hospital microbiological diagnostics in light of new...

8
Journal of Health Policy, Insurance and Management – Polityka Zdrowotna 79 Hospital microbiological diagnostics in light of new legislation HOSPITAL MICROBIOLOGICAL DIAGNOSTICS IN LIGHT OF NEW LEGISLATION Diagnostyka mikrobiologiczna w szpitalu w świetle nowych aktów prawnych ABSTRACT The identification of infective etiological factors and determination of their antibiotic resistance are the basic tasks of hospital microbiological diagnostics. This forms the basis for undertaking further procedures and making a prognosis for infection development. Microbiological procedures are also aimed at monitoring infection epidemiology in the hospital as those data are necessary for the prevention of nosocomial infec- tions. Analysis of the antibiotic resistance of strains isolated from the patients and the hospital environment enables rational antibiotic therapy. Another important task of the microbiological laboratory is the detection of nosocomial outbreaks and alert pathogens. The above-mentioned measures, implemented in cooperation with the Committee for the Control of Nosocomial Infections are to improve the quality of medical procedures and rationalize treatment costs by decreasing the number of infections, reducing patient hospitalization time, and introducing rational antibiotic therapy. Keywords: hospital acquired infection, laboratory procedures, alert pathogen, microbiology laboratory directives Słowa kluczowe: zakażenia szpitalne, procedury laboratoryjne, alert patogeny, rozporządzenia w sprawie laboratoriów mikrobiologicznych NOSOCOMIAL INFECTIONS Nosocomial infections ( nosos illness, komien – care) emerged with the advent of hospi- tals for the treatment of the sick. Initially, hospitals were mostly surgical facilities. At that time, it was thought that operations performed at the patient’s home were 3 to 5 times safer than those performed at the hospital, while infections were very often attributed to “thick air,” to be prevented by open- ing the windows. 1 The progress of medicine, including the introduction of complicated surgi- cal operations, implants, and new medicines, has led to improved medical outcomes. Unfortunately, this progress has not eliminated infections despite reducing them. 2 Infections are becoming a grow- ing problem, as they bring additional suffering on patients, undermine the outcomes of expensive treatment, and negatively affect the reputation of the hospital. The number of infections in hos- pitals varies depending on the organization of the facility, equipment, type of adopted procedures, and the profile of the patients. The greatest inci- dence of infections has been recorded in the fol- lowing departments: neonatology, intensive care, hematology, and transplantology. 3 The definitions of a nosocomial infection and of the major clinical forms of infections in hospi- talized patients have been developed by the Center for Disease Control and Prevention (CDC) 4 and are also accepted in Poland. It should be remembered that nosocomial infections include infections Anna Przondo-Mordarska, Danuta Smutnicka, Wroclaw Medical University 1 Przondo-Mordarska A, Zagadnienia ogólne I. [in:] Zakażenia szpitalne etiologia i przebieg. Continuo. Wrocław 1999: 9-15. 2 Wenzel R P. Heath Care-Associated Infections: Major Issues in the Early Years of the 21st Century; Clin. Infect. Diseases (45). 2007: 85-88. 3 Bulanda M. Zakażenia szpitalne na oddziałach zabiegowych. Krakowska Oficyna Naukowa. 2008. 4 CDC is an American institution recording data on occurrence of microorganisms and infectious diseases and monitoring vaccinations and infection prevention systems.

Upload: others

Post on 29-Jul-2021

2 views

Category:

Documents


0 download

TRANSCRIPT

Page 1: HOSPITAL MICROBIOLOGICAL DIAGNOSTICS IN LIGHT OF NEW ...journal-healthmanagement.com/pliki/zasobydokumentu... · nts: neonatology, intensive care, hematology, and transplantology

Journal of Health Policy, Insurance and Management – Polityka Zdrowotna 79

Hospital microbiological diagnostics in light of new legislation

HOSPITAL MICROBIOLOGICAL DIAGNOSTICS IN LIGHT OF NEW LEGISLATION

Diagnostyka mikrobiologiczna w szpitalu w świetle nowych aktów prawnych

AbstrAct

The identification of infective etiological factors and determination of their antibiotic resistance are the basic tasks of hospital microbiological diagnostics. This forms the basis for undertaking further procedures and making a prognosis for infection development. Microbiological procedures are also aimed at monitoring infection epidemiology in the hospital as those data are necessary for the prevention of nosocomial infec-tions. Analysis of the antibiotic resistance of strains isolated from the patients and the hospital environment enables rational antibiotic therapy. Another important task of the microbiological laboratory is the detection of nosocomial outbreaks and alert pathogens.

