(LAB_PTCQI Lab disaggregate) Number of laboratories and blood centers/banks

Export Indicator

Number of laboratories and blood centers/banks
What it measures

This indicator identifies which PEPFAR-supported laboratories and blood centers/banks are, or are not, actively engaged in an international, national, or regionally-recognized process for CQI and demonstrating measured improvement towards accreditation.

A PEPFAR-supported laboratory or blood center/bank is defined as:

A laboratory is defined as: A) Having dedicated physical laboratory infrastructure

B) Having dedicated trained laboratory professionals performing testing.

C) Conducting laboratory testing in one or more of the following areas:

a. Diagnosis of HIV infection with EIA or molecular methods

b. HIV care and treatment monitoring with CD4 testing or HIV viral load

c. Early Infant Diagnosis (EID)

d. Hematology

e. Clinical chemistry

f. Serology

g. Microbiology

h. Blood banking

i. TB diagnostics

j. Malaria infection diagnostics

k. STI diagnostics

l. OI (Opportunistic Infection) diagnostics, including Cryptococcal antigen

Note: A laboratory, as define above, that uses POCT type assays (such as the Pima or rapid diagnostic tests) are to be counted as a laboratory.

Blood centers/banks:

A) Performs any service involved in blood donor recruitment, blood and plasma collection, testing, processing, storage, and distribution of blood and blood products.

B) Blood banks/centers may exist within a laboratory and should be counted as a laboratory.

A laboratory or blood center/bank should be counted for engaged activities supported by a recognized external CQI or accreditation preparedness program which is a national or regionally-recognized continuous quality improvement process towards meeting international standards. For laboratories, accreditation program may be a stepwise laboratory quality improvement approach such as WHO AFRO Stepwise Laboratory Quality Improvement Process Towards Accreditation (SLIPTA) and CDC/PAHO Caribbean Laboratory Quality Management System Stepwise Improvement Process towards Accreditation (CDC/PAHO LQMS-SIP). For blood centers/banks this may be participation in an internationally-recognized accreditation program such as the African Society for Blood Transfusion (AfSBT).

Laboratories enrolled and have achieved the minimum level of recognition (audit score) in a nationally or regionally-recognized continuous quality improvement program using the country or region’s equivalent to the WHO AFRO SLIPTA Checklist (i.e., a laboratory with at least one star on the WHO AFRO SLIPTA checklist or at least tier one level of the CDC/PAHO LQMS-SIP checklist) by a qualified external auditor. Similar organizations or bodies in other regions or countries may issue this recognition under their respective continuous quality improvement program. While enrollment in a CQI program is critical, all laboratories are not expected to be accredited.

Full accreditation is achieved when the laboratory or Blood bank/center is recognized by an accrediting organization as to meeting the standards to achieve full accreditation. Accreditation must be maintained and not expired to be counted.

Countries are encouraged to monitor the number of laboratories and testing sites performing HIV-related testing as well as the capacity of these sites. This effort seeks to evaluate PEPFAR support for laboratory capacity that will provide access to high quality, rapid, affordable diagnostic tests for care, treatment, prevention, and surveillance for HIV/AIDS.

Participation in PT programs can help monitor and improve the quality of HIV-related testing at the testing sites. This indicator will encourage countries to implement a PT program if none exists, expand the PT program to cover all HIV testing sites, and will help improve quality of diagnostic and monitoring testing at all sites. The PT program is not intended to be punitive; the PT data is used for targeted technical assistance and improving overall quality of testing.

The purpose is to determine the following:

1. Laboratories and blood centers/banks that are doing the HIV-related testing

2. Laboratories and blood centers/banks that are participating in a PT program specific for each test.

3. Laboratories and blood centers/banks achieving successful passing criteria on the most recent PT panel. This will be specific to each test, as specified in the disaggregation.

