Incorrect test results: How to involve a clinic or laboratory. Invitro - a specialist’s opinion on the quality of analyzes Money was withdrawn from bank cards, but cash was not dispensed from ATMs

Every year in Russia, thousands of laboratories perform billions of tests. But is there a guarantee that results your laboratory tests truthful?

Errors can be different: from incorrectly defined to incorrect interpretation of cytological material. Only mistakes that lead to very serious consequences become public. For example, as a result of a laboratory technician’s mistake, a 33-year-old woman was not diagnosed with a malignant tumor at an early stage, although she did all the tests recommended by her doctor. She calmed down, but when the tumor was discovered, it was too late...

Most mistakes, fortunately, do not entail any serious consequences. You may not even realize there is a mistake. For example, if the hemoglobin level shows low, you simply include iron-rich foods and iron-containing food supplements in your diet, and a repeat test shows that the hemoglobin is normal. But even if the result of the first analysis was erroneous, you simply ate excess iron.

Where do mistakes lie?

Laboratory research consists of three parts: preanalytical(from preparing the patient until the moment the biomaterial enters the work), in fact analytical And post-analytical(from the moment the material leaves the device until the results are delivered to the patient). And at each of these stages an error can occur.

1. Error can be laid down already at the beginning, upon registration research order. This stage accounts for more than half of all errors. The nurse may write the patient's name incorrectly or illegibly, or confuse the directions for tests or test tubes.
2. Error can happen directly during the analysis. In laboratories that use outdated research methods, the likelihood of such errors is higher. They do not involve the use of disposable laboratory glassware; many operations are performed manually. But in equipped with modern devices In laboratories, the possibility of error during research is practically eliminated.
3. Error possible when interpreting studies of cytological and histological materials. In these cases, exclusively expert assessment is used, that is, the doctor examines the material under a microscope. There is a possibility that he will not “see” certain changes in the patient’s cells or tissues or will misinterpret them.
4. The culprits of the mistakes I can be failures in the operation of devices.
5. Exists probability of transfer of microscopic particles of biomaterial from one sample to another, although it is very small.

How to protect yourself?

Get laboratory tests only in government medical institutions or commercial laboratories licensed for medical activities. If it is not framed in the reception area, ask to see it. About high quality work institution also testifies to its long-term presence in the medical services market .

Feel free to check that the nurse has written your last name, initials, and date of birth correctly. Make sure that your first and last name, identification number or unique barcode were applied to your test tube.

If research were carried out within medical examination or, for example, to obtain a medical certificate, and the results showed deviations from the norm, you should consult a doctor. He will assess how significant these deviations are and will refer you for repeat examinations in seven to ten days. If deviations are detected again, he will order in-depth studies.

If you are found Clinical signs one or another diseases, and laboratory studies do not confirm this, then you can individually conduct the study again using the same material.

A special case - histological and cytological studies, requiring expert assessment. In some cases, the materials are examined by two doctors, in others - by one doctor, but all complex and questionable cases are sent for verification to a medical institution with which the laboratory has an agreement.

If a positive result is detected for such socially significant infections as HIV or hepatitis, the laboratory, according to current legislation, is obliged to conduct a confirmatory test from the same material. The patient should be informed about the results of the studies only after a definitively confirmed answer has been received.

Our expert Elena Anatolyevna Kondrashova, director of the technological department of the INVITRO laboratory:

Most mistakes happen when placing an order for research. Automation of this process can reduce these types of errors to almost zero. At this stage, the laboratory employee creates an order and assigns it unique barcode. All data about the client is entered immediately in his presence to the information system. The barcode is stuck to the test tube and with this test tube the client goes to the treatment room. Subsequently, the test tube comes with this barcode into all devices. Modern equipment allows you to use it in 99% of cases "primary tube", i.e. biomaterial, for example blood, is not transfused from one large test tube, as was the case before, into several small ones. Everything is automated: the test tube “moves” in the device from one analyzer to another who reads barcode. Thus, it is no longer possible to mix up initially correctly designed test tubes.

