Biometric Scanning On Your i-Phone But Not at Your Local Hospital

So - you got a nice new i-Phone 5 equipped with that neat biometric scanner!  You can scan your finger tips, your nose, your toes, even your nipple will work to identify you to your new cell phone.  That is really cool.  You can even have your i-Phone open up to your spouse or significant other by scanning their appendages too.  Isn't it great how science betters our lives?

Why don't hospitals employ this now commonly available method for human identification in Emergency rooms and admitting offices?  I sure don't know why?  With the risks of health care fraud so great in today's dangerous world why would a hospital not employ this method to identify visiting patients? Let's explore the science of biometric scanning, how it works, and why this technology should be mainstream but is not.

My first exposure to biometric scanning was at the GA DDS - Dept.of Driver Services office when I applied for a drivers license in GA.  My finger was scanned at the office then I was issued my drivers license.  My next encounter with a biometric scanner was with my wife' Leslie of  Leslielovesveggies new i-Phone 5.  Now it is all the rage on that new Apple device.  No more remembering a pass code to open your phone.  Just swipe your finger, her finger, or my finger!  But, biometric scanning is not new.  The use of biometric scanning has been employed to identify humans and our pets for many years although identifying pets requires a chip implanted under the skin.  That is a big no-no for civilized humans.  However, humans have excellent physical traits that are perfect for biometric scanning such as finger print, vein recognition, eye recognition, palm scanning, on and on.  You name a part and it can identify quickly and noninvasively.  Biometric scanners for the finger or palm read the patterns in the skin and/or veins then archive the image in a database tied to your identity.  This method of identification is used all over the globe to open doors for employees, open safes for the rich, identify the sick at the hospital and the not so nice folks at the jail.

There is one country across the globe that uses biometric scanning practices to identify its population; India.  As of 2013 nearly 600 million people in that huge country have been identified in the largest database of its kind.  Countries such as Australia, Brazil, and Germany all use biometric scanning to identify its population to some degree.  So what is biometric scanning for the identification purpose?  It is the use of a scanning device capable of capturing distinctive attributes or traits selectively identifying a human being, storing those captured attributes in a database, with capability of matching scanned attributes to match identities.  Biometric scanning can use finger print, palm print, vein recognition, facial recognition, or iris scan.  The first time identity is established with biometric scanning methods is called "enrollment".  Identity is confirmed thereafter with verification which matches a scan against database knowledge to confirm identity.  Simple right?  Well not exactly.  Finger prints wear out, iris characteristics change, faces change and that can produce false reads or naive reads. With the development of more sophisticated multi modal systems false read rates can be eliminated.

So why if this technology is widely available, easy to use, and is non-invasive do so many health care facilities not use biometric scanning to identify patients?  Health care can be administered safely and accurately if we properly identified patients?  EHR or Electronic Health Record is so important to keep accurate but is so easy to become compromised, stolen, or abused.  Your EHR is worth hundreds of thousands dollars to the criminal element. Defrauding a hospital Emergency Room is not hard.  Hijacking your medical record and financial health information is not that much more difficult.  The only way to stop medical fraud is by positively identifying the patient.  So here is an example.  You have health insurance but your brother does not and he needs some acute treatment, maybe some stitches for a laceration or he needs antibiotics for a festering skin lesion right?  So he goes to the hospital that you have gone before recently.  He walks in with no ID but says he is Mr. SO&So Smith.  He arms his memory with his brothers SS# and some other background info such as his employment, address, telephone number.  Bingo! He looks like his brother, almost the same age, ba-da-bing he now is the brother.  Wam-Bam out the door discharged with treatment covered by his brothers insurance or worse Medicaid/Medicare. Don't think it happens?  I have a bridge at the western tip of Long Island for sale.  It is a steal at One Million Dollars - yeah that's the ticket....

Anyway, that is just one way how hospitals, doctors offices, clinics, and pharmacies are defrauded by health record hijacking and identity abuse.  The only way to stop it is by positively identifying the patient.  Estimates are as high as 28$ million per hour for health care fraud and abuse in the United States.  The FBI is in charge of investigating Health Care Fraud and has tips on prevention .  Their investigations in 2010 totaled up to $80 billion dollars in health care fraud.  The FBI has a long mugshot list [Mug Shots]of individuals wanted for Conspiracy to Commit Health Care Fraud.  With government health care spending poised to balloon into $Trillions per year the criminal element is just salivating at the chance to hijack your health record and set up criminal operations like none seen before.

