An Introduction to Laboratory Regulations – Part II (Testing Complexity)

Last month we reviewed the different federal regulatory agencies responsible for establishing laboratory testing guidelines, and a brief overview of the different roles each department has. This month we’ll attempt to demystify testing complexity (waived, non-waived, PPM) and why testing classification matters. Still to come, we’ll review the optional accreditations available to labs, and how accreditation differs from certification.

For all in vitro diagnostic tests, the FDA is responsible for categorizing each test based on their perceived complexity during the pre-market approval process. From least to most complex, the categorizations are waived, moderate complexity, and high complexity. The reason this is important is because with each jump in test category, the CLIA rules associated with performing testing will change – as will the permit designation required to perform testing. This includes things such as QC requirements, validation testing, and personnel requirements to define who can perform testing in the first place.

Waived tests are considered easy to use, with little to no chance that the test result will provide wrong information or cause harm if it is done incorrectly. This includes over-the-counter tests such as home use urine pregnancy kits, where if the sample is applied incorrectly or in insufficient volume there will simply be no result obtained at all. Many Point of Care tests fall under this category, with testing performed in a wide variety of locations including physician offices, urgent care clinics, imaging centers and nursing homes. Locations performing waived testing only are still required to obtain an appropriate CLIA Certificate of Waiver. (See the reference links at the end for a list of all FDA approved CLIA-Waived tests.)

For waived testing, laboratories must follow the manufacturer’s instructions for testing, including the stated FDA approved intended use, without any deviation. If the procedure is modified, or the test is used with specimens not approved by the FDA – the complexity classification of the test will change from waived to high complexity. A common situation where this occurs is with fingerstick whole blood glucometers. Most device manufacturers on the market today for point of care glucose testing are not FDA approved for use with critically ill patients. Using these waived meters for patients deemed “critically ill” based on your local institution’s designation would change the complexity of testing from waived, to high, for this population of patients as it would be considered “off-label use” – meaning you are using it against FDA recommendations and approved forms of use for the test/instrument.

Another caveat to be mindful of is your local state regulations. Certain states (NY, especially) have very strict rules regarding testing complexity designation. In NY, all tests performed within the same designated laboratory space will have the same testing complexity designation. Meaning that if you have a moderate complexity CBC analyzer in the same room you perform your waived urine pregnancy tests – both are now considered moderate complexity. Even though you’re following the manufacturer’s instructions for the pregnancy kit, using only approved specimen types, and the kit is on the FDA approved CLIA-Waived list – that test is now moderate complexity just because it is in the same room as other higher complexity tests. That same pregnancy kit is considered waived when kept separate in the emergency department, but becomes moderate complexity (or higher) when used in the central laboratory.

Nonwaived tests refer to both moderate and high complexity testing. After the FDA has approved a marketing submission, their CLIA categorization of the test follows by utilizing a scorecard to grade the test complexity on 7 different criteria. All phases of testing (preanalytic, analytic and postanalytic) are evaluated in these steps:

  1. Knowledge – low scores require minimal scientific and technical knowledge to perform the test, and knowledge needed can be easily obtained through on-the-job instruction.
  2. Training & Experience – low scores require minimal training and limited experience to perform the test.
  3. Reagents & Materials Preparation – low scores have stable and reliable reagents, and require no special handling, precautions, or storage conditions. They typically come prepackaged, premeasured, and ready for use; whereas high scores may include manual steps such as volumetric measurements and/or reconstitution.
  4. Characteristics of Operational Steps – low scores have automatically executed steps (such as dispensing specific volumes of sample/reagent, temperature monitoring, or timing of steps); high scores require close monitoring or control, precise temperatures or timing, accurate pipetting or extensive calculations.
  5. Calibration, Quality Control, and Proficiency Testing Materials – low scores have all required reagents, controls and PT material commercially available and products are stable.
  6. Test System Troubleshooting & Equipment Maintenance – low scores have automatic troubleshooting or self-correction of errors (failed internal QC will automatically repeat), or requires minimal judgement. Equipment maintenance will be performed by the manufacturer or is minimal and easily performed, whereas high scores require decision-making and direct intervention to resolve most issues, or maintenance tasks require special skills and abilities.
  7. Interpretation & Judgement – low scores require minimal interpretation and judgement for resolution of problems or determination of test results.

Low scores indicate low complexity, with tests obtaining a total score of ≤12 being categorized as moderate complexity. Tests with final scores >12 are categorized as high complexity.

PPM: Within the category of nonwaived tests is a subcategory referred to as Provider Performed Microscopy (PPM). These are tests that are performed directly by a clinician during a patient visit, and require the use of a microscope limited to bright-field or phase-contrast microscopy. Based on the nature of the sample obtained, testing must be performed immediately at the time of collection as delays could compromise the accuracy of test results. As controls are typically not commercially available for these tests, the testing is restricted to clinicians only as knowledge and judgment is required to confirm testing accuracy and correlation to the clinical presentation.

