Best Practices for Quality Point-of-Care Testing

James H. Nichols, PhD, DABCC, FACBProfessor of Pathology, Microbiology and Immunology

Medical Director of Clinical Chemistry and Point-of-Care Testing

Vanderbilt University School of Medicine

Nashville, Tennessee, USA

james.h.nichols@vanderbilt.edu

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Objectives

1. Describe the regulatory requirements for GLP

2. Identify challenges for POCT

3. Illustrate ways to manage the quality of POCT

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Vanderbilt University Medical Center

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Vanderbilt University Medical Center• Among nation’s premier institutions of academic medicine, grown to

world-class enterprise over past 137 years

• 21,000 employees, 1900 students, 1440 residents/fellows

• Vanderbilt University Hospital (584 beds)– 54,000 admissions annually

– 1.3 million ambulatory visits

– 58,000 emergency visits

– 2,519 LifeFlight patient air transports

• Monroe Carell Jr. Children’s Hospital– 198,000 ambulatory visits

– 52,000 emergency visits

• Vanderbilt Psychiatric Hospital (88 beds)

• Vanderbilt Stallworth Rehabilitation hospital (80 beds)

• Vanderbilt Clinic – Laboratory >7 million tests4

Laboratory Regulations

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CLIA• Clinical Laboratory Improvement Amendments of 1988

• Basis for quality laboratory testing in the US

• Applies to all tests performed for clinical/patient care

• Regulations cover testing regardless of location

– Hospital

– Clinic and point of care

– Ambulance/transport

– Home health care and long-term nursing facilities

• CLIA describes good laboratory practice for lab testing

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CLIA Laboratory CertificatesJune 2015 (246,650 Labs)

Compliance (State

inspected, non-waived)

18,385 (7.5%)

Waiver 177,016 (71.8%)

PPMP 34,808 (14.0%)

Accreditation (CAP, Joint

Commission)

16,441 (6.7%)

CLIA Test Complexity• Waived (more than 2/3 of licensed labs – simple POCT)

– Follow manufacturer instructions

– Pay biennial fee for CLIA certificate

• Moderate

– Specific requirements for all aspects of testing

– Preanalytic, analytic, postanalytic process control

• High

– Builds on moderate complexity requirements

– Most stringent requirements

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Good Laboratory Practice

• Staff education and training

• Method validation, policies and procedures

• Reagent management and environment

• Quality control

• Documentation of results

• Proficiency testing

• Problem resolution and improvement

• Periodic inspection

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Personnel

• Medical director: MD or PhD with board certification

• Clinical consultant: can be filled by medical director

• General/Technical supervisor: manage staff, resources and ensure policies are followed

• Testing personnel: minimum education requirement depends on test complexity

– Waived – PCT/aids with High school and on the job training

– Non-waived – 2/4 year college degree with science major10

Challenges with Training• POCT staff at different levels – LPN, RN, CPT, Aids

• Requirement for 6 elements of competency

– Direct observation of routine test performance

– Monitoring recording/reporting of results (include criticals)

– Review intermediate worksheets (QC, PT, maintenance)

– Direct observation of maintenance and function checks

– Assessment of test performance with known samples

– Evaluation of problem-solving skills

• Initial training, 6 months and annually after

• Non-waived require all 6 elements!11

Requirements• Method validation

– Accuracy, precision, reportable range, interferences

– Other performance as needed – carry-over

• Policies and procedures

• Reagent management – temp monitoring, water quality, humidity, dust/air quality, vibration, etc.

• Proficiency testing - min 6 mos, Blood gas, 3x/yr

• Calibration verification – 6 mos

• Instrument correlation – 6 mos12

Method Challenges

• Refrigeration

– Shipping conditions and reagent validation before use

– Storage and premature expiration at room temperature

• Instrument maintenance

• Calibration

• QC – performance, interpretation, documentation

• Following policy – QC frequency, sample application, over/underfilling

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Requirements

• Test order and result documentation

• Problem resolution

– Test performance , PT, QC and complaint trends and failures

– Physician and patient satisfaction

• Improvement

– Benchmarking performance and improvement

• Periodic inspection

– Waived has no mandated inspections

– Moderate/High complexity tests - biennial14

Documentation Challenges

• Ensuring physician order

• Documenting patient results

– POCT manual tests like pregnancy and urine dipsticks

• Documenting QC results and failure troubleshooting

• Benchmarking performance trends

• Ensuring quality improvement

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Point-of-Care TestingQuality Issues

• Complaints about SMBG devices represent the largest number filed with the FDA for any medical device (by 1993, over 3200 incidents, including 16 deaths). Greyson J. Diabetes Care 1993;16:1306-8.