Here is an example of how you can be a victim of Medical Identity Error resulting in financial harm. Suppose you are sick and go to the hospital for treatment.  You have been there before and you trust the care you will get.  The patient registration person gathers your identification and then finds you in the hospital database.  Your name is Jim or Jane Smith.  You know how many J. Smiths are in any given hospital database?  Well, your visit at the ER is matched up to J Smith alright, except he is James Smith, who is HIV +  and owes the hospital thousands of dollars in bad debt and unpaid bills.  Bingo, you now own James Smith' medical bills and a disease that is mandated to be reported.

Up till now I have just been talking about the financial risks associated with health care fraud deliberately perpetrated by criminals for financial gain or by error.  What about the "Medical Errors" that occur across this country on a daily basis?  Errors you say?  There are errors in health care?  Why yes. According to the American Association For Justice preventable deaths from medical errors average 98,000 deaths per year.  An error starting with patient identification can be deadly!
 Here is another example; Suppose your wife is ill and you take her to the ER.  She has been there before, they have a record of her because she is diabetic, and also highly allergic to certain preparations of insulin. The staff identify her and but register her under a medical record one number off of her true medical record number because of a data entry typo error on the keyboard.  In the ER she gets real bad and goes into Diabetic coma.  The doctor gives insulin but now your wife goes into anaphylactic shock because it is the wrong insulin. A few short minutes go by and your wife is in ICU, nearly dead, clinging onto life.  Hours go by and you think she is ok for the night so you go home for some rest.  Your awakened by hospital staff in the early hours to come to the hospital without any further explanation...

These are just a  few scenarios that could happen because of patient mis-identification.  Hospitals have a process whereby duplicate medical records are reconciled into one.  Sometimes when you visit a hospital ER the computer system is down for some reason so all patients are registered on paper record which is then entered into the computer database systems later.  You will be given a temporary medical record number until your visit can be reconciled to you historical records. This is called "MRN Merging". Not so bad if you truly do have a duplicate EHR and the two are merged together.  But what if the merge is incorrect?  Catastrophic consequences can be produced in some cases.  Your blood type can be changed, you can suddenly acquire a disease you never had before, or you can unexpectedly own debt that is not yours or your insurance company' responsibility.

So why do health care facilities not want to positively identify their patients?  There are less than 300 hospital facilities in the United States that employ biometric scanning to correctly identify their patients?  They may have the most expensive and sophisticated equipment on hand but will ask you who you are to identify yourself.  If you have picture ID use it but some people show up at the ER without ID.  The reasons why health care facilities do not use biometric scanning are:

• $$$Expense - Biometric scanning Systems and the database management tools used to identify patients and relate this data to EHR is expensive.  Probably the most common reason this technology has not been adopted to main-stream health care practices.

• Abuse of such databases has great financial enticement - the sale of such biometric identification data is a lucrative proposition for those who will have access.  However, the penalties for sharing PHI - Protected Health Information are steep and can include jail time for those found guilty of Health Care Fraud Conspiracy.

• Civil Rights activists and privacy proponents hate anything that positively identify the population and store such identification in databases.

Well then, it is a two way street.  Maintain privacy but then risk acquiring the medical record of someone else.  Raise the level of health care safety at the expense of losing anonymity?

I would much rather be positively identified when it comes to serious medical treatment like surgery, pharmaceuticals, or transfusions than be mis-identified or have my medical record abused for financial gain by someone else.

What can you do to protect yourself..

1. When you visit your doctor or most importantly a hospital make note of your MRN.  Next time you go back compare that number to any new registrations or visits to make sure the registration process identifies you properly.
2. Carefully monitor EOB- Explanation of Benefits that you receive in the mail.  Report any inconsistencies to the hospital , insurance company, medicare (CMS), or your doctor.
3. Carefully monitor your bank statements and credit card statements for any suspicious  or unknown healthcare charges and take action immediately if anything suspicious shows on a statement.
4. Never give any personal information about yourself over the phone.  A "scammer" might get a hold of your name and phone number to call you asking about your last visit to a health care facility as a Customer Service Survey.  Hoping to gain additional information; you may be asked for this information directly on the call or purposely asked to verify incorrect info so that you can "Correct the Records".
5. If you have a choice of hospitals to go to and one uses biometric scanning and one does not, go to the one with biometric scanning.  Tell the staff you came because they can positively identify you.
6. Call your local hospital and request they start using biometric scanning for identification and that would make you more confident making a visit.

