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Chapter 5 : The Impact of Regulatory Requirements

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Abstract:

Clinical laboratories operate in a constantly changing environment. Much of that change is driven by rules, regulations, and laws, as well as voluntary standards affecting the operation of every clinical laboratory in the United States. This chapter explains the regulatory requirements facing laboratories and the basics of laboratory inspection and accreditation. The health and safety of employees, their fair and equitable treatment, management of pathogens and chemicals, shipping of specimens, and the accreditation of clinical laboratories are a few of the aspects of laboratory medicine regulated by laws or standards. The chapter presents an overview of Clinical Laboratory Improvement Amendments 1988. It also explains the impact of increasing scrutiny on the practice of transfusion medicine. Careful scrutiny of each step in the process from the requisition to coding and claims submission often identifies opportunities to correct patterns of noncompliance or denied payments or lost cash flow. The chapter evaluates model compliance plans and reviews the intent and impact on patients, physician providers, hospital and laboratory providers, employers, and payors. It goes on to review medical necessity, local medical review policies, advanced beneficiary notification, and Medicare secondary payor (MSP) requirements. Patient registration staff should be familiar with Coordination of Benefits and the organization’s process to establish MSP status.

Citation: Roseff S, Russell D, Anderson C, Mercer R. 2014. The Impact of Regulatory Requirements, p 84-138. In Garcia L (ed), Clinical Laboratory Management, Second Edition. ASM Press, Washington, DC. doi: 10.1128/9781555817282.ch5

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Citation: Roseff S, Russell D, Anderson C, Mercer R. 2014. The Impact of Regulatory Requirements, p 84-138. In Garcia L (ed), Clinical Laboratory Management, Second Edition. ASM Press, Washington, DC. doi: 10.1128/9781555817282.ch5
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Tables

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Table 5.1

CLIA categorization of test systems, assays, and examinations

CLIA categorizes laboratory tests as waived, moderate, or high complexity. Each test system (test plus instrument), assay, or examination is graded. A grading system using seven criteria and scores of 1, 2, and 3 is employed—a score of 1 being the lowest, 3 the highest, and 2 intermediate. Scores are totaled. A test system, assay, or examination with a score equal to or less than 12 is assigned to the moderate-complexity category, and those with a score of greater than 12 to the high-complexity category (The Food and Drug Administration website provides additional information on grading of test complexity at www.fda.gov [accessed March 15, 2012].)

Citation: Roseff S, Russell D, Anderson C, Mercer R. 2014. The Impact of Regulatory Requirements, p 84-138. In Garcia L (ed), Clinical Laboratory Management, Second Edition. ASM Press, Washington, DC. doi: 10.1128/9781555817282.ch5
Generic image for table
Table 5.2

Examples of waived, moderate-complexity, and high-complexity tests

The Food and Drug Administration website provides additional information on grading of test complexity at www.fda.gov (accessed March 15, 2012).

Citation: Roseff S, Russell D, Anderson C, Mercer R. 2014. The Impact of Regulatory Requirements, p 84-138. In Garcia L (ed), Clinical Laboratory Management, Second Edition. ASM Press, Washington, DC. doi: 10.1128/9781555817282.ch5
Generic image for table
Table 5.3

Federal laws prohibiting job discrimination (EEOC)

The website of the Equal Employment Opportunity Commission, www.eeoc.gov (accessed March 15, 2012), provides details regarding the various laws prohibiting employment discrimination.

Citation: Roseff S, Russell D, Anderson C, Mercer R. 2014. The Impact of Regulatory Requirements, p 84-138. In Garcia L (ed), Clinical Laboratory Management, Second Edition. ASM Press, Washington, DC. doi: 10.1128/9781555817282.ch5
Generic image for table
Table 5.4

Hazard classes and definitions

See reference .

Citation: Roseff S, Russell D, Anderson C, Mercer R. 2014. The Impact of Regulatory Requirements, p 84-138. In Garcia L (ed), Clinical Laboratory Management, Second Edition. ASM Press, Washington, DC. doi: 10.1128/9781555817282.ch5
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Table 5.5

Blood-borne pathogen exposure control plan requirements

See http://www.osha.gov/Publications/osha3186.pdf (accessed August 1, 2012).

