Bichari Rai, 45, from Khotang District, battled for over three years and spent some Rs 500,000 (US$ 5,653) in an attempt to have his medical problems diagnosed only to end up in a hospital bed, with both his kidneys completely damaged due to delayed diagnosis.
DEV KUMAR SUNUWAR: CIJ
Only then did Rai realize that he was swindled by the doctors he consulted with and the pathology laboratories where he had undergone several tests over the years.
“Both your kidneys are in the last stage, they are about to collapse,” doctors at Tribhuvan University Teaching Hospital (TUTH) told him on October 13, 2011. Currently, Rai undergoes hemodialysis thrice a week at TUTH. “I’m losing my confidence of recovering. I’ve spent my last paisa,” an exasperated Rai says.
As of September 3, 2012, Rai has undergone hemodialysis for the 95th time. Each dialysis costs between Rs 10,000 and Rs 12,000.
Doctors advise an immediate kidney transplant but Rai says he has spent all the money he had on hemodialysis. “How can I afford to transplant my kidneys?”
On October 15, 2009, Rai closed down his small restaurant in Malaysia after a hospital in Kuala Lumpur diagnosed problems with his kidneys. Unable to afford the medication in Malaysia, Rai returned home.
On arrival, Rai began visiting different hospitals in Kathmandu. At first, he visited Bir Hospital where he was advised to consult Dr Rajendra Kumar Agrawal at his Kanti Path-based private clinic, Kantipur Diagnostic Center and Policlinic (KDCP).
Dr Agrawal is a Senior Consultant Physician and Nephrologist at Bir Hospital and heads the Nephrology Unit.
Rai continued his treatment with Dr Agrawal and visited different private pathology laboratories in Kathmandu periodically. He hoped to recover soon but suffered a serious dilemma from the conflicting prognoses reports given by unscrupulous laboratories and medication based on those very reports.
On February 4, 2011, Rai underwent nearly one dozen tests as prescribed by Dr Agrawal. Surprisingly, the lab reports showed both his kidneys were functioning normally.
According to the report, the creatinine level was 1.3 mg/dl and the urea level read 45 mg/dl. However, Rai continued his medications, as instructed by his medical consultants. Under normal conditions, the creatinine level would be 0.4 to 1.5 mg/dl, while the urea level is 10 to 45 mg/dl.
However, test reports conducted 40 days earlier on December 26, 2010 at Kantipur Diagnostic Center and Policlinic showed his kidneys condition to be worrisome. The lab report showed his creatinine level at 6.6 mg/dl and urea level at 121 mg/dl, much higher than normal.
Rai was then told to get tested at National Reference Laboratory (NRL), New Baneshwor. The lab report from NRL on March 10, 2011 also showed his creatinine level at 6.6 mg/dl and urea level at 96.7 mg/dl.
Nepal’s renowned Consultant Nephrologist at National Kidney Centre, Dr Rishi Raj Kafle, says, “As per the lab report, Rai’s Kidneys are at a critical stage.”
“As a layman, I couldn’t understand the condition of my kidneys. Neither my consultant doctor Agrawal nor the pathologists at NRL and KDCP advised me to have renal transplant or take hemodialysis immediately,” says Rai.
In his defense, Dr Agrawal says that Rai visited him at the end-stage of the disease. He said he would have suggested better options like preemptive renal transplantation or hemodialysis. “But he quit consulting with me in the middle of his treatment,” says Dr Agrawal. Contrary to Dr Agrawal’s claim, Rai insists that each time he visited Dr Agrawal, he would prescribe different medicines and advise further tests and follow-up visits every month.
Dr Agrawal does not seem to have proposed the idea of preemptive kidney transplantation, as would be the normal practice before a patient requires dialysis.
According to Chief of Kidney Transplant Unit at Bir Hospital, Dr Pukar Chandra Shrestha, preemptive transplant has been conducted on nearly a dozen patients so far at Bir Hospital.
The Clinical Journal of the American Society of Nephrologists, 2008, says that preemptive renal transplantation is the best treatment for kidney patients reaching the end-stage renal disease, like Rai. At this stage, a patient can opt for a transplant and avoid dialysis.