The above-mentioned measures, implemented in cooperation with the Committee for the Control of Nosocomial Infections are to improve the quality of medical procedures and rationalize treatment costs by decreasing the number of infections, reducing patient hospitalization time, and introducing rational antibiotic therapy.

Keywords: hospital acquired infection, laboratory procedures, alert pathogen, microbiology laboratory directives

Słowa kluczowe: zakażenia szpitalne, procedury laboratoryjne, alert patogeny, rozporządzenia w sprawie laboratoriów mikrobiologicznych

nosocoMIAl InfectIons

Nosocomial infections (nosos – illness, komien – care) emerged with the advent of hospi-tals for the treatment of the sick. Initially, hospitals were mostly surgical facilities. At that time, it was thought that operations performed at the patient’s home were 3 to 5 times safer than those performed at the hospital, while infections were very often attributed to “thick air,” to be prevented by open-ing the windows.1 The progress of medicine, including the introduction of complicated surgi-cal operations, implants, and new medicines, has led to improved medical outcomes. Unfortunately, this progress has not eliminated infections despite reducing them.2 Infections are becoming a grow-ing problem, as they bring additional suffering

on patients, undermine the outcomes of expensive treatment, and negatively affect the reputation of the hospital. The number of infections in hos-pitals varies depending on the organization of the facility, equipment, type of adopted procedures, and the profile of the patients. The greatest inci-dence of infections has been recorded in the fol-lowing departments: neonatology, intensive care, hematology, and transplantology.3

The definitions of a nosocomial infection and of the major clinical forms of infections in hospi-talized patients have been developed by the Center for Disease Control and Prevention (CDC)4 and are also accepted in Poland. It should be remembered that nosocomial infections include infections

Anna Przondo-Mordarska, Danuta Smutnicka, Wroclaw Medical University

1 Przondo-Mordarska A, Zagadnienia ogólne I. [in:] Zakażenia szpitalne etiologia i przebieg. Continuo. Wrocław 1999: 9-15.

2 Wenzel R P. Heath Care-Associated Infections: Major Issues in the Early Years of the 21st Century; Clin. Infect. Diseases (45). 2007: 85-88.

3 Bulanda M. Zakażenia szpitalne na oddziałach zabiegowych. Krakowska Oficyna Naukowa. 2008.4 CDC is an American institution recording data on occurrence of microorganisms and infectious diseases and

monitoring vaccinations and infection prevention systems.

Page 2: HOSPITAL MICROBIOLOGICAL DIAGNOSTICS IN LIGHT OF NEW ...journal-healthmanagement.com/pliki/zasobydokumentu... · nts: neonatology, intensive care, hematology, and transplantology

80 2013 Nr XII/II

Anna Przondo-Mordarska, Danuta Smutnicka

acquired by the hospital personnel during work; they are termed health care associated infections.5

The main risk factors for nosocomial infec-tions include:• patients susceptible to infections – those with

failing defense mechanisms and a compro-mised immunological system;

• microorganisms that have high pathogenicity and are resistant to antibiotics;

• invasive diagnostic and treatment methods. The above risk factors are linked to both the

patient’s health and the unit in which the patient is hospitalized. It should be noted that patient infections may be divided into two types: exog-enous and endogenous. The source of exogenous infections is the dry environment, which is a nat-ural reservoir of Gram-positive bacteria (includ-ing spore-forming bacteria) and fungi, and the wet environment with Gram-negative bacteria. The endogenous source of infections is the flora colo-nizing the patient and “shared flora” of the patients and the personnel. Efforts to reduce infections in hospitals are indispensable for improving the quality of medical services and enabling rational medical costs.6

The fact that the WHO recognized nosoco-mial infection control as the principal criterion for assessing the quality of the hospital shows the importance of the problem. Organization of the control and prevention of hospital-acquired infec-tions is based on establishment of Committees for the Control of Nosocomial Infections. The rules for their operation and appointing their members are set forth in the Regulation on Qualifications of Members of the Team for the Control of Nosocomial Infections and in the Regulation on the Scope, Manner and Frequency of Conducting Internal Control in the Area of Measures Preventing the Spread of Infections and Infectious Diseases, both of May 27, 2010.

