Minimum standard for equipping Moscow clinics with ultrasound diagnostic devices

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Abstract

BACKGROUND: A variety of ultrasound equipment and a lack of generally accepted classifications lead to inefficient equipment of medical organizations, incorrectly selected types of device, sets and probes’ characteristics, as well as a level of study quality. A systematic approach to equipping similar medical organizations with ultrasound devices will ensure the availability and improve the quality of primary medical care in outpatient centers.

AIM: To develop a calculation algorithm and recommendations for the minimum standard for equipping regional outpatient medical facilities of the state healthcare system based on the Moscow example.

MATERIALS AND METHODS: In conducting the study, we used software for statistical and comparative analysis based on the data of the Material Support Management System of the Unified Medical Information and Analytical System (MSMS UMIAS), Form No.30 of Federal Statistical Observation, as well as a number of assigned population to the outpatient center (hereinafter referred to as the OC), technical data, and reviews of modern ultrasound diagnostic devices.

RESULTS: The developed minimum standard for equipment considers the following factors: 1) need to provide medical care to children and adult populations separately; 2) compliance with modern diagnostic technologies; 3) ensuring the territorial availability of diagnostics under the condition of efficient equipment operation.

CONCLUSIONS: Standardization of equipment of outpatient medical facilities with ultrasound diagnostic devices contributes to improving the quality of diagnostics and the availability of providing required examinations to the assigned population, reducing the waiting time for examinations, reducing the shortage of necessary equipment, expanding the range of medical services provided to the city population, and minimizing duplicate studies at subsequent stages of medical care.

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INTRODUCTION

In the early 2020s, state outpatient care facilities were equipped by the Order of the Ministry of Health and Social Development of the Russian Federation No. 753 dated December 1, 2005,1 which divides all healthcare facilities by types of subordination and recommends equipping them according to the schedules provided. However, these standards do not fully reflect the current equipment need of healthcare facilities both in terms of the equipment quantity and availability of state-of-art diagnostic technologies. Therefore, determining diagnostic tasks to be solved using specific types of equipment and comparing them with actual market supply are important. To estimate the need for equipment, it is necessary to forecast the equipment utilization for the next 10 years. By the Order of the Department of Health of Moscow No. 751 dated July 31, 2020, for the effective utilization of ultrasound diagnostic devices (UDDs) in a healthcare facility,2 the annual number of planned examinations should be approximately 9000 per device provided that a device is operated 12 h a day, 5 days a week.

Currently, healthcare facilities may be equipped as follows [1]:

  • Procuring new equipment
  • Procuring used equipment
  • Procuring modernized equipment
  • Long-term equipment leasing

After the procurement of new equipment is approved, a term of reference (TOR) shall be prepared as follows:

  1. At the planning stage, technical specifications and equipment configuration shall be clinically reasonable.
  2. A qualitative (availability) or quantitative characteristic shall be provided for the parameters required, e.g., the minimum and maximum frequency ranges of probes.
  3. When preparing the TOR, suppliers must be contacted to obtain equipment characteristics, clarify technical issues, evaluate the relevance of the TOR for the actual medical equipment market, and make competitive purchases with at least three manufacturers.
  4. To prepare the TOR, healthcare facilities may use the list of Russian state standards (GOSTs) for compliance with requirements for state procurement and various healthcare standards.

If the TOR is not consistent with the above-mentioned principles, equipment problems may arise, for example, it is impossible to use adult ultrasound probes in pediatric healthcare facilities, and vice versa. The inadequate configuration of probes and programs can also result in the replacement of the entire system because of limitations in expanding the range of healthcare services of the ultrasound diagnostic department [2].

To prevent such errors in large-scale purchases, methodological materials shall be developed, comparing equipment needs by types of facilities and healthcare services provided to set a minimum equipment standard [3].

To introduce a unified systematic approach to resource distribution, a minimum standard for equipping outpatient centers of the Department of Health of Moscow with UDDs has been developed, indicating the quantity and quality of equipment [4].

