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Chapter 5 : The Impact of Regulatory Requirements

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Abstract:

This chapter gives readers a basic understanding of the regulatory requirements facing laboratories. Clinical laboratories are governed by federal and state laws. Regulations are promulgated by many agencies. Primary among them are occupational safety and health administration (OSHA), the centers for disease control and prevention (CDC), and the food and drug administration (FDA). Other federal agencies and voluntary-standard-setting organizations also regulate and shape the everyday operations of laboratories. A major responsibility of laboratory managers and directors is keeping constantly abreast of new and revised laws and regulations. In addition to following the laws and regulations governing the operation of clinical laboratories, additional expectations are placed on transfusion medicine services. With increased awareness of transmissible diseases, and the sophisticated methods to detect them in the blood supply, have come mandated programs of donor screening and blood testing. These programs have contributed to the increased cost of blood, but they have also led to a safer blood supply. Health Insurance Portability and Accountability Act of 1996 (HIPAA) addresses the five basic principles for the protection of privacy: consumer control, accountability, public responsibility, boundaries, and security. Consumers have the right to see a copy of their medical records, request corrections, and obtain documentation of disclosure of their health information. Appropriate security measures should protect against deliberate or accidental misuse or disclosure of health information.

Citation: Roseff S, Harris A, Rodgers C. 2004. The Impact of Regulatory Requirements, p 79-134. In Garcia L, Baselski V, Burke M, Schwab D, Sewell D, Steele J, Weissfeld A, Wilkinson D, Winn W (ed), Clinical Laboratory Management. ASM Press, Washington, DC. doi: 10.1128/9781555817695.ch5

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Process for evaluating biological product deviations. Available from the FDA, CBER.

Citation: Roseff S, Harris A, Rodgers C. 2004. The Impact of Regulatory Requirements, p 79-134. In Garcia L, Baselski V, Burke M, Schwab D, Sewell D, Steele J, Weissfeld A, Wilkinson D, Winn W (ed), Clinical Laboratory Management. ASM Press, Washington, DC. doi: 10.1128/9781555817695.ch5
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Citation: Roseff S, Harris A, Rodgers C. 2004. The Impact of Regulatory Requirements, p 79-134. In Garcia L, Baselski V, Burke M, Schwab D, Sewell D, Steele J, Weissfeld A, Wilkinson D, Winn W (ed), Clinical Laboratory Management. ASM Press, Washington, DC. doi: 10.1128/9781555817695.ch5
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Citation: Roseff S, Harris A, Rodgers C. 2004. The Impact of Regulatory Requirements, p 79-134. In Garcia L, Baselski V, Burke M, Schwab D, Sewell D, Steele J, Weissfeld A, Wilkinson D, Winn W (ed), Clinical Laboratory Management. ASM Press, Washington, DC. doi: 10.1128/9781555817695.ch5
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Citation: Roseff S, Harris A, Rodgers C. 2004. The Impact of Regulatory Requirements, p 79-134. In Garcia L, Baselski V, Burke M, Schwab D, Sewell D, Steele J, Weissfeld A, Wilkinson D, Winn W (ed), Clinical Laboratory Management. ASM Press, Washington, DC. doi: 10.1128/9781555817695.ch5
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Citation: Roseff S, Harris A, Rodgers C. 2004. The Impact of Regulatory Requirements, p 79-134. In Garcia L, Baselski V, Burke M, Schwab D, Sewell D, Steele J, Weissfeld A, Wilkinson D, Winn W (ed), Clinical Laboratory Management. ASM Press, Washington, DC. doi: 10.1128/9781555817695.ch5
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Citation: Roseff S, Harris A, Rodgers C. 2004. The Impact of Regulatory Requirements, p 79-134. In Garcia L, Baselski V, Burke M, Schwab D, Sewell D, Steele J, Weissfeld A, Wilkinson D, Winn W (ed), Clinical Laboratory Management. ASM Press, Washington, DC. doi: 10.1128/9781555817695.ch5
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Citation: Roseff S, Harris A, Rodgers C. 2004. The Impact of Regulatory Requirements, p 79-134. In Garcia L, Baselski V, Burke M, Schwab D, Sewell D, Steele J, Weissfeld A, Wilkinson D, Winn W (ed), Clinical Laboratory Management. ASM Press, Washington, DC. doi: 10.1128/9781555817695.ch5
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Citation: Roseff S, Harris A, Rodgers C. 2004. The Impact of Regulatory Requirements, p 79-134. In Garcia L, Baselski V, Burke M, Schwab D, Sewell D, Steele J, Weissfeld A, Wilkinson D, Winn W (ed), Clinical Laboratory Management. ASM Press, Washington, DC. doi: 10.1128/9781555817695.ch5
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149. Brownstone Publishers. October 2000. Laboratory Compliance Insider. Brownstone Publishers, New York, N.Y.
150. Kazon, P.M. 1998. Legal basis and interpretations of medical necessity. Clin. Lab.Manag. Rev. 12(5):375382.
151. Keoppel, P. 2001.How to perform a compliance audit of your laboratory. Clinical Laboratory Management Association Annual Conference and Exhibition, St. Louis,Mo.
152. McCurdy, K.,, and K. Gregory (ed.). 2000. Blood Bank Regulations from A to Z, 3rd ed. American Association of Blood Banks, Bethesda, Md.
153. Murray, T.,, and L. Byrne. 1999. To the hill and back: CLMA and the negotiated rule making experience. Vantage Point 3:7.
154. Young, C. 2001. Crosswalking: the tip of the iceberg. Vantage Point 5(9):13.
155. Young, C. 1999. OIG releases compliance guidance for third party medical billing. Vantage Point 3(2):14.
156. Young, C. 1998. Patient protection from liability: advance beneficiary notices (part 1). Vantage Point 2(9/10):16.
157. Young, C. 1998. Patient protection from liability: advance beneficiary notices (part 2). Vantage Point 2(10):13.

