The Complexity of Compliance in Clinical Specimen Collection

In the United States, the Clinical Laboratory Improvement Amendments (CLIA) were introduced to the Public Health Services Act in 1988. CLIA laws, which have been amended several times since their inception, oversee clinical lab testing and certification, including specimen collection. Navigating the many stages, challenges, and situations presented by specimen collection while remaining compliant is a difficult task for labs of all sizes and specialties. 

Maintaining integrity during chain of custody 

The chain of custody process spans the full journey that a patient sample will take, from collection to processing and testing completion. The name illustrates the passing of responsibility from one healthcare professional to the next as a clinical sample makes its way from the collection site to the testing lab and eventually to storage. This includes eight distinct stages:

1. Collection: The specimen is collected from the patient at a medical laboratory services lab either by the patient, if possible, or by a specialist such as a phlebotomist. 
2. Labeling: The sample is labeled by the lab professional with the patient’s name, date of birth, medical number, and unique specimen identification number. Labels are then securely attached to the sample to ensure identification during the subsequent processes. 
3. Transportation: The sample is transported in appropriate containers to the site of testing. During transport, chain of custody documentation accompanies the sample and specimen integrity is expected to be diligently maintained through humidity and temperature control, and usage of medical-grade, sample-matched storage vessels. 
4. Reception: The specimen is received at the testing lab and specific tests are ordered. Detailed, up-to-date documentation ensures proper handling and traceability during processing. 
5. Processing and analysis: The specimen undergoes the procedures entailed by the ordered tests. Complete documentation of processing steps is required to ensure the correct testing protocol is carried out, quality control is maintained, and laboratory information system (LIS) documents are up to date.
6. Storage: The specimen may be stored for future testing or reference purposes, but must be stored under conditions that minimize integrity loss and stability. Documentation must continue to accompany the sample during this period. 
7. Reporting: The test results will be reported back from the test facility to the ordering physician through an electronic transmission or printed report. The report must include any results, interpretive comments, storage/testing conditions, and be privacy protected. 
8. Disposal: After testing is complete and the sample is no longer needed, it will be destroyed along with unnecessary documentation. Documentation required for future reference will be filed. 

Discerning the challenges of compliant specimen collection

A variety of personnel are involved in the specimen collection process, and each stage of the collection process comes with a unique set of compliance and regulatory requirements. From the phlebotomist to the specimen collector or clinical laboratory assistant, every person has a role in the collection lab. Collection of patient samples requires high levels of regulatory compliance on two sides: The samples themselves and the information attached to them, and the patient identification assigned to these samples and test results derived from them. 

There are a number of challenges that clinical lab staff encounter when collecting compliant samples. These include:

1. Multiple regulatory requirements: In addition to CLIA, there are requirements such as the College of American Pathologists (CAP) and the Food and Drug Administration (FDA) testing requirements for compliance maintenance. 
2. Diverse testing protocols, since clinical labs often perform a wide range of testing on an even wider range of different specimens, each of which must be stored and transported in a way that maintains sample integrity. 
3. Adequate training such as safe handling, OSHA, and maintenance of documentation for all levels of staff to ensure regulations are met. 
4. Handling staff turnover, which is a frequent problem for some clinical labs. 
5. Equipment maintenance, ensuring calibration and documentation are current and correct for compliance purposes.
6. Industry external factors such as healthcare policy changes, reimbursement regulations on behalf of government or insurance agencies, or industry guideline changes. 
7. Novel technology emergence, prompting a shift in procedures, protocol rewrites, or equipment upgrades to maintain compliance. 
8. Supply chain factors including storage and management, which require a high level of control and precision for clinical sample integrity maintenance. 
9. Errors, contamination, and mishandling are all human mistakes that can be made during collection and transport. Mitigating these risks is crucial in maintaining compliance, which requires not only documenting these events but also taking steps to reduce their prevalence and impact.
10. Being prepared for routine audits and inspections is mandatory for clinical labs, and they must ensure practices and documentation are aligned with current requirements. 

Common problems faced by patients of clinical labs 

The need for meticulous record-keeping in the clinical lab goes beyond the need for regulatory compliance. The patient is directly impacted when mishandling of samples, loss of integrity, or paperwork problems arise, and the consequences can be dire. Incomplete documentation, patient misidentification, or damage to sample integrity can all result in incorrect or no results reaching the individual and their healthcare team who need them. In particular, this emphasizes the need for precise and thorough documentation for every patient case, and is why the paperwork demands for regulatory compliance are high. 

In addition to paperwork, there are other problems that can negatively affect patients and impair the compliance rating of a particular lab: 

• Lack of communication, leading to incorrect patient self-sampling (contamination of the sample, lack of fasting, and other errors) 
• Privacy concerns: If a medical lab faces a data breach, this costs not only compliance standing but results in patient distrust 
• Accessibility barriers such as limited clinic hours, transportation, or language barriers can cause unintentional documentation errors

All of these potential problems can cost a clinical lab their patients, regulatory compliance, and reputation. Ensuring good documentation and clinical practice is essential for good business standing and compliance. 

The vital role of the lab manager in the clinical specimen collection process 

As the supervisory body over this precise and regulated process, the lab manager is in a pivotal role to ensure all of the above conditions are met as daily operations are executed. Clinical samples demand stringent management to maintain the integrity of the chain of custody. As well as compliance documentation, the lab manager must ensure that other documentation such as the Clinical Laboratory Standards Institute (CLSI), American Association of Blood Banks (AABB), and National Academy of Clinical Biochemistry (NACB) licensing may also be required, depending on the type of samples handled at the medical laboratory services company or clinical lab. 

Juggling these needs and monitoring the expiration dates of all documentation is a responsibility that cannot be overstated in the clinical specimen collection and transportation process. Robust quality control and assurance protocols throughout specimen collection and transport processes are crucial. Lab managers must ensure that they are continually improving their documentation and processes to best serve the needs of their patients and lab employees.