MATERIALS AND METHODS

Based on the current equipment stock available, equipment utilization and distribution were assessed for outpatient centers of the Department of Health of Moscow, separately in adult and pediatric centers and in branches and head offices. The minimum equipment standard was developed considering the size of the attended population, concentration of clinical specialists in the head office, and number of examinations conducted during the reporting period.

We used the data of the Procurement Management System of the Unified Medical Information and Analysis System (UMIAS or EMIAS) of the Department of Health of Moscow (Federal Statistical Monitoring Form No. 30 for the reporting period) and publicly available technical specifications and reviews of state-of-art UDDs.

Most often, TORs classify devices into multipurpose (260250), hand-held (324320), and special cardiovascular (192070) devices, which are indicated in the Nomenclature of Medical Devices,3 to cover a wide range of necessary examinations for the attended adult and pediatric population.

RESULTS

Status of UDD stock in outpatient care facilities of the Department of Health of Moscow

According to the Federal Statistical Monitoring Form No. 30 for 2019, 86 outpatient centers (including city outpatient clinics, pediatric city outpatient clinics, diagnostic centers, clinical diagnostic centers, and consultative and diagnostic outpatient clinics) are equipped with more than 1,300 UDDs, which are designed to examine the attended population (>10 million) using the territorial program of state guarantees (Table 1).

 

Table 1. Current status of ultrasound diagnostic equipment in outpatient centers*

Parameter

Outpatient centers

Adult

Pediatric

Total

Number of equipment (pcs)

964

428

1392

Average service life of UDD (years)

7

8

8

Number of UDDs with service life >10 years (%)

17

21

19

Number of UDDs with service life <3 years (%)

10

2

6

Note. * Based on Federal Statistical Monitoring Form No. 30 for 2019. UDD, ultrasound diagnostic device.

 

To classify UDDs by types of care, three types of devices were considered: multipurpose, special cardiovascular, and hand-held devices (Table 2).

 

Table 2. Distribution of equipment stock by types of care*

Parameter

Outpatient centers

Adult

Pediatric

Total

Number of multipurpose UDDs (pcs)

726

376

1102

Number of special cardiovascular UDDs (pcs)

192

9

201

Number of hand-held UDDs (pcs)

46

43

89

Note. * Based on Federal Statistical Monitoring Form No. 30 for 2019. UDD, ultrasound diagnostic device.

 

In accordance with the Letter of the Primary Healthcare Office of the Department of Health of Moscow No. 41-18-54078/18, for Ultrasound Diagnostics Departments with two-shift working mode, the target efficacy indicator is 40 examinations per day4. The average number of examinations per day is 19, and the average number of shifts is 1.6. Changes in available UDD utilization are presented in Table 3.

 

Table 3. Changes in outpatient UDD utilization, 2017–2019*

Type of healthcare facility

2017

2018

2019

Outpatient centers

55

57

59

Note. * Based on the data of Procurement Management System of the Unified Medical Information and Analysis System (UMIAS, EMIAS), 2017–2019.

 

Considering the head office and all branches, the attended population included 92,000–300,000 and 28,000–73,000 people per adult and pediatric outpatient centers, respectively. According to the Federal Statistical Surveillance Form No. 30 for 2019, more than 4,800,000 and 2,000,000 ultrasound examinations were performed in adult and pediatric outpatient centers, respectively (including more than 2,300,000 and 214,000 cardiovascular ultrasound examinations). There are approximately 663 and 286 wage rates for diagnostic ultrasound technicians in adult and pediatric outpatient centers, respectively (including 604 and 204 HCPs).

DISCUSSION

Minimum equipment standard

According to Reporting Form No. 30 for 2019, adult and pediatric outpatient centers are equipped with more than 1300 UDDs with an attended population of more than 10 million and with more than 7 million examinations performed; therefore, the average annual number of examinations is 6000 per 1 UDD.

