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Clinical Assessment for Systems Strengthening (ClASS)
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CLINICAL MODULE
INTRODUCTION TO THE TOOL
The Clinical Module of the ClASS Toolkit is a guide, not a checklist, for reviewers conducting assessments of health facilities or
programs providing or supporting patient care services (e.g., local agencies such as nongovernmental or governmental
organizations). The first 10 sections have been used for assessing the comprehensiveness and quality of services provided at
treatment sites or programs, and the last four for assessing the ability to provide clinical technical support and oversight to
beneficiary organizations. Areas of competency have been linked with references, wherever possible, with WHO and other
international standards or best practices in clinical care and treatment. Reviewers should also always reference local National
standards for each country in which an assessment occurs to see if their guidelines/standards differ in any way.
The Module is divided into 14 sections covering the following areas:
1.
2.
3.
4.
Facility, Staffing & Services
Clinical Care & Oversight
Infection Control
Maternal, Infant, Child Health & Pediatric HIV
Services
5. Referrals & Access to Relevant Services
6. Pharmacy & Supply Chain Management
7. Quality Improvement &Performance Monitoring
8.
9.
10.
11.
12.
13.
14.
Laboratory & Other Diagnostic Services
Client/Patient Involvement in Care
Health Management Information Systems
Clinical/Technical Capacity
Clinical/Technical Support Approaches
Clinical/Technical Support Outcomes
Ongoing Program Support: Critical Gaps and
Technical Assistance Needs
Each section begins with a set of core competencies followed by a series of questions that can be used to facilitate discussions with
organization representatives. Verification criteria for the most important core competencies and questions follow along with space
for reviewers to make notes. Reviewers should not feel compelled to complete the tool sections in the order presented, but should
proceed with flexibility to accommodate the time and availability of staff.
It is assumed that there will be at least six hours available to reviewers at each site in order to allow for completion of the tool.
When time is limited, reviewers should determine which sections to prioritize. In such a rapid visit, the highlighted competencies in
the various sections should be addressed; these items are denoted in bold-face type. Reviewers will find that all of the sections of
the tool will not apply to all types and levels of facilities/organizations. For example, some sections may not apply to health centers
or other lower level facilities. The decisions on which sections to use or prioritize should be made after the opening presentation
and in consultation with the team lead.
Note: Section 10 covers the key HMIS core competencies but should also be accompanied by a review of the patient’s medical
records. Additional tools for conducting a systematic chart review for adult, pediatric and PMTCT clients are provided. The reviewer
should decide on an appropriate number of charts for review to get a good understanding of both cross sectional and longitudinal
care and a quick determination of the quality of documentation and overall quality of care. Where time does not allow a systematic
chart review, a detailed review of two or three charts should be done focusing on continuity of care and level of documentation.
International standards and best practices referenced in this module were identified from the following resources:
“Operations manual for delivery of HIV prevention, care and treatment at primary health centres in high-prevalence, resourceconstrained settings” WHO December, 2008 (cited as IMAI OM); “Consolidated Guidelines on the Use of Antiretroviral Drugs for
Treating and Preventing HIV Infection” WHO, June 2013; The President‘s Emergency Plan for AIDS Relief Technical Considerations
Provided by PEPFAR Technical Working Groups for FY 2012 COPS and ROPS; “Outreach Services as a strategy to increase access to
health workers in remote and rural areas” WHO, 2011; PEPFAR Guidance on Integrating Prevention of Mother to Child Transmission
of HIV, Maternal, Neonatal, and Child Health and Pediatric HIV Services, January 2011; “Managing Drug Supply Series”, MSH
Resource Center, January, 2000; “Essential prevention and care interventions for adults and adolescents living with HIV in resourcelimited settings”, WHO, July, 2008; Global Laboratory Initiative, WHO, 2007; PQS Performance Specification, WHO, 2007.
ClASS Clinical Module | Revised January, 2014
CLINICAL ASSESSMENT FOR SYSTEMS STRENGTHENING
ClASS Clinical Module
REVIEWER: _______________________ DATE: _____________
SITE: _______________________________________________
KEY: Rapid visit items-Bold| Extended visit items: All
SECTION 1: FACILITY STAFFING & SERVICES
Core Competencies:

The facility provides a comprehensive range of convenient and integrated services, either onsite or by referral
(IMAI Operations Manual (OM), Chapters 2 and 3)


Staffing number, mix, qualifications, and expertise consistently meet client needs. (IMAI OM, Chapter 9)
Hours of operation, services and space consistently meet client needs and the overall demand for services
OM, Chapter 5)

The facility provides outreach services through mobile clinics and/or support to lower-level facilities (WHO
Technical Report Number 2, “Increasing Access to Health Care Workers in Rural and Remote Areas” (2011)
Open-Ended Questions:

What services are provided to HIV-positive patients either at the facility or by referral?

Do the services provided meet client needs?