Tables

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Table 5.1

CLIA categorization criteria for test systems, assays, and examinations

CLIA categorizes laboratory tests as waived or moderate or high complexity. Each test system (test plus instrument), assay, or examination is graded. A grading system using the seven criteria listed and scores of 1, 2, and 3 is employed. A score of 1 is the lowest, 3 is the highest, and 2 is 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; those with scores of greater than 12 are assigned to the high-complexity category. The FDA website, at http://www.fda.gov (accessed 11 July 2003), provides additional information on grading of test complexity.

Citation: Roseff S, Harris A, Rodgers C. 2004. The Impact of Regulatory Requirements, p 79-134. In Garcia L, Baselski V, Burke M, Schwab D, Sewell D, Steele J, Weissfeld A, Wilkinson D, Winn W (ed), Clinical Laboratory Management. ASM Press, Washington, DC. doi: 10.1128/9781555817695.ch5
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Table 5.2

Federal laws prohibiting job discrimination (EEOC)

The website of the EEOC, at http://www.eeoc.gov (accessed 10 July 2003), provides details regarding the various laws prohibiting employment discrimination.

Citation: Roseff S, Harris A, Rodgers C. 2004. The Impact of Regulatory Requirements, p 79-134. In Garcia L, Baselski V, Burke M, Schwab D, Sewell D, Steele J, Weissfeld A, Wilkinson D, Winn W (ed), Clinical Laboratory Management. ASM Press, Washington, DC. doi: 10.1128/9781555817695.ch5
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Table 5.3

Hazard classes and definitions

See reference .

Citation: Roseff S, Harris A, Rodgers C. 2004. The Impact of Regulatory Requirements, p 79-134. In Garcia L, Baselski V, Burke M, Schwab D, Sewell D, Steele J, Weissfeld A, Wilkinson D, Winn W (ed), Clinical Laboratory Management. ASM Press, Washington, DC. doi: 10.1128/9781555817695.ch5
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Table 5.4

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/hospital_etool/mainpage.html (accessed 24 April 2003). The CDC provides more detailed information on laboratory ergonomics, including a checklist, at the website http://www.cdc.gov/od/ohs/ergonomics/labergo.htm (accessed 24 April 2003).

Citation: Roseff S, Harris A, Rodgers C. 2004. The Impact of Regulatory Requirements, p 79-134. In Garcia L, Baselski V, Burke M, Schwab D, Sewell D, Steele J, Weissfeld A, Wilkinson D, Winn W (ed), Clinical Laboratory Management. ASM Press, Washington, DC. doi: 10.1128/9781555817695.ch5
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Table 5.5

Elements of a chemical hygiene plan

See reference .

