A Complete Guide to Understanding Compliance Issues in Clinical Laboratories

Compliance is not just about following the laws; it is important for long-term success. Clinical labs are facing regulatory compliance issues in the dynamic healthcare industry and it is leading to financial and reputation damage.

Clinical laboratories are one of the most highly regulated areas of medicine and are properly governed by the regulatory bodies. They should maintain the quality of laboratory testing and the healthcare professionals must comply with the regulations.

What Is Regulatory Compliance?

Regulatory compliance means following all the standard procedures, laboratory billing policies, and HIPAA regulations to provide the best lab services. The multiple regulatory bodies that provide guidelines for clinical laboratories include the following;

• Clinical Laboratory Improvement Amendments (CLIA)
• US Food and Drugs Administration (FDA)
• Good Laboratory Practices (GLP)

Significance Of Regulatory Compliance

Laboratory professionals need to stay compliant with regulations of patient data privacy and financial practices. Here’s how complying with these regulations can be beneficial for the laboratories as it;

• Improves the laboratory servicestandards
• Helps clinical laboratories to avoid violation penalties
• Corrects their Revenue Cycle Management (RCM).
• Ensures the protection of patients’ information
• Guarantees the integrity of labs in handling information
• Boosts the confidence of healthcare professionals in the lab results
• Prescribes the best-fitting healthcare solutions
• Generates accurate CPT/ICD codes for laboratory billing services.

And what if the labs fail to maintain regulatory compliance? It can cause serious implications concerning the Lab operations, finances, and reputations.

Top 10 Compliance Issues in Clinical Laboratories

The inspection team targets different areas of lab businesses to check how they regulate their procedures. Some laboratories pass through these inspections while some don’t. So, if your lab has to go through this process, it will revolve around these areas of lab compliance violations.

Let’s see what every healthcare professional should know about the highlighted regulatory compliance challenges in the industry.

1. Managing Discounts for Out-of-Network Patients

Managing discounts and waivers for out-of-network patients is one of the most recurring compliance challenges. Clinical laboratories focus on providing the best possible laboratory services to their patients. Also, they ensure that patients have easy access to lab services regardless of their insurance coverage plans.

Reputed laboratories like CureCloudMD offer discounts for particular lab tests. However, offering such discounts can potentially trigger violations of federal laws like

• Eliminating Kickbacks in Recovery Act (EKRA)
• Anti-Kickback Statute (AKS)

The clinical labs provide financial assistance to patients, particularly those without healthcare insurance. However, this act opens the gates for

• HIPAA violations
• EKRA violations
• Noncompliance with the AKS Act

Thus, it becomes compulsory to set up a written financial assistance policy for clinical labs to minimize the risk of making a regulatory violation and avoid penalties.

2. Challenges in Specimen Collection

Specimen collection protocols become quite challenging because of the lack of phlebotomists-networks.

Larger labs can collect specimens through networks of phlebotomistsand patient service centers. Whereas, smaller labs often fail to carry out the process efficiently. To reduce this problem, some clinical laboratories agree with others to collect specimens on their behalf.

These specimen collection agreements may trigger compliance issues for the laboratories. For instance, in 2022, the Health and Human Services Office of Inspector General (HHS/OIG), issued an advisory opinion regarding payments to clinical labs on a pre-patient-encounter basis for specimen collection protocols.

As per the HHS opinion, this type of agreement may provoke theAnti-Kickback Statute because itinvolves compensation from other entities (clinical labs).

3. Telefraud and Criminal Enforcement Actions

In recent years, the U.S. Department of Justice (DOJ) has keenly observed the telefraud schemes.

What Are These Schemes?

The laboratories carry out fraudulent orders for their services that had been attained due to telemedicine visits. Such unfair orders are submitted to clinical laboratories for testing and billed to Medicare and other third-party payers.

What Steps Should the Labs Take to Reduce the Telefraud Schemes?

Following are the ways to minimize the risk of engaging in fraudulent schemes unintentionally.

• Clinical labs should remain cautious regarding doubtful sources
• They must review the backgrounds of referring clinical labs
• They must incorporate such checks as part of their compliance strategy

4. Strict Calibration Standards for clinical labs

Strictcalibration standards are essential to ensure the accuracy and precision of laboratory instruments. Improper calibration distorts the lab results and ultimately affects patient diagnosis and treatment decisions.

Key calibration standards are as follows;

• Clinical Laboratory Improvement Amendments (CLIA) come under the domain of CMS.
• It regulates calibration standards for clinical laboratories involved in testing specimens.
• It requires quality control measures such as regular maintenance and proficiency testing that ascertain the accuracy of the equipment used for testing.
• ISO 15189  is an international standard used for developing quality management systems and assessing the competence of laboratories. This standard ensures that the labs adopt a procedure for maintaining and calibrating instruments and they should be bound to comply with ISO.

