Clinical and Anatomic Pathology Test Volume by Specialty and Subspecialty Among High- Complexity CLIA-Certified Laboratories in 2011

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1 Clinical and Anatomic Pathology Test Volume by Specialty and Subspecialty Among High- Complexity CLIA-Certified Laboratories in 2011 Frank H. Wians, Jr., PhD, MT(ASCP), 1 Gary W. Gill, BA, CT(ASCP) 2 It can be difficult to find reports that summarize the volume of tests performed annually by all laboratories in the United States. Moreover, it is even more difficult to obtain stratification of this test volume by specialty and subspecialty of clinical or anatomic pathology. Recently, one of us (G.W.G.) requested public-domain statistics on laboratory test volume by specialty and subspecialty of laboratory medicine from the Centers for Medicare & Medicaid Services (CMS). The information provided by CMS included annual test volume data reported by all Clinical Laboratory Improvement Amendments (CLIA) certified high-complexity laboratories (n = 172,467) for calendar year (CY) The data summarized in this report were derived from the DOI: /LMPGOCRS216SVDZH Abbreviations CMS, Centers for Medicare & Medicaid Services; CLIA, Clinical Laboratory Improvement Amendments; HLA, human leukocyte antigen; MCH, mean cell hemoglobin; CPT, current procedural terminology; FNA, fine needle aspiration; IVD, in vitro diagnostic 1 LoneStar Pathology Laboratory and Scientific Writing Consultants, Inc, Helotes, TX, 2 Independent Cytological Consultant, Indianapolis, IN *To whom correspondence should be addressed. fwiansjr@yahoo.com ABSTRACT Test volume data (approximately [~] 6 billion tests during calendar year [CY] 2011) across all specialty and subspecialty areas of clinical and anatomic pathology can be useful in many different ways. For instance, in vitro diagnostics (IVD) companies could focus their limited resources on new innovations in the specialty/subspecialty areas of clinical or anatomic pathology that are offered in the largest number of Clinical Laboratory Improvement Amendments (CLIA) certified highcomplexity laboratories and/or those with the highest test volume. We obtained test-volume data from the Centers for Medicare & Medicaid Services (CMS) for all CLIA-certified high complexity laboratories (n = ~172,000) and CMS-defined specialty and subspecialty areas of clinical and anatomic pathology. Herein, we present our analysis of these data. Keywords: laboratory, CLIA, CMS, specialty, subspecialty information provided to CMS on Form CMS-116 (10/10), Clinical Laboratory Improvement Amendments of 1988 (CLIA) Application for Certification. 1 The instructions for completing Form CMS-116 require laboratories to specify their category of service using 1 of 29 codes, from 01_Ambulance to 29_Other (specify). Codes 14_Hospital Lab and 15_Independent Lab apply to most laboratories; however, the distribution of all laboratories by code was not provided. Stratification of test-volume data on this form is defined by CMS based on the following specialty (n = 9)/ subspecialty classification: I. Histocompatibility a. Transplant b. Nontransplant II. Microbiology a. Bacteriology b. Mycobacteriology c. Mycology d. Parasitology e. Virology III. Diagnostic Immunology a. Syphilis Serology b. General Immunology IV. Chemistry a. Routine b. Urinalysis c. Endocrinology d. Toxicology V. Hematology Spring 2013 Volume 44, Number 2 Lab Medicine 163

2 VI. Immunohematology a. ABO Group and Rh Group b. Antibody Detection (Transfusion) c. Antibody Detection (Nontransfusion) d. Antibody Identification e. Compatibility Testing VII. Pathology a. Histopathology b. Oral pathology c. Cytology VIII. Radiobioassay IX. Clinical Cytogenetics We requested annual test volume data by subspecialty from CMS because the agency routinely combines test-volume data by subspecialty under one of the 9 specialty categories previously cited. In other words, a laboratory that provides annual test-volume data for the subspecialties of histopathology, oral pathology, and cytology is reported by the CMS under the specialty Pathology as the sum of the test-volume data for each of these subspecialties, rather than the individual test-volume data for each of the 3 subspecialties. CMS Guidelines for Counting Tests for CLIA Application for Certification CMS guidelines for counting tests for CLIA Application for Certification are as follows: 1 Histocompatibility: Each human leukocyte antigen (HLA) typing (including disease-associated antigens), HLA antibody screen, or HLA cross-match is counted as 1 test. Microbiology: Susceptibility testing is counted as 1 test per group of antibiotics used to determine sensitivity for 1 organism. Cultures are counted as 1 per specimen regardless of the extent of identification, number of organisms isolated, and number of tests or procedures required for identification. General Immunology: Testing for allergens should be counted as 1 test per individual allergen. Hematology: Each measured individual analyte of a complete blood count or flow cytometric test that is ordered and reported is counted separately. The white blood cell differential test is counted as 1 test. Immunohematology: Each ABO test, Rh test, antibody screen, cross-match test, or antibody identification test is counted as 1 test. Histopathology: Each block (not each slide) is counted as 1 test; autopsy services are not included. For laboratories that perform special stains on histologic slides, the test volume is determined by adding the number of special stains performed on slides to the total number of specimen blocks prepared by the laboratory. Cytology: Each slide (not each case) is counted as 1 test for Papanicolaou tests (Pap smears) and nongynecologic cytologic tests Clinical Cytogenetics: The number of tests is determined by the number of specimen types processed for each patient; eg, a bone marrow and a venous blood specimen received for 1 patient are counted as 2 tests. Chemistry: Each analyte in a profile counts as 1 test. Urinalysis: Microscopic and macroscopic examinations each count as 1 test. Macroscopic tests (eg, dipstick tests) are each counted as 1 test regardless of the number of reagent pads on the strip. All specialties/subspecialties: Do not count calculations (eg, A/G ratio, mean cell hemoglobin [MCH], free thyroxine index, etc), quality control, quality assurance, or proficiency-testing assays. An approach to counting clinical or anatomic pathology tests based on billed tests by current procedural terminology (CPT) code may be more accurate than the approach used by the CMS. However, the test-volume data in this report are based on the CMS data. Distribution of Laboratories by Specialty or Subspecialty The distribution of all CMS-certified high-complexity laboratories (n = 172,467) by specialty or subspecialty of clinical or anatomic pathology is shown in Figure 1. Distribution of Test Volume by Specialty The distribution of total test volume (approximately [~] 6 billion) among the 9 specialties, including subspecialty test volume, for all CMS-certified high-complexity laboratories is shown in Figure 2. Analysis of the Data The data can be summarized as follows (Figures 1 and 2): There are ~172,000 total CLIA-certified high-complexity laboratories in the United States. 164 Lab Medicine Spring 2013 Volume 44, Number 2

3 Compatibility Testing 5014; 2.9% Antibody Identification 3287; 1.9% Histopathology 9111; 5.3% Oral Pathology 1646; 0.9% Cytology 3995; 2.3% Radiobioassay 477; 0.3% Clinical Cytogenetics 561; 0.3% Histocompatibility 247; 0.1% ABO Group and Rh Group 6529; 3.8% Hematology 23,876; 13.9% Antibody Detection (Nontransfusion) 4653; 2.7% Antibody Detection (Transfusion) 5040; 2.9% Toxicology 6847; 4.0% Endocrinology 9683; 5.6% These laboratories performed ~ 6 billion total tests across all CLIA-defined specialty and subspecialty areas of clinical and anatomic pathology. The percentages of all laboratories reporting testvolume data by specialty (bolded) or subspecialty (italicized) were, in decreasing order: º Hematology (13.9%) º Routine Chemistry (11.2%) º Urinalysis (9.8%) º Bacteriology (8.2%) Bacteriology 14,165; 8.2% Routine (Chemistry) 19,236; 11.2% Mycobacteriology 2196; 1.3% Mycology 9619; 5.6% Parasitology 9586; 5.6% º General Immunology (6.4%) º Endocrinology (5.6%) º Mycology (5.6%) º Parasitology (5.6%) º Histopathology (5.3%) º Toxicology (4.0%) º ABO Group and Rh Group (3.8%) º Syphilis Serology (3.0%) º Antibody Detection (Transfusion) (2.9%) º Compatibility Testing (2.9%) Virology 3529; 2.0% Syphilis Serology 5207; 3.0% General Immunology 11,104; 6.4% Urinalysis 16,949; 9.8% Figure 1 Distribution of all Centers for Medicare & Medicaid Services (CMS) certified high-complexity laboratories by number of laboratories and percentage of all laboratories (n = 172,467) by specialty or subspecialty of clinical or anatomic pathology for calendar year (CY) Spring 2013 Volume 44, Number 2 Lab Medicine 165

4 Figure 2 Distribution of test volume (in billions, % of total) by clinical or anatomic pathology specialty as a percentage of total test volume (n = billion) for calendar year (CY) Pathology 0.621; 10.3% Clinical Cytogenetics 0.067; 1.1% Radiobioassay 0.082; 1.4% Histocompatibility 0.059; 1.0% º Antibody Detection (Nontransfusion) (2.7%) º Cytology (2.3%) º Virology (2.0%) º Antibody Identification (1.9%) º Mycobacteriology (1.3%) º Oral Pathology (0.9%) º Clinical cytogenetics (0.3%) º Radiobioassay (0.3%) º Histocompatibility (0.1%) Personnel in a broad distribution of laboratories perform testing related to 1 or more specialty or subspecialty areas of clinical or anatomic pathology. (Note: We did not attempt to stratify individual laboratories by the number and type of specialty and subspecialty areas therein.) Only a small proportion (<1%) of all CMS-certified highcomplexity laboratories perform clinical cytogenetic, radiobioassay, and/or histocompatibility testing. The distribution of total test volume (6.037 billion), by CMS-defined specialty, of clinical or anatomic pathology laboratories across the spectrum were, in decreasing order: º Chemistry (21.0%) º Hematology (18.7%) º Diagnostic Immunology (17.5%) º Microbiology (16.8%) Immunohematology 0.734; 12.2% Hematology 1.130; 18.7% º Immunohematology (12.2%) º Pathology (10.3%) º Radiobioassay (1.4%) º Clinical cytogenetics (1.1%) º Histocompatibility (1.0%) Chemistry 1.270; 21.0% Microbiology 1.015; 16.8% Diagnostic Immunology 1.059; 17.5% Chemistry laboratories perform the highest volume of tests among all specialties, whereas the fewest number of tests are performed among radiobioassay, clinical cytogenetics, and histocompatibility specialties. (Note: If urinalysis testing were performed in the Hematology laboratory, this specialty would perform the highest number of laboratory tests among all specialties within the CLIAcertified high-complexity laboratories in the United States). The lower volume of radiobioassay, clinical cytogenetic, and histocompatibility testing is not surprising since these tests are more esoteric than tests performed by other specialties. For example, histocompatibility testing typically is performed in laboratories that support tissue and organ transplant programs, and mostinstitutions or locations do not provide such programs. In the United States there are 150 transplant centers, and histocompatibility laboratories represent <0.1% of all CLIAcertified high-complexity laboratories. 2 Anatomic pathology tests account for only about 10% of all laboratory tests. 166 Lab Medicine Spring 2013 Volume 44, Number 2

5 In its next revision of Form CMS-116, we encourage CMS officials to request annual test-volume data in the specialty of Cytology, including data for the following categories: Pap tests (conventional) Pap tests (liquid-based) Non-gynecological tests Fine needle aspiration (FNA) Such data would answer important questions about cytologic testing (eg, the percentage of laboratories performing Pap testing using conventional and/or liquidbased specimens) that cannot be answered currently using data from other sources. We hope that the clinical and anatomic laboratory communities and other groups will find our analysis and discussion useful. For example, in vitro diagnostics [IVD] companies may find these data useful in focusing their resources on specialty/subspecialty areas of clinical or anatomic pathology that represent the largest number of CLIA-certified high-complexity laboratories and/or the highest volume tests. LM References 1. Clinical Laboratory Improvement Amendments (CLIA) Application for Certification. Centers for Medicare & Medicaid Services Web site. Accessed January 1, Transplant_Center/Things_to_Consider/Transplant_Center_ Comparison_%28PDF%29.aspx. Accessed February 7, To read this article online, scan the QR code, ascpjournals.org/content/44/2/163. full.pdf+html Spring 2013 Volume 44, Number 2 Lab Medicine 167