Control Plan (IQCP): Laboratory Risk Management in … · •Define risk management and its...

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James H. Nichols, Ph.D., DABCC, FACB

Vanderbilt University School of Medicine

Nashville, TN

7013 - How to Develop an Individualized Quality

Control Plan (IQCP): Laboratory Risk

Management in Action James H. Nichols, Ph.D., DABCC, FACB

Professor of Pathology, Microbiology, and Immunology

Vanderbilt School of Medicine

[email protected]

Speaker Disclosure

In the past 12 months, I have had a significant

financial interest or other relationship with the

manufacturer(s) of the following product(s) or

provider(s) of the following service(s) that will

be discussed in my presentation.

CLSI : Chairholder of the EP23 Document Development Committee

Member of the Board of Directors

Member of the Evaluation Protocols Consensus Committee

CLSI is a non-profit professional standards development organization

www.ascp.org/ascp2014

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Objectives

• Define risk management and its application to clinical laboratory testing

• Understand common sources of error in the laboratory and mechanisms to reduce risk.

• Use the CLSI EP23 document as a resource for developing a quality control plan

mailto:[email protected]

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History

• CLSI EP23 introduces industrial and ISO risk management principles to the clinical laboratory

• CMS adopted key risk management concepts to develop the IQCP option for quality control

• IQCP allows laboratories to develop a plan that optimizes the use of engineered, internal control processes on a device and the performance of external liquid QC

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Why Should Labs Care About EP23?

• New generation of laboratory devices contain a variety of internal control processes.

• Labs are challenged with deciding appropriate liquid QC interval given internal QC on devices.

New CMS QC Recommendations

• Two levels of liquid QC for each day of testing OR

• Laboratory develops an IQCP:

• Balance instrument control processes with liquid QC • Reduce frequency of liquid QC to minimum recommended

by manufacturer • Maximize clinical outcome, available staff resources and cost

effectiveness in the lab

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Definitions • Risk management is a way for labs to develop an individualized

QC plan for their tests.

• A “Quality Control Plan” –from CLSI EP23 – a document that describes the practices, resources, and sequences of specified activities to control the quality of a particular measuring system or test process to ensure requirements for its intended purpose are met.

• An “Individualized Quality Control Plan (IQCP)” – from CMS CLIA Interpretive Guidelines – a new quality control option based on risk management for CLIA laboratories performing non-waived testing.

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Risk Management Definition

• Systematic application of management policies, procedures, and practices to the tasks of analyzing, evaluating, controlling, and monitoring risk (ISO 14971)

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Risk Definition

• Risk – the chance of suffering or encountering harm or loss (Webster’s Dictionary and Thesaurus, 1993 Landoll, Ashland, Ohio)

• Risk can be estimated through a combination of the probability of occurrence of harm and the severity of that harm (ISO/IEC Guide 51)

• Risk essentially is the potential for an error to occur

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What could go wrong?

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Quality

• There is no “perfect” device, otherwise we would all be using it!

• Any device can and will fail under the right conditions

• Any discussion of risk must start with what can go wrong with a test (errors)

• Lab tests are not fool-proof!

What Could Go Wrong?

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Sources of Laboratory Error • Test System:

– Reagent contamination, deterioration, lot variation

– Reaction fluctuations

– Inadequate sampling

– Improper or loss of calibration

– Electronic or mechanical failure

– Power supply

• Environmental: – Temperature and airflow

– Humidity

– Light intensity

– Altitude

• Operator: – Improper specimen prep, handling

– Incorrect test interpretation

– Failure to follow test system instructions

CLIA Interpretive Guidelines for Laboratories.

Appendix C, Subpart K. §493.1256 Standard:

Control Procedures. Interpretive Guidelines

§493.1256(a) – (c).

http://www.cms.gov/Regulations-and-

Guidance/Legislation/CLIA/Interpretive_Guidelines

_for_Laboratories.html

Managing Risk with a Control Process

• Once we identify the risks, we need to detect and prevent those errors from harming the patient.

