Pathology is a branch of medicine dealing with identifying, classifying and forecasting diseases based on morphological changes in cells, tissues and organs. The role of diagnostic pathology is critical in diagnosing various diseases, such as cancers. Test results determine the fate of a patient - forecasts and selection of treatment methods. In case of oncological patients time is the key. Their survivorship depends mainly on how early cancer is diagnosed.

Diagnostic pathology is all the more important that malignant tumours are an increasing health, social and economic issue of the Polish society. The number of cancer cases in Poland within the past three decades has more than doubled. Malignant tumours are the second most frequent cause of death in Poland. In 2017, they caused the death of over 26 percent of men and 23 percent of women.

An infographics showing stages of anatomical pathology test: 1. Collection of material (tissue or cytology); 2. Fixation (if required); 3. Transport to diagnostic pathology facility/ laboratory; 4. Approval for test and registration; 5. Preparation of material for microscopic assessment (macroscopic assessment - if required), collection of specimens and their processing to obtain paraffin block(s), making of paraffin sections and staining); 6. Microscopic examination of specimen(s); 7. Making of additional examinations, if required (e.g. histo- and immunohistochemical and/ or using molecular biology techniques); 8. Microscopic examination of specimen(s); 9. Making of pathological diagnosis and its authorisation; 10. Transfer of the diagnosis to the test ordering facility; 11. Archiving of the block(s) and/ or specimen(s). Source: NIK’s own analysis based on definitions provided by three Polish professors, specialists in anatomical pathology (Andrzej Marszałek, Renata Langfort and Janusz Ryś).

The NIK audit revealed that in the audited period (2017-2019), the access to diagnostic pathology was hampered and the quality of tests was questionable in many cases.

The absence of separate financing of pathology tests is an issue. There is no separate pricing of these procedures and their costs are part of medical services provided by outpatient clinics and hospitals. As a result, the cheapest diagnostic methods are chosen. Besides, medical facilities, due to limited funds for critical investments, are not interested in investing in anatomical pathology facilities or laboratories. As a consequence, medical specialists have limited development prospects. Thus, there are few candidates willing to take specialty in anatomical pathology or neuropathology. The number of pathologists is too small to meet the demand. The data of the domestic pathology consultant show that in 2017 and 2018 the number of people per one pathologist in Poland was 85 thousand, where the average for the EU countries was 35 thousand. That situation is a follow-up of long-term negligence. From 2015 to 2019, the number of doctors specialised in anatomical pathology went up slightly (by 7 percent).  At the end of 2019, there were 599 professionally active pathologists in Poland (with the 2nd degree and specialists) and 28 neuropathologists.

A map showing the number of professionally active pathologists in individual provinces (as of 31 December 2019). Total number of doctors with anatomical pathology specialty in Poland: 783; including 1st degree specialty: 184; including 2nd degree specialty and doctors who obtained the specialist degree defined in the Polish law: 599. Source: NIK’s own analysis based on the data of the Supreme Medical Chamber.

A map showing the number of professionally active neuropathologists in individual provinces (as of 31 December 2019). TOTAL IN POLAND: 28. Source: NIK’s own analysis based on the data of the Supreme Medical Chamber.

Also, NIK has stressed that a large group (42 percent) of pathologists is over 60 years old. It is even worse with neuropathologists - 57 percent are older than 60.

An infographics showing the age structure of professionally active anatomical pathologists (as of 31 December 2019). Up to 40 years: 93 (12%); From 41 to 50 years: 136 (17%); From 51 to 60 years: 227 (29%); Above 60 years: 327 (42%). Total number of 1st and 2nd degree specialists and physicians who obtained the specialist degree defined in the Polish law: 783 (100%). Source: NIK’s own analysis based on the data of the Supreme Medical Chamber.