Does the current staffing meet current needs?
Performance Criteria
The facility provides a
comprehensive range of
1. convenient and integrated
services, either onsite or
by referral.
The facility and services
2. meet client and
service/program needs
Verification Information
a. The following services are provided:
 HIV counseling and testing; PITC and VCT.
 HIV care and treatment (outpatient)
 Inpatient services.
 TB/HIV treatment.
 Primary care.
 Orphans & vulnerable children (OVC)
 Home-based care (HBC).
 Reproductive health (RH) services.
 Maternal, infant, and child health (MICH)
services, including PMTCT
 Prevention interventions (e.g., condoms, male
circumcision, post-exposure prophylaxis (PEP))
 Lab and other diagnostic services.
 Screening for oral diseases and oral cancer.
 Oral health education.
 Support groups.
b. Outreach services are provided:
 The facility supports delivery of HIV services at
lower-level facilities or satellites.
 Other Outreach services are provided (Specify)
a. Service days and hours are displayed in the
appropriate languages.
b. Facility is clean.
c. There are adequate waiting, counseling and
ClASS Clinical Module | Revised January, 2014
Comments
Page 1
(IMAI
3.
Services are easily
accessible to patients.
Staffing number, mix,
qualifications, and expertise
4. consistently meet client
needs
When locally allowed or
necessary, task shifting/
5.
sharing strategies are
implemented, including:
examination areas for clients.
d. Clinical areas provide confidentiality.
e. Counseling rooms provide confidentiality.
f. There are marked emergency exits.
g. There is safety equipment.
h. There is running water.
i. There is electricity.
j. There is a functioning back-up generator.
a. Family days (adults and pediatrics) are specified.
b. Evening and/or weekend services are provided.
c. Service areas are well marked.
d. There is simple and easy patient flow for different
visit types between points of service delivery
e. Services are free; if there is a service fee, it is
affordable and can be waived for patients who
cannot afford.
f. There is a designated reception/ registration area to
facilitate patient access to services.
g. Clients with physical disabilities have easy access to
the premises.
h. The facility is easily accessible by public
transportation.
a.Staff number and mix meet local/ national
requirements.
b. The staff is competent and has received adequate
training:
 All HIV clinic staff has received basic HIV/AIDS
training.
 All medical providers/clinicians have received
advanced HIV/AIDS training.
 There are trained pediatric HIV/AIDS providers.
 There are trained TB/HIV providers.
c. There is access to trained and supervised volunteers.
d. There is access to trained and supervised expert
patients.
a. Task shifting from Medical Officers to Clinical
Officers.
b. Task shifting from MO/CO to nurses for such tasks
as drug refills and follow-up care of stable patients.
c. Task shifting from nurses to lay workers or expert
patients.
d. Task shifting from facility care to community care.
ClASS Clinical Module | Revised January, 2014
Page 2
Notes:
SECTION 2: CLINICAL CARE & OVERSIGHT
Core Competencies:

Providers have access to experienced consultation, relevant training, mentoring and supportive supervision.

(IMAI OM, Chapters 9.3 and 9.4)


(WHO
Patients
are scheduled, and appointments are tracked, and patients are actively retained into care. (IMAI OM,
Volume 2, Section 13.5 and 13.11; IMAI OM, Chapter 6)

Management uses local data to monitor volume and quality of services. (IMAI OM, Chapter 6)

Open-Ended Questions:

How are training needs assessed and how do staff obtain expert consultation, mentoring and or supportive

What
system exists to schedule appointments and retain patients in the program (Pre-ART and ART)?
supervision?
Performance Criteria
The HIV clinic has a strong
clinical management team
1. with the authority to make
clinical and management
decisions.
Verification Information
Comments
a. Clinical team meetings held.
b. Clinical team meeting minutes kept.
c. Team has multi-disciplinary members.
d. Clinical team regularly looks at HMIS data to make
clinical and management decisions.
a. There is an effective process/ system for scheduling
patients.
The clinic has an effective
process or system for
2. scheduling patients and
follow-up of missed
appointments.
b. What systems are utilized to follow missed
appointments or address loss to follow up among
ART patients
 Running timely reports
 FU phone calls
 Using community health volunteers.
 PLHIV support groups.
 Adherence buddies/treatment supporters.
 HBC team
 Other active processes (specify).
c. What systems are utilized to follow missed
appointments or address loss to follow up among
pre-ART patients:
 Running timely reports.

FU phone calls.

Using community health volunteers.

PLHIV support groups

Adherence buddies/treatment supporters.
ClASS Clinical Module | Revised January, 2014
Page 3
3.
Treatment guidelines or
protocols are used.
4.
Patient visit procedures are
well streamlined.
Clinical staff have sufficient
5. opportunities for
consultation.