• Control processes reduce risk by enhancing detection of errors or limiting harm if errors go undetected.

• Control processes can take many forms from liquid quality control to engineered checks within a device

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Types of Quality Control • “On-Board” or Analyzer QC – built in device controls or system

checks (IL GEM, Radiometer ABL80, i-stat)

• Internal QC – laboratory analyzed surrogate sample controls. (Manufacturer controls performed on kit)

• External QC – blind proficiency survey, samples sent a few times a year to grade an individual laboratory’s performance against other labs (CAP or Wisconsin State)

• Other types of QC – Control processes either engineered by manufacturer or enacted by laboratory to ensure result reliability (reagent barcoding to prevent use of expired reagent)

http://www.cms.gov/Regulations-and-Guidance/Legislation/CLIA/Interpretive_Guidelines_for_Laboratories.html






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Quality Control

• Advantages

– QC monitors the end product (result) of the entire test system.

– QC has target values: if assay recovers the target, then everything is assumed stable (ie, instrument, reagent, operator, sample).

• Disadvantages

– When a problem is detected, one must go back and reanalyze patients since the last “good” QC.

– If results are released, then results may need to be corrected.

• Need to get to fully automated analyzers that eliminate errors up front

– Until that time, need a robust QC plan (QCP)

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Quality Control

• No single quality control procedure can cover all devices, since devices may differ in design, technology, function, and intended use.

• QC practices developed over the years have provided labs with some degree of assurance that results are valid.

• Newer devices have built-in electronic controls, and “on-board” chemical and biological controls.

• Quality control information from the manufacturer increases the user’s understanding of device overall quality assurance requirements so that informed decisions can be made regarding suitable control procedures. ISO 15198:2004 Clinical laboratory medicine: In vitro

diagnostic medical devices – Validation of user quality

control procedures by the manufacturer.

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CLSI Project: EP23

• Laboratory Quality Control Based on Risk Management.

• James H. Nichols, Ph.D., Chairholder

• EP23 describes good laboratory practice for developing a quality control plan based on manufacturer’s information, applicable regulatory and accreditation requirements, and the individual healthcare and laboratory setting

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EP23 Laboratory QC Based on Risk Management

Medical

Requirements for

Test Results

Test System Information:

Provided by the manufacturer

Obtained by the Laboratory

Information about

Health Care and

Test-Site Setting

Input Information

Process Risk Assessment

Output Laboratory Director’s QC Plan

Post Implementation Monitoring

Continuous

Improvement

Regulatory and

Accreditation

Requirements

CLSI EP23 Table

Developing a Quality Control Plan

• Where to start?

• How does a laboratory develop a Quality Control Plan?

• Collect information and map process

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Step 1: Collect Information • Collect information about the test and limitations

– Package insert, owner’s manual, instructions for use

– Peer literature, advice from colleagues using test

• Clinical use of the test to define error tolerance

– Why test was ordered

– How result will be used in managing patient

– Allowable performance – accuracy and precision

• Environment

– Where test will be run and who will do testing

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Blood Gas and Electrolytes

• Generic unit-use blood gas/lytes analyzer in a same-day surgical center

• Low volume: 0 - 5 tests/day

• Need for daily liquid QC uses two kits ($10 each) and adds to turnaround time (TAT).

• Adoption of nontraditional QC through EP23 would improve cost, test, and labor efficiency.

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• Portable clinical analyzer for in vitro quantification of various analytes in whole blood

• Analyzers and cartridges should be used by healthcare professionals trained to use the system according to the facility’s policies and procedures.