Good luck my friends.  Its a dangerous Health Care World out there.

Scott R. Mayorga A.A.S., BS MT(ASCP)H CLS

For more information on health care fraud  and biometric scanning click the links below.
NHCAA

Clinical Laboratory Licensing and Certification; What is the difference?

Laboratory Certification - Laboratory Licensing - What does it all mean?

 With over 239,000 clinical laboratory facilities registered in the US under CLIA - Clinical Laboratory Improvement Amendments; the public can get quite confused about regulations, certification, and licensing of these facilities.  Under CLIA, there are 29 different categories of Clinical Laboratories.  These can range from a mobile facility on wheels, health fares, hospital labs, and the mega reference labs performing millions of tests per year.  Various States operate licensing or permit programs of clinical labs.  The employees working the lab bench performing the testing of specimens are regulated by certification agencies and State level licensing via each locale.  So what is Laboratory certification?  What is the difference between certification and licensing?  Can a laboratory be certified but not licensed?  Can labs be licensed but not certified?  Can labs lose either certification or licensing and continue to operate?  I will try to answer these questions and explain concepts which can be confusing to laboratory consumers.  What is a Laboratory Consumer?  A lab consumer is you, me, the patient in general.  The doctor orders blood testing for us.  We go to a laboratory to submit specimens for testing, or the Doctor collects  specimens in the office and labs pick them up, or hospital staff come to your bed side to collect specimens.  Your specimens are received in a lab facility and tested.  Laboratory results are then delivered to the doctor who ordered your tests.  We are all consumers of lab testing facilities.  You do have a choice of who, what, where your specimens go for analysis.  What about that lab data?  What is a lab result?  What is lab data?  Laboratory data is the data produced within the laboratory from analysis of specimens; Unconfirmed data.  Clinical Laboratory Scientists test specimens by various methods and instrumentation.  Until that data is confirmed it is just that - data.  Once the data is verified as accurate and under control then the data is confirmed as laboratory results.  Lab results are then conveyed to the doctor for his or her evaluation.  This is a crucial concept to understand.  Lab data is subject to all sorts of regulations, guidelines, control, and evaluation before the data is declared laboratory results.  Just because a lab instrument issues numerical data does not mean that data is ready to be used to evaluate your medical condition or asses the health of an individual.  If quality control checks fail during the analysis of my specimen then the analysis is flawed and must be repeated and evaluated.  If my specimen does not meet guidelines for analysis then a new specimen must be obtained for testing.  Lab results are reported to our doctors.  Lab data is the unverified numbers or raw data issued by the testing method.  You nor I want lab data reported to the doctor.  We want verified lab results being perused by the doctor.

Laboratory licensing is sometimes synonymous with the Lab Permit.  Laboratories are a business.  Labs pay taxes to cities, states, and the federal government.  Various fees, registration fees, rent for building space, etc.  are paid by clinical labs.  A lab must have a permit to operate and test specimens.  Depending on the location of the lab facility a state permit is required and issued by the state department of health to the laboratory on an annual, bi-annual, or some other time period basis.  Renewal is required.  Some states also require inspection of the laboratory facility to maintain license or a lab operator permit.  To complicate the licensing issue, some specimens are collected from patients and transported across state lines or across the country to a central testing facility.  In those cases, the state where the specimens originate have jurisdiction over the performing laboratory no matter where the lab is located.  I personally know of a clinical laboratory that holds national certification but lost a state license due to revocation.  Even though this is a laboratory with quality processes, this facility is analyzing specimens without proper license from a state where samples are collected and jurisdiction is owned.  These lab results reported to physicians are reliable however there is great liability and risk if this facility where to be embroiled in a litigious process.  Basically, in absence of proper licensing laboratories are a risk to public health - especially when there is revocation involved.

