SEPTEMBER 2020
STRENGTHENING THE QUALITY OF VIRAL LOAD TESTING DATA WITHIN HIV PROGRAMMES AND PATIENT MONITORING SYSTEMS
WEB ANNEX C: SHORT CLINICAL FACILITY VIRAL LOAD SERVICE AND DATA QUALITY TOOL
IMPLEMENT ATION TOOL
SH OR T C LI NIC AL F AC IL IT Y V IR AL L OA D S ER VIC E A ND D AT A Q UA LI TY T OO L
The objective of this short clinical facility viral load (VL) service quality tool is to facilitate monitoring HIV service and data quality for critical steps of the VL cascade as countries strive to achieve the UNAIDS Fast-Track targets of 95–95–95. This tool can be used during initial and follow-up visits to clinical facilities, and the findings can be used to develop a facility-specific VL service and data quality improvement plan. This is a short supervision tool intended for routine use focusing on reviewing key areas of VL testing service delivery and data quality. Annex 4 is a more comprehensive and detailed tool that can be used either when more in-depth assessment is required or when time allows. Indicator or monitoring areaSource(s)MethodsResponseComments VL testing status and lab–clinic interface Routine versus targeted VL testingHealth facility manager, HIV service providerDuring an introductory briefing meeting with key facility staff, including management, laboratory focal point and HIV service provider, confirm whether viral load testing is routine for all populations or targeted to specific populations or groupsRoutine testing provided for all patients: Y/N (please circle) Testing targeted to specific populations: Y/N (please circle) If yes, specify population(s): Date VL testing beganVL testing lab database or laboratory information management system (LMIS) or facility VL sample and results tracking log
Date first VL sample was collected from the facility(MM/YYYY) Number of VL tests reported by VL testing lab for this facility
VL testing lab database (LMIS)Refer to the VL testing lab database for the number of VL tests for this facility over a specific time period (such as the previous 1 month, 3 months or 6 months), including samples pending processing and rejected specimens
Time period: Number processed with results: Number pending processing: Number of rejected specimens:
Not applicable (if data from testing lab not accessible) Number of high VL test results (≥ 1000 copies/mL) reported by the VL testing lab for this facility
VL testing lab database (VL sample management system)During the same time period above, refer to the VL testing lab database for the number of high (≥1000 copies/mL) VL results from this facility Time period: Number of High VL results:
Not applicable (if data from testing lab not accessible)
Facility name: Facility code:Date: Assessor’s name:Organization: Contact number: Facility VL focal person name: Facility VL focal person contact number:
Indicator or monitoring areaSource(s)MethodsResponseComments VL testing status and lab–clinic interface Number of suppressed VL test results (<1000 copies/ mL) reported by the VL testing lab for this facility VL testing lab data base (VL sample management system)During the same time period above, refer to the VL testing lab database for the number of suppressed (<1000 copies/mL) VL results from this facility Time period: Number of suppressed VL results:
Not applicable (if data from testing lab not accessible) Number of VL test results received and reported by this facility
Facility VL sample and results tracking log or LMISDuring the same time period used for the VL testing lab, refer to facility VL sample and the results tracking log or LMIS for the number of VL test results received and reported Number processed with results: Number pending processing:
Document time period reviewed if VL testing lab data are not accessible Time period: Number of high VL results received and reported by this facility
Facility VL sample and results tracking log or LMISDuring the same time period used for the VL testing lab, refer to the facility VL sample and results tracking log or LMIS for the number of high VL test results (≥1000 copies/mL) received and reported
Time period: Number with VL results (≥1000 copies/mL): Number of suppressed VL results received and reported by this facility
Facility VL sample and results tracking log LMISDuring the same time period used for the VL testing lab, refer to the facility VL sample and results tracking log or LMIS for the number of suppressed VL test results (≥1000 copies/mL) received and reported
Time period: Number of with suppressed VL results (<1000 copies/mL): Eligible patients have VL testing and results documented in the patient fileAntiretroviral therapy (ART) register and patient filesFrom today’s date: month/yearFor example, Jan 2020 Go back 6–8 months: month/yearFor example, Jun-Apr 2019 Check the ART register for patients who initiated 6–8 months ago. Make note of the approximate number of patients
For example, n = 100 Select every nth file to give you a total of 10% of the above number of patients (do not include patients who are lost to follow-up) Make note of the ART numbers and give to the data clerk to pull the required number of patient files
For example, every 20th file out of 100: 5 files selected Check the files to see how many had a VL result documented Do not include in the count if the VL test was ordered but there is no result
For example, 2 Numerator: number of ART files with a documented VL result Denominator: total number of files reviewed For example, 2/5=40% Numerator/denominator (%):
Indicator or monitoring areaSource(s)MethodsResponseComments Eligible patients have VL testing and results documented in the patient fileFacility VL sample and results tracking log, patient file and LMIS (VL sample management system) Randomly select and review 10% of patient files with VL results documented within the past month. Check the onsite VL testing lab database or LMIS to verify whether the result in the patient file matches the most recent VL result in the database Tick yes if the VL result in the patient file matches the most recent result in the VL testing database or LMIS
Not applicable (if the data from testing lab are not accessible) Facility VL sample and results tracking log, patient file, site electronic medical record (EMR)/ electronic patient database
Randomly select and review 10% of patient files with VL results documented within the past month. Check the onsite EMR or electronic patient database to verify that the result in the patient file matches the most recent VL result in the EMR or patient database Tick yes if the VL result in the patient file matches the most recent result in the EMR or patient database Not applicable (if data from the EMR or electronic patient database are not accessible)
YesNo Total yes XXTotal no XX % of sampled patient files with discordant VL results in paper patient files versus the VL database or LMIS: YesNo Total yes XXTotal no XX % of sampled patient files with discordant VL results in paper patient files versus EMR or patient database:
Indicator or monitoring areaSource(s)MethodsResponseComments VL requisition form completionVL requisition formMake note of the ART number for every nth VL requisition form from the past month to give you a total of 10% of files with VL results documented in the past month. Then give the ART number to the data clerk to pull the patient files
Not applicable (if VL requisition forms are not accessible) Are the fields listed below in the VL requisition form filled in accurately and completely compared with the data in the patient file? Tally the responses for each patient file. Mark “yes” if the field is both accurate and complete. If no/missing or incorrect, make a note in the comments VL sample collectionVL sample and results tracking logIs there a VL sample collection log that documents every VL sample collected from every patient, with the date of sample collection?