Tests allowed under a PPM certificate are mostly related to OB/GYN procedures, with a full list available through CMS here:

https://www.cms.gov/Regulations-and-Guidance/Legislation/CLIA/Downloads/ppmplist.pdf

So why does it matter?

So the next time you receive a request to add a new test at your laboratory, you’ll be armed with a fairly long list of the requirements that come with that test based on its complexity. Coming up next month we’ll discuss the difference between laboratory certification and accreditation, along with the benefits of obtaining accreditation for your lab.

References

  1. Electronic Code of Federal Regulations: https://www.ecfr.gov/cgi-bin/text-idx?SID=1248e3189da5e5f936e55315402bc38b&node=pt42.5.493&rgn=div5
  2. CLIA-Waived Analytes: https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfClia/analyteswaived.cfm
  3. CLIA Complexity Database: https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfCLIA/Search.cfm?sAN=0
  4. FDA Approved Devices: https://www.accessdata.fda.gov/scripts/cdrh/devicesatfda/index.cfm


-Kyle Nevins, MS, MLS(ASCP)CM is one of ASCP’s 2018 Top 5 in the 40 Under Forty recognition program. She has worked in the medical laboratory profession for over 18 years. In her current position, she transitions between performing laboratory audits across the entire Northwell Health System on Long Island, NY, consulting for at-risk laboratories outside of Northwell Health, bringing laboratories up to regulatory standards, and acting as supervisor and mentor in labs with management gaps.

An Introduction to Laboratory Regulations: Part 1

Everyone who works in a laboratory knows that there are certain rules and regulations to be followed to ensure accuracy in testing, and the safety of both the patient and testing personnel. With all the acronyms floating around (CLIA, FDA, CAP, CMS, TJC) it can get confusing to keep track of who controls what, and which rules apply to your specific lab. In the first installment of this 3-part series on regulations, we’ll review the different federal agencies responsible for oversight and moderation of the laboratory. In part 2 we’ll go further in-depth to demystify testing complexity (waived, non-waived, PPM) and why it’s important to know the correct classification for the tests you perform. Lastly, we’ll review the optional accreditations available to labs, and how accreditation differs from certification.

CLIA

CLIA refers to the Clinical Laboratory Improvement Amendments of 1988. These amendments were drafted to the Public Health Services Act, in which the federal program was revised to include certification and oversight of clinical laboratory testing. Although there have been two additional amendments made after 1988 (1997, 2012), the law still continues to be cited as CLIA ’88 as it is named within legislation.

These CLIA regulations helped to establish quality standards for all U.S. laboratory testing performed on human specimens (except for research) for the purpose of assessment of health, or the diagnosis, prevention, or treatment of disease. The regulations cover all aspects of testing including general laboratory requirements, quality monitors, pre-analytics, analytic performance, post-analytics, and personnel requirements.

In addition to setting the basic ground rules for performing quality laboratory testing, the CLIA regulations also require clinical laboratories to be certified by their state as well as the Center for Medicare & Medicaid Services (CMS) before accepting human samples for diagnostic testing. Laboratories can obtain multiple types of CLIA certificates, based on the kinds of diagnostic tests they perform. In order for laboratories to receive payments from Medicare or Medicaid, laboratories must be properly certified for the testing they are performing and billing for.

There are 3 federal agencies responsible for enforcing the CLIA regulations: The Food & Drug Administration (FDA), Center for Medicaid Services (CMS) and the Center for Disease Control and Prevention (CDC). Each agency has a unique role in assuring quality laboratory testing.

CMS

The Centers for Medicare & Medicaid Services (CMS) is the federal agency responsible for ensuring that the CLIA standards are upheld and enforced. Their responsibilities include the following:

  • Issuing laboratory certificates
  • Collecting user fees
  • Conducting inspections and enforcing regulatory compliance
  • Approving private accreditation organizations (such as CAP) for performing inspections, and approves state exemptions
  • Monitoring laboratory performance on Proficiency Testing (PT) and approving PT programs
  • Publishing CLIA rules and regulations

FDA

The Food & Drug Administration (FDA) is primarily responsible for reviewing and approving new tests, instruments, and equipment used in diagnostic laboratories. They also perform the following tasks:

  • Categorize tests based on complexity
  • Review requests for Waiver by Application from manufacturers
  • Develop rules/guidance for CLIA complexity categorization

CDC

The Center for Disease Control and Prevention (CDC) responsibilities include the following tasks:

  • Provide analysis, research, and technical assistance
  • Develop technical standards and laboratory practice guidelines, including standards and guidelines for cytology
  • Conduct laboratory quality improvement studies
  • Monitor proficiency testing practices
  • Develop and distribute professional information and educational resources
  • Manage the Clinical Laboratory Improvement Advisory Committee (CLIAC)

To summarize, CLIA establishes the rules and guidelines that laboratories must follow to ensure they are providing accurate laboratory results. Federal agencies then work together to support the CLIA amendments and enforce compliance. All certified laboratories will be subject to inspection by regulatory agencies to ensure compliance with the rules. In some cases, your local state Department of Health (DOH) or accrediting agency may be more stringent or have additional requirements to be followed – always go with the stricter requirement to ensure compliance with all agencies.