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• System consists of: – Portable clinical analyzer – Test cartridges sealed in foil

pouch for protection during storage

– Quality assurance materials • Control solutions • Calibration verification set

– Data Management System • Server class computer • Data management software • Wireless connectivity and

LIS/HIS interfaces

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Device

Device

Device

Device


• Unit use cartridge contains all components to perform the testing – Calibrating solution

– Reagents

– Sample handling system

– Sensors

• Analyzer automatically controls all steps of the testing process: – Fluid movement

– Calibration

– Reagent mixing

– Thermal control

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Cartridge Operations

• Cartridges are standardized to plasma core lab methods using multi-point calibration curves stored in the device memory that are stable over many lots

• Upon insertion, a calibrant solution in the cartridge is passed across the sensors.

• Signals produced by the sensor’s responses to calibrant are measured – A one-point calibration adjusts the offset of stored multi-point calibration curve.

• Analyzer then moves sample over sensors, and the signal of the sensor responses to the sample are measured off the adjusted calibration curve

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Internal Control Processes

• Simulated internal QC - diagnostic check of the edge connector, internal electronics, and analyte circuitry.

• Internal QC simulates electronic signals produced by the sensors during a cartridge test.

• An isolated region of the internal circuit board sends a range of simulated sensor signals through the cartridge measurement channels

• Range of signals encompasses entire linear range expected from blood analytes

• Next, conductivity out of the connector pins is measured, insuring no contamination is present in the edge connector which would interfere with the test.

• Signal measurements must fall within strict predetermined thresholds to pass.

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Quality Control Recommendations

• Internal Simulated QC: – Automatically performed by device every 8 hrs – If significant change in analyzer temp (cold to hot) – Whenever performance of device in question

• Liquid QC: – Each shipment of cartridges – New lots of cartridges – If cartridges experience temperature shift >8°C (15°F) – Periodically as required by facility policies

• Temperature Verification – Monitored continuously during each patient test, but verification

cartridge available and recommended annually, or as required by facility policy

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Step 2: Map the Process • Map the steps including preanalytic, analytic and postanalytic processes

– Follow sample from order to analysis to reporting results

– Engage users in mapping the process

• Identify weak steps, look for potential sources of error

– Order to specimen collection – patient identification, tube type, labeling of tube, proper mixing and transport to lab

– Ensuring instrument is ready for testing – calibration, QC, technologist training and competency, reagent viability

– Reporting of results, communication of critical results

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Incorrect Test Result

1

Samples

2

Operator

3

Reagents

5

Measuring

System

4

Laboratory Environment

Sample Integrity

Sample Presentation

- Lipemia

- Hemolysis

- Interfering subtances

- Clotted

- Incorrect tube

- Bubbles

- Inadequate volume

Operator Capacity

Operator staffing

Atmospheric Environment

Utility Environment

- Training

- Competency

- Short staffing

- Correct staffing

- Dust

- Temperature

- Humidity

- Electrical

- Water quality

- Pressure

Reagent Degradation

- Shipping

- Storage

- Used past expiration

- Preparation

Quality Control Material Degradation

- Shipping

- Storage


- Preparation

Calibrator Degradation

- Shipping

- Storage

- Use past expiration

- Preparation

Instrument Failure

Inadequate Instrument Maintenance

- Software failure

- Optics drift

- Electronic instability

- Dirty optics

- Contamination

- Scratches

Identify Potential Hazards

Process Map: Blood Gas/Electrolytes - Finding the Failure Points • Work from the current package insert • Test order – electronic or hardcopy • Test collection

– Incorrect collection – bubbles, sample exposure to air – Wrong tube type – calcium titrated, heparinized BG tubes – Indirect phlebotomy – line draw contamination – Undermixing/overmixing – sample clots, hemolysis – Analytic delay – glucose, BG, pH, iCa, etc.

• Analysis – Wrong sample volume loaded onto cartridge – Incorrect procedure, timing, result interpretation – Expired reagent – Reagent exposure during shipment – Degradation during storage

• Infection Control • Result reporting errors

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Step 3: Risk Assessment

• Examine the hazards of greatest risk first:

– Errors with greatest frequency or potential for harm

– Consider new staff and ability to follow procedure

– Determine complexity and readability of policies

• For each hazard, identify a process to reduce risk

– Consider tech training, instrument maintenance and other common sources of error

– Balance instrument controls (electronic and system checks) with frequency of liquid quality controls

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Blood Gas and Electrolytes Risk Assessment

• Work from the manufacturer’s current package insert.