For multipurpose UDD utilization for the attended adult population, the above parameter was calculated using the ratio of the attended population to the number of UDDs, multiplied by the ratio of the average attended outpatient population to the total number of examinations, multiplied by the ratio of the number of examinations per 1 UDD per outpatient center to the number of examinations per 1 UDD (excluding cardiovascular examinations). For the attended pediatric population, the minimum equipment standard value is based on the comparison of the number of examinations conducted and the size of attended adult and pediatric populations.

For special cardiovascular UDD utilization for the attended adult population, the above parameter was calculated using the ratio of the average number of cardiovascular examinations per outpatient center to the average number of examinations per one UDD per outpatient center. For the attended pediatric population, the minimum equipment standard value is based on the comparison of the number of examinations conducted and the size of the attended adult and pediatric populations.

To improve the efficiency of radiology and imaging departments, the recommendation was to provide at least one hand-held UDD per adult and pediatric outpatient center, both in head and branches, for sedentary patients and medical check-ups and follow-up examinations outside healthcare facilities.

The minimum equipment standard for adult and pediatric primary outpatient centers (Tables 4 and 5; both tables were included in Order No. 1043 dated September 15, 20205) describes the equipment system at a certain time according to the needs at the city level. An increase in the population with the development of districts requires an increase in UDD stocks. If reasonable, if the number of HCPs is sufficient for full equipment utilization, exceeding the minimum equipment standard is allowed.

 

Table 4. Minimum standard for equipping adult primary outpatient centers with UDDs

Type of ultrasound device

Outpatient center

Head office,

per 1000 population

Branch office,

per 1000 population

Multipurpose UDD

<50 — 1 pc

50–100 ― 2 pcs

100–150 ― 3 pcs

>150 ― 4 pcs (but no >4 pcs per office, including 1 expert UDD)

<50 — 1 pc

>50 ― 2 pcs

Hand-held UDD

1 pc (expert UDD)

1 pc

Special cardiovascular UDD

<100 ― 1 pc

>100 ― 2 pcs

1 pc

 

Table 5. Minimum standard for equipping pediatric primary outpatient centers with UDDs

Type of ultrasound device

Outpatient center

Head office,

per 1000 population

Branch office,

per 1000 population

Multipurpose pediatric UDD

<30 ― 1 pc

>30 ― 2 pcs

<15 ― 1 pc

>15 ― 2 pcs

Hand-held pediatric UDD

1 pc

1 pc

Special cardiovascular pediatric UDD

<50 — 1 pc

>50 ― 2 pcs

-

 

To increase the efficiency, it is necessary not only to supply UDDs but also to ensure their complete set. For each device type, certain types of examinations are supposed to be performed (Table 6).

 

Table 6. Comparison of examination types by types of UDD

Examination type

Hand-held

Multipurpose

Special*

Neurosonography (for pediatric outpatient centers)

+

+

-

Ultrasonography of superficial organs and structures

+

+

-

Transabdominal ultrasonography of the abdominal cavity, kidneys, retroperitoneal space, and pelvic organs

+

+

-

Ultrasonography of the pleural cavity

+

+

+

Echocardiography

+ (screening level)

+ (screening level)

+ (expert level)

Transcranial vascular ultrasonography

+ (screening level)

+ (screening level)

+ (expert level)

Vascular ultrasonography of the neck and upper and lower extremities

+ (screening level)

+ (screening level)

+ (expert level)

Intracavitary ultrasonography of pelvic organs

-

+

-

Note. * For cardiovascular ultrasonography.

 

To obtain conclusive results of the above-mentioned examinations, in addition to the minimum model for calculating the equipment need of adult and pediatric outpatient centers, the minimum delivery package was developed for UDDs with minimum frequency ranges (Table 7).

