Rapid assessment of the quality of services in rubella immunization provided through the primary health care service network in the Polonnaruwa district.

: To assess the quality of services in munization provided through Primary Health Care clinics at the divisional level using the Lot Quality Assurance Sampling method. Methodology: A non-participant observation was carried out at 20 randomly selectedclinics using Lot Quality Assurance Sampling (LQAS)method with a threshold level of a triage system of 80 and 50% The-defective elements (clinics) neededto reject the lot and make improvements was six. Taking into account that not only rubella immunization is provided in a clinic, ten deliveries of rubella immunization in a clinic were studied with a triage system of95 %, 75% (providerrisk 1%, Consumer risk 23%), These repetitive activities were judged by LQAS10:3 binary rules. The study instrument was a pre-tested, structured observational checklist that comprised essential activities of vaccination referred to as sub-systems. Results: In the subsystem “sterility”, the hand washing procedure proved to be defective. The maintenance ofsterilization chart was found to be poor. Cold chain maintenance was extremely good and none ofthe related activities was found to be defective. Thescreeningof eligible clients was poor. A tegister of eligible rubella immunization was not maintained in any of clinics supervised. Theregister immunization was completed after vaccination. In none of clinics were immunized clients totalled and categorized according to age groups at the end ofsessions leading to inability to detect any unrecorded vaccinated vaccinations with the dosages of vaccines used and to calculate the vaccine wastage. Conclusion: Apart from the defective activities already mentioned, overall quality of services was satisfactory in majority of essential activities Recommendations: It is essential to carry out regular supervisions to detect and modify substandard itemsby supervisorystaff. Steps should be taken to improve documentation during and at the end oftheclini


Introduction
Immunizationis an effective means of prevention of childhood diseases and contributes significantly to reduce infant and childhood mortality. It is defined as one ofthe eight essential components ofPrimary Health Care (PHC) and one of the most cost effective public health measures. The expansion of the immunization coverage was a necessary and important step towards attaining the international goal of "Health for All by the Year 2000" (1).
In December 1989, Universal Child Immunization (UCI)status wasdeclared in Sri-Lanka(2). Having reached high coverage,in addition to sustenance of the coverage over the years, there are new challenges in the future such as ensuring quality assurance in relation to immunization and paying special attention to areas with low coverage Countries may also need to consider adding other vaccines to their schedules. The vaccination of womenagainst rubella to prevent congenital rubella syndrome is such an example (3).
Theprogram of rubella immunization was launched in Polonnaruwadistrict in December 1997. Sinceits introduction, ill effects and terminations of pregnancies associated with rubella immunization have been reported. Further, professionals have refused to offer immunizations to clients due to unreasonable fears of the ill effects of vaccination thus depriving clients of the potential ben: of rubella vaccination. Since the launch of the program,it has not been monitoredor evaluatedin a comprehensive manner. Therefore, it is highly appropriate that the quality ofrubella immunization services provided through the Primary Health Care network be assessed within thedistrict (4).
The present study is a component of a comprehensive evaluation ofthe rubella immunization program in the district with the objective of assessment of the quality of rubella immunization services .It is hoped that the findings will provide informationon service deficiencies and help program managers to plan strategies to overcomeservice deficienciesin relation to rubella vaccination in order to contribute a small step towards the goal of prevention of congenital rubella syndrome (CRS)in Sri Lanka.

Methodology
Adescriptivestudy wascarried out in the district to assess the quality of rubella immunization services using the quality control procedure based on "Lot quality assurance sampling" that provides simple, rapid and precise information tc improve substandard items of supervision. Twenty clinics were randomly selected to apply the method. A threshold of a triage systemfor identifying priorities was defined with administrators and program managers' The threshold levels selected were 80%. 50%.
'The numberofclinics needed to bestudiedto test the hypothesis that the number ofclinics providing bad services is at 5% level was 20.If the defective elements (clinics) were to be > 6,the lot should be rejected, and improvements are needed. If the defective elements werefound to be < 6,it is not an immediate priority for improvement.
The service delivery was studied, taking into accountthat rubella immunization was not the only service provided in a clinic. Therefore, it was decided to study 10 deliveries of rubella immunization in a clinic. The triage system used was 95 %, 75% (provider risk 1%, Consumerrisk 23%)A specificity of 99 % was preferred to ensure that resources were used to improveclinics that really need improvement.
Non-repetitive activities were marked as adequate or not, by using a binary rule. Repetitive activities were judged by LQAS10:3 binary rules. More than three defective components were considered to be substandard per clinic. The presence of more than six such defective subsystems for 20 clinics was considered a failure, which needed immediate attention, A pre-tested,structured observational checklist that comprised essential activities of vaccination referred to as sub-systems which include infection control procedures (sterilization), maintenance of cold chain, screening of eligible clients, vaccination technique and maintenanceof records were used in non-participatory observation to assess the quality of immunization services. The purpose of the visit was explained but the rubella component was not Journal of the College of Community Physicians of Sri Lanka revealed to the clinic staff to minimize the Hawthome effect.

Results
Results of the non-participatory observation are given below. In repetitive activities such as vaccination, a high specificity was preferred to ensure that among detected defective elements, false positives were minimal (high positive predictive value). By ensuring a highspecificity, the program manageris able to divert his attention to improve substandard items, which really need inputs thus avoiding unnecessary diversions of scarce resources (cost, training efforts, time requirement for the task ete.) to false positive items. Low sensitivity may cause high false negatives, This can be avoided by regular supervisions that help to detect false negatives in subsequent supervisions.
There is only a small likelihood that a misclassification of an inadequate as an adequate during one round of supervision willbe misclassified during a secondround. By increasing number of supervision rounds, the error decreases by a greater amount. Subsequently, it is vital to conduct frequent supervisions to minimize consumer tisk. Although the high specificity is achieved at the cost of lw sensitivity, experts believe that this trade-off is worthwhile, when resources should be investedin activities that really need reform (5). Onelimitation of the study is the Hawthomeeffect. However, since wide ranges of activities were assessed, substandard activities detected will be a clearer area for improvement, although PHM performs better thanusual Thefirst subsystem consisted of "sterility". The hand washing procedure proved to be defective. In every clinic, they washed hands only at the beginning of the clinic session. When immunization activities were to be resumed after every cessation, washing of hands was not adheredto. Maintenance of a sterilization chart is required to ensure 20 minutes of boiling. The maintenanceof this chart 'was found to be poorin the study.
Cold chain maintenance was extremely good and none of the related activities was found to be defective.
Thescreening of eligible clients was poor. Public Health Midwives were keen to exclude pregnancy but other contraindications were not excluded, Circulars, which contained contraindications to immunization, have been issued with regard to immunization. This had been clearly explained in the orientation program.
A. register of eligible women for rubella immunization was not maintained in any of the Journal of the College ofCommunity Physicians ofSri Lanka clinics supervised. Theregister of immunization was completed after vaccination. In noneofclinics were immunized clients totalled and categorized according to age groups at the end ofthe session. Hadthis beenperformed, any unrecordedvaccinated client would have been detected by comparing the number of vaccinations with the dosages of vaccines used. Not adhering to totalling at the end of the day leads to under reporting if anyvaccinatedclients are left unrecorded. It leads to inability to calculate vaccine wastage as well. Despite the defective activities already mentioned, overall quality of services wassatisfactory.

Recommendations
It is essential to carry out regular supervisions by supervisory staff to detect and modify substandard items. Asa few deficiencies were observed in record Keeping at the clinic, steps should be taken to improve documentation during and at the end of the clinic session.