FASTING BLOOD GLUCOSE LEVEL HIGHER THAN POST-MEAL IN OTHERWISE HEALTHY SUBJECTS

 FASTING BLOOD GLUCOSE LEVEL HIGHER THAN POST-MEAL IN OTHERWISE HEALTHY SUBJECTS

In clinical and laboratory practices, many of the time a healthy normal subject will present a fasting blood glucose value higher than the post meal blood glucose value. This creates confusion since there is a common perception that in blood, postprandial (PP) glucose level should be higher than fasting (F) glucose level. The repeated investigation subsequently yields somewhat similar type of result. A review of fasting blood glucose and post meal blood glucose is been presented here in such cases and possible explanations are formulated for such type of laboratory results. Read more @ www.wjpr.net/download/article/1402745343.pdf.......

MONITORING QUALITY IN POINT Of CARE TESTING

MONITORING QUALITY IN POINT Of CARE TESTING

A quality indicator is defined as an objective measure evaluating critical health care domains as defined by the Institute of Medicine (IOM) (patient safety, effectiveness, equity, patient centeredness, timeliness, and efficiency). In other words, a quality indicator is a tool enabling us to quantify the laboratory’s performance by selecting a certain comparative criterion. Any potential quality indicator needs to fulfill primarily two inclusion criteria: it must be an indicator of laboratory functioning and it must cater to at least one IOM health care domain. However, the quality indicators selected should be designed to identify those events that reflect the actual situations in question, are user friendly, are easy to measure, provide the information for improving performance, are understandable, and encourage prompt and suitable corrective or preventive action.

Taking into account everything that has just been said about the continuous monitoring and improvement of the system as a whole, it should be emphasized that the main goal is to achieve the maximum quality with minimum waste and minimal error rate. As of clinical laboratory, it means to offer a right patient, right service in the right moment; i.e. to provide the reliable result from the best available sample with appropriate interpretation and in the most cost-efficient way.

Quality indicators

POCT main principles do not differ significantly from those governing the central hospital laboratory. "To get the right test for the right patient, getting the right specimen and right results in right time, getting right patient record and timely right treatment!" Quality indicators are measurable, objective, quantitative measures of key system elements performance. They indicate the extent up to which a certain system meets the needs and expectations of the customers. Quality indicators can either be measures of processes, outcomes or contribution of the laboratory to the patient care. They can indicate the quality of the key, strategic (organization and management), and support (external services and supplies, maintenance, environmental safety) processes. It is of utmost importance that quality indicators address all three key processes in the laboratory: preanalytical, analytical and postanalytical.

Quality indicators are useful not only just for self evaluation but also for identifying opportunities for implementing corrective action; performing a root cause analysis; developing a quality improvement strategy; modifying targets or action thresholds; reporting to interested parties; and deciding to continue monitoring or stop monitoring the indicator.

Significance of Quality Indicator

v  Snapshot on Laboratories supporting CT.

v  Highlight potential quality concerns.

v  Identify areas that need further quality

v  improvement.

v  Monitor changes and improvements over time.

v  Monitor processes that have potential to put patients at risk!

Problems with POCT

Multi-test menu

Multiple test sites

Multiple testing devices

Multiple non-laboratory trained operators

Immediate results availability

Immediate therapeutic implications

Selection of QI in POCT

4 W

Ø  What will you measure?

Ø  What steps should you take to meet the target?

Ø  Why are you collecting this information?

Ø  What will you do if it indicates acceptable performance or if it does not?

Three types of problems

v  Process Problem

v  Knowledge Problem

v  Behavioral Problem

Stages in QI plan

1.Define the scope of your monitors carefully

Quality Monitors may be unit, analyzer, section, hospital or system

2. Data collection frequency may depend on the difficulty it takes to capture the data

3. Performance Improvement Steps

• Plan

• Do

• Check

• Act

Targets for QI

•Competency of personnel

•Instrument evaluation and validation

•Method correlation

•Instrument maintenance

•Reporting patient results

•External QC

•Internal QC

•Clinician satisfaction

•Communication!?

