ARGUMENT:

AS A QUALITY IMPROVEMENT FACILITATION MANAGER, WRITE A PATIENT SAFETY QUALITY IMPROVEMENT PROPOSAL FOR QUALITY IMPROVEMENT INTERVENTION IN RURAL SETTING OF LOW- AND MIDDLE- INCOME COUNTRY (LMIC).

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THE QUALITY-OF-CARE PROBLEM SELECTED IS - MATERNAL MORTALITY: MEDICAL MISMANAGEMENT OF THE THIRD STAGE OF LABOR IN RURAL SETTING OF LOW- AND MIDDLE-INCOME COUNTRY (LMIC) – A CASE OF QUALITY IMPROVEMENT INTERVENTION AT PRIME HOSPITAL, BACITA, KWARA STATE, NIGERIA.
Introduction:

Safety is one of and the leading dimension of quality in healthcare systems. Although “the Institute of Medicine (IOM) defined safety as freedom from unplanned injury,”  1 this definition covers a broader perspective, “Patient safety is a discipline in the health care sector that applies safety science methods toward the goal of achieving a trustworthy system of health care delivery. It is a characteristic of health systems; it decreases the frequency and effect of, and make the most of recovery from, harmful occurrences.”  2 An adverse event or harmful occurrence is an inadvertent or unnecessary harm that leads to a momentary or long-lasting incapacitation or loss of life, which is related with the health system rather than the causal disease process. Unintended or preventable connotes systemic or clinical flop which allowed the process of care to harm the patient, which was unnecessary. 1,3,4 The World Health Organization (WHO) definition of patient safety considered the availability of resources, the contemporary knowledge, and the setting in which the care is delivered with a balance between the risk of management or non-management of the case. 5 A study of adverse events across 26 LMIC gives the rate to be about 8 of every 100 cases of this 83% are avoidable with 30% mortality. 6

The Community setting:

Prime Hospital Bacita is in Local Government Area (LGA) of Kwara State, it has a predominantly Muslim population who are Nupe, Hausa and Yoruba by tribe. It is one of the four most populous settlement in Edu LGA. It’s a farming settlement, which used to host the Nigeria Sugar Factory, and it’s a land blessed with some mineral resources. The population as of the last census in Nigeria in 2006 was 201,469. 10 Bacita has poor road networks from adjoining communities; it is either tarred but riddled with potholes or untarred. Prime Hospital is one of the two private hospitals in the community providing secondary care. There are two other old and unkempt government owned primary healthcare centers. There is growing access to phone calls and internet in the community, although with poor to average network strength. The built environment is poor with erratic power supply.



The Clinical Setting

Prime Hospital is a private hospital owned by a medical doctor. It is one of the hospitals on the Health Insurance Scheme running in the State. The Health Insurance Agency pays capitation and fees for service for the care provided for enrolled clients. The health insurance scheme has 44 other hospitals distributed across the state. Referral is made from this hospital to the Tertiary Hospital about 3hours drive away. The hospital also attends to unenrolled patients and gets paid from out of pocket, this patient population accounts for less than 10%. The hospital has on employment: 2 medical doctors, 2 Nurses, 2 Community Health Extension Worker (CHEW), a laboratory technician, a health records staff, and a pharmacy technician, covering 24 hours of operation. The hospital is 40 bedded private facility providing general clinical practices including Maternal and Newborn care.

The Patient Safety Problem :

Post-partum hemorrhage (PPH) is the top etiology of maternal demise worldwide from child births. Between 87% and 99% of maternal deaths have been reported in studies to happen in LMIC, while 30% of these deaths have been linked with bleeding post-delivery of the fetus, which is the third stage of labour.  The third stage of labor which commences with the delivery of the fetus till the complete exit of the placenta. Incomplete or defective parting of the placenta leads to the separation of blood sinuses and post-partum bleeding. The prolonged third stage of labor is considered as the most important factor of excessive bleeding or PPH which is considered being blood loss post-delivery in excess of 500mls for assisted or spontaneous vaginal delivery (SVD) with clinical signs of hypovolemia within 24 hours of childbirth. 11-13 Any care short of the following three stages listed below will lead to medical mismanagement of mothers in this stage of labour and put her at risk of bleeding and death

  • Timely administration of adequate doses of uterotonics to help with uterine contraction,
  • skillful and timely clamping of the umbilical cord and
  • controlled cord traction applied by a trained hand to deliver the placenta completely without retained products.

Active management of the third stage of labour was an improvement intervention to reduce severe blood loss at birth and prevent unnecessary death. 14-16

The current rate of post-partum hemorrhage at Prime hospital has about 11 of every 100 deliveries, with most occurring at the third stage of labour. Of these excessive post-partum bleeding approximately 1 of these 11 cases results in maternal deaths, with others presenting with different degrees of maternal morbidity requiring several medical interventions, prolonged hospital admissions and increasing the cost of care. Three priority factors came up during root cause analysis in the hospital linking the cases of PPH with:

  • Erratic supply of medications, uterotonics and delivery kits to the hospital
  • Poorly functioning equipment needed for proper deliveries
  • Absence of well-trained and skilled staff at each delivery to elicit early warning signs and ensure strict adherence to the policy for active management of the third stage of labour

This quality improvement proposal is to reduce the numbers of deliveries with medical mismanagement by improving the supplies of medications and functioning equipment needed for safe deliveries thereby improving the outcomes of the management of the third stage of labour for each delivery and reducing maternal morbidity and death from PPH.



Design of QI Intervention and Implementation Process:

The goal of this quality intervention is to address the identified factors at Prime Hospital that predisposes to maternal deaths. As high as 3 of every 4 maternal deaths may occur during and around childbirth, especially in resource restricted settings. 17 This intervention is to ensure that there is adequate supply of all medications, uterotonics with functional equipment for the active management of labour to achieve safe maternal and neonatal care became necessary to address the high maternal mortality rate. 15,16

To provide adequate supply of medical consumables and maintain functional equipment, we will get the Health Insurance Scheme to set up a drug revolving and medical credit fund for the hospital. Advocacy will be to all stakeholders involved in health care from the State Commissioner for Health, the Executive Secretary of the Health Insurance scheme, The Directors of some selected pharmaceutical companies operating in the State, the association of pharmacy outlets in the state and the medical director of Prime Hospital. We will set this fund up in a central account at the Health Insurance Agency (HIA), with the participating pharmaceutical companies and pharmacy outlets having a contract to supply and get re-imbursed within 7 working days. We will design a policy framework for the centralization of transportation of medications at the required temperature to Prime Hospital Bacita, which is 3 hours away from the State capital on a poor road. Pharmacy Technician will audit medication supplies daily and submit report to the medical director. To prevent supply chain gap, a facility minimum re-order level of 30% for all medications required for safe delivery is established. Once an order is placed by the Medical Director on the hospital internet-based database which can be viewed by staff of the pharmaceutical company and staff of the Health Insurance Agency, the Pharmacy technician is to follow up the process until it is delivered in right quantity, appropriate temperature, and quality packaging. The pharmacy technician also updates the database to show goods are received in good quality, quantity, and appropriate temperature.

This revolving fund is also used to supply medical equipment based on a Credit Fund loan which is made available at an interest rate which is 6% less than the prevailing Commercial Bank interest rate to be paid over five years from the capitation and fees for services received from the HIA. Hence any non-functional medical equipment such as adjustable delivery couch, angle poise lamp, refrigerators, drip stands, which is unrepairable would be purchased from the credit fund. We will find evidence of this in the Fixed Asset and Maintenance register of the Hospital.

These interventions are policy driven and will be subjected to three layers of audits to ensure effectiveness. The interventions will be deemed effective if after evaluation we found that supply of medications, uterotonics and functional equipment is sustained at 100% and at outcome level, this improved supply chain leads to reduction in the PPH rate at the hospital, reduce maternal complications from excessive bleeding and ultimately alleviate maternal deaths. 

Evidence from Literature Supporting Intervention:

Availability of uterotonics in the delivery room, timely administration of oxytocics, skillful controlled cord traction and adequate lighting in the delivery room have been demonstrated in several studies to improve the outcomes of delivery, prevent maternal complications and deaths. 13,17-19. This study on high prevalence of poor quality of oxytocin in LMIC concluded that to achieve efficient supply of oxytocin to the facility level at the required temperature of 2 to 8 degree Celsius and keep its potency especially for rural setting in LMIC a standardized procurement system amongst other interventions has to be in place otherwise there will be erratic supply, or presence of poorly potent or heat destroyed oxytocics leading to stubbornly high MMR. The study also supports advocacy to stakeholders with a view to improve administration and responsibility in building an efficient distribution process. 20

Another study in 6 Mesoamerican countries discussed the essence of “proper monitoring and management of oxytocin supplies” and “Pharmacy Inventory Monitor” in resource restricted settings to address adequate supply of oxytocin for the control of PPH through improved supply chain, procurement structure and infrastructural development. Availability of oxytocin also lead to increase administration and improved management of maternal bleeding. 21 A study from a LMIC nation, Tanzania in 2012 observes significant improvement in use of oxytocin by about 20% following an increase in about 36 % availability at facility level and leading to an overall drop of 7.5% in PPH across the 52 hospitals with timely administration. They recorded more improvements in facilities at the lower level of care, similar to Prime Hospital than higher-level hospitals. 22 Innovative funding of availability of oxytocin for a hospital on a health insurance scheme is therefore necessary to improve availability, increase administration, prevent PPH and ultimately maternal deaths.

Barriers to Implementation:

Administrative bureaucracy and efficient allocation of financial resources from the Health Insurance Agency. Corrupt practices of inflating the value of medications, equipment, and delays in reimbursing the pharmaceutical companies to ensure efficient supply chain management. Staff attrition rate is high because it’s in the rural environment. It does not motivate staff to work in rural settings due to weekly travel times spent on bad roads because their families live in the city, security challenges on the roads, poor remunerations, suboptimal accommodation facilities and average internet connectivity. Therefore, staff training is a continuous process.

Supply chain challenge; transporting medications and other consumables to rural settings at optimal temperature and maintenance of the temperature within the facility due to erratic power supply. To retain the potency of oxytocin, it must be kept at a certain temperature range. This requires a 24 hour power supply. Erratic power supply and average internet connection also affects the efficiency of the internet dependent database system.

Quality Improvement Monitoring and Evaluation Plan

For monitoring and evaluation of intervention, the facility will form a quality team led by a quality champion who is a physician or midwife trained in Maternal, Newborn and Children under five Health (MNCH). The quality team will use a checklist daily to measure quantity of delivery kits and uterotonics used, quantity remaining, temperature of the refrigerator and room temperature as well as functionality of all equipment in the delivery room. This is signed and dated and reported to the Medical Director. The Medical Director updates the record on the Hospital Database which can be viewed by all stakeholders. The database system flags figures approaching the minimum re-order levels for medications.

Unscheduled weekly spot checks of patient documentation by the in-facility quality team to ensure strict adherence to protocols for management of labor. The spot checks are to look through the delivery notes and nurses’ records to ensure:

  • adequate doses of uterotonics were administered to patient during delivery, timeliness of administration as well as outcomes of the delivery
  • optimal functionality of all equipment used during deliveries
  • that all deliveries were attended to by skilled health care worker

The reports of this will be reviewed monthly during the visit by a care coordinator from the Health Insurance Agency. The Health Insurance Agency (HIA) has Care Coordinators who are trained quality improvement assessors. These care coordinators perform monthly unscheduled visits to the facility, they also review the records of the weekly spot checks and documentation audits. This helps the hospital to stay focused on maintaining the supply chain system.

External Assessors are contracted by the Health Insurance Agency to perform a scheduled visit twice a year. The External assessors are trained and certified SafeCare Surveyors. During their assessment, the surveyors will assess the hospital by observing them while working, perform extensive patients’ and nurses’ documentation reviews, and review the Hospital database and come up with a report. The report is to capture the following at the hospital level:

  1. efficiency rate of the supply chain for medications in the hospital and the functionality rate of the hospital equipment in the delivery room
  2. the number of patients with PPH despite administration of adequate doses of medications
  3. The total number of patients with PPH leading to morbidity and mortality
  4. the maternal mortality rate in the hospital

This report will then show the effectiveness of our intervention in reducing the maternal mortality rate by improving the supply of medications, uterotonics, and functionality of equipment in the delivery room.

Conclusion

Improvement in the supply chain for medications, availability, and administration of adequate doses of uterotonics and presence of functional equipment during each delivery with reduction in number of cases of PPH per 100 deliveries as well reduction in morbidity and mortality rate in the hospital affirms the effectiveness of this quality improvement intervention. We can scale this up to other hospitals on the health insurance program. To prevent maternal deaths as a harmful occurrence in our hospitals the presence of motivated, continuously trained health workers, availability of functioning equipment, adequate supply of medical consumables is required, and all these comes at a cost irrespective of the ownership structure of the health care facility. 8

REFERENCES

1. Institute of Medicine, Committee on Quality of Health Care in America, Linda T. Kohn, Janet M. Corrigan, and Molla S. Donaldson, Editors. To err is human: Building a safer health system. Washington, DC: The National Academies Press; 1999. https://www.nap.edu/catalog/9728/to-err-is-human-building-a-safer-health-system. Accessed Oct 13, 2020. 10.17226/9728.

2. Emanuel L, Berwick D, Conway J, et al. What exactly is patient safety? In: Henriksen K, Battles JB, Keyes MA, Grady ML, eds. Advances in patient safety: New directions and alternative approaches (vol. 1: Assessment). Rockville (MD): Agency for Healthcare Research and Quality; 2008. http://www.ncbi.nlm.nih.gov/books/NBK43629/. Accessed Oct 11, 2020.

3. Read “patient safety: Achieving a new standard for care” at NAP.edu. . https://www.nap.edu/read/10863/chapter/10. Accessed Oct 16, 2020. 10.17226/10863.

4. Adverse events, near misses, and errors. . . http://psnet.ahrq.gov/primer/adverse-events-near-misses-and-errors. Accessed Oct 16, 2020.

5. WHO | patient safety. WHO Web site. http://www.who.int/patientsafety/en/. Accessed Oct 11, 2020.

6. WHO | 10 facts on patient safety. WHO Web site. http://www.who.int/features/factfiles/patient_safety/en/. Accessed Oct 13, 2020.

7. AbSTrACT. Sophie Goyet,  1 Valerie broch-alvarez,2. BMJ Glob Health. 2019;4(5). https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6747907/. Accessed Oct 11, 2020. doi: 10.1136/bmjgh-2019-001562.

8. Banke-Thomas A, Abejirinde IO, Banke-Thomas O, Maikano A, Ameh CA. Cost of maternal health services in low and middle-income countries: Protocol for a systematic review. BMJ Open. 2019;9(8). https://explore.openaire.eu/search/publication?articleId=od_______267::4c7734fce31b28478bb33b3769dcb18f. Accessed Oct 11, 2020. doi: 10.1136/bmjopen-2018-027822.

9. The Joint Commission. Proactive prevention of maternal death from maternal hemorrhage . . 2019(51):1-3. https://www.jointcommission.org/-/media/tjc/idev-imports/blogs/qs_51_maternal_hemorrhage_10_25_19_final2pdf.pdf?db=web&hash=02AE0400464CD0D26649C888AB6A5A93.

10. Local government areas | Kwara state government. . . https://kwarastate.gov.ng/government/lgas/. Accessed Sep 29, 2020.

11. Wormer KC, Jamil RT, Bryant SB. Acute postpartum hemorrhage. In: StatPearls. Treasure Island (FL): StatPearls Publishing; 2020. http://www.ncbi.nlm.nih.gov/books/NBK499988/. Accessed Oct 15, 2020.

12. WHO | WHO recommendations on prevention and treatment of postpartum haemorrhage and the WOMAN trial. WHO Web site. http://www.who.int/reproductivehealth/topics/maternal_perinatal/pph-woman-trial/en/. Accessed Oct 15, 2020.

13. Don’t dismiss the dangerous: Obstetric hemorrhage. . . http://psnet.ahrq.gov/web-mm/dont-dismiss-dangerous-obstetric-hemorrhage. Accessed Oct 15, 2020.

14. Delivering the placenta in the third stage of labour. /CD007412/PREG_delivering-placenta-third-stage-labour. Accessed Oct 14, 2020.

15. Kemal Güngördük,1,* Yusuf Olgaç,2 Varol Gülseren,3 and Mustafa Kocaer4. Active management of the third stage of labor: A brief overview of key issues. Turk J Obstet Gynecol. 2018 Sep; 15(3): 188–192. 2018. https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6127474/.

16. Gülmezoglu AM, Lumbiganon P, Landoulsi S, et al. Active management of the third stage of labour with and without controlled cord traction: A randomised, controlled, non-inferiority trial. The Lancet. 2012;379(9827):1721-1727. https://www.thelancet.com/journals/lancet/article/PIIS0140-6736(12)60206-2/abstract. Accessed Oct 14, 2020. doi: 10.1016/S0140-6736(12)60206-2.

17. Goldenberg RL, McClure EM, Saleem S. Improving pregnancy outcomes in low- and middle-income countries. Reproductive health. 2018;15(Suppl 1):88. https://search.datacite.org/works/10.7916/d8sj33gb. doi: 10.7916/d8sj33gb.

18. Maternal mortality. https://www.who.int/news-room/fact-sheets/detail/maternal-mortality. Accessed Oct 11, 2020.

19. Güngördük K, Olgaç Y, Gülseren V, Kocaer M. Active management of the third stage of labor: A brief overview of key issues. Turk J Obstet Gynecol. 2018;15(3):188-192. https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6127474/. Accessed Oct 17, 2020. doi: 10.4274/tjod.39049.

20. Lambert P, McIntosh MP, Widmer M, et al. Oxytocin quality: Evidence to support updated global recommendations on oxytocin for postpartum hemorrhage. J Pharm Policy Pract. 2020;13. https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7227300/. Accessed Oct 21, 2020. doi: 10.1186/s40545-020-00205-7.

21. Kamath AM, Schaefer AM, Palmisano EB, et al. Access and use of oxytocin for postpartum haemorrhage prevention: A pre-post study targeting the poorest in six Mesoamerican countries. BMJ Open. 2020;10(3):e034084. https://bmjopen.bmj.com/content/10/3/e034084. Accessed Oct 21, 2020. doi: 10.1136/bmjopen-2019-034084.

22. Bishanga DR, Charles J, Tibaijuka G, et al. Improvement in the active management of the third stage of labor for the prevention of postpartum hemorrhage in Tanzania: A cross-sectional study. BMC Pregnancy Childbirth. 2018;18. https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5998542/. Accessed Oct 21, 2020. doi: 10.1186/s12884-018-1873-3.

Summarized By Dr.Joshua Kolawole

(MD, MBA, MASc., FISQua, CPHQ, PMP)

Agile Program Manager & Transformational Leadership Expert, Valdymas Intelligence LLC, Grand Prairie, Texas, USA.

 valdymas@valdymasintelligence.org

 

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