The Rong Regulation: Conflicts between NABL 112, CLSI EP23, and ISO 15189
During my last trip to India, I had the fortune to Dr Satish Ramanathan and Dr CN Srinivas of MIOT Hospitals, Chennai. They shared with me some unique challenges that laboratories face in India, namely the disconnect between the NABL 112, which is the local implementation of ISO 15189, and the other global standards and guidelines. Here are just a few of the discrepancies between NABL, CLSI EP23, and ISO 15189 that they have found.
Discrepancies, Inconsistencies, and Incoherence between regulations, requirements, and global standards
A look at the differences between NABL 112, CLSI EP23, and ISO 15189:2013
Professor. Dr. CN Srinivas, MD(Path), DipNB, FCAP, PGDHRM, eMBA, CLLMC
Fellowship in Immunodiagnostics and Molecular Pathology,USA
Director - Department of Laboratory Medicine,
Head - Transplantation Immunology and Molecular Diagnostics
Dr Satish Ramanathan MD Biochemistry
Head-Clinical Chemistry & Serology / Deputy Quality Manager,
Dept of Laboratory Medicine,
Ms.Smitha.S MSc; Mphil; MBA
Dept of Laboratory Medicine,
MIOT International Hospitals
4/112 Mount Poonamalee Road
Chennai 600089, INDIA
|GUIDELINES FOR ESTABLISHING QC PROCEDURE IN HAEMATOLOGY
|According to NABL 112:2016, the laboratory shall design the internal quality control procedure appropriate to its size and scope. NABL guidelines does not mention about IQCP (individualised quality control procedure).
|CLSI EP23 (2009)Recommends IQCP. It strongly recommends a patient centric approach towards quality control practice based on quality risk assessment.
|All guidelines indicate the IQC procedure to be designed as per the needs of the laboratory. ISO 15189 says, according to clause 188.8.131.52 that the laboratory shall design quality control procedures that verify the attainment of the intended quality of results but NABL does not specify a detailed IQC procedure for labs.
|HOW MANY LEVELS OF CONTROL HAVE TO BE RUN FOR IQC IN HAEMATOLOGY
|NABL 112:2016 clause 5.6 mentions that the laboratory shall use two levels of control once a day.
|CLSI EP23 (2009) strongly recommends a laboratory to define its quality requirements in form individualised quality control plan for laboratories as a part of risk management.
|There is no mention about which levels have to be used as the CBC QC has three levels. The global guideline recommends IQCP for practicising internal quality control
|CAN THE LAB USE MANUFACTURER’S MEAN INSTEAD OF LAB MEAN
|NABL 112:2016, Clause 5.6 explains that since controls for some analytes like CBC and Blood Gases have a short life, the lab can use the manufacturer’s assigned mean and SD to detect out of control values.
|CLSI EP23 (2009) strongly recommends a laboratory to define its quality requirements in the form of an individualised quality control plan for laboratories as a part of risk management.
|NABL guidelines do not mention about the use of lab mean, SD derivation but global guidelines strongly recommend.
|IQC IN CHEMISTRY
|Two levels of QC shall be included once a day of performing the test irrespective of the size of the laboratory. If the laboratory is operational 24/7, two levels of QC shall be run in peak hour subsequently one level every 8 hours
|CLSI EP23 describes good laboratory practice for developing an ICQCP or a QCP based on the manufacturer’s risk mitigation information, applicable regulatory and accreditation requirements, and the individual health care and laboratory setting.
|ISO standard (15189:2012) states that laboratory shall define its quality control procedure according to its needs. But NABL 112:2016 recommends a traditional QC practice rather than an evidence-risk based QC practice recommended globally according to the CLSI guidelines.
|HANDLING IQC OUTLIERS
|Handling IQC outliers The laboratory shall analyze QC outliers, their causes and take immediate corrective action. The laboratory shall analyze the out-of-control situation by applying the following steps: • Search for recent events that could have caused changes • Examine environmental conditions. • Follow manufacturer‟s troubleshooting guide • Refer to instructions of manufacturers of equipment, reagents or QC / calibrator
|CLSI EP23 recommends a risk assessment in form of a process map for QC practice which includes all phases of testing process which have a significant impact on patient safety.
|Global guidelines look into QC practices as a part of quality management and take into account, all elements of testing process and recommends laboratories to approach the laboratory errors through risk assessment based on requirements of a laboratory. NABL though suggests risk assessment QC, the document fails to address the needs.
This highlights not just a problem in India, but a problem everywhere that has a local agency implementing a global standard. As NABL 112 attempts to create a more vertical document out of the horizontal ISO 15189 standard, there are opportunities for gaps and errors. The local implementation of a global standard will inevitably lag behind the latest editions of the standard, as the local agencies must meet, debate, and reach consensus on how the abstract standard will be specifically implemented and enforced. As new editions of ISO 15189 has been issued, it takes time for national agencies to catch up. Further, the CLSI guidelines, suchs as EP23, are not perfectly aligned with the ISO 15189 standard, and that can generate another opportunity for a misunderstanding. ISO 15189 does not require the implementation of EP23, so local agencies have to evaluate whether or not the EP23 recommendations, many of which are geared specifically to solve US problems, are applicable to their own regions.
We will see more and more of this in the future, intersecting, overlapping, confusing mesh networks of global standards, regulations, and guidelines. The laboratory will need more professional skill to sift and winnow the useful requirements from the compliance-oriented chaff.