CN-122025051-A - Verification method for intravenous drug sterile configuration operation

CN122025051ACN 122025051 ACN122025051 ACN 122025051ACN-122025051-A

Abstract

The invention provides a verification method of intravenous drug sterile configuration operation, which comprises the steps of executing a preset simulated intravenous drug sterile configuration flow by a tested person in a preset environment, evaluating operation standardability of the flow executed by the tested person according to a preset quantitative evaluation table to obtain operation scores, carrying out microorganism sampling and culture counting on air sedimentation bacteria in an operation area where the tested person is located, the surfaces of key objects after operation and fingertips of worn gloves in the process of executing the flow by the tested person to obtain environment monitoring results, culturing a simulated product prepared by executing the flow, determining microorganism growth conditions to obtain a simulated product culture result, judging whether the technical scores, the environment monitoring results and the simulated product culture result meet preset standards, and judging that the current sterile operation test of the tested person is qualified if the operation standard is met. The invention can improve the accuracy and reliability of the verification result.

Inventors

YUE YANTAO
ZHAO LIANG
AN SHUAI
LI YANHUA
SHANG DANDAN

Assignees

许昌市中心医院

Dates

Publication Date: 20260512
Application Date: 20260128

Claims (10)

1. A method of verifying an intravenous administration sterile configuration procedure, the method comprising: Executing a preset simulated intravenous drug sterile preparation process in a preset environment by a tested person; according to a preset quantitative scoring table, evaluating the operation normalization of the simulated intravenous drug sterile preparation process executed by the tested person to obtain an operation score; In the process of executing the simulated intravenous drug sterile preparation flow by the tested person, performing microorganism sampling and culture counting on the air sedimentation bacteria in the operation area where the tested person is located, the surfaces of key objects after operation and fingertips of the worn gloves to obtain an environment monitoring result; Culturing the simulated product prepared by executing the simulated intravenous drug sterile preparation flow, and determining the growth condition of microorganisms to obtain a simulated product culture result; Judging whether the technical score, the environment monitoring result and the simulated product culture result meet preset standards or not; And if the operation scores, the environment monitoring results and the simulated product culturing results all meet preset standards, judging that the aseptic operation test of the time of the tested personnel is qualified.
2. The method of claim 1, wherein the predetermined simulated intravenous administration sterile compounding procedure comprises: orderly placing the test materials in the kit; Evacuating the original liquid in the final container; Adding a primary drug and a diluent to the final container; Re-dissolving the medicine in the penicillin bottle by using a solvent; the medicine in the penicillin bottle and the medicine in the ampoule are mixed in a two-way cross way; all medications were pooled into the final container.
3. The method of claim 2, wherein the total number of sterile fluid transfers in the simulated intravenous administration sterile compounding procedure is not less than a predetermined number.
4. A method according to claim 2 or 3, wherein the test material in the kit comprises: At least one ampoule, said ampoule having a sterile medium or a mimetic enclosed therein; At least one penicillin bottle, wherein a sterile culture medium or a simulator is packaged in the penicillin bottle; At least one final container; A plurality of sterile syringes; Sterilizing water for injection and 0.9% sodium chloride injection; Sampling swabs and contact discs; an operation instruction file, wherein the operation instruction file prescribes the steps of the simulated intravenous drug sterile preparation flow; and quantifying the scoring table.
5. The method of claim 1, wherein evaluating the operational normative of the test person performing the simulated iv administration sterile compounding procedure according to a predetermined quantitative scoring table, the obtaining an operational score comprising: According to a preset quantitative evaluation list, evaluating operation normative of the simulated intravenous drug sterile preparation process executed by the tested person from multiple dimensions of personal preparation, disinfection program, sterile barrier use, article transfer and operation method respectively to obtain scores of the dimensions; And adding the scores of the dimensions to obtain an operation score.
6. The method of claim 5, wherein if the operational score is not less than a predetermined score, determining that the operational score meets a predetermined criterion.
7. The method of claim 1, wherein the performing the microbial sampling and culturing counting on the airborne bacteria, the operated key object surface and the fingertips of the worn gloves in the operation area where the tested person is located, and obtaining the environmental monitoring result comprises: Placing a sedimentation bacteria plate in an operation area where the tested person is located, monitoring air cleanliness, and performing microorganism sampling and culture counting; The method comprises the steps of using a swab method to sample and culture microorganisms on the surface of a key object operated by a tested person, wherein the surface of the key object comprises a penicillin bottle rubber plug and an ampoule bottle mouth; And (3) performing microorganism sampling and culture counting on the fingertip parts of the glove worn by the tested person by using an imprinting method.
8. The method according to claim 7, wherein if the microbial count value obtained after the air sedimentation bacteria of the operation area where the person to be tested is located, the surface of the key object after the operation, and the fingertips of the worn glove are subjected to the microbial sampling and culturing does not exceed a predetermined number, the environmental monitoring result is determined to meet a preset standard.
9. The method of claim 1, wherein culturing the simulated product prepared by performing the simulated intravenous drug sterile formulation procedure to determine microbial growth comprises culturing the simulated product prepared by performing the simulated intravenous drug sterile formulation procedure for 14 days to see if there is microbial growth.
10. The method of claim 9, wherein if the simulated product after 14 days of incubation is clear and no microorganisms are growing, determining that the simulated product incubation meets a predetermined criterion.

Description

Verification method for intravenous drug sterile configuration operation Technical Field The invention relates to the technical field of medical infection control, in particular to a verification method for intravenous drug sterile configuration operation. Background In medical institutions, particularly in intravenous administration deployment centers or ward treatment rooms, in order to promote the aseptic operation level of medical staff, the risk of medical infection is stopped, and the aseptic operation skills of the medical staff are usually checked and verified. At present, the traditional sterile operation skill examination and verification in China is mainly subjective observation with teaching or simple operation demonstration, the verification method is highly dependent on subjective judgment of examination staff, the examination standard difference among different examination staff is large, and invisible microbial contamination cannot be detected, so that the accuracy and reliability of examination and verification results are low. Disclosure of Invention The verification method for the intravenous drug sterile configuration operation can improve the accuracy and reliability of verification results. In a first aspect, the present invention provides a method of verifying an intravenous administration sterile configuration operation, the method comprising: Executing a preset simulated intravenous drug sterile preparation process in a preset environment by a tested person; according to a preset quantitative scoring table, evaluating the operation normalization of the simulated intravenous drug sterile preparation process executed by the tested person to obtain an operation score; In the process of executing the simulated intravenous drug sterile preparation flow by the tested person, performing microorganism sampling and culture counting on the air sedimentation bacteria in the operation area where the tested person is located, the surfaces of key objects after operation and fingertips of the worn gloves to obtain an environment monitoring result; Culturing the simulated product prepared by executing the simulated intravenous drug sterile preparation flow, and determining the growth condition of microorganisms to obtain a simulated product culture result; Judging whether the technical score, the environment monitoring result and the simulated product culture result meet preset standards or not; And if the operation scores, the environment monitoring results and the simulated product culturing results all meet preset standards, judging that the aseptic operation test of the time of the tested personnel is qualified. Optionally, the predetermined simulated intravenous administration sterile formulation procedure comprises: orderly placing the test materials in the kit; Evacuating the original liquid in the final container; Adding a primary drug and a diluent to the final container; Re-dissolving the medicine in the penicillin bottle by using a solvent; the medicine in the penicillin bottle and the medicine in the ampoule are mixed in a two-way cross way; all medications were pooled into the final container. Optionally, the total number of sterile fluid transfers in the simulated intravenous administration sterile compounding procedure is not less than a predetermined number. Optionally, the test materials in the kit comprise: At least one ampoule, said ampoule having a sterile medium or a mimetic enclosed therein; At least one penicillin bottle, wherein a sterile culture medium or a simulator is packaged in the penicillin bottle; At least one final container; A plurality of sterile syringes; Sterilizing water for injection and 0.9% sodium chloride injection; Sampling swabs and contact discs; an operation instruction file, wherein the operation instruction file prescribes the steps of the simulated intravenous drug sterile preparation flow; and quantifying the scoring table. Optionally, the evaluating the operation normalization of the simulated intravenous drug aseptic preparation process performed by the tested person according to the preset quantitative scoring table, and obtaining the operation score includes: According to a preset quantitative evaluation list, evaluating operation normative of the simulated intravenous drug sterile preparation process executed by the tested person from multiple dimensions of personal preparation, disinfection program, sterile barrier use, article transfer and operation method respectively to obtain scores of the dimensions; And adding the scores of the dimensions to obtain an operation score. Optionally, if the operation score is not lower than a preset score, determining that the operation score meets a preset standard. Optionally, the performing the microorganism sampling and culturing counting on the airborne bacteria, the operated key object surface and the fingertips of the worn gloves in the operation area where the tested person is located, and obtaining