Laboratory Test Rules

2021

The Ministry of Health updated the standard for equipping clinical diagnostic laboratories

In November 2021, the Ministry of Health of the Russian Federation issued an order that amended the rules for laboratory research. One of the innovations was an increase in the number of possible codes for one type of equipment, which, according to the agency, will allow the medical organization to choose the equipment that most fully meets the needs of the clinic, including taking into account the availability of domestic-made medical equipment on the market.

Another innovation is that an automatic spermogram analyzer is included in the regulations for equipping clinical diagnostic laboratories of the second and third levels, and a test tube heater is included in the list of auxiliary equipment.

The Ministry of Health has updated the standard for equipping clinical diagnostic laboratories

To the equipment of centralized, specialized, inter-district laboratories of the 3rd level, a system for moving laboratory containers, robotic IVD (automatic) and software for storing and organizing glassware images were added.

New requirements for the equipment of clinical and diagnostic laboratories will come into force with 01.03.2022 and will be valid by 31.08.2027.

In September 2021, the Ministry of Health proposed adding to the standard for equipping a clinical diagnostic laboratory (express diagnostics) and laboratories of the first and second levels an analyzer for determining hemoglobin in two versions (automatic and semi-automatic), but they were not included in the final version of the updated regulations.

Order of the Ministry of Health of the Russian Federation dated 23.11.2021 No. 1088n "On Amending the Order of the Ministry of Health of the Russian Federation dated May 18, 2021 No. 464n" On Approving the Rules for Laboratory Research "is available by reference. The document signed by Minister of Health Mikhail Murashko was registered with the Ministry of Justice on November 30, 2021.

Ministry of Health of the Russian Federation approved the rules for laboratory research

On June 1, 2021, the Ministry of Justice of the Russian Federation registered an order from the Ministry of Health of Russia "On Approval of the Rules for Laboratory Research." The document will enter into force on September 1, 2021 and will be valid until September 1, 2027.

Russian Ministry of Health approved the rules for laboratory research

Medical organizations will have to follow new laboratory rules, which include instructions on the organization of laboratory work, on standard standards and equipment standards. Here are some of the main points:

• Referral for laboratory examination of the patient is carried out by the attending physician or paramedic, midwife in case of placing on them separate functions of the attending physician. The referral for laboratory research is issued in the form of a document on paper or is formed in the form of an electronic document.
• In the event of a threat of the spread of infectious and other diseases, mass laboratory tests are carried out, including in the direction of the employer.
• Laboratory examination can be carried out with the patient's independent appeal without registration of referral as part of the provision of paid medical services.
• The laboratory should have a clinical laboratory quality management system developed in accordance with the requirements of national and industry standards, carry out internal quality control and safety of medical activities.
• All human biological material supplied for laboratory research to medical and other organizations carrying out medical activities should be considered by the medical organization as potentially infected.
• A report on the results of clinical laboratory tests is issued to the customer (patient, attending doctor or medical organization) on the organization's form in electronic form or on paper.
• A copy of the clinical laboratory results report may be issued to the patient or his legal representative
• The duration of clinical laboratory tests should not exceed the deadlines established in the state guarantee program for the free provision of medical care to citizens.^[1]

Notes