• Samples – Physician order – POCT possible w/o order, need written or

electronic physician order before commencing test. – Wrong tube type – train to use BG syringes/tubes – Line contamination – train on preferred collection and techniques

if catheter collection is only option – Sample mixing – analyzer has clot detection, but will not detect

hemolysis - train on proper mixing technique – Analytic delay – YES – train to analyze immediately, no longer

than 15-30 mins of collection

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• Operator – Operator lock-out – prevents use of analyzer by untrained

operators – Sample volume detection – Analyzer detects inadequate sample

volume and prevents overloading. – Incorrect procedure, timing, result interpretation – analysis and

result interpretation fully automated, clotted sample or bubbles will be detected by analyzer.

– Expired reagents – cartridges are bar-coded with lot number and expiration date, analyzer prevents use past expiration

– Wireless Connectivity – data management automates reporting of result provided patient properly identified, train on proper patient ID, use barcoded wristbands

– Infection control – train to clean and disinfect after each use

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Blood Gas and Electrolytes Risk Assessment (cont’d)

Blood Gas and Electrolytes Risk Assessment

• Reagents – Test exposure outside specifications (eg, temperature,

humidity) during shipment – analyze liquid QC with each shipment

– Lot-to-lot variability – analyze liquid QC with each lot

– Liquid QC degradation – monitor refrigerator (2 to 8C), bring to room temperature at least 30 minutes before use, discard within 30 days of opening bottle

– Degradation during storage – monitor storage conditions, (stable @ room temp for 2 years). If refrigerated, bring to room temperature at least 30 minutes before use, (analyze liquid QC due to temp change).

– What about other QC frequency?

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CLIA

CMS IQCP: Minimum QC Frequency

• CLIA will not set a minimum QC frequency for labs performing IQCP

• However… – Performing no QC is unacceptable

– QC frequency can not be less than the manufacturer’s instructions

– The RA & lab’s data must support the QC frequency

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Blood Gas/Electrolyte Liquid QC Frequency • Minimum – follow manufacturer recommendations and regulatory

requirements (CLIA for BG analysis – one QC sample q 8 hr, two levels q 24 hrs, one QC w/ each pt sample unless calibration every 30 mins)

• Manufacturer recommends event base liquid QC with each – Shipment – New lot – Significant change in cartridge temperature (>8 C)

– Whenever question of test system performance

• Options for determining liquid QC frequency – Peer publications – verify what others are already doing – Develop QC rules based on six-sigma of test system – Verify in your facility:

– analyze 2 levels each day for several weeks, then reduce to every few days, weekly or monthly after more experience with test system

• QC-lockout assists with compliance

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• Environment – Incorrect collection – train staff anaerobic phlebotomy

– Compliance with documentation – risk bases on prior issues with other testing noted at this location (refrigerator monitoring, QC documentation, etc.)

• Clinical Application – Immediate medical decisions – test results used to manage

critical patients, higher risk since only one chance to get right result!

– Sample not stable – analyze immediately, presents higher risk since can’t be repeated!

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Blood Gas and Electrolytes Risk Assessment (cont’d)

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Step 4: Summarize the QC Plan

• A QC Plan simply lists each hazard identified and the actions taken by lab to address each risk

• CMS recommendations for IQCP:

– Conduct a Risk Assessment to identify

– Have a documented QC Plan

– Monitor the effectiveness of QC Plan over time

– No liquid QC is unacceptable, QC Plan should indicate frequency of liquid QC and rationale for that frequency!

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Risk Assessment

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Hazard Manufacturer

Control Process

Laboratory Action

Risk Clinically Acceptable?