HBC team

Other active processes.
d. No active system exists to follow-up missed
appointments
a. There is a copy of most recent guideline in clinic.
b. There are written SOPs for most key clinical
activities.
a. There is a written patient flow & triage processes.
b. There are specific processes and procedures for the
following:
 Enrollment in care
 Initial visit.
 Initiation of ART.
 Follow-up or refill visits.
 Urgent care/emergencies.
a. Experienced providers are accessible for immediate
consultation:
 At the clinic.
 By phone.
 Clinicians have internet access at their
workstations.
 Clinicians have onsite access to relevant clinical
literature.
 No consultative resources are immediately
available.
b. Experienced providers provide consultation,
monitor the quality of care, assess training needs,
and mentor staff:
 They are based on site.
 They are based at a higher-level facility.
 They visit the clinic on scheduled days.
 No experienced provider monitors the quality of
care, assesses training needs, or mentors the
staff.
Notes:
ClASS Clinical Module | Revised January, 2014
Page 4
SECTION 3: INFECTION CONTROL
Core Competencies:

Facility provides a safe environment for staff and patients. (IMAI OM, Chapter 6; WHO 2013, Chapter 8)

TB prevention interventions are prioritized. (IMAI, Vol. 1, Section 6.12; Volume 2, Chapter 14)

Processes exist to minimize the risk of infection after exposure to infectious material (IMAI, Vol. 1, Chapter 6, Section 6.9
and IMAI, Vol. 2, Sections 19.4 and 19.5)

Staff are trained in basic infection control. (IMAI, Vol. 1, Chapter 6; Vol. 2, Section 19.4)
Open-Ended Questions:

What policies and procedures are in place to protect staff and patients from infectious agents and manage
those exposed?

What activities are promoted to reduce the risk of TB transmission at the facility?

How is staff trained on infection control procedures?

How is medical waste handled?
Performance Criteria
There are written policies
1. and procedures for
infection control (IC).
2.
Staffs practice infection
control interventions
Verification Information
Comments
a. IC procedures are displayed or IC policy document is
in the clinic.
b. No policy is available
a. There is running water for hand washing in relevant
places.
b. Relevant protective gear is available:
 Sterile gloves
 Uniforms (lab coats, aprons) are worn by staff.
 Masks are worn by coughing patients.
 N95 masks (if handling TB) are available to staff.
 Staff follows universal precautions.
a. There is a written TB infection control plan.
There are procedures to
3. reduce exposure of staff
and patients to TB.
b. Coughing patients are identified at first point of
contact within the facility.
c.HIV patients are screened for TB at every visit (state
actual % screened out of a random sample of charts
assessed if possible).
d. Once identified, TB suspects or patients:
 Use a designated space away from other patients
(Outpatient – Inpatient).
 Use facemasks while at the clinic.
 Are fast tracked.
e. The following strategies are used to decrease the
risk of transmission of TB:
 Waiting rooms and exam rooms are wellventilated.
 TB cases are promptly started on therapy.
 TB cases are isolated from other patients until
ClASS Clinical Module | Revised January, 2014
Page 5
they are potentially not infectious.
f. IPT is implemented at the facility per national
guidelines
There are procedures in
place
a. for handling medical
4. and non-medical waste and
sharps.
Post-exposure
c. 5
prophylaxis
5. (PEP) is readily available.
a. There are official policies and procedures for
handling waste and sharps.
b. There are separate waste disposal containers (for
regular waste, for potentially infectious waste, and
for sharps) in all clinical areas.
c. Potential infectious waste is incinerated onsite.
a. There are written procedures in case of exposure to
blood and other potentially infectious body fluids.
b. PEP protocol is displayed.
c. There is access to PEP at all times.
d. Staff has been trained and is aware of PEP policies
and procedures.
Notes:
SECTION 4: MATERNAL, INFANT , CHILD HEALTH (MICH) & PEDIATRIC HIV SERVICES
Core Competencies:

HIV-positive pregnant women and HIV-positive or exposed infants have convenient access to all relevant
services (e.g., HCT, ART, FP, STI care, counseling, PwP, EID, nutritional support, education). (IMAI, Vol. 2, Chapter 14,
14.1; PEPFAR Guidance on Integration of PMTCT and MNCH, January 2011; WHO June 2013, chapters 5, 7, 10)

PMTCT is integrated in antenatal services and other MICH activities. (PEPFAR Guidance on Integration of PMTCT and MNCH,
January 2011; WHO June 2013, Chapter 9)

Services are age-appropriate, including those for HIV-positive adolescents. (IMAI, Vol. 2, Section 13.14; WHO June 2013,
Chapters 5, 7-9)
Open-Ended Questions:

What services are available to HIV-positive or exposed pregnant women, mothers, and children?

How are PMTCT services integrated with other clinic (MICH) activities?

What linkages exist between PMTCT, other MICH activities, hospital and community services?

