Compliance Information and Courses from MediaLab, Inc.

Examples of administrative safeguards include:Policies and proceduresStaff training programsAuditing and monitoring compliance with policies and proceduresEmployee confidentiality agreements

A record keeping system is a vital component of an internal quality control program. Record keeping systems include: instrument maintenance logs calibration logs temperature logs water quality logs quality control results quality control chartsEach log includes: date time name of employee performing check or maintenance results description of maintenance performed problem description problem solving and verification stepsThe record keeping system can be used to: monitor compliance with quality control procedures train employees in problem detection and problem solving help prevent instrument breakdowns evaluate service personnel performance identify topics for continuing education programs help ensure reliable patient results

A clinical laboratory director is responsible for the overall administration of the clinical laboratory. Responsibilities include:Hiring other laboratory personnelOverseeing performance and reporting of accurate test resultsVerifying the laboratory's compliance with federal and state lawDelegating certain administrative duties to supervisorsBeing available for on-site, telephone, or e-mail consultationEnsuring that test methods and procedures, quality control, and verification methods provide reliable and accurate resultsEnsuring compliance with quality control and quality assurance programsMonitoring laboratory employees and identify those who need remedial trainingSelecting which tests the laboratory offers and which employees may perform themEstablishing and maintaining patient identification and billing procedures

The government believes that fraud, abuse and waste exist in the healthcare industry today because of cases it has settled and prosecuted.All healthcare providers, including laboratories, make billing errors.The Office of Inspector General (OIG) believes that honest members of the healthcare community can police themselves if they receive guidance.The OIG has published Compliance Program Guidance documents for health care providers, including laboratories.

An effective compliance program includes seven basic elements.Element 1: The laboratory has written and distributed to all affected employees standards, policies and procedures that instruct employees in the proper legal and ethical conduct expected in all areas of business the laboratory conducts.These policies must be adhered to by all employees regardless of status or position in the company.

The laboratory has established a comprehensive training and education program about the laws and regulations that govern the laboratory and the standards, policies and procedures of the compliance program. Mandatory for all employees regardless of status or position in the company. There is additional training for those employees who work in higher compliance risk areas of the laboratory such as billing, marketing, and sales. This interactive software is a component of that training program.

Element 6: The laboratory monitors and regularly audits compliance activities, policies and procedures to ensure they are being followed.If a problem is detected through the audit or monitoring process, it should be reported to the appropriate supervisor, manager or the CO.

Documentation of compliance activities is the responsibility of all employees. All forms must be completed and properly filed. All procedures must be followed and properly documented. If documentation of compliance activities cannot be established during an audit or investigation, the government will assume that the compliance program is not being followed. Release of test results by phone, fax and other non-routine methods: Employees should release test results only to the person who ordered the test. Never release test results to another physician or entity unless authorized by the ordering physician in writing. Never release the results of a test to a patient unless authorized in writing by the ordering physician.

The HCFA (Health Care Financing Administration) Common Procedural Coding System (HCPCS) and the CPT (Current Procedural Terminology) codes are used to describe specific tests or services. The amount of payment for a test is dependent on the HCPCS or CPT code. HCPCS or CPT codes should be assigned under the supervision of the laboratory technical staff. Billing department employees should never change a HCPCS or CPT code without the approval of a manager or compliance officer. If a billing department clerk notices that a particular HCPCS or CPT code is being rejected by a payer they should report it to their manager. It is against the law to use the wrong HCPCS or CPT code for the purpose of causing or increasing payment for a test.

Behavior of the manager will set the tone for employees.Managers must have good attitude about compliance.Managers should encourage problem detection and reporting by responding properly.Never guess at the answers to questions.Attend training and education sessions with employees when possible.

The laboratory should not offer or provide free testing to any individual in a position to make or control referral for laboratory services: The laboratory may write off charges only when laboratory errors in billing or testing occur. Sales and marketing personnel cannot offer free testing in any form unless approved by the compliance officer. Free testing for indigent patients must be approved by the compliance officer. Sales and marketing personnel cannot offer or give anything of value to a customer or potential customer beyond the usual promotional items. If a client solicits a questionable or illegal item or special consideration, it should be reported to the sales manager or compliance officer.

Laboratories may only lease space from physicians who refer Medicare patients to them under certain circumstances: There must be a written lease for at least one year. Lease price must be at "fair market value." All leases must be reviewed by legal counsel to ensure compliance with antikickback and Stark laws.When leasing or renting equipment to a physician or from a physician the same basic rules apply as for space.If the laboratory is located in a hospital, the relationship between the hospital and a physician who refers to the lab may have antikickback or Stark implications.

