unaltered), or other commutable materials with known concentrations or activities may be used to verify accuracy. The use of routine quality control materials or calibrators used to calibrate the method is not appropriate. NOTE 2: Precision is verified by repeat measurement of samples at varying concentrations/activities within run and between run over a period of time. NOTE 3: The reportable range of an assay is the range of values that the laboratory reports for that assay. NOTE 4: If multiple identical instruments or devices are in use, there must be records (data and written assessment) showing that the method performance specifications have been separately verified for each test and instrument or device. NOTE 5: If a method is verified by someone other than the laboratory's personnel (eg, manufacturer's representative), the laboratory must have records to show that the verification correlates with its in-house test performance by showing confirmation of performance specifications by the laboratory personnel testing known specimens. NOTE 6: The requirement for a written assessment applies to all tests implemented after June 15, 2009; however, all nonwaived tests must have records of completed analytical verification, regardless of the implementation date. The written assessment must include an evaluation of each component of the verification study, including the acceptability of the data. If data include discordant results, there must be a record of the discordance and investigation of any impact on the approval of the test for clinical use. Evidence of Compliance: Written procedure for verifying test method performance specifications AND Records of verification and written assessment of each component of the test method performance specifications for each test REFERENCES 1) | Department of Health and Human Services, Centers for Medicare and Medicaid Services. Clinical laboratory improvement amendments of 1988; final rule. Fed Register. 2003(Jan 24) [42CFR493.1253]
2) | Clinical and Laboratory Standards Institute. Preliminary Evaluation of Quantitative Clinical Laboratory Methods; Approved Guideline. 3rd ed. CLSI document EP10-A3-AMD. Clinical and Laboratory Standards Institute, Wayne, PA; 2014.
3) | Clinical and Laboratory Standards Institute. A Framework for Using CLSI documents to Evaluate Clinical Laboratory Measurement Procedures. 2nd ed. CLSI report EP19-ED2. Clinical and Laboratory Standards Institute, Wayne, PA; 2015.
4) | Clinical and Laboratory Standards Institute. Evaluation of Precision of Quantitative Measurement Procedures; Approved Guideline. 3rd ed. CLSI document EP05-A3. Clinical and Laboratory Standards Institute, Wayne, PA; 2014.
5) | Clinical and Laboratory Standards Institute. Evaluation of the Commutability of Processed Samples; Approved Guideline. 3rd ed. CLSI document EP14-A3. Clinical and Laboratory Standards Institute, Wayne, PA; 2014.
Thanks for your time!
Traci Schumann
Mayo Clinic - Rochster, MN
Mayo Clinic - Rochster, MN
1 Reply
Reply
Subgroup Membership is required to post Replies
Join POCT Listserv now
Suggested Posts
| Topic | Replies | Likes | Views | Participants | Last Reply |
|---|---|---|---|---|---|
| Piccolo express | 3 | 0 | 262 | ||
| Quantra | 5 | 0 | 339 | ||
| PPM Procedures/Resources | 5 | 0 | 256 |
1: Accuracy.
2: Precision. We use QC but a different lot of QC. (min of 10 over 2 days)
3: Reportable range study if new a sensor.
4: Method comparison if a new location/not replacing a broken ISTAT.
5::Linearity.
I did recently send this to CAP because Abbott had run a minimum of 20 times each level over 2 days
Good Morning Sylvia,
Manufacturer instructions must be followed. Failure to do so would change the test complexity to a FDA modified instrument, which would affect the validation/verification study requirements.
I hope this helps.
Sincerely,
Manager Inspection Services