•Accuracy of patient identification (POC data management software)

Quality Indicator Data Collection

Find a way to measure…Data capture options –

• IT Departments can be helpful in generating LIS/HIS queries

• POC data management software

• Manual reviews/audits

• Your data will drive your process improvement planning

Quality Indicator Evaluation

• Evaluation Frequency is dependent upon the Quality Indicator, and defined by the institution.

• General Evaluation Format

– Goal :

– Threshold:

– Performance Data:

– Action:

– Comments and Review:

Here are some POCT quality indicators:

Ø  number of bad quality samples,

Ø  number of wrong samples,

Ø  samples without identification (no patient identification),

Ø  sample handling errors

Ø  number of inadequate sample – haemolytic, clotted,

Ø  insufficient sample volume, inappropriate collection container

Ø  education documentation (certification),

Ø  critical values notifications,

Ø  quality control performance (internal and external quality control),

Ø  instrument management (instrument evaluation and validation, calibration

          verification, method correlation, instrument maintenance),

Ø  inventory management (reagents and controls),

Ø  incident reports,

Ø  reporting patient results,

Ø  number of missing patient results records,

Ø  number of cases where operator didn’t detect interference,

Ø  reporting incidents, etc.

POC QM Plan QSE Components

1. Documents and Records

– Record retention, Procedure manuals

2. Organization

– Responsibility, licensure, accreditation

3. Personnel

– Training, competency

4. Equipment

– Instrument evaluation and validation, calibration verification, method

correlation, instrument maintenance

5. Purchasing and Inventory

– Purchasing, inventory management of reagents and controls

6. Process Control

– Quality control frequency, remedial action, QC review, patient testing, reagent

storage

7. Information Management

– Patient result reporting, normal/therapeutic ranges, critical results, result

review

8. Occurrence Management

– Incident reporting, staff communication

9. Assessments

– Proficiency testing, inspections

10. Process Improvement

– Quality Indicators

11.Customer Service

– Unit rounds, multidisciplinary meetings, satisfaction surveys

12.Facilities and Safety

– PPE, Collection devices, exposure investigation

END OF TB

END OF TB

The World Health Organization (WHO) has presented new guidelines as part of its Post-2015 Global Tuberculosis Strategy (End TB). This document outlines a 20-year blueprint and now addresses the management of latent tuberculosis. The new guidelines promote for the first time the screening of specific vulnerable populations for latent TB infection and treating the infection to prevent progression to active TB disease, which currently kills 1.5 million people a year. The guidelines recommend programmatic intervention for more than 100 countries with an incidence below 100 cases per 100,000. An estimated nine million people worldwide had active TB disease in 2013 and 1.5 million died of the disease, according to the WHO. While treatment efforts in the past two decades have reduced the death toll from the ongoing TB epidemic, the disease is still taking lives in all regions of the world. The WHO is putting forward a broad strategy to end the global epidemic by 2035, reduce TB deaths by 95%, cut active cases by 90%, and eliminate the catastrophic economic burdens in TB-affected regions. The strategy outlines actions to strengthen TB treatment and prevention; mobilize resources; accelerate development of new drugs, vaccines, and diagnostics; and reform social support.

For the first time, the WHO calls on health authorities to confront the problem of latent TB infection (LTBI)—a global pool of two billion people infected with Mycobacterium tuberculosis, who stand up to a 10% chance of developing active, contagious TB disease. The WHO recommends screening the most at-risk populations, such as HIV-positive patients, young children, people in contact with active TB patients, and immunocompromised patients, and providing preventive treatment to those considered at risk of active TB development. The strategy also calls for more study of preventive treatment in a range of high-risk groups