Article 15, Sections 1-3 of the Act on the Prevention and Control of Infections and Infectious Diseases in Humans of December 5, 2008 clearly specify the membership of these committees.

Well-designed and implemented plans reduce the number of infections, shorten patient hospital-ization time, decrease treatment costs, and enable rational antibiotic therapy.

role of the lAborAtory In MonItorIng nosocoMIAl InfectIons

The basic objectives of microbiological diag-nostics include:• detecting the etiological factor of the infection

to a) confirm diagnosis, b) make a diagnosis (in undiagnosed patients), c) make a prognosis, d) implement appropriate therapy;

• enabling rational antibiotic therapy by deter-mining microbial sensitivity to antibiotics and chemotherapeutics, identifying microbial resistance mechanisms, and monitoring the spread of drug resistance;

• controlling the epidemiology of infections in the hospital by a) phenotypic and genotypic comparison of strains isolated from patients, b) detecting strains with high pathogenicity and drug-resistance, c) testing the personnel who come in contact with the infected patients to make sure they are not carriers, d) examin-ing natural reservoirs in the animate and inani-mate environment.An epidemiological study, which

is necessary to control nosocomial infections, consists of microbiological testing of patients (and sometimes of the personnel), monitoring of the environment, and monitoring of disinfection and sterilization.

5 Heczko P B, Wójkowska-Mach J. Zakażenia szpitalne. PZWL. 2009.6 Heczko P B, Wójkowska-Mach J. Op. cit.; Przondo-Mordarska A, Op. cit.

Continent/Country Percentage of infections

Europe 1-5%

Asia, Africa, Latin America up to 40%

Mediterranean countries 8.7%

Table 1. The number of nosocomial infections around the world according to Nguyen 2010

Source: own work

Page 3: HOSPITAL MICROBIOLOGICAL DIAGNOSTICS IN LIGHT OF NEW ...journal-healthmanagement.com/pliki/zasobydokumentu... · nts: neonatology, intensive care, hematology, and transplantology

Journal of Health Policy, Insurance and Management – Polityka Zdrowotna 81

Hospital microbiological diagnostics in light of new legislation

information about:• the microbiological profile of the hospital or its

unit in terms of infection classification and the types of etiological factors found;

• sources and natural reservoirs of microorgan-isms as well as routes of microbial transmission;

• sensitivity of strains to antibiotics, resistance mechanisms, changes in resistance patterns, and efficacy of antibacterial medicines.

Analysis of microbiological tests makes it possible to implement appropriate targeted therapy, design the principles of empirical thera-py and perioperative prevention, and monitor the spread of resistance among hospital strains. It also enables identification of epidemiological threats in the hospital, including outbreaks.

For a laboratory to meet the above require-ments, it must provide a wide range of services, be adequately equipped, and meet the basic quality standards under internal and external quality con-trol (certificate or accreditation). Pursuant to the Regulations of 2004 and 2006 and the Act of 2008, the head of the laboratory should be a laboratory diagnostician specialized in microbiology, who should also sit on the Committee for the Control of Nosocomial Infections, periodically prepare reports for the Committee, and communicate with the clinicians and the medical team. Articles 11 and 14, Sections 1-7 of the Act on the Prevention and Control of Infections and Infectious Diseases in Humans of 2008 stipulates that directors of hos-pitals should ensure full access to microbiological diagnostics in the hospital and round-the-clock availability of a microbiological laboratory, which means that they need to employ an adequate num-ber of diagnosticians.

orgAnIZAtIon of A MIcrobIologIcAl lAborAtory defIned In the regulAtIon of 2004

For committees and teams for the control and prevention of nosocomial infections to be effec-tive, they need to take full advantage of the micro-biological laboratory, which should be either within the structures of the hospital, or a separate entity conducting tests for the hospital and closely

cooperating with the committee.The requirements as to the structure and organ-

ization of a diagnostic microbiological laboratory are specified in the Regulation on Requirements for Medical Diagnostic Laboratories of March 3, 2004.7 The regulation stipulates the following basic requirements as to the premises of a labora-tory performing diagnostics for a hospital of about 1000 beds:• rooms for receiving patients,• diagnostic units: bacteriological, virological,

mycological, parasitological, and serological,• a nosocomial infection unit• auxiliary rooms (culture room, cleaning room,

sterilization room, storage room)• staff room.