What specific services are available to HIV-infected adolescents?
ClASS Clinical Module | Revised January, 2014
Page 6
Performance Criteria
Pregnant women and their
HIV-positive/exposed
1. infants have access to a
range of high quality
services.
PMTCT is integrated into
2. other maternal infant and
child health programs.
3.
There are linkages between
different services.
4.
Pediatric HIV services are
age-appropriate.
Verification Information
Comments
a. Staff have received relevant training on PMTCT,
pediatric HIV care and treatment, and adult HIV
care and treatment).
b. PMTCT interventions follow national guidelines.
c. Pediatric HIV care and treatment follows national
guidelines.
d. Adult HIV care and treatment follow national
guidelines.
e. The following services are available onsite:
 HCT (couple HCT, EID, children HCT).
 CD4 testing, including CD4 %.
 General antenatal care.
 Prophylactic or therapeutic ART for pregnant
women

Prophylactic ART for the newborn.
Intrapartum care/labor and delivery.
 Post-natal care and growth monitoring
 Counseling on feeding options are AFASS.
 Free breast milk substitutes.
 Screening for STIs, TB, and OIs.
 Comprehensive range of family planning services.
 Management of opportunistic infections.
 Prevention with Positives (PwP).
 OVC and psychosocial services.
 Home ARV prophylaxis for mothers.
 Home ARV prophylaxis for infants.
 Adult HIV care and treatment.
 Pediatric HIV care and treatment (% of Children
on ART out of all patients on currently on ART).
 Cotrimoxazole prophylaxis.
a. ANC and PMTCT services are integrated or colocated.
b. Staff are cross-trained in PMTCT, and adult &
pediatric HIV care.
c. There is a pediatrician on staff.
d. There are dedicated days for children/ adults.
e. HIV-positive children and mothers receive care
from the same provider (as family-based care).
f. Immunizations are available onsite.
g. Cotrimoxazole prophylaxis is provided from 6
weeks of age.
a. Referrals are used and tracked.
b. There are services to track mothers and infants in
the community.
a. Pediatric counseling and age-appropriate HIV
status disclosure is provided.

ClASS Clinical Module | Revised January, 2014
Page 7
b. Adolescent services are provided.
c. The clinic is child-friendly.
Notes:
SECTION 5: REFERRALS & ACCESS TO OTHER RELEVANT SERVICES
Core Competencies:

The facility has documented relationships with other service providers, particularly for services it is unable to
provide. (IMAI OM, Chapter 3.3)

Referrals are properly documented and followed up. (IMAI OM, Chapter 6)

A functional referral network is in place. (IMAI, Vol. 1, Pages 79-71, 217; IMAI OM, Chapter 6)
Open-Ended Questions

What formal relationships does the facility maintain with other service providers for services it does not provide
and how do PLHIV access those services?

Where are patients referred for key services the clinic/organization is unable to provide?

What systems are currently in place to document and monitor referrals and send or receive feedback between
the different facilities?
Performance Criteria
The referral process is
standardized and
1.
systematic.
Verification Information
Comments
a. A standard referral form is used.
b. Referral form is part of national patient
management forms.
c. Referrals are recorded and tracked.
a. Feedback from referrals is tracked.
b. Referral logs are used.
a. TB treatment.
b. Nutrition support services.
c. Psychosocial services.
Relevant services are readily
d. RH/FP services.
3. available in the community,
e. Pain management/end-of-life care.
including:
f. Community-based care/HBC.
g. Support groups.
h. Oral health services (preventive and curative)
2.
There is feedback to and
from referral sites.
ClASS Clinical Module | Revised January, 2014
Page 8
Notes:
SECTION 6: QUALITY IMPROVEMENT & PERFORMANCE MONITORING
Core Competencies

The clinic has a quality improvement process. (IMAI OM, Chapter 11)

The facility has set key performance indicators and uses them to improve patient care. (IMAI OM, Chapter 11; WHO June
2013, Chapter 11)
Open-Ended Questions

What is the process and who is involved in the process for identifying and clinical systems problems and making
improvements?

How does the program utilize local data to improve the quality of services?

What is the process for documenting improvements and sharing them with staff?
Performance Criteria
1.
The clinic has a process for
quality improvement.
Verification Information
a. A QI team exists.
b. A written QI plan exists.
c. A report of QI activities is available for the last year.
d. Minutes of QI meetings are kept.
e. The following QI activities are documented:
 Charts review process.
 Retention in care/Loss-to-follow-up.
 Mortality meetings.
Comments
a. Medical charts peer-review.
b. Nursing notes peer-review
c. Counselor notes peer-review
a. Indicators are set / displayed.
Clinical indicators and
b. Indicators are monitored on a timely basis.
targets are set and
monitored on a timely basis. c. Clinic met last year’s targets for:
Last year’s targets were
 HIV testing.
met.
3.
 Enrollment in HIV care (cumulative, new, or
The following peer-review
2.
processes are in use:
ClASS Clinical Module | Revised January, 2014
Page 9
current).
 Enrollment in ART care (new or current).
 Retention on ART.
 Pediatric care (cumulative, new, or current).
 Pediatric ART (new or current and as % of all on
ART).
Notes:
SECTION 7: PHARMACY & MEDICINES SUPPLY
Core Competencies

Monitoring systems are in place to ensure the continuous availability of medicines for all HIV services (e.g., ART,
opportunistic infections, palliative care). (msh.org/resource-center, managing drug supply; WHO June 2013, Chapter 9)

Patients receiving medications are given adequate information about their treatment and adherence to
treatment is assessed. (msh.org/resource-center, managing drug supply; WHO June 2013, Chapter 9)

Processes are in place to prevent dispensing errors and to track missed pharmacy appointments. (msh.org/resourcecenter, managing drug supply)
Open-Ended Questions

What systems are in place to ensure the adequate and uninterrupted supply of medicines, laboratory reagents
and other consumables?