VISION	A world free of tuberculosis – zero deaths, disease and suffering due to tuberculosis
GOAL	End the global tuberculosis epidemic
MILESTONES FOR 2025	– 75% reduction in tuberculosis deaths (compared with 2015); – 50% reduction in tuberculosis incidence rate (compared with 2015) (less than 55 tuberculosis cases per 100 000 population) – No affected families facing catastrophic costs due to tuberculosis
TARGETS FOR 2035	– 95% reduction in tuberculosis deaths (compared with 2015) – 90% reduction in tuberculosis incidence rate (compared with 2015) (less than 10 tuberculosis cases per 100 000 population) – No affected families facing catastrophic costs due to tuberculosis
PRINCIPLES
1. Government stewardship and accountability, with monitoring and evaluation 2. Strong coalition with civil society organizations and communities 3. Protection and promotion of human rights, ethics and equity 4. Adaptation of the strategy and targets at country level, with global collaboration
PILLARS AND COMPONENTS
1. INTEGRATED, PATIENT-CENTRED CARE AND PREVENTION A. Early diagnosis of tuberculosis including universal drug-susceptibility testing, and systematic screening of contacts and high-risk groups B. Treatment of all people with tuberculosis including drug-resistant tuberculosis, and patient support C. Collaborative tuberculosis/HIV activities, and management of co-morbidities D. Preventive treatment of persons at high risk, and vaccination against tuberculosis
2. BOLD POLICIES AND SUPPORTIVE SYSTEMS A. Political commitment with adequate resources for tuberculosis care and prevention B. Engagement of communities, civil society organizations, and public and private care providers C. Universal health coverage policy, and regulatory frameworks for case notification, vital registration, quality and rational use of medicines, and infection control D. Social protection, poverty alleviation and actions on other determinants of tuberculosis
3. INTENSIFIED RESEARCH AND INNOVATION A. Discovery, development and rapid uptake of new tools, interventions and strategies B. Research to optimize implementation and impact, and promote innovations

CENTRAL LABORATORY ROLE: TO COPE WITH DEMAND FOR POC

CENTRAL LABORATORY ROLE: TO COPE WITH DEMAND FOR POC

The healthcare landscape is undergoing dramatic changes: hospitals are consolidating into regional networks with highly specialized medical care performed in core facilities, generalized medical care provided in satellite hospitals, and ambulatory services offered at point-of-care (POC) locations.

Diagnostic laboratory testing is undergoing a similar transformation. Complex, non-urgent tests are performed in core facility laboratories or in reference sites; routine, acute diagnostic tests are performed in core laboratories or in satellite hospital facilities; and point-of-care testing is performed in outpatient clinics, physician office laboratories, retail clinics, and in-home testing. With an increased effort to provide cost-effective, timely medical care for ambulatory patients, patients are seeking treatment at local physician offices and retail clinics at a rate higher than ever before, and POC laboratory testing has become one of the fastest areas of growth in the medical field, with the number of tests increasing at an estimated 10% to 12% annually.

The transformation of POC testing is not without challenges. Testing has to be accurate, technically uncomplicated, inexpensive, and actionable. It is also critical to note that, particularly in the POC arena, lab tests play a role much larger than identifying or isolating disease-causing organisms. These tests are the start of an end-to-end chain of care that provides timely information to providers and determines patient outcomes. Accurate results are critical to ensuring antibiotic stewardship, initiating prompt and appropriate treatments, and preventing unnecessary auxiliary tests. These results inform the provider’s treatment decisions and allow for immediate action. Thus, as techniques are enlisted to ensure appropriate procedural characteristics to meet POC demands (e.g., turnover time, implementation cost, etc.), the effectiveness of each test must continue to hold equal importance.

An additional challenge for POC testing is somewhat unique—the accommodation of seasonal variation in test volume. Hospital-based laboratories provide a broad menu of diagnostic tests and have a proportionately large technical staff available to meet the testing demands. During peak test volumes for diagnostic services, the laboratory has the flexibility to adjust staffing to meet these needs. In contrast to this situation, POC testing sites generally have minimal staffing to perform tests, and the service providers (e.g., technician, medical assistant, secretary, nurse) will frequently have other responsibilities. Thus, the heavy influx of POC testing that occurs at certain times of the year yields an exceptionally high demand for on-location diagnostic tests.