Yes No Review the first five entries from the previous month. Are the dates of sample collection and results received complete?
Yes No Discussion with health facility lab focal pointHow frequently are samples picked up for processing?Daily Weekly Every other week Monthly Other, specify Reasons for deviations from sample pick-up schedule: Is the schedule for pick up followed?Yes No
Yes (tally for each VL form)No (tally for each VL form)Total “yes”Total “no”% of discordance (total “no”/ number of files reviewed) times 100 Requesting health facility nameFor example, IIIIFor example, II42 Unique ART number Date of birth or age Gender Sample type Current ART regimen Pregnancy and breastfeeding status Indication for VL testing Requesting clinician Phone number VL request date
Indicator or monitoring areaSource(s)MethodsResponseComments Clinic VL results receiptIs there a specific individual at the facility responsible for (describe process)? A. Receiving VL results from the VL testing lab (hard copy versus email)? B. Checking for the return of a result for every VL sample that is collected?
Yes No Yes No
Process: Process: What is the average turnaround time of VL results? Describe the process of following up with the laboratory if the results are not returned to the facility after the expected turnaround time
Average turnaround time (days) from the date of sample collection to the date the clinic receives the VL results: < 2 weeks 2–4 weeks > 4 weeks
Process: Is there a specific individual at the facility who is notified if a VL sample is rejected or not processed at the testing facility? Describe the process.
Yes No How are VL results communicated to patients when available?By a health–care worker at next clinic visit Phone call Text message Other (please include details in comments column) Use of electronic systems for VL monitoringInterview with data clerk, HMIS officer or facility management and direct observation of the electronic system in use
Check through direct observation whether the facility is currently using electronic medical records or an electronic laboratory information management system
Yes NoIf yes: Are VL results incorporated into EMR or a separate electronic laboratory information management system? Please list the name of the system(s) used: Interview with data clerk, HMIS officer or facility management and direct observation of electronic system in use
Check with the data clerk how often data are entered and observe whether there is a backlog of data entryHow often are data entered into the system? Daily Weekly Monthly Other
Backlog of data entry: Yes No Explanation for backlog: Direct observationCheck whether the facility keeps a paper backup other than patient charts of VL test resultsYes NoIf yes, is it: VL register Laboratory results form Other tool, please specify:
Indicator or monitoring areaSource(s)MethodsResponseComments Use of electronic systems for VL monitoringInterview with data clerk, HMIS officer or facility management and direct observation Check with data clerk, HMIS officer or service provider whether the facility follows quality control procedures for data entry of VL monitoring into EMR or laboratory information system or a paper-based register. Request to see documentation of these procedures.
Yes No Direct observation of standard operating proceduresCheck whether the facility has a tool that can be used for conducting internal data quality checks that includes viral load monitoring data
Yes No VL sample and results tracking log (Answer only if a separate log is kept at the clinic site)
Are VL results entered into a VL sample and results tracking log (maintained at the clinical side) with the expected data fields complete (such as result, date of result return to the facility)? Describe the process (who, when, where?)
Yes NoNot applicable (if no separate VL sample and results tracking log are kept in the clinic) Process: VL sample and results tracking log and patient fileDescribe the process of placing VL results in patients’ files (who, when, where, hard copy and/or electronic)Process: VL sample and results tracking log and patient fileReview random entries from the VL sample and results tracking log that were returned to the facility about 1–2 months ago for 10% of patient files with VL results documented in the past month. Make note of the ART number and ask the data clerk to pull the corresponding patient files. How many patient files have VL results documented? (numerator: number of files with VL result documented; denominator: number of files reviewed). Check both electronic and paper patient files.
