Emerge Lab

Clare Appleyard asked:


Natural colored diamonds are some of the rarest and most beautiful diamonds that you can imagine.  Mined at a number of varieties across the world, including South Africa and Australia, colored diamonds are prized by collectors and are sold for 10’s of thousands of dollars per carat.

Colored diamonds are increasing in popularity and as such, more and more purchasers are looking to invest in colored diamonds.  However, there are a number of points to bear in mind when investigating and purchasing diamonds of color.

First and foremost, a buyer needs to know whether the color in the diamond is natural, or enhanced.  This is not to be confused with whether the diamond is a natural diamond or a synthetic diamond, but where the color in the diamond actually comes from.  What do we mean by this?

A diamond with a naturally occurring color, say yellow or blue, is a result of chemical impurities in the diamond (nitrogen for yellow, boron for blue) that were incorporated as the diamond grew in the earth’s mantle.  The colour is intrinsic in the diamond, it is the colour it always was.

Because naturally colored diamonds are so rare, so expensive and now, so popular, a variety of laboratory techniques have been developed to alter, induce and enhance the natural color of a diamond.  These laboratory techniques can artificially increase the value of a diamond and, despite diamond dealers being legislated by government authorities to report any laboratory treatments to clients, this does not always happen.  An unscrupulous dealer could sell a laboratory treated yellow diamond as a natural yellow diamond and receive a higher purchase price from the unsuspecting client.

So, what are the laboratory treatments and the enhancements that you should be aware of?  Irradiation of diamonds and high pressure – high temperature (HPHT) treatments are some of the more common processes that diamonds may be subjected to, to improve color and enhance perceived value.

By subjecting brown diamonds to HPHT treatments, the color of the diamond can be changed to a more desirable color of yellow or green.  Lighter brown diamonds or grey-tinted diamonds can be turned almost colorless, immediately improving their perceived value according to the diamond D-Z color scale.  HPHT treatments are traditionally permanent, meaning that the diamond color will not return to its original, natural color.

Irradiation of diamonds in a natural setting (such as the earth’s crust or mantle) leads to very rare green diamonds.  Similarly, by irradiating a diamond in a laboratory, one can produce a green or blue-green diamond and, upon further treatment, even orange or pink stones.  Many black diamonds are also the result of laboratory irradiation.

It is very easy to identify whether a diamond is natural or synthetic (laboratory-grown) but it is more difficult to identify whether the color in a diamond is natural or laboratory-induced.  Certification laboratories such as the GIA possess the necessary equipment to investigate the color in diamonds and any questionable diamonds should be submitted to the GIA for investigation and proper certification.

If you are in the market for colored diamonds, be aware of the laboratory treatments and make sure that your retailer knows the origin of the colour, the origin of the diamonds and can provide you with the necessary certification for the stones you are buying.

Peter Salazar asked:


What is the job of technicians of clinical laboratories? Basically they have to conduct some laboratory tests, which is an aid used in diagnosis, treatment of a disease and in detection. The technicians of clinical laboratories are named as technicians of medical laboratory or medical technicians. Usually, the physicians known as pathologists supervise the technicians of clinical laboratory. The specialization done by these pathologists is to diagnose the disease.

Work

Most of the clinical technicians of laboratory work in the hospitals. Some of them work in clinics or research institutes. The left out technicians are employed in medical laboratories, which are commercialized and run various diagnosis tests on the fees charged by hospitals or doctors.

The technicians of clinical laboratory have to perform work or tasks on daily or routine basis. The work of them is to take samples of patients, diagnose by taking certain tests of urine or blood. The next step is to label them and possess some simple tests on the samples taken. For this they prepare, label slides, sterilize, stain certain instruments and keep a record of the various tests being taken. Even the tests which are involved in blood banks are done by clinical technicians. They can easily determine the blood of the donor with the help of blood samples and sterilize instruments, prepare the stain, and label slides; and keep records of tests. Clinical laboratory technicians also perform tests involved in blood banking. For example, they may help to determine a donor’s blood type. They may work in several areas of the clinical laboratory or specialize in just one.