Rationale

Number of laboratories and blood centers/banks:

A. Engaged in Continuous Quality Improvement (CQI) activities

B. Audited and achieved accreditation

C. Performing an HIV-related test and participating in and passing Proficiency Testing (PT)

Numerator

Number of laboratories and blood centers/banks:

A. Engaged in Continuous Quality Improvement (CQI) activities

B. Audited and achieved accreditation

C. Performing an HIV-related test and participating in and passing Proficiency Testing (PT).

Denominator

N/A

Calculation

Q4 only.

Method of measurement

Site level data for all laboratories and blood centers/banks to indicate enrollment and recognition in a CQI program are obtained from program records of the PEPFAR-funded partners. Site level documentation of being audited by an external auditing agency and scores to indicate if quality standards are met and accreditation achieved.

Site level information from test directory for HIV-related tests perform plus site level documentation of participation in a PT program and passing (satisfactory or successful) scores on the latest PT panel.

How to report indicator:

A PEPFAR-supported site should be allocated as either a Laboratory or Blood Bank/Center or Point-of-Care Testing site or both.

Note: A laboratory and POCT may both be present at a facility site.

Note: A laboratory, as defined above, that uses POCT type assays (such as the Pima or rapid diagnostic tests) are to be counted as a laboratory.

How to review for data quality:

See how to report indicator

Reporting Level:

Site level, Facility only

Measurement frequency

Q4 only

Disaggregation

Numerator (required):

Number of laboratories and blood banks/centers

1. CQI

Is this PEPFARsupported Laboratory or Blood Bank/Center participating in a continuous quality improvement (CQI) program to achieve accreditation?

2. CQI

What is the current status of this laboratory or Blood Bank/Center toward achievement of accreditation, select one of the following options

3. PT

Does this PEPFARsupported laboratory or Blood Bank/Center participate in and successfully pass Proficiency Testing (PT) for either HIV diagnosis, EID, HIV VL, or TB

4. Test performed (required)

HIV Diagnostics, EID, HIV Viral Load, TB Xpert, TB AFB, TB Culture

5. PT participation and passing score (required)

HIV Diagnostics, EID, HIV Viral Load, TB Xpert, TB AFB, TB Culture

1. Perform Test;

2. Perform Test and participate in PT,

3. Perform Test and passed PT,

NA for each of the testing categories not performed at the site

Description of Disaggregate

1. Yes/No N/A

2. -1) Not Audited

-2.2) Externally audited but does not meet full accreditation standards,

-2.3.) Fully Accredited

3. 1) Perform Test 2) Participate in PT 3) Pass PT

4. -

5. Only applicable if specific test is performed. The most recent PT panel must be scored satisfactory to be counted as a passing score.

Denominator N/A

 

Explanation of the numerator

A. Number of PEPFAR-supported laboratories and blood centers/banks either participating in/and not participating in a CQI program to achieve accreditation.

B. Number of PEPFAR-supported laboratories and blood centers/banks which have been externally audited but do not meet full accreditation standards, and the number which are fully accredited.$ C. Number of laboratories and blood centers/banks performing any of following tests: HIV Diagnosis, Early Infant Diagnosis (EID), HIV viral load, TB Xpert, TB Acid-fast bacillus (AFB) smear, or TB culture. If performing the analytic-specific test, the number of laboratories and blood centers/banks participating in and passing PT test for the analytic -specific test.

Further information

MER 1.0 to 2.0 Change

This indicator is a combination of LAB_PT and LAB_CQI.

PEPFAR Support definition

DSD:

Sites will be counted as receiving direct service delivery support from PEPFAR with provision of key staff, on-site mentoring, infrastructure, information systems, maintenance service, equipment, or commodities.

TA-SDI:

Sites will be counted as supported through TA-SDI when the point of service delivery receives support from PEPFAR that meets to improve the quality of services with trainings, mentoring, and services offered at a national or sub-national level.

DREAMS SNU Specific Guidance

None