checklist to review quality management systems at ictcnacoprayogshala.in/nari/images/ictc_checklist...

1

Checklist to review Quality Management Systems at ICTC

Name of the ICTC

Name of the Reviewer(s):

Signature of Reviewer

Date of Review

The final percentage score and the grades to be filled by the reviewer

Operational (O) : .................

Technical (T) : .................

Monitoring & Evaluation (M&E) : .................

Logistics (L) : .................

Total Score :

.................... Percentage (%)

:

....................

Grade 1 Poor Immediate

remediation needed (0-29%)

Grade 2 Below Average

(30-54%)

Grade 3 Average (55-74%)

Grade 4 Above average

(75-89%)

Grade 5 Excellent

(90-100%)

2

AIDS Acquired Immunodeficiency Syndrome

CDC Centers for Disease Control and Prevention

DAPCU District AIDS Prevention & Control Unit

DMC Designated Microscopy Center

EQAS External Quality Assurance Scheme

FICTC Facility Integrated Counseling and Testing Center

GLP Good Laboratory Practice

HIV Human Immunodeficiency Virus

HRG High Risk Group

ICTC Integrated Counseling and Testing Centre

IEC Information Education and Communication

IQC Internal Quality Control

KP Key Population

LaQSH Laboratory Quality Systems in HIV

LT Lab Technician

NABL National Accreditation Board for Testing and Calibration Laboratories

NACO National AIDS Control Organization

PEP Post Exposure Prophylaxis

PPE Personal Protective Equipment

PID Patient Identification Digit

PPTCT Prevention of Parent to Child Transmission Center

QC Quality Control

QMS Quality Management Systems

QSE Quality Systems Essentials

SACS State AIDS Control Society

SOP Standard Operating Procedures SRL State Reference Laboratory

TI Targeted Intervention

UPS Uninterrupted Power Supply

WHO World Health Organization

Abbreviations

3

Checklist to Review Quality Management Systems at ICTC Quality Management Systems (QMS) can be implemented in a stepwise approach through

systematic planning. In order to a establish QMS at ICTCs, NACO along with CDC and SHARE India

propose to develop through this checklist optimum quality standards that need to be

implemented in the ICTCs. This also helps to review the set minimum quality standards at ICTCs

and take necessary corrective actions for Continual Quality Improvement (CQI).

This checklist specifies the optimum requirements for ICTC services in terms of sample

collection, disinfection and sterilization, patient safety, Biosafety, Good Laboratory Practice

(GLP), storage of kits, maintenance of cold chain, HIV rapid testing procedures, availability of

laboratory internal quality control systems, adherence to standard operating procedures,

interpretation of test results, waste management, external quality assurance procedures,

regular calibration, monitoring and maintenance of equipment, proper documentation and

inventory management.

Scope

The scope of this checklist is:

To review laboratory functioning at ICTC in a standardized approach based on defined

minimum standards to implement Quality Management Systems

To generate numerical indicators related to laboratory capacity and quality

To follow improvement of a laboratory over a period of time

To evaluate management and technical requirements of peripheral laboratory

To periodically self-evaluate for improvement of the ICTC (by the ICTC staff/Medical Officer)

Normative References

The following reference documents have been used in preparing this checklist:

Operational Guidelines for ICTCs 2007 (NACO) ISO 15189:2012 Third edition

National Guidelines for HIV testing 2015 (NACO)

CLSI GP26-A4; A Quality Management System Model for Laboratory Services – Fourth

Edition

National Health Mission (NHM) Operational Guidelines for Quality Assurance in Public

Health Facilities. 2013

The Review Process:

Total score is 246 covering four sections: Section 1- Operational; Section 2- Technical; Section 3-

Monitoring and Evaluation and Section 4- Logistics.The review uses the following methods:

1. Direct Observation

Observe ICTC infrastructure and activities and verify their compliance as per this checklist,

which is based on the references above

4

2. Record review

Review of records/registers/reports/adherence to SOPs/manuals/lab consumables/

maintenance of equipment/EQAS/proficiency testing/universal safety precautions/ cold

chain/ storage/ waste management/ results from EQAS at the SRL

Review of sample documents and extract relevant information for reviewing the

performance

3. Interviews

The review involves interaction with the ICTC Medical Officer/Head of the department, Lab

Technician, Counselor. Ask open ended questions during interviews: Ask questions like,

“show me how…” or “tell me about…” or “help me understand”. It is often not necessary to ask

all questions verbatim

4. Guidance to fill the checklist:

If the ICTC shows full compliance to the criterion, then score it maximum, If partially

complied then score it proportionately. Don’t score for the non-scoring section

If the item does not apply to the audited site, e.g. if the site is not a designated EID

collection site, record as non-applicable (N/A) and subtract thee points from the total

“Comments” column is provided for taking notes/comments

Under each section space for summary is provided to capture challenges, best practices and

overall impressions etc., received in interviews with ICTC staff

5. Points to remember:

Do not carry any documents/registers/reports from the ICTC, nor ask for photocopies of any

of these documents. Consider all ICTC data confidential.