Training and Education Requirements

A clinical technician must possess a diploma of high school or a degree equivalent to it. The degree should be of a technician of clinical laboratories. Basically the high schools provide courses in science and maths for a good preparation. A specialized training is required after completing high school either of a degree of an associate or certificate of technical or vocational institute or from a hospital or from a junior college or from U.S.

Benefits and Earnings

A clinical laboratory technician earns a salary of $30,840. But the experienced workers earn more than the common medical technicians. They get benefits such as paid vacations and holidays. Even some of the workers get good pension plans.

Getting Job to the medical technicians

For a medical technician, the office of school provides placements, for getting jobs. Even you can apply directly in clinics, research institutes, hospitals and laboratories. You should always check the newspaper ads which have vacancies; even you can search on Internet in the job banks column as well as professional journal.

Peter Odeh asked:


The field of medicine is one which is very crucial to humanity and must be devoid of egocentrism, monopoly and similar sentiments and dogmatism that at the long run will transpire into an inimical and detrimental outcome which will negatively impact on the primary beneficiary- the patient. The fundamental goal of any healthcare delivery system should be how to meet the challenges of providing the best possible healthcare services that is pragmatic, efficient, proficient, timely, and accurate, and at the same time less expensive.

                 

Consequently revisiting the Medical laboratory science profession and trying to reposition, rejuvenate and restructure its current curriculum to meet and if possible surpass the currently achieved standard of healthcare services is very crucial and almost nearly indispensable if the country hope to modernize and achieve the primary goals of the medical and healthcare profession and aspirations.

Without an iota of doubt, this noble profession is as complex as humanity itself and any approach thereof in trying to elucidate the best way to uplift the field must definitely take into cognizance such complexity and diversity. Medicine as we used to know has evolved a great deal and today represents greater diversity than seen in the 19th and even the 20th century. From a general perspective when link with the healthcare profession as a whole, this laudable and very imperative field can be broadly divided into Clinical and Laboratory with specialty such as diagnostics falling into the later even when they might not be directly related, while on the other hand nursing and pharmacy among others may fall into the clinical aspect of the medicine.  

The fundamental inclination to this brief summation is essentially related to how does the status quo hope to modernize the medical and allied healthcare profession in such a way that the medical laboratory technology discipline is allow to reach its full potential in becoming the true corner stone of modern medicine and its professionals are given the due recognition by the state? I wish to reiterate the fact that my perspective may vary from some of my colleagues principally as a result of my background training which by omission or commission imbibe in me the mentality of seeing my profession from a noble and pragmatic angle in terms of its usefulness, necessity and indispensability in the provision of a comprehensive healthcare services.  

Consequently the call for modernization of the profession is not in any way one which blatantly request for a synonymous training scope with that of physician or pathologist, instead it is a call for the incorporation of curriculum that will enable the medical technologist to be able to professionally and legally interpret, aid in the diagnosis, therapy, management and prophylaxis of a given medical condition without compromising either the patient or the primary healthcare provider. This again raise the concern about why it is necessary for the field to determine that monopoly and egocentrism within the multi-complex discipline should be relegated to the background and instead focus and emphasis must be on providing the best healthcare delivery system.  

I am very quick to point out that as a consequence to the emergence of varieties of complex scenarios which cloud the easy elucidation of the causative organisms or agents implicated in diseased conditions, the role of the medical laboratory scientists have changed dramatically from that of primarily responding to just the healthcare provider,  to now include the determination of the exactness, that is the accuracy and that the same time the best possible treatment and prevention of the cause as necessitated by the contemporary curriculum. Medical Laboratory Scientist are therefore evolving to become more independent in decision making and in some cases have tremendously helped to reduce both cost and waste as a result of their timely intervention, a fact that has been widely recognized within the status quo but never allowed to be publicize for reason beyond imagination.  

The modernization of the medical laboratory profession should be able to make an average graduate to be capable of comprehensively utilizing the new curriculum to assist in the interpretation, diagnosis and treatment recommendation of the condition(s) as it relates to the laboratory test(s). This in my opinion can be achieved with the help of adopting a scheme of studying that may be similar to that of the Physician Assistance training, in respect of pragmatically understanding the clinical implications of laboratory data, but with less emphasis on clinical and invariably greater inclinations to the laboratory management of diseases and other medical conditions.  