Over the last 12 months, how many stock-outs of ARV, lab reagents and OI drugs occurred? For each, describe
their duration and cause(s)?

What systems are in place to dispose of expired medications?

How is adherence assessed and ensured at the pharmacy?
Performance Criteria
Verification Information
Comments
a. Drug supplies are:

Part of the national supply chain;
Sourced locally by the facility from pharmacies;
Supplied by the international partner;

Supplied by Partner

There is an effective supply
1. system for medications/
pharmaceuticals.

b. Inventories are separated by supply source.
c. Consumption data is collected either electronically
or on paper documents.
ClASS Clinical Module | Revised January, 2014
Page 10
d. Stock monitoring is up-to-date.
e. An effective forecasting system is in place.
f. An effective ordering system is in place.
g. There is at least a 2 month buffer stock for ARVs.
Pharmaceuticals are stored
2. securely and safely and
dispensed safely.
Patients are given adequate
3. information about their
medications.
There is an effective supply
chain system and supplies
4.
are stored securely and
safely.
5.
There have been no
stockouts of ARVs, OI drugs
a. There are designated secured storage area onsite
(e.g., warehouse, pharmacy, dispensing areas).
b. Drugs are stored within the required temperature
and humidity ranges.
c. In the storage facilities, temperature is documented
appropriately.
d. There are no expired drugs on the shelves.
e. There is a record of expired drugs and their
disposition.
f. There is a process to first dispense drugs with shorter
expiration dates.
g. Pharmacist(s), clinic director and others (specify)
have the keys to the pharmacy.
h. A dedicated pharmacist or legally certified
dispenser is present during regular clinic hours.
i. Only the pharmacist(s) and other legally certified
staff dispense medications. Specify who dispenses.
j. There are processes to minimize prescribing and
dispensing errors (e.g., pre-printed prescriptions,
verification of drug switches, electronic dispensing
tools).
a. Patients are counseled on how to store and
administer drugs, and on how to minimize potential
side effects and safely stop ART.
b. There are separate procedures for patients
initiating ART and for those needing refills.
c. Records are kept, either electronically or in paper
form, of who gets what medication.
d. There is a dedicated space for adherence
assessment and counseling.
e. Adherence is regularly assessed by the dispenser
either through pill count or patient self-reports.
a. Inventories are separated by supply source.
b. Supply stocks are monitored.
c. An effective forecasting system is in place.
d. An effective ordering system is in place.
e. There is an alternative mechanism for emergency
supplies.
f. For supplies purchased locally, an efficient and
competitive process is used.
g. There are designated secured storage facilities
onsite.
a. A stockout of ARVs occurred in the past 12 months.
If so, of which ARVs? How often and how long did
ClASS Clinical Module | Revised January, 2014
Page 11
and lab reagents in the past
12 months.
each last?
b. A stockout of OI drugs occurred in the past 12
months. If so, of which OI drugs? How often and
how long did each last?
c. A stockout of lab reagents occurred in the past 12
months. If so, for which tests? How often and how
long did each last?
Notes:
ClASS Clinical Module | Revised January, 2014
Page 12
SECTION 8: LABORATORY & OTHER DIAGNOSTIC SERVICES
Core Competencies

Patients have access to essential lab tests and other diagnostic services onsite or through specimen referrals.
(IMAI OM, Chapter 8; WHO June 2013, Chapter 9)






Staff numbers, skills, lab space, equipment and reagents meet facility needs at all times. (IMAI OM, Chapter 8.20-8.21)
HIV-related lab services are integrated with those of the entire facility (Global Laboratory Initiative, WHO, 2007)
Equipment maintenance and service/repair contracts are available and up-to-date. (IMAI OM, Chapter 8.22)
Standard operating procedures (SOPs) are available for relevant lab tests. (MAI OM, Chapter 8.5)
Tests and appropriate controls are conducted following SOPs. (IMAI OM, Chapter 8.5)
The cold chain for reagents is maintained and monitored at all times. (WHO/PQS/E06/IN0 2.1, 2006)
Open-Ended Questions

Which HIV-related lab investigations are conducted onsite and how are they integrated within the hospital lab?

What procedures are in place to ensure accurate/high quality results? (Probe: SOPs, training, QC, equipment
service contracts, information systems)

What systems are currently in place to ensure that equipment is regularly serviced?

