Ask the Expert
| Article Date: 5/31/2007 |
Sharps Containers in Pediatric Practices
Q. Our pediatric practice has added computers to some of the exam rooms, and to make room for the monitors, sharps containers were moved beside the exam table. Since your March “Ask the Expert” column only mentioned the OSHA regulations, the office thinks that the sharps containers are in the best location for the staff. I think their placement is a dangerous liability for our practice. Is there somewhere specifically that states where sharps containers cannot be placed? I’ve included pictures of an exam room. Also, please comment about the location of the sharps containers above the light switches. Can you suggest a location? Thanks for your help
A. In the first three exam room pictures you sent, the sharps container is placed in an area that meets OSHA regulations, but I understand your concerns about the safety of your pediatric patients. Perhaps it is better placed on the adjacent wall where it will be out of reach of little hands but remain within arm’s length of caregivers. In the last picture, the sharps container is not directly over the switch, so it’s acceptable.
HPV Test For Doctor’s Offices?
Q. Is there an HPV test that can be performed in physician offices? What ever happened to the mandate for HPV vaccination?
A. At this time, the only tests for high-risk human papilloma virus (HPV) are DNA- based and highly complex (both from a CLIA standpoint and from a technical standpoint). Because of this, they’re available only in large referral labs.
Merck’s Gardasil vaccine continues to spark a morality debate. Some folks contend that immunizing girls against a sexually transmitted disease such as HPV might lead to more premarital sex. I’m not too sure about this, unless they give the girls those little “I’VE BEEN VACCINATED AGAINST HPV” badges, marking them as easy targets for the affections of randy schoolboys. I can’t imagine a young girl, enticed into the back seat of a car, thinking about her HIV/HCV/HPV/GC/BV/COOTY status and saying ….”What the heck, I’m protected against HPV”!
So far, 24 states are considering laws to mandate HPV vaccines for girls entering sixth grade (6th grade????), but most medical professional societies and the CDC support only voluntary vaccination. Up to now, vaccines mandated by the government have been for diseases that are spread casually. If a kid comes to school with measles, it's going to rapidly spread to unvaccinated kids. Hopefully, kids are at lower risk for HPV in school, although….close your eyes if you have teenagers…..CDC says 25% of kids entering ninth grade are sexually active.
HIV Screening
Q. You mentioned in a previous column that the CDC wants those between 13 and 64 years old to be screened for HIV. Is this annually or a one-time test?
A. It’s a one-time test repeated annually only for those at high risk, such as those who behave badly or already have a bloodborne disease such as hepatitis C. Also, test during pregnancy in the first and third trimester. If the woman's HIV status is still unknown at the time of labor, run a rapid HIV test, and administer antiretroviral prophylaxis.
To make it faster and easier to screen in physician offices using a CLIA-waived rapid HIV kit, the CDC suggests scrapping the signed consent and pre-test counseling, except in high-risk settings such as STD clinics. If the patient declines an HIV test, document this decision in his medical record.
The CDC also urges clinicians to test patients with symptoms of acute HIV infection, which resemble those of influenza, mononucleosis and other viral illnesses. Also test patients with opportunistic illnesses associated with AIDS.
The big question that arises from these Guidelines is who will pay for this testing? For more details from CDC, see the 2006 Surveillance Summary in the Morbidity and Mortality Weekly Report.
Mercury Ban?
Q. We are opening a new practice and the person in charge of the process says that mercury blood pressure units are now banned. Is this a state or federal law? We’re in Michigan.
A. Mercury is not banned nationwide, but several locales have partially or totally outlawed mercury use in healthcare and home settings. A new Michigan law will prohibit the sale and use of mercury-containing sphygmomanometers and the sale of mercury containing gastrointestinal devices beginning Jan 1, 2008. These two items represent the largest use of mercury in medical facilities, with leaks and accidental spills exposing people to harmful mercury vapors. For a complete list of states that impose restrictions on mercury use, visit http://www.hcwh.org/us/mercury/ordinances.
Sharps Containers in Hallways
Q. Our practice is setting aside one exam room for seeing psychiatric patients and drug abusers. For obvious reasons, we want no sharps containers in this room; rather, we want to hang one on the wall outside the room. Is this an OSHA violation?
A. Yes. OSHA requires that sharps containers be located within close proximity-about arm’s length- to where a procedure is being performed. It’s definitely an OSHA violation for a healthcare worker to walk out of an exam room to dispose of a sharp, even if a safety needle is in use. Since it’s also a violation to keep sharps containers inside locked cabinets, solve your problem by using pocket-sized sharps containers that can be taken in and out of the room by the caregiver.
Lab Logs: Required or Recommended?
