Sunday, September 22, 2013

The Whacky Antics of a Laboratory Night Shift Staff; No Not My Lab? - Oh Yes!

 What goes on behind the door down the hall leading to "that Laboratory"

For the most part Clinical Laboratories are tight run ships, designed with aspects of quality, efficiency, and redundancy.  Staff are well trained and train new staff as needed.  Equipment is well kept, maintained meticulously, calibrated per specification, and checked with quality control systems on a daily basis.  The busiest sections of a clinical laboratory often have multiples of the same instruments to have built in redundancy in case an instrument needs maintenance or is flat out broke.  The work goes on especially in a hospital laboratory where it is 24/7/365.  Well what about those clinical laboratory scientists?  Are they calibrated, checked with QC, well maintained, with built in redundancy?  You can bet on that.  Often, the off shift staff are highly trained multi-taskers who master all sorts of tasks on all the laboratory instruments and procedures.  When one scientist goes on break another can come up right in their place and carry on the task at hand whether it be calibration procedures, quality control processes, specimen testing, or maintenance.  What about that break time?  What about when sample receipt in the lab is slow?  What do the wacky scientists do?  I will tell you what they do?  They play Bocce-Bagel! They play Poker.  They sleep.  Sometimes they sleep at the microscope-more about that later.  They take the elