Laboratory Management

Centers for Medicare and Medicaid Services

The United States does not have a national, single-payer health insurance system. Rather, US citizens obtain health insurance from a variety of federal or private carriers. The Centers for Medicare and Medicaid Services (CMS) is a federal agency that provides health insurance to qualified individuals through the Medicare and Medicaid programs. Together, Medicare and Medicaid provide health care to about 40% of Americans (more than 100 million people). Besides Medicare and Medicaid, CMS also administers the Clinical Laboratory Improvement Amendments (CLIA) and Health Insurance Portability and Accountability Act (HIPAA) programs, as well as some other national health programs.

CMS is 1 of 11 divisions of the U.S. Department of Health and Human Services (DHHS), a cabinet-level department created in 1953. Some of the other divisions of DHHS are the National Institutes of Health, the Food and Drug Administration, and the Centers for Disease Control and Prevention (CDC).

To bill for and receive Medicare or Medicaid payments, a laboratory must be certified. To obtain a certificate, it must be accredited by an approved accrediting organizations, usually either the Joint Commission or the College of American Pathologists.

The Joint Commission

The Joint Commission (TJC) is an independent, not-for-profit organization that evaluates and accredits more than 20,000 health care organizations and 1500 laboratories in the United States. It is governed by a board of commissioners that includes physicians, consumers, and administrators, and its corporate members include professional societies such as the American Medical Association and the American Hospital Association.

Founded in 1951, TJC has developed standards for evaluating hospitals, assisted living facilities, outpatient services, and clinical laboratories. It has been accrediting hospitals since 1953 and laboratories since 1979. Laboratories surveyed by TJC have been deemed certifiable under CLIA 88 requirements. To earn accreditation, a hospital or laboratory undergoes an on-site survey. To maintain accreditation, hospitals are surveyed every 3 years and laboratories every 2 years. Surveys have been unannounced since 2006.

For its survey process, TJC uses patient “tracers,” an evaluation method that traces patients through the care they have received. When they visit a cytology laboratory, TJC surveyors tour the laboratory and select a handful of random accession numbers, examining all aspects of the cytology process represented by those cases, including (but not limited to) specimen processing, instrument maintenance, results reporting, cytotechnologist and cytopathologist personnel records, compliance with quality assurance regulations, results of proficiency testing, and documentation of workload limits.

College of American Pathologists

The College of American Pathologists (CAP) is a professional society of pathologists that offers a Laboratory Accreditation Program that inspects more than 8000 laboratories in the United States and worldwide. Surveys are performed every 2 years and have been unannounced since 2006. Volunteer surveyors use inspection checklists that undergo regular revision to reflect federal regulations and professional standards. Like those inspected by TJC, CAP-inspected laboratories are eligible for a CLIA certificate.

Commission on Accreditation of Allied Health Education Programs

The Commission on Accreditation of Allied Health Education Programs (CAAHEP) is an independent certifying agency for health education programs. It accredits cytotechnology training programs in the United States upon the recommendation of the Cytotechnology Programs Review Committee of the American Society of Cytopathology. As of 2018, there were 22 accredited schools of cytotechnology in the United States and Puerto Rico.

Occupational Safety and Health Administration

The Occupational Safety and Health Administration (OSHA) was created by Congress in 1971 under the Occupational Safety and Health Act, also known as “the safety bill of rights,” a response to public outcry in the 1960s against rising workplace-related injuries and deaths. A division within the Department of Labor, OSHA’s mission is to prevent injuries, illnesses, and deaths on the job. OSHA conducts inspections in response to reports of high injury rates or imminent dangers; fatalities or serious accidents; and employee complaints. Violations of standards can result in stiff monetary penalties. Of particular relevance to cytology laboratories are the OSHA Bloodborne Pathogens Standard and the OSHA Laboratory Standard , which are available on the OSHA website.

National Fire Protection Association

Despite its name, the National Fire Protection Association (NFPA) is an international nonprofit organization, founded in 1896, which serves as the premier advocate of fire protection. Its more than 300 safety codes and standards influence the design and construction of every building in the United States. A cytologist must be familiar with applicable safety codes to ensure that they are being observed. Of the numerous standards published by NFPA, the two of greatest relevance to cytology laboratories are the Health Care Facilities Code (NFPA 99) and the Standard on Fire Protection for Laboratories Using Chemicals (NFPA 45) .

Clinical Laboratory Improvement Amendments of 1988

In the 1980s there was an extraordinary flurry of media attention on the problem of false-negative Papanicolaou (Pap) test results. The seminal article appeared on the front page of the Wall Street Journal . These media reports were a driving force behind legislation enacted by the U.S. Congress called the Clinical Laboratory Improvement Amendments of 1988 (CLIA 88). (A less stringent act, Clinical Laboratory Improvement Act 67, had been passed in the 1960s, which mandated rescreening of 10% of negative Pap test results.) The final regulations of CLIA 88 were published in 1992, and minor modifications appeared in 2003. They can be found at https://wwwn.cdc.gov/clia/Regulatory/default.aspx . Congress charged CMS with the implementation of these standards.

To bill for and receive Medicare or Medicaid payments, a clinical laboratory must have a CLIA certificate, which is granted after inspection by one of two approved accrediting organizations, TJC or the CAP. In a few states such as Washington and New York, a laboratory may obtain a state license in lieu of a CLIA certificate.

Specialized surveys, required by CLIA 88, are performed by the American Society for Cytotechnology Services (ASCT Services) on a small proportion of cytology laboratories with CLIA certificates. A laboratory is selected either at random or if a complaint has been lodged against it with the CMS. The survey team evaluates the laboratory’s operations and reviews at least 100 Pap cases. If applicable, a statement of deficiencies is forwarded to the laboratory via the CMS Regional Office, and the laboratory is given an opportunity to respond with a plan of correction. For example, between 1988 and 2006 a total of 616 laboratories underwent a specialized survey, and 32% were found to be noncomplaint with CLIA. After filing a plan of correction, only 4% of laboratories received sanctions, had their certificates revoked, or voluntarily withdrew from the program.

An advisory committee known as the Clinical Laboratories Improvement Advisory Committee (CLIAC) consists of 20 members, including laboratorians and consumer advocates. CLIAC meets at least twice yearly and advises CMS and other governmental agencies on the need for and nature of any revisions to the standards that govern laboratory testing.

Health Insurance Portability and Accountability Act of 1996 (HIPAA)

HIPAA is a comprehensive law that regulates several unrelated areas of health care, such as the protection of (1) health care coverage for those who change jobs and (2) the privacy of medical information. The law asked Congress to pass comprehensive privacy legislation by August 1999. Because Congress did not do so, the law required DHHS to write the Privacy Rule/Regulation. DHHS published the Final Rule on December 28, 2000, which took effect on April 14, 2001, requiring compliance by health care providers by April 14, 2003.

The Rule governs the use of so-called “individually identifiable” health information and is intended to ensure that a patient’s health information is used only for health care purposes unless permission is obtained for other purposes. This information includes, for example, a cytologic diagnosis linked to an identifier such as a social security number, medical record number, or accession number. The DHHS Office of Civil Rights is responsible for implementing the Rule and has issued written guidelines for health care providers that can be viewed at http://www.hhs.gov/ocr/hipaa .

HIPAA also requires that every provider who does business electronically use the same health care transactions, code sets, and identifiers. Code sets (e.g., Current Procedural Terminology [CPT], Healthcare Common Procedure Coding System [HCPCS], and International Classification of Diseases, tenth revision [ICD-10-CM]) are the codes used to identify specific diagnoses and procedures on claims and encounter forms.

Laboratory Director

Every laboratory performing so-called “high complexity” testing (cytology falls into this category under CLIA 88 regulations) must have a laboratory director. This is the individual who is named the laboratory director on the CLIA certificate. (Institutions might also designate individuals as laboratory directors of cytology, microbiology, etc., but they are not the “laboratory director” in the eyes of CMS if they do not hold the CLIA certificate.) He or she may direct more than one CLIA laboratory, but no more than five. It is the laboratory director who has ultimate responsibility for the work performed in the laboratory.

Technical Supervisor

The technical supervisor (TS), as defined by CLIA 88, is the pathologist responsible for the “technical and scientific” oversight of the laboratory. He or she is not required to be on site at all times, but must be available on an as-needed basis. The TS may perform the duties of a general supervisor and a cytotechnologist.

The TS of a cytology laboratory is usually someone that the institution (but not necessarily CLIA) considers the “laboratory director” of cytology. The TS may delegate some of his or her responsibilities to a trainee in the final year of training in anatomic pathology.

The American Society of Cytopathology no longer certifies cytopathologists; the last examination was in 1978. The TS need not have specialty qualification (“boards”) in cytopathology. In any given laboratory, more than one individual may qualify as a TS, but only one is designated as such.

General Supervisor

Each cytology laboratory must have a general supervisor (GS). The GS is responsible for the day-to-day oversight of operations and personnel. He or she must be accessible to provide on-site, telephone, or electronic consultation to resolve problems in accordance with procedures established by the TS. The same individual may fulfill the roles of both TS and GS.

Cytotechnologist

The job description of a cytotechnologist varies depending on the laboratory where he or she works. Most are involved in slide examination. In some laboratories, they are also involved in quality-control (QC) activities, teaching, research, cytopreparation, and assistance with preparation of smears and adequacy assessments during fine-needle aspirations (FNAs). The following responsibilities of a cytotechnologist are the minimum established by CLIA 88.

Cytotechnologists are not required under CLIA 88 to be certified by a certifying agency, so long as they have graduated from an approved school. The current certifying agency is the Board of Certification (BOC; formerly the Board of Registry) of the American Society of Clinical Pathologists, which offers two certificates: “cytotechnologist“ (CT) and “specialist in cytotechnology” (SCT). The SCT certificate requires a higher level examination. As of 1988, a bachelor’s degree, plus graduation from an accredited cytotechnology program, is required for eligibility for a certificate. The BOC used to offer an “experience route,” but this is no longer the case, and CTs who have not attended an approved school of cytotechnology can no longer sit for the BOC examination.

The certificates offered by the ASCP BOC became time limited more than 10 years ago. As a result, the ASCP BOC now offers a Certification Maintenance Program (CMP). The CT certifications that were issued effective 2004 and beyond are valid only for a 3 year period. The same expiration applies to the SCT certifications issued effective 2006 and beyond. For these individuals, recertification is required every 3 years to maintain valid certification. Voluntary participation in the CMP is encouraged for those certified as CT before 2004.

The former Department of Health, Education, and Welfare (now the DHHS) once offered CT certification, but this ended many years ago. Certification by the International Academy of Cytology (IAC) is not sufficient for those who wish to practice in the United States because the IAC is not an approved certifying agency. Some states require licensure of CTs, but most do not.

Procedure Codes

A medical bill submitted to an insurer for payment needs to describe the medical procedure/service that is being billed. The common language that is used in the United States to communicate the vast majority of procedures is called CPT , for Current Procedural Terminology , a registered trademark of the American Medical Association (AMA). The AMA owns and maintains CPT. The first edition was published by the AMA in 1966 when the (then-new) Medicare program needed a terminology for describing medical services. To this day, CMS, which administers the Medicare program for DHHS (U.S. Department of Health and Human Services), agrees via contract with the AMA to use the CPT codebook as the main source of codes and descriptors for processing medical claims. With the implementation of the HIPAA regulations in 2003, CPT became the language that must be used by all providers, government agencies, and private insurers.

According to the AMA, the objective of CPT is to provide “a uniform language that will accurately describe medical, surgical, and diagnostic services, and will thereby provide an effective means for reliable nationwide communication among physicians, patients, and third parties.” A CPT code has been assigned to virtually every type of physician and laboratory service, including cytologic slide preparation and interpretation. (For example, CPT code 10021 describes the procedure of performing an FNA without image guidance.) CPT codes describe even the most complex of medical procedures in the form of a simple 5-digit numeric code. Tell a knowledgeable person, for example, that you just performed an 88164, and he or she will know immediately that this was a manual screening of a cervical/vaginal smear (not a liquid-based preparation); that Bethesda terminology was used to report the result; and that the procedure included only the so-called “technical” component (staining, covering with a coverslip, CT review, but not a pathologist’s interpretation). All this from a 5-digit code!

CPT codes are the foundation for determining facility (“technical”) and physician (“professional”) payments, in conjunction with Medicare’s Resource-Based Relative Value System (RBRVS) or its clinical laboratory fee schedule (CLFS). The RBRVS is a system for comparing the relative value of medical services across all specialties, based on work, practice expense, and other factors. By doing so, the RBRVS establishes a relative value unit (RVU) for every current medical procedure. The dollar value of any given medical service or procedure is determined by its composite relative weight, multiplied by a nationally set (by CMS) dollar conversion factor. The RVUs and conversion factor for physician services are published annually in the Federal Register by CMS. Various geographic cost-of-living adjustments and other factors are also applied to obtain the specific allowed charge for any given procedure and locale, and therefore the process is not so simple as multiplying an RVU by the conversion factor. (It is not within the scope of this chapter to elaborate on the detailed formula.) CMS provides an allowed charge lookup system on its website. Medicare’s CLFS is briefly described below in conjunction with Pap test technical services.

Healthcare Common Procedure Coding System (HCPCS) codes are a separate set of codes used to describe drugs, supplies, and certain other services not included in CPT. Like CPT codes, HCPCS codes have 5 digits, but the first is a letter and the rest are numbers (e.g., G0123). The HCPCS codes are administered not by the AMA but by the CMS. Responsibility for maintaining and updating them is vested in a national panel composed of representatives from CMS, the BlueCross BlueShield Association, and America’s Health Insurance Plans. Cytologists need to be concerned with only a small number of HCPCS codes: those for routine and high-risk Pap tests for Medicare beneficiaries.

In some circumstances, CPT and HCPCS codes require the use of modifiers to avoid filing a false claim and to assure accurate and prompt payment by payers. A complete discussion of modifiers is beyond the scope of this chapter, but familiarity with the concept of modifiers is important. Some commonly used modifiers for cytology cases deserve mention.