Citation: Roseff S, Harris A, Rodgers C. 2004. The Impact of Regulatory Requirements, p 79-134. In Garcia L, Baselski V, Burke M, Schwab D, Sewell D, Steele J, Weissfeld A, Wilkinson D, Winn W (ed), Clinical Laboratory Management. ASM Press, Washington, DC. doi: 10.1128/9781555817695.ch5
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Table 5.6

Safe handling of chemicals

See reference .

Citation: Roseff S, Harris A, Rodgers C. 2004. The Impact of Regulatory Requirements, p 79-134. In Garcia L, Baselski V, Burke M, Schwab D, Sewell D, Steele J, Weissfeld A, Wilkinson D, Winn W (ed), Clinical Laboratory Management. ASM Press, Washington, DC. doi: 10.1128/9781555817695.ch5
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Table 5.7

Accrediting organizations having deemed status under CMS

CMS maintains a current list of accrediting organizations having deemed status at its website, http://www.cms.hhs.gov/clia (accessed 10 July 2003).

Citation: Roseff S, Harris A, Rodgers C. 2004. The Impact of Regulatory Requirements, p 79-134. In Garcia L, Baselski V, Burke M, Schwab D, Sewell D, Steele J, Weissfeld A, Wilkinson D, Winn W (ed), Clinical Laboratory Management. ASM Press, Washington, DC. doi: 10.1128/9781555817695.ch5
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Table 5.8

Types of laboratory CLIA certificates

Information about the various types of CLIA certificates is available at the CMS website, http://www.cms.hhs.gov/clia (accessed 14 January 2004).

Citation: Roseff S, Harris A, Rodgers C. 2004. The Impact of Regulatory Requirements, p 79-134. In Garcia L, Baselski V, Burke M, Schwab D, Sewell D, Steele J, Weissfeld A, Wilkinson D, Winn W (ed), Clinical Laboratory Management. ASM Press, Washington, DC. doi: 10.1128/9781555817695.ch5
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Table 5.9

Summary of personnel responsibilities under CLIA '88

A more detailed description of personnel responsibilities under CLIA '88 is available on the CDC website at http://www.phppo.cdc.gov/clia (accessed 24 April 2003).

Citation: Roseff S, Harris A, Rodgers C. 2004. The Impact of Regulatory Requirements, p 79-134. In Garcia L, Baselski V, Burke M, Schwab D, Sewell D, Steele J, Weissfeld A, Wilkinson D, Winn W (ed), Clinical Laboratory Management. ASM Press, Washington, DC. doi: 10.1128/9781555817695.ch5
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Table 5.10

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 CMS website at http://www.cms.hhs.gov/clia (accessed 10 July 2003).

Citation: Roseff S, Harris A, Rodgers C. 2004. The Impact of Regulatory Requirements, p 79-134. In Garcia L, Baselski V, Burke M, Schwab D, Sewell D, Steele J, Weissfeld A, Wilkinson D, Winn W (ed), Clinical Laboratory Management. ASM Press, Washington, DC. doi: 10.1128/9781555817695.ch5
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Table 5.11

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 http://www.ascls.org (accessed 25 April 2003).

Citation: Roseff S, Harris A, Rodgers C. 2004. The Impact of Regulatory Requirements, p 79-134. In Garcia L, Baselski V, Burke M, Schwab D, Sewell D, Steele J, Weissfeld A, Wilkinson D, Winn W (ed), Clinical Laboratory Management. ASM Press, Washington, DC. doi: 10.1128/9781555817695.ch5
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Table 5.12

Pros and cons of LB

Citation: Roseff S, Harris A, Rodgers C. 2004. The Impact of Regulatory Requirements, p 79-134. In Garcia L, Baselski V, Burke M, Schwab D, Sewell D, Steele J, Weissfeld A, Wilkinson D, Winn W (ed), Clinical Laboratory Management. ASM Press, Washington, DC. doi: 10.1128/9781555817695.ch5
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Table 5.13

Essential elements of a quality system

See reference .