Do not take photographs or videography of any of the activities at the ICTC

Do not take video or audio record any of the interviews fully or partially

The assessor may share the review checklist and audit methodology with ICTC staff

If institution has both PPTCT and ICTC then they have to be reviewed separately

The filled checklist is to be retained with the ICTC in-charge with a copy to the reviewer

5

General Information

Name & Address of the ICTC

Telephone No Email ID of ICTC

Type of facility (√) Government PPP

Location of ICTC (√) Medical College District Hospital

Sub-District Hospital PHC CHC AH

Date of Establishment of facility DD / MM / YYYY

Location of ICTC lab

Name of the SRL linked

ICTC located in DAPCU district (√) Yes No

Staff Details Name Phone Email ID

ICTC In charge Medical Officer

Counselor/s

Lab Technician/s

6

Grading of ICTC

(Score to be entered at the end of the review)

Domain Attribute Maximum

Score

Score

Obtained

Percentage

Scores

Grades

1. Operational (O)

1.1. Organisation and Management 10

1.2. Accommodation and Environment 20

1.3. Human Resource 16

1.4. Communication–Internal/External 14

1.5. Referrals and Linkages 18

Sub Total 78

2. Technical (T)

2.1. Pre Examination 18

2.2. Examination 10

2.3. Personnel safety 20

2.4. Post Examination 30

2.5. Continuous Quality Improvement (CQI)

12

Sub Total 90

3. M & E (M)

3.1. Documents and Records (are they available, complete and correct)

44

3.2. SIMS reporting status 6

Sub Total 50

4. Logistics (L)

4.1. Inventory Management 20

4.2. Supply Chain Management (Storage)

8

Sub Total 28

TOTAL 246

7

S No. Description Maximum

Score Score

Obtained Comments What to look for

1.1 Organisation and Management

1.1.1 Has the LT attended the induction/refresher training at the SRL in the last one year?

2

Ask LT about having attended induction, refresher training (consider panel distribution as refresher training) within last one year

Look for documented evidence of Training certificate / training relieving order / training attendance certificate/ Email communication/ any other relevant training record. Verify date of training from the record

1.1.2 Has the Counselor attended induction/refresher training in the last one year?

2

Ask Counselor about having attended Induction/refresher training within last one year

Look for documented evidence of Training certificate / training relieving order / training attendance certificate/ Email communication/ any other relevant training record. Verify date of training from the record

1.1.3 Did the TO-SRL visit the ICTC in the last six months? 2

Ask LT whether the TO visited the ICTC in last six months.

Look for documented evidence of TO visit such as Visitor register or book/ copy of a visit report/ Email communication enlisting summary of visit observations and recommendations.

Verify the date of visit records.

1.1.4

Is the Counsellor/LT from the ICTC attending the DAPCU/District monthly/Quarterly review meeting regularly?

2

Ask LT and Counselor about attending DAPCU/district review meeting

Look for documented evidence of DAPCU/district review meeting such as minutes of meeting in register/ copy of DAPCU meeting attendance sheet/ of Check the minutes of the meeting register or Minutes of meeting copy from DAPCU.

Section 1: Operational

8


Score Score


1.1.5 Did the District ICTC Supervisor visit the ICTC in the last three months?

1

Ask the counselor whether the DIS visited the ICTC in last three months.

Look for documented evidence of DIS visit such as visitor register or book/ copy of a visit report/ Email communication enlisting summery of a visit observations and recommendations. Verify the date of visit records.

1.1.6 Are duly completed visit reports (LaQSH Project, NACO, DAPCU, TO-SRL visits) present at ICTC?

1

Ask LT about visits conducted by officials and the procedure to maintain visit/feedback reports

Look for documented evidence of site visits such as feedback in visitors register or book / copy of a visit report/ Email communication enlisting summery of a visit observations and recommendations. Verify the date of visit records.

Check for the signature of Medical officer on visit reports.

Sub Total 10

1.2 Accommodation and Environment

1.2.1 Does the ICTC have separate rooms for counseling and testing?

2

Look for separate rooms demarcated for counseling and testing

If separate rooms are not available check whether the counseling and testing area separated from each other with a complete partition

1.2.2 Does the Counselor’s room support audio visual privacy? 2

The audio from counseling should not be heard outside the counseling room.

If the counseling area is demarcated with a partition then the partitions should be from ceiling height and there should not be a gap between partition and ceiling.

1.2.3

Does ICTC have a cabinet /cupboard for keeping records under lock and key?

2

Look for a cabinet and/ or cupboard for storage of records with a provision of lock and key or observe whether the records are not accessible by unauthorized persons.

9


Score Score


1.2.4.a Does the ICTC have sufficient lighting to perform routine activities in ICTC?

2

Look throughout the ICTC area for availability of sufficient visible light to perform the testing in ICTC.

Look for the light source, if there are bulbs used, then note that bulbs produce heat and this may affect the testing, it dry up the devices if kept very close to the lab work desk

1.2.4.b Does the ICTC area have proper ventilation? (for protection of employee health and fire prevention)

2

Look throughout the ICTC area for proper ventilation, where direction of air should flow airflow from low hazard to high hazard area.

1.2.5 Does ICTC have separate space for specimen collection and testing?

2

Look for separate demarcated space for sample collection and testing.

1.2.6 Does ICTC have clean and non-corrosive surface available to perform testing?

2

Look for cleanliness and tidiness in the laboratory bench top.

Testing surface should be of non-corrosive material (minimum covered with rexine sheet).

1.2.7 Does the laboratory have a continuous water supply with sink?

2

Look for the availability of continuous water supply and a sink.