For consumers in the service sector, there is currently a very large choice. In addition to municipal medical institutions and diagnostic laboratories, there are private clinics and diagnostic centers. In almost any private laboratory or city clinic where self-supporting funding exists, you can take tests and receive a medical report for a fee. If you have a medical policy, services of this kind are provided in municipal institutions free of charge.

Is there a risk of fraud when taking tests?

Regardless of whether it is a municipal or private clinic, laboratory, medical center, the possibility of fraud when taking tests exists.

There are several options for this type of deception:

• When taking tests, the medical worker, due to his own carelessness, mixed up the biomaterial. As a result, someone else’s biomaterial ended up being studied. Ultimately, the patient will receive information about other people's indicators. A laboratory employee who directly conducts the research can also make such a mistake.
• The biomaterial obtained for the study was lost due to some circumstances due to the fault of the workers of the medical institution, and someone else’s tests were used for the study.
• When entering analysis data into a computer program and typing text, errors were made in the direction of decreasing or increasing biochemical parameters in the analyzes.
• The study was conducted in bad faith and does not contain true data.

As a rule, almost all actions lead to the same result - when taking tests, they gave incorrect data.

What should you do if you receive incorrect data when taking tests?

When considering the problem through the human factor, nothing terrible seemed to have happened. A situation that occurs quite often in life. And who doesn’t make mistakes in this life?

But in the case of medicine, it is important to understand that we are talking about the most important thing - human life and health. Under such circumstances, the client of a medical institution loses time and often money. Well, if suddenly we are talking about a sick person, then time may in this case be worth its weight in gold.

How to restore your violated rights?

First, you need to analyze the circumstances, examining the details: what documents are available confirming the tests, payment, visit to the organization and, finally, indicating an error.

In order to more clearly understand your next actions, the best decision would be to seek legal help in a medical dispute. A qualified lawyer can explain the legal nature of the actions of employees of a medical institution, the procedure for restoring violated rights and the limits of responsibility of doctors.

Correctly and timely provision of legal assistance in a medical dispute is already almost 1/3 of the solution to the problem.

If you don’t want to raise a scandal and have free time to take tests again, you can offer the medical staff and administration of the diagnostic and treatment institution an alternative. For example, free repeated tests with biomaterial taken out of turn. Or an accelerated study with results in the shortest possible time. Most often, in order not to make a fuss, offenders go to meet their client.

Each case is individual, and the person who applies for the service decides for himself how antisocial and dangerous to human health and life the legal violation was committed by the doctors and how important it is for him to hold the doctors, hospital, or clinic accountable.

What consequences await medical staff in this case?

When deciding how to hold doctors, hospitals, or clinics accountable, the degree of negative consequences that resulted from erroneous test results given to the patient will be important. Whether for this reason circumstances arose that worsened the patient’s health condition. For example, an erroneous test for the body’s susceptibility to a certain chemical or drug, when used, can lead to undesirable negative consequences.

In any case, medical personnel and the administration of the medical institution are responsible. The nature of their actions and the legal analysis of the situation makes it possible to decide what kind of responsibility we are talking about. For example, about civil, administrative or criminal.

As part of their job descriptions, employees of a medical institution may be punished in accordance with the norms of Labor Legislation and in the field of healthcare.

The administration of a medical institution may be held accountable for violating administrative legislation.

If the client goes to court with claims for compensation for material and moral damage, then we are talking about civil liability.

In case of serious consequences that have caused damage to the life and health of the patient, the question often arises of bringing the employees of the medical organization and management to criminal liability.

In this case, Constitutional human rights are also violated, for example the right to life.

It is quite difficult to solve such a problem on your own, and in any case, the right decision would be to contact a lawyer to resolve this type of dispute.

It is important to understand that the medical staff of any medical institution bears responsibility for the health and life of the person who comes to the appointment. They are required to comply with ethics, their job descriptions, and legal acts regulating healthcare in Russia.

When visiting paid and municipal hospitals, clinics and laboratories, you must be vigilant and careful. Read the labels on containers with biomaterial, carefully study the documents that are given for signature. If you discover any fraud on the part of a medical worker, contact the administration of this organization with a complaint. Ask questions when in doubt.

Important! For all questions of a medical dispute, if you don’t know what to do and where to go:

Call 8-800-777-32-63.

Medical lawyers and attorneys who are registered with Russian Legal Portal, will try to help you from a practical point of view in this matter and advise you on all issues of interest.

And about the quality of analyzes in this laboratory, following a discussion in one of the social network groups.
I will quote the entire post here in full.
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Medical damage. PART 6. The myth about laboratory tests or the whole truth about INVITRO!

Today we’ll get personal by mentioning the name of the laboratory... Do you know what prompted me to write this article? But just yesterday on Facebook, in the pro-mam group, there was a thread in which it was discussed that many doctors do not advise taking in vitro tests. They say they are slacking, their blood clots, they lose tests, etc. Wow, let's take a closer look at what's really going on, otherwise the world of the Internet is full of rumors, yeah... And these rumors are from supposedly very authoritative doctors, yes, yes!!

I’ll say right away that I am not engaged, not affiliated and not lured in vitro, that is, I have no relation to this laboratory at all and never have had anything to do with it. Neither direct nor indirect, and people who believe rumors more than a person who has a valid certificate as a doctor of clinical laboratory diagnostics and has worked in one of the largest laboratories in Russia can cool their ardor, intending to accuse me of lobbying someone or something !

Let's start! So, the first myth. Invitro is a small basement laboratory, we have been there more than once, they are sitting in the basement. Cool down, comrades. Invitro is one of the largest players in this segment of medicine, and what you call a basement laboratory are just franchise offices that anyone can open by paying a couple of million and hanging an INVITRO sign. But this does not mean that the analyzes are done there. Invitro provides its franchisees with consumables, and the courier picks up the biomaterial at a strictly defined time and delivers it to its own laboratory, where the production process itself takes place... Yes, yes, that’s what it’s called!

Second myth. In invitro they do tests by hand and everything depends on the change of doctor. If migrant workers are on shift, they will do it wrong, so the blood clots and the results are incomprehensible. This is generally a rare nonsense. Firstly, such a laboratory per day, and such laboratories work around the clock, processes tens of thousands of samples, and if everything is done by hand, then the laboratory staff will be many thousands, which will lead to the fact that prices for analyzes will be tens of times higher than they are Now. Almost all analyzes are performed on automatic analyzers from leading global companies and their measurement accuracy is hundreds of times higher than when performed manually. Only microbiological cultures, determination of sensitivity to antibiotics and some ELISA and CLLA tests can be done by hand. [The laboratory now, judging by the “Equipment” section on the website, has at least 2 microbiological analyzers and a pre-analytical sorting system, i.e. they try to minimize manual work and the “human factor” in errors].

The third myth. Their test standards are incorrect. The medical textbook contains other norms for blood tests. This is a very common mistake here. Anything can be written in a textbook and it will be far from the truth. Each laboratory may have its own standards and they may differ from the standards of other laboratories. Norms or REFERENCE VALUES are set not by the laboratory, but by the manufacturer of the consumables that the laboratory uses! unfortunately, many doctors don’t know this either and also refer to textbooks from the 60s and 70s, calling the laboratory and making a scandal that they don’t know how to interpret the analysis, since the references differ from those written in the textbook.....

The fourth myth. Invitro saves on tests and invents results without doing a real analysis. Well, I won’t comment on anything here at all, sorry. This is more like post-hangover syndrome. This is a judicial matter and each test tube that is sent to the laboratory is stored for up to 14 days after the analysis is completed and can be sent for re-work if there are doubts about the result or a re-order is needed for execution from the same test tube. This, for example, happens when an analysis has been performed, the result has come to the doctor, and he wants to look at some more parameters based on the result obtained. Then an additional appointment is made and a new sample is made from an existing test tube for analysis. By the way, few people know about this, but it can be used!
This is not to say that everything is smooth; there are problems in laboratory diagnostics. For example, 2-5% of all analyzes may be performed with errors. and this is not an in vitro problem, this is a global practice. Well yes, unfortunately...
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and now the traditional digression and the whole truth about doctors. The problem, comrades, is not in the laboratory, but in the qualifications of our doctors or, even worse, in the love of our people for self-diagnosis, self-prescription and self-medication.
Most errors occur not during the production of the analysis, but at the preanalytical stage, that is, at the stage of taking the analysis. There are certain rules of preanalytics that are violated by our doctors and franchisees left and right, this happens due to the low qualifications of the medical personnel, but they don’t want to admit it, it’s easier to blame the laboratory.
For example, I have encountered scandalous surgeons who send pus to the laboratory for microbiological culture and determination of sensitivity to antibiotics. There are hundreds and hundreds of such examples. And among these doctors there are honored figures, doctors of science, professors. But none of them knows that horseradish can be grown from pus, since by definition these are dead microorganisms, blood plasma and the same dead leukocytes….. And something can only be grown from living…. But they are good at arguing and yelling and beating themselves in the chest that everyone is bad, but they are doing everything right!
Things are even worse with gynecologists. These people generally like to take tests without really understanding why and for what purpose, and even less understanding the rules for taking tests in gynecology. For example, for most gynecological smears it is necessary to take discharge from the vagina, urethra or cervical canal. But it is precisely the separated, not the allocated. Can't you hear the difference?? Well, gynecologists don’t smell it either and take what’s secreted, not what’s discharged. That is, what the vagina secretes by itself, that is, discharge, while according to the rules it is precisely necessary to completely remove these discharges and scrape the mucous membrane, that is, separate the epithelium. Most smears are performed using the polymerase chain reaction, or PCR, method, in which blood and mucus can act as an inhibitor of the reaction and lead to a false negative result.
And so we can continue to tell, and there is a lot to tell. Each technique has preanalytical rules and those who carry out the analysis should know them.

So, the results! A minimum set of knowledge, so to speak!

1. If you do self-diagnosis and prescribe tests, then take the trouble to read multi-volume works on laboratory diagnostics or at least call the medical department of the laboratory and find out the rules for taking a particular test.

2. Reference values. We remember that they may differ from each laboratory, and if you take tests over time, then they should be taken in one laboratory, and not in several, then you will be able to clearly track the dynamics and evaluate the quality of treatment. [My article about ].

3. It is always better to donate blood from a vein rather than from a finger. Unfortunately, many doctors claim that it is better to donate blood from a finger, especially for young children. This is mistake! Modern tubes are vacuum, which ensures their filling with blood along a pressure gradient and minimal trauma, as well as the preservation of blood due to the lack of contact with the external environment and the presence of a preservative inside the tube, while all these criteria are absent when taking blood from a finger. This procedure is much more traumatic and the degree of reliability of the analysis may be lower than when taken from a vein.

4. Spermogram. It’s better to hand it over not at a collection point located far away, in the franchisee’s office, but at a collection point located in the laboratory itself, this will ensure a minimum delivery time to a laboratory doctor and a more reliable result. By the way, here it should also be remembered that having received not very good spermogram results, a competent doctor does not rush to prescribe treatment, but investigates all the reasons, collecting information about the preanalytical stage and concludes about the need to prescribe treatment only based on the results of 2-3 spermograms taken for a certain period of time.

