comparison and reconciliation of tuberculosis data elements · parenchyma, brain (tuberculoma),...

DE Comparison Rating: 1

Data Element Data Definition Permissible Values from ATS Permissible Values from HL7 TB DAM HL7 Comparable DE NumberATS Page Location Noted Differences

High prevalence Countries, facilities, populations, or groups of people with certain behaviors where TB is seen more frequently

Disadvantaged populations (e.g., homeless, malnourished, overcrowded). Increased TB also due to spread of HIV and immigration from areas of high TB incidence. Table 7 lists: Persons born in countries with high prevalence & groups with poor access to health care. Those that live in or frequent nursing homes, correctional institutions, drug treatment centers, homeless shelters, injection drug users.

Immigrant from high-TB-prevalence country; refugee from high-TB-prevalence country; incarceration; lived in a refugee camp; contact of an active TB case; injection drug use; non-injection drug use; alcohol abuse within last 3 past years; current or recent employee or volunteer in a nursing home; current or recent employee or volunteer in a homeless shelter; current or recent employee or volunteer in a jail or prison; homeless within past year; resident of long-term care facility; migratory agricultural worker; unemployed for past 24 months (non-retired non-student); history of cigarette smoking (current or past smoker); previous TB diagnosis; country of birth is a high-burden country; travel to high-burden country (>3 months); healthcare worker; other (specify); unknown; none

#11 -Titled “TB Social History” 377 and Table 7 on page 1389

Listed attributes in common: countries with high prevalence, correctional institutions, injection drug user, immigrants from high prevalence countries

Mycobacteria species/complex

The group of Mycobacteria organisms that can cause TB M. tuberculosis, M. bovis, M. africanum, M. microti, and M. canetti M. tuberculosis; M.bovis; M. africanum; M. canettii; M. microti; M. bovis BCG; M.bovis; M. avium complex; M. kansasii; other non-tuberculosis Mycobacterium; other

#60 -Titled “Mycobacterium Species” Page 1377 DAM has these additional organisms listed: M. bovis BCG ; M. avium complex; M. kansasii; other non-tuberculosis Mycobacterium; Other

Culture Cultivation of Mycobacteria in culture media provides a more sensitive analysis than microscopy, organism growth for species identification, drug susceptibility testing, and genotyping.

Positive for Mycobacteria, negative for Mycobacteria, indeterminate. #49: Yes, no, unknown #49 -Titled “Culture Test Done” Page 1384-1385 Many HL7 DAM elements devoted to various aspects of TB culture.

Culture quantitation on agar plates (number of colonies)

Centers for Disease Control & Prevention (USA) grading system for mycobacterial growth on solid media agar plates.

No colonies seen: report as negative; fewer than 50 colonies: report actual number seen; 50-100 colonies: report as 1+, 100-200 colonies report as 2+; 200-500 (almost confluence): report as 3+; >500 (confluence): report as 4+.

#57: Negative (no colonies of M. tuberculosis complex seen); #1-49 of actual number of colonies seen if <50 colonies; 1+ (50-100 colonies); 2+ (>100-200 colonies); 3+ (>200-500 colonies); 4+ (>500 colonies); no M. tuberculosis complex growth but positive for growth of other non-tuberculous Mycobacteria; contaminated, but also with evidence of M. tuberculosis complex; contaminated; not done; unknown

#57 -Titled “Solid Media Result: CDC Quantitation Method.”

1385- Table 3 Virtually identical. HL7 DAM does not use the word confluence.

Reporting of culture quantitation on agar plates (quantity reported)

Inoculation on culture media as per Centers for Disease Control & Prevention (USA) reporting classification system for mycobacterial growth on solid media agar plates.

Negative, report of actual number seen, 1+, 2+, 3+, 4+. #57: See above #57 -Titled “Solid Media Result: CDC Quantitation Method.”

Page 1385-Table 3 Semantically equivalent. HL7 DAM separates elements into quantitation and reporting.

Nucleic acid amplification (NAA)

Direct test of a clinical specimen (prior to culture) using an amplification technique to detect specific DNA or RNA fragments unique to M. tuberculosis complex. Used for initial diagnosis only.

Positive for Mycobacteria, negative for Mycobacteria, indeterminate Yes, no, unknown #47 -Titled “Direct Nucleic Amplification Completed” and #48 -Titled “Direct Nucleic Acid Amplification Interpretation”

Page 1384 HL7 DAM divides this element into two categories: test completed and test interpretation.

Chest radiograph finding normal/abnormal (ATS) in defining classification #3

Radiographic evidence of current tuberculosis defining the rating of a Class 3 person.

