Point-Of-Care Testing in Primary Care Kent Lewandrowski MD Associate Chief Pathology Director of Clinical Laboratories and Molecular Medicine) Massachusetts General Hospital Professor Harvard Medical School
Laboratory Testing On Airline Flights
Conventional Wisdom POCT is: • More expensive than central laboratory testing • Is difficult to manage quality and documentation • Is difficult to comply with regulatory requirements For these reasons POCT should only be performed if there is a demonstrable benefit (e.g. outcomes)
Objectives • Describe the classification of outcomes including medical, financial and outcomes relating to hospital operations • Analyze different models for performing laboratory testing in primary care • Evaluate different tests that have been shown to improve outcomes and practice efficiency in primary care
Types Of Outcomes • Medical outcomes: Live longer, better – Very difficult to document • Financial outcomes: Save money, more cost effective – Complex and difficult to document • Operations outcomes: Improve length of stay, improve efficiency, streamline processes – Easier to document 5
Options for Obtaining Laboratory Testing in Primary Care 1. Sending the patient to a central laboratory after the office visit: Inconvenient for the patient. Patient may never show up at the laboratory. Prevents test results from being reviewed with the patient at the time of the office visit. Follow-up letters and phone calls and follow-up office visits may be required. 2. Sending the patient to a central laboratory several days before the office visit: Assumes the required tests can be anticipated in advance. Patient may never show up at the laboratory. Allows test results to be reviewed with the patient during the office visit. Requires an extra trip to the laboratory which may be inconvenient and may incur costs including travel, parking and potentially lost wages.
Options for Obtaining Laboratory Testing in Primary Care 3. Performing testing in the physician’s office at the time of the patients visit using rapid POCT devices: Individual tests do not need to be anticipated in advance Results can be reviewed directly with the patient. Follow-up letters and phone calls may be reduced and revisits for abnormal test results potentially eliminated. Which choice would you prefer?
A Relative of Mine • Saw physician for a chronic complaint • Tests ordered and the patient was told to go to a phlebotomy site 15 miles away • Round trip would require several hours away from work • Due to inconvenience the patient never went
Sample Acquisition: A Key Issue With Point- of-Care Testing • Most practices do not have on-site phlebotomy • Finger-stick tests therefore highly desirable • Alternate sample types useful in some cases (e.g. salivary samples, urine) • New technologies coming on the horizon
One New Technology Place device on skin Collects 20 uL of blood essentially without pain Future devices planned to collect a larger sample
Key Factors Impacting POCT in Primary Care • Accuracy of the test • Cost of testing supplies • Labor cost • Space • Ease of use • Need for finger stick or phlebotomy on-site • Billing revenues • Clinical impact of the test on patient care • Clinical impact of the test on the practice
The All Important CLIA Waiver Status In Primary Care Office practice using only CLIA waived tests • Requires certificate of waiver • No routine inspections by regulators • No proficiency testing required Office practice using moderately complex tests • Requires certificate of compliance • Routine inspections by regulators • Proficiency testing required
What Type of Practice is it? • Private practice Basically functions as a small business Very sensitive to cost and revenue • Hospital affiliated practice Functions as a business unit in the larger organization Very sensitive to annual budget • Salaried staff physician Functions as an employee of the organization Sensitive to the overall organizational cost
Selected Traditional POCT Tests in Primary Care Rapid Strep A Influenza Sexually transmitted diseases Rapid HIV Dipstick urinalysis Pregnancy testing HbA1c Glucose Fecal occult blood PT-INR Lipid panel
Examples of Missing Tests and Potentially Emerging Tests • CBC: No viable current options. A major missing piece in POCT • Chemistry panels (CMP/BMP): Some options available but all require phlebotomy • Thyroid screen: A common rule out for many patient presentations • BNP/NT proBNP: Manage patients with heart failure: Some options available but all require phlebotomy • Salivary DOA: Eliminates observation of urine sample collection • Lyme serology: CDC estimates 300,000 cases annually