Citation: Roseff S, Russell D, Anderson C, Mercer R. 2014. The Impact of Regulatory Requirements, p 84-138. In Garcia L (ed), Clinical Laboratory Management, Second Edition. ASM Press, Washington, DC. doi: 10.1128/9781555817282.ch5
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Table 5.6

Clarifications provided in enforcement procedures for the occupational exposure to blood-borne pathogens

Citation: Roseff S, Russell D, Anderson C, Mercer R. 2014. The Impact of Regulatory Requirements, p 84-138. In Garcia L (ed), Clinical Laboratory Management, Second Edition. ASM Press, Washington, DC. doi: 10.1128/9781555817282.ch5
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Table 5.7

Computer workstation and general ergonomic guidelines (not a comprehensive list)

OSHA provides an “e-tool” on hospital ergonomics, with specifics for laboratories, on its website at http://www.osha.gov/SLTC/etools/hospital/index.html (accessed March 15, 2012). The CDC provides additional information on ergonomics at http://www.cdc.gov/niosh/topics/ergonomics/ (accessed March 15, 2012).

Citation: Roseff S, Russell D, Anderson C, Mercer R. 2014. The Impact of Regulatory Requirements, p 84-138. In Garcia L (ed), Clinical Laboratory Management, Second Edition. ASM Press, Washington, DC. doi: 10.1128/9781555817282.ch5
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Table 5.8

Elements of a laboratory safety program

Citation: Roseff S, Russell D, Anderson C, Mercer R. 2014. The Impact of Regulatory Requirements, p 84-138. In Garcia L (ed), Clinical Laboratory Management, Second Edition. ASM Press, Washington, DC. doi: 10.1128/9781555817282.ch5
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Table 5.9

Elements of a chemical hygiene plan

See reference .

Citation: Roseff S, Russell D, Anderson C, Mercer R. 2014. The Impact of Regulatory Requirements, p 84-138. In Garcia L (ed), Clinical Laboratory Management, Second Edition. ASM Press, Washington, DC. doi: 10.1128/9781555817282.ch5
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Table 5.10

Safe handling of chemicals

See reference .

Citation: Roseff S, Russell D, Anderson C, Mercer R. 2014. The Impact of Regulatory Requirements, p 84-138. In Garcia L (ed), Clinical Laboratory Management, Second Edition. ASM Press, Washington, DC. doi: 10.1128/9781555817282.ch5
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Table 5.11

Types of laboratory CLIA certificates

Information about the various types of CLIA certificates is available at the Centers for Medicare and Medicaid Services website, www.cms.gov/clia (accessed February 2, 2012).

Citation: Roseff S, Russell D, Anderson C, Mercer R. 2014. The Impact of Regulatory Requirements, p 84-138. In Garcia L (ed), Clinical Laboratory Management, Second Edition. ASM Press, Washington, DC. doi: 10.1128/9781555817282.ch5
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Table 5.12

Accrediting organizations with deemed status under the CMS

The Centers for Medicare and Medicaid Services maintains a current list of accrediting organizations with deemed status at its website (www.cms.gov/clia, accessed February 1, 2012).

Citation: Roseff S, Russell D, Anderson C, Mercer R. 2014. The Impact of Regulatory Requirements, p 84-138. In Garcia L (ed), Clinical Laboratory Management, Second Edition. ASM Press, Washington, DC. doi: 10.1128/9781555817282.ch5
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Table 5.13

Summary of personnel responsibilities and qualifications under CLIA '88

All qualifications are a partial list. More details can be found at http://www.cdc.gov/clia/regs/subpart_m.aspx.

Citation: Roseff S, Russell D, Anderson C, Mercer R. 2014. The Impact of Regulatory Requirements, p 84-138. In Garcia L (ed), Clinical Laboratory Management, Second Edition. ASM Press, Washington, DC. doi: 10.1128/9781555817282.ch5
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Table 5.14

CMS-approved certification boards, doctoral degree clinical consultants, and directors of high-complexity testing

The most current list of approved certification boards may be found at the Centers for Medicare and Medicare Services website: https://www.cms.gov/CLIA/16_Certification_Boards_LaboratoryDirectors.asp#TopOfPage (accessed February 1, 2012).

NRCC and ABFT will certify individuals who do not hold a doctoral degree; all others require one.

Citation: Roseff S, Russell D, Anderson C, Mercer R. 2014. The Impact of Regulatory Requirements, p 84-138. In Garcia L (ed), Clinical Laboratory Management, Second Edition. ASM Press, Washington, DC. doi: 10.1128/9781555817282.ch5
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Table 5.15

States and territories requiring licensure of laboratory personnel

The American Society for Clinical Laboratory Science maintains a list of states requiring licensure of laboratory personnel at www.ascls.org (accessed March 13, 2012). Click “New Graduate Information.”