Physician order Operator training Yes

Specimen - Anaerobic collection for blood

gases

Operator training Yes

Specimen - Incorrect tube additive Operator training Yes

Specimen - Clots, hemolysis (undermixing or

over-mixing)

Clot and bubble detection Operator training Yes

Specimen - Delays in analysis Operator training Yes

Operator - trained/competent Operator lock-out Yes

Operator - Over-filling or under-filling Sample detection Yes

Operator - Incorrect procedure Automated test analysis Yes

Operator - Use of expired reagents Expiration date barcoded in cartridge Yes

Operator - Failure to document results Wireless connectivity Yes

Operator - Forgetting to clean device Operator training Yes

Reagent - Exposure during cartridge

shipment

Analyze liquid quality controls Yes

Reagent - Lot-to-lot variability Analyze liquid quality controls Yes

Reagent - Cartridge degradation during

storage

Monitor storage conditions

Analyze liquid quality controls

Yes

Device failure – electrical, sensor,

computational

Internal checks and internal QC Monitor error codes Yes

Environment temperature and humidity Continuously monitored Yes

Blood Gas and Electrolytes Quality Control Plan

• Analyze liquid QC. – Each new shipment* – Start of a new lot* – After significant change in cartridge temperature (>8 C) * – Whenever uncertainty about analyzer performance* – Monthly (based on facility verification and experience with test) – Note: Simulated multi-level quality control automatic every 8 hours and

internal calibration with each test cartridge **

• Use checklist to document training/competency. – Test only when electronic or written physician order – Proper patient identification – Use BG syringes/tubes for specimen collection – Arterial BG collection (preferred), or line draws as required – Use anaerobic technique – Mix specimens appropriately and analyze immediately – Monitor refrigerator and room temperatures – Clean and disinfect analyzers after each use * (* Manufacturer recommendations) (** Mandated by accreditation regulations)

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Step 5: Plan Implementation Monitor the Effectiveness of the QC Plan

• Number of physician complaints

• Frequency of specimen errors – clots, clumped cells or other phlebotomist errors

• Liquid QC failure rates

• Frequency of instrument error codes

• Any other unexpected error

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EP23 Laboratory QC Based on Risk Management

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Create a Process Map

(Preanalytic – Analytic – Postanalytic)

Identify Weaknesses in the Process

Define a Process that will Mitigate Risk

Summarize Processes and Actions in a

QC Plan

POCT

• Dozens of sites

• Hundreds of devices

• Thousands of operators!

• Too many cooks…

spoil the broth!

• The number of sites, devices and operators plus the volume of testing creates a situation where rare events can become probable in every-day operations

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Falsely Decreased Glucose Results

• Complaint from an ICU of sporadic falsely decreased glucose results

• Immediate repeat test on same meter, gave significantly higher “clinically sensible” values

• Inspection of unit found nurses taking procedural shortcuts to save time

• Bottles of test strips dumped on counter in spare utility room

• Some strips not making it into trash, falling back on counter and being “REUSED”

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Risk of Error from Open Reagents

• Glucose test strips exposed to air for as little as 2 hours have been shown to cause -26% bias.1

• Strips left on counters pose risk of reuse, leading to falsely low results.

• Some meters catch reuse and “error” preventing a result. Other meters do not!2

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1. Keffer P, Kampa IS. Diabetes 1998; 47; abs 0170.

2. Silverman BC, Humbertson SK, Stem JE, Nichols JH. Operational errors cause

inaccurate glucose results. Diabetes Care 2000;23:429-30.

Manufacturer Engineered Checks

• Internal test strip checks can detect damage or abuse to strip (scratches, humidity, temperature)