As a result of the increasing mandate for POC testing, there is a need for laboratories to implement strategies that accommodate quick turnover in large volumes; labs must not only ensure that there are enough tests available at all times, but also ensure that newly developed tests are suitable for procedural operations at POC locations and meet the end goal of prompt and quality patient care. Diagnostic tests for influenza virus are a noteworthy example of the tremendous burden on labs and healthcare providers every year. In the traditional flu season, which lasts from October to March, there are millions of flu tests administered. Not only does this yield a higher-than-average demand for almost half of the year, but this demand is being realized almost entirely at POC locations. The majority of symptomatic patients go directly to their local physician office at first sign of illness. As a result, it becomes even more critical for front-line providers and their lab partners to weigh the benefits of various POC diagnostics in order to handle such a high volume of tests in a compact timeframe.

Influenza diagnostics has undergone dramatic changes in the past decade. Historically, in vitro viral culture was the most sensitive available test, but this could only be performed in hospital-based laboratories, requiring specialized technical expertise and testing facilities, and results were not available for a number of days. Thus, this testing was confirmatory and not particularly helpful for the management of acute infections. A transformation occurred when real time nucleic acid amplification tests (e.g., real time polymerase chain reaction, RT-PCR) became available. These tests are now the gold standard for detecting influenza virus in clinical labs, as they have shown high sensitivity and specificity. However, on the procedural level, these tests do not lend themselves to operational compatibility at POC locations. Commercially available RT-PCR tests have a turnaround time of one to six hours and are run frequently in batches, which can further delay results. Additionally, although testing has been greatly simplified with the introduction of commercial platforms and diagnostic assays, testing is still generally restricted to hospital-based laboratories and has not been extended to POC facilities.

The solution for POC testing lies in the development of immunoassays for the detection of influenza antigens. In principle, immunoassays offer solutions to the procedural limitations of PCR tests; commercial immunoassays for influenza virus have a turnaround time of 15 to 30 minutes, require much less costly equipment, and are generally easy for point-of-care providers to operate. However, the accuracy of the first-generation tests has been appropriately questioned. The most common tests show only 10 percent to 70 percent accuracy based on the commercial assay and circulating strains of influenza virus.⁸ The majority of these tests use a manual visual read system for results in which the user determines assay results by reading an output of colored lines to indicate a negative or positive sample. The inherent subjectivity of such readings has been shown to result in user variability and error rates as high as 56 percent. Thus, while operationally these tests are a good fit for POC locations handling either small or large volumes of tests, they fall short in facilitating the end-goal of POC testing, which is to help providers make accurate diagnoses. Instead, providers find themselves torn between incurring additional costs by requesting repeat samples, and making actionable decisions based on an uncertain result.

Many believe that the best strategy to fulfill the need in point-of-care testing is to commit to meeting both procedural and quality standards in lab diagnostics. A newer generation of tests—digital immunoassay rapids (DIAs)—is designed to meet such requirements. Built to handle large volumes of tests in a short period of time and integrate into larger output systems, DIAs are a promising solution. By offering an instrument-based, digital read-out test that can be measured objectively and using immunoassay crafted particles and antibodies, these tests ensure precise detection and have been shown to be nearly as accurate as PCR. Digital immunoassays take just over 10 minutes, and some are CLIA-waived. Current systems, and similar systems in development, have the potential to help lab operations align with the shift to POC occurring in clinical settings. The rapid turnover between test times and ability to be easily used by many locations and providers allow the physician network to handle high patient volume. Providers can then consider the option of initiating treatment early in the infection, when it has the best chance of being effective and leading to successful patient outcome.

Ultimately, the shift toward point-of-care diagnostics is positive: the more access people have to quality local care, the more likely they are to be seen when needed, and the less likely they are to receive unnecessary and costly tests—all of which will inevitably result in a positive impact on patient health. The laboratory is in many ways the start of this chain of care. Thus, it is critical that diagnostics continue to be developed to adequately equip POC sites with the tools they need to meet a high and timely demand. By strategically incorporating procedural and functional elements, diagnostic providers can ensure that tests are capable of performing at the level and frequency necessary to function in point-of-care and provide patients with the most convenient, quality care possible.