Depending on hospital size (number of beds) and range of tests performed, the number of diagnosticians may vary.

Laboratory equipment, which is also defined in the regulation, is divided into:• basic – refrigerators, freezers (-80°C), labora-

tory incubators, autoclaves, pH meters, etc.,• measurement and testing devices: a system for

blood culture, microorganism identification, and antibiograms; a system for serological test-ing; and other devices depending on the range of tests performed.

procedures for MIcrobIologIcAl tests

The procedures for tests performed at microbiological laboratories are based on the Regulation on Test Quality Standards for Medical Diagnostic and Microbiological Laboratories of March 29, 2006.8

Figure 1. General scheme of a microbiological test

Source: own work

Phases of a microbiological test

3.Interpretationof test results

2.Laboratory

test of a sample

1.Consulting prior to test

7 Rozporządzeniu z dnia 3 marca 2004 r. w Sprawie Wymagań Jakim Powinno Odpowiadać Medyczne Laboratorium Diagnostyczne (Dz.U. Nr 43, poz. 408).

8 Rozporządzeniu z dnia 29 marca 2006 r. ‒ w Sprawie Standardów Jakości Badań dla Medycznych Laboratoriów Diagnostycznych i Mikrobiologicznych (Dz.U. Nr 61, poz. 435).

The microbiological laboratory also provides

Page 4: HOSPITAL MICROBIOLOGICAL DIAGNOSTICS IN LIGHT OF NEW ...journal-healthmanagement.com/pliki/zasobydokumentu... · nts: neonatology, intensive care, hematology, and transplantology

82 2013 Nr XII/II

virological, mycological, or parasitological) con-sists of three phases, as shows in Figure 1.

The first phase, that is, consulting prior to the test, involves standards of ordering microbio-logical tests and collecting samples, taking into account the type of microorganism (bacteria, fun-gi) and the testing method (microscopic examina-tion, culture, serology, nucleic acid determination).

The regulation also provides detailed informa-tion on sample transport and storage standards, emphasizing that the material in question is infec-tious and perishable.

Procedures for this phase, also known as the preanalytical phase, are developed by the laborato-ry and implemented outside the laboratory by phy-sicians, nurses, and administrative staff. It is a very

Errors Test results Note

Specimen for blood culture collected only once Negative culture results

It is accepted that 3 specimens (2 bottles each) should be taken to ensure valid results of blood culture

Smear collected from the wound surface

Random microorganisms colonizing the wound shown in the results

Smear should be collected from deeper parts of the wound

Peritoneal or pleural fluids collected at the time of the highest concentration of the antibiotic in the serum and tissues

Negative culture resultsSpecimen should be collected prior to antibiotic therapy or immediately before administering the next dose

Urine storage and transport at room temperature

False positive results of quantitative urine culture

Urine must be stored at 4°C immediately following collection

Table 2. Examples of errors in the preanalytical phase of microbiological testing

Source: own work

Anna Przondo-Mordarska, Danuta Smutnicka

important stage of diagnostics, because the pres-ence and viability of microorganisms in the sample depend on the time and site of its collection. Failure to adhere to the procedures of the preanalytical stage causes the greatest percentage of erroneous test results in microbiological diagnostics.The next diagnostic phase is conducted in the laboratory using methods based on current medical knowl-edge, recommendations of reference centers, and the national consultant for medical microbiology.9 The Regulation specifies standards for: conduct-ing microbiological tests (among others, specify-ing tests appropriate for different purposes and types of examination), species identification using phenotypic and genotypic methods, determina-tion of microbial resistance to medicines, and validation of test methods. The regulation permits ordering some tests from another microbiological laboratory.