• Poorly maintained urinometers and blood gas analyzers can act as an infectious reservoir for resistant microbes. Acolet D et al J. HospInfection 1994;28:273-86. Rutala WA et al. Am J Med 1981;70:659-63.

• Nine patients at two nursing facilities in Southern California were diagnosed with hepatitis B infection transmitted in association with blood glucose monitoringState of California Health and Human Services, Department of Health Services, Licensing and Certification Program. Recommendations on the prevention and control of HBV transmission in diabetic patients who require blood glucose testing. July 2000.

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POCT is a Complex System• Laboratory

– One site

– Limited instrumentation to perform bulk of testing

– Limited staff, focused on same equipment daily

– Staff trained in laboratory skills

• POCT

– Dozens of sites, hundreds of devices and thousands of operators

– Staff are clinically focused on patient not on equipment

– Testing delegated to lower level staff (TAs, MAs)

– Staff do not have laboratory training background or experience in meeting laboratory regulations

Why Do We Need a POCT Program?

• Organize the activities involving POCT

• Meet federal and accreditation regulations

• Identify what tests are conducted outside the formal core laboratory

• Approve/disapprove new test requests

• Determine who is performing POCT

• Document staff competency

• Manage POCT test results

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POCT Management

Medical Director

POCT Coordinator

POCT Staff POCT Staff

POCT Staff Affiliate

Hospitals and Clinics

POCT

Committee

POCT Coordinator

• Staff manager of overall POCT program

• The most important person next to the Medical Director in the POCT Program

• Ensures documentation meets regulatory compliance

• Maintains records of sites and testing

• Coordinates IT services for data transfer of results to medical record

• Keeps policies and procedures up-to-date

• Troubleshoots testing problems

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POCT ManagementVanderbilt Medical Center

Vanderbilt POCT

Rehabilitation

HelicoptersVanderbilt

Medical Center

One Hundred Oaks Clinic

Williamson County

Medical Center

Ambulances

Vanderbilt Psychiatric

HospitalChildren’s Hospital

Vanderbilt Medical Group

Practices

Hillsboro Clinic

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Department /

Area / Clinic

# [Certificates

filed under cost

center #]

Name of

Accrediting/

Certifying

Agency

Medical

Director

D. Trainer

PHONE Address

Test Performed Manager

CAP

Proficiency

Au #

(If

applicable)

1. FAMILY

PRACTICE

(First Floor)

20323XXXX CLIA

44XXXX

Exp.7/11/

13

Dr.

Warren

MD

Louis PC 555-1234 , TN. 37067 Flu, strep, Clinitek

Status, urine

pregnancy, Sure

Step glucose

Hemocue,

Hemocult, PPM

KOH, wet preps,

Loretta

Lynn

2.

PEDIATRIC

CLINIC

(Second

Floor)

20311XXXX CLIA

44XXXX

Exp.

2/14/14

Dr. Miller

MDKim Jones

RN

555-2121 Clinitek Status

Urine, DCA

HgBA1C Advantage

Sure Step, Glucose,

Flu, Strep,

Hemocult

Ms. Price

3. INTERNAL

MEDICINE

(Third Floor)

20322XXXX CLIA

44XXXX

Exp.

7/10/13

Dr.

Smith

MD

Ron Night 555-0102

TN 37067

Flu, strep, Clinitek

Status, urine

pregnancy, Sure

Step glucose,

Hemocult PPM

KOH, wet preps

Jackie

Chan

GI CLINIC

(third floor)

20326XXXX GI I IM

share lab

CLIA

Dr.