But Rai had no idea about the new treatment procedure. Also, his doctor at Bir Hospital did not advise him to undergo the procedure at Bir. He followed all the instructions given to him hoping that he would recover soon under the care of a qualified doctor. But all the while, his health actually deteriorated.
On October 13, 2011, Rai was taken to the Emergency Unit at Bir Hospital where he was told that he needed hemodialysis without delay. By then, both his kidneys were damaged.
Rai, who is from Chipring in Khotang, is not alone in suffering from wrong diagnosis reports produced by different medical diagnostic centers. Many people have similar stories to tell: stories of suffering, serious dilemmas, inaccurate reports, moving from center to center, spending money, and never actually getting proper diagnoses.
Dr Gita Shakya, Chief at National Public Health Laboratory (NPHL) under the Ministry of Health & Population (MoHP), estimates that approximately 1,300 private health laboratories that include pathology laboratories, polyclinics, diagnostic centers and clinical laboratories are registered in the country where roughly 20,000 people get services everyday.
Each patient gets a test at a minimum cost of between Rs 300–500. On an average, these centers make a transaction of Rs 7.5 to 10 million per day. But the irony is they are producing more patients in the process through their substandard reports.
Dr Bhupendra Basnet, attending doctor at Gastroenterology Unit at Bir Hospital, says that the number of patients visiting hospitals with different prognoses has increased appallingly in the last couple of years. The varied diagnosis reports even pose doctors serious dilemmas while treating patients as they are confused as to what medication to prescribe or even to decide on further investigations.
Pathology laboratories and medical diagnostic centers began mushrooming in major cities of Nepal especially in early 2000s. The problems relating to wrong prognoses and substandard lab reports soared in later years. This led the MoHP to devise Minimum Laboratory Standard (MLS) for non-government hospitals, nursing homes and private health laboratories in 2004.
The sufferers of substandard lab reports have increased considerably, as there has been a corresponding increase in the number of such labs, further aggravating the situation.
Orthopedic patient Kanti Maya Tamang, 80, from Samundradevi in Nuwakot has her own story to tell.
On April 20, 2012, Tamang visited Tribhuvan University Teaching Hospital (TUTH) and consulted Dr Rabin Nepali. After clinical examination, she was referred for several tests, including albumin, RBC-WBC, urea, ultrasound, among various others, before reporting for a follow-up a week later.
The technicians at the Pathology Lab Unit of TUTH told her that her ultrasound report could be delayed by a week and instead advised her to visit private laboratories where she could get her report by the end of the day. She got her ultrasound done from Om Sai Swati, a private clinic.
The shocking finding was that the TUTH lab report showed she suffered from a kidney-related problem while the ultrasound at the private polyclinic showed nothing wrong with her kidneys.
On April 25, 2012, Dr Nepali admitted he was confused with the conflicting reports.
Dr Nepali surmised that the swelling below her knee was because of trapped fluids which could have been either due to renal or heart disease, or both.
“We can treat accordingly on the basis of the lab reports. But the problem is, her lab reports are conflicting,” says Dr Nepali. The hospital lab reports identified a problem with her kidneys and showed albumin imbalance, while the ultrasound report from private lab was normal.
Since he could not prescribe any medication, Dr Nepali referred Tamang for an ECG at Manmohan Cardiothoracic and Transplant Centre.
When Kanti Maya visited the center, she was asked to wait for four more days or pay an extra Rs 1,500 for immediate services. She returned home without test or treatment.
The stories of sufferings from wrong prognosis reports and unnecessary lab tests are not limited to Kathmandu Valley.
Ramala Khanal, 53, a gastritis patient of Rohawara in Jhapa also suffered from inaccurate reports.
On April 27, 2012, Khanal visited Dr Roshan Shrestha at TU TH. She presented a bag full of lab reports from pathologists in Biratnagar, Dharan, Jhapa and Kathmandu.
Dr Shrestha told Khanal that she was normal and explained that she only suffered from gastritis. He also assured her that it could be cured by common antacids.
Khanal now regrets having consulted so many doctors and having spent over Rs 120,000 on diagnostic tests.
Khanal had first approached Dr Parvez Kumar at Birat Hospital and Research Centre (BHRC) in Biratnagar. The consultation lasted over 15 months from Feb 22, 2011 to May 4, 2012 and she also underwent several tests as advised.
