Tuesday, March 27, 2018

Lab Licenses for Lease

17 April 2016

By: Walid Salah
Cairo, Egypt (Feb,2016)

Aswat Masriya – News of her mother’s kidney failure struck her like a thunderbolt.
The mother had undergone tests at a lab in the Shubra district of Cairo Governorate and now she had to prepare for a long and arduous journey to get treated. Kidney failure means continuous dialysis sessions and a kidney transplant.
With a heavy heart, she took the results of her lab tests to urologist and nephrologist Dr. Nabil Amin in downtown Cairo. The doctor asked her to repeat the same tests in a different lab, to verify the results before starting the treatment. In a pleasant surprise, the new results showed excess salts in the kidneys but no failure.
This is not a dramatic plot of a movie but a reality in Egypt. Why? Because 1825 out of 8777 labs operating in Egypt without license, according to Dr. Ahmad Safwat, Director of the Central Administration of Laboratories of the Ministry of Health. The actual number may be far higher.
The protagonist in this real story is Marian, 29: A catastrophic test result could have cost her mother her life or turned the family’s life upside down because of neglect and indifference.
Marian investigated staff of the first lab and learned that the service provider is not a qualified doctor but a young man who has a degree in commerce. The lab was sublet to him though he does not have any qualifications related to medical analysis, he calls himself Dr. R.
Marian warned others of the alleged doctor. But she opted not to file a complaint though the penalty ranges between total or partial closure .
Investigation begins
Marian’s story was the motive to conduct an investigation into a booming market where lab licenses are sublet. Fraud is rife in violation of law No. 367 of 1954, which requires the presence of specialists in labs. The fraudsters use the names of doctors to do the paperwork in return for a fee, opening the door to non-specialists in this market who operate through intermediaries.
The author picked up the first lead from the internet. There he found ads promoting the rental of medical labs for those who want to save time and energy to obtain new licenses. There are some feasibility studies available online, detailing the needed equipment and procedures to start a lab. The lab owner needs a sum of $1265 to $3165 equivalent in local currency to prepare a simple lab for chemical analysis, which covers analysis of bodily chemical functions like hormones, enzymes, and hematological functions, and microbiology tests.
For more complex analyses, samples can be sent to other labs (lab-to-lab services), where the first lab obtains a discount of up to 50 percent or more.
The author sought the help of a volunteer who holds a degree in sciences. The volunteer is not qualified to get a lab license, as the law requires a more specialized degree. Posing as a chemist and using Facebook, she contacted one of the intermediaries to rent a lab license. She also insisted that the doctor who would rent out the license not interfere in the work.
After several communications with Dr. O., the person in charge of the Facebook page, it was agreed to rent a license in return for around $76 a month.
At a major mall, the volunteer and the author posing as her friend met with the owner of the license, who holds a postgraduate degree in pathology and has a court ruling allowing her to hold licenses for two labs. One of them is already being rented and the second is the one being negotiated. She works at a major lab in the country.
The owner of the license noted the need for a medical doctor to be present and to submit a copy of his/her membership of the Doctors Syndicate with the rest of the paperwork. His role would be limited to using his name as a specialist in drawing samples from patients as per the law regulating labs (367/1954).
The volunteer contacted the owner of the Facebook page to ask him how to find a medical doctor for that purpose. He told her in the event there is no doctor to be found, he can give her his membership card or find her a doctor in return for a $253 fee.
It did not stop at this point. The owner of the page further advised: “It is possible to open the lab and start operating before obtaining the license, because there is no oversight.”
Licensing chaos
Between a Law 367 that has not been amended for over 60 years, the fact that licenses are guaranteed for holders of various degrees and the ambiguity of how licenses are issued, the responsibility for this chaos is scattered.
The law regulating labs dates back to 1954. It allows many segments to obtain licenses for labs, including medical doctors, pharmacists, chemists, and graduates of agricultural and veterinary medicine.
For his part, Dr. Mahmoud Abdel Azim, coordinator of the Association of Clinical Pathology Physicians, who is in charge of laboratory affairs at the Syndicate, said: “We are dealing with a law on medical analyses that has not changed all this time, despite the huge developments in the field over these years.”