 

Table 7. Approximate configuration of UDDs with a minimum range of probe frequencies

Type of device

Technical specifications

Outpatient center, head and branch offices

Adult

Pediatric

Special cardiovascular UDD

Linear probe, frequency range, MHz

3–10

5–12

Curvilinear probe, frequency range, MHz

3–5

3–7

Sector-phased array probe, frequency range, MHz

2–5

2–5

Sector-phased array probe, frequency range, MHz

-

5–8

Hand-held UDD

Linear probe, frequency range, MHz

5–12

8–14

Curvilinear probe, frequency range, MHz

3–5

3–7

Sector-phased array probe, frequency range, MHz

2–4

2–4

Sector-phased array probe, frequency range, MHz

-

5–8

Multipurpose UDD

Linear probe, frequency range, MHz

5–12

8–14

Curvilinear probe, frequency range, MHz

2–5

3–7

Intracavitary microconvex probe, frequency range, MHz

4–9

-

Sector-phased array probe, frequency range, MHz

-

5–8

Sector-phased array probe, frequency range, MHz

2–4

2–4

 

Comparison of equipment standards

  1. Let’s consider equipment for adult and pediatric outpatient centers by the Order of the Ministry of Health and Social Development of the Russian Federation No. 753 dated December 1, 2005,6 and the minimum equipment standard proposed (Tables 8 and 9).

 

Table 8. Estimated need for UDDs in an adult outpatient center

Parameters

Adult outpatient center X

Head office

Branch office No. 1

Branch office No. 2

Branch office No. 3

Total

Number of attended population

26 451

20 190

26 583

18 925

92 149

Number of UDDs required according to the Order of the Ministry of Health and Social Development of the Russian Federation No. 753 dated December 1, 2005

Medical UDD

2

2

2

2

8

Hand-held

1

1

1

1

4

Number of UDDs required by the minimum equipment standard

Multipurpose

2

1

1

1

5

Special

1

1

1

1

4

Hand-held

1

1

1

1

4

Note. UDD, ultrasound diagnostic device.

 

Table 9. Estimated need for UDDs in a pediatric outpatient center

Parameters

Pediatric outpatient center Y

Head office

Branch office No. 1

Branch office No. 2

Branch office No. 3

Total

Number of attended population

20 640

14 639

10 160

13 889

59 328

Number of UDDs required according to the Order of the Ministry of Health and Social Development of the Russian Federation No. 753 dated December 1, 2005

Medical UDD

1

1

1

1

4

Number of UDDs required by the minimum equipment standard

Multipurpose

2

1

1

1

5

Special

2

0

0

0

2

Hand-held

1

1

1

1

4

Note. UDD, ultrasound diagnostic device.

 

The need for UDDs in an adult outpatient center was calculated as follows: an adult center was considered a basis, having a head office and three branches located at different addresses remote from each other, and each site has a certain size of an attended population.

The number of UDDs was calculated based on the size of the attended adult population (92,149). According to the minimum equipment standard (Table 4), the head office and branches (<50,000) should be provided with two multipurpose UDDs and one special cardiovascular UDD, and one multipurpose UDD and one special cardiovascular UDD, respectively. Each office should have one hand-held UDD, regardless of the size of the attended population, for low-mobility patients and examinations outside a healthcare facility.

Therefore, by the Order of the Ministry of Health and Social Development of the Russian Federation No. 753 dated 01.12.2005, 12 UDDs of two proposed types are needed to equip an adult outpatient center with one head office and three branches. The current minimum equipment standard recommends equipping such a center with 13 UDDs, which are divided by types and evenly distributed among branches.

The UDD need in a pediatric outpatient center was calculated similarly to the adult outpatient center.

Based on the size of the attended pediatric population (59,328), the number of devices was calculated. According to the minimum equipment standard (Table 5), the head office and branches (<15,000) should be provided with two multipurpose UDDs and two special cardiovascular UDDs, and one multipurpose UDD, respectively. For each office, one hand-held UDD is required, regardless of the size of the attended population.

