developing model compliance programs your faculty · developing model compliance programs- ©apf...

Developing Model Compliance 1/14/2014

Developing Model Compliance Programs- ©APF and ASCP 2014 1

A joint collaboration between Preparing Laboratory

Leaders for Today and

Tomorrow

Developing Model Compliance Programs

Your Faculty

Karen Rupke MT(ASCP)DLM

CMQ/OE, CQA (ASQ)

Grand Rapids, MI

Heather Signorelli, DO Pathology Resident, PGY-4

University of Colorado Anschutz Medical Campus

Aurora, CO



Importance of

Compliance

Compliance programs are essential to

• your lab’s ethical and business policies

• establishing a culture of prevention,

detection and resolution

• meeting federal and state laws for patient

safety

• meeting federal, state and private payer

health care requirements

INTRODUCTION

Benefits COMPLIANCE

PLANS

What are the benefits of compliance plans?1

1. Demonstrate the clinical laboratory’s strong commitment to

honest and responsible corporate conduct

2. Provide a more accurate view of employee behavior relating to

fraud and abuse

3. Identify and prevent criminal and unethical conduct

4. Improve the quality, efficiency and consistency of services

5. Create a centralized source for distributing information related to

fraud and abuse and related issues

• health care statutes

• regulations

• other program directives



Benefits COMPLIANCE

PLANS

What are the benefits of compliance plans?1

7. Develop a methodology that encourages employees to report

potential problems

8. Develop procedures that allow the prompt, thorough investigation

of alleged misconduct by corporate officers, managers and other

employees

9. Initiate immediate, appropriate, and decisive corrective action

10.Through early detection and reporting, minimizing the loss to the

Government from false claims

Objectives INTRODUCTION

Upon completion of this course, you should be able to

• Define critical areas of compliance for all laboratories

• List the basic elements of a model compliance plan (OIG)

• State the basic requirements of HIPAA

• Describe types of CLIA certification

• State key requirements of CLIA compliance

• Define required Quality Systems in a lab



Edward and Celeste have been tasked by their supervisor to ensure the

current compliance planS for their lab have all the bases covered.

INTRODUCTION

Thanks for meeting with me about this

Celeste. Between the two of us, I think we

can make sure our policies are up to

FEDERAL standards.

I am happy to help- I know it is a big

undertaking. Can you tell me a little

more about what areas of compliance

we need to review?

Areas of Compliance INTRODUCTION

THREE critical areas of compliance for all laboratories are defined by

• Office of Inspector General (OIG)

• Health Insurance Portability and Accountability Act (HIPAA)

• Centers for Medicare and Medicaid Services (CMS) and the Clinical

Laboratory Improvement Amendments of 1988 (CLIA)



Office of Inspector General’s (OIG) Mission

Protect the integrity of the Department of Health and Human Services

(DHHS) programs and health and welfare of the program beneficiaries.