On Dr Kumar’s advice, she then underwent more than 48 different tests that included ultrasonogram, renal profile, gastric biopsy, routine blood examination, differential count etc. But the reports showed nothing and so she was advised to go through more tests to get to the core of the problem.
“After scrutinizing the reports, Dr Kumar recommended me to visit Dr RL Karwa, Chief at the Department of Surgery and Endoscopy Unit in Koshi Zonal Hospital in Biratnagar,” Khanal recalls being further subjected to 14 more tests, including x-ray, USG-abdomen scan, UGI endoscopy at New Unique Lab Clinic at Rangeli Road, Biratnagar. All this took a month and yet there were no results. The tests continued at Ananda Diagnostic and Imaging Centre of Hospital Chowk in Biratnagar.
“I spent nearly two years consulting different doctors and visiting pathology labs, but my condition didn’t improve. Finally, I visited TUTH and now I’m finally okay.”
Nephritic patient Moti Lal Gole, 44, from Nibuwatar in Makawanpur also has stories of visiting different pathology labs and collecting test reports one after another.
On March 6, 2012, Gole visited Dr Surya Devkota at Manmohan Cardiothoracic Vascular and Transplant Centre at TUTH. After a short clinical examination, Dr Surya advised him to conduct 25 tests.
It took a week to obtain all reports,” Gole recalls, “When I visited for a follow-up, Dr Devkota suspected problem in my kidneys and referred me to Dr Dibya Singh Shah at her private clinic, Meridian Health Care Centre, a policlinic and diagnostic centre in Maharajgunj.”
It must be noted that Dr Shah is an attending doctor at TUTH with a fully equipped renal unit.
Nevertheless, Gole visited Dr Shah’s private clinic on March 1, 2012 with lab reports from TUTH. But Dr Shah rejected all the test reports from TUTH without any reasons and suggested 25 additional tests at NRL. Most of the reports showed similar results as those of TUTH lab reports.
Dr Shah defends herself saying that a doctor requires lab tests to diagnose a problem. “He was on medications and I needed to see if there were any improvements, so I referred him to NRL.”
On the basis of new lab reports, Dr Shah then prescribed medicines suspecting an initial stage of a malfunctioning kidney. Gole regrets paying extra for tests.
Bichari Rai, Kanti Maya Tamang, Ramala Khanal and Moti Lal Gole are the victims of ‘malpractice’ of medical professionals, as stated in Nepal Medical Council (NMC) Act 1964 and Medical Code Ethics.
“As a practicing doctor, it’s unethical to refer patients for tests at specific private labs despite the availability of those services in the hospital lab itself. Medical ethics and the NMC Act 1964 point that as ‘malpractice’ and ‘unethical’,” says Dr Shashi Sharma, Vice-President of NMC, who is also the Chief of General Medicine at TUTH.
Dr Sharma says that NMC cannot monitor the day-to-day work of each doctor. However, if any complaint is lodged, the Council can form a probe committee. If the committee finds doctors guilty of malpractices, NMC can cancel the registration of such doctors, whereas it is the duty of the hospital managements to take actions against unethical doctors in their hospitals.
NMC is the sole government entity to regulate the professional practices of more than 12,000 doctors in Nepal.
Officials say that NMC also has received complaints on ‘unethical practices’ of working doctors, including repeated referrals of patients to private clinics for tests. But to date, it has not taken any action.
National policy and general practices
The provisions of MLS 2004 for private, non-government hospital and nursing homes and private health laboratories require institutions, including laboratories, which provide health services to be registered under the Monitoring and Quality Control Division (MQCD) of the MoHP as per the recommendation of NPHL with the provision for periodic renewal.
Similarly, it also directs all laboratories to compulsorily participate in the quality assurance programs of NPHL. But it is alarming that neither does the MQCD exist in the Ministry nor does the law entrust any government body to monitor the quality of lab services.
The division, as mentioned in the MLS, does not exist within its system, and the MoHP delegated the responsibility of registration and renewing of pathology labs and medical diagnostic centers to the Regional Health Directorate (RHD) based on the recommendation furnished from NPHL and District Public Health Office (DPHO).
At present, laboratories get registered at the Office of the Company Registrar (OCR) or the Small and Cottage Industries Development Centre (SCIDC) under the Ministry of Industry (MoI). Only a few pathology labs and medical diagnostic centers in Nepal have sought approval from MoHP as provisioned by MLS.