1.2.8 Does the ICTC have displayed signs of Biohazard for restricted access?

2

Look for the signage for restricted access (e.g. authorized personnel only/ restricted entry).

Laboratory testing area and specimen storage area should have a biohazard sign displayed

1.2.9

Is there a freshly prepared working solution of 1% Sodium Hypochlorite available and the process documented?

2

Interview the LT about the procedure for preparation of 1% Sodium Hypochlorite solution.

Look for the log book to confirm fresh (daily) preparation of 1% Sodium Hypochlorite.

1.2.10 Is the flow of individuals organized such that access to interdepartmental referrals is hassle free?

Look for the individuals flow in the ICTC. Check for the individual flow chart displayed in the ICTC.

Sub Total 20

10


Score Score


1. 3 Human Resource

1.3.1.a Is there a Medical Officer (designated ICTC in-charge) available to monitor the activities of the ICTC?

2

Ask LT/Counselor about the availability of a designated medical officer.

Observe for signatures on test reports, worksheet, daily logs etc.

1.3.1.b Does the ICTC have staff sufficient as per guidelines for smooth functioning of its activities

2

Look for the monthly individual load of the ICTC for last three months and determine the average load per month

Check whether sufficient number of staff is posted as per the NACO guidelines

Counselor

Criteria and mechanism of deployment: One counselor appointed on a contractual basis. In the SA ICTC where counseling is required to be done for more than 500 individuals in a month, an additional counselor may be appointed, based on the review

Lab Technician

Criteria and mechanism of deployment: One LT appointed on a contractual basis, with less than 10,000 annual test load. For every additional 5,000 annual tests, one additional LT, subject to the maximum of three LTs, may be appointed on a contractual basis.

1.3.2 Is there a full time LT available in the facility? 2

Look for the documented evidence of appointment letter/ contract letter from DAPCU/ SACS/ Institute.

The LT should hold at minimum a Diploma in Medical Laboratory Technology, DMLT, from state government approved institution. However, the services of the existing LTs who do not hold DMLT may continue if they have done Certificate Course in Medical Laboratory Technology and have over 5 years of experience working in ICTC.

11


Score Score


1.3.3

Is there a full time Counselor (male/female/both) available in the facility?

2

Look for the documentary evidence of appointment letter / contract letter from DAPCU/ SACS/ Institute.

1.3.4 Does the LT have a qualification of Diploma in Medical Laboratory Technology (DMLT) from an institution approved by the State/Central Government?

2 Look for the qualification records such as degree certificate/

mark sheet etc. in personnel file.

Check for the name if it is an approved institute/ University.

1.3.5

Does the Counselor hold a post graduate degree in Psychology/Social work/Anthropology or Human development with a minimum of 3 years of experience in the field of HIV/AIDS?

2

Look for the qualification records such as degree certificate/ mark sheet etc. in personnel file.

Counselor should be a graduate degree holder in Psychology/Social Work/Sociology/ Anthropology/Human Development OR diploma in Nursing with minimum 3 years of experience in HIV/AIDS. In case of those recruited from community of people infected with or affected by HIV/AIDS, graduates from any field or diploma in Nursing may be considered if they have minimum 1 year of experience in HIV/AIDS. It is desirable that counselor holds post -graduate degree in Psychology, MA, /MSc, or Social Work.

1.3.6

Is the personnel file of ICTC staff maintained with copies of qualification, experience, trainings (both internal and external) degrees/diplomas/certificates of training courses attended? Registration with professional bodies?

2 Look to the staff personnel file for the documents.

1.3.7 Is the Counselor and the lab technician sensitized to provide friendly services?

2 Observe staff behavior during their routine activities.

Sub Total 16

12


Score Score


1.4 Communications - Internal/External

1.4.1.a Are the directions from Entrance and other sections of the hospital to ICTC available?

2 Look for the directions/signage/Display charts (bilingual)

directing towards ICTC

1.4.1.b Are different sections of ICTC such as counseling room, blood collection/ receiving area, testing area labeled?

2

Look for the display charts mentioning the section of activity

1.4.2 Are the ICTC working timings displayed at appropriate locations such as patient waiting area / outside of the counseling room etc.? individual

2

Look for display of working hours in the ICTC. (e.g. working days

& timing, lunch time and time for blood collection, counseling and reporting)

1.4.3

Is the IEC material available with facility (TV/Posters/flipchart/Pamphlets/leaflets provided by NACO) and displayed?

2

Observe the IEC material available in the ICTC, check with counselor for availability and if it is in regional language.

Look for display of IEC material in key areas like patient waiting area/ reception, counseling area, blood collection area etc.

1.4.4 Does the facility have a defined procedure to obtain a feedback/ complaint or suggestion from individual?

2

Ask ICTC staff about the mechanism of feedback/ complaint/ suggestion received from the individual.

Look for evidence of feedback registered/ complaint or suggestion box and the frequency of such events.

1.4.5 Is there a proper documentation of all internal (within institution) and external (SRL, SACS, DAPCU, NACO etc.) communication in the form of register/file?

2

Look for the evidence of recording all communications in the ICTC

Look for dispatch register/ correspondence file/minutes of staff meeting etc.

