SOP Manual for Medicals Laboratories


This U.S. industry comprises establishments known as medical laboratories primarily engaged in providing analytic or diagnostic 

services, including body fluid analysis, generally to the medical profession or to the patient on referral from a health practitioner.

List of Globally Popular Companies and their countries

Thermo Fisher Scientific-Waltham, MA, Becton, Dickinson and Co.-Franklin Lakes, NJ, Agilent Technologies, Inc.-Santa Clara, CA, Illumina, Inc.-San Diego, CA, Mettler Toledo-Columbus, OH, Danaher Corp.-Washington, D.C., Waters Corp.-Milford, MA, Bio-Rad Laboratories, Inc.-Hercules, CA, Bruker Corp.-Billerica, MA, PerkinElmer, Inc.-Waltham, MA, Roche Holding AG-Switzerland, Olympus Corp.-Japan, Zeiss Group-Germany, Spectris-United Kingdom, Sartorius Group-Germany, JEOL, Ltd.-Japan, Eppendorf AG-Germany

The following are some of the top critical issues facing medical laboratories leadership. 

  • Laboratory errors in the Total Testing Process
  • Establishing the context of risk management in clinical laboratories
  • Failure Mode Effect Analysis in risk identification
  • Individualized quality control plan for total testing process
  • Use of quality indicators for risk control and monitoring
  • Communication and consultation with stakeholders

It can be controlled by the systematic application of management policies, procedures and practices to the tasks of analysing, evaluating, controlling, and monitoring risk.  It is a process that involves anticipating what could go wrong (errors), assessing the frequency of occurrence of these errors, as well as the consequences or severity of harm they cause and finally what can be done to reduce the risk of potential harm to an acceptable level.

Some of the International Organisations related to Medical Laboratories,

  • The American Association for Clinical Chemistry (AACC)- aacc.org
  • American Medical Technologists (AMT) - americanmedtech.org
  • Association for Molecular Pathology (AMP) - amp.org
  • American Society for Clinical Laboratory Science (ASCLS) - ascls.org
  • American Society for Histocompatibility and Immunogenetics (ASHI) - ashihla.org
  • American Society of Cytopathology (ASC) - https://cytopathology.org/
  • Clinical Laboratory Management Association (CLMA) - clma.org
  • National Accrediting Agency for Clinical Laboratory Sciences (NAACLS) - naacls.org

Various Industry Standards will be followed by each specific Medical Laboratories to maintain their reputation in the field of interest.

  • Medical Laboratory Technicians and Technologists Act, 1999.
  • Pathology Laboratory Act 2007
  • Laboratory Access for Beneficiaries Act 2019
  • Medical Laboratory Technology Act, 2000

CMS published a response indicating the cuts to the clinical lab tests will not be frozen. Also, the delay in the reporting period will not change the fact that every year the clinical lab fee schedule is subject to fee reduction,” said Forsman. “The fees for 2020 and 2021 will still be based upon the 2017 data and subject to a 10 percent cap on cuts in 2020 and 2021. Subsequent cuts in 2022, and 2023 can be up to 15 percent each year. CMS stated that the cycle will begin again in 2024.

Some of the Magazines that will keep you on track

  • MEDLAB Magazine
  • Lab Manager
  • Clinical Lab Products
  • Medical Lab Observer
  • Laboratory Medicine
  • Health Business Magazine
  • Health Data Management
  • Insights Care

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Written by Bharath Ravi

Business Consultant whose qualification includes a Bachelor’s degree in the field of Mechanical specialized in Automobile & Manufacturing; Trained in Certified Supply Chain Professional (CSCP) Certification, Hands on Foundation Certificate in Business Analysis, BCS (UK) and Certified Professional for Requirements Engineering (CPRE-FL).

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