Case Example: HIV Testing Over 1 million people in US infected with HIV Over 250,000 unaware of their infection CDC Guidelines • Screen all people 13-64 years old • Identify HIV infected patients and connect them to early care • Educate patients of risk factors • Three quarters will modify at-risk behaviors when they know their HIV status
The Problem • Many at-risk patients have poor access to the health care system and are easily lost to follow-up • Many never return to learn their results • Kassler et al. AIDS 1997;11:1045-1051 Compared rapid testing to central laboratory testing Rapid testing resulted in a 210% increase in patients learning their HIV status for uninfected and a 23% increase for infected patients • Rapid in-office HIV tests result in more patients being tested and connected to follow-up care and education
Case Example: HbA1c for Diabetes Care Clinical Utility of HbA1c Traditional use: Monitoring diabetic therapy Requires reproducible assay New uses (utilize fixed cut-points thus assays must be accurate, reproducible and free from bias) Screening for diabetes Diagnosis of diabetes
First Order of Business The Test Has to Work 14 y = 1.0005x - 0.0668 Note: Not all POCT 12 R 2 = 0.9876 P HbA1c O 10 assays perform with C acceptable T 8 accuracy 6 and precision 4 2 2 4 6 8 10 12 14 Main Laboratory
A Word Of Caution On Some POCT Devices Clin Chem 2010 Jan;56(1):44-52. Six of eight hemoglobin A1c point-of-care instruments do not meet the general accepted analytical performance criteria. Lenters E and Slingerland HbA1c devices should conform to standards of the National Glycohemoglobin Standardization Program Only 2 of eight POCT devices for HbA1c passed NGSP criteria
POCT Outcomes: Glycemic Control Some (but not all) studies of POCT for HbA1c have shown an improvement in glycemic control Cagliero et al, Diabetes Care 1999;22:1785-1789 Randomized controlled trial in 201 diabetic patients • HbA1c levels decreased over 6 and 12 months with POCT by 0.57% and 0.40% • No change in HbA1c in controls
Case Example: Rapid testing For Strep A Culture requires 18-24 hours: This delay leads to over diagnosis and unnecessary preemptive antibiotic usage Clinical diagnosis is unreliable One study: 48% of patients with pharyngitis received antibiotics Only 28% were positive by culture Rapid strep A tests are highly specific but will miss some cases of Strep A pharyngitis
Clinical evaluation Two pharynx swabs History of rheumatic fever and classic clinical findings or rash or scarlet fever Yes: Culture and No: Rapid strep test treat Positive: Treat Negative: Send second swab for culture, write prescription to be filled only if culture is positive
Case Example: POCT PT-INR For Managing Anticoagulation: Frank et al. Ann Fam Med 2008;6:s28-s32 Evaluated POCT for PT-INR in combination with a Coumadin dosing guideline
Results Baseline control 32.1 % of patients within the INR goal With POCT-INR 45.9 % of patients within INR goal
Reimbursement Models • Traditional fee for service • Global reimbursement or capitation • Risk sharing reimbursement model Each reimbursement model creates its own incentives and disincentives with regards to: – Practice costs – Revenues – Practice efficiency metrics – System wide costs
Traditional Fee-For-Service • Practice gets paid for each billable unit of service it produces • Outpatient labs often profitable • Favors POCT assuming there are easy to use devices that don’t require phlebotomy
Global Reimbursement or Capitation • Practice gets paid a fixed amount to provide all needed services • Many carve-outs can create perverse incentives (e.g. lab carve-out) • Strongly discourages POCT unless there is a carve-out • Accountable Care Organizations (ACO’s) will introduce a global fee for all services to a healthcare organization (not an isolated practice)
The Basic Accountable Care Model Doctors Hospitals Ancillary Services Pharmacy Other stakeholders
Risk Sharing Reimbursement Contracts: Pay for Performance The physician is typically subject to a payment withhold pending performance of: • Quality metrics • Utilization metrics • Financial metrics
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