Certification is the process a clinical laboratory under takes to gain prestige amongst other clinical laboratories and other competing laboratories; competing for our business.  Is certification of a clinical laboratory required?  No.  However, certification can be a supporting factor in the permit or licensing procedure of a laboratory.  Just depends on the licensing body of that facility.  Various organizations can certify clinical laboratories; the most notable is CAP - College of American Pathologists.   CAP certification is optional is some states or locales; however, that is a tricky road to embark on if you are a lab owner.  CAP certification is often inter-twined in the licensing procedure.  Just depends where the lab is physically located.  Hospitals can also be monitored/certified by JCAHO - Joint Commission on Accreditation of Health care Organizations.

CLIA Certification is different than lab certification described above.  CLIA certification is the permit or license if you will issued by the federal government so that a clinical laboratory can receive payment from CMS - Centers for Medicare and Medicaid Services.  A lab must be CLIA Certified to receive payments for testing specimens of patients enrolled in medicare or medicaid.

So, now that we know about laboratory certification and licensing what now?  Is this important?  Should a patient be concerned about these concepts when they visit their doctor for a check up?  The answers are yes, yes.  There are labs out there that either are not certified, not licensed, or have lost license or certification, or otherwise there is a lapse of one, both , or the other.  If there is a loss of either license or certification the big question is why?  Did the loss occur because of quality issues, performance issues, or some sort of regulatory infraction?  Either way, would you want your specimens used to screen your health analyzed by a laboratory that has lost certification or license?  I think not.  Do you feel comfortable bringing your car to Joe Smoe shade tree mechanic or your next door neighbor to fix your transmission?  No you don't and you would not do that.  You want someone who knows what they are doing and can prove it. The same with a clinical laboratory.  You want your specimens analyzed at a fully licensed, boastfully certified laboratory that can prove it 24/7/365.

But does a patient really have a choice where their specimens wind up to be tested?  Well sort of.  That depends on their doctor.  Some doctors have business relationships with clinical laboratories.  There is much federal regulation about this area of health care involving the prevention of kick-backs by labs to referring doctors.  The relationship is a loose agreement that the lab will pick up specimens and deliver medical reports to the doctor and may also provide supplies to collect specimens.  Anything more than that basic arrangement between doctor and laboratory and someone is going to jail.  There has been recent re-occurrence of kick-back payments by labs to doctors whereby thousands of dollars are passed to the doctor each year for the lab business from the doctor.  Prosecution of these cases has resulted in doctors going to jail for a long time.

However, you do have a choice where your specimens go.  When the doctor orders testing the order can be written on paper, or script.  You can take that script and go to any lab of your choosing.  You can do your own research and verify the certification and or licensing of labs and go to the one you are satisfied with.  Otherwise, you can let your doctor choose where the specimens go.

Be wise about your health care and be an informed consumer of health services.  Not all labs hold the proper license and certification to perform testing of your laboratory specimens.

To find a CAP Accredited Laboratory near you anywhere in the world click this link:
CAP
To find Laboratories that hold License with New York State DOH click this link:
NY State Clinical Laboratory Permit Holders
To find a licensed laboratory in Florida click this link;
Florida Laboratories
For more info about Laboratory Certification and certification of Clinical Laboratory Scientists
click this link; ASCP

Scott R. Mayorga
A.A.S., BS MT(ASCP)H CLS
Straight Talk From The Hematech

How to Pass the NGSP A1c Proficiency Testing Survey Like a Pro

 Proficiency Testing (PT) of clinical laboratories is an important part of Laboratory Quality Assurance

All clinical laboratories participate in subscription type PT such as (CAP) or CDC Lipid Survey in addition to State Sponsored PT programs such as N.Y. State DOH or PA DOH, etc.  One of the toughest most difficult PT surveys to pass in my opinion is either the CDC Lipid Survey or the
NGSP - National Glycohemoglobin Standardization Program.
HBA1c is a component of Hemoglobin that is glycated (Hemoglobin + Glucose) at normal levels in patients with normal sugar metabolism.  Individuals with diabetes do not metabolize sugars normally and therefore glucose levels in the blood are erratic leading to all sorts of ancillary disease states of the kidneys and circulatory system as well as negatively affecting ones vision and propensity to develop infections.  Good glucose control is the key to surviving with diabetes for an extended lifetime.  Those with poor control of glucose suffer many different ways on a daily basis and do not live a long life time.  As a clinical laboratory it is for the good of all people to be able to produce the most accurate reproducible data possible day after day, patient after patient, normal and abnormal.  Passing a HBA1c CAP survey is good but passing NGSP is better.  Then there are some patients that have a Hemoglobin make up that interferes with all HBA1c testing methods. For more info on that click here;Testing interference with HBA1c