An infographics showing the age structure of professionally active neuropathologists (as of 31 December 2019). Up to 40 years: 2 (7%); From 41 to 50 years: 3 (11%); From 51 to 60 years: 7 (25%); Above 60 years: 16 (57%). Total number of professionally active neuropathologists: 28 (100%). Source: NIK’s own analysis based on the data of the Supreme Medical Chamber.

The shortage of pathologists resulted in their work overload. That was the case in ⅓ of the audited entities which owned an anatomical pathology facility/ laboratory.

In Poland in the past years, the number of anatomical pathology facilities as well as histopathology and cytology laboratories increased slightly. In 2019, there were 163 anatomical pathology facilities registered, which is eight (over 5 percent) more than in 2015. Also the number of cytology laboratories grew from 177 in 2015 to 185 in 2019 (by 4.5 percent). The number of histopathology laboratories increased as well, from 121 in 2015 to 145 in 2019 (i.e. by nearly 20 percent).

Though, a barrier in the access to such tests is uneven distribution of anatomical pathology facilities and laboratories.

A map showing organisational units in medical facilities providing on-site 24/7 health services in individual provinces (as of 27 February 2020). Total in Poland: 173 organisational units, including 86 anatomical pathology facilities, 53 histopathology laboratories and 34 cytology laboratories. Source: NIK’s own analysis based on the data from the Register of Health Care Providers, as of 27 February 2020.

A map showing organisational units in medical facilities providing ambulatory health services in individual provinces (as of 27 February 2020). Total in Poland: 319 organisational units, including 72 anatomical pathology facilities, 101 histopathology laboratories and 146 cytology laboratories. Source: NIK’s own analysis based on the data from the Register of Health Care Providers, as of 27 February 2020.

NIK has underlined that outsourcing of pathology tests is a commonly used solution. The reason is the lack of appropriate, costly equipment and devices as well as qualified staff. From among the audited entities only the Institute of Oncology in Warsaw carried out the whole spectrum of pathology tests.

One of the problems is the lack of supervision of the way pathology is functioning. NIK has alarmed that in half of the audited entities pathology tests took longer than required by in internal regulations and contracts signed with sub-contractors. Tissue materials were transferred to anatomical pathology facilities with delays reaching 40 days from their collection, which could have ended in lower quality of test results. That situation posed a risk of lowering the quality of specimens, related mainly to the impact of formalin on the tissue material, in a time span longer than recommended, until it was secured and fixed. Besides, it delayed the decision-taking process about the method of treating a patient.

The quality of pathology diagnosis depends on many factors, such as: experience of the clinician, the method of fixation and processing of the collected tissue material, communication between the clinician and the pathologist (histopathology test referral) and experience of the pathologist (1). Nowadays the diagnostic pathology is mainly the microscopic diagnosis. The traditional visual assessment of specimens made by pathologists is subjective. The assessment results of the same specimen by several pathologists may vary and thus make it difficult to take proper decisions regarding further treatment (2).

Source: (1) M. Jeleń, Diagnostyka patomorfologiczna i patomorfologiczne czynniki prognostyczne, [”Diagnostic pathology and pathological forecasting factors”: J. Kornafel, Rak piersi [”Breast cancer”] and (2) C. Helak-Łapaj Metody analizy komputerowej ekspresji reakcji immunohistochemicznej i histochemicznej oraz ocena struktur w badaniach mikroskopowych [„Methods of computer analysis of the expression of the immunohistochemical and histochemical reaction and the assessment of structures in microscopic tests”].

NIK has underlined that the quality of pathology tests is not good in some cases. According to the data of the Institute of Oncology, 90 percent of the histopathology test results made in other entities, both state-owned and private (with which patients reported for the first time to the Institute’s outpatient clinics) included a description of the result and a diagnosis which could not be the basis to decide about the method of treating a patient. That required taking repeated tests which delayed the diagnosis and generated extra costs. To cut costs, service providers often chose the simplest and the cheapest diagnostic methods. An issue was also the lack of a standardised description of the pathology test result. The effective law does not specify what information is obligatory in that description. That may make it necessary to repeat the test in other facilities.

An infographics about uselessness of some pathology tests. From among patients who reported for the first time to the Institute’s outpatient clinics (in the 2nd quarter of 2019) with the result of a histopathology test made in another facility (both state-owned and private), the following was established after repeating tests based on the provided paraffin blocks or microscopic specimens: 10% of cases - pathological diagnosis was made properly, without the need to make additional immunohistochemical, histochemical or molecular tests; 40% of cases - diagnosis had to be extended to immunohistochemical, histochemical and/ or molecular tests; 5% of cases - the material could not be diagnosed (wholly or partly) due to improper fixation, poor-quality paraffin or excessive cutting of the material for previous tests; 25% of cases - the result included only initial diagnosis, which could not be the basis for taking therapeutic decisions (consultations were about making the diagnosis by the Institute of Oncology); 20% of cases - diagnosis has been changed or complemented in a way considerably changing the initial diagnosis. Source: NIK’s own analysis based on audit results.

NIK has noted that the system of consultation networks was not in place. The networks would make the diagnosis easier in difficult and ambiguous cases. The tissue material would be sent to the most experienced facilities. However, the law does not provide for the way of financing and submitting materials for consultation.

Moreover, in nearly 70 percent of the audited entities tests were made in conditions that did not comply with the law. Requirements related to the types of rooms or sanitary and technical conditions were not met. The irregularities included e.g.: the lack of dissection rooms, special techniques laboratory, cytology or histopathology laboratory or the body release room. NIK’s objections were also related to significant wear of the bathroom floor and fitting, dirty walls and ceiling or inoperative ventilation.

Besides, in 56 percent of the audited facilities, the concentration level of formaldehyde (which is harmful for humans) was not tested or measured. The personnel was thus exposed to its toxicity. In the audited period, the highest acceptable concentration of formaldehyde was exceeded in four entities but still the frequency of tests and measurements was not increased

According to NIK, from 2017 to 2019, the Minister of Health failed to ensure good diagnostic pathology, despite the measures taken. No in-depth analysis of its organisation or financing was conducted. And that should be the basis of future works on comprehensive solutions related to the improvement of quality and availability of those services. Also, no assessment was made of the type or scale of the tests, their costs and operating anatomical pathology facilities.

The Supreme Audit Office has positively evaluated the implementation of organisational standards in anatomical pathology. NIK has also noted that the Minister has already started legislative works to improve the quality of diagnostic pathology and work out mechanisms of financing services in this area. However, since these measures are at their initial stage, it was hard to evaluate the effectiveness of the proposed solutions.

Recommendations

NIK has addressed the following recommendations to the Minister of Health:

  • to strengthen the role of diagnostic pathology in the healthcare system by optimal use of available tests, required quality and proper financing, including the reduction of risk of excessive increase of services’ total costs;
  • to speed up works on separating procedures of diagnostic pathology to define their costs and price;
  • to intensify works on developing accreditation standards in diagnostic pathology to be implemented in anatomical pathology facilities/ laboratories in a scheduled timeframe;
  • to ensure proper allocation of funds for even geographic distribution of anatomical pathology facilities/ laboratories and to encourage people to take specialty in anatomical pathology and neuropathology to limit the deficit of that medical personnel;
  • to use the statutorily guaranteed instruments for effective supervision of the way anatomical pathology facilities/ laboratories operate (to improve the quality of tests);
  • to implement the system of consultation networks to the diagnosis in difficult and ambiguous cases.

NIK has also made a de lege ferenda proposal to specify the standard description of a pathology test result which should deliver information crucial to plan a patient treatment.

Article informations

Date of creation:
11 October 2020 23:53
Date of publication:
11 October 2020 23:53
Published by:
Marta Połczyńska
Date of last change:
23 October 2020 14:14
Last modified by:
Andrzej Gaładyk
A tester making a microscopic examination. © Adobe Stock

NIK about diagnostic pathology

Read content once again