Last update: 06-Dec-2013 4:49 am
Friday, December 06, 2013
Trinidad & Tobago Guardian Online
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Health minister should regulate labs
Calls are being made for Health Minister Dr Fuad Khan to pass legislation to regulate the establishment of medical laboratories in T&T. The call came from the general manager of OneLab Medical Laboratory, Leigh-Anne Koylass. In an interview at her office at Lady Hailes Avenue, San Fernando, Koylass said it was too easy to set up a lab in T&T.
“It is quite scary when we think of how easy it is to set up a lab. In Trinidad, there is no legislation regarding medical laboratories, so a doubles vendor could buy a piece of equipment out of China, bring some staff to do tests, set the lab up close to a doctor’s office and give people faulty test results. We don’t have anybody monitoring who has a lab, or how it is run, or whether the staff members are qualified,” she said.
Koylass pointed out that 60 to 70 per cent of all decisions regarding a patient’s diagnosis and treatment are based on laboratory results, yet far more emphasis is placed on the selection of a physician than on the selection of the laboratory that would guide the decisions the physician makes.
During the third quarter of 2012, Koylass said a group of laboratory specialists, led by pathologist and clinical director Dr Wayne Mohammed, decided to offer to T&T “the first medical laboratory that, from its inception, would adhere to 21st century international standards for laboratory design and practice.”
“We selected a location and began renovation in August 2012. By December, all equipment had been imported and placed in the laboratory. Equipment installation was done during the first quarter of 2013, with several local engineers, as well as engineers from the US on the team. During these months, test runs were completed and the equipment certified by foreign consultants.
“On March 4, 2013, OneLab Medical Laboratory Ltd was opened to the public, offering full services in haematology, clinical chemistry, immunology/serology, microbiology and histology.” Koylass said because many laboratories are not regulated, patients have to be careful to choose reputable facilities.
“Patients need to recognise that the selection of a laboratory based on its location, pricing or speed of test reporting, may not be in their best interest. Cheap results may be an indication that the test reagents being used are not FDA approved, that machine calibrations are not being performed often, or that controls are not run for each time a test is performed—as all of these contribute to the cost of a test.
“Similarly, results that are available very fast could be an indication that a “rapid test” is being used, or that controls are not being run together with the patient sample,” she explained.
Before choosing a laboratory, Koylass advised that a patient inquire and receive some information about the laboratory’s clinical director—the person that makes the decisions regarding testing procedures and validates reports; the qualification and experience of the phlebotomist—the person that takes the blood sample—as getting the right result is highly dependent on getting the right sample.
“Communication about ‘being unable to find the vein’ or ‘having to repeat a test as the lab didn’t get enough blood’ are generally indicative of a phlebotomist that isn’t qualified or experienced.” Koylass said doctors who refer patients to medical labs often request a financial incentive which is a contrary to international standards and best practices.
ISO 15189:2012 version of the Standard—
(pg 11) Clause 4.4.1—Establishment of Service Agreements Note 3:
“Laboratories should not enter into financial arrangements with referring practitioners or funding agencies where those arrangements act as an inducement for the referral of examinations or patients or interfere with the practitioners’ independent assessment of what is best for the patient.” Koylass said OneLab is unable to offer incentives for referrals.
“The fact is there is no legislation regarding laboratories in Trinidad and Tobago, it is not necessary to adhere to these rules, and as such, we face a minor setback. Our target market, however, is specifically those clients who understand the value of accurate reporting, and as such, we are well supported by several physicians, institutions and corporate clients.”
What OneLab offers
Koylass said patients with a requisition from a referring physician, as well as those interested in self testing for sexually-transmitted infections, or those who wish to monitor their health can get same-day results. “We also do house visits for senior or bedridden patients who cannot make it to the hospital,” she said.
In the case of histology, Koylass explained that the surgical specimen can either be delivered to the laboratory by the patient’s relative with the appropriate documentation, or collected by a courier from any private hospital at no additional cost. “We also do health screening and drug screening for several corporate clients following the United States Department of Transport guidelines.” Asked how the facility was different from others, Koylass said OneLab is the only full-service private laboratory in T&T.
“We are also the only privately-owned medical laboratory with a board-certified pathologist as clinical director. “All testing methods and equipment used for testing relevant to 21st century diagnostics are FDA approved. All members of staff are highly qualified and experienced. OneLab performs all testing on-site, and each patient report is reviewed by either the laboratory’s clinical director or chief technologist before release.”
She explained that the laboratory is on its way to becoming ISO 15189 accredited under the guidance of laboratory accreditation professionals who work with several accredited laboratories in the US, UK and Africa. “We are working with a very strict timeline and will achieve full accreditation in 2014.
“At this point, however, physicians and patients are guaranteed that the strictest quality control procedures are adhered to each day, thereby, allowing us to offer the most accurate results. Physicians using our service are free to request calibration or control data and documentation relating to any report that is issued by our lab.”
Dr Wayne Mohammed
A fellow of the Royal College of Pathologists of Great Britain (FRCPath), working in the field for 18 years. Dr Mohammed is a lecturer in anatomical pathology at the faculty of medical sciences, University of the West Indies, St Augustine campus. He also presently serves as a consultant in histopathology at the Eric Williams Medical Sciences Complex and the San Fernando General Hospital.
After graduating in 2004 with BSc (Hons) biochemistry with analytical chemistry from the University of the West Indies, Koylass has worked in the service industry for nine years with clients in Trinidad, USA, Jamaica, Suriname and Puerto Rico. She held the position of laboratory manager at a private hospital for three years prior to her post at OneLab Medical Laboratory.
Ramnarine holds an associate in applied science degree in medical laboratory technology from the College of Science, Technology and Applied Arts of Trinidad and Tobago, and postgraduate certification in haematology and microbiology from the Michner Institute of Canada. She possesses a wealth of experience, having worked in the field for over 30 years. Ramnarine is well recognised by several physicians, as well as her peers, in the fields of microbiology, haematology, immunology and serology.
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