Overview of OIG OFFICE OF

INSPECTOR

GENERAL

• hospitals

• clinical laboratories

• home health agencies

• third-party billing

companies

• durable medical equipment

• prosthetics

• orthotics

• supply industry

• hospices

• Medicare advantage

organizations

• nursing facilities

• ambulance suppliers

physicians

• pharmaceutical

manufactures

Compliance programs are mandatory for all Medicare and Medicaid

providers including

Components of

Compliance Plans

OFFICE OF

INSPECTOR

GENERAL

The 7 elements of an effective compliance program include

1. written policies and procedures

2. compliance officer and compliance committee

3. training and education

4. lines of communication

5. well-publicized disciplinary guidelines

6. auditing and monitoring

7. prompt response and corrective action



Written Policies &

Procedures

COMPLIANCE

PLANS

• Standards of Conduct

• Medical Necessity

• Billing

• Reliance on Standing Orders

• Compliance with Applicable HHS Fraud Alerts

• Marketing

• Prices Charged Physicians for Profiles

• Retention of Records

• Compliance as an Element of a Performance Plan

This should include

Compliance Officer &

Compliance Committee

COMPLIANCE

PLANS

• Oversees and monitors the implementation of the compliance program

• Regularly reports to clinical laboratory’s governing body

• Develops and distributes written polices and procedures to all affected

employees

• Revises the program based on necessary changes within the organization

• Develops, coordinates and participates in educational and training

programs on the elements of the compliance plan

The Compliance Officer



Compliance Officer &

Compliance Committee

COMPLIANCE

PLANS

• Ensures physicians who order services from the clinical laboratory are

informed of the compliance program standards

• Assists the clinical laboratory’s financial management in coordinating

internal compliance review and monitoring activities

• Responds and investigate to all reports of compliance problems

• Develops policies and programs that encourage employees to report

suspected problems without fear of retaliation

Compliance Committee should be established to advise the compliance

office and assist in the implementation of the compliance program.

The Compliance Officer

Training &

Education

COMPLIANCE

PLANS

• At first hire

• Periodically thereafter (i.e. yearly)

This should include training in Federal and State

statutes, regulations, program requirements, the

policies of private payers and ethics.

Targeted training for employees whose actions

affect the accuracy of the claims submitted to the

government and private payers.

All affected employees should be required to attend specific training



Well-published

Guidelines

COMPLIANCE

PLANS

• Discipline policy and actions for employees who have failed to comply with

the clinical laboratory’s standards of conduct, policies and procedures or

Federal and State Laws

• New employee policy that has a prudent background investigation

including a reference check for each employee that may have

discretionary authority to make decisions that involve compliance with the

law or compliance oversight

This should include a

Lines of

Communication

COMPLIANCE

PLANS

• Access to the compliance officer

• Use of hotlines or other forms of anonymous

communication can :

• foster compliance throughout your department

• encourage continuous improvement

• awareness of problems

This should include



Auditing & Monitoring COMPLIANCE

PLANS

Establish ongoing evaluation processes involving thorough monitoring

and regular reporting to the clinical laboratory’s corporate officers.

Compliance audits by either internal or external auditors with experience in

Federal and State health care statues, regulations and program requirements

of private insurers is recommended.

Suggested techniques include

• On-site visits

• Interviews with personnel

• Questionnaires

• Review of requisition forms and

other documents that support

claims for reimbursement

• Review of written materials and

documentation produced by the

lab and used by the physicians

and other staff that order tests

• Trend analysis looking for

deviations in billing or ordering

• Be independent of line

management

• Have access to existing audit

resources and personnel

• Present written reports on

compliance activities

• Identify areas for improvement

Assessing the compliance plan is an component of the compliance

plan under OIG guidelines

• Identifies weaknesses

• Provides insight for improvements

• Demonstrates effective policies and procedures

• Ensures a complete and effective compliance plan

Assessing

Compliance Plans

COMPLIANCE

PLANS



Prompt Response &

Corrective Action

Click NEXT to continue

COMPLIANCE

PLANS

This is important for the compliance office to promptly investigate deal

with violations and take corrective actions if necessary.

Report the matter to the appropriate governmental authority within a

reasonable period, but no more than 60 days after determining that there is a

credible evidence of violation.

Knowledge Check

Scenario

An employee comes to you and says she knows that the techs are not

putting in the proper computer codes for a “TNP” (test not performed) on

clotted samples. She is concerned that the lab is billing for these tests.

COMPLIANCE

PLANS

What are the next steps for the compliance office?

Compare your response to this model answer:

The next steps are for the compliance office are:

1. Investigate the alleged fraudulent activity

2. Take corrective actions

3. Take disciplinary actions if necessary

4. Report the incident within a reasonable time frame (no more than

60 days)

5. Provide re-training/education for employees



Health Insurance Portability and Accountability Act of 1996 (HIPAA)2

• specifies a series of administrative, technical and physical security

procedures

• assures the confidentiality of electronic protected health information

• provides national standards and training to improve efficiency of the

health care system

Overview of HIPAA HIPPA

• Health plans

• Health care clearinghouses

• Health care providers that

transmit health information in

electronic form

What information is protected?3

• Any information that identifies a patient as it relates to

– the individual’s past, present or future health condition

– the provision of health care received by the individual

– the past, present, or future payment for the provision of health

care to the individual

HIPPA Privacy Rule

Who is covered by the HIPPA

privacy rule?

