Roszdravnadzor holds panel session to discuss improvements in healthcare federal state control

As part of the Medicine and Quality 2016 conference, the Federal Service for Surveillance in Healthcare (Roszdravnadzor) held a regular panel session on Improvements in Healthcare Federal State Control, chaired by Roszdravnadzor’s Head Mikhail Murashko.

The session discussed issues of federal state control in healthcare, introduction of a risk-oriented approach to planning of control activities, quality and safety control of medical practice, as well as up-to-date approaches to surveillance of medical devices and medicines, and analyzed performance in the first nine months of 2016.

In 2016, Roszdravnadzor cooperated with individual experts and expert organizations in holding 5,850 inspections of compliance with citizens’ rights to health protection (up 8% against the same period in 2015). The surveillance exercise resulted in the issue of 2,327 prescriptive orders on corrective actions and 439 administrative offence reports. In 581 cases, the inspection records were submitted to the prosecutor’s office, and in another 93 to law enforcement agencies. Records of 565 inspections were filed with public authorities of subjects of the Russian Federation.

Roszdravnadzor‘s officials also held 5,617 inspections of compliance by healthcare organizations with the established procedure of rendering medical assistance.

As a result of 3,254 inspections (57.9% of the total number of inspections held by Roszdravnadzor), 5,392 violations of the procedure of medical care provision were revealed. The main fault of healthcare providers in this context was failure to meet  equipment standards – 3,261 cases (58.1 of the total number of inspections).

The surveillance exercise resulted in the issue of 3,254 prescriptive orders on corrective actions and 392 administrative offence reports. In 677 cases, inspection records were forwarded to prosecution authorities for the prosecutor’s action, and in 47 of those cases, the prosecution authorities issued submissions. In 113 cases inspection records were submitted to law enforcement agencies, and in 979 cases to public authorities of subjects of the Russian Federation.

The quality of medical practice depends largely on the quality and efficiency of medicines and medical devices used in the diagnostic and treatment process.

Control over circulation of medicines revealed 1,553 violations of compulsory requirements by healthcare, pharmacy and other organizations in the selection of medicines. The control activities resulted in administrative fines in the total amount of over RUB 23 million (the main violations include incompliance with storage standards, especially with regard to temperature-sensitive medicines, and default on retail regulations).

Owing to Roszdravnadzor’s control activities, 3,234,580 packages of poor-quality and falsified medicines were withdrawn from circulation and destroyed in the first half of the current year. Circulation of 503,596 unregistered units, 1,009,035 poor-quality units and 11,020 falsified units of medical devices was prevented, while the use of 889,499 units of medical devices and 17,411 expired units of medical devices was suspended.

Roszdravnadzor’s control over circulation of medical devices during the first ten months of 2016 resulted in 1,348 administrative offence reports in the total amount of over RUB 20 million.

Having heard reports and discussed vital issues, the members of Roszravnadzor’s panel drew up guidelines for further improvement of healthcare federal state control for 2017:

  • Categorization (classification) of controlled facilities by grades of potential risk of their operations for health and life of individuals;
  • Determination of the frequency of inspections with account to possible risk for health and life of individuals;
  • Introduction of unified control approaches in the whole territory of the Russian Federation, including the use of questionnaires;
  • Drawing up a list of proactive efforts aimed at prevention of offences in healthcare;
  • Creating consciousness of those involved in the healthcare system of the need for compliance with laws and regulations and internal self-control in order to prevent offences;
  • Improvement of appraisal methods for efficiency of performance of Roszdravnadzor’s regional offices;
  • Ensuring regular interaction with public and patient organizations, war veteran committees, regional branches of the All-Russia Popular Fund and other organizations concerned in the discussion of problems of healthcare delivery and its quality in subjects of the Russian Federation.