The third phase of the diagnostic process is reporting the results on a form prescribed by law and signed by a microbiologist or another competent person. Of great importance is inter-pretation of results, which may be written

(in the form of an attachment) or oral (consulta-tion with the physician who ordered the test. If a sample from the patient is tested, the micro-biologist should indicate in the results the etiological factor of infection to avoid con-fusion with strains colonizing the patient or microorganisms contaminating the specimen. Antibiogram results usually require interpreta-tion to facilitate the choice of antibiotic therapy. Microbiological analysis of the hospital environ-ment also requires a microbiologist’s interpretation concerning the risk of an outbreak (or its absence).

Methods used In MIcrobIologIcAl dIAgnostIcs

The first phase of a microbiological test con-sists of: choosing the correct type of specimen and time of collecting it, indicating the objective of the test, filling in an order form, as well as ensuring adequate sample storage and transport. In the sub-sequent phase, the specimen is tested in the labora-tory – microorganisms are isolated and identified,

9  Bulanda M. Op. cit.; Forbes B A, Sahm D F, Weissfeld A S. Diagnostic microbiology. Mosby. 1998.

Every microbiological test (bacteriological,

Page 5: HOSPITAL MICROBIOLOGICAL DIAGNOSTICS IN LIGHT OF NEW ...journal-healthmanagement.com/pliki/zasobydokumentu... · nts: neonatology, intensive care, hematology, and transplantology

Journal of Health Policy, Insurance and Management – Polityka Zdrowotna 83

Hospital microbiological diagnostics in light of new legislation

and their sensitivity to antibiotics is determined.10 Diagnostics of bacterial infections, depend-

ing on the indication for the test, the type of spec-imen, and the potential of the laboratory, may be conducted in a conventional manner, that is, by direct smear, manual culture, phenotypic identification, determination of microbial sen-sitivity to antibiotics, and determination of the resistance mechanism of the isolated microor-ganism. Adequate equipment in the laboratory makes it possible to accelerate conventional tests by using commercial automated monitoring cul-ture systems and automated systems for the identification of microorganisms and determina-tion of their sensitivity to medicines.11 It is also important to have an IT system in the laboratory to enable fast result reporting. Apart from conven-tional testing, in detecting etiological factors, bac-teriological diagnostics takes advantage of sero-logical methods to determine bacterial antigens (e.g., for Legionella and Salmonella) or specific antibodies indicating an existing or past infec-tion (e.g., for Lyme disease). Serological tests are often performed in addition to bacterial cul-tures, and may be decisive in making a diagnosis (e.g., in toxoplasmosis).12

Diagnostic methods in fungal infections are based on: a) microscopic examination of variously stained direct smears, b) culture on special media, c) detecting fungal metabolites by mass spectro-photometry or gas chromatography. In diagnos-ing fungal infections, of importance are serologi-cal tests used to detect: a) cell wall antigens, b) antibodies against whole cell lysates as well as the antigen fractions of some fungi.

Microbiological laboratories increasingly often perform diagnostics of viral diseases, which is particularly important for patients in trans-plantation, neonatology, and infectious disease units.13 Viral cultures on cell lines are difficult to perform and take a long time to grow, so few laboratories offer such tests. In this area the most often used diagnostic methods involve detecting

antigens by immunofluorescence, immunoen-zymatic assays, immunoblotting, or the latex fixation test. Antibody detection in viral infec-tions is of diagnostic value only if paired sera are tested. Furthermore, nucleic acid detection tech-niques have gained widespread application in the diagnostics of viral infections.14

Great advances in microbiological diagnostics have been made thanks to knowledge of microbial genetics. In bacteriology, virology, and mycology, genetic tests may be used to identify microorgan-isms directly in the studied material by means of the polymerase chain reaction (PCR) method and in situ hybridization probe, which, in con-junction with fluorescein staining, is termed the FISH technique.15 Using this testing method, results may be obtained even within several hours. Determination of bacterial DNA is reliable and enables identification of “non-cultured” bacteria in the tested sample. However, molecular meth-ods limit the possibility of obtaining information concerning the antibiotic sensitivity of strains. Furthermore, they may not be applied for iden-tification of bacteria in materials contaminated with physiological flora, such as sputum or stool. Genetic techniques are very widely applied in epi-demiological studies, both for nosocomial and non-nosocomial infections caused by bacteria and fungi.16 In these methods, the DNA of the patho-gens is identified and compared to detect similar-ity and relationship between strains. These tech-niques include restriction fragments length poly-morphism (RFLP), random amplification of poly-morphic DNA (RAPD), multilocus sequence typ-ing (MLST),17 nucleic acid sequencing, and the microchip method.