HIPPA



Knowledge Check

Scenario

A man walks into the clinical lab demanding a copy of his blood test

results. He is unhappy because the physician that ordered the test has not

provided his test results in a timely manner. The patient is upset when he

hears that the lab does not routinely release patient test results to the

patient and says “I know my rights, HIPPA regulations says patients have

the right to get copies of their medical records.”

Must the lab release his test results?

oYes

oNo

HIPPA

No. Labs certified under the Clinical Laboratory

Improvements Amendments (CLIA) may

disclose test results or reports only to

authorized people. Individual states can choose

to adhere to the federal law’s definition of

authorized person, which is the person who

orders the test - in this case, the physician.

Key Elements CLIA

• Based on complexity

• Proficiency Testing (PT)

• Quality assessment and quality

systems

• Personnel standards

• Specific state laboratory

requirements

Can you tell me some basics about

CLIA before we get into the specifics?



Who needs a CLIA Certificate?5

• All facilities performing even one test, including waived tests

• Tests completed on materials derived from the human body for the

purpose of

Clinical Laboratory

Improvement Amendments

CLIA

• diagnosis

• prevention

• treatment of any disease or

impairment

• assessment of health

This also includes “procedures to determine,

measure, or otherwise describe the presence

or absence of various substances or organisms

in the body.”4

CLIA

Certificate of Waiver (COW)

Certificate for Provider

Performed Microscopy

(PPM) Procedures

Certificate of Registration

(COR)

Certificate of Compliance

(COC)

Certificate of Accreditation

(COA)

CLIA Certification CLIA

Click on each of the certification types below to

learn more.

Note: All types of CLIA certificates are

effective for two years.

Certificate of Waiver (COW)5

The certificate of waiver is issued to a

lab that only performs waived tests.



CLIA




(PPM) Procedures


(COR)


(COC)


(COA)



learn more.



Certificate for Provider Performed

Microscopy (PPM) Procedures5

• physician, midlevel practitioner or

dentist performs specific

microscopy procedures on the

patient

• a limited list of microscopy

procedures is included

• categorized as moderate

complexity.

CLIA




(PPM) Procedures


(COR)


(COC)


(COA)



learn more.



Certificate of Registration (COR) 5

• Issued to labs conducting

nonwaived testing until the lab has

been inspected to determine its

compliance

• Only labs applying for a certificate

of compliance or a certificate of

accreditation will receive a

certificate of registration



CLIA




(PPM) Procedures


(COR)


(COC)


(COA)



learn more.



Certificate of Compliance (COC) 5

• Issued to labs performing

nonwaived (moderate and/or high

complexity) testing

• Issued to a lab once CMS has

ensured compliance with CLIA

requirements (usually an on site

inspection by CMS or a state

agency)

• Laboratory remits appropriate fees

CLIA




(PPM) Procedures


(COR)


(COC)


(COA)



learn more.



Certificate of Accreditation (COA) 5

• Issued to a lab on the basis of

accreditation by an organization

approved by CMS

• Issued to labs performing

nonwaived (moderate and/or high

complexity) testing



CMS-Approved

Accreditation Organizations

CLIA

CERTIFICATION

CMS-approved

Accreditation Organizations

American Association

of Blood Banks (AABB)

American Osteopathic Association

(AOA)

American Society of

Histocompatibility &

Immmunogenetics (ASHI)

College of American

Pathologists (CAP)

COLA

Joint Commission

(JC)

Click on each button to learn more

information about each accredited

organization

Tests Based on

Complexity

Waived

Physician Performed Microscopy (PPM)

Moderate and High Complexity

CLIA

COMPLEXITY

Click on each of the buttons below to review specific

requirements for tests based on complexity



• Waived test status applies to labs performing test systems, assays or

examinations that are cleared by FDA for home use

• They employ methodologies that simple and accurate as to render the

likelihood of erroneous results negligible

• Tests pose no reasonable risk of harm to the patient if the test is performed

incorrectly

Waived Tests5 CLIA

COMPLEXITY

Visit website

Click here for more information

• Examination is personally performed by a physician, midlevel practitioner or

dentist during a patient visit

• Procedure must be categorized as moderately complex

• Primary instrument for performing the test is a the microscope, limited to

bright field or phase contrast microscopy

• Specimen is labile or delay in performing thee test could compromise the

accuracy of the test results

• Control materials are not available to monitor the entire testing process

• Limited specimen handling or processing is required

Physician Performed

Microscopy (PPM)5

CLIA

COMPLEXITY

Visit website

Click here for more information



Each test system, assay and examination not listed as waived, is categorized as

moderate or high complexity based on scores in 7 criteria:

1. Knowledge

2. Training and experience

3. Reagents and materials preparation

4. Characteristics of operational steps

5. Calibration, quality control, and proficiency testing materials

6. Test system troubleshooting and equipment maintenance

7. Interpretation and judgment

Moderate and High

Complexity5 CLIA

COMPLEXITY

• More complicated tests require a greater degree of skill and are subject to

greater levels of regulation including, but not limited to personnel standards.

• All laboratories performing moderate and/or high complexity testing must

meet specified CLIA requirements for

– proficiency testing

– quality assessment

– personnel

– facility administration

Moderate and High

Complexity5

See CLIA website for

list of specialties

CLIA

COMPLEXITY

Click here to visit

the Website



Submit

Knowledge Check

Which type of test is described below?

When a specimen is labile or delay in performing the test could compromise

the accuracy of the test results.

CLIA

COMPLEXITY

o Waived Test

o Physician Performed Microscopy

o Moderate or High Complexity

o None of the above

This type of test must be categorized as

moderately complex. Limited specimen

handling or processing is required and

control materials are not available to

monitor the entire testing process. An

example of this type of test is a KOH prep

of a skin scraping taken during a physician

visit.

Review the effectiveness of the assessments and corrective actions

Take corrective actions based on these assessments

Monitor and assess all laboratory activities

Discuss the assessment activities and findings with appropriate staff

Revise policies and procedures to prevent recurrence of problems

Document all assessment activities

Functions of Quality

Systems QUALITY

SYSTEMS



QUALITY SYSTEMS

General Laboratory

Preanalytic

Analytic

Postanalytic

QUALITY

SYSTEMS

Click on each of the buttons below to review functions

of each type of guideline.

• Ensure confidentiality of patient information through all phases of

the testing process

• Ensure specimen identification and optimum integrity of the

patient’s specimen

• Ensure the lab documents and investigates all reported complaints

and problems

• Identify and document problems that occur as a result of a

breakdown in communication

• Establish and follow written policies and procedures to assess

employees, and if applicable, consultant competency

General Laboratory

Quality Systems CONCLUSION



• Test requests follow specified requirements.

• The lab follows written policies and procedures regarding specimen

submission, handling and referral.

Preanalytic

Requirements QUALITY

SYSTEMS

Preanalytic systems must ensure:

• Written procedure manuals for all tests, assays and examinations are

available to and followed by lab personnel.

• Select and use appropriate test systems, equipment, instruments, reagents,

materials and supplies.

• Follow manufacturer’s instructions in a manner that provides test results

within the lab’s stated performance specifications.

• Establish and/or verify the performance specifications for all test systems.

• Perform and document maintenance and function checks as required by the

manufacturer or as established by the lab.

• Ensure the lab performs and documents required calibration and calibration

verification procedures.

Analytic


SYSTEMS



• Use control procedures to monitor the accuracy and precision of the

complete analytical process.

• If different methodologies are used, compare test results or instruments for

the same test. Also compare patient results that appear inconsistent with

relevant criteria.

• Corrective action policies and procedures are available and followed.

• Maintain operation for testing patient specimens in a manner that ensures

accurate and reliable patient test results and report.

• Ensure an information or record system maintains required test records.

• All control procedures and correct actions are documented.

Analytic


SYSTEMS

• Ensure adequate manual or electronic

systems are in place to deliver test results

• Deliver accurate and reliable test results and

other patient specific data to the final repost

destination

• Deliver timely test results

• Maintain reports or records are required

Postanalytic


SYSTEMS



Submit

Knowledge Check

Scenario

The hematology manager has noticed that the department has an

increased number of samples with clumped platelets. She starts

documenting the clients who are sending in the samples with clumped

platelets and then calling the clients to discuss sample collection

techniques.