In order to obtain a license to manage an analysis lab, article 3 of the law requires the applicant to be: “an Egyptian national or from a country whose laws allow Egyptians to practice professions stated in Article I, and to have a Bachelor of Medicine and Surgery from one of the Egyptian universities, or a diploma in clinical pathology, or pharmacology, chemistry, veterinary medicine or agriculture from an Egyptian university, or a degree or a certificate of specialization from one the Egyptian universities in biochemistry or chemistry of food analysis or pharmaceutical analysis or bacteriology or pathology, as required. “
However, those in the market for subletting licenses circumvent the law in the absence of reliable control and punishment, while responsibility is scattered amid the complexity of procedures for obtaining lab licenses for non-medical doctors. This pushes other segments mentioned in the law to try to circumvent it. Meanwhile, some doctors who have obtained licenses to operate labs seek easy profit by renting them to others, even if they are non-specialists.
Difficult procedures
Chemists, pharmacists, and agricultural scientists complain that they face many obstacles when trying to obtain licenses to operate labs. They accuse officials at the Ministry of Health of giving doctors preferential treatment- even when the law treats them on an equal footing.
Dr. Ahmed Wagih, member of the Association of Scientists, said the problem starts at the level of the committee that issues licenses at the Ministry of Health. Wagih insisted that the law equates doctors, vets, pharmacists, chemists, and agricultural scientists.
The paperwork needed to obtain a license includes graduation certificate, evidence of advanced diploma or a Master degree, an application for a lab license and fees of around $63 equivalent in Egyptian pounds. If the applicant is a medical doctor, procedures do not take more than two weeks. For others, however, the process may take up to three months and they must operate the lab under the supervision of a doctor.
Some scientists may resort to the courts to remove this requirement. But the process may take up to five years.
Dina Naim, who holds a Bachelor of Science degree since 2000 and holds a master’s degree from the Faculty of Veterinary Medicine, shared her bitter story of how her application for a license was rejected. She filed a lawsuit that lasted three years. In the end, she won the case and obtained a license to operate a lab.
Dr. Wagih said about 70% of those working in the field are from scientific backgrounds. She complains that the 1954 law is applied in a way that gives preferential treatment to doctors. “Those in charge at the Ministry of Health and the licensing committee are doctors.”
He continued: “It does not matter whether the analysis will be conducted by the doctor himself or that the doctor will lease the license, even to a non-specialist. What seems to matter is that the applicant is a medical doctor for the paperwork to be wholesome”. She lamented the absence of clear criteria.
The “intransigence of the Ministry of Health,” as described by Dr. Wagih, is evident in the insistence on the presence of a doctor to supervise the lab. This opens the door to doctors who have licenses to sign analysis results without knowing much about them in return for a fee.
The Syndicate denies accusations leveled at the Ministry of Health and the Doctors Syndicate of bias in favor of graduates of colleges of Human Medicine. The syndicate says it seeks to provide laboratory services in a way that best serves the patient.
The Doctors Syndicate weighs in
Amid this tug of war, the Doctors’ Syndicate announced in April its intention to form a committee to review the draft law submitted by pathologists to codify the administration of analysis labs under medical supervision and submit it to the legislative bodies “soon.”
The Doctors Syndicate pledged to reach out to the Ministry of Health to create a department for laboratory inspection, which would supervise privately-owned labs along the lines of the pharmacological inspection department, in coordination with the Free Treatment Department which is responsible for managing the inspection and control of all private medical institutions in Egypt.
The Syndicate also said it would confront what it described as an assault on the profession of its members, and would seek to prevent license holders who are non-physicians from impersonating doctors, by placing the name and qualification details of the license holder on the reports of test results issued by a given lab, as well as issuing certification of “safe laboratory under full medical supervision” following an inspection and review by the syndicate.
The General Assembly of the Doctors Syndicate proved to be effective. The Ministry of Health complied and issued circular no. 6 of 14 April 2015 compelling all health directorates in various provinces to alert license holders to place their qualifications (graduate and post-graduate) in a conspicuous location at the laboratory and on reports issued by their labs, as well as on all banners and signs, after verifying the license conforms with the qualifications of the license-holder and staff, and that the lab is not operating outside of its official specialty.
In a tour of ten laboratories in the regions of Faisal and Umraniya in Giza and Shubra in Grater Cairo, the author only found one laboratory that conformed to the instructions of the Free Treatment Department. None of the reports of the ten labs could be verified.