The setting is the cafeteria in a hospital or the lounge in an independent laboratory. Two employees from different departments are old friends are having lunch together. A billing clerk and a medical technologist are friends and are having lunch together. The billing clerk mentions that she saw a bill go through the system for one of her coworkers for a biopsy. She asks the medical technologist if she has the necessary security level access to see pathology test results because she is concerned about the welfare of the coworker. The medical technologist does have the necessary security clearance to see the results. She should:Correct Answer: Refuse to look up the results for the clerk and remind the clerk that it is a violation of compliance policies to do so, or to ask another to do so. Remind her of the requirement for each employee to report any violations of policy. Discussion: The Medical technologist has a responsibility to report violations of compliance policies and the friend has put her in a difficult position. For that reason, it is not enough to just refuse the clerk's request. If the medical technologist does not take the responsibility to inform the employee of the policy then there is a possibility that the employee would ask some other employee to do it for her.

The Client Services department which is a crowded room divided into cubicles which contain desks separated only by thin moveable dividers. Lots of activity, phones ringing, multiple conversations going on at once etc. A client service representative receives a call from a large client office that she speaks with every day for a variety of reasons. Today the client is requesting the laboratory to write off the charges for a test that the office person ordered incorrectly by mistake even though the laboratory has already done the test and reported the results back to the office. Since this service representative works with this office frequently she believes that this is a rare request. Actions that the client service representative may take are:Correct Answer: Refuse to write off the charges for the test and inform the client that it could be considered an inducement if the laboratory does that, which would make both the laboratory and the office liable should it ever come to light. Offer whatever billing options are available according to lab policies. or Refuse to write off the charges and explain to the client that approval must be obtained from the department manager or the laboratory compliance officer before any action can be taken because writing the test off could be considered an inducement.Discussion: The primary reason is that the test is not written off simply because the client asks for it to be done. Tests should never be written off by the laboratory automatically. There should always be an approval process involved or a policy that strictly forbids any write off except in the case an error on the part of the laboratory where documentation exists to support it.

Busy hospital laboratory in a 350 bed urban hospital that provides laboratory testing for the hospital and for the hospital's outreach testing laboratory. A medical technologist in the microbiology department receives a call from a friend who works in a laboratory in a physician office. The physician is not a regular client of the laboratory currently but uses another laboratory for most of their work. The microbiologist knows that the sales department would like to get this account. The friend explains to her that she is doing a quality control check on her in-office microbiology testing and her regular laboratory will do it but is going to charge her for it. She asks the microbiologist if she will do it for free since it is quality control, not Medicare and is not going to be billed to anyone.She tells the microbiologist that she would like to use the hospital lab for everything but her doctor insists on using the competitor. She indicates that the favor might help get the doctor to try the hospital laboratory for other tests. The microbiologist should:Correct Answer: Explain to her friend that if the hospital does the tests for no charge on the promise of other referrals, both the physician office and the hospital could be liable for violations of the antikickback statute.Discussion: The antikickback statute is implicated in this scenario because the free testing is solicited on the condition that other referrals may occur as a result of providing the favor. In fact, the solicitation itself is a violation of the law. The fact that Medicare patients are not specifically mentioned in the scenario is not sufficient to remove the risk. The technologist should also report the incident to the Compliance Officer and seek advise about what documentation, if any, should be kept concerning the incident.

An employee has certain responsibilities: Voluntary Compliance Programs should detect and prevent billing errors and fraud in the clinical laboratory. Compliance programs must be effective to be beneficial in case of an investigation. Compliance is every employee's responsibility regardless of status or position in the company. All employees are subject to disciplinary action if they violate compliance policies or laws. Employees must understand their responsibility to report any problems or suspect activity they encounter in the laboratory. Employees will not be disciplined for reporting problems. Employees should use the Hotline or other established anonymous reporting system if they are afraid of retribution.

In December of 1991, OSHA issued a standard to guard against occupational exposure to bloodborne pathogens.This standard, part 1910.1030 of the Code of Federal Regulations was published in the Federal Register.On November 27, 2001, OSHA published a compliance directive 2-2.69 that now includes the revisions to the original standard.These regulations are law!

TDM provides a quantitative measure of the circulating concentration of a drug. The physician determines if the dosage of the drug needs to be adjusted based on this information.If a drug concentration is determined to be outside the therapeutic range, it may be for one of the reasons listed in the table below. Reason Discussion Noncompliance Patients may (intentionally or unintentionally) not take the drug. TDM can thus help monitor compliance. Dosing errors The dose may have been erroneous or inappropriate given the patient's condition. Malabsorption The TDM result will reveal if the drug cannot be absorbed well through the gut and an alternative route of administration will be needed. Drug interactions Many drugs interfere with the absorption or metabolism of other drugs. These interactions will be revealed by TDM. Kidney or liver disease Any pathology that affects elimination will cause an elevation in a drug level that will be unmasked by TDM. Altered protein binding Changes in serum proteins can lead to big changes in the amount of free drug in serum. Variations in the genetics of drug-metabolizing enzymes can also affect drug concentrations in the body. This is the field of pharmacogenomics that will be discussed later in the course.