risk mitigation strategies for poc testing: focusing on post-analytic components of testing sonya i....

Risk Mitigation Strategies for POC Testing:

Focusing on Post-Analytic Components of Testing

Sonya I. Evans, MT(ASCP)

POC Coordinator

Greenville Health System

Greenville, SC

AACC, July 2015

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Objectives:

The participant will learn to:• Identify risks associated with the post-analytic

phase of POC testing.• Review examples of identified risks and steps

taken to mitigate those risks.• Begin to develop an effective IQCP and a

Quality Assurance Plan, including audit tools to effectively monitor the IQCP.

• Evaluate and alter the Quality Control Plan based on audits and QA failures.

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About GHS and My Role

North Greenville Long-Term Acute Care Hospital

Greer Memorial Hospital

Greenville Memorial Hospital

Laurens County Memorial Hospital

Hillcrest Hospital

Oconee Memorial Hospital

Patewood Memorial Hospital and Outpatient Center

Offices/Cancer Centers/ Urgent Cares/OP Services

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GHS Information

• Academic Healthcare Delivery System• Recently opened a Medical School and will soon graduate our

first class of physicians (223 residents)• Approximately 12,770 employees• Licensed beds: 1,358• Neonatal Intensive Care beds: 80• Affiliated Office Practices: 181• Average Inpatient Daily Census: 819• Total Outpatient Visits: 2.9 Million• Total ER Visits (Level 1 Trauma Center): 214,590• Total Air Transports: 668• Total Babies Delivered: 6,527• Total Inpatient and Outpatient Surgical Procedures: 45,928

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GHS POC Program

• 3.0 Full-time positions (located at main campus)• Each location has a bench tech who is the site contact and

“resident expert” for POC testing• POC is inspected by The Joint Commission; a few glucose

meters are also inspected under the main lab’s CAP inspection cycle

• Requests for new POC testing are reviewed and approved through a Multi-disciplinary POC Committee

• All general policies and procedures are pushed out from the main campus and the full-time POC staff to the satellites

• Perform approx. 438,000 waived tests and 130,750 non-waived tests annually (hospital and clinic-based testing only – does not include offices)

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New Regulations from CLIA–

The “Right” QC• IQCP – Individualized Quality Control Plan• Effective January 1, 2016• A risk-based Quality Control plan• Eliminates “equivalent QC”• Required for all non-waived testing where traditional QC (two/three

levels of QC daily) is not performed; required for any non-waived tests that use electronic, procedural or built-in controls

• If you currently perform two/three levels of QC daily, IQCP is a choice, not a requirement, but could allow reduction of QC frequency

• Excludes Anatomic Pathology and Cytopathology(with some exceptions)

• IQCP per location is required (not per test)• Offers a higher level of safety for the patient

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Definitions

• Risk – a failure that could cause harm• Risk Mitigation - taking steps to reduce the likelihood of

adverse effects before they happen• How do I determine risk with a lab test?

– Document steps in a process– Determine which steps in the process are covered by process

controls or built-in instrument controls– For steps NOT covered by some sort of control, risk mitigation

is needed.• Start with steps that show the highest risk• Move to the next lowest risk• Determine how the risk mitigation will be audited to assure continued

patient safety

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IQCP – Elements

• Must cover pre-analytic, analytic and post-analytic phases of testing

• Must meet or exceed both CLIA /CMS regulations, your inspecting agencies regulations, and manufacturer requirements

• Must address Reagents, Environment, Specimen, Test System and Testing Personnel

• Use – your own historical data (QC, temps, Prof. Testing, Cal

Verifications, Incident reports), – manufacturer’s manuals and package inserts, – testing site specifics, and – medical requirements and decision points for the test

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The ProcessI need to check my patient’s potassium level.

I see my patient’s Potassium was 4.0 mg/dL.

