Can quality assurance in American clinical laboratories be applied to Indian system?

Dr Gaurav Sharma

Quality assurance in pathology services has made rapid strides in the US since the passing of the Clinical Laboratory Improvement Amendments in 1988 by the US Congress. The objective of drafting and implementing CLIA’ 88 was to ensure accuracy, reliability and timeliness of patient test results, regardless of where the test was performed.

Scope of CLIA’88

CLIA was applicable to all laboratories that performed any testing on human specimens for the purpose of diagnosing, prevention and treatment of disease or assessment of health. This meant that the scope of its implementation ranged from physicians performing simple glucose stick test to institutions performing molecular pathology studies from human specimens. This disparity in complexity of the laboratories prompted the need for classifying the regulations to suit the needs and functioning of individual lab services.

Classification and certification of laboratories All pathology investigations were divided into three broad categories depending on the complexity of the procedure. The main focus of CLIA guidelines is to implement and govern the quality standards for proficiency testing, patient test management, quality control, quality assurance and personnel qualifications in the laboratories performing complex tests. The laboratories are awarded ‘Compliance’ certification after an inspection and the next level of certification is ‘Accreditation’, which is issued to a laboratory on the basis of the laboratory’s accreditation by a designated accreditation organisation.

CLIA advisory committee

CLIA advisory Committee was established in 1992 by the Health and Human Services (HHS) to advise and make recommendations on the technical and scientific aspects of CLIA. Members are selected from authorities that have expertise in the fields of microbiology, immunology, chemistry, hematology, pathology and representatives of public health authorities and medical technology industry.

Implementation Centre for Medicare & Medicaid Services (CMS) is the main federal agency that oversees the implementation of CLIA. The Clinical Laboratory Improvement Amendments Committee is convened by CDC to oversee the policy matters for CLIA implementation. Food and Drug Administration (FDA) is responsible for test categorisation and home use products.

CLIA ‘88 requirements

CLIA has specified the essential educational qualifications and responsibilities for every administrative and technical position. It recommends planning and implementation of a QC system of the highest attainable standards for a laboratory. These recommendations include existence of an internal quality assurance system, which includes documented calibration after any change in the status.

CLIA has specific guidelines for environment as well as a detailed policy acceptance, storage, use and disposal of reagents and controls. CLIA addresses the issues of implementing a documented and detailed laboratory management system for preventing pre-analytical, analytical and post-analytical errors in an investigation cycle.

Investigation records have to be maintained for a minimum of five years in clinical pathology and 10 years in anatomical pathology. CLIA wants every laboratory to formulate a uniform system of reporting the test results. Lot of importance is accorded to proficiency and precision testing. These include inter laboratory comparison and repeat testing of same specimen by two operators when manual procedures are used. Private non-profit organisations, Federal or State agencies provide the PT samples. A successful PT is defined as meeting target values greater than 80 per cent times and ‘failure’ is described as unsatisfactory performance in less than 2 consecutive cycles.

Approved accreditation organisations like College of American Pathologists (CAP) accredits usually stand-alone laboratories while Joint Commission on Accreditation of Healthcare Organisations (JCAHO) audits laboratories that are part of the hospital system. COLA (Clinical Laboratory Accreditation and Education) accredits on the other hand covers physician office labs, small clinical laboratories and department of defense labs. Present system In India, a mandatory system to accredit a clinical laboratory does not exist. We do not have such a system for other specialties either. We have legislation that regulates medical practice but awareness about this does not exist in the masses. Quackery prevails in all the fields of medicine including laboratory medicine.

How to improve this system Step One; First Five years: Indian and state Medical Council Acts should be implemented. They have clear guidelines that under normal conditions a medical graduate should do general practice and a specialist should practice his specialty. As a result, only person with postgraduate qualification in pathology will authenticate results generated by an establishment consisting of laboratory equipment, personnel and quality management system.

If a pathologist is at the helm of the affairs, quality of laboratory testing will automatically improve. Similarly quackery in all the specialties of medicine will go. A voluntary certification/accreditation system should be introduced.

Step Two: Next five years In a matter of five years, a mandatory accreditation system can be introduced. One must not forget CLIA regulations came into existence way back in 1968. It took almost more than two decades for American laboratories to have a mandatory, uniform and unbiased accreditation system.

Existing accreditation system in India At present, laboratories are usually going for two types of certification/ accreditation systems. First one is ISO 9000, assessors of which certify that a “Quality Management System” exists in the organisation. Quite a few quality conscious pathologist go for this accreditation because it brings in quality management in the system. Since they are postgraduates in pathology, they do not require any auditor to assess their competence.

Process is simple and certifying agencies are usually private bodies. It is reasonably priced with minimal bureaucratic hurdles. Despite this, we have only about 200 laboratories conforming to this standard; ISO 17025 & ISO 15189 Other certification is accreditation by NABL. This was accrediting to ISO 17025 standard and will start accrediting Clinical Laboratories to ISO 15189 standard from June onwards. These standards cover both the aspects: quality management and professional competence. Despite being a better accreditation, only 40 laboratories have opted this standard. It is not that specialists are not quality conscious or incompetent but the system has a few drawbacks.

The accreditation process is lengthy, taking as much as three to six months to get acknowledgment of application. Few months later a lead auditor is appointed. It generally takes a couple of weeks to fix pre-assessment date.

During pre-assessment, a few relevant and irrelevant non-conformities are raised. Many a times they are based on whims and fancies of Assessor. Assessee has to address them. A straight-forward and righteous assessee stops the process. Subsequent to pre-assessment accreditation audit takes place.

For a medium-sized laboratory, which has a team of two or three postgraduates it is quite tedious to face assessors who are usually five to seven in number. Small laboratories may not think of this accreditation. Auditors raise a few non-conformances, which are to be taken care of and recommend scope of tests to accreditation committee. Accreditation committee meets every three to four months. Even if accreditation committee approves the laboratory for accreditation, it might take a few more months to receive the certificate of accreditation.

Conclusion

The American System of Accreditation can be implemented in phased manner in India. A laboratory may require about two years to get accreditation. It is because of the approach of accrediting agency, which has a monopoly. Process is expensive. Most of the accredited laboratories are either supported by pharmaceutical giants or are their investigating arms. Funds for accreditation usually comes from the budget of clinical trials conducted by them. A very small proportion of these accredited laboratories is a stand-alone laboratory owned by professionally qualified pathologists.

The writer is clinical observer, department of pathology, University of Chicago, USA