Q. We do only CLIA-waived tests and one of my new employees insists that we need to keep a Lab Log. We’ve gotten along fine without one all these years and I really don’t want to create more paperwork if it isn’t a legal requirement. Do we have to have a log?
A. There is no requirement for CLIA-waived labs (or non-waived labs for that matter) to keep a Lab Log. The only reason to have one is to be able to quickly look up test results by date and see who ordered and performed the test. This is most important when needing to cover one’s derriere such as when a CLIA inspector asks for this information, so usually only non-waived labs use Logs for organizing their testing. Other physician office labs achieve the same objectives using patient charts, superbills or electronic medical records. As long as somewhere in your system this information exists (patient name, ID #, date, time, test performed, test results and who performed the test), feel free to go without a log.
Physician “Exempt” From Using Safety Needles
Q. One of our physicians says he is exempt from having to use safety needles. Which procedures are exempt?
A. Ha - that’s a good one! There are no exempt procedures per se, but apparently this guy thinks he is exempt. Does he also believe he’s exempt from other laws, such as speed limits? If so, he’s a legend in his own mind!
Seriously, the only person in a medical practice that is exempt from having to use safety needles is the employer, and that’s only when he/she doesn’t involve employees in any way when using unsafe sharps. This means not leaving dirty, uncapped needles on a tray for others to clean up or passing a sharp to someone else during surgery.
For most medical practices, physicians who are sole proprietors and in partnerships are employers. Physicians in other business arrangements, including most corporations, are employees and are required personally to use safety needles.
The only other excuses for an employer to not provide employees with safety needles are: 1. The product is not commercially available. 2. The product is not available in the size needed to perform the procedure. 3. The product interferes with the patient procedure. OSHA inspectors didn’t fall off the turnip truck yesterday! They know that 85% of the injection needles and phlebotomy devices in use today are the safety versions, and that there are hundreds of types of safety needles on the market, so they will cite practices that haven’t switched for common procedures.
CLIA-Waived Chemistry Test Panels
Q. We’d like to do chemistry panels in our office but we’re low volume and CLIA-waived and don’t want to upgrade to moderately complex. Are there any CLIA-waived chemistry analyzers that do tests other than lipids?
A. Yes. In addition to lipid panels (cholesterol, HDL, triglycerides), Abaxis’ Piccolo analyzer provides 13 CLIA-waived chemistries. Cholestech’s LDX analyzer is another choice with glucose, lipid and liver panel tests.
Q. Our pediatric practice has added computers to some of the exam rooms, and to make room for the monitors, sharps containers were moved beside the exam table. Since your March “Ask the Expert” column only mentioned the OSHA regulations, the office thinks that the sharps containers are in the best location for the staff. I think their placement is a dangerous liability for our practice. Is there somewhere specifically that states where sharps containers cannot be placed? I’ve included pictures of an exam room. Also, please comment about the location of the sharps containers above the light switches. Can you suggest a location? Thanks for your help
A. In the first three exam room pictures you sent, the sharps container is placed in an area that meets OSHA regulations, but I understand your concerns about the safety of your pediatric patients. Perhaps it is better placed on the adjacent wall where it will be out of reach of little hands but remain within arm’s length of caregivers. In the last picture, the sharps container is not directly over the switch, so it’s acceptable.
HPV Test For Doctor’s Offices?
Q. Is there an HPV test that can be performed in physician offices? What ever happened to the mandate for HPV vaccination?
A. At this time, the only tests for high-risk human papilloma virus (HPV) are DNA- based and highly complex (both from a CLIA standpoint and from a technical standpoint). Because of this, they’re available only in large referral labs.
Merck’s Gardasil vaccine continues to spark a morality debate. Some folks contend that immunizing girls against a sexually transmitted disease such as HPV might lead to more premarital sex. I’m not too sure about this, unless they give the girls those little “I’VE BEEN VACCINATED AGAINST HPV” badges, marking them as easy targets for the affections of randy schoolboys. I can’t imagine a young girl, enticed into the back seat of a car, thinking about her HIV/HCV/HPV/GC/BV/COOTY status and saying ….”What the heck, I’m protected against HPV”!
So far, 24 states are considering laws to mandate HPV vaccines for girls entering sixth grade (6th grade????), but most medical professional societies and the CDC support only voluntary vaccination. Up to now, vaccines mandated by the government have been for diseases that are spread casually. If a kid comes to school with measles, it's going to rapidly spread to unvaccinated kids. Hopefully, kids are at lower risk for HPV in school, although….close your eyes if you have teenagers…..CDC says 25% of kids entering ninth grade are sexually active.
HIV Screening
Q. You mentioned in a previous column that the CDC wants those between 13 and 64 years old to be screened for HIV. Is this annually or a one-time test?