Pre-analytic

AnalyticPost-Analytic

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Focus on Post-Analytic Phase of POC Testing

• Risk Points for Result reporting• Interfaced or manual?• Report forms (including downtime forms)• Delivery of results (critical values with read back and

documentation)• Delay in reporting

– Interface failures– Poor / implausible / no results– Questionable results

• Clear reporting– Units of measure– Reference Range available– Interpretative comments

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Risk Mitigation – Result Reporting Failures

• For Manual Entry – must have a 2nd review within 24 hours by another operator

• For Interfaced Results –– Initial validation of all results from order codes to

results in all systems– Periodic audits of interfaced results (review a

subset of results monthly)– For interface failures, an automated e-mail is sent

from Middleware when a certain threshold of “pending” results is reached; POC and Information Services both get these alerts

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Focus on Post-Analytic Phase

of POC Testing• Sample/Result Validity - training

– Results not plausible (ex. Potassium > 9.0 mmol/L); train staff to suspect hemolysis

– Extremely low values; train staff to suspect contamination from IV fluids (especially with line draw specimens) (ex. ACT >1000 seconds)

– Result not in line with recent values (Delta checks, chart reviews)

– All results different than most recent collection (Suspect misidentification)

– Other info the caregiver may need? (ex. Whole blood K versus plasma K, Hct measured or calculated?)

– Units of measure correct? (Ex. Ionized calcium reported in mg/dL or mmol/L?)

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Focus on Post-Analytic Phase of POC Testing

Case Study #1• Issue – inconsistent reporting and interpretation

of vaginal pH testing• Color Result card from manufacturer showed

actual value while some staff were interpreting and reporting as positive/negative

• Risk Mitigation – redesign of report form; training

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Risk Mitigation – Redesign of Report Form

Original Color Card from Manufacturer only provided colors and pH values

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Risk Mitigation – Redesign of Report form

BEFORE

AFTER

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Focus on Post-Analytic Phase

of POC TestingCase Study #2 – NICU ABG Testing• Process mapping allowed for decrease of

testing steps as well as assessment of risk points

Previous Process Map New Process Map

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Risk Mitigation – Result Reporting Failures

• Issue - Changing the process for critical values removed the lab system’s automatic trigger for ordering of a phone test; critical values were not being recognized or documented consistently.

• Manual audit revealed poor compliance with documentation in the Resp. Therapy section of the chart

• Indepth review revealed that we were asking RT to assess criticals for new lab tests (ex. K, Na, Glucose, etc.) they were unfamiliar with

• Risk Mitigation – use instrument controls and visual aid; re-educate staff; monthly audits

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Risk Mitigation – Result Reporting Failures

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Risk Mitigation – Result Reporting Failures

• Use Middleware

Reports to determine

if delay is due to

Analytic errors• Re-educate individual

Staff members• Review/revise training

Material to be sure that

Behavior and error is

addressed

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Monitoring the Post-Analytic Phase of POC Testing

• Audits– Crystal reports– Access database for sorting/analysis (vendor?)

• Use a standardized review process• Track and trend data using a set target value• Communicate and take action on all deficiencies

found• For IQCPs, reassess your Plan to determine if

additional risk mitigation steps are needed.

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Monitoring the Post-Analytic Phase of POC Testing

Example of a Standardized Review

Form

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Monitoring the Post-Analytic Phase of POC Testing

Example of Tracking/Trending of Review Data

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Conclusion for Risk Mitigation

• IQCP and risk determination/mitigation includes much of what we already do to assure quality, but takes it to the next level, in the interest of patient safety

• Gather information FIRST to start your IQCP• Understand the limitations of your

instrument/test per manufacturer’s instructions• Include all players to assess risk

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Conclusion for Risk Mitigation (continued)

• Document your risk mitigation actions (ex. Policy, procedure, training/education, electronic controls, etc.)

• Complete the IQCP with a cover sheet for that CLIA’s Lab Director to sign off (initially, at any change and annually)

• Make changes as issues are noted –repeat IQCP steps

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Let’s get started ---Are you ready?

Oh, no! Was that TODAY?

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Thank you!

Sonya Evans, MT (ASCP)POC CoordinatorGreenville Health System701 Grove Rd.Greenville, SC 29605

sevans@ghs.org864-455-4494

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