Ask The Expert

I was told by my Medical Supply Rep that I would not have to do anything for Quality Control with a product his company is offering. Does this sound right?

Ah, the infamous Medical Supply Rep. Sales is their business, and business is good! Most MSRs (medical supply reps) are not laboratorians and do not know the ends and outs of CLIA. Their job is to sell you a product, not make sure you meet regulations. With this in mind, we will now take out our Number 2 pencils and take a test.

True or False

1. Quality control is never required on waived tests. 

2. Once the testing personnel review the manufacturer's instructions for a test, it is not   necessary to review them again. 

3. Documented training is not required of testing personnel in a waived lab. 

4. A waived lab can perform CBCs if the test is not billed. 

5. Quality assurance is not required for PPM labs.

The correct answer to all of these questions is "False." Being a CLIA waived or PPM lab does not mean that there are no specific regulatory criteria for the POL to adhere to.

Under the CLIA regulations, POLs with a Certificate of Waiver (COW) may perform only those tests that have been classified as waived. POLs with a Provider Performed Microscopy (PPM) certificate may perform tests, using a microscope, during the course of a patient visit on specimens that are not easily transportable, along with the waived tests. The microscopic exam can only be performed by the physician or nurse practitioner.

Waived labs are required by CLIA to:

·         Enroll in the CLIA program 

·         Pay applicable certificate fees biennially 

·         Follow manufacturers' test instructions

The number and types of tests waived under CLIA have increased from 8 tests to approximately 100 since the inception of the program in 1992; as a result, the number of waived labs has grown exponentially from 20% to 54% of the total 171,000 laboratories enrolled.

PPM labs are required by CLIA to:

·         Enroll in the CLIA program 

·         Pay applicable certificate fees biennially 

·         Address certain quality and administrative requirements

PPM labs represent 22% of the laboratories in the United States; consequently, 76% of the labs have no direct routine oversight (inspections or surveys). The regulations do provide for inspections of waived and PPM labs in certain situations.

Pilot Studies

In 1999, the states of Colorado and Ohio initiated on-site inspections of a random sample of CLIA waived and PPM labs as a result of the increases in the types of tests waived, the large number of labs with no oversight and the CLIA defined deficiencies found during complaint investigations of these waived labs. CMS reported that significant quality and certification problems were identified in over 50% of the inspected labs. If quality problems were found, the inspectors provided educational support to the labs to help them ensure accurate results. The study further showed that 10% of the labs in Ohio and 7% of the labs in Colorado were testing beyond their certificate. Between October 2000 and January 2001 CMS expanded the pilot to include eight additional states throughout the US in order to follow-up and verify the scope and seriousness of the initial findings, The states included Arizona, Idaho, Iowa, Massachusetts, Mississippi, New Mexico, New York, and Pennsylvania. Using Colorado and Ohio's pilot as a model, CMS inspected 2.5% (or 436) of waived and PPM labs in the selected states. The quality problems found under the expanded October 2000 through January 2001 survey process were:

Problems in Waived Laboratories

32% failed to have current manufacturer's instructions
32% did not perform QC as required by manufacturer or CDC
20% cut occult blood cards and urine dipsticks
19% had personnel who were neither trained nor evaluated
16% failed to follow current manufacturer's instructions
9% did not follow manufacturer's storage and handling instructions
7% did not perform calibration as required by manufacturer
6% were using expired reagents/kits
23% had certificate issues (i.e., change of name, director or address)

It is worth noting that 21% of the inspected waived labs voluntarily participate in proficiency testing and/or performed QC beyond the manufacturer's instructions. Additionally, none of the labs were found to be operating in a manner that posed immediate jeopardy.

Problems in PPM Labs

38% had no PT (did not evaluate test accuracy 2 times a year)
36% had no microscope/centrifuge maintenance
28% no director approved procedure manual
25% did not document personnel competency (QA)
23% had certificate issues ( wrong name on certificate, etc.)

So, what do you really need to do if you are a Waived or PPMP lab?

Use the most recent package insert of manufacturer's instructions. Kit instructions may change slightly from lot to lot - date the insert with the date the shipment was received as documentation. 

Perform quality control and/or calibration as specified by the kit manufacturer – most of the test kits receiving waived status after the publication of the CLIA 88 regulations have specific quality control requirements. Maintain the QC documentation for two years. 

Use the test kits/reagents in the form they are received; do not alter reagent strips by cutting them in order to test more samples per strip. 

Store and handle all test kits according the manufacturer's instructions. 

Never use outdated reagents. Date your kits when received and opened. Also indicated when the kit expires. Note- Most kits have a shortened expiration once opened.

Document training of all testing personnel in their personnel file – training for each test and test method is required. Update the training records whenever a test method changes (either the method or the manufacturer). 

Inform the POLs surveying agency of any change in status of the lab (e.g., change in the medical director, practice name, address, etc.).