Citation: Roseff S, Harris A, Rodgers C. 2004. The Impact of Regulatory Requirements, p 79-134. In Garcia L, Baselski V, Burke M, Schwab D, Sewell D, Steele J, Weissfeld A, Wilkinson D, Winn W (ed), Clinical Laboratory Management. ASM Press, Washington, DC. doi: 10.1128/9781555817695.ch5
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Table 5.14

Steps in processing biological product deviations

Citation: Roseff S, Harris A, Rodgers C. 2004. The Impact of Regulatory Requirements, p 79-134. In Garcia L, Baselski V, Burke M, Schwab D, Sewell D, Steele J, Weissfeld A, Wilkinson D, Winn W (ed), Clinical Laboratory Management. ASM Press, Washington, DC. doi: 10.1128/9781555817695.ch5
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Table 5.15

Typical compliance functions within blood centers and transfusion medicine services

Citation: Roseff S, Harris A, Rodgers C. 2004. The Impact of Regulatory Requirements, p 79-134. In Garcia L, Baselski V, Burke M, Schwab D, Sewell D, Steele J, Weissfeld A, Wilkinson D, Winn W (ed), Clinical Laboratory Management. ASM Press, Washington, DC. doi: 10.1128/9781555817695.ch5
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Table 5.16

Hospital financial exposure

Citation: Roseff S, Harris A, Rodgers C. 2004. The Impact of Regulatory Requirements, p 79-134. In Garcia L, Baselski V, Burke M, Schwab D, Sewell D, Steele J, Weissfeld A, Wilkinson D, Winn W (ed), Clinical Laboratory Management. ASM Press, Washington, DC. doi: 10.1128/9781555817695.ch5
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Table 5.17

Medicare provider designation

See reference .

Citation: Roseff S, Harris A, Rodgers C. 2004. The Impact of Regulatory Requirements, p 79-134. In Garcia L, Baselski V, Burke M, Schwab D, Sewell D, Steele J, Weissfeld A, Wilkinson D, Winn W (ed), Clinical Laboratory Management. ASM Press, Washington, DC. doi: 10.1128/9781555817695.ch5
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Table 5.18

References for coding systems used for third-party claims

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

Citation: Roseff S, Harris A, Rodgers C. 2004. The Impact of Regulatory Requirements, p 79-134. In Garcia L, Baselski V, Burke M, Schwab D, Sewell D, Steele J, Weissfeld A, Wilkinson D, Winn W (ed), Clinical Laboratory Management. ASM Press, Washington, DC. doi: 10.1128/9781555817695.ch5
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Table 5.19

Billing and coding errors: areas of potential risK

See reference .

Citation: Roseff S, Harris A, Rodgers C. 2004. The Impact of Regulatory Requirements, p 79-134. In Garcia L, Baselski V, Burke M, Schwab D, Sewell D, Steele J, Weissfeld A, Wilkinson D, Winn W (ed), Clinical Laboratory Management. ASM Press, Washington, DC. doi: 10.1128/9781555817695.ch5
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Table 5.20

Billing modifiers

See reference 94.

Citation: Roseff S, Harris A, Rodgers C. 2004. The Impact of Regulatory Requirements, p 79-134. In Garcia L, Baselski V, Burke M, Schwab D, Sewell D, Steele J, Weissfeld A, Wilkinson D, Winn W (ed), Clinical Laboratory Management. ASM Press, Washington, DC. doi: 10.1128/9781555817695.ch5
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Table 5.21

HIPAA benefits

Citation: Roseff S, Harris A, Rodgers C. 2004. The Impact of Regulatory Requirements, p 79-134. In Garcia L, Baselski V, Burke M, Schwab D, Sewell D, Steele J, Weissfeld A, Wilkinson D, Winn W (ed), Clinical Laboratory Management. ASM Press, Washington, DC. doi: 10.1128/9781555817695.ch5
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Table 5.22

HIPAA criminal penalties

Citation: Roseff S, Harris A, Rodgers C. 2004. The Impact of Regulatory Requirements, p 79-134. In Garcia L, Baselski V, Burke M, Schwab D, Sewell D, Steele J, Weissfeld A, Wilkinson D, Winn W (ed), Clinical Laboratory Management. ASM Press, Washington, DC. doi: 10.1128/9781555817695.ch5

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