Stable, worsening, improving; normal, abnormal, cavitary presence. #77: normal; abnormal, consistent with tuberculosis; abnormal, not consistent with tuberculosis; inactive tuberculosis; low suspicion of active tuberculosis; unknown; not done; unable to determine

#77 - Titled “CXR Image Interpretation” Page 1391

Comparison and Reconciliation of Tuberculosis Data ElementsMary L. Parker, RN, BSN1, Anita Walden, BA2, Meredith Nahm, PhD2,1Duke University School of Nursing, Durham, NC, 2Duke Center for Health Informatics Institute, Durham, NC

Abstract

A unified set of standards must be available for use in Tuberculosis (TB) diagnosis, treatment and reporting to help achieve a global continu-ity of TB detection and care. Document analysis principles1 applied to the diagnostic standards2 for TB (1999) published by the American Tho-racic Society (ATS), found 43 data elements ab-sent from the HL7 adult pulmonary TB Domain Analysis Model (TB DAM). Additionally, 23 rep-resentational differences were identified for se-mantically equivalent data elements.

Introduction

Tuberculosis, one of the oldest recorded dis-eases, continues to kill almost 2 million people annually with 8.8 million new cases reported each year. It is estimated that 1/3 of the world’s population is infected by this pathogen.3 A key goal for medical and other scientific disciplines involved in the diagnosis, treatment and con-trol of TB is the integration, dissemination and application of emerging diagnostic and treat-ment data. One of the most critical needs is the development of interoperable data standards in TB healthcare data with the ability for health care organizations, caregivers and researchers to exchange this data and their observations nationally and internationally.

Process Methodology

Document analysis principles were applied to the ATS guidelines to identify data elements used in the diagnosis and classification of adult pulmonary TB. Two independent raters read the guidelines and documented each mention of a possible data element. Differences were adju-dicated in a consolidated list of data elements by both raters. Afterwards the consolidated list was compared to the existing version of the TB DAM Each data element was classified as (1) ex-actly represented in the TB DAM, (2) partially represented in the TB DAM, or (3) not repre-sented in the TB DAM.

DCRI COMMUNICATIONS • OCTOBER 2011

Results

The analysis revealed 43 data elements within the ATS guidelines which were not listed in the HL7 TB DAM. Additionally, 23 representational differences were found to have semantically equivalent data elements.

Conclusion

This process has identified gaps that exist be-tween the clinical guidelines and the current version of the HL7 TB DAM. Document nalysis has successfully been applied to identify infor-mation gaps between the guidelines and the standards. Additionally, the document analysis methodology used in this process can be refined and may serve as a framework for developing other domain models.

References

1. Campbell, D (1998). “Discourse analysis and document analysis: SGML, scholarly publishing and structuralist theory” Empty String Informa-tion Science at the Dawn of the Next Millenni-um, (p. 193). Calgary: Canadian Assoc Informa-tion Science.

2. Diagnostic Standards and Classification of Tuberculosis in Adults and Children . This Offi-cial Statement of the American Thoracic Society and the Centers for Disease Control and Preven-tion was Adopted by the ATS Board of Direc-tors, July 1999. This Statement was endorsed by the Council of the Infectious Disease Society of America, September 1999. Am J Respir Crit Care Med. 2000 April 1, 2000;161(4):1376-95.

3. Smith, I., Nathan, C., & Peavy, H. (2005). Prog-ress and new directions in genetics of tuberculo-sis: an NHLBI Working Group Report. American Journal of Respiratory & Critical Care Medicine, 172(12), 1491-1496. Retrieved from EBSCOhost.

Key:(1) exactly represented in the TB DAM,(2) partially represented in the TB DAM,(3) not represented in the TB DAM.

Results:1s - 7; 2s - 23; 3s - 43



High risk Patients with certain conditions or within categories that increase their chance of contracting TB

Children <4, HIV coinfection, close contacts of TB-infected persons, persons whose tuberculin skin test converted to positive within past 1-2 years, persons with chest radiographs suggestive of old TB, persons with certain medical conditions (see Coexisting Conditions)

Leukemia; lymphoma; cancer of the head or neck; diabetes mellitus; immunosuppressive therapy organ transplant recipient; chronic renal failure; underlying pulmonary disease; HIV/AIDS; gastric resection; jejunoileal bypass; weight loss more than or equal to 10% of ideal body weight; other medical condition (specify); HIV; hepatitis; seizure disorders; immunosuppressant drugs; heart disease; NA; unknown; none

#12 -Titled “Medical History Predisposing to TB”

Page 1389- Table 7 1 attribute in common: HIV coinfection

Anatomic location of TB infection (SNOMED Anatomy)

The anatomic site which is affected by tuberculosis. Bone involvement more common in children than adults.