Monitor room and refrigerator temperatures for tests that are affected by temperature or humidity. (See the package insert)

Follow all OSHA regulations that pertain to laboratory testing (e.g., Bloodborne Pathogens regulations). See  HYPERLINK "http://www.osha-slc.gov/dts/oom/bbp.html" \o "OSHA" \t "_blank" http://www.osha-slc.gov/dts/oom/bbp.html for additional information.

Hi, many months ago, someone had sent in a question asking how to disinfect medical equipment.  I never had a chance to go online to read the answer and I was wondering whether you could tell me the best way to do it.  Thank you for any help you can provide.

That is a good question. Are you old enough to remember the Lysol commercials from the seventies? The tag line was that Lysol “cleans and sanitizes”. It sounded great! Problem is, “sanitizes” means the exact same thing as “cleans”. So now you can say to your child to “Sanatize your room, right now, young man!”

First, we need to clarify what disinfection is and is not. The following are definitions to help clarify things.

Disinfection means the use of a chemical procedure that eliminates virtually all recognized pathogenic microorganisms but not necessarily all microbial forms (e.g., bacterial endospores) on inanimate objects. There are three levels of disinfection: high, intermediate, and low. High-level disinfection kills all organisms, except high levels of bacterial spores, and is effected with a chemical germicide cleared for marketing as a sterilant by the Food and Drug Administration. Intermediate-level disinfection kills mycobacteria, most viruses, and bacteria with a chemical germicide registered as a "tuberculocide" by the Environmental Protection Agency (EPA). Low-level disinfection kills some viruses and bacteria with a chemical germicide registered as a hospital disinfectant by the EPA.

Sterilization means the use of a physical or chemical procedure to destroy all microbial life, including highly resistant bacterial endospores. The major sterilizing agents used in hospitals are a) moist heat by steam autoclaving, b) ethylene oxide gas, and c) dry heat. However, there are a variety of chemical germicides (sterilants) that have been used for purposes of reprocessing reusable heat-sensitive medical devices and appear to be effective when used appropriately, i.e., according to manufacturer's instructions. These chemicals are rarely used for sterilization, but appear to be effective for high-level disinfection of medical devices that come into contact with mucous membranes during use (e.g., flexible fiberoptic endoscopes).

Heat stable reusable medical devices that enter the blood stream or enter normally sterile tissue should always be reprocessed using heat-based methods of sterilization (e.g., steam autoclave or dry heat oven). 

Laparoscopic or arthroscopic telescopes (optic portions of the endoscopic set) should be subjected to a sterilization procedure before each use; if this is not feasible, they should receive high-level disinfection. Heat stable accessories to the endoscopic set (e.g., trocars, operative instruments) should be sterilized by heat-based methods (e.g., steam autoclave or dry heat oven). 

Reusable devices or items that touch mucous membranes should, at a minimum, receive high-level disinfection between patients. These devices include reusable flexible endoscopes, endotracheal tubes, anesthesia breathing circuits, and respiratory therapy equipment. 

Medical devices that require sterilization or disinfection must be thoroughly cleaned to reduce organic material or bioburden before being exposed to the germicide, and the germicide and the device manufacturer's instructions should be closely followed. 

Except on rare and special instances, items that do not ordinarily touch the patient or touch only intact skin are not involved in disease transmission, and generally do not necessitate disinfection between uses on different patients. These items include crutches, bedboards, blood pressure cuffs, and a variety of other medical accessories. Consequently, depending on the particular piece of equipment or item, washing with a detergent or using a low-level disinfectant may be sufficient when decontamination is needed

If you have questions about a low- or intermediate-level disinfectant and certain sterilants, contact the manufacturer, or the Antimicrobial Program Branch, Environmental Protection Agency (EPA) hotline (703) 308-0127 or email:  HYPERLINK "mailto:info_antimicrobial@epa.gov" info_antimicrobial@epa.gov. 

The EPA is the federal regulatory agency for low- or intermediate-level disinfectants and some sterilants. The EPA usually is very responsive on their hotline numbers

If you have questions about high-level disinfectants (sterilants), or how to clean, disinfect or sterilize a particular medical device, first contact the manufacturer of the product. If you are unable to obtain sufficient information in this manner, contact the Food and Drug Administration (FDA) regional office or the FDA Center for Devices and Radiological Health at (301) 443-4690. 

The FDA is the federal regulatory agency for safe and effective use of medical devices and is now also responsible for regulation of chemical sterilants. The FDA regulates so many things these days that it is sometimes difficult to get a person who knows how to locate the information you need. (Your tax dollars hard at work)

Lastly, I can recommend a couple of good products for general disinfecting of hard surfaces. One is PDI™: Sani-Cloth Plus -Surface Disinfectant. These are pop-up towelettes that are great for cleaning countertops and the exterior surfaces of medical equipment.

Another is Caltech™: Dispatch Disinfectant Spray with Bleach. This is a rapid acting spray cleaner/disinfectant that is very effective, very quickly.