5. Preventive Maintenance

Preventive maintenance in clinical labs ensures the reliability, accuracy, and compliance of lab equipment with regulatory standards. Regular inspection of equipment prevents contamination and mechanical failures.

Temperature-sensitive equipment like refrigerators and incubators require continuous maintenance to ensure optimal conditions. Proper record-keeping is essential for tracking performance and meeting regulatory guidelines of FDA, CAP, and ISO.

• CAP Certification Requirements – The College of American Pathologists provides strict guidelines for instrument maintenance, calibration, and quality assurance. Clinical labs need to maintain records of calibration activities and undergo proficiency testing to ensure precise results.
• Regulatory guidelines of FDA (U.S.) – The FDA regulates laboratory instruments classified as medical devices. So, the manufacturers’ medical devices should pass quality control and validation standards to provide accurate results.
• ISO 17025 –Proper maintenance of equipment is considered essential to achieve accurate and reliable test results. As per this ISO standard, labs should adopt good procedures for routine calibration, maintenance, and equipment verification.
• ISO 13485 – This ISO standard also demands maintenance and calibration of instruments used for providing laboratory services

6. Data Integrity and Documentation

Clinical laboratories should ensure integrity and proper documentation to maintain regulatory standards for laboratory services. Data integrity means;

• Data Accuracy
• Data Completeness
• Reliability of information

Similarly, documentation integrity pertains to the correctness of recorded information. Data integrity and proper documentation also help clinical labs generate accurate billing codes for laboratory billing services.

How To Enhance the Data Integrity?

The data integrity can be improved through safe electronic systems like;

• Electronic health records (EHR)
• Laboratory Information Management Systems (LIMS)

Clinical labs can also take assistance from reputed medical billing partners like Curecloudmd for laboratory billing solutions.

Can The Laboratories Comply with All the Laws and Regulations?

No, it is quite challenging for Clinical laboratories to comply with laws and regulations imposed by CLIA, HIPAA, and ISO simultaneously.

• CLIA sets standards for managing documentation and record-keeping
• HIPAA focuses on protecting patients’ information
• ISO describes the competency of testing laboratories and proper documentation

7. Training and Competency of Staff

Lack of staff training and competency are two major reasons causing compliance issues for clinical labs. In the ever-evolving healthcare industry, HIPAA, CLIA, and FDA bring new regulatory standards for improving the quality of laboratory billing services.

New CPT Codes and ICD-10 codes are introduced to provide better laboratory services. Under this dynamic situation, clinical laboratories should train their employees regarding advanced laboratory billing practices.

8. Medicare Enrolment Issues

Medicare enrolment is a matter of great concern for clinical labs because it ensures lab revenue originating laboratory billing services.

Why Does a Lab Get Disenrolled?

CMS can cancel the enrolment of labs anytime because of

• Filing claims that do not satisfy Medicare requirements
• False and misleading information presented in its enrolment application

So, the labs should be ‘operational’ and ‘open for inspection’ by Medicare and should be in proper communication with the latter regarding their closure and relocation to avoid compliance problems.

9. Handling Out-of-Specification (OOS) Results

What are the Out-of-specification (OOS) results? These include all test results falling outside the specifications or acceptance criteria established in drug applications, drug master files (DMFs), official compendia, or by the manufacturer.

Laboratories must establish an SOP for managing out-of-specification results, including retesting, equipment checks, and, of course, corrective actions. Because, if OOS results are not handled properly, it may induce noncompliance.

10. Adherence to Good Laboratory Practices (GLP)

Good Laboratory Practices (GLP)ensures the accuracy and reliability of lab results. Unfortunately, clinical laboratories are seen violating GLP and the reasons include;

• Lack of investment
• Under-trained staff
• Poor management
• Pressure to deliver results
• Complexity of law

FDA and CMS frequently conduct audits to ensure the implementation of good laboratory practices. Noncompliance with these triggers’ strict actions against Laboratories, such as;

• Disqualification of labs
• Claims denials for laboratory billing services

The Verdict!

By and large, the ever-evolving healthcare industry offers great challenges for clinical labs. To ensure effective compliance, labs can use advanced software like EHR and LIMS to handle laboratory billing services.

Ready to get the Best Laboratory Billing Services? Curecloudmd is the perfect choice!

Want to ensure regulatory compliance and boost your RCM with specialized laboratory billing services? Contact CureCloudMD and stay ahead of HIPAA, CLIA, and CMS regulations effortlessly!