In order for the field of medical laboratory profession to pragmatically achieve such goal of making it to become a 21st century specialty, which will be responsive to primary healthcare providers and the patients, there is no doubt that Physicians and Pathologist must buy into the idea of allowing what is best for the patient to become a reality rather than becoming sentimental- which is understandable. Relying on the conviction that the patient comes first, I do believe that the prevailing status quo can work itself out and aid the field to become ready.  

At this juncture I wish to briefly but modestly narrate an incident that happened during a flight from Frankfurt Germany to Washington Dulles Airport in which a passenger on board developed symptom of acute fatigue and thirst leading to fainting. The flight attendance immediately announced that there was a medical emergency on board and seeks the intervention of any medical personnel. Without giving the credit to myself alone, I recognize among other things that the pulse rate and the blood pressure was okay and the dry mouth might be sequel to dehydration and or anxiety. The passenger had to lie on the floor with the head slightly down in comparison to the leg in order to allow for greater blood flow to the brain. With the vital signs okay and the patient having regain consciousness I advice that he should given as much fluid as possible and in the absent of pure glucose-D drink the juice on board did suffice for this purpose. Fortunately there was no need for fluid infusion and by the end of the day it all went well.  

Upon arrival in the USA I was later presented with an American Express gift certificate and a thank you letter from the medical director of the airline in addition to the many on board gifts and appreciation. The above narration is not about wanting anybody to thank me further, but rather as an example of how knowledge if well utilized can save life! I had a background training that to a greater extent recognize the essentiality of first aid and being a part of the primary healthcare delivery system. I am not a doctor or physician, but rather a medical laboratory scientist whose professors recognizes the fact that during the course of our training we must know how to deal with some situation without compromising life and at the same time impersonating.   Is it therefore possible to train medical laboratory scientist in such a way that they too can have the knowledge base to intervene if need be in a medical situation to the extent that life can be preserve as far as it depends on that knowledge?  

There is an absolute necessity of training the modern medical laboratory scientist in the fashion that they are vastly knowledgeable in the area of physiology, anatomy, biochemistry and pharmacology and some basic clinical maneuvers in addition to the most fundamental essentiality of performing diagnostic and or laboratory tests.   We all cannot be a nurse, pharmacist or Genetics, nevertheless we can lend a professional helping hand by being able to assist in the most comprehensive manner the bone of contention and by so doing elevate the practice for the benefit of the patient and the system at large.  

By and large, any curriculum that hopes to accommodate the tentative modernization that I am asking for may take a minimum of 3 years post graduation from the medical laboratory technology program. During the 3 years period, the prospective student shall receive the necessary educational and professional training needed to enhance his or her capacity to midwife in the most qualified manner the laboratory results, the clinical interpretation from a laboratory management perspective and recommend if need be further test(s) or elimination of some already ordered ones.  

Two years shall be spent on correlating clinical and laboratory studies in relation to patients through the thorough studying of the physiology, anatomy, biochemistry and pharmacology, and also pathology. The last year of study should be concentrated in a given area of the clinical laboratory discipline namely; clinical biochemistry (chemical pathology), hematology, microbiology, immunology, coagulation study, urinalysis and instrumentation (automation), laboratory information services (LIS), genetics, among others.  

In a nutshell in order to reposition the field of medical laboratory science to become better equip to deal with the challenges of the 21st century medical and health concerns, there is an absolute necessity to upgrade or modernize this area of healthcare that is very crucial and in some cases nearly indispensable as far as the diagnosis, treatment, management and prevention of a medical condition is concerned. Its professionals who are involved in the carrying out of diagnostic tests in order to generate results that is use to substantiate or refute a given provisional diagnosis and or in adequately and scientifically managing the conditions must be treated with respect and be given due sue place of honor among the committee of professions.  

The patients stand to gain the most if we can allow our selfish interest or desire for monopolistic inclination to be sacrificed in order to move the United States of America healthcare delivery system forward in order to become second to none in the world and by so doing once more provide the kind of leadership that mankind is expected of the country. As the saying goes necessity is the mother of invention and the medical laboratory profession is in itself a child of necessity that should be allow to grow, rather than being truncated or marginalized at the detriment of the patients.  

