The World Health Organization (WHO) recently released its first-ever list of essential diagnostic lab tests to improve diagnosis and treatment outcomes worldwide.
The list, titled WHO Model List of Essential In Vitro Diagnostics, (First edition 2018),(www.who.int) focuses on in vitro tests, or tests of human specimens such as blood and urine, and outlines 113 products.
Of those, 58 tests are used for the detection and diagnosis of a wide range of conditions commonly seen in primary care, including anemia, diabetes, urinary tract infections and one-time events such as pregnancy.
The other 55 tests on the list are used to detect, diagnose and monitor WHO-classified priority diseases such as HIV, hepatitis B and C, and HPV infections, as well as syphilis and malaria.
According to a May 15 WHO press release,(www.who.int) it's not unusual for people around the world to lack access to diagnostic services. Not surprisingly, the organization noted, "Many are incorrectly diagnosed. As a result, they do not receive the treatment they need, and in some cases, may actually receive the wrong treatment."
- For the first time, the World Health Organization has released a list of 113 essential diagnostic lab tests to help ensure people around the world get the diagnostic lab tests and treatments they need.
- Many U.S. family physicians provide point-of-care testing in their clinics to ensure timely diagnosis and treatment.
- The AAFP Proficiency Testing Program helps reassure physicians of the quality of the tests they provide in their clinics.
The WHO catalog of essential tests was created to fill that gap.
"No one should suffer or die because of a lack of diagnostic services or because the right tests were not available," said WHO Director-General Tedros Adhanom Ghebreyesus, Ph.D., M.Sc., in the press release.
Two years in the making, the list was developed with extensive input from resources both inside and outside the organization before a WHO advisory panel of 19 international experts conducted a final review. The list will be updated regularly.
Providing Point-of-Care Testing
U.S. family physicians and their patients face challenges far different from those of their counterparts in impoverished and underdeveloped countries around the world.
Most of the essential lab tests listed by WHO are routinely ordered for patients in this country, and some of those tests are provided right in a family physician's office.
In fact, of the AAFP members who responded to the Academy's 2014 practice profile survey, about 94 percent said they performed clinical laboratory testing in their offices with tests ranging from a simple dipstick urinalysis or strep screen to more complex tests.
Amy Mullins, M.D., the AAFP's medical director of quality improvement, told AAFP News that her former practice in Whitehouse, Texas, provided point-of-care testing.
"Offering in-office lab testing prevents a delayed diagnosis that can stretch into days," said Mullins. "The patient is diagnosed and treated sooner," and in many cases, that quick action lessens the chance that the patient will spread a communicable disease to someone else.
Tracey Allen-Earhart, manager of the AAFP's Center for Quality, added this: "When family physicians don't have in-house lab testing and send patients to another facility, a percentage of patients simply don't follow through." Patients may not have transportation, can't take additional time off work or face some other obstacle, she noted.
"We want family physicians to be able to provide these lab tests in their practices. And we also want to assure the quality of those tests," said Allen-Earhart.
An efficient way to do that is through the AAFP Proficiency Testing (AAFP-PT) Program.
Why Proficiency Testing?
Christine Schimpf, manager of the AAFP-PT Program, defined proficiency testing for AAFP News as an "external quality-control process" that considers how an office lab performs on specific tests -- with the end goal of assuring accurate results.
Internal quality-control measures are not enough, she added.
By testing unknown specimens, AAFP-PT is able to provide an objective assessment of the competencies of lab staff in performing tests at point-of-care, or of complex instrumentation. That assessment includes the handling of specimens, functionality of equipment and reporting of results.
"Trust is an imperative part of the doctor-patient relationship, and when lab results aren't accurate, that trust can be shattered," Schimpf explained. For instance, parents are not happy when they have to return to a clinic with a sick child after receiving a false-negative strep test two days earlier.
That inaccurate test result could have been the result of a busy schedule and skimping on the required one-minute incubation time, Schimpf said.
Mullins added her family physician perspective on the importance of accurate test results.
"Proficiency testing is important because it gives you assurance the diagnostics you get in your clinic are correct -- and that means you can treat your patient with confidence in a timely manner," she said.
No one would argue that accurate lab results are not crucial to patient care.
However, labs that have received a certificate of waiver through the Clinical Laboratory Improvement Amendments (CLIA)(www.cms.gov) -- the CMS program that ensures quality laboratory testing in the United States -- are not required to perform proficiency testing.
Waived labs are on the lowest level of CLIA's four lab tiers, but that doesn't make them any less important to the family medicine practices that perform these tests for patients.
"We encourage waived labs to perform PT, too. It's good laboratory practice, and assures safety and accuracy for your patients," said Allen-Ehrhart.
AAFP-PT Program Specifics
Some of the tests on the WHO list of essential diagnostic lab tests are included in the AAFP-PT Program; for instance, the AAFP program provides PT for tests such as
- human chorionic gonadotropin (pregnancy),
- urine dipstick and urine microscopy,
- microscopy, and
- prothrombin time test and international normalized ratio.
The AAFP-PT Program ships participating clinics three testing kits per year that contain samples tailored to the practice's menu of lab tests.
Clinic staff members perform the tests during a set time period, and report their results to AAFP-PT. Those results are graded, and the practice receives a report.
"We have a team of experienced laboratorians available to offer technical assistance and guidance on how to correct issues detected by the test results," said Allen-Ehrhart.