Therefore, by the Order of the Ministry of Health and Social Development of the Russian Federation No. 753 dated December 1, 2005, for a pediatric outpatient center with one head office and three branches, only four UDDs of the same type are required. The current minimum equipment standard recommends equipping such a center with 11 UDDs, which are divided by types and evenly distributed among branches.

  1. Let’s consider equipping an adult and a pediatric outpatient center before and after implementing the minimum equipment standard proposed (Tables 10 and 11).

 

Table 10. Comparison of UDD availability in an adult outpatient center

Parameters

Adult outpatient center A

Head office

Branch office No. 1

Branch office No. 2

Branch office No. 3

Total

Number of attended population

36 051

51 162

45 589

33 653

166 455

Number of UDDs available before equipping according to the minimum equipment standard

Ultrasound imaging system

8

6

4

4

22

Hand-held ultrasound imaging system

1

0

0

1

2

Number of UDDs available after equipping according to the minimum equipment standard

Multipurpose

2

2

1

1

6

Special

2

1

1

1

5

Hand-held

1

1

1

1

4

Note. UDD, ultrasound diagnostic device.

 

Table 11. Comparison of UDD availability in a pediatric outpatient center

Parameters

Pediatric outpatient center B

Head office

Branch office No. 1

Branch office No. 2

Branch office No. 3

Total

Number of attended population

14 357

17 931

18 346

13 663

64 297

Number of UDDs available before equipping according to the minimum equipment standard

Ultrasound imaging system

4

3

2

2

11

Hand-held ultrasound imaging system

1

0

0

0

1

Number of UDDs available after equipping according to the minimum equipment standard

Multipurpose pediatric

2

2

2

1

7

Special pediatric

2

0

0

0

2

Hand-held pediatric

1

1

1

1

4

Note. UDD, ultrasound diagnostic device.

 

Table 10 shows the equipment for an adult outpatient center. In total, such a center is equipped with 22 stationary UDDs and two hand-held UDDs per attended population (166,000). The analysis of the equipment utilization efficiency for 2019 shows that the average efficiency of the current UDD stock is 64%, which corresponds to a low level of efficiency. Therefore, the adult outpatient described in the example has some extra UDDs or lacks HCP wage rates to ensure the utilization of stationary UDDs 5 days a week in two shifts, based on the target equipment utilization rate7. According to the minimum standard of equipment, this center requires equipping with six multipurpose, five special, and four hand-held UDDs (total of 15 UDDs) and only 11 stationary UDDs, which require a smaller number of HCP wage rates for full and efficient utilization of the equipment.

Table 11 shows the equipment of a pediatric outpatient center. In total, such a center is equipped with 11 stationary UDDs and one hand-held UDD per attended population (64,000). The analysis of the equipment utilization efficiency for 2019 shows that the average efficiency of the current UDD stock is 91%, which corresponds to a high level of efficiency. According to the minimum equipment standard, this center requires seven multipurpose, two special and four hand-held UDDs (total of 13 UDDs).

Therefore, it is necessary to reduce the number of UDDs, re-equip centers, and distribute UDDs by types (Tables 10 and 11) to provide the attended adult and pediatric populations with all the necessary types of ultrasound examinations and increase the efficiency of the new equipment in accordance with international standards8.

According to this paper, the outpatient ultrasound equipment standard is included in the database that defines the minimum requirements for equipping healthcare facilities with radiology and imaging equipment9, approved and implemented by the Department of Health of Moscow.

CONCLUSION

The proposed minimum equipment standard for adult and pediatric outpatient centers contributes to improving the quality of diagnostics. The standard allows even distribution of equipment throughout the healthcare facility for better and more affordable primary medical care in the attended population in the corresponding outpatient center.