5. Blood culture for sterility. In general, I do not recommend taking this test, which doctors love to prescribe. This is complete nonsense. Blood is inherently sterile BY DEFINITION! There are no bacteria from which colonies can be grown and a microbiological test for antibiotic sensitivity can be done. If a doctor prescribes this test, then he is a complete idiot! IMPORTANT TO REMEMBER! a disease in which the blood ceases to be sterile is called SEPSIS, motherfucker... Google it and look at pictures of what a person with sepsis looks like. He doesn’t go to doctors, he lies there and passes into another world... You can take his blood for sterility, but from others it’s pointless!

6. General blood test. You can take it not only in the morning and not only on an empty stomach. If you ate and took a general blood test immediately after eating, then you don’t have to worry, its reliability will not decrease, but this does not apply to biochemical tests!

7. Hormones! It is very important to know preanalytics! Many hormones have rhythmic peaks of production and some hormones should be taken strictly at a certain time, as well as at rest. For example, prolactin, beloved by gynecologists, tends to significantly increase for almost any reason (I’m exaggerating, of course). And if you have elevated prolactin, this is already a reason for the doctor to prescribe an x-ray of the sella turcica or an MRI of the pituitary gland, while you just need to redo the analysis or take the trouble to find out under what conditions the analysis was collected. A prolactin value above 800-1000 units may indicate the likelihood of the presence of an adenoma (prolactinoma) of the anterior pituitary gland. Do not rush to immediately do an MRI of the brain and faint with your doctor; often it is enough just to retake the test to make sure that everything is OK.

In general, by tradition, I wish you all good health, Nikita Yuryevich Istomin, clinical laboratory diagnostics doctor, obstetrician-gynecologist, ultrasound diagnostics doctor, osteopathic doctor, was on the air with you. Hello to the group, I hope I answered your questions. If you have any other questions, I will try to answer!
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Alexandra, hello!

Your relationship with a medical organization is subject to the Law of the Russian Federation of 02/07/1992 N 2300-1 “On the Protection of Consumer Rights”. You should submit a claim addressed to the head of the organization (in two copies, on yours they must put a mark indicating receipt of the claim), stating, according to your choice, the requirements provided for in Art. 29 of the Law on ZPP:

Article 29. Consumer rights when discovering deficiencies in the work performed (service provided)
1. When discovering deficiencies in the work performed (service provided), the consumer has the right, at his own discretion, to demand:
free elimination of deficiencies in the work performed (service provided);
corresponding reduction in the price of work performed (service provided);
free production of another thing from a homogeneous material of the same quality or repeat work. In this case, the consumer is obliged to return the item previously transferred to him by the contractor;
reimbursement of expenses incurred by him to eliminate deficiencies in the work performed (service provided) on his own or by third parties.
Satisfying the consumer's demands for the gratuitous elimination of defects, for the manufacture of another item, or for the repeated performance of work (provision of a service) does not relieve the contractor from liability in the form of a penalty for violating the deadline for completing the work (provision of a service).
(as amended by Federal Law No. 212-FZ of December 17, 1999)
The consumer has the right to refuse to fulfill the contract for the performance of work (rendering a service) and demand full compensation for losses if, within the period established by the specified contract, the shortcomings of the work performed (service provided) are not eliminated by the contractor. The consumer also has the right to refuse to fulfill the contract for the performance of work (provision of a service) if he discovers significant deficiencies in the work performed (service provided) or other significant deviations from the terms of the contract.
(as amended by Federal Law dated December 21, 2004 N 171-FZ)
The consumer also has the right to demand full compensation for losses caused to him in connection with deficiencies in the work performed (service provided). Losses are compensated within the time limits established to satisfy the relevant consumer requirements.

Attach documents confirming the expenses you incurred for repeated tests, the results of these tests (copies), and you also have the right to indicate the amount you require as compensation for moral damage (Article 15 of the ZPP Law).

Your demands must be satisfied within a period not exceeding 10 days from the date of delivery of the claim.

If your claim is ignored or denied, you have the right to go to court.

I hope I was able to help you. If you have any additional questions, please contact us.