Checklist of Best Practice for Risk Management in Statistical Quality Control 2017 Survey

1.Your contact information helps us to understand who is participating in our study and will be kept confidential. We will include your data (anonymously) in the summary which will be discussed at the January 10th webinar.(Required.)

First Name

Last Name

Email

Institution, City, Country

Remember, the question is “DOES your laboratory do this?”, not “SHOULD your laboratory do this?”

4."Incorrect result – result that does not meet the requirements for its intended medical use;
NOTE 1: In the case of quantitative test procedures, a result with a failure of measurement that exceeds a limit based on medical utility." ⁴

5."The allowable total error is equivalent to the error that does not significantly contribute to wrong clinical decisions." ³

6."The Laboratory director must ensure that the test methodologies selected have the capability of providing the quality of results required for patient care.” ²

7."The Laboratory director must ensure the establishment and maintenance of acceptable levels of analytical performance for each test system; (Ref 2c)" ²

8."Risk is the combination of: [A] the probability of occurrence of harm, and [B] the severity of that harm" ¹

9.“Acceptable risk – a state achieved in a measuring system where all known potential events have a degree of likelihood for or a level of severity of an adverse outcome small enough such that, when balanced against all known benefits— perceived or real— patients, physicians, institutions, and society are willing to risk the consequences.” ⁴

Do your QC reports include the number and clinical cost of existing and potential laboratory errors?

10.“Risk evaluation – process of comparing the estimated risk against given risk criteria to determine the acceptability of the risk.” 4

11.“Evaluate the potential costs both in terms of the patient’s well-being and in terms of financial liability of the treating parties vs. known benefits to the patient.” 4

Remember, the question is “DOES your laboratory do this?”, not “SHOULD your laboratory do this?”

12."Control Samples - Quality control sample – A stable sample designed to simulate a patient sample." ⁴

13."The Laboratory director must ensure that verification procedures used are adequate to determine the accuracy, precision, and other pertinent performance characteristics of the method; and Laboratory personnel are performing the test methods as required for accurate and reliable results." ²

14."The Laboratory director must ensure that the quality control and quality assessment programs are established and maintained to assure the quality of laboratory services provided and to identify failures in quality as they occur;" ²

15."The Laboratory director must ensure that all necessary remedial actions are taken and documented whenever significant deviations from the laboratory’s established performance characteristics are identified, and that patient test results are reported only when the system is functioning properly." ²

16."At the least, the ability of the QC procedures to detect medically allowable error should be evaluated." ⁴

Can you look at your QC reports and see the data required to meet this recommendation?

22.Do you endorse this checklist as a fair and reasonable presentation of best practice for statistical QC to manage acceptable patient risk?

23.Is this list missing anything critical for a first review?

24.Would you like to receive reports comparing your results to peers, attend the webinar with Q&A of these surveys, help analyze survey results and discuss conclusions for webinar? Please comment here. I am looking for collaborators. Contact me here or zoe@awesome-numbers.org.

Checklist of Best Practice for Risk Management in Statistical Quality Control 2017

Compare your QC Processes and Reports to Best Practice for Risk-Based Statistical QC.