As it was mentioned above, diagnostic molec-ular methods are widely applied in the identi-fication of viruses and monitoring viral infec-tions (HCV, HIV). They include branched DNA (bDNA) methods, reverse transcriptase polymer-ase chain reaction (RT PCR), and quantitative competitive polymerase chain reaction (QC PCR).

10  Forbes B A, Sahm D F, Weissfeld A S. Op. cit.; Heczko P B, Wójkowska-Mach J. Op. cit.11 Forbes B A, Sahm D F, Weissfeld A S. Op. cit.12 Forbes B A, Sahm D F, Weissfeld A S. Op. cit.13 Dzierżanowska D. Patogeny Zakażeń Szpitalnych. α-medica Press. 2007; Strauss J M, Strauss E G. Viruses and

Human Disease. 2nd ed. San Diego. Academic. 2007.14 Forbes B A, Sahm D F, Weissfeld A S. Op. cit.15 Dzierżanowska D. Op. cit.16 Dzierżanowska D. Op. cit.; Singh A et al. Application of Molecular Techniques to the Study of Hospital Infection. Clinical

Microbiology Reviews vol. 19, No. 3. 2006: 512-530.17 A locus is the specific location of a gene on a chromosome.

Page 6: HOSPITAL MICROBIOLOGICAL DIAGNOSTICS IN LIGHT OF NEW ...journal-healthmanagement.com/pliki/zasobydokumentu... · nts: neonatology, intensive care, hematology, and transplantology

84 2013 Nr XII/II

deterMInAtIon of sensItIvIty to AntIbIotIcs And cheMotherApeutIcs

In reference to conventional bacteriological and mycological tests, it should be remembered that fol-lowing the isolation and identification of the etio-logical factor of infection, the next stage of exami-nation involves determining its sensitivity to anti-biotics and chemotherapeutics. If a microorganism responsible for infection has been isolated and identified, the laboratory goes on to determining its antibiotic sensitivity. The performance of an anti-biogram requires full standardization according to the methods defined by the National Reference Center for Antimicrobial Sensitivity (KORLD).

Antimicrobial sensitivity is evaluated as the activity of chemotherapeutics against the isolated strains and expressed in terms of: 1) sensitive/resistant categories, 2) minimal inhibitory concentrations (MIC) and

their breakpoint values, 3) resistance mechanisms.

It is necessary to determine the drug sensi-tivity of a strain to implement targeted antibiotic therapy. Determination of resistance mechanisms reveals the resistance phenotype of a given path-ogen and forms the basis for monitoring the dis-semination of resistance among hospital strains.18 Resistance to antibiotics or chemotherapeutics may be a primary trait of the microorganisms, delineat-ing the limits of antibiotic action, or an acquired trait, turning an initially sensitive microorganism into a resistant one. Acquired resistance emerges as a result of genetic mutation or translocation of genes, which may be present on transposable elements, integrons, gene cassettes, and plasmids. Genes coding resistance to one or several antibiot-ics are transferred to daughter cells (clonal spread of resistance) or to other bacteria through conju-gation (epidemic spread of resistance). Through selection, induction, and depression, antibiotics considerably influence the emergence of resist-ance, especially in the hospital environment.19

Of particular concern is the increasing

resistance of methicillin resistant Staphylococcus aureus to vancomycin and of pneumococci to high concentrations of penicillin and other antibiotics, as well as the emergence of Gram-negative bacte-ria producing various enzymes such as extended spectrum lactamases (ESBL),20 AmpC,21 carbap-enemases, metallo-β-lactamase (MBL),22 and Klebsiella pneumoniae carbapenemase.23

Due to increased bacterial resistance, it is nec-essary to introduce new dosage schedules, com-bine medicines, revise breakpoint concentrations for antibiotics, and determine efficacy parameters for new antibacterial medicines.

The effect of an antibiotic in the patient’s organism depends on the kinetic reaction medi-cine – host (PK) and the kinetic reaction medi-cine – microorganism (PD). The antibacterial activity of a medicine is a function of time and concentration, and the effect of the medicine (e.g., a β-lactam antibiotic) depends on the time dur-ing which its serum concentration remains over the minimal inhibitory concentration (T > MIC). In turn, the effectiveness of aminoglycoside anti-biotics depends on antibiotic concentration and the post-antibiotic effect (CMAX/MIC). On the basis of the MIC determined in the laboratory, the physician chooses a dose and mode of admin-istration. As mentioned above, antibiotic therapy modifies strain sensitivity, especially in the hospi-tal, so it is necessary to conduct continuous sur-veillance of medicine use and update therapeutic schedules. Thus, microbiological examinations form the basis of the antibiotic policy of the hos-pital. Table 3 shows the great differences in the cost of treatment with appropriately selected anti-biotics depending on the level of sensitivity of the strain responsible for infection.

The most dangerous infections for hospital-ized patients are infection outbreaks, which are detected by the laboratories most frequently and most rapidly. In a hospital, an infection out-break is the occurrence of at least two infections linked to the same etiological factor. In the case of an outbreak, epidemiological surveillance must

Anna Przondo-Mordarska, Danuta Smutnicka

18 Heczko P B, Wójkowska-Mach J. Op. cit.; Szymczuk K. Oznaczanie mechanizmów oporności drobnoustrojów, Leczenie zakażeń szpitalnych (5) Suppl. 3. Dzierżanowski D. α-medica Press. 2007: 238-277.

19 Ziółkowski G, Ziółkowska B. Wpływ antybiotykoterapii na wielooporność patogenów bakteryjnych. Sepsis (2). 2009.

20 Plasmid β-lactamases, produced by Enterobacteriaceae, degrade most β-lactam antibiotics, but not carbapenems.21 β-Lactamases are coded by chromosomal ampC genes occurring in most Enterobacteriaceae.22 They are enzymes (β-lactamases) hydrolyzing β-lactam antibiotics, including carbapenems; they are insensitive

to β-lactamase inhibitors.23 They are enzymes (β-lactamases) hydrolyzing all carbapenems, that is, antibiotics of last resort.

Page 7: HOSPITAL MICROBIOLOGICAL DIAGNOSTICS IN LIGHT OF NEW ...journal-healthmanagement.com/pliki/zasobydokumentu... · nts: neonatology, intensive care, hematology, and transplantology

Journal of Health Policy, Insurance and Management – Polityka Zdrowotna 85

be introduced as soon as possible.24 It consists of exact identification of the genotypic and pheno-typic characteristics of the pathogen isolated from the outbreak, determination of its drug resistance (MIC) and the mechanism of resistance of the strain(s), as well as virulence factors (e.g., produc-tion of toxins). Other issues that should be ana-lyzed include:25 1) infection cases, 2) infection source and routes of transmission

(in the environment),3) risk factors,4) clinical parameters of the infected patients,

5) prevention methods.The occurrence of an outbreak in a hospital or its

unit often leads to modification of antibiotic therapy.Another important task of the laboratory

is monitoring alert pathogens, that is, microor-ganisms with very high pathogenicity (adhesion, invasiveness, toxicity) and high resistance to anti-biotics, which are able to survive in the envi-ronment and are easily transmittable, resistant to physicochemical factors, and resistant to dis-infectants (examples of such strains are given in Table 4).26

Hospital microbiological diagnostics in light of new legislation

Daily dose Cost of daily dose

Gram-negative bacteria

Amoxicillin/clavulanate 3 × 1.2 g iv 3 × 9 = PLN 27 Ampicillin/sulbactam 4 × 1.5 g iv 4 × 18 = PLN 72 Ceftazidime 3 × 1 g iv 3 × 22 = PLN 66 Ceftriaxone 1 × 2 g iv 1 × 30 = PLN 30

Gram-negative bacteria ESBL (+)

Piperacillin/tazobactam 3 × 4.5 g iv 3 × 68 = PLN 204 Imipenem 4 × 0.5 g iv 4 × 86 = PLN 344

Gram-negative bacteria KPC, NDM-1

Tigecycline 2 × 50 mg iv 2 × 300 = PLN 600

Table 3. Costs of therapy of infections with Gram-negative bacteria revealing different levels of antibiotic resistance

Source: own work

Pathogen Resistance characteristicsStaphylococcus aureus MRSA, VISA, VRSAStreptococcus pneumoniae PRP (resistance to penicillins/cephalosporins IIIg)Streptococcus pyogenes MLSB resistance to macrolidesEnterococcus VRE, HLARGram-negative bacteria ESBL, AmpC, MBL, KPC

Pseudomonas aeruginosa Resistance to carbapenems or two other groups of medicines

Acinetobacter baumanii MBL-positiveMycobacterium tuberculosis MDR, XDR

Table 4. Alert pathogens

Source: own work

24 Fleischer M. Postępowanie w przypadku wystąpienia szpitalnych ognisk epidemicznych, materiały szkoleniowe dla pielęgniarek epidemiologicznych. 2006.

25 Tacconelli E, Screening and isolation for infection control, Journal of Hospital Infection. 2009: 371-377.26 Dzierżanowska D. Op. cit.

Page 8: HOSPITAL MICROBIOLOGICAL DIAGNOSTICS IN LIGHT OF NEW ...journal-healthmanagement.com/pliki/zasobydokumentu... · nts: neonatology, intensive care, hematology, and transplantology

86 2013 Nr XII/II

The amount of information obtained from the microbiological laboratory and its use depends on the quality of diagnostic examinations, appro-priate organization of the laboratory, as well as cooperation between the microbiologist and the Committee for the Control of Nosocomial Infections and the clinicians. Figure 2 shows a pattern of collaboration between hospital units and the microbiological laboratory.

Proper organization of microbiological diagnostics

Hospital units Microbiological lab units

Central database

Microscopic examination, manual and automated cultures, identification (automatic, quick tests), determination of drug sensitivity

Results sent to hospital units

A

C

B Well-organized, quick transport

1 32

Nosocomial infection unit

Computer recording of results

references

1. Bulanda M. Zakażenia szpitalne na oddziałach zabiegowych, Krakowska Oficyna Naukowa. 2008.

2. Dzierżanowska D. Patogeny Zakażeń Szpitalnych. α-medica Press. 2007.

3. Fleischer M. Postępowanie w przypadku wystąpienia szpitalnych ognisk epidemicznych, materiały szkoleniowe dla pielęgniarek epidemio-logicznych. 2006.

4. Forbes B A, Sahm D F, Weissfeld A S. Diagnostic microbiology. Mosby. 1998.

5. Heczko P B, Wójkowska-Mach J. Zakażenia szpi-talne. PZWL. 2009.

6. Przondo-Mordarska A, Zagadnienia ogólne I. [in:] Zakażenia szpitalne etiologia i przebieg, Continuo. Wrocław 1999: 9-15.

7. Singh A et al. Application of Molecular Techniques to the Study of Hospital Infection, Clinical Microbiology Reviews vol. 19 No. 3. 2006: 512-530.

Figure 2. Proper organization of microbiological diagnostics

Source: own work

Anna Przondo-Mordarska, Danuta Smutnicka

8. Strauss J M, Strauss E G. Viruses and Human Disease. 2nd ed. San Diego. Academic. 2007.

9. Szymczuk K. Oznaczanie mechanizmów oporności drobnoustrojów, Leczenie zakażeń szpitalnych (5) suppl. 3. Dzierżanowski D. α-medica Press. 2007: 238-277.

10. Tacconelli E, Screening and isolation for infec-tion control, Journal of Hospital Infection. 2009: 371-377.

11. Wenzel R P. Heath Care-Associated Infections: Major Issues in the Early Years of the 21st Century, Clin. Infect. Diseases (45). 2007: 85-8.

12. Ziółkowski G, Ziółkowska B. Wpływ antybio-tykoterapii na wielooporność patogenów bak-teryjnych. Sepsis (2). 2009.

A microbiological laboratory is obligated to periodically file reports with the Sanitary and Epidemiological Station concerning the occur-rence of alert pathogens at the hospital. The list of strains that must be reported is specified in the Regulation on Recording Health-Care Associated Infections and Reports on the Occurrence of Such Infections of March 11, 2005.27

27 Rozporządzeniu z 11 marca 2005 r. w Sprawie Rejestrów Zakażeń Zakładowych oraz Raportów o Występowaniu Tych Zakażeń (Dz.U. Nr 21 poz. 94).