1.4.6 Is there a display of turnaround time for the test report (test report should be given on the same day)?

2

Look for the display of TAT in the patient waiting area and in

front of counseling area

13


Score Score


1.4.7

Does laboratory have a documented procedure for communication with individual in case of an unforeseen event? E.g. Delayed report due to indeterminate status/ repeat sample collection etc.

Ask ICTC staff how do they communicate with patient in case of unforeseen events.

Look for the documented evidence.

1.4.8 Is courtesy towards individuals maintained? (Observe) Observe ICTC staff while working in ICTC

Sub Total 14

1.5 Referrals and Linkages

1.5.1.a

Is the counselor screening all the individuals for the symptoms of TB (4s i.e. 4 symptoms screening)? Are the records of such screening documented? (Score 2, if the Counselor is screening all individuals and documenting the process; Score 1, if the Counselor is screening and not documenting the process; Score 0, if the Counselor is not screening)

2 Look for the knowledge of counselor and look for the

documentary evidence of the activity.

1.5.1.b

Is the counselor providing counseling to the individuals with the help of 10 point counseling tool for the individuals suspected to have TB or referred from RNTCP? Are the records of such counseling documented? (Score 2, if the Counselor is counseling the individual with 10 point tool and documenting the process; Score 1, if the Counselor is counseling but not documenting the process; Score 0, if the Counselor is counseling the individual with the help of 10 point tool)


documented evidence of the 10 point TB counseling.

1.5.1.c

Is the counselor screening all the individuals for the symptoms of STI/ RTI? (Score 2, if the Counselor is screening all individuals and documenting the process; Score 1, if the Counselor is screening and not documenting the process; Score 0, if the Counselor is not screening)


documentary evidence of the activity.

14


Score Score


1.5.2

Percentage of individuals tested for TB out of the number referred from ICTC to DMC in the last three months. (Source: ICTC consolidated HIV/TB line list) 2

Score 2, if more than 80% of TB suspects tested for TB at DMC

Score 1 if 50-79% of TB suspects tested for TB at DMC

Score 0 if less than 50% of TB suspects tested for TB at DMC)

1.5.3 The percentage of HIV positive individuals screened for TB at DMC in the last three months. (Source: ICTC consolidated HIV-TB line list)

2

Score 2, if more than 80% of HIV positive individuals screened for TB at DMC

Score 1 if 50-79% of HIV positive individuals screened for TB at DMC

Score 0 if less than 50% of HIV positive individuals screened for TB at DMC

1.5.4

Is the system of recording referral from ICTC to ART regularly in HIV positive line list/ PLHIV card/PPTCT beneficiary card (observe for last three months)

2 Look for documented evidence in the HIV positive line list

register/PLHIV Card/ PPTCT Beneficiary card

1.5.5

Is the system of recording referral from ICTC to DMC, DMC to ICTC and recording of HIV-TB co-infection in HIV-TB register regularly maintained in the ICTC? (observe for last three months)

2 Look for the documented evidence in HIV/TB register, HIV/TB

Line list and check with the referral slips

1.5.6

The number and percentage of TB cases referred from DMC to ICTC for HIV counseling and testing in the last three months. (Not to be scored)

Look for the denominator at DMC and numerator at ICTC.

1.5.7 Does the ICTC refer indeterminate samples to the designated SRL/NRL?

2 Look for the number of indeterminate samples reported by the

ICTC and the number of samples referred to SRL/ NRL for confirmation. Source: Lab register/sample referral log

1.5.8 Number of EID samples sent to the reference lab in the last six months (Not to be scored)

Look for the documented evidence in EID register/ line list /

EIC-3 register

15


Score Score


1.5.9

Is the LT and MO aware of the referral procedure for confirmation of HIV 1 + 2 test results? (Interview the LT and MO) (Score 2, if both LT and MO are aware (Score 2, if both LT and MO are aware Score 1, if one of them is aware Score 0, if none of them are aware)

2

Interview the LT and MO

Ask for the latest algorithm to be followed for referral of HIV-2 sample

Look for the copy of latest guidelines

Look for the records of sample referral

Sub Total 18

16

Section summary:

17


Score Score

Obtained

Comments What to Look for

2.1 Pre Examination

2.1.1 Does the Lab follow SOP for specimen collection, handling and storage?

2 Look for availability of SOP for Sample collection, handling and

storage and observe the activity for evidence.

2.1.2

Does the Lab have a defined specimen acceptance and rejection criteria? (Look for: SOP and observe for compliance)

2

Look for the availability SOP and observe the occurrence register

for evidence.

Look for authorized signature on SOP

2.1.3

Does the LT explain to the individual the procedure before blood collection and the precautions to be taken by the patient after the collection?

2

Look for availability of SOP for Sample collection, handling and storage and observe the activity for evidence

2.1.4 Does the LT match the patient details with the laboratory number before collecting a blood sample?

2

Observe whether the LT is verifying the details of patient written on PID slip with patient and those written on sample collection tube.

Check for the adherence to two identifier system for specimen labeling

2.1.5

Whether the informed consent is documented using the appropriate form (signature/Left Thumb Impression should be taken appropriately)?

2

Look for the availability of bilingual consent form

Observe whether the details are explained to the individual before the consent is signed (signature/ left thumb impression) by individual.