What processes are in place to ensure that the cold chain for reagents is constantly maintained?
Performance Criteria
Reliable laboratory tests
are performed; results are
1.
accurately recorded and
confidentiality ensured.
Verification Information
a. There is a designated lab where HIV-related tests
are performed.
b. Qualified lab scientists supervise the lab.
c. SOPs are available, displayed, and followed for all
tests performed onsite.
d. Staffs who perform testing have received
appropriate training.
e. Staffs have access to unexpired reagents and
controls for all testing performed onsite.
f. Testing platforms utilized are on the government
approved list.
g. Testing platforms utilized respond to local needs
(through output, turnaround time, staff time and skill
levels, space and supply requirements).
h. A laboratory information system is in place to
ensure confidentiality and the correct reporting of
results.
i. Lab results are given to providers in a timely
fashion.
j. Processes are in place for urgent testing.
k. Processes are in place to expedite the reporting of
critical results.
l. The lab has reliable electrical power.
m. The lab has reliable access to clean water (or sterile
water if indicated).
n. Cold chain is maintained for all reagents.
ClASS Clinical Module | Revised January, 2014
Comments
Page 13
The lab is equipped to conduct the following (Tick
the relevant column):
a. HIV testing and confirmation tests

ONSITE
BY REFERRAL
HIV antibody testing / Rapid Tests
PCR DNA / EID
b. Monitoring Testing:
 Hemoglobin only
 Full blood count and differential
 Pregnancy tests
 CD4 count
 CD4 percentage
 Viral load (RNA quantitative)
 Serum chemistries (ALT, Creatinine)
 Blood glucose
 Lipid profile
 HIV resistance testing
c. Lab diagnosis of opportunistic infections and other
co-morbidities
 Sputum smear microscopy for AFB
 Rapid syphilis testing
 Gram stain
 Indian ink or cryptococcal antigen
 TB culture
 Hepatitis B surface antigen (rapid HBs Ag)
a. There is an up-to-date written record documenting ‘
the inspection, testing, calibration and maintenance
schedules for all equipment, including pipettes.
b. There is a record of how Internal QA and QC are
done.

Patients have access to an
2. extensive range of
laboratory services
The laboratory is regularly
inspected, the equipment
is maintained and
3.
calibrated, and processes
are in place to ensure
quality testing.
4.
Patients have access to
imaging tests.
c. There is a record of how External QA (EQA) and QC
are ensured.
d. EQA and proficiency testing has been conducted
within the past year. Results of the EQA support the
provision of quality services.
a. X-ray is available on-site
b. Abdominal ultrasonography on- site
c. Equipment properly maintained.
d. Imaging staff are qualified and sufficiently trained.
ClASS Clinical Module | Revised January, 2014
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Notes:
SECTION 9: PATIENT INVOLVEMENT IN CARE
Core Competencies:

Health education is provided regularly. (WHO OMS_EPP_AFF; IMAI OM, Chapter 4; WHO June 2013, Chapter 9)

Patients/clients are empowered to be active participants in the management of their care. (IMAI OM, Chapter 4)

The organization/facility gathers and incorporates feedback from clients and the community on priority health
needs. (IMAI OM, Chapter 4)
Questions:

What health education do clients receive, who provides it and in what form?

What are the ways in which clients provide input or feedback to the program/facility?

What is done to empower PLWHA to become full participants in decisions about their care?
Performance Criteria
Patient understanding of
his/her condition and
1.
associated beliefs are
assessed.
2.
Health education is
provided.
Patient informed consent is
3. obtained for major care
decisions.
Verification Information
Comments
Patient understanding and acceptance of their
disease is documented in the medical or nursing
record.
a.Posters and other reading materials are displayed
in appropriate/relevant languages.
b. Health education sessions are documented in the
medical or nursing chart and include the following:
date, subject, method, presenter, etc.
c. Education sessions are provided for individuals or
groups.
d. PLWHA understanding is assessed and documented
after each education session.
a. There is a process and/or procedures for notifying
partners.
b. There is a process for and documentation of client
agreement for family member HIV testing.
c. Documentation of client agreement for starting
ART.
ClASS Clinical Module | Revised January, 2014
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There are opportunities for
patients to contribute to
4.
decision making regarding
services they obtain.
d. Documentation of client agreement for invasive
procedures.
a. There is documentation of patient surveys at the
facility.
b. There is documentation of community surveys or
other feedback.
c. Suggestion boxes are available and opinions
expressed are analyzed and acted upon.
d. Patients are enrolled in support groups;
e. Support groups are age and/or gender specific.
Notes:
SECTION 10: HEALTH MANAGEMENT INFORMATION SYSTEMS
Core Competencies

A formalized system exists for the maintenance and organization of medical records. (IMAI OM, Chapter 6, Annex 6)

HMIS staff is able to provide data summaries and reports that enable assessment of the quality of care. (IMAI OM,
Chapter 6, Annex 6)



HMIS ensures the confidentiality, security, and accuracy of patient data. (IMAI OM, Chapter 6, Annex 6)
Records are maintained in a consistent and organized manner. (IMAI OM, Chapter 6, Annex 6)
Relevant staff have received HMIS training, mentoring and supportive supervision. (IMAI OM, Chapter 6, Annex 6)
Open-Ended Questions

What system is used to capture, organize and report clinic data?

What processes are used to enhance data quality?