On the other hand, none of the concerned government bodies – MoHP, OCR, SCIDC, RHD or NPHL – have any rules and regulations that regulate health laboratories and effectively monitor their services.
NPHL Chief, Dr Geeta Shakya says that there is no laboratory policy in the country and nor is there any law that outlines which institution is responsible for monitoring and ensuring the quality of laboratories and what sort of action is to be taken in case of any violation of MLS. In the absence of clearly defined punitive measures, most labs have thus not bothered to register themselves.
Illegal labs and illicit practices
The MLS clearly entrusts paramount authority to NPHL to take necessary legal actions if any health institutions ignore the directives. But both NPHL and the MoHP; the apex bodies to regulate the health sector, have failed to curb illegal operations of health institutions.
On November 11, 2011, medical lab technologist of Narayani Sub-Regional Hospital in Birgunj, Ram Binaya Shah lodged a complaint with the Minister of State for Health, Khadga Bahadur Basyal urging him to take action against Thyrocare Service Center Nepal of Chabahil for allegedly operating lab services illegally without prior registration for over a decade and without having even the basic facilities.
Acting upon the complaint, MoHP directed the NPHL and Kathmandu District Health Office (KDHO) to undertake a spot study and take appropriate actions.
The field visit report of KDHO which was submitted to MoHP on January 26, 2012 shows that the lab was in fact operating illegally.
The response letter of the Chief of NPHL Dr Shakya to the Public Health Administration, Monitoring and Evaluation Division (PHAMED) under MoHP, also states that the lab does not even have the bare minimum facilities.
The same letter reads, “NPHL has no legal authority to take action in this case. Therefore, NPHL suggests that this case be handled by the Ministry itself.”
The Director of Thyrocare Service Center Nepal, F.H.R Mistry admits to not having a single syringe in his lab and questions why a collection center needs to be registered at MoHP. According to him, they only collect blood samples from patients, labs, and hospitals in Nepal and then send them to Vashi, the Mumbai-based Thyrocare Technology Limited from where they obtain the reports online and pass them on to the concerned.
This however is not the sole case of illegally operating labs. There are many others like Thyrocare but the authorities have failed to take action against the violators.
On March 28, 2012, Bichari Rai lodged a complaint at the MoHP against New Baneshwor-based Sudarshan Clinic Pathology Lab, citing that the pathology lab provided him wrong prognoses report, causing negative effects on his health.
MoHP then directed NPHL to conduct spot study and take necessary legal action if found guilty. NPHL appointed Bhupa Raj Rai, senior medical technologist, to undertake the study.
The study report reveals that over six different date-expired reagent kits, like creatinine reagent kit, alkaline phosphatase kit, urea reagent kit, and Hepatitis B vaccines were found in the lab. The pathologist working in the lab was trainee Bimala Maharjan who had only attended a short-term informal course.
As per the findings, NPHL recommended MoHP to close down Sudrashan Clinic Pathology Lab but the Ministry didn’t respond.
Previously, Bichari Rai had also filed a complaint against the same clinic and ‘health professional’ Maharjan at Nepal Health Professional Council (NHPC), the sole government entity to regulate health professionals. But NHPC officials too didn’t respond.
Maharjan however claims that she has attended a 15-month laboratory course and obtained a license from NHPC.
Section Officer at Public Health Administration, Monitoring, and Evaluation Division at MoHP, Tulsi Bhattrai laments the lack of appropriate laws and questions how it would be possible to take action against illegitimate health institutions.
“On the basis of the findings of the field study, we’ve written to the Chief District Officer (CDO) in Kathmandu. It’s the CDO who has the authority to decide whether or not to take legal action,” says Bhattarai.
However, CDO Chudamani Sharma says it is the duty of MoHP to regulate health institutions. Unless the MoHP gives proper reasons and legal grounds, it is impossible to take action against any healthcare providers. He also says that Kathmandu District Office does not have any records of action taken against pathology labs and diagnostic centers as per the recommendation of MoHP.
Ministry sans responsibilities
Records at Mid-Regional Health Directorate Office shows that up until Kartik 2068 BS, only five pathology labs, one x-ray clinic and 301 medical diagnostic centers and policlinics have been registered in Kathmandu Valley while only 13 medical diagnostic centers and policlinics are registered in Bhaktapur District. Likewise, there are only six registered pathology labs and 32 medical diagnostic centers and policlinics in Lalitpur District.
Dr Gita Shakya estimates that approximately 800 pathology laboratories and diagnostic centers currently operate in the Kathmandu Valley.
The actual number of labs in the country is not known, as none of the concerned government bodies like MoHP, OCR, SCIDC, NPHL or RHD have a standard recording keeping system, while quality monitoring system is a distant dream.
Chief of the Curative Division at MoHP, Dr Senendra Upreti, says that the Ministry has often formed monitoring teams comprising senior radiologists, pathologists, technicians, and general physicians under the leadership of the Chief of NPHL to supervise and monitor the labs and diagnostic centers working in the country.
Dr Gita Shakya says that a team was formed in 2008. Unfortunately, the monitoring team was not focused on its facilities and quality of service but to facilitate those labs demanding registration from the Government.
Dr Shakya also states that NPHL has no authority other than issuing laboratories recommendation for registration. Moreover, NPHL lacks resources to revisit the labs that are already registered. Action against defaulters hence is a far cry.
MoHP Secretary Dr. Pravin Misra says due to lack of policy dealing with pathology labs, MoHP has been unable to regulate them. MLS, he says, is merely a directive for setting up laboratories. Misra informs that MoHP is currently formulating a policy to regulate the private health institutions and laboratories and a separate body will be formed to oversee that the regulations are not violated and necessary action is taken in case of any violations.
Nonfunctioning legal provisions
The provisions in the Muluki Ain 2064 BS related to ‘cheating’ states that with/without carrying out any tests, if pathology laboratory provides wrong prognoses, both the pathology lab and person/s performing laboratory tests are made to compensate for the fees paid by the service seekers and are fined up to Rs 5,000 as well as sentenced to imprisonment for five years.
The Consumers Protection Act 2054, Section 18 (D) provisions fines up to Rs 500,000 and five years of imprisonment to violating individuals and institutions providing false services or counseling by taking fees/charges.
The Medical Code of Ethics (2.7) passed by Nepal Medical Council (NMC) which has all doctors registered under the NMC Act 1964, says under its title ‘Commission’ that it is unethical to receive or offer any gifts, gratuity, commission, or bonus in consideration of or in return for referring, recommending, or procuring of patients for prescribing medical and surgical treatment, investigation and consultation.
The NMC Act 1964 stipulates that NMC can invalidate the registration of the doctors performing such unethical acts, as per the recommendation of the probe committee formed to conduct the study upon such act, as well as on the complaints lodged against the violation of the code of ethics.
The NHPC Act 2053 BS provisions that the government appoints an Investigation Officer to investigate unethical acts performed by the health professionals and lodge the complaint against them in Court. The Act also entrusts the authority to NHPC to fine up to Rs 10,000 against those health professionals who perform the services without obtaining the license from the Council.
The MLS for private, non-government hospital and nursing homes and private health laboratories 2061 provisions that NPHL shall take action as per the existing laws against those pathological laboratories providing services without registration under MoHP and not participating on the quality assurance program carried out by the NPHL.
But the shocking fact is that the NMC, NHPC, NPHL, MoHP, which are meant to regulate health institutions, health professionals, doctors and pathology labs have failed to execute the responsibilities outlined by the law.
Medicare frauds
A study conducted by Nepal Association for Medical Laboratory Science (NAMLS) from August 2008 to January 2009 on the Status of Private Clinical Laboratory Medicine Service in and around Kathmandu Valley shows that 84% of the pathology labs did not meet the core criteria as outlined in the MoHP regulation.
Frighteningly, 82% of the path labs were not participating in the external quality assurance program conducted by NPHL as provisioned in the MLS for the quality control of the laboratories.
NPHL is the sole government body to ensure the quality of pathology laboratories in the country.
Rajan Dahal, General Secretary of NAMLS, an organization of health professionals working in pathology labs across the country, admits that the pathology labs in Nepal don’t meet the prescribed standards and are minting money while putting public health at risks.
The NHPC Act 1996 stipulates that every health professional working in pathology labs and medical diagnostic centers is obliged to be registered with NHPC and is required to obtain a license to join any health related business and institution.