2.1.6 Does the ICTC follow NACO algorithm for testing?

2

Ask LT about the testing algorithm followed at ICTC and kits used

for the same

Observe the test procedure and look for the documented evidence in Laboratory register and worksheets/report book.

In case of any deviation from algorithm look for the documentary evidence of any such instruction given by NACO / SACS / DAPCU.

Section 2: Technical

18


Score Score

Obtained

Comments What to Look for

2.1.7 Are all the test kits currently in use within the expiration date?

2 Look for the expiry date on the kits

2.1.8 Are test kits labeled with date received and initials?

2

Look for date of opening and signature on the test kit box.

2.1.9 Does the ICTC Laboratory technician prepare a worksheet before initiating the test procedure?

2

Observe for the documentary evidence of worksheet preparation and use of worksheet for performing test

Check for the signature of laboratory technician and MO on worksheet.

Sub Total 18

2.2 Examination

2.2.1 Does the ICTC LT use control while opening a new box of test?

2

Whenever a new box of test kit is opened a positive and a

negative control is to be run along with the test samples.

Check the lab records (worksheets/QC register)

2.2.2 Are positive and negative quality control (QC) specimens routinely used and documented (e.g., daily or weekly) according to NACO guidelines?

2

Ask LT about policy applied for the use of internal quality controls

Look for the use of internal controls as per NACO guideline (whenever a new box of test kit is opened).

Look for the evidence in QC register/ stock register/ worksheet etc.

2.2.3 Are timers available and used routinely for HIV rapid testing?

2

Observe Look for the availability if timers in ICTC and observe for

its routine use.

2.2.4 Are sample collection devices (test tubes, vacutainer, disposable pipettes) used accurately?

2

Observe LT while performing sample collection

2.2.5 Are testing procedures followed? 2 Ask LT about the procedure followed for testing

Look for the SOP/work instructions/manufacturer instructions displayed in the testing area

Sub Total 10

19


Score Score


2.3 Personnel Safety

2.3.1

Is personal protective equipment (PPE) always

available to LTs?

2

Interview ICTC staff whether there is an uninterrupted supply of PPEs such as gloves, masks etc.

Observe for the records of stock of PPE

2.3.2 Is PPE consistently used by all LTs? 2 Interview ICTC staff about the correct use of PPE and verify the

same with direct observation

2.3.3 Is PPE properly used by all LTs through the

testing process?

2

Interview ICTC staff about the correct use of PPE and verify the

same with direct observation

2.3.4 Has the staff completed the full course of the

Hepatitis B and record maintained?

2

Ask ICTC staff about vaccination details

Check for the details of vaccination against Hepatitis - B in personnel file

2.3.5

Is the laboratory staff aware of the first aid

measures for patient related emergency?

(vasovagal attack, needle stick injury etc.)

2

Interview LT about the first aid measures giving a hypothetical situation

2.3.6 Is there a first aid material readily available in the lab?

2

Check for the availability of first aid material and its accessibility in case of emergency. Ask for the frequency of review for the content of first aid box

2.3.7

Is the laboratory staff trained in spill

management and whether the spill

management material available on-site

2

Interview LT about how will they manage a spillage giving a hypothetical situation

Check for the availability of material required for spill management and its accessibility in case of emergency

2.3.8 Is there a contingency plan for post

exposure prophylaxis (PEP)?

2

Ask whether they are aware whom to contact in case of

accidental exposure and also in case of unavailability of PEP drugs at hospital which ART center they have to contact?

2.3.9

Is the laboratory staff aware of the Nodal

person/facility responsible to report for

providing PEP?

2

Look for whether the Details about the Nodal person/facility responsible to report for providing PEP are displayed at key locations

20


Score Score


2.3.10

Is IEC material regarding PEP

protocol available/displayed?

2

Look for the availability and display of IEC material regarding PEP protocol at key locations like sample collection and testing area and counseling area

Sub Total 20

2.4 Post Examination

2.4.1

Does the ICTC maintain turnaround time for HIV

rapid testing (result to be reported within the

same day)?

2

Look for the % of individuals whose report is dispatched to

counselor on same day for three consecutive days. ( Source: ICTC counseling register and laboratory register and dispatch register tally date and time) Score 0 if it is <50%, score 1 if it is between 50 to 80, score 2 if it is > 80%

2.4.2

Is confidentiality maintained during posttest

counseling? (Interview the counselor to

understand the environment of Post Test

counselling. Ex: Group counseling, Patient

attendant present during this, are HIV +ves are

counseled separately. Additionally, look for

arrangement for counseling in In-patients)

2

Interview the counselor to understand the environment of Post Test counseling. Ex: Group counseling, Patient attendant present during this, are positives are counseled separately.

Additionally look for arrangement of counseling area

2.4.3 Percentage of individuals receiving post-test

counselling along with test reports. 2

Observe last three months data (Counseling register/ SIMS report)

Score 2 if it is 100% or else score 0

2.4.4 Are results interpreted and recorded according to SOP

and site protocol?

2

Cross check Test Reports in Lab Register and Work sheet and see

if it matches with SOP with signature of LT and MO

2.4.5 Randomly pick up five individual details from

the ICTC counselling register and trace it to the

lab register for verification.

2

Randomly select 5 individuals from counseling register and check for the individual flow with the help of registers such as blood collection register, specimen log in / laboratory register, worksheet, individual report and dispatch register.