• Used or wetted test strips

• Strip and code key match

• Compensate for hematocrit and temperature

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Incorrect Test Result

1

Samples

2

Operator

3

Reagents

5

Measuring

System

4

Laboratory Environment

Sample Integrity

Sample Presentation

- Lipemia

- Hemolysis

- Interfering subtances

- Clotted

- Incorrect tube

- Bubbles

- Inadequate volume

Operator Capacity

Operator staffing

Atmospheric Environment

Utility Environment

- Training

- Competency

- Short staffing

- Correct staffing

- Dust

- Temperature

- Humidity

- Electrical

- Water quality

- Pressure

Reagent Degradation

- Shipping

- Storage


- Preparation

Quality Control Material Degradation

- Shipping

- Storage


- Preparation

Calibrator Degradation

- Shipping

- Storage

- Use past expiration

- Preparation

Instrument Failure

Inadequate Instrument Maintenance

- Software failure

- Optics drift

- Electronic instability

- Dirty optics

- Contamination

- Scratches

Identify Potential Hazards

Sample Errors: Interferences

• Analytic error

• Maltose (Glucose dehydrogenase PQQ) falsely increased results

• Acetaminophen falsely increased results on glucose dehydrogenase and falsely decreased results on some glucose oxidase meters,

• Vitamin C falsely increases results on some glucose dehydrogenase and falsely decreases results on glucose oxidase meters.

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• Minimize test interference at the bedside.

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• Select technologies not affected by

common medication interferences

• Watch for maltose, icodextrin, and

other common substances like

ascorbic acid known to interfere

with glucose meters at elevated

levels.

• Assess bias from oxygen and

hematocrit effects.


• No current control process for hemolysis

• Problem with whole blood sampling on blood gas and electrolyte analyzers for K+

• We centrifuge all whole blood samples before reporting K+ to detect hemolysis and comment results!

• What about applying too much/too little sample?

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Sample Errors: Specimen Volume • Some glucose meters recommend that operators visually inspect

strips for uniform color development after each test (detects underfilling and bubbles)

• Other meters have automate sample detection. (Fill-trigger is designed to prevent short-sampling.)

• Test starts only when enough blood has been applied.

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Operator Errors: Training/Competency

• Operator lockout

• Functions through number code or barcoded ID

• List of operators and training/competency dates maintained in data manager system–

• Devices can warn operators of impending certification due dates (in advance of lockout)

• Newer U.S. CLIA Interpretive Guidelines requires 6 elements of competency for moderate complexity tests

• Includes – 1 observe test performance, 2 result recording, 3 intermediary worksheets (QC, PT, maintenance), 4 observe maintenance, 5 analyze sample of known concentration, 6 problem-solving – Competency documentation not fully automated!

• Infrequent operator competency, need intuitive devices

• Note – operators can share ID numbers to access override lockout!

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Operator Errors: Performing QC

• Devices require periodic liquid QC

• Operators are patient focused and can forget to run QC, or fail QC targets, and proceed with patient testing.

• QC lockout shuts off patient testing if QC not performed or fails target ranges.

• Prevents patient testing unless QC documented

• Operators workaround QC lockout by performing patient testing in QC mode!

• Newer devices distinguish QC samples, prevent patient testing in QC mode and can also warn when operators run a high QC for low range QC and vice-versa.

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Operator Errors: Patient Identification • Incorrect entry of patient identification can

– Chart results to the wrong patient’s medical record

– Lead to inappropriate medical decisions and treatment

– Improper billing and compliance

• Barcoded patient wristbands reduce the chance of misidentification, but patients can be banded with: – Another institution’s identification

– Outdated account numbers

– A wrong patient’s wristband

• Residual risk of error even with barcoded ID bands

• Barcoded ID entry alone doesn’t satisfy requirement for patient safety - 2 unique identifiers

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National Patient Safety Goals

• Joint Commission: “Use at least two ways to identify patients. For example, use the patient’s name and date of birth. This is done to make sure that each patient gets the correct medicine and treatment.”

• College of American Pathologists: “Personnel must confirm the patient’s identity by checking at least two identifiers before collecting a specimen. For example, an inpatient’s wristband may be checked for name and unique hospital number; an outpatient’s name and birth date may be used.”

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Operator Errors: Patient Identification

• Some devices have positive patient ID – ADT feed to device

• Two identifiers plus active confirmation (also satisfies Joint Commission time out)

• Positive patient ID reduced errors from 61.5 errors/month to 3 errors/month.1 (unregistered patients; 2 ED and 1 non-ED) conducted over 2 months—38,127 bedside glucose tests.