However, a NHPC study assisted by World Health Organization (WHO) on the performance of health professionals from October 2010 to 2011 in 22 districts in Nepal, including Kathmandu, Bhaktapur and Lalitpur, shows that approximately 90% of the technicians are unskilled.
President of NHPC, Dr Hari Lamsal, says, “Unskilled technicians are involved in conducting X-ray print, blood sugar and blood urea tests, uric acid and creatinine tests and platelets counting. They have little knowledge about laboratory science.”
Dr Lamsal highlights the need for lab tests to be handled by professionals who have graduated in laboratory science from recognized health institutions and laments that MoHP has not involved NHPC in the supervision and monitoring team.
Further explaining the malaise of the pathology labs, Dr Lamsal says that the majority of pathology labs and medical diagnostic centers display rented equipments of other equipped labs when there is an inspection by government officials, or they maintain that they are in the process of obtaining license. In case a supervisor visits the labs, Lamsal alleges that they are bribed to silence.
Chief Drug Administrator at MoHP, Dr Bhupendra Bahadur Thapa, says that pharmacies which obtain license merely for selling medicines also provide pathology lab services without adequate equipments. Many such shops act as collection centers, which is unethical and unlawful. But there is no authority to curb such illicit practices.
Unmonitored: Substandard chemical reagents and medical kits
Nepal imports chemical reagents and medical kits, the essentials for quality lab test statements, but the government is yet to establish a mechanism to ensure the quality of reagents and kits used in the laboratories across the country.
“Perhaps Nepal is the only country in the world where such sensitive medical supplies like chemical reagents, drugs, medical kits, medical equipments etc. are freely imported without any verification,” says Dhiraj Thapaliya, President of Chemical and Medical Suppliers Association, Nepal (CHEMSAN).
Substandard chemical reagents and medical kits can produce wrong prognoses. Reagents or kits require a cold chain in order to maintain their stability and remain as effective diagnostic tools. Large consignments of such sensitive reagents are transported by road in vehicles that are not properly equipped.
Informal records show that Nepal imports medical supplies worth over Rs. 20 billion every year. Pathology labs use chemical reagents and medical kits costing over Rs. 60 million every year.
A reason for this anomaly could be the absence of coordination between the MoHP and the Ministry of Commerce (MoC).
Ramindra Neupane, Director of Web Trading Concern, one of the chemical reagents and medical kits suppliers in Nepal, says that suppliers under the headship of CHEMSAN had appealed to MoHP to make the registrations of each brand of chemicals reagents and medical kits compulsory.
This would control the quality and the market of substandard chemical reagents and medical kits on two grounds. One would be that suppliers would need to certify each lot and brand of reagents and kits imported in the country, and the second would be that the government could easily regulate and monitor and take actions against any wrongdoers.
In all likelihood, Nepal is one of the very few countries having no policy and designated government agencies to oversee this matter. India has its Central Drugs Standard Control Organization (CDSCO), for instance, and the United States has Food and Drug Administration.
National Drug Policy (NDP) 1995 includes reagents and medical kits under the definition of drugs. National Medicines Laboratory and Drug Inspectors are responsible for supervising and monitoring the drugs, including chemical reagents and medical kits.
The Department of Drug Administration (DDA) under the MoHP is the national authority for regulating medicines, including chemical reagents and medical kits. However, it seems reluctant to carry out its duties.
Radha Raman Prasad, the Chief Drug Administrator at DDA, says that DDA does not have any regulation, policy or directives for regulating the chemical reagents and medical kits market.
The NDP defines chemical reagents and medical kits as part of drugs. But Prasad insists that the regulation is silent on it. This means that there is no standard mechanism for supervising and monitoring chemical reagents and medical kits, as in the case of drugs.
“Government authorities are running away from their responsibilities. Whereas, in the absence of a regulating body and stringent legislation, pathology laboratories and diagnostic centers in the country are sucking money out of destitute patients,” says Ram Chandra Simkhada, advocate and Secretary of Forum for Protection of Consumer Rights.
“The malaise has plagued the health services sector. It’s high time that the Health Ministry and stakeholders came together and acted promptly,” he says.
Sunuwar is an investigative journalist and is associated with Centre for Investigative Journalism.
The investigative piece will be continued in the next edition of The Week.