QUALITY

SYSTEMS

This is an example of which type of quality measure?

o general

o preanalytic

o analytic

o postanalytic

The monitoring of unacceptable specimens and,

when indicated, correcting problems identified are

elements of a good preanalytic quality system. The

laboratory must also include a review of the

effectiveness of the corrective actions taken to

reduce the number of unacceptable samples and

document all preanalytic system activities.

All laboratories performing moderate or high complexity testing, must be

enrolled in approved Proficiency Testing programs!

• Severe penalties exist for laboratories that fail to comply with the CLIA PT program

including (but not limited to):

– Failure to enroll in approved programs

– Testing PT material outside the normal testing processes

– Failure to submit PT results in a timely manner

– Engaging in inter or intra laboratory communication about PT results

– Sending PT material to another laboratory for any analysis

– Failing to successfully participate in an approved PT program

Labs must also document evaluation of all PT failures. This includes any

results ungraded by the PT provider.

Proficiency Testing PROFICIENCY

TESTING



Personnel standards for non-waived testing are a key element of

CLIA standards.

CLIA Standards

• There are job specific qualifications

and responsibilities

• All personnel performing testing

(moderate or high complexity) must

have documentation of training for the

types and complexity of testing

• Training must be completed prior to

analyzing patient specimens

PERSONNEL

REQUIREMENTS

Competency is the ability of personnel to apply their skill, knowledge and

experience to perform their laboratory duties correctly.

Assessing

Competency

The following 6 procedures meet the minimal regulatory requirements for assessing

competency6

1. Direct observation of routine patient test performance including patient preparation

(if applicable) specimen handling, processing and testing

2. Monitoring the recording and reporting of test results

3. Review of intermediate test results or worksheets, quality control records,

proficiency testing results, and preventative maintenance records;

4. Direct observation of performance of instrument maintenance and function checks

5. Test performance via previously analyzed specimens, internal blind testing

samples or external proficiency testing samples

6. Assessment of problem solving skills

PERSONNEL

REQUIREMENTS



Who is required to have a competency assessment?

Assessing

Competency

Documented CA is required for personnel fulfilling these responsibilities

• clinical consultant (CC)

• technical consultant (TC)

• technical supervisor (TS)

• general supervisor (GS)

• testing personnel (TP)

When is competency required?

Competency must be assessed at least semiannually during the first year an

individual test patients and annually thereafter.

Click here to visit the review an FAQ

PERSONNEL

REQUIREMENTS

Visit website

• In addition to CLIA regulations, each lab must comply with state laws and

regulations. These may be more stringent than CLIA.

• States may have laws specific to Proficiency Testing, personnel licensing and

out of state lab testing.

• Two States (New York and Washington) are CLIA-Exempt states. Labs in

these states must follow state testing laws.

Specific State Lab

Requirements

STATE LAWS AND

REGULATIONS



Knowledge Check

Scenario

While reviewing PT results, the chemistry supervisor noticed that the laboratory

received an 80% success rate on the glucose analyte. He signed and dated the PT

report without taking any further action. In his monthly report to the laboratory director

he commented that the department passed the PT survey.

COMPLIANCE

PLANS

During an on site inspection, the department could be cited for which

of the following deficiencies? (Check all that apply)

Failure to enroll in a proper PT program

Failure to evaluate all PT failures

Failure to have an analytic quality system

Failure to take proper corrective action steps for PT failures

Failure to report all PT results to the agency

As part of the general laboratory systems quality assessment, CLIA

requires laboratories to review and evaluate proficiency test

performance. By not evaluating the one failed PT result and by not

taking nor documenting any corrective actions taken to address that

failed result, the laboratory is not meeting CLIA requirements for a

general laboratory system quality assessment.

CONCLUSION

I appreciate your help in reviewing all of the

areas Celeste. Before we get started, let’s

review some key points.



• The laboratory must comply with several regulatory agencies

and requirements

• The laboratory should have a “plan” to ensure compliance with

each agency’s requirements

• Your compliance plan should comply with

– federal fraud and abuse standards

– federal privacy and health information standards

– CLIA standards

Quality systems and processes are necessary to provide quality care for

patients and meet regulatory standards.