21


Score Score


2.4.6

Does the lab conduct repeat HIV testing for a

sample received in emergency condition (ANC

mother visiting facility in labor condition with

unknown HIV status) as per the algorithm followed

in ICTC?

2

Interview ICTC staff about the procedure followed

Check the records of tests done in emergency department/labor room and ICTC

2.4.7 Does the ICTC maintain records of unforeseen

circumstances / occurrence/ incidence? 2

Ask ICTC staff about the procedure

Verify the availability of register/ file for maintaining records of any such event

In case of no such event check for “No Occurrence/ Incidence ” entry

2.4.8

Is there an acceptable method to dispose the needle

tips collected in the needle destroyer after the

container is full? (Ask the LT to demonstrate the

process and look for

2

Ask LT to explain and demonstrate the procedure followed for

disposing needle tips from the needle destroyer

Look for the availability of needle destroyer and blunt forceps.

2.4.9 Are sharps handled properly and disposed into

puncture proof container with freshly prepared

sodium hypochlorite solution?

2

Ask LT about the procedure followed for disposal of sharps.

Look for the availability of puncture proof container, freshly prepared Sodium hypochlorite

2.4.10 Has the lab displayed posters for segregation of

bio medical waste as per regional/national

guidelines?

2

Look for the display of posters portraying biomedical waste management as per the regional / national guidelines

2.4.11 Does the lab have separate color coded

bins for segregating of waste as per

regional/national guidelines?

2

Look for the availability and appropriate use of color coded bins with bio hazard symbol for segregation of waste material as per the regional / national guidelines.

2.4.12

Does the laboratory staff store the

segregated biomedical waste in a secured

place before final disposal within 48

hours? Are designated areas set up for

storage of waste and monitored

appropriately?

2

Ask ICTC staff about the procedure followed for safe disposal of biomedical waste.

Look for the secured place where the waste material is stored before disposal and the duration for which it is stored.

Verify biomedical waste management log and records of amount of waste generated and handed over for disposal.

22


Score Score


2.4.13

Are infectious and non-infectious waste

containers emptied regularly as per the SOP

and/or job aides? (Look for appropriate

documentation)

2

Ask LT about the frequency of emptying waste containers and verify biomedical waste log.

2.4.14 Are storage areas set up for storage of samples and monitored appropriately?

2

Look for the space for storage of samples and log sheet

2.4.15 Does lab issue HIV test report to an individual only if IQC is in limit?

2

Interview LT about the procedure followed for issue of test report to individual

Observe for daily IQC records

Ask about the procedure followed in case of IQC failure and observe for the policy or a documented evidence of the same

Sub Total 30

2.5 Continual Quality Improvement (CQI)

2.5.1

Proficiency testing (PT): Does the ICTC participate in all the notified cycles of proficiency testing conducted by SRL? Are the results of the PT available with the ICTC lab?

2

Ask ICTC staff about the participation in PT

Verify with the documented evidence (Check for the PT reports and verify dates)

2.5.2

Does the ICTC send samples to SRL for retesting as recommended in NACO guidelines? (Randomly selected 20% of positive and 5% of negative samples collected in the first week of every quarter)? If yes, is comparative analysis/evaluation of results documented/received from the SRL? (Verify if the staff is aware of correct method of calculating number of specimens and random selection of specimen to be sent)

2

Ask LT about the participation in quarterly retesting activity and Verify if the staff is aware of correct method of calculating number of specimens and random selection of specimen to be sent.

Verify the information from Laboratory register and EQAS register/ File

Check for the reports received from SRL for last 1 year

23


Score Score


2.5.3 Is the laboratory staff aware of the process of corrective and preventive action to be taken in case of any discordance in PT/ retesting results?

2

Ask ICTC staff about the incidence of discordance in PT and / or retesting and about the corrective and preventive action taken for the same.

If there is no such incidence look for the awareness of the staff

Look for the documented procedure in case of discordance in PT/ retesting and if applicable, documented evidence of previous corrective and preventive action records.

2.5.4 Does the lab document both IQC failure and corrective action taken in case of failed IQC?

2

Check for the documented evidence of IQC failure and corrective

action taken in case of failed IQC in IQC register and corrective action register

2.5.5 Does the lab document PT and retesting along with corrective actions taken in case of unsatisfactory/ discordant results?

2

Observe for the documented procedure in case of discordance in

PT/ retesting and if applicable, documented evidence of previous corrective and preventive action records.

2.5.6 Does laboratory follow policy for investigation of root cause analysis for investigation of errors?

Check whether the ICTC has a mechanism for identifying the error

(route cause analysis) in case of an incidence/ occurrence.

If yes check for the documented evidence of the same

2.5.7 Are QC records reviewed by the person in charge routinely?

2

Ask MO about the review of QC records and its frequency

Check for the signature of MO in worksheets/QC register and Lab reports.

Sub Total 12

Section summary:

Section 3: Monitoring and Evaluation

24


Score Score


3.1 Documents and Records (are they available, complete and correct)

3.1.1 Does the ICTC have a copy of the National HIV counselling & testing Services Guideline? (soft or hard copy)

2

Copy of the NACO ICTC operational and HIV testing

guidelines (either soft or hard copy)

3.1.2 Is the ICTC taking individual consent for pretest counselling? (local language/ bilingual)

2

As per National HSTS guideline, no separate Consent form will be maintained. Consent will be taken in the registers itself as Thumb impression/Signature.