Lungs, upper lung zones, lymphatics, hilar lymph nodes, bronchial tree, respiratory bronchiole, alveolus, bone marrow, liver, spleen, kidneys, brain (tuberculoma), pleural, empyema, lung parenchyma, genital, bones, joint, skeletal, meningeal, mouth, peritoneum, terminal ileum, cecum, rectal, pericardium

Lung parenchyma; skin, other subcutaneous and dermal; muscle, tendon, ligament; disseminated (bone marrow, blood, miliary); spleen; superficial lymph node (cervical, occipital, supraclavicular, axillary, inguinal, or other superficial); lymph node, intrathoracic; GI tract; throat, upper airway (nose, sinus, nasopharynx, epiglottis); larynx; pleural tissue or fluid; pericardial tissue or fluid; mouth, lip, tongue, dental structures, salivary gland; liver; stomach, small intestine, appendix, colon, rectum, anus; gastrointestinal contents (feces); omentum, peritoneum, peritoneal fluid; renal tissue; urine; male reproductive tract; female reproductive tract; meningeal (cerebrospinal fluid, meningeal tissue, dural sinus, choroid plexus); brain (tuberculoma); spinal cord, cranial, spinal and peripheral nerve; ocular (eye); pus; other site (specify);

#2 -Titled “Site of Tuberculosis” Page 1377, Page 1380, Page 1381

ATS doc adds (HL7 lacks) 11: bones; hilar lymph node; upper lungs; bronchial tree; respiratory bronchiole or alveolus, empyema, joint, skeletal, terminal ileum, cecum. Shared Terms (14): lymph nodes; bone marrow; liver; kidneys (renal tissue in DAM); spleen, pleural, lung parenchyma, brain (Tuberculoma), genital (male/female reproductive tract in HL7), meningeal, (meningeal tissue, dural sinus, choroid plexus in HL7), mouth, peritoneum, pericardium (HL7 lists pericardial tissue and fluid), rectal (HL7 lists rectum, anus.)

Derived location of disease (ATS guidelines)

Clinically active cases of TB have M. tuberculosis in one of these systems. ATS grades these as Class 3, defined by clinically active TB in these listed locations.

Pulmonary, pleural, lymphatic, bone and/or joint, genitourinary, disseminated (miliary), meningeal, peritoneal, other #2, Site of Tuberculosis, see above. #2 -Titled “Site of Tuberculosis” Page 1391 A generic location listing for TB. HL7 only lists “superficial and intrathoracic lymph nodes,” Abdominal (HL7 has most abdominal organs listed).

Radiologic finding- Abnormalities which may be seen on the chest x-rays of patients with pulmonary TB

Granuloma, middle lung zone infiltrate, lower lung zone infiltrate…ipsilateral hilar adenopathy…atelectasis… enlarged lymph nodes….cavitation…cavitation in apical- posterior segment of left upper lobe….pleural scarring…loss of lung parenchymal volume… calcification, intrathoracic adenopathy…. intrathoracic lymphatic involvement, extrathoracic lymphatic involvement… patchy bronchopneumonia…miliary....dense pulmonary nodules with calcifications in hilar area or upper lobes, dense pulmonary nodules without calcifications in hilar area or upper lobes….smaller nodules with or without fibrotic scars in upper lobes with or without upper-lobe volume loss…. Nodules and fibrotic lesions of old, healed tuberculosis present with sharp margins, described as ‘hard’…..bronchiectasis of the upper lobes….calcified nodular lesions, calcified granulomas, apical pleural thickening.

#71: right lung, left lung; bilateral; right upper lobe, left upper lobe, middle right lobe, lingula, lower right lobe, lower left lobe #72: cavity; fibrosis; infiltrates; mass; calcified; nodules not calcified; volume loss; or volume collapse; unable to determine; miliary tuberculosis #73: apical cap; effusion; costophrenic (CP) angle obliteration; pleural thickening; unable to determine, #74: tracheal deviation; lymphadenopathy hilar; lymphadenopathy mediastinal; calcified lymph nodes; cardiomegaly; pericardial enlargement; NA #75: yes; no; unable to determine; #80: same as #71; #81: cavity; fibrosis; infiltrates; nodules; granulomas calcified; granulomas not calcified; volume loss or collapse; unable to determine

#71 -Titled “Region of Lung Affected & Indicated by CXR Image,” #72 -Titled “CXR Image Parenchymal Result,” #73 -Titled “CXR Image Pleural Abnormalities,” #74 - CXR Image Central Structure Pleural Abnormalities,” #75 -Titled “CXR Presence of Fibrotic Lesion,” #80 -Titled “Region of Lung Affected Indicated by CT Image,” #81 - Titled “CT Scan Image Parenchymal Result”

Page 1378-1379 Many new values for this DE which is split among many DEs in the TB DAM.

Co-existing conditions

Other medical conditions which may also be seen in conjunction with TB

Silicosis, diabetes mellitus, and diseases associated with immunosuppression, HIV infection, alcoholism, chronic renal failure, diabetes mellitus, neoplastic diseases, drug abuse leukemia, Hodgkin's disease, head and neck cancers, severe kidney disease, certain intestinal conditions, malnutrition

#13: Silicosis; chronic obstructive pulmonary disease (COPD); lung cancer; emphysema; other (specify) #13 - Titled “Underlying Pulmonary Disease”

Page 1378 & Page 1389

Missing from HL7 DAM: 13. Common Value: 1 (silicosis).