Coming up next we’ll review how the FDA decides the complexity of each test, and how this designation will affect the CLIA rules to be followed.

References

  1. Electronic Code of Federal Regulations: https://www.ecfr.gov/cgi-bin/text-idx?SID=1248e3189da5e5f936e55315402bc38b&node=pt42.5.493&rgn=div5
  2. Interpretive Guidelines for Laboratories: https://www.cms.gov/regulations-and-guidance/legislation/clia/interpretive_guidelines_for_laboratories.html

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-Kyle Nevins, MS, MLS(ASCP)CM is one of ASCP’s 2018 Top 5 in the 40 Under Forty recognition program. She has worked in the medical laboratory profession for over 18 years. In her current position, she transitions between performing laboratory audits across the entire Northwell Health System on Long Island, NY, consulting for at-risk laboratories outside of Northwell Health, bringing laboratories up to regulatory standards, and acting as supervisor and mentor in labs with management gaps.

Product Recalls and Patient Safety

Manufacturers issue product recall notifications when their product doesn’t perform as it should. A few examples include control materials not performing as expected, instrument software malfunctions, or in-vitro diagnostic devices (IVDs) such as glucometers and hemoglobinometers failing to perform. There are different classification of product recalls according to the Food and Drug Administration (FDA).

  • Class I recall: a situation in which there is a reasonable probability that the use of or exposure to a violate product will cause serious adverse health consequences or death.
  • Class II recall: a situation in which use of or exposure to a violate product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote.
  • Class III recall: a situation in which use of or exposure to a violate product is not likely to cause adverse health consequences.

In some cases, these situations also are considered recalls:

  • Market withdrawal: occurs when a product has a minor violation that would not be subject to FDA legal action. The firm removes the product from the market or corrects the violation. For example, a product removed from the market due to tampering, without evidence of manufacturing or distribution problems would be a market withdrawal.
  • Medical device safety alert: issued in situations where a medical device may present an unreasonable risk of substantial harm.

These notifications require acknowledgement of receipt as well as an action plan to assess if the malfunctioning material or instrument affected patient care. Recalls need to be taken seriously due to the potential of patient harm resulting from inaccurate test results. It’s not uncommon for laboratories to receive non-compliance findings in this area, usually due to lack of documentation and proof of action to assure patient safety.

The Joint commission standard MSE.8.2 requires that an organization has a product/equipment recall system. Element of performance 11(EC.02.01.01) requires that hospitals have a way to respond to product recalls and notices. Accordingly, each laboratory needs to establish a product recall system that includes documentation of any actions taken in response to a Letter of Recall notice. This documentation should include distribution lists to departments in the hospital, acknowledgment of read/action from department (s), initial/ date, identification of the returned/ recalled products affected or confirmation that no products were affected per manufacturer’s instruction, and the patient safety assessment study conducted that’s reviewed and approved accordingly by the department manager and/or quality assessment manager. Management should insure that none of the recalled products were used to conduct patient tests. If the products were used and the resulting potential result inaccuracy might harm patients, communication to the providers and/ or patients, needs to be considered.

 

Information on policies or practices are solely from my personal experience ONLY and have NO relation to my affiliation with any regulatory or government agency.

satyadi

-Caroline Satyadi, MT(ASCP), SM, DLM, SLS, MBA, MS, CQA (ASQ) has been a laboratory management professional for over 25 years. She has worked with several different medical industries for CLIA/CMS, FDA/ICH/ISO, TJC/CAP/COLA/HFAP accreditation survey readiness.

Does Your Laboratory Personnel Meet the CLIA Regulation and Accreditation Requirements?

On December 21, 2012, the Centers for Medicare and Medicaid Services (CMS) published Survey & Certification letter: (S&C-13-07-CLIA) with Brochure #10 on Personnel Competency. It cites the six minimal regulatory requirements for assessment of competency for testing personnel:

  1. Direct Observation of testing procedure
  2. Monitoring the recording and reporting of test results
  3. Review of test results
  4. Performance of instrument Preventive Maintenance
  5. Test performances, i.e. blind unknowns, etc.
  6. Assessment of problem solving skills.

Since early 2013, some CMS surveyors have joined accrediting agencies such as The Joint Commission (TJC) and College of American Pathologists (CAP) in their bi-annual lab accrediting surveys to check testing personnel’s qualification. This qualification includes proof of a minimum education requirement (usually a college diploma). Healthcare organizations need to assure the qualifications for testing personnel are fully met pursuant to the federal, state, and accrediting agency requirements. This includes personnel that perform point-of-care testing (POCT). Because this testing might be performed by non-laboratory staff, these personnel might not have the required education requirements for moderate complexity testing pursuant to the CLIA requirements.

In such cases where the testing personnel licensure is required (for example, by the state) copies of staff diplomas would not be necessary. Licensure is different than certification, which is sponsored by a private sector, nongovernmental institution, such as American Society of Clinical Pathology (ASCP). By requiring personnel licensure, the state government has taken additional measures to protect harm to the public in the state. Currently, there are 12 states with laboratory personnel licensure requirements (California, Florida, New York, North Dakota, Rhodes Island, Tennessee, Louisiana, Nevada, West Virginia, Montana and Georgia). The components of the laws for personnel licensure vary from one state to another; it usually involves a fee, a continuing education provision, and a minimum education requirement, and a professional competency requirement.

Due to the economic situation in the United States and the laboratory workforce shortage, some state government agencies have not actively enforced all compliance aspects among healthcare organizations. For example, some laboratories allow medical lab technicians (MLTs) to perform high-complexity testing due to the medical lab technologists’ (MTs) shortages across the country. However, according to CLIA regulations, MLTs should only work in moderate complexity testing areas that require limited independent judgments. The high complexity testing environments that include blood banking, microbiology identification procedures, microscopy, etc. require a high level of independent judgment and should only be performed by MTs.

Technical supervisory positions in the clinical laboratory require a minimum of five years technical experience. It would not be in compliance with the regulations when the clinical laboratory general supervisors are chosen from MLTs or related field, such as cytology or histology or radiology. Healthcare organizations need to assess their lab personnel qualification and competency to assure that they are meeting the standard requirements pursuant to CLIA regulations, state regulations, and accreditation requirements.

If you’d like more information about these regulations, please read the Code of Federal Regulations part 493.

 

Information on policies or practices are solely from my personal experience ONLY and have NO relation to my affiliation with any regulatory or government agency.

satyadi

-Caroline Satyadi, MT(ASCP), SM, DLM, SLS, MBA, MS, CQA (ASQ) has been a laboratory management professional for over 25 years. She has worked with several different medical industries for CLIA/CMS, FDA/ICH/ISO, TJC/CAP/COLA/HFAP accreditation survey readiness.

Prime Time: the Fine Line Between Innovation and Regulation

We live in an age of wonders. New technologies with new and usually improved capabilities are springing up far faster than we can keep up with them. And those new technologies occasionally revolutionize not only the field they spring up in, but other, sometimes unrelated fields. A good example of this is how tandem mass spectrometry revolutionized newborn screening (NBS). An instrument and test system once considered essentially a research tool has led the way to improving and standardizing NBS across the United States. Because this is true we must always be ready and willing to learn about the newest technology. However, sometimes it’s difficult to walk that fine line between leaping ahead too fast and not moving ahead at all.

In the laboratory field, and the medical field in general, a LOT of checks and balances are in place, many of them in the form of the regulations and controls we love to hate so much. If you are going to be possibly putting a person’s health, well-being or even life on the line, the level of checks and balances becomes totally understandable and even necessary. However, we must be careful not to refuse to see new technology because it doesn’t fit the mold of our current regulatory environment. Sometimes in order to move forward, we must reinvent the regulations as well as the technology. A good example of this was learning to deal with and regulate electronic quality control when instruments like the I-STAT were introduced to the field.

There can be an incredibly fine line between stifling innovation and having necessary and appropriate controls in place. It takes an astute eye, keen insight, and understanding of not only the new technology, but also the purpose and design of the regulations. It’s not enough to blindly follow the letter of the regulation. We must ask ourselves: What was the intent of the crafters? Why is this important? Is there a way to make sure the new technology meets the regulation? Can the regulation be reinvented to make sure the new tech does follow the intent of having that regulation in place? Next generation sequencing has been struggling to perform this balancing act since its inception. We do not wish to sacrifice neither our ability to create and innovate, nor our need for safety and “do no harm.” When an innovation enters the laboratory, we need to make sure both it and the regulations which monitor its performance are “ready for prime time.”

 

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-Patti Jones PhD, DABCC, FACB, is the Clinical Director of the Chemistry and Metabolic Disease Laboratories at Children’s Medical Center in Dallas, TX and a Professor of Pathology at University of Texas Southwestern Medical Center in Dallas.