Dr. Abdel Azim stresses that only medical doctors should be qualified to operate labs, arguing that their studies allow them to be specialized in the fields related to medical tests while other segments can only be specialized in one aspect of medical analyses.
This in fact consistent with international norms. In the US, medical analysis can only be practiced after obtaining the American Board qualifications. This requires study and training for about 5 years. In Britain, it requires obtaining a fellowship and membership of the Royal College of Pathology, which also requires around 5 years of study.
However, Dr. Abdel Azim’s statements conflict with the law that equated doctors with other segments mentioned earlier, though Article 6 requires filing for each discipline in a separate record at the Ministry of Health. The law requires the Ministry of Health to establish a record for the names of people qualified as per conditions stated in the law, with a separate record for medical chemists, bacteriologists, clinical pathologists and doctors respectively.
Dr. Abdel Azim noted that other segments who are non-doctors, are not qualified to carry out delicate tests. He said they must therefore do one of two things: carry out the analysis at the same lab, which carries risks for precision and accuracy, or sending the sample to a different lab.
Dr. Abdel Azim noted that the current punishment is a $25 fine and closure of the lab. He said the amendment proposed by the syndicate toughens the law to deter abusers.
When this reporter told him that some medical doctors are taking part in the fraud, he responded that evidence from social media is no proof and claimed that online pages are smearing doctors.
He noted that letters from the Syndicate exchanged with the Free Treatment Department of the Ministry of Health require all labs to display all degrees and qualifications to allow patients to verify the background of the service provider, in line with a decision issued in April 2014.
According to the official, current proposals include developing a mechanism whereby the license-holder must be present for a number of hours at the laboratory every day. The Ministry of Health would carry out inspection visits to the laboratories, and would close down labs that are in violation of this condition in addition to disciplining measures at the syndicate, implemented through the Free Treatment Department.
Lab owners weigh in
Citing international figures, Dr. Mu’mina Kamel, director of a major laboratory in Egypt (Al-Mukhtabar), said that the medical analysis profession represents 30 percent of the medical sector.
“We in Egypt need a new system for issuing lab licenses to keep pace with the times and developments in the field” she said. “When the restructuring of the licensing process takes place, new specifications will be imposed compelling everyone even the owners of small labs to work in accordance with international quality standards, with the use of equipment and chemical substances in a way that produce sound results.”
Dr. Kamel is of the view that those who work in labs must receive training for three months to a year to properly handle analyses. She expressed support for amending the law regulating the field, to restrict it to medical professionals, saying each specialization plays a role. “What matters is that every person should be qualified to deal with a certain aspect of the analysis, and for the field to see the integration of all specializes in the field of analysis.”
The identity of the service provider is not important
The crisis of private labs in Egypt is summed up by Dr. Saber Ghoneim, director of the Free Treatment Department, who said: “I have only eight inspectors in the central administration and 27 directors in the 27 governorates with an assistant or two. We thus conduct inspections only once a year. If there are no complaints, those inspections are deemed sufficient. We know however that this is not sufficient.”
He added: “The department carries out inspections on labs and other medical facilities routinely in line with a schedule. If the inspection turns out people who do not carry licenses a recommendation is made to close the lab and revoke the license. A warning is issued to the owner as well. This is after carrying analysis on patients to verify the results issued by the lab are inaccurate.”
Some 65 complaints have been made against labs in 2015, all related to discrepancies in results. It was decided to shut down 279 labs during that year, for lack of appropriate license or because of violation of some conditions according to Dr. Ghoneim.
Amid all this controversy, labs have not stopped issuing wrong results. This happened with Suhair al-Gohari, 35, who went to a lab to do a pregnancy test after she missed her period for over two months. The test came negative, and the doctor thus decided to treat her for hormonal imbalance.
When her period did not come for another month, she used a home test and was shocked to find that she was pregnant. But because she took medicines for hormonal imbalance based on the test results, it was expected that the fetus would be deformed. She aborted her pregnancy based on the doctor’s advice.

This investigation was completed with the support of Arab Reporters for Investigative Journalism (ARIJ) www.arij.net and coached by Amal Nour.


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