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1. Alreja G, Setia N, Nichols J, Pantanowitz L. Reducing patient identification errors

related to glucose point- of-care testing. J Pathol Inform 2011; 2: 22

[http://www.ncbi.nlm.nih.gov/pmc/articles/PMC3097526/]

Operator Errors: Data Transfer • POCT results may not get recorded

in patient’s medical record, particular problem for manual tests

• POCT data management ensures capture of data in device (QC and Patient results), but doesn’t guarantee transfer until operators dock device

• Wireless ensures data transmitted to patient record. (Need continuous wireless or operators may forget to push send button)

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Reagent Errors: Calibration

• Incorrect entry of calibration code can lead to inaccurate test results

• Devices have automatic calibration via barcode scanning of reagent vials/strips. (no code chips or risk of wrong calibrator codes)

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Reagent Errors: Expired Reagents

• Centers for Disease Control • “Check and record expiration dates of

reagents/kits, and discard any reagents or tests that have expired.”1

• U.S. Food and Drug Administration • “Check the expiration date on the test

strips. As a test strip ages, its chemical coating breaks down. If the strip is used after this time, it may give inaccurate results.”2

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1. Ready? Set? Test! Centers for Disease Control booklet http://wwwn.cdc.gov/dls/waivedtests/ReadySetTestBooklet.pdf

2. Useful Tips to Increase Accuracy and Reduce Errors in Test Results from Glucose Meters, U.S. Food and Drug Administration

http://www.fda.gov/MedicalDevices/Safety/AlertsandNotices/TipsandArticlesonDeviceSafety/ucm109519.htm

Strip Wastage When Outdated • Operator must check manufacturer’s expiration date prior to

testing.

• Vials/strips and controls must be manually dated when opened by operator (prematurely expires once opened)

• Undated, opened vials must be discarded. (? expiration)

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Discarded strips due to no date1 1. Undated vials between September, 2010 and May, 2011, Willis-

Knighton Medical Center, Shreveport, Louisiana

http://wwwn.cdc.gov/dls/waivedtests/ReadySetTestBooklet.pdf

http://www.fda.gov/MedicalDevices/Safety/

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Reagent Errors: Expired Reagents

• Serialized vials/strips and controls barcoded for lot number and expiration date (good to stamped expiration date) can recognize individual vials on opening (30, 60 or 90 day open expiration)

• Automatic lockout for expired test strips and controls

• Some devices can also recognize exposure to humidity (few hours), wet or reused strips as additional control measure

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Environment Errors: Temperature • Devices can fail if used under temperature extremes

• Traveling nurses storing devices/strips and controls in cars during summer heat and winter cold

• We experienced increased temperature errors after switching glucose meters in our ambulances

– Old temp range 0° - 46° C New temp range 15° – 40° C

• Worked with bioengineering student to design a heated carrier

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Rust M, Carlson N, Nichols J. A thermo-modulating container for

transport and storage of glucose meters in a cold weather environment.

Point of Care 2012 in press.

Measuring System Errors: Contamination

• POC devices pose a risk of transmitting infectious organisms

• POC blood testing devices, such as glucose meters and PT/INR anticoagulation meters, should be used only on one patient and not shared.1

• If dedicating POC blood testing devices to a single patient is not possible, the devices should be properly cleaned and disinfected after every use as described in the device labeling.1

• POC devices need more durable plastics, fewer crevices and seams, and a design that prevents liquid egress into ports

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1) US Food and Drug Administration. Use of Fingerstick Devices on More

Than One Person Poses Risk for Transmitting Bloodborne Pathogens:

Initial Communication: Update. US FDA Medical Device Alerts and

Notices. Updated November 29, 2010.

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Device Cleaning

• POC devices need more durable plastics, fewer crevices and seams, and a design that prevents liquid egress into ports

• We replaced over 50 meters in first months after instituting new cleaning guidelines with our old meter!