A. It’s a one-time test repeated annually only for those at high risk, such as those who behave badly or already have a bloodborne disease such as hepatitis C. Also, test during pregnancy in the first and third trimester. If the woman's HIV status is still unknown at the time of labor, run a rapid HIV test, and administer antiretroviral prophylaxis.
To make it faster and easier to screen in physician offices using a CLIA-waived rapid HIV kit, the CDC suggests scrapping the signed consent and pre-test counseling, except in high-risk settings such as STD clinics. If the patient declines an HIV test, document this decision in his medical record.
The CDC also urges clinicians to test patients with symptoms of acute HIV infection, which resemble those of influenza, mononucleosis and other viral illnesses. Also test patients with opportunistic illnesses associated with AIDS.
The big question that arises from these Guidelines is who will pay for this testing? For more details from CDC, see the 2006 Surveillance Summary in the Morbidity and Mortality Weekly Report.
Mercury Ban?
Q. We are opening a new practice and the person in charge of the process says that mercury blood pressure units are now banned. Is this a state or federal law? We’re in Michigan.
A. Mercury is not banned nationwide, but several locales have partially or totally outlawed mercury use in healthcare and home settings. A new Michigan law will prohibit the sale and use of mercury-containing sphygmomanometers and the sale of mercury containing gastrointestinal devices beginning Jan 1, 2008. These two items represent the largest use of mercury in medical facilities, with leaks and accidental spills exposing people to harmful mercury vapors. For a complete list of states that impose restrictions on mercury use, visit http://www.hcwh.org/us/mercury/ordinances.
Sharps Containers in Hallways
Q. Our practice is setting aside one exam room for seeing psychiatric patients and drug abusers. For obvious reasons, we want no sharps containers in this room; rather, we want to hang one on the wall outside the room. Is this an OSHA violation?
A. Yes. OSHA requires that sharps containers be located within close proximity-about arm’s length- to where a procedure is being performed. It’s definitely an OSHA violation for a healthcare worker to walk out of an exam room to dispose of a sharp, even if a safety needle is in use. Since it’s also a violation to keep sharps containers inside locked cabinets, solve your problem by using pocket-sized sharps containers that can be taken in and out of the room by the caregiver.
Lab Logs: Required or Recommended?
Q. We do only CLIA-waived tests and one of my new employees insists that we need to keep a Lab Log. We’ve gotten along fine without one all these years and I really don’t want to create more paperwork if it isn’t a legal requirement. Do we have to have a log?
A. There is no requirement for CLIA-waived labs (or non-waived labs for that matter) to keep a Lab Log. The only reason to have one is to be able to quickly look up test results by date and see who ordered and performed the test. This is most important when needing to cover one’s derriere such as when a CLIA inspector asks for this information, so usually only non-waived labs use Logs for organizing their testing. Other physician office labs achieve the same objectives using patient charts, superbills or electronic medical records. As long as somewhere in your system this information exists (patient name, ID #, date, time, test performed, test results and who performed the test), feel free to go without a log.
Physician “Exempt” From Using Safety Needles
Q. One of our physicians says he is exempt from having to use safety needles. Which procedures are exempt?
A. Ha - that’s a good one! There are no exempt procedures per se, but apparently this guy thinks he is exempt. Does he also believe he’s exempt from other laws, such as speed limits? If so, he’s a legend in his own mind!
Seriously, the only person in a medical practice that is exempt from having to use safety needles is the employer, and that’s only when he/she doesn’t involve employees in any way when using unsafe sharps. This means not leaving dirty, uncapped needles on a tray for others to clean up or passing a sharp to someone else during surgery.
For most medical practices, physicians who are sole proprietors and in partnerships are employers. Physicians in other business arrangements, including most corporations, are employees and are required personally to use safety needles.
The only other excuses for an employer to not provide employees with safety needles are: 1. The product is not commercially available. 2. The product is not available in the size needed to perform the procedure. 3. The product interferes with the patient procedure. OSHA inspectors didn’t fall off the turnip truck yesterday! They know that 85% of the injection needles and phlebotomy devices in use today are the safety versions, and that there are hundreds of types of safety needles on the market, so they will cite practices that haven’t switched for common procedures.
CLIA-Waived Chemistry Test Panels
Q. We’d like to do chemistry panels in our office but we’re low volume and CLIA-waived and don’t want to upgrade to moderately complex. Are there any CLIA-waived chemistry analyzers that do tests other than lipids?
A. Yes. In addition to lipid panels (cholesterol, HDL, triglycerides), Abaxis’ Piccolo analyzer provides 13 CLIA-waived chemistries. Cholestech’s LDX analyzer is another choice with glucose, lipid and liver panel tests.
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