TB signs and symptoms (non-radiographic)

Physical signs and symptoms associated with TB Fever, loss of appetite, weight loss, weakness, night sweats, and malaise….increases in the peripheral blood leukocyte count and anemia…increase in white blood cell count (leukemoid reactions) ….leukopenia.…increase in the peripheral blood monocyte and eosinophil counts…. Anemia….pancytopenia… hyponatremia, cough (productive or non), hemoptysis, pleuritic pain, dyspnea, rales, bronchial breath sounds, atelectasis from enlarged lymph nodes (seen primarily in children).

#3: productive cough; sputum with blood; fever; night sweats; loss of appetite; weight loss without dieting; inability to gain weight; fatigue; cervical adenopathy; fibrosis on CXR; shortness of breath; weakness; malaise; chest pain; hemoptysis (coughing up blood); confusion; headache; other (specify)

#3 -Titled “Tuberculosis Symptoms” Page 1378 & Page 79

Missing from HL7 DAM: 15. leukocyte increase, anemia, WBC increase, leukopenia, monocyte increase, eosinophil increase, anemia, pancytopenia, hyponatremia, non-productive cough, pleuritic pain, dyspnea, rales, bronchial breath sounds, atelectasis. HL7 should clarify if the attribute listed as chest pain as cardiac or pleuritic in nature. Common Values: 8

Duration of fever Once therapy has started, length of time that a person has an above-normal temperature

Median duration after beginning treatment - 10 days; range 1-109 days after beginning treatment. #5: Unknown; numeric value #5 -Titled “Duration of Fever” Page 1378 Missing from HL7 DAM: duration of fever after treatment started --HL7 only notes duration of fever without qualifier. Extended duration of fever after therapy initiation may be a sign of a drug resistant TB strain.

Drug susceptibility Sensitivity of M. tuberculosis bacteria to various antibiotics that may be used to treat TB. Direct method used when there is a high prevalence of drug resistance.

Direct method (source is smear positive specimen); Indirect method (growth from a primary culture or subculture). #66: Information on whether or not mycobacterial growth was inhibited by a specific drug at a given concentration. #67: The anti-mycobacterial agents used in standard chemotherapy regimens for the treatment of drug-susceptible TB; Group of anti-TB medications, recommended by WHO and others, that are used to treat subjects with active disease when there is a reason to believe the M. tuberculosis is resistant to, or can grow and multiply in the presence of, two or more of the first-line drugs.

#66 -Titled “Drug Susceptibility Results,” #67 -Titled “Tuberculosis Drugs to Test for Susceptibility”

Page 1385 HL7 DAM omits mention of direct versus indirect methods of susceptibility

Specimen type Sample from suspected source or location of TB infection Sputum, induced sputum, gastric aspirates, bronchial washings, bronchoalveolar lavage, transbronchial biopsy, urine, blood, CSF, tissue, other bodily fluids.

Expectorated sputum; induced sputum; gastric lavage; bronchoalveolar lavage (BAL); lung biopsy/aspirate; other biopsy/aspirate/swab; Specific Anatomic Code

#38 -Titled “Smear Specimen Source” Page 1382 5 Elements not in DAM: transbronchial biopsy (DAM has lung biopsy/aspirate) urine, blood, CSF, tissue. Common Elements: 5.

AFB smear for presence of mycobacteria

Stained specimen smears examined microscopically will generally provide the 1st bacteriologic evidence of the presence of mycobacteria.

10-100 organisms for positive culture #40: Acid-fast stain and light microscopy; fluorescent stain and fluorescent microscopy #41: 1+ (rare); 2+ (few); 3+ (many); 4+ (TNTC); not done

#40 -Titled “Smear Stain Test Method,” #41 -Titled “Smear Quantitation”

Page 1383 ATS document adds number of organisms needed for a positive culture rating.

AFB smear quantitation (carbolfuchsin)

Quantitation guidelines for categorizing the results of a carbolfuchsin AFB stain.

No AFB/300 fields reported as: no AFB seen; 1-2 AFB/300 fields reported as: doubtful, repeat test; 1-9 AFB/100 fields reported as: rare (1+); 1-9 AFB/10 fields reported as Few (2+); 1-9 AFB/field reported as Moderate (3+); greater than 9 per field reported as Numerous (4+).

#40-41: See Row 17, #42: No AFB (no AFB/300 fields); doubtful, repeat test (1-2 AFB/300 fields); rare (1+) (1-9 AFB/100 fields); few (2+) (1-9 AFB/10 fields); moderate (3+) (1-9 AFB/field); numerous (4+) (>9 AFB/field); not done; unknown, #44: Negative (Zero AFB/100 HPF); scanty (1-9 AFB/100 HPF); 1+ (10-99 AFB/100 HPF); 2+ (1-10 AFB/1 HPF); 3+ (> 10 AFB/1 HPF); not done; unknown.

#40 -See above, #41 -See above, #42 -Titled “Smear Quantitation CDC Control Method for Carbolfuchsin Staining,” #44 - Titled “Smear Quantitation WHO/Union Method for Carbolfuchsin Staining”

Page 1383 ATS document provides only the CDC stated quantitation guidelines.

AFB smear quantitation (fluorochrome)

Quantitation guidelines for categorizing the results of a fluorochrome AFB stain.

No AFB/30 fields reported as: no AFB seen; 1-2 AFB/30 fields reported as: doubtful, repeat test; 1-9 AFB/10 fields reported as: rare (1+); 1-9 AFB/field reported as: few (2+); 10-90 AFB/field reported as moderate (3+); greater than 90 per field reported as numerous (4+).

#43: No AFB (no AFB/30 fields); doubtful, repeat test (1-2 AFB/30 fields); rare (1+) (1-9 AFB/10 fields); few (2+) (1-9 AFB/field); moderate (3+) (10-90 AFB/field); numerous (4+) (>90 AFB/field); not done; unknown

#40 -See above, #41 -See above, #43 -Titled “Smear Quantitation: CDC Method for Fluorochrome Staining.”

Page 1383 HL7 DAM -DE 40 includes florescent stain and florescent microscopy

AFB smear quantitation (abstract)

The process of counting the number of acid-fast bacilli present in an AFB smear to determine the likelihood or presence of a TB infection.

No AFB seen; doubtful, repeat test; rare (1+); few (2+), moderate (3+); numerous (4+). #40-44: See above. #45: negative (zero AFB/300 HPF); scanty (1-29 AFB/300 HPF); 1+ (30-299 AFB/300 HPF); 2+ (10-100 AFB/1 HPF); 3+ (> 100 AFB/1 HPF); not done; unknown.

40,41, 42, 43, 44, 45 Page 1383 HL7 DAM does not contain the report value: “numerous 4+ for element #45.”

Susceptibility testing methods

Testing of initial mycobacterium isolate, either a smear-positive specimen (direct method) or growth from a primary culture or subculture (indirect method), to determine the resistance to various anti-tuberculosis drugs.

Agar proportion, liquid radiometric, absolute concentration, resistance ratio method. #62: Solid media; liquid media #62 - Titled “Susceptibility Testing Method”

Page 1385 The absolute concentration and resistance ratio method are not employed in the U.S., but are listed in the ATS document

Drug resistance Susceptibility to TB drug therapy as evidenced by the percentage of isolate growth when exposed to drug.

No drug resistance; resistance at lower drug levels; multiple drug resistance (MDR). #66: Resistant; susceptible; partially resistant; not done; unknown #138: No MDR tuberculosis: confirmed MDR tuberculosis; suspected MDR tuberculosis; no XDR; confirmed XDR; suspected XDR; unknown

66 -Titled “Drug Susceptibility Results”, #138 - Titled “Multi Drug Resistant Tuberculosis Status”

Page 1386-87 ATS document does not include extreme drug resistance (XDR).

MDR Mycobacterium isolate testing shows resistance to multiple TB drugs.

1% or more of the tested M. tuberculosis colonies show resistance to more than one TB drug. #138: No MDR tuberculosis: confirmed MDR tuberculosis; suspected MDR tuberculosis; no XDR; confirmed XDR; suspected XDR; unknown

#138 - Titled “Multi Drug Resistant Tuberculosis Status”

Pages 1381, 1387 Different from the ATS document, HL7 DAM lists: no XDR; confirmed XDR; suspected XDR; unknown

Genotyping the Mycobacteria species

A replacement for phage typing for determining the clonality of bacterial cultures. It is also useful in determining laboratory cross contamination, investigating outbreaks of TB.

Southern Blotting Method #91: Spoligotype; MIRU; RFLP #91 -Titled “Genotype” Page 1387 HL7 DAM attributes are: spoligotype; MIRU; RFLP. Southern blotting method is not included.

PPD-Mantoux- purified protein derivative (PPD)

Antigen skin test used to detect a cellular immune response to diagnose TB infection or disease. The Mantoux is also known as a PPD (purified protein derivative), and involves receiving a small bolus of serum under the skin of the forearm using a small needle and syringe.

Aplisol-isolated by the ammonium sulfate(AS) precipitation method; Tubersol-isolated by the trichloroacetic acid (TCA) precipitation method.

#23: Mantoux; Tine; Heaf; not done; unknown #24: 1TU; 5TU;10TU,250TU #23 -Type of Tuberculin Skin Test, #24 -Mantoux Strength

Page 1387 ATS document defines the 2 manufactured versions of the PPD test serum.

PPD-multiple puncture

Antigen skin test used to detect a cellular immune response to diagnose TB infection or disease. The Tine and Heaf tests are multi-prong skins tests containing M. tuberculosis antigen.

Less reliable. Only considered positive is vesiculation is seen. #23: Mantoux; Tine; Heaf; not done; unknown #27: yes; no; not documented #23 -Type of Tuberculin Skin Test, #27 -Titled “Blistering Status”

Page 1388

Presence of induration

The reaction to intracutaneously injected tuberculin exhibits a delayed (cellular) hypersensitivity reaction producing induration through local vasodilatation, edema, fibrin deposition, and recruitment of other inflammatory cells to the area.

Presence, absence, positive (mm induration), negative (0 mm induration). #25: mm of induration; unknown. #26: positive; negative; unknown; unable to determine #25 -Titled “Tuberculin Skin Test (TST) Result” #26 -Titled “Interpretation of Tuberculin Skin Test (TST)”

Page 1388 “Unknown, Unable to determine” are attributes only listed in the HL7 DAM

Size of reaction Transverse diameter of induration which indicates a positive (false or true) or a negative (false or true) reaction to the tuberculin antigen.

0-* mm #25: mm of induration; unknown. #26: positive; negative; unknown; unable to determine. #27: yes; no; not documented.

#25 -Titled “Tuberculin Skin Test (TST) Result” #26 -Titled “Interpretation of Tuberculin Skin Test (TST)” #27 -Titled “Blistering Status”

Page 1388 HL7 DAM has a DE for the “presence” of a blister, but no DE for size. Size in mm is very important and a result that is negative should always be recorded as “0 mm.” DE #25 does contain “mm of induration, unknown,” but the “0-* attribute is not listed..

Tuberculin antigen type

Culture filtrates called “tuberculins” are administered to a patient. Those patients who have a M. tuberculosis infection and a functioning immune system exhibit a delayed hypersensitivity reaction to the tuberculin.

PPD: Parke-Davis Pharmaceuticals (Aplisol) and Pasteur Merieux-Connaught Laboratories (Tubersol), Mantoux, Multiple Puncture Test ( Tine and Heaf not mentioned).

#23: Mantoux; Tine; Heaf; not done; unknown #23 -Type of Tuberculin Skin Test Page 1387 HL7 DAM does not have the manufacturer names included in the “type” element.

Dose of tuberculin “The dosage of antigen that produces a delayed-type hypersensitivity reaction to certain antigenic components of the organism that are contained in extracts of culture filtrates called “tuberculins.””

5-TU PPD, 0.1 ml, intradermally. #24: 1TU; 5TU;10TU,250TU 24 Page 1387-1388 “ATS document recommends the 5 TU and states that the 1 and 250 TU are remnants of the old graduated system of administration (125) and represent the smallest and largest doses of tuberculin that were administered. These strengths of tuberculin are not commonly available and, even if available, are not standardized by bioassay. The clinical utility of these concentrations of tuberculin is minimal.”



Radiologic findings in HIV+ patients

Noted radiologic findings seen in the adult pulmonary TB, HIV-positive patient, which can vary according to extent of immunocompromise produced by the HIV infection. TB occurring early in course of HIV infection may not exhibit radiographically. Although listed, cavitation is uncommon.

[Early in course of HIV infection]: normal CXR. [Advanced HIV disease]: atypical findings, lower lung zone infiltrate or diffuse infiltrates, intrathoracic adenopathy; cavitation.

New element Page 1379

Predisposing medication

Medications that can increase susceptibility to TB. In these permissible values the drugs lower the host's immune defenses to disease.

Corticosteroids; other immunosuppressive drugs New element Page 1389, Page 1390 -Table 8

Article gives definition of immunosuppressed patients as those receiving >15 mg/d Prednisone for > 1 mo.

High-risk age Less than 4 years of age New element Page 1377, Page 1378 & Page 1390 Table 8

Not covered in HL7 DEs.

Prior latent untreated TB infection

A person may be infected with Mycobacterium tuberculosis, but the disease may not be active.

Yes, no, undetermined New element 1378 The HL7 DEs 120-124 cover different aspects of LTBI, but lacks a DE that defines LTBI.

Enhanced NAA Approved by the FDA and has a sensitivity of 75%-88% and a specificity of 100%, and as with the NAA, may enhance certainty where prompt treatment is necessary.

Positive for Mycobacteria, negative for Mycobacteria, indeterminate New element Page 1384 HL7 DAM does not contain an element for the enhanced NAA test.

High-performance liquid chromatography (HPLC)

Biochemical method to distinguish Mycobacterium species based on observation that each Mycobacterium synthesizes a unique set of mycolic acids and is able to distinguish >50 MTB species.

Positive, negative, undetermined complex, undetermined due to impure culture sample New element Page 1385 HL7 DAM does not contain an element for the high performance liquid chromatography test.

Nucleic acid hybridization

Biochemical method to distinguish Mycobacterium species using molecular probes that can hybridize specifically with the MTB complex organisms. Limited availability, completed within hours, with sensitivities and specificities approaching 100%.

Positive, negative, undetermined complex. New element Page 1385 HL7 DAM does not contain an element for the nucleic acid hybridization test.

Susceptibility to isoniazid-

Testing of initial mycobacterium isolate to the drug isoniazid Positive or less than 1% living mycobacterium seen in drug's presence. Negative or greater than 1% living mycobacterium seen in drug's presence.

New element Page 1386 Table 4 HL7 DAM has a very general DE for drug susceptibility, but this much more granular DE is beneficial because it gives the attributes of Yes/No to a specific drug tested.

Susceptibility to rifampin

Testing of initial mycobacterium isolate to the drug rifampin Positive or less than 1% living mycobacterium seen in drug's presence. Negative or greater than 1% living mycobacterium seen in drug's presence.

New element Page 1386 Table 4 See above.

Susceptibility to ethambutol

Testing of initial mycobacterium isolate to the drug ethambutol Positive or less than 1% living mycobacterium seen in drug's presence. Negative or greater than 1% living mycobacterium seen in drug's presence.


Susceptibility to pyrazinamide

Testing of initial mycobacterium isolate to the drug pyrazinamide Positive or less than 1% living mycobacterium seen in drug's presence. Negative or greater than 1% living mycobacterium seen in drug's presence. P. 1386 If the isolate tests resistant to pyrazinamide, especially if it tests resistant to pyrazinamide alone, the identity of the isolate must be confirmed since M. bovis and M. bovis BCG are pyrazinamide-resistant.


Susceptibility to streptomycin

Testing of initial mycobacterium isolate to the drug streptomycin Positive or less than 1% living mycobacterium seen in drug's presence. Negative or greater than 1% living mycobacterium seen in drug's presence. P. 1386.


Drug susceptibility reporting-

Information needed concerning drug susceptibility test results. Method used; name of the drug; concentration tested; result (susceptible or resistant for the BACTEC method, susceptible or percent resistant for the agar proportion method).

New element Page 1386 Not included in the HL7 DAM elements

Genotyping rationale

Genotyping or DNA fingerprinting of M. tuberculosis is a method for determining the clonality of bacterial cultures.

Laboratory cross-contamination, investigating outbreaks of TB, evaluating contact investigations, determining whether new episodes are due to reinfection or reactivation, elucidating sites and patterns of transmission within communities.

New element Page 1387 Not included in the HL7 DAM elements

Phage typing Older testing method for determining the clonality of bacterial cultures that uses bacteriophages that infect a particular bacteria to identify different strains of bacteria within a single species.

Results are strain-specific and phage typing has been replaced as a method for determining clonality, although it still may be in use internationally if genotyping is not available.

New element The importance of this element for possible inclusion in the HL7 DAM may need to be considered from an international usage need.

Appearance of administered PPD-Mantoux skin test

The appearance of a properly administered PPD skin test. Discrete, pale elevation of the skin (wheal), 6-10 mm in diameter when properly administered. New element Page 1388 The HL7 DAM only includes an element for the appearance of the PPD test result.

TST recording Administrative recording details for complete and accurate recording of TST test and results.

(Mantoux or multiple puncture.) Kind and dose of tuberculin, size of reaction in millimeters of induration, date, time, placement location. New element Page 1388

TST reading technique

TST evaluation details which provide continuity in interpretation. Test read after 48 hours and before 72 hours; reading performed in good light; reading with forearm slightly flexed at elbow; observation by side view against light; palpation; result diameter measured traversely to the long axis of the forearm; measured in millimeters.


Delayed hypersensitivy reaction

Delayed reaction longer than the 72 hour norm, usually seen in the elderly and those being tested for the first time.

TST reaction that peaks after 72 hours, not within the normal 48-72 hour maximal induration time. New element Page 1388

Immediate hypersensitivity reaction

Reaction that usually appears prior to 24 hours after the TST is administered. TST reaction that occurs within 24 hours after the TST is administered and usually lasting no longer that 24 hours. New element Page 1388

Causes for false negative TST results

Reasons other than lack of infection with M. tuberculosis that may prevent the immune system from reacting to a TST.

Poor nutrition, poor general health, overwhelming acute illness, HIV+ status, malignancy, immunosuppressive medications, corticosteroids, vaccinations with live-attenuated virus vaccines, infections, ineffective tuberculin, incorrect administration of TST, incorrect assessment, incorrect documentation, multiple puncture TST (less reliable).

New element Page 1388-1389

Infections causing false-negative TST results

Infections or medical conditions that can reduce or exhaust the body's T cells, which are necessary for the body to be able to mount a reaction to a foreign virus or bacteria.

Viral: measles, mumps, chicken pox, HIV; bacterial: typhoid fever, brucellosis, typhus, leprosy, pertussis, overwhelming TB, tuberculosis pleurisy; fungal: South American blastomycosis; metabolic derangements: chronic renal failure; low protein states: severe protein depletion, afibrinogenemia; diseases affecting lymphoid organs: Hodgkin disease, lymphoma, chronic leukemia, sarcoidosis; stress: surgery, burns, graft-versus-host reactions


Age factors causing false-negative TST results

Age groups that can experience reduced or exhausted T cells which are necessary for the body to be able to mount a reaction to a foreign virus or bacteria

Newborns, elderly patients with “waned” sensitivity New element Page 1389

Factors causing false-negative TST results related to tuberculin used

Storage factors that can contribute to a false-negative result. Improper storage (exposure to light and heat), improper dilutions, chemical denaturation, contamination, adsorption (partially controlled by adding Tween 80).


Factors causing false-negative TST results related to method of administration

Improper administration techniques that can contribute to a false-negative result. Injection of too little antigen, subcutaneous injection, delayed administration after drawing into syringe, injection too close to other skin tests. New element Page 1389

Factors causing false-negative TST results related to incorrect assessment

Reader deficiencies that can contribute to a false-negative result. Inexperienced reader, conscious or unconscious bias. New element Page 1389

Factors causing false positive TST results

Factors that can produce a positive TST reaction even though active or LTBI infection may not be present.

Vaccination with BCG, previous infection with other mycobacteria. New element Page 1389

Vaccination factors causing false-negative TST results

Reactions to recent immunizations can impair or exhaust T cells, which are necessary for the body to be able to mount a reaction to a foreign virus or bacteria.

Measles, mumps, rubella, oral polio, varicella, yellow fever, BCG, oral typhoid. New element Page 1388

Factors influencing the likelihood a positive TST represents a true infection

Factors that increase the likelihood an individual may have a active TB infection. Local TB prevalence, individuals in close contact with a TB-infected person, persons with abnormal chest radiographs, organ transplant patients, other immunosuppressed patients.


Positive predictive value of a TST- mm of induration when compared to normal and abnormal disease states that indicate a positive TST result

mm of induration when compared to normal and abnormal disease states that indicate a positive TST result.

Induration ≥ 5 mm; induration ≥ 10 mm; induration ≥ 15 mm. New element Page 1390

Factors indicating a positive TST result with an induration ≥ 5 mm

Immunocompromised states, recent exposed individuals and other conditions that may contribute to a positive TST result/induration of ≥ 5 mm.

HIV positive persons, recent contacts of TB case, fibrotic changes on chest radiograph consistent with old TB, patients with organ transplants, other immunosuppressed patients receiving > 15mg/d prednisone > 1 month



Factors that contribute to a positive TST result/induration of ≥ 10 mm.

Recent arrivals (<5 y) from high-prevalence countries; injection drug users, residents and employees of high-risk congregate settings (prisons, jails, nursing homes and other health care facilities, residential facilities for AIDS patients, homeless shelters); mycobacteriology laboratory personnel; persons with clinical conditions that make them high-risk (silicosis, diabetes mellitus, chronic renal failure, some hematologic disorders, e.g. leukemias and lymphomas, other specific malignancies, e.g. carcinoma of the head/neck and lung, weight loss of > 10% of ideal body weight, gastrectomy, jejunoileal bypass); children <4 y of age or infants, children, and adolescents exposed to adults in high-risk categories.



A reaction of 15 mm induration is considered positive. Persons with no risk factors for TB New element Page 1390

Classification of persons exposed to and/or infected with TB

A patient classification system outlined in the ATS document that is based on the broad host-parasite relationships as described by exposure history, infection, and disease. It is intended mainly as an operational framework for public health programs. The HIV status of an individual should be known, since HIV infection may change the approach to diagnosis and therapy for tuberculosis.

0, 1, 2, 3, 4, 5 New element Page 1391

Classification 0 See above. No history of TB exposure, not infected, and a negative reaction to TB skin test (if tested). New element Page 1391

Classification 1 See above. Positive history of TB exposure, negative reaction to TST. New element Page 1391

Classification 2 See above. Latent TB infection, no active disease, positive TST, negative bacteriologic studies (if done), and no clinical, bacteriological, or radiographic evidence of active tuberculosis.


Classification 3 See above. Tuberculosis, clinically active: clinical, bacteriologic and/or radiographic evidence of current tuberculosis, including those with relapse or previous history of active disease.


Classification 4 See above. Tuberculosis not clinically active: history of previous episode(s) of tuberculosis or abnormal stable radiographic findings in a person with a positive reaction, negative bacteriologic studies (if done) and no clinical and/or radiographic evidence of current disease. Persons in Class 4 may never have received chemotherapy, may be receiving treatment for latent infection, or may have completed a previously prescribed course of chemotherapy. Persons with potentially active, unknown disease, especially if treated in the past: treat as TB suspect until diagnostic evaluation permits classification in either 3 or 4.


Classification 5 See above. Tuberculosis suspect (diagnosis pending): persons should be so classified when a diagnosis of TB is being considered, whether or not treatment has been started, until diagnostic procedures have been completed. Persons should not remain in this class for more than 3 months. When procedures completed, the person should be placed in one of the preceding classes.


Bacteriologic status (ATS) in defining classification #3

Bacteriological evidence needed to define the rating of a Class 3 person.

Not done, negative microscopy (date), negative nucleic acid amplification (NAA) (date), negative culture (date), positive microscopy, positive nucleic acid amplification, positive culture (date), susceptibility results with method and concentration used (date).


Chest radiograph finding cavitary/non-cavitary (ATS) in defining Classification #3

Radiographic evidence of current tuberculosis defining the rating of a Class 3 person with cavitary findings.

Cavitary, non-cavitary. New element Page 1391

Tuberculin skin test reaction necessary under certain conditions to define Classification 3

Test that may be needed to determine if a person remains in Class 3.

Positive (mm induration), Negative (0mm induration). New element Page 1391

comparison and reconciliation of tuberculosis data elements · parenchyma, brain (tuberculoma),...

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