NGSP is a subscription PT testing program that challenges all aspects of a laboratories glycohemoglobin testing including the testing platform, reagents, calibrators, user technique, and ancillary equipment.  NGSP is the ultimate PT QA program for ensuring quality in testing and reproducible results in HBA1c testing.  Click here for more info about obtaining certification. The data analysis of the NGSP PT results are so exact and statistically critical; passing this survey a difficult endeavor to undertake.  I know, I have managed a laboratory that successfully passed the NGSP for 5 years straight while employed at that lab.  Possibly not as excruciating to pass as the CDC Lipid Survey which I also participated in and actually visited the laboratory at the CDC in Atlanta that prepares the specimens for the CDC Lipid Survey.  I sat down to talk with the director in charge of administering the CDC Lipid Survey program; that was really neat.  The next CDC Lipid PT I had overseen passed as well.  Although, continued success with the CDC Lipid PT is almost impossible under the scrutiny of any manager.

Let me tell you about my experience with the NGSP PT Survey and offer some helpful hints to any laboratory wishing to endeavor down the path of NGSP Certification.  NGSP is a certification process whereby a laboratory, instrument vendor, or other entity is awarded certification for one year.  Renewal of the certification occurs on an annual basis on the certified labs anniversary.  There are 4 testing events throughout the year including the certification or re-certification process and 3 quarterly testing events.  Each testing event consists of small samples shipped from NGSP HQ on dry ice to the subscribing laboratory.  Each testing event must be completed within stipulated time period with results emailed, shipped, or otherwise electronically returned to the NGSP program for analysis.
NGSP will statistically analyze submitted laboratories data and compare against other certified laboratories.  The comparison performed may be against same method or different methodology.  It really doesn't matter who is used as comparison.  NGSP is the standard by which all instruments, methods, and laboratories are compared to.  Your lab either compares or does not.  If your lab compares well enough on the certification PT process Level II certification can be obtained.  If your lab performs really well, Level I Certification is obtained.  Currently for 2013, there are 138 laboratories worldwide that are certified with 100 certified as Level I labs.  There is a reason why some lab can only achieve Level II certification - The process is arduous, difficult, stressful, and fraught with possible minute unknown errors in testing that can skew results tenths of a percentage which can make any lab a Level II lab.  It is rather stressful simply because the annual expense  is $5000 USD for a Level I lab and once you achieve Level I and the status the certification brings to a lab it is terrible to lose that status.  NGSP and the directorship of that program are globally recognized as experts in HBA1c metabolism, testing, testing methods, and testing procedures not to mention a fine PT program with astute statistical data analysis.  If your lab is contemplating NGSP Certification then buckle up ~ you are in for a rough ride.  Put up your money and get prepared to take a beating.

Ok lets get started - What do you need to know?
1st - NGSP is not your run of the mill CAP survey.  There are more samples to test than CAP and lets face it passing a CAP survey for HBA1c is like driving a car through the Lincoln Tunnel.
 CAP HBA1c 2013 Summary  The data analysis applied to the NGSP  survey program is exacting and tight.  There is no room for error and minute changes in instrument function form day to day will bring you down to Level II fast.
2nd - Do your homework.  Go to NGSP on the World Wide Web and look around.  See who is listed as Level I and Level II.  Make sure you take note of the manufacturers and what they routinely pass as either Level I or Level II.  If a particular instrument can't routinely make Level I what makes you think you can do better with the same instrument on your lab bench with your scientists? If you don't have a Gold Standard method think about getting a Gold Standard method Such as Tosoh or Bio-Rad before going down this lonely country road to NGSP Certification.
3rd - Make sure you have well trained scientists who can tell the instrument is not running right on a minutes notice and can rectify issues expertly.  Also, make sure your maintenance program is fastidious and complete without lapse.  Make sure your chemistry is spot on.  Everything about your instrument has to be perfect or even Level II will be out of your grasp.
4th- If you currently have QC ranges that you can drive a city bus through (> 0.3% HBA1c on any given level of Quality Control) and use every tenth of that range on a monthly basis you are going to fail miserably.  Don't even think about NGSP if you can't handle an sd of 0.1 across your whole testing linearity.  Your lab will fail miserably otherwise.
5th - Once Level I Certification is obtained a Level II testing event will place your lab on "Probation".  Passing the next quarterly event with Level I is a necessity otherwise your Lab will be officially graded as Level II for your poor Level II two testing event performance.  