Citation: Roseff S, Russell D, Anderson C, Mercer R. 2014. The Impact of Regulatory Requirements, p 84-138. In Garcia L (ed), Clinical Laboratory Management, Second Edition. ASM Press, Washington, DC. doi: 10.1128/9781555817282.ch5
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Table 5.16

Pros and cons of lookback

Citation: Roseff S, Russell D, Anderson C, Mercer R. 2014. The Impact of Regulatory Requirements, p 84-138. In Garcia L (ed), Clinical Laboratory Management, Second Edition. ASM Press, Washington, DC. doi: 10.1128/9781555817282.ch5
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Table 5.17

Essential components of a quality management system

See reference .

Citation: Roseff S, Russell D, Anderson C, Mercer R. 2014. The Impact of Regulatory Requirements, p 84-138. In Garcia L (ed), Clinical Laboratory Management, Second Edition. ASM Press, Washington, DC. doi: 10.1128/9781555817282.ch5
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Table 5.18

Steps in processing biological product deviations

Citation: Roseff S, Russell D, Anderson C, Mercer R. 2014. The Impact of Regulatory Requirements, p 84-138. In Garcia L (ed), Clinical Laboratory Management, Second Edition. ASM Press, Washington, DC. doi: 10.1128/9781555817282.ch5
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Table 5.19

Typical compliance functions within blood centers and transfusion medicine services

Citation: Roseff S, Russell D, Anderson C, Mercer R. 2014. The Impact of Regulatory Requirements, p 84-138. In Garcia L (ed), Clinical Laboratory Management, Second Edition. ASM Press, Washington, DC. doi: 10.1128/9781555817282.ch5
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Table 5.20

Hospital financial exposure

See http://oig.hhs.gov/oas/reports/region3/39400021.pdf (accessed October 22, 2012).

Citation: Roseff S, Russell D, Anderson C, Mercer R. 2014. The Impact of Regulatory Requirements, p 84-138. In Garcia L (ed), Clinical Laboratory Management, Second Edition. ASM Press, Washington, DC. doi: 10.1128/9781555817282.ch5
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Table 5.21

Medicare provider designation

Citation: Roseff S, Russell D, Anderson C, Mercer R. 2014. The Impact of Regulatory Requirements, p 84-138. In Garcia L (ed), Clinical Laboratory Management, Second Edition. ASM Press, Washington, DC. doi: 10.1128/9781555817282.ch5
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Table 5.22

References for coding systems used for third-party claims

AHA, American Hospital Association; NCHS, National Center for Health Statistics.

Citation: Roseff S, Russell D, Anderson C, Mercer R. 2014. The Impact of Regulatory Requirements, p 84-138. In Garcia L (ed), Clinical Laboratory Management, Second Edition. ASM Press, Washington, DC. doi: 10.1128/9781555817282.ch5
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Table 5.23

Billing and coding errors: areas of potential risk

See reference .

Citation: Roseff S, Russell D, Anderson C, Mercer R. 2014. The Impact of Regulatory Requirements, p 84-138. In Garcia L (ed), Clinical Laboratory Management, Second Edition. ASM Press, Washington, DC. doi: 10.1128/9781555817282.ch5
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Table 5.24

Billing modifiers

See reference .

Citation: Roseff S, Russell D, Anderson C, Mercer R. 2014. The Impact of Regulatory Requirements, p 84-138. In Garcia L (ed), Clinical Laboratory Management, Second Edition. ASM Press, Washington, DC. doi: 10.1128/9781555817282.ch5
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Table 5.25

HIPAA benefits

Citation: Roseff S, Russell D, Anderson C, Mercer R. 2014. The Impact of Regulatory Requirements, p 84-138. In Garcia L (ed), Clinical Laboratory Management, Second Edition. ASM Press, Washington, DC. doi: 10.1128/9781555817282.ch5
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Table 5.26

HIPAA criminal penalties

Citation: Roseff S, Russell D, Anderson C, Mercer R. 2014. The Impact of Regulatory Requirements, p 84-138. In Garcia L (ed), Clinical Laboratory Management, Second Edition. ASM Press, Washington, DC. doi: 10.1128/9781555817282.ch5
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Table 5.27

HIPAA civil money penalties

Citation: Roseff S, Russell D, Anderson C, Mercer R. 2014. The Impact of Regulatory Requirements, p 84-138. In Garcia L (ed), Clinical Laboratory Management, Second Edition. ASM Press, Washington, DC. doi: 10.1128/9781555817282.ch5

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