The standard is simple to apply because it classifies the equipment by types and describes the necessary equipment. Thus, the equipment required by the head office and branches of outpatient centers should be clarified in accordance with this standard to increase the availability of the necessary examinations to the attended population, reduce the waiting time, ensure reasonable equipment planning for a given period, reduce the shortage of necessary equipment (forecasting the future number of examinations), and expand the range of medical services provided to the local population. A state-of-art set of devices is necessary to obtain conclusive results of the examination of various organs and systems and minimize duplicate examinations at subsequent stages of the patient’s journey.

The analysis of the outpatient center with a total attended population of 10 million people showed the adequacy of the proposed approach to provide high-quality ultrasound diagnostics. To estimate the economic effect, long-term observations are required because of the gradual replacement of equipment. However, the proposed solution does not reduce the availability of this category of examinations.

An algorithm for calculating the minimum equipment standard can be proposed for other regions of the Russian Federation to standardize the re-equipment of outpatient care facilities.

ADDITIONAL INFORMATION

Funding source. This study was not supported by any external sources of funding.

Competing interests. The authors declare that they have no competing interests.

Authors’ contribution. All authors made a substantial contribution to the conception of the work, acquisition, analysis, interpretation of data for the work, drafting and revising the work, final approval of the version to be published and agree to be accountable for all aspects of the work. S.G. Kireev — the idea of the study, processing the results, writing the text of the article; N.N. Vetsheva, A.I. Gurevich — editing of the manuscript, peer review; I.V. Soldatov, Z.A. Lantukh — processing of results, writing the text of the article; A.I. Gurevich, A.N. Mukhortova — editing the manuscript.

×

About the authors

Natalia N. Vetsheva

Moscow Center for Diagnostics and Telemedicine

Email: vetsheva@npcmr.ru
ORCID iD: 0000-0002-9017-9432
SPIN-code: 9201-6146

MD, Dr. Sci. (Med.)

Russian Federation, Moscow

Ilya V. Soldatov

Moscow Center for Diagnostics and Telemedicine

Email: i.soldatov@npcmr.ru
ORCID iD: 0000-0002-4867-0746
SPIN-code: 4065-6048
Russian Federation, Moscow

Zoya A. Lantukh

Moscow Center for Diagnostics and Telemedicine

Email: z.lantukh@npcmr.ru
ORCID iD: 0000-0001-6623-9610
SPIN-code: 5486-6496
Russian Federation, Moscow

Sergey G. Kireev

Moscow Center for Diagnostics and Telemedicine

Author for correspondence.
Email: s.kireev@npcmr.ru
ORCID iD: 0000-0002-3324-3733
SPIN-code: 3611-2336
Russian Federation, Moscow

Anzhelika I. Gurevich

Filatov N.F. Children’s City Hospital

Email: gurevichai@yandex.ru
ORCID iD: 0000-0001-8187-214X
SPIN-code: 7641-1319

MD, Dr. Sci. (Med.)

Russian Federation, Moscow

Anna N. Mukhortova

Moscow Center for Diagnostics and Telemedicine

Email: a.mukhortova@npcmr.ru
SPIN-code: 9051-1130
Russian Federation, Moscow

References

  1. Morozov SP, Aronov AV, Gabai PG. Fundamentals of medical imaging management. Ed. by S.P. Morozov. Moscow: GEOTAR-Media; 2020. 432 p. (In Russ).
  2. Krotov IA, Konovalov OE, Terletskaya RN. Evaluation by medical specialists of the state of ultrasound diagnostics in pediatric practice. Problems of social hygiene, healthcare and history of medicine. 2021;29(1):76–79. (In Russ). doi: 10.32687/0869-866x-2021-29-1-76-79
  3. European Society of Radiology (ESR). Renewal of radiological equipment. Insights Imaging. 2014;5(5):543–546. doi: 10.1007/s13244-014-0345-1
  4. European Society of Radiology (ESR). Position statement and best practice recommendations on the imaging use of ultrasound from the European Society of Radiology Ultrasound Subcommittee. Insights Imaging. 2020;11(1):115. doi: 10.1186/s13244-020-00919-x

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