Typical Infrastructural Constraints (and Opportunities)

Despite the best of intentions, most emerging market countries still lack the basic infrastructure and quality standards necessary for effective medical laboratories and hospitals. For many, the problem seems overwhelmingly complex and expensive. The bullets below are an effort to capture some of the more common constraints facing countries in need. Note that the information below is focused on medical laboratories, although most of the constraints listed would also apply to collection centers, hospitals and clinics:

• Clinically-compromised laboratories
• Deficient or missing quality standards
• Deficient or missing lab infrastructure information
• Insufficient qualified personnel
• Substandard & inadequate facilities
• Missing, substandard & unaffordable equipment & supplies
• Missing safety regulation on diagnostic imports
• Inconsistent, ineffective laboratory design & setup
• Lack of oversight, practical policy and accountability
• Lack of standardized protocols
• Problematic, unsafe sampling & contaminated test samples
• Unsafe & unsanitary waste disposal
• Poor lab documentation & records
• Dependence on unsustainable foreign aid
• Disbelief – due to limitations of other paradigms
• Constant threat of epidemic & pandemic disease
• Difficulty finding an affordable & credible solution

Fortunately, proper laboratory quality assurance can help overcome many of these deficiencies without the need for huge infrastructural investments.

The “Quality” Imperative

Every country has at least four systemic pressures driving them to action, including the following:

• Health imperatives
• Political imperatives
• Professional ethics imperatives
• Economic imperatives 

Fortunately, every individual in every country can relate to at least one of these imperatives, thus making the call for fundamental laboratory improvement universal and pressing. Fortunately, OneWorld-Lab has customizable country solutions that provide the platform to enable client governments to remedy these constraints.

More Detail on Typical Infrastructural Constraints

For those interested in more details on the constraint and opportunities listed above, please see the explanations below:

• Clinically-Compromised Laboratories: Although there are some exceptional labs in every country, access to quality medical laboratories is inconsistent at best. Often, access by the majority of the population to affordable, safe, and competent labs is not possible - either due to geographic constraints, economic limitations, or the simple gap between supply and demand. Outdated or insufficient lab equipment, facilities, training, maintenance & materials sometimes pose an immediate patient risk-of-harm and even jeopardize the safety of the laboratory personnel. 
  
  
• Lack of Quality Standards: Most countries lack sufficient quality standards, associated education, appropriate regulation & credible independent laboratory audit/assessment. Even in countries with standards there is often no enforcement and even if there was, labs would currently be incapable of compliance without education. Many labs’ personnel cannot accurately explain the meaning of quality assurance or quality control. 
  
  
• Deficient Information: Basic infrastructural information on most aspects of laboratory setup and operations is often missing or inaccurate.  In some cases, government health officials are unable to locate the most essential information, including lab addresses and contact information. Many countries have widely disparate estimates of the capabilities of their individual labs and of the needs of the patients they serve.
   
• Insufficient Qualified Personnel: A common challenge in most regions is inadequate supply of qualified competent personnel, training opportunities & continuing education.
  
  
• Substandard Facilities: Substandard or inadequate facilities, facility safety precautions, maintenance contracts, and facilities planning is the norm rather than the exception.
  
  
• Unaffordable Equipment & Supplies: Limited access to appropriate, affordable diagnostic equipment and supplies is significantly hampering improvement efforts. Unfortunately, many countries have not taken advantage of their purchasing power to push aggressive downward price pressures (and the reduction of minimum order quantities) on diagnostic companies.
  
  
• No Restrictions on Diagnostic Imports: Equipment, kits, reagents and materials often enter a country and subsequently the lab without any government oversight, validation testing, quality control, or other protections. This can and does lead to the deployment and use of inappropriate equipment without maintenance contracts, available supplies, and proper operational training.
  
  
• Inconsistent Lab Design & Setup: Although some countries have more than 100,000 laboratories, there is often little consistency in laboratory design, setup, capacity & service offering. This creates significant systemic increases in costs, the potential for a large gap between supply and demand of basic services, and specific missing critical healthcare services.
  
  
• Lack of Oversight and Accountability: There is often a lack of clarity about laboratory and government authority, responsibility & accountability in the oversight of national, regional and local laboratory services. 
  
  
• Lack of Standardized Protocols: Most labs have few standardized protocols or operating procedures for testing, equipment, maintenance, facilities, or other capabilities. At the very least, this inconsistency creates pockets of unacceptable (clinically compromised) laboratory services, and greatly increases the cost of each country’s lab operations.  Many laboratories in primary healthcare settings, especially those in rural areas, rely on mostly manual methods for laboratory testing. These manual methods are typically the most labor intensive and require the most calculations and judgment by the laboratory worker. Without basic quality standards and standard operating procedures, these manual methods can yield dangerous results.
  
  
• Contaminated Test Samples: Lab processes for the collection, labeling, storage and transportation of test samples are often significantly lacking - rendering samples unusable or contaminated. 
   
• Unsafe Waste Disposal: The safe disposal of sample waste is often overlooked or skipped for cost reasons or due to a lack of awareness of the consequences.
   
• Poor Lab Documentation & Records: Lab documentation is often poorly kept; records are mismatched and lost; sample labeling is error-prone and patient health/safety practices are not always followed. This can and does result in inappropriate patient diagnosis, everyday – often with tragic results, and unwanted legal & media attention.
   
• Problematic, Unsafe Sampling: In many countries, centralized laboratories receive patient samples from unsophisticated “collection centers” that typically have rampant safety and quality violations.  These centers (which can contribute up to ~60% of the testing errors) operate in locations without regard for facility adequacy or staff qualifications – sometimes in the back of coffee shops and restaurants. However, collection centers perform an important function in the market & must be retained and improved.
  
  
• Dependence on Unsustainable Foreign Aid: Some countries are dependent on unsustainable foreign aid. All too often, when that aid is reduced or stopped, the temporary gains that were realized are lost or significantly reduced. That is not to say that foreign aid is not useful. However, it needs to have a plan for local sustainability.
   
• Disbelief and Fear: Current paradigms mistakenly reinforce the “impossibility” of large-scale medical laboratory improvement, since the typical options for quality improvement are often only affordable for the largest and wealthiest of private laboratories. There is also a simple and understandable fear of failure based on a sense that even a good solution might be overwhelming to implement.
  
  
• Threats of Epidemic & Pandemic Disease: The spread of epidemic and pandemic infectious diseases and life-threatening non-infectious & vector diseases pose a significant and constant threat, around the world. Medical labs play an important role in the early detection and diagnosis process for these diseases.
   
• Difficulty Finding an Affordable & Credible Solution: A solution that is credible domestically & internationally (for medical tourism & clinical trials) is often unaffordable and/or unsustainable.