So- you have the nerve to force your scientists to a 0.1 sd under much grumbling from them and you are confident for several months like that.  Go ahead - go for it.  Just know that one little slip of the wrist during pipetting, diluting off by tenths of a %, and any maintenance lapses will cause unknown suffrage and possible failure.  Even Level I labs suffer an inconsistent Level II testing event now and then; in five years of straight NGSP testing I had two Level II events; that was 90% Level I for 5 years.  If you consistently use the same instrument, the same scientist, the same pipettes, chances are your consistency will prevail a strong Level I performance time after time.  But, that is not reality.  If you have the stomach like I do you will monitor everything like a crazy nut ensuring that no matter what instrument, what scientist, what pipette, what Lot number of reagent, and what calibrators are used, and dam those torpedo's. I passed year after year after year.  Yeah - that's how you do it.  I had 6 instruments and 7 scientists and rotated amongst them all with expert success.  Am I bragging - You Bet! "Don't try this at home folks I am a professional".

 Alright you take the plunge - You purchase your certification kit and wait for it to arrive.  Now what?
Make sure you have staff on hand that can competently receive and store the testing kit once it arrives at your facility.  You must keep the kit frozen at -80ºC at all times until ready to test.  -20ºC is going to ruin the samples.  If the kit gets lost in your facility and the samples thaw uncontrollably you are going to have to beg NGSP for another kit.  Do it a second time and you may not get a replacement kit.  If the kit gets lost along the way you must let NGSP know immediately after the expected receive date.  That is not the labs fault.  But, once the package is signed for it is yours.

Make sure everyone involved in the testing is trained well, knows what they are doing, can handle the 0.1 sd QC no problem, and did I say they must know what they are doing???  I am not kidding.  There is no room for minute error in the NGSP statistical analysis.

Make sure your instrument maintenance is up to date or complete it before the testing event starts.  Be careful though.  You must also ensure mechanical performance will continue for the testing event.  The last thing you need is for mechanical failure in auto dilution area of the instrument day 3 or 4 into the testing event.  If this is your Certification Process - you better pray nothing happens during the 20 days of testing!  You bet. That is what I said.  Certification is 20 straight days of testing HELL!  If anything breaks down during that time, you better fix it and fix it so the instrument performs just the same as before it broke.  Hence you will fail miserably.

A word about calibration.  Most HBA1c instruments produce a calibration from two analyzed samples in the calibration kit and that kit is compatible with certain or single lots of reagent.  Make sure you are following instrument manufacturer guidelines for use of calibrators exactly as specified.  No cutting corners, no deviations, no mistakes or you will fail NGSP miserably.
You must make sure everything about the testing instrument is perfect, producing the same result on the same sample day after day after day.  NGSP is not only testing for accuracy but just as importantly reproducibility.  Don't kid yourself and don't be a fool. Preparation is the key.  Human error is the enemy, instrument mal-function on a sporadic basis is the unknown.  You will know something bad happened that you were not aware of when you get your results back from NGSP and you missed Level I by 0.03 or something minute like that or worse yet don't even make Level II performance.

Ok, so I think I have successfully scared anyone unknowing of the the NGSP process.  Can it really be that bad?  Yes it can.  Can Level I labs fail now and then? Yes.  Will they ever figure out what happened? Possibly not.  Will they pass next event with Level I performance?  probably yes.  But just remember, out of 139 certified labs only 100 attained Level I Certification.  39 labs were unable to attain Level I performance for two straight testing events!  Here is what you really need to know to successfully pass this arduous PT program.  