CONCLUSION

Think about it CONCLUSION

Quality is never an accident. It is always the result of intelligent

effort. - John Ruskin9



You have successfully completed the online learning course:

Developing Model Compliance Plans

Credit is awarded upon successful completion of the post-test.

Access the post-test by exiting the course and returning to the course

content page.

Click the link Post-Test to take the exam. You must score 80% in three

attempts for credit to be awarded.

Interested in applying these best practices on the job?

You can download LMU Educational Tools and Resources from your

Learning Plan in LMU.

Please join the discussion in the Lab Management University online

communities of practice. The more you participate and share, the more

everyone can benefit including you and your team.

Congratulations COMPLETION

REQUIREMENTS

References CONCLUSION

1- Federal register. August 24, 1998. 63 (163). Office of Inspector General website.

Accessed December 12, 2013: https://oig.hhs.gov/authorities/docs/cpglab.pdf

2- Health information privacy. DHHS website. Accessed December 2, 2013:

http://www.hhs.gov/ocr/privacy/hipaa/understanding/index.html

3- 45 CFR Parts 160 and 162- Health insurance reform: Standards for electronic

transactions. Accessed December 12, 2013:

http://aspe.hhs.gov/admnsimp/final/txfin00.htm

4- Clinical Laboratory Improvement Amendments of 1988 (CLIA)—CLIA applicability for

laboratory testing associated ted with blood, cells/tissue, and organs. www.cms.gov

website. Accessed December 12, 2013: http://www.cms.gov/Medicare/Provider-

Enrollment-and-

Certification/SurveyCertificationGenInfo/downloads/SCLetter11_08.pdf

https://oig.hhs.gov/authorities/docs/cpglab.pdf

http://www.hhs.gov/ocr/privacy/hipaa/understanding/index.html

http://aspe.hhs.gov/admnsimp/final/txfin00.htm

http://www.cms.gov/Medicare/Provider-Enrollment-and-Certification/SurveyCertificationGenInfo/downloads/SCLetter11_08.pdf









References CONCLUSION

5- How to apply for a CLIA certificate, including international laboratories. www.cms.gov

website. Accessed December 2, 2013: http://www.cms.gov/Regulations-and-

Guidance/Legislation/CLIA/How_to_Apply_for_a_CLIA_Certificate_International_Labor

atories.html

6- What do I need to do to assess personnel competency? www.cms.gov website.

Accessed December13, 2013: http://www.cms.gov/Regulations-and-

Guidance/Legislation/CLIA/Downloads/CLIA_CompBrochure_508.pdf

7- Clinical Laboratory Improvement Amendments brochure. DHHS website. Accessed

December 2, 2013: https://www.cms.gov/Outreach-and-Education/Medicare-Learning-

Network-MLN/MLNProducts/downloads/CLIABrochure.pdf

8- Categorization of tests. www.cms.gov website. Accessed December 12, 2013:

http://www.cms.gov/Regulations-and-

Guidance/Legislation/CLIA/Categorization_of_Tests.html

9- Quality quotes. Brainy Quote website. Accessed December13, 2013:

http://www.brainyquote.com/quotes/keywords/quality_2.html#QJfxCIK0OowElbCs.99

http://www.cms.gov/Regulations-and-Guidance/Legislation/CLIA/How_to_Apply_for_a_CLIA_Certificate_International_Laboratories.html






http://www.cms.gov/Regulations-and-Guidance/Legislation/CLIA/Downloads/CLIA_CompBrochure_508.pdf







https://www.cms.gov/Outreach-and-Education/Medicare-Learning-Network-MLN/MLNProducts/downloads/CLIABrochure.pdf












http://www.cms.gov/Regulations-and-Guidance/Legislation/CLIA/Categorization_of_Tests.html







http://www.brainyquote.com/quotes/keywords/quality_2.htmlQJfxCIK0OowElbCs.99

http://www.brainyquote.com/quotes/keywords/quality_2.htmlQJfxCIK0OowElbCs.99

developing model compliance programs your faculty · developing model compliance programs- ©apf...

Documents