Is the health information system able to generate reliable clinic performance outcome (and process) measures
and aggregate reports?

To what extent is the health information system customizable so that it can be modified rapidly to respond to
new/ changing data collection and reporting needs?

Do staffing numbers, skills sets and HMIS system meet clinic needs?
Performance Criteria
1.
A formalized medical
record system is in place.
Verification Information
The clinic medical record system is:
a. Paper-based or electronic.
ClASS Clinical Module | Revised January, 2014
Comments
Page 16
Patient medical records
2. are standardized and
structured.
3.
Records are systematically
filed and safely stored.
4.
Medical record flows are
organized.
b. Governed by written policies/ procedures.
c. No uniform formalized records are used.
d. Standardized forms are used for patient care and
data collection.
e. When required, national forms are used.
f. Each patient record is identified by a unique
identifier or by name or both.
a. Paper-based:
 In lockable cabinets.
 In a lockable room.
 There is a designated Records Officer(s).
b. Electronic
 Computers are housed in a lockable room.
 User passwords are maintained.
 Data is regularly backed up.
 Back-ups are securely stored.
 There is a person responsible for data storage
and security.
There is a system for the following:
a. Sharing data between the HIV clinic and other
facility departments.
b. Separating inactive (e.g., dead, transfer-out, or lostto-follow-up) patient files from active ones.
c. Tracking checked-out records within the facility.
Medical records are
5. checked for completeness
and accuracy.
Medical records are checked:
a. Manually or electronically at fixed intervals.
b. Through a peer review process.
a. Patient-level databases are up-to-date. There is no
backlog.
b. The DQA processes ensure that data contained in
the database is reliable.
c. The data-entry staff has been adequately trained.
Patient-level electronic
databases are up-to-date,
6. accurate, utilized, and
protected.
d. The Data Officer(s) has been trained on running
customized reports.
e. The database is regularly backed-up; backed-up
data are securely stored in a separate building.
f. The database is regularly backed-up; backed-up
data are securely stored in a separate building.
g. Only encrypted or de-identified patient-level data
are shared outside of the facility.
h. If the database is used for research, the research
has received all appropriate local ethical clearances.
ClASS Clinical Module | Revised January, 2014
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Notes:
ClASS Clinical Module | Revised January, 2014
Page 18
Please Note: Sections 11-14 of this module are for reviewers conducting assessments of organizations that
support patient care services (e.g., local agencies such as nongovernmental or governmental organizations).
These sections assess the partner organization’s ability to provide clinical technical support and oversight to
beneficiary organizations.
SECTION 11: CLINICAL/TECHNICAL SUPPORT CAPACITY
Core Competencies

Partner provides support at various levels (e.g., local/district, state/provincial/regional and/or national).

Partner directly provides and/or supports a comprehensive range of integrated HIV care and treatment
services at sites.

Partner possesses the clinical/technical capacity in key service areas (e.g., continuous quality improvement
(CQI), laboratory, pharmacy, supply chain management (SCM), monitoring and evaluation (M&E), use of data
and strategic information (SI), costing analysis, etc.) to support HIV care and treatment.

Local (e.g., MOH, other local organizations) and/or USG (e.g., CDC, USAID) resources and/or expertise are used.
Open-Ended Questions

What support is provided by the Partner to various levels of the health care system (e.g., local/district,
state/provincial/regional and/or national)?

What does the Partner/organization do to support of HIV care and treatment? Provide examples.

What collaborations are there between the Partner and the MOH, other donors and/or implementing
partners?

Does the Partner possess the clinical/technical capacity (e.g., staffing, equipment, and infrastructure) in key
service areas to support HIV care and treatment (e.g., CQI, laboratory, pharmacy, SCM, M&E, use of data and
SI, costing analysis, etc.)?

To what extent are local (e.g., MOH, other local organizations) and/or USG (e.g., CDC, USAID) resources and/or
expertise used?
Performance Criteria
1.
2.
Current beneficiaries of
the Partner
clinical/technical support
include:
Clinical/technical areas of
support includes:
Verification Information
a. National government (policy, guidelines
development, advocacy)
i. MOH at various levels: local/ district,
state/provincial/regional
ii. National HIV/AIDS Control Program and/or
related offices
b. Other local organizations: faith-based networks,
universities, NGOs, PLWHA groups, CBOs, etc.
i. Clinical sites: tertiary/referral centers,
district/secondary hospitals, primary health
facilities and or dispensaries.
ii. Community-based service providers.
Comments
a. Primary health care, including preventive
oral/dental care.
b. Care and treatment and related services: HIV
counseling and testing (HCT); voluntary counseling
and testing (VCT); provider-initiated counseling and
testing (PICT); adult and pediatric TB/HIV care.
ClASS Clinical Module | Revised January, 2014
Page 19
c. Prevention, including sexual health, male
circumcision, and abstinence-based programs.
3.
4.
d. Maternal, neonatal, and child health (MNCH), family
planning (FP), prevention of mother-to-child
transmission (PMTCT).
e. Other support: home-based care, community-based
care, orphans and vulnerable children (OVC)
support, psycho-social care, and people living with
HIV (PLHIV) empowerment.
a. CQI, laboratory, pharmacy, SCM, M&E, SI/data use,
costing analysis, etc.
b. Direct support versus support-through-subcontracts
Partner has capacity for or
for several or all areas identified in 3a.
currently provides the
c. Clinical HIV expertise: at: local, district, region,
following;
national and/or international level.
d. Adequate staffing (i.e., levels and
expertise/experience) to meet; (i) present and (ii)
projected/post-transition program needs.
When available, the Partner utilizes or has utilized USG resources and/or expertise.
Notes:
SECTION 12: CLINICAL/TECHNICAL SUPPORT APPROACHES
Core Competencies
 Partner uses evidence-based approaches to assess needs, train, mentor, and provide supportive supervision.
 A CQI strategy/plan is in place and ensures the monitoring, documentation and sharing of success stories and
best practices
Open-Ended Questions
 To what extent does the Partner use evidence-based approach to assess needs, train, mentor, and provide
supportive supervision?
ClASS Clinical Module | Revised January, 2014
Page 20