Ours is the generation that has the pragmatic potential for change as epitomized by the inauguration of the 44th president of the United States of America in President Barack Obama which some cynic pundits have concluded will never happen in the country. The attestation to the pragmatism, broadmindedness and the desire for concrete actions and solutions to the nefarious problems facing the nation especially in context of the economic maladies has been one of the fundamental reasons why the president defeated his opponent in the November 4th 2008 general election.

Physicians, Pharmacists, Nurses and the other allied healthcare professionals could be making history and changing the spectrum of the profession for the best if only they are willing to support the aspiration of the medical laboratory scientists in orchestrating the necessary modalities that will bring about a lasting and durable change and career progression with the ultimate goal of positively impacting on the healthcare delivery system and further leading to a reduction in the cost of doing business.  

It has never been my dream to train as a physician as epitomized by my aspiration to pursue the medical laboratory science profession during my undergraduate studies at the University of Calabar College of Medical Sciences. However I was also made to understand within my professional and academic training that I will be very useful and respected as a medical laboratory scientist especially based on my job discretion, performance and potential to make a pragmatically positive difference. In the United States of America the above conviction seems to be a mirage and consequently it may not be good enough for those who aspire to be like me.

We must change, since the later is just inevitable; life without change is not worth living and that is why I do hope that somehow the healthcare profession and its professionals can help the medical laboratory profession to transition from its current status to that which will enable the citizenry to better utilize their profession at full capacity rather than the prevailing circumstances in which the job and responsibilities are more or less haphazardly distributed in context of how laboratory data are generated and yet the generators have little or no input as to how these results are consequently utilized to bring about the diagnosis, treatment and management of the conditions that might have necessitated the request in the first place.

I am proud of being who I am and look forward to achieving the peak of my career which based on my mentors may culminate in the award of a doctorate degree in the field of medical laboratory profession in addition to the capacity to touch lives through researches and other veritable tools that will help bring about further progress, innovation and discovery in the health and medical profession.

May God bless the noble professionals in this field of healthcare, who have continued to give their best with little or no recognition at all for their indispensable services that have been miniaturized into the generation of laboratory data as against the real values and capacity that abound in this very noble profession, amen.

Aarkstore Enterprise asked:


Clinical laboratory testing is generally categorized as either of two general areas–clinical testing and anatomical pathology testing. Clinical and anatomical pathology procedures are frequently ordered as part of regular physician office visits and hospital admissions in connection with the diagnosis and treatment of illnesses. As such, clinical laboratory analysis is one of the most important sections of medical care. The purpose of this report is to describe the specific segments of the clinical laboratory analysis business. The emphasis in this review is on those companies that are actively developing and marketing laboratory data for the clinical setting, including hospitals, independent labs, physician’s offices and miscellaneous clinics. This study concentrates on the clinical laboratory industry in the U.S. It defines the dollar volume of sales in each major market and analyzes the factors that influence the size and the growth of the individual market segments. The study surveys some of the primary companies known to be marketing clinical laboratory data into the market. Each company is discussed in depth with a section on the history of the company, the product line, business and marketing analysis, and a subjective commentary of the position of the company in its market.

Table of Contents :