Jones M

D

POCT 555-1212 Third Floor

Franklin TN

37067

Hemocult Lori

Done

The POCT Committee

• Representation from laboratory, purchasing, medical staff, nursing, and IT services

• Approves new test requests

• “Depersonalizes” response – committee decision rather than single person/director

• Provides oversight of POCT management

• Reviews QC trends, ongoing test problems and ensures method is meeting clinical needs

• Ensures POCT is conducted in a safe manner23

POCT Roles• Nursing and Clinical Staff:

– Ensure staff are trained/competent

– Perform and document device QC

– Rotate stock/destroy expired reagents

– all other aspects of the day-to-day management of the testing process

• Laboratory:

– Drafts procedures and training checklists

– Validates new reagent/QC lots

– Arranges for repair/replacement of devices

– Provides technical, training, consultative and QI support of clinical staff and testing process

– Supervises data management

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Tips to Simplify Regulatory Compliance

• Standardize instrumentation and methods across the health system

– Minimizes number of different devices

– One policy can be shared amongst sites

– Central management system (ie oversight and data management)

– Same methodology, clinical limitations

– Share reference intervals (normal values)

– Simplifies training and competency, float staff

Sources of POCT Challenges• Lack of experience:

– Lower level staff w/ less training

– More staff involved – less opportunity to test

• Unfamiliar with regulations:– Need for QC, training/competency, validation, documentation

• IT Integration– Capturing results, separating POC in EMR, device lockouts

• Complex workflows:– Refrigerated storage vs room temp stability

– Open vial stability (30 days v imprinted expiration)

– Sample collection, transport, and test application26

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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 automatically. (Need continuous wireless or operators may forget to push send button)

Operator Errors: Data Management• Middleware

• Access from anywhere, home, office, POC

• Ensures quality testing and regulatory compliance

• Can access test result history and status of any analyzer

• Manage operators, set competency and lock-outs

• Review QC/corrective actions29

POCT Operations• POCT is portable, allows testing bedside

– Cleaned between each use

– Infection control of supplies

• POCT devices can be stationary

– Samples must be transported to device

– Potential for sample mix-up, requires labeling

– Separates clinical staff from patient

• Each has unique challenges!

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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

• 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 goals – 2 patient identifiers

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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.

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/]

Sample Collection• Not all fingersticks are the same!

– Easier than phlebotomy? For the nurse…

– Variation in operator technique and potential for error

• Apply directly to cartridge/test

• Collect into a micro collection tube – transfer into test kit/analyzer

• Collect into a capillary – transfer to test cartridge

• Concern for blood gas exposure to environment

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Capillary Sample Challenges

• Adequacy depends on depth and blood flow!

• Well known issue: operator technique, patient variation

• Safety and ability to mix with anticoagulant

• Capillary differs from venous in patients with poor circulation – source of FDA concerns over the use of glucose meters in critically ill patients

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This limitation is new

as of December 2012

for all glucose meters!

Definition of Critically Ill• No universal definition of critically ill exists

• Critical illness is any disease process which causes physiological instability leading to disability or death within minutes or hours.(1)

• All inpatients, by virtue of their hospitalization, may be considered “critically ill”. So, critically ill patients are not just those patients in the ICU

– Consider the OR, ED, Trauma, Sepsis, and others

• CMS and FDA indicate that the definition of what constitutes “critically ill” must be defined by each institution.

36British Journal of Hospital Medicine, October 2007, Vol 68, No 10

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CLSI POCT17 Options to CMS Changes

• Proposed Policy Change

– Least disruptive

– No change in practice, staff already trained and doing this

– Meets letter of the regulatory change by defining what “critically ill” means for this device – the pkg insert limitations – so not testing under “off-label” uses

• Change to a meter cleared for “critically ill” use

– Caution, no meter is cleared for use of capillary samples in critically ill patients!

• Stop using glucose meters for “critically ill” patients – use an “alternative” method

– Blood Gas Analyzers – rapid, already available on the critical care units!

– Core lab testing with delays in results that could impact care

• Use glucose meters “off-label”

– CLIA high-complexity testing with required validation in critically ill patients

– Consequences for staff educational background, licensure (med director), and ongoing documentation.

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Indirect Phlebotomy (Line Draws)

• Potential to contaminate sample with line fluid

• Can dilute or elevate results depending on test and what is being infused through the line

• Collection through heparin lock –coagulation test results will be altered

• Not generally recommended – but a universal practice

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Preanalytical Issues

• Adequate sample – right additive, well mixed, labeled

• Clots – delay in mixing, delay of analysis (no additive)

• Bubbles – transfer of small volumes promotes bubbles

• Drug interferences

• Documentation of collection issues – hard to comment in devices or patient’s charts when preanalytical issue noted

• Some POCT analyzers can monitor the sample quality and detect common operator errors and interferences

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Summary

• Regulations mandate good laboratory practices

• Laboratories face many challenges in meeting regulatory requirements for POCT

• A formal POCT organization within the hospital assists with managing POCT quality

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