What plans does the Partner currently have to ensure monitoring, documentation and sharing of success
stories and best practices/through CQI?
Performance Criteria
1.
Partner approaches to
clinical/technical support:
Verification Information
a. Reflect a needs assessment conducted with the
involvement of beneficiary sites/organizations;
b. Include centralized trainings (e.g., curriculum
enhancement, didactic sessions, in-service upgrade
training and other adult learning methodologies,
ToT, step down or cascade training);
c. Incorporate “on-site” trainings and/or distance
learning; and
Comments
d. Provide real-time access to expertise via cell phone,
e-mail and/or distance consultation.
2.
Mentoring/supportive
supervision is provided
through a
multidisciplinary team.
CQI applied to clinical/
technical support
3.
activities provided,
including:
Notes:
a. Teams include experts on several specialties (e.g.,
site management, clinical, lab, CQI, M&E).
b. Mentoring/supportive supervision can be verified
and/or assessed by examining the following:
i. Monitoring or report forms documenting
frequency and duration of visits;
ii. Written trip reports, which contain both action
points and issues lists; and
iii. Follow-up visits and subsequent reports
providing an overview of progress to-date.
a. Outcome/performance measurement; and
b. Specific CQI activities (e.g., plan-do-check-act
(PDCA) activities, small tests of change).
SECTION 13: CLINICAL/TECHNICAL SUPPORT OUTCOMES
Core Competencies

Partner is able to use different approaches to monitor and evaluate the clinical/technical support activities it
provides.

Partner is able to track and report on clinical/technical support provided.
Open-Ended Questions

How does the Partner monitor and evaluate the clinical/technical support activities it provides?

How does the Partner ensure that it meets the needs of the beneficiary organization? Provide examples.
ClASS Clinical Module | Revised January, 2014
Page 21
1.
2.
3.
Performance Criteria
The outcomes of various clinical/technical support efforts are
measured.
Challenges in providing effective clinical/technical support are
identified and documented.
There are mechanisms to ensure that the clinical program
management provided meets the needs of the receiving
organization.
Comments
Notes:
SECTION 14: ONGOING PROGRAM SUPPORT- CRITICAL GAPS & TECHNICAL ASSISTANCE NEEDS
Core Competencies

The Partner has capacity to provide clinical support/support for all or some of the HIV/AIDS related
programs/services.
Open-Ended Questions

What services can the Partner fully support a) immediately; b) in the medium term, and c) only after
significant capacity building has taken place.

How will the Partner monitor and maintain the quality of service delivery?

What are the critical gaps that are currently NOT being addressed?
ClASS Clinical Module | Revised January, 2014
Page 22


1.
2.
3.
What are the common underlying issues that explain the gaps?
How can this underlying issue(s) be addressed? By whom? By when? What sorts of inputs will be needed?
Performance Criteria
Partner presently
possesses the capacity to
provide clinical oversight
for some or all of the
following program
components currently
provided by the
International Partner: CQI,
laboratory, pharmacy,
SCM, M&E/SI,
training/mentoring and
supportive supervision.
Verification Information
a. Which of the above-listed components does the
Partner presently have the capacity to take over?
b. Which of the above-listed activities CAN the
Partner rapidly take over with some capacity
building?
c. Which of the above-listed activities is the Partner
UNABLE to take over without major capacity
building?
d. Which of the above-listed activities does the
Partner plan to provide through subcontracts?
e. Identify the key remaining challenges and
proposed solutions related to the transfer of
service provision.
Written plans are in place to monitor and maintain the quality of clinical/technical
services?
Written plans are in place outlining the involvement of various levels of MOH –
(local/district, state/provincial/regional and national) in supporting the clinical
program.
If such plans are not presently available in a written form, describe any general
understandings among staff and stakeholders that exist on the matter and make
recommendations for formalizing these understandings.
Comments
Notes:
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