• Xanax will be your friend.
• Treat your NGSP testing kit samples like gold.  Refreeze them immediately after done testing the samples for the day.  Don't waste them.  Don't wait hours to refreeze either.  Unstable NGSP samples are a terrible thing to use.  Make sure they are clearly identified for future use.  NGSP knows labs save the samples for future reference and they send only about 0.5 mL of sample in each tiny vial. Re-test old NGSP samples before the testing event starts.  This will insure exact analysis is coming from your instrument.  If you have more than one instrument then test against both or two or three of your available instruments.  Pick the best performing instrument.
• Once you establish that your instrument is analyzing exactly as needed Do Not Make Any Changes that will affect performance.  Get your maintenance procedures done an any instrument that may be used for NGSP, preliminary test with old NGSP samples and calibrators as unknowns, then promptly start NGSP if you are satisfied.  The more time that elapses after you "prelim" the instrument and NGSP testing starts the more unknown can happen.
• If your staff is not comfortable using such small quantity of PT sample in a small tiny vial then have them practice with such small vials before the testing event begins.
• Save calibrators that were used during very successful NGSP testing events.  Test these calibrators as unknowns in the same manner as true NGSP samples will be tested in your lab.  Make sure you are recovering exactly the data you expect with the saved calibrators.  This can be used as a reference mark to make sure analytically your instrument is performing optimally before the NGSP testing event commences. 
• Make sure any pipettors used are in good mechanical order and are calibrated as exact.  This is going to be the most common issue that will bring you down to Level II or fail you miserably.  I cannot stress this enough.
•  Make sure you have enough reagent on-board to complete the testing event.  If you run out of reagent mid way and change even a buffer solution, you run the risk of failure.
• Make sure your scientist is a pipetting expert.  Pipette by the book.  There is no room for slouching here.  Practice can be obtained via a laboratory scale.  The testing scientist must be able to pipette minute sample amounts with the same accuracy time after time.  Practice until perfect.  Did I already say that pipetting errors will bring you down?  Take heed.  Make sure the technique is spot on perfect.
• Make sure you know what type of freezer is used to store the NGSP test kit.  If you store in a frost less freezer you will ruin the samples.  It is a done deal.  Get yourself a good lab grade freezer that will not cycle off and on furiously to avoid frosting.  Yes they are expensive and frost will build up inside like a glacier but that is the only way to successfully store the kit and any samples you save from the kit post test event for future reference.

Overall you must be confident in your technology, your technique, and your abilities.  If you have all three you will pass.  If you falter, well you know the end result.  Level II or worse and ultimate humiliation of not passing a PT you paid good hard earned money for the nerve to take a numb skull crack at it try.  

If NGSP is for you - know well what you are getting into.  Only a short list of labs can pass this strict PT program. Will you be one of them?  Do you have the nerves of steal?  Do you have the knowledge and experience with your testing method to realize what is good and what is bad data and how to fix that mess?  If so, see you in the winners circle! http://www.ngsp.org/docs/labs.pdf

 Take care my brave friends - Test with confidence and see you in the NGSP winners circle.

Scott R. Mayorga A.A.S., BS MT(ASCP)H CLS




   

Going for Employment? You will probably be drug tested. What you should know.

Gainful employment is exciting, rewarding, and is patriotic.  Being able to support oneself and family without public assistance is quite patriotic in this present economy where so many are under-employed or out of work completely.  Seeking employment can be stressful as well as hard work.
Once a position is offered to a candidate a series of checks are completed by the employer to make sure the candidate is who they say they are and meets hiring standards for that organization.  Credit checks, criminal record background checks, driving records, credential checks can all be included in the checks process.  Commonly one of the hiring standards is a no drug policy but can include no tobacco use as well.  Many organizations will send perspective employees to a reference lab to have specimens collected for drug screen testing.  Many health care facilities will perform some or all of the screening tests within the organization facilities.  What you must know is if you are abusing drugs you will test positive.  If the organization has a No Smoking policy screening tests for tobacco use may be performed as well.  Perspective applicants will be rejected based on the outcome of these screening tests.