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Measuring System Errors: Contamination

• Reagents and carriers besides the devices can also transmit infectious organisms.1,2

• Recommendation to dedicate vials of strips to individual patients. Manufacturers should further consider single-use packaging.1

• We estimated cost of dedicating strips based on survey of glucose monitoring in 100 inpatients. – Average number of 3.4 tests/day (1 – 7.2)

– Average of 8.4 day length of stay (1 – 81 days)

– 278 patients per day requiring glucose monitoring

• Annual cost of test strip waste ranged from >$80,000 for 25 count vials to >$170,000 for 50 count vials compared to single-use packaging. (Nichols

JH. Estimated strip wastage from glucose meter infection control recommendations Clin Chim Acta 2012;414:91-2.)

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1 Vanhaeren S, et al. Bacterial contamination of glucose test strips: Not to be neglected. Am J Infect

Control 2011;39:611-13.

2 Louie RF, et al. Multicenter study of the prevalence of blood contamination on point-of-care

glucose meters and recommendations for controlling contamination. Point of Care

2005;4:158-63.

Falsely Increased Hgb Results

• Spurious increased Hgb results 18 – 23 g/dL (55 – 70% Hct) on ICU patients

• Meter, QC and reagents examined and fine, no single operator tied to trend

• Continue to experience spuriously high results, trend went on for several weeks

• One day, POC coordinator watching operator perform Hgb test in spare utility room. Operator took shortcut (procedure is to load cuvette from fresh drop of well mixed sample)

• Instead, operator was filling cuvette from drop of blood remaining from glucose test. Test strip was absorbing plasma portion of sample and artificially increasing Hgb/Hct in remaining drop!

• Remedial action to retrain entire unit staff!

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Resource for Reducing Errors

• Clinical Chemistry book recently released!

• Focus on errors in the Chemistry Laboratory including POCT

• Discussion of real-world errors and what can be done to detect and prevent errors.

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71 CLIA

The “Right QC” is IQCP

• CMS will incorporate key EP-23 concepts into CLIA Interpretive Guidelines (IG) as an alternative QC policy called IQCP (Individualized QC Plans)

• Effective Jan 1, 2014, IQCP will be implemented

• Existing CLIA QC & quality system concepts won’t change

• No regulations will change!

• CMS’ survey process won’t change

• 2 year phase-in and educational process

• Accreditation agencies, CAP and Joint Commisstion will release more information in 2014.

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The “Right QC” is IQCP

• Permits labs to develop an IQCP using many of their existing quality practices/information

• Is based on labs’ patient population, environment, test system, clinical uses, etc.

• Applies to CMS-certified non-waived labs

• IQCP is a choice & default is 2 external QC/day

• Labs must follow mfr’s. instructions if > CLIA

• Includes existing & new analytes/test systems

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Nashville, TN

Individualized Quality Control Plan

Individualized Quality

Control Plan

Risk Assessment

Quality Control

Plan

Quality Assessment

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Benefits of IQCP to Lab

• Single-use cartridge based methods – use engineered controls in lieu of 2 levels QC/day

• POCT analyzers – perform QC by lot of cartridge (using subset of devices) rather than every lot and each device.

• Core lab analyzers higher complexity tests – helps labs identify weaknesses and appropriate actions to reduce risk of error (may need >2 levels QC/day)

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Summary

• An IQCP/EP23 quality control plan simply summarizes the risk for potential errors with a device and how the lab intends to address those risks.

• An IQCP can be high level or very detailed depending on the device, the laboratory, and clinical application of the test result and may vary from one lab to next.

• Risk management and developing quality control plans are generally accepted by the industry. Depends on extent to which the device’s intended features or actions, achieve its intended purpose in union with the lab’s expectation for ensuring quality test results.

• Once implemented, the IQCP is assessed and monitored for effectiveness and over time, modified as needed to maintain risk to an acceptable level.

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