Percent of testing facilities (laboratories) that are accredited according to national or international standards

Export Indicator

Percent of testing facilities (laboratories) that are accredited according to national or international standards
What it measures

This indicator measures the progress and extent to which USG-support has built laboratory capacity, quality, and sustainability by determining the number of accredited clinical laboratories and the laboratories’ ability to maintain accreditation over time.

Rationale

Laboratory services are an essential component in the diagnosis and treatment of persons infected with the human immunodeficiency virus (HIV), and other related diseases of public health significance, including malaria and TB. Presently, the laboratory infrastructure for HIV, malaria, and TB testing and quality assurance remains weak in most PEPFAR-supported countries. There is therefore an urgent need to strengthen the laboratory. The establishment of accreditation systems will help countries to improve and strengthen the capacity of their laboratories. Accreditation provides documentation that the laboratory has the capability and the capacity to detect, identify, and promptly report all diseases of public health significance that may be present in clinical and research specimens. The accreditation process further provides a learning opportunity, a pathway for continuous improvement, a mechanism for identifying resource and training needs, and a measure of progress.

Numerator

Number of testing facilities (laboratories) that are accredited according to national or international standards

Denominator

Denominator is lab indicator number H1.1.D
Number of testing facilities (laboratories) with capacity to perform clinical laboratory tests

Calculation

Numerator / Denominator

Method of measurement

A PEPFAR-supported clinical laboratory is counted as being accredited if it has received national or international accreditation that meets the World Health Organization (WHO) Accreditation of Public Health Laboratory Networks standard.

Full accreditation and levels of accreditation are assessed by a standardized set of criteria defined by WHO Accreditation of National Laboratory Systems or other acceptable international and national standards. Full accreditation is defined by meeting acceptable criteria in order to receive certification by a recognized approved accreditation organization, such as College of America Pathologist (CAP), International Organization for Standardization (ISO), South African National Accreditation System (SANAS), or other WHO approved accreditation organizations. Accreditation certificates are a formal recognition that a laboratory is competent to perform clinical testing.

Laboratories may also be assessed using the WHO/AFRO Laboratory Accreditation Checklist. This checklist is specific for the tiered level of the laboratory, either:
1. Primary health center lab,
2. Secondary district/regional lab,
3. Tertiary regional or provincial lab
4. National reference lab.
Laboratory will be evaluated in a step-wise process towards full laboratory accreditation using scores on the checklist. Levels of accreditation will be assigned after assessment and laboratories that meet a minimal acceptable level with be counted as being accredited.

Any fully accredited laboratory that loses accreditation compared to the last reporting year will not be counted. A partially accredited laboratory should be counted. However, if a partially accredited laboratory does not achieve at least one level higher towards full accreditation from that of the previous year, this laboratory should not be counted.

Measurement frequency

Continuously

Disaggregation

Age group:

Condom type: N/A

Education: N/A

Gender: N/A

Geographic location: N/A

HIV status: N/A

Pregnancy status: N/A

Sector: N/A

Service Type: N/A

Target: N/A

Time period: N/A

Type of orphan: N/A

Type/Timing of testing: N/A

Vulnerability status: N/A

Explanation of the numerator
Explanation of the denominator
Strengths and weaknesses

This indicator monitors the scale up of accreditation practices in testing facilities (laboratories) supported by PEPFAR. This indicator assesses the quality systems of a laboratory and the ability of a laboratory to maintain quality.

Determining the number of accredited clinical laboratories, the progress of a laboratory towards accreditation, and the laboratory’s ability to maintain accreditation over time provides documentation that the laboratory has the capability and the capacity to perform quality-assured clinical laboratory testing for HIV diagnostic and care and treatment services. Maintaining accreditation is a continuous process and can serve as a measure of sustainability of quality laboratory service.

This indicator counts the number of partially accredited laboratories which may not deliver full quality services necessary to support PEPFAR. But it will measure a laboratory’s effort to improve on quality as compared to if the laboratory was unmonitored or unaccredited.

Accreditation is an assessment of the ability of a laboratory to deliver quality laboratory service. This indicator will not measure the effectiveness of lab accreditation on the delivery of quality services for HIV/AIDS diagnosis, care and treatment. However, the process of assessing labs for accreditation will produce information that can help determine the effectiveness of the laboratory service. These processes include determining testing turn-around times, development of effective workflow, document management, and others.

This indicator may undercount the number of accredited facilities as some countries may not at present have the ability to monitor progress toward accreditation or to implement an inspection scheme to accredit a clinical laboratory. Some labs may be capable of receiving an acceptable level of accreditation, but currently the system may lack the means to conduct an accreditation assessment. Development of these monitoring processes and accrediting schemes with the assistance of USG PEPFAR support and implementing partners will help to strengthen in-country laboratory networks and build sustainability.

Further information