1. Overview 5

1.1 Objectives of the Report 5

1.2 Methodology 6

1.3 Scope of the Report 7

1.4 Executive Summary 8

2. IVD Clinical Laboratory Market 10

2.1 Introduction 10

2.2 Key Players for Independent Clinical Labs 11

2.3 Reimbursement Pressure 11

2.4 Medicare Part B Spending Trends 13

2.5 Cost of Billing and Average Receipts for Commercial Labs 15

2.6 Hospital Outreach Programs 16

2.7 Criteria for Selection of Lab Services 20

3. The Clinical Laboratory Testing Market 21

3.1 U.S. Market 21

3.1.1 Hospital-based Clinical Laboratories 23

3.1.2 Commercial Clinical Laboratory Testing 23

3.1.3 Physician Office Laboratories (POLs) 24

3.2 Clinical Lab Testing Key Players 29

3.2.1 Commercial Clinical Labs 29

3.2.2 Hospital Lab Collaborative Ventures 30

3.2.3 Specialty Labs 31

3.3 Revenue and Reimbursement 32

3.4 Outlook for Clinical Laboratory Testing 35

3.4.1 Long-Term Changes 35

3.4.2 Market Drivers 36

3.4.3 The Limits to Growth 37

3.4.4 Key Technologies 37

3.4.5 Conclusion 38

4. Hot Sectors in the Clinical Lab Testing Market 39

4.1 Workplace Drugs-of-Abuse Testing 39

4.2 Clinical Toxicology 39

4.3 Clinical Testing for the Pharmaceutical Industry 40

4.4 Heavy Metal, Trace Element, and Solvent Analyses 40

4.5 Diabetes (Glucose) Testing 40

4.6 Molecular Diagnostic Testing 40

4.7 Cardiac Markers 41

4.8 Blood Bank Screening 41

4.9 Genetic Testing 41

4.10 Predictive Medicine Testing 42

4.11 Personalized Medicine 44

4.12 Cancer Testing 44

4.13 Cell Based Cancer Testing 45

4.14 Monitoring Technologies 47

4.15 Anatomic Pathology 48

5. Important Technology Trends 49

5.1 Technology Platform Innovations in Point-of-Care Testing 49

5.2 The New Paradigm 49

5.3 Consolidated Workstations 49

5.4 Automation in the Laboratory 51

5.5 Laboratory Information Systems 52

5.6 New User-friendly Interface 52

5.7 Data-Management Issues 53

5.7.1 Wireless LANs 53

5.7.2 Data and Workflow Management Systems 54

5.7.3 Beckman Central Command 54

5.7.4 Clinical IT More Widely Available in Physician Practices 55

5.7.5 Physician Electronic Health Records (EHRs) 56

5.7.6 Specimen Tracking and Processing 56

6. Business Trends in the Clinical Laboratory Analyzer Sector 57

6.1 Key Developments 57

6.2 Sector Consolidation 57

6.3 Acquisition Pricing 58

6.4 A Closer Look at Recent Lab Deals 59

6.5 Acquisition, License Agreements, Internal Development and Partnerships 60

6.6 Merger, Acquisition, Financing and Partnering Activities in the Clinical Lab Industry 61

6.7 Comparison of Quest and LabCorp 65

6.7.1 Acquisitions 65

6.7.2 Quest’s Growth, 2000-2006 65

6.7.3 Laboratory Corporation of America 66

6.7.4 LabCorp’s Growth, 2000-2006 66

6.7.5 Competitive Advantages at Quest and LabCorp 67

6.7.6 National Managed Care Contracts 67

6.7.7 Billing and Collection Management 68

6.7.8 Lower Reagent and Supply Costs 68

6.7.9 Esoteric Testing Capabilities 68

6.7.10 Ability to Invest in Web-Based Connectivity Solutions 68

6.7.11 Competitive Disadvantages of Quest and LabCorp 68

6.7.12 Difficulties with Turnaround Times and Stat Services 69

6.7.13 Physician-Laboratory Communication 69

6.7.14 Specimen Pickup Scheduling Inflexibility 69

6.8 Regulation of Clinical Laboratory Operations 70

6.8.1 CLIA and State Regulations 70

6.8.2 Drug Testing 70

6.8.3 Controlled Substances 71

6.8.4 Medical Waste, Hazardous Waste and Radioactive Materials 71

6.8.5 FDA 71

6.8.6 Occupational Safety 71

6.8.7 Specimen Transportation 71

6.8.8 Corporate Practice of Medicine 71

6.9 Hospital Outreach Programs 72

6.10 Supply Chain and GPO Contracting 72

6.11 Specialty Labs 72