Results documented (for example, 2/3, 67%) Numerator/denominator (%): ___/____ ( %)
Not applicable (if no results have been returned within the past 2 months) Patient fileHow many have date of sample collection correctly documented with the VL result in the patient file or ART card? (numerator: number with the date of sample collection correctly documented with the VL result; denominator: number of files reviewed)
Date of sample collection with VL result (for example, 1/3, 33%) Numerator/denominator (%): ___/____ ( %) High VL results management (>1000 copies/mL)Are VL results triaged to identify those that are ≥1000 copies/mL to be handled by specific clinic staff for earlier action than that taken for VL results <1000 copies/mL? Describe the process.
Yes NoProcess: Are patients contacted to return to the clinic earlier for results ≥1000 copies/ml? Describe the process (for example, who initiates, within what period of time of receiving high VL results and how often the patient contacted)
Yes NoProcess: Does the facility use a high VL register?Yes No
Indicator or monitoring areaSource(s)MethodsResponseComments High VL (>1000 copies/mL) results reported by VL testing lab found in the facility high VL VL testing lab data base (VL sample management system) and VL sample and results tracking log or high VL register
Review the number of high VL test results (≥1000 copies/mL) reported by the VL testing lab for this facility during the same time period as in Section 1. How many high VL results are in the facility high VL results documentation relative to what was reported by the VL testing lab? Numerator: number of individuals with high VL found in the high VL register Denominator: number of individuals with high VL reported from the VL testing lab
Note time period: High VL test results reported by the VL testing lab: Review the high VL register for the same time period. How many high VL results are found in the high VL register? Number: Numerator/denominator (%): ___/____ ( %) Management of patients with high VL (>1000 copies/mL) resultsPatient files and individual high VL formsSelect 5 random ART numbers from the high VL register and give them to the data clerk to pull the 5 patient files. In each patient file, is there documentation of ARV adherence over the last month at enhanced adherence counselling session 1? (tally the yes and no responses and put the total for each) Numerator/denominator (%): ___/____ ( %) Is there documentation of specific adherence barriers for each enhanced adherence counselling session? (tally the yes and no responses) Note any omissions or deviations. Numerator/denominator (%): ___/____ ( %)Yes No Total “yes”Total “no” Yes No
Indicator or monitoring areaSource(s)MethodsResponseComments Management of patients with high VL (>1000 copies/mL) resultsHigh VL register and/or patient files and individual high VL forms
Is there documentation of a specific agreed plan of action that relates to the identified adherence barriers? (Tally the yes and no responses) Note any omissions or deviations. Is there one month or less between the date of sample collection for the high VL result and the first enhanced adherence counselling session? Note any observations from reviewing the 5-patient longitudinal enhanced adherence counselling entries Are documented enhanced adherence counselling sessions approximately one month or less apart? Note any observations
Observations: High VL registerReview the last completed page in the high VL results register. What is the shortest and longest time between the date of sample collection for the high VL result and the first enhanced adherence counselling session?
Shortest time: ____ days Longest time: ____ daysObservations: Review the high VL results register from 12 months before today’s date. Are there any results for date of follow-up VL?
Yes NoObservations: From the review of the high VL results register from 12 months before today’s date, what is the shortest and longest time between the date of sample collection for the high VL result and the date of second (repeat) VL?
Shortest time: ____ days Longest time: ____ daysObservations: Review the repeat VL results that are high (≥1000 copies/mL). Is there documentation of switch to second- line ART in these patients?
Yes NoObservations:
Yes No Yes No Yes No
Indicator or monitoring areaSource(s)MethodsResponseComments Identification of stable patients with suppressed VL (<1000 copies/mL)VL testing lab database (VL sample management system) and VL sample and results tracking log or ART register Review the number of suppressed VL test results (<1000 copies/mL) reported by the VL testing lab for this facility during the same time period as in Section 1
Note the time period: Suppressed VL test results reported by VL testing lab: Patient files or ART registerHow many patients with suppressed VL (<1000 copies/ ml) were identified as eligible for differentiated service delivery and, of these, how many actually received differentiated care?
Number eligible for differentiated service delivery: Number receiving differentiated care:
Describe the differentiated service delivery model used by the facility: for example, providing a 3-month or 6-month supply of ARV drugs (multimonth ARV drug dispensation): Monthly 3 months 6 months Other, specify:
Data Source Section Selection criteria for patient files Patient ART number ART register 2 Among patients who initiated ART 6–8 months
ago, document ART numbers for every nth patient to get a total of 10% of these patient files
1.
2.
3.
4.
5.
n. etc.
VL sample and results tracking log
2 ART Number of of10% of random patients whose VL results have been returned within the past one month
1.
2.
3.
n. etc.
6 ART numbers of 10% random patients whose VL results have been returned 1–2 months ago
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2.
3.
n. etc.
VL requisition forms 3 ART numbers of random selection of 10% patient files with VL results in the past month
1.
2.
3.
4.
5.
n. etc.
High VL register 7 ART numbers of 5 random patients from high VL register
1.
2.
3.
4.
5.
n. etc.