The Drug Screen:  Drug screens can vary by laboratory or what an employer is specifically looking for as abused drugs or for prescription drug use.  Years ago there was a great amount of folklore about drug testing, what can cause a false positive, how to avoid testing positive when abusing, and even common dietary intake that can cause a false positive.  Today, drug testing is very sophisticated and thorough.  The most common drugs of abuse employers test applicants for are:

• Cannabis
• Cocaine
• Amphetamine 
• Methamphetamine (also Ecstasy)
• Benzodiazepines (Valium)
• Methadone and Opiates (also Heroin)
• Phencyclidine (PCP)
• ETOH (Alcohol/booze)

Some employers are taking a no tobacco use stance and are within their rights to refuse employment to any applicants testing positive for tobacco use.  Unfortunately, for tobacco users the test for tobacco use is very inexpensive, very accurate, and very sensitive.  A urine specimen is all that is required to test for the tobacco metabolite Cotinine.  Blood nicotine or the metabolite cotinine can linger in the blood stream of a smoker for weeks.  Urine tests can detect cotinine for several weeks to more than a month after a person ceases exposure.  I say exposure because it does not matter whether the tobacco products are inhaled, pipped, chewed, patched, E-Cig, or the exposure can be environmental (2nd hand smoke).

Employer administered drug tests can be performed on blood, urine or both.  Rarely will employers go through the expense of testing saliva or hair.  Hair testing although expensive, can show exposure to what ever is tested for up to six months or more. Some employers can use a reference lab to administer the testing or the employer themselves can use a disposable testing cup which has testing strips contained that will screen for many different drugs of abuse.  Some of these products are available to general public so individuals can test themselves or minor loved ones for the presence of drugs.  The tests available in whatever format or testing medium are accurate, reliable, and sensitive.  If you are going to be drug tested and have used any of the drugs being tested for within the last 24 hours - Bingo you are going to score a big positive.  If drug use was in the last 24-48 hours you may or may not score a positive.  Depending on the drug type, half-life of drug metabolism, etc. a positive screen can occur within the last 2 weeks of exposure or intake.  Alcohol dissipates rather quickly from the body and may not be detected  in less than 24 hours after last exposure.

What should you do if you are accepting an offer of employment?  Expect that you will be screened for drug use.  Expect that if abusing, you are going to score a positive.  If you think you will be able to "fool" the test(s) and/or prepare to test negative while abusing; don't fool yourself.  Drinking large quantities of water to "dilute", excessively exercising, taking other drugs to mask drug abuse,  substituting, are all methods that can get you into hot water.  Testing methods are sophisticated.  Facilities used during the specimen collection process are prepared before the arrival of the applicant and checked after the collection process is complete.  The screen testing available today is inexpensive.  If urine drug screening tests are administered, precautions taken to prevent a non-legitimate or adulterated sample being submitted  are many, well thought out, and will include prevention methods just short of direct observation of the specimen collection process.  Although, direct observation of the urine collection is not out of the question.  I we can walk into a public restroom and pee into a urinal or toilet in font of bystanders, then a supervised urine submission is not out of the question.  Blood testing is 100% impossible to fool the testing via an adulterated specimen because there is a medical person (phlebotomist or nurse) actually performing the needle stick to collect blood directly into blood collection tubes.

The bottom line is if you are seeking employment and are really serious about landing that job if offered to you; stop abusing well before you start looking for a job.  Once an application is submitted for employment the process can progress slowly or rapidly escalate to an offer depending on the needs of the employer and the efficiency of the hiring process.  Don't be caught off guard. Don't abuse.  Commonly, once the offer is made, the applicant is given a period of time to submit to testing and usually that time period is 3 days or less especially if you have to go to a collection facility for the testing to be performed at a clinical reference lab.  Usually, an offer will not be made at the end of a week.  This would give an abusing applicant 2-3 days extra to clean up.  During my search for my current job, immediately after my 2nd interview I was asked to submit to drug testing by the hiring manager.  Before I had left the premises just minutes after the interview ended, I had submitted both blood and urine samples for the screening tests.  I had nothing to worry about.  Now, how embarrassing would it been if I said "no I cannot submit samples that day - I will come back though".  I could have said no.  But, that would probably have jeopardized my efforts of becoming employed.  That is what you can expect if seeking employment at a health care facility especially one prepared and equipped to perform the testing on site.

Bottom line - don't abuse, be clean and be proud to pass a drug test when asked to submit.

Take care friends - be clean

Scott R. Mayorga A.S.S, BS MT(ASCP)H CLS

  

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