Survey #2 "DIMS Test" for Checklist of Best Practice for Risk Management in Statistical Quality Control

Does It Make Sense for QC Processes and Reports to implement Best Practice this way?

Question Title

* 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.

First Name

Last Name

Institution, City, Country

Question Title

* 2. What is your primary connection with laboratory quality?

I do not work in a laboratory. I'm a "PIP." Patient, Institutional representative like a CEO or CFO, Physician or just a general member of Society. In risk management, I may approve quality and risk standards and/or pay the price of failure to meet them. (Hint ... everyone is a PIP - unless perhaps you are from another planet!)

I am a Laboratory Director: I am responsible for the quality of lab results produced. I set quality standards, assure staff competency, design and verify effectiveness of QC processes.

I am a Quality or Risk Manager: I interpret QC stats and create procedures to continuously maintain acceptable quality/risk and ensure day-to-day acceptable quality/risk.

I am a Risk Controller: I make real-time front line decisions if patient results are good enough to report and troubleshoot problems. I wear a lab coat and do what needs to be done to follow procedures and work with the tools & time provided.

I am an Educator, member of a Regulatory Agency, or Manufacturer of Analytical Processes or QC Samples. 5. I design, create or implement Integrated, Validated, Software, Education & Competency/Certification Programs.

I am a Risk Master: I support and enable the rest of the team. I research, publish. design, create, validate, teach, or advise the proper understanding and use of the tools and processes that others use to maintain acceptable quality/patient risk.

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* 3. Would you rather have your blood tested

Laboratory A whose QC process is validated to allow no more that 1 medically-unreliable result/year

Lab B that uses a manufacturing/statistical limit of 2 sigma at 1,560 MUR (Medically-Unreliable Results)/Year

Whichever is located closest to you

Other (please specify)

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* 4. What makes the MOST SENSE from a clinical perspective to control and manage PROBABILITY of harm

... for The medical director in collaboration with "The PIPS" and validated software to control and manage PROBABILITY of harm by setting acceptable risk criteria primarily as the number and cost of Medically-Unreliable Results (MURs) per year, and per failure event?

… for assorted individuals within the laboratory with a variety of commercial and home-made software to control and manage PROBABILITY of harm by setting acceptable risk criteria primarily at the statistical norm of 5% allowable error to be considered significant, as published circa 1974

… for assorted individuals within the laboratory with a variety of commercial and home-made software to control and manage PROBABILITY of harm by setting acceptable risk criteria primarily at the lower limits of acceptable quality for manufacturing set at '3 sigma' or '2 sigma' as recommended in 1987?

No Clue

Why is this best?

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* 5. What makes the MOST SENSE from a clinical perspective

... for The medical director in collaboration with "The PIPS" and validated software to control and manage:
SEVERITY of harm by setting limits of medical utility (medical goals) – and the associated cost of failure to meet those goals?

… for assorted individuals within the laboratory with a variety of commercial and home-made software to control and manage:
SEVERITY of harm by setting allowable total error limits at legislated or calculated (biological variation) values , and to NOT consider the associated cost of failure to meet those goals?

No Clue

Why is this best?

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* 6. DIMS … to report risk as the number and cost of patients at risk based on data ONLY from a QC sample that is verified to represent patients?

Definitely Yes

I think so

No Clue

I do not think so

Definitely not

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* 7. DIMS … to report Pass/Fail evaluations for acceptable risk?

Definitely yes

I think so

No Clue

I do not think so

Definitely not

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* 8. DIMS … that method validation experiments and reports prove that the test methodologies selected have the capability of providing the clinical quality of results required for patient care before being put into use, and periodically thereafter?

Definitely yes

I think so

No Clue

I do not think so

Definitely not

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* 9. DIMS … to use the same medical goals and acceptable risk criteria for method validation and ongoing quality control?

Definitely yes

I think so

No Clue

I do not think so

Definitely not

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* 10. DIMS … that "At the least", the ability of the QC procedures to detect medically allowable error should be evaluated every 1-4 weeks by comparing EXISTING # MURs and clinical/legal cost to medical goals and acceptable risk criteria?

Definitely yes

I think so

No Clue

I do not think so

Definitely not

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* 11. DIMS … for the Risk Controllers to use validated software to recommend necessary remedial actions whenever risk levels close to acceptable risk criteria and clearly say "STOP" if methods fail acceptable risk criteria.

Definitely yes

I think so

No Clue

I do not think so

Definitely not

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* 12. DIMS … that Validated software can advise or auto-implement the frequency of QC sample test events increases or decreases when method inaccuracy or imprecision becomes worse or better.

Definitely yes

I think so

No Clue

I do not think so

Definitely not

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* 13. DIMS … that Validated software reports can include confirmation that "The type and number of QC samples tested per test event” is defined in policies with sample validation procedures.

Definitely yes

I think so

No Clue

I do not think so

Definitely not

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* 14. DIMS … that Validated software can either auto-recommend for staff to input to QC software, or can be fully automated with interfaced software, “The statistical QC Limits" (QC Rules) used to evaluate the acceptability of patient risk before reporting results?

Definitely yes

I think so

No Clue

I do not think so

Definitely not

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* 15. DIMS … that Validated Software advises increased frequency of QC chart review when analytical quality decreases, and reduces chart review to minimal in excellent stable methods?

Definitely yes

I think so

No Clue

I do not think so

Definitely not

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* 16. DIMS … that Validated Software can auto-recommend the actions taken when results exceed acceptable limits - and direct staff to the specific faults for accuracy and precision in the affected processs.

Definitely yes

I think so

No Clue

I do not think so

Definitely not