Embed Size (px)
Citation preview
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
2
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.
3
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
4
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
5
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)
6
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
7
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
8
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
9
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
10
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
11
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
12
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?)
13
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
14
Risk Mitigation – Redesign of Report Form
Original Color Card from Manufacturer only provided colors and pH values
15
Risk Mitigation – Redesign of Report form
BEFORE
AFTER
16
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
17
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
18
Risk Mitigation – Result Reporting Failures
19
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
20
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.
21
Monitoring the Post-Analytic Phase of POC Testing
Example of a Standardized Review
Form
22
Monitoring the Post-Analytic Phase of POC Testing
Example of Tracking/Trending of Review Data
23
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
24
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
25
Let’s get started ---Are you ready?
Oh, no! Was that TODAY?
26
Thank you!
Sonya Evans, MT (ASCP)POC CoordinatorGreenville Health System701 Grove Rd.Greenville, SC 29605
27