Consent will be taken in the registers itself as Thumb impression/Signature

3.1.3 Is the Counseling Register available and complete for general individuals and pregnant women in counselling room?

2

Verify if the correct method of generating PID is followed, especially for HRG who are repeat tested in a year

Verify PID Register (separate for general individuals and pregnant women) Completeness of PID register

3.1.4 Is there a Post-natal Follow-up Register/ANC line list register/ PPTCT Beneficiary Card in counselling room in ICTC?

2

Verify the availability and completeness

3.1.5 Is there a register for referral of suspected TB cases? 2 Verify the availability and completeness

3.1.6 Is there a record of EID of babies born to HIV infected mothers? (according to EID protocol)

2 Observe for EID register and its completeness.

Ask ICTC staff about the number of babies Tested till date and line list

3.1.7 Is there display of charts/Dashboard showing the number of patients screened for HIV in the previous two calendar years?

2

Look for availability of consolidated information

displayed (tables/ charts/ Dashboard)

3.1.8 Is there display of number of tests performed in this calendar year?

2

Look for availability of consolidated information

displayed (tables/ charts)

25


Score Score


3.1.9

Is there a record of monthly report sent to DAPCU/SACS/NACO through SIMS? Verify if the staff is aware of how to fill the monthly reports (all sections A-E) and is correctly filling these reports.

2

Interview ICTC staff about the different sections of SIMS and the sources of information from where each section is filled.

Look for the records of previous SIMS reports

3.1.10 Does ICTC have a lab register/log book that is complete? (Review the data of last three months)

2

Verify the availability and completeness of the register/log books.

3.1.11 Does the ICTC LT maintain a lab worksheet while doing routine testing? Are all worksheets maintained in a file?

2

Verify the availability and completeness of the worksheet. (Observe the worksheets of last 1 months)

3.1.12 Is the LT maintaining a stock register and is updated till date?

2

Verify the availability and completeness of the stock register, including the signature of LT and MO. (randomly match 1 to 2 items of stock register with the physical balance)

3.1.13 Are the lab worksheets and reports signed by In-charge MO? 2

Verify the laboratory worksheet and test reports for the signature of LT and MO with name

Check for the completeness of the worksheet and reports

3.1.14 Are the records of IQC results maintained by LT? 2

Verify the availability and completeness of IQC result records.

Check if the IQC results verified by MO on daily basis.

3.1.15 Does the laboratory have incident / occurrence register? 2

Verify the availability and completeness of incident/

occurrence register

3.1.16 Is a PEP register maintained by the ICTC (Counsellor/LT)? 2

Verify the availability and completeness

Sub Total 32

26


Score Score


3.1.17 Does the ICTC maintain the records of complaints / suggestions received and follow-up till a corrective and/ or preventive action taken and observe for the impact of it?

2

Ask counselor/LT about the follow-up of complaints and suggestions by individuals

Look for the documented evidence in complaint / suggestion register/ file and Corrective and preventive action register

3.1.18 Does the Laboratory have an inventory register for equipment (pipette, centrifuge, and refrigerator)?

2 Verify the availability and completeness inventory

register

3.1.19 Does the ICTC have updated SOP in use? 2

Look for the master list of SOPs as per NACO QMS guideline and verify if it is updated as per the date of signature on the document.

Check for the archival of versions not in use.

3.1.20 Are all the SOPs read by concerned staff responsible to perform that activity and accepted to have understood and willingness to comply with it?

2

Look for the documented evidence of reading and

accepting to follow SOP by the staff responsible to perform the activity

3.1.21 Are registers/logbooks properly labeled and archived when full?

2

Check for the master list of records and registers and the correctness of location of the records

Check for the storage of records after completion and whether it is easy for retrieval

3.1.22 Do all LTs at the testing point test the EQA/PT samples?

2

Check for the records of EQA/PT and look for

evidence/signature of all the LT and counter signature of MO in-charge

Sub Total 44

3.2 SIMS Reporting status

3.2.1 Is the ICTC using SIMS for monthly reporting? Verify if correct formats are in use.

2 Verify the SIMS format and check for the recent reports

(last 3 months ) submitted

27


Score Score


3.2.2 Are test results properly maintained for confidentiality, accessible, archived and retrievable?

2

Check the records and registers for the correctness of location.

Check for the storage of records, accessibility, archival and irretrievability.

3.2.3 Does the ICTC have disaggregated data by sex, marital status and Key Population? (Observe for one quarter)

2

Verify the availability of data in the last quarter from the

Counseling register

Sub Total 6

Section summary:

28


Score Score


4.1 Inventory Management

4.1.1 Is a refrigerator available and in good working condition? 2

Check the availability of a refrigerator, check whether it is in working condition, look for the temperature record of the refrigerator for last 3 months

4.1.2 Is the temperature log maintained? 2

Verify the temperature log of refrigerator and room, look for the correctness of frequency for noting temperature.