6.12 Expansion of Hospital-Based Labs and Hospital Outreach Programs 73

6.13 Managed Care 73

7. Company Profiles 74

7.1 ACM Medical Laboratory 74

7.2 American Esoteric Laboratories (Sonic Healthcare) 74

7.3 American Pathology Partners 74

7.4 AmeriPath (Quest) 75

7.5 ARUP Laboratories 75

7.6 Athena Diagnostics 76

7.7 Aurora Diagnostics 76

7.8 Bio-Reference Laboratories, Inc. 76

7.9 BioTech Labs 77

7.10 CBLPath 77

7.11 Centrex Clinical Laboratories 77

7.12 Clarient, Inc. 77

7.13 Clinical Laboratories of Hawaii (Sonic Healthcare) 78

7.14 Clinical Reference Laboratory 78

7.15 Clongen Laboratories 78

7.16 CompuNet Clinical Laboratories 78

7.17 Diagnostic Systems Laboratories 79

7.18 Enzo Biochem, Inc. 79

7.19 Esoterix 79

7.20 Focus Diagnostics 80

7.21 Fresenius Medical Care AG & Co. KGaA 80

7.22 Geneva Laboratories 81

7.23 Genomic Health, Inc. 81

7.24 Genzyme 82

7.25 IBT Laboratories 83

7.26 Integrated Regional Laboratories (IRL) 84

7.27 LabCorp 84

7.28 MDS Diagnostic Services 85

7.29 MEDTOX Scientific, Inc. 86

7.30 Meriter Health Services 86

7.31 Mid America Clinical Laboratories (MACL) 86

7.32 Monogram Biosciences, Inc. 86

7.33 Myriad Genetics, Inc. 87

7.34 National Jewish Medical and Research Center 87

7.35 Parkway Clinical Laboratories 88

7.36 Pathology Associates Medical Laboratories (PAML) 88

7.37 Psychemedics Corporation 88

7.38 Quest Diagnostics Incorporated 88

7.39 RDL Reference Laboratory 89

7.40 Satellite Laboratory Services 89

7.41 Spectrum Laboratory Network 89

7.42 Sonic Healthcare 90

8. Clinical Laboratory Testing Sector Trends and Forecasts 91

8.1 Home Care Analysis 91

8.2 Non-Traditional Collection for Laboratory Testing 91

8.3 New Systems for Critical-Care and Near-Patient Testing 91

8.4 Shift to Preventative Medicine 91

8.5 Mergers of Diagnostic Companies 91

8.6 Information Management Advances 91

8.7 Test Ordering Patterns 91

8.8 Patient Satisfaction 91

8.9 Move Away from Central Laboratory 92

8.10 Healthcare Cost Controls 92

8.11 Competition for Services 92

8.12 Drivers and Barriers of Clinical Laboratory Testing 92

8.13 Confluence of New Technology 93

8.14 New Trends in Clinical Laboratory Testing 93

8.14.1 Trends in Reimbursement Practices 93

8.14.2 Managed Care 95

8.14.3 Point of Care Testing 96

8.14.4 Satellite Facilities 96

Dana H asked:


Today’s business environment places many demands on technical managers and corporate executives. At a time when global competition forces companies to introduce products at a faster pace with higher efficiency and productivity, quality systems like ISO and Six Sigma, stipulate rigorous testing documentation. Regulatory systems, such as Good Manufacturing Practices (GMPs) and Good Laboratory Practices (GLPs), require examination of manufacturing components— raw materials, production intermediates, and finished goods— together with meticulous records of every action and result. Customers routinely insist that manufacturers keep auditable schedules and thorough documentation as a condition of doing business.

These factors place strict guidelines on data management and document handling by manufacturing organizations and the testing laboratories that support them. Data archiving, retrieval, and auditing must provide traceability, accountability, and compliance with regulations. LIMS is an excellent mechanism to meet these complex data management requirements and to facilitate the move to an electronic records environment in compliance with the electronic data integrity requirements of the U.S.

FDA (21 CFR Part 11), U.S. EPA, OSHA (Occupational Safety & Health Administration), and their international counterparts.

Traceability, accountability, and quality

Traceability is defined as “the property of the result of a measurement or the value of a standard whereby it can be related to stated references, usually national or international standards, through an unbroken chain of comparisons all having stated uncertainties.” In a strict sense, traceability refers to results of measurements by scientific instruments. It is not the property of the instrument, the calibration report, or the originating laboratory. A traceable measurement is performed in a measurement system (i.e., analytical instrument) that is clearly understood and under control. Traceability implies that the instrument is subjected to a quality assurance program; is calibrated; is regularly tested against a standard reference before, during, and after sample measurement; and has established measurement uncertainty (commonly reported as variance or standard deviation)2 for every step in the process.

In a broader sense, traceability includes accountability to customers, regulatory agencies, and quality systems. It extends to recordkeeping, sample tracking, staff training, certification maintenance, and more.

A result would be considered traceable when documented procedures exist (supported by meticulous records) that demonstrate very low risk of error, which adds more items beyond equipment maintenance and calibration.

This article describes what it takes to establish traceability, accountability, and quality in a testing laboratory, and how a LIMS facilitates the process.

LIMS and traceability

A LIMS stores information in a relational database, such as Oracle (Oracle Corp., Redwood Shores, CA), DB2 (IBM, White Plains, NY), or MS SQL (Microsoft, Redmond, WA). Each table in the relational database is assigned a primary key, e.g., a column or set of columns, whose values uniquely identify every row (record) in the table. Tables are related to each other by using foreign keys. A foreign key in one table (the foreign table) contains a value corresponding to the primary key of another table (the primary table).

This relates the information in the foreign table to that in the primary table. The use of foreign keys allows the LIMS to establish links between samples, storage conditions, test dates, analyst certifications, instrument calibration, and testing parameters. Most LIMS provide an interface that takes the place of direct SQL queries to the database.

Maintaining a quality organization

For reliable data generation, each aspect of the laboratory performance must meet quality standards. Staff needs to be trained and certified in equipment use and sample handling.

Training must be current and certified by an external organization. Equipment must be regularly inspected, maintained, and calibrated. Controls must be an integral part of the measurement cycle. To prove chain of custody, samples require tracking from receipt through analysis, through data entry and approvals up to the final report. Every action must be logged, and every record properly signed and archived for future retrieval.

A compliant LIMS follows the laboratory workflow at every step. It accepts manual sample and data entries, uploaded documents, and computer file attachments (faxes and word processor and spreadsheet files) and stores them in a database. It communicates with analytical equipment. It schedules laboratory work, equipment maintenance, and staff training, and updates staff, managers, and customers with the latest information.

A compliant LIMS product makes policy enforcement, data integrity, and traceability an easy reality.

LIMS and electronic record-keeping

Modern scientific instruments, such as spectrometers, chromatographs, and microscopes, generate data in electronic formats using integrated or external data acquisition and processing systems. Older equipment has (or can be retrofitted with) serial ports to transfer data to external computers. Modern LIMS software can interface with scientific equipment through the network to automatically retrieve and store the information in a database without the need for human intervention.

The data fields provided by analytical instruments often include technician and sample details, operational parameters, and analyst’s comments, in addition to the technical data

(e.g., spectrum, chromatogram, and image). The LIMS collects and processes the instrument data for archiving and retrieval. For increased security and performance, the data are stored in an external database server running Oracle or MS SQL. These database servers offer redundancy, high availability, fault tolerance, and strong security.

A good LIMS is flexible and configurable, and allows automated entry of additional fields.

With such flexibility, a single data archive format can be generated by different instruments, and data collection is easily updated when the instruments or their software are upgraded.

StarLIMS from L.I.M.S. (USA) Inc. (Hollywood, FL) has a Data Capture Utility (DCU) that automates numerical data entry from all principal laboratory instruments.

Data is collected through the network, allowing simultaneous access to multiple instruments without requiring direct connection or even physical proximity.

The full automation of results entry reduces technician workload and eliminates transcription errors.

StarDOC, a StarLIMS module, captures and archives unstructured data (spectra, photos, and other documents) in accordance with 21 CFR Part 11. A unique ID number is created for each data file. This ID, sample information, and raw data are all stored together as a single entity, as required by GLP. These data are easily tracked, sorted, and retrieved at any time. It is possible to view the data using the StarDOC utility, the original applications that generated the data, and a special viewer such as the ACD spectral viewer.

For more information visit: www.starlims.com