Interview LT about the procedure followed

Check whether temperature log is up to date

4.1.3 Is centrifuge available and in good working condition? 2

Check the availability of a Centrifuge, check whether it is in

working condition, look for the calibration / validation record of the centrifuge for RPM

4.1.4 Are the micropipettes available and in good working condition?

2

Check the availability of a Micropipette with appropriate range (10-100µl), check whether it is in working condition, look for the calibration / validation record of the micropipette, verify the pipette tips used and look for its appropriateness

4.1.5 Is the LT aware which equipment has to be calibrated? Are calibration records for all equipment maintained?

2

Interview LT regarding the knowledge and the source for calibration

Check for the calibration / validation records of equipment

4.1.6 Are needle destroyers/needle cutter available and functional?

2

Check the availability and functionality

4.1.7 Are disposable syringes and needles, test tubes, gloves available? Adequate stock for one month?

2

Check for the availability and inventory records for the adequacy depending on the daily consumption

4.1.8 Is a discard jar/puncture proof container with sodium hypochlorite available in testing site?

2

Check for the availability and log of freshly prepared 1% sodium

hypochlorite and check for signature of the LT

Section 4: Logistics

29

Section summary:

4.1.9 Are spirit, cotton swabs, tourniquets, lab aprons available in lab?

2

Check for the availability and inventory records for the

adequacy depending on the daily consumption

4.1.10 Are test tube racks, sticker labels, tissue rolls, markers available in the lab?

2

Check for the availability and inventory records for the

adequacy depending on the daily consumption

Sub Total 20

4.2 Supply Chain Management (Storage)

4.2.1 Does the ICTC follow standard procedures for storage of kits?

2

Interview LT about the procedure followed for storage of kits.

Look for adherence to FEFO, proper circulation of air within the storage facility, segregation of kits such as test kit 1, test kit 2, test kit 3 etc.)

4.2.2 Is stock of condoms available with ICTC? 2 Check for the availability and inventory records for the

adequacy depending on the daily distribution

4.2.3 Does the LT practice First Expiry First Out (FEFO) while using HIV kits supplied by NACO?

2

Interview LT about the procedure followed for storage and retrieval of kits. Look for FEFO being followed.

4.2.4 Is the LT aware of the procedure of handling and disposing of expired kits as per the national operational guidelines?

2

Interview LT about the procedure

Verify the documentation of procedure in case of any such event within last one year

Sub Total 8

30

The purpose of this section is to capture field events that can influence the quality of lab services

S No. Description Comments What to look for

5.1 Non scoring (in relation to the quality parameters in the rest part of the document)

5.1.1 No. of days the testing services disrupted on account of non-availability of LT. (In last 6 months)

Ask MO/ ICTC staff for any such occurrence and related document

5.1.2 No. of days the testing services disrupted on account of non-availability of kits. (In last 6 months)


5.1.3 No. of days the confirmatory testing services disrupted on account of non-availability of second/third antigen test kits. (In last 6 months)


5.1.4 Is there a process in place for an alternative HIV testing mechanism in case of expired or shortage of test kit(s)?

Ask MO/ ICTC staff for any such event of shortage of test kit and availability of alternative mechanism.

Check for the stock register and indent records

(In last 6 months) Month-1 Month-2 Month-3 Month-4 Month-5 Month-6

5.1.5 No. of pretest counselling done at the ICTC? Refer counseling register and SIMS data

5.1.6 No. of Pregnant women registered for ANC services (last 3 months)

Refer ANC OPD register

5.1.7 No. of Pregnant women tested for HIV during (last 3 months)

Refer Counselling register for Pregnant women / Lab register

5.1.8 No. of testing done at the ICTC?

Refer Laboratory and stock register and SIMS data

5.1.9 No. of post-test counselling done at the ICTC? Refer counseling register and SIMS data

5.1.10 No. of HIV sero+ diagnosed at the ICTC?

Refer counseling register, laboratory register and SIMS data

5.1.11 No. of referrals done at the ICTC? Refer counseling register and SIMS data

Section 5: Non Scoring Section

31

S No. Description Comments What to look for

5.1.12 No. of HIV-2 cases referred from ICTC to ART? Refer counseling register, laboratory register and SIMS data

5.1.13 No. of indeterminate cases at the ICTC?

Refer laboratory register and indeterminate sample file

5.1.14 No. of invalid tests at the ICTC? Refer Worksheet and stock register

5.1.15 No. of CAPA done at the ICTC? Refer CAPA register

5.1.16 No. of wastage documenting practices done at the ICTC?

Refer Worksheet and stock register

5.2 Early Infant Diagnosis

5.2.1 Specify the mechanism of sending the EID sample (Postal/human carrier/Courier) to designated EID lab.

Ask LT and verify the records of procedure followed

5.2.2 What is the TAT for EID report? Ask LT and verify using the EID register

5.2.3 No. of samples rejected at EID lab (against the total number of samples received, in last 6 months).

Ask LT and verify using the EID register

5.2.4 Check if EID algorithm is displayed (staff aware of the algorithm).

Interview LT and observe for the display of EID algorithm

5.2.5 Check if the lab technician is trained in DBS collection.

Interview LT and look for training records

5.2.6 Check if adequate stock is available for DBS cards (check expiry).

Check for the availability and inventory records for the adequacy depending on the daily consumption and expected number of babies

5.2.7 Does the ICTC report monthly stock to NACO?

Verify monthly data

5.2.8 Check if the latest format of monthly report is used.

Look for monthly report format

5.2.9 Whether the LT had undergone training on DBS sample collection by SRL in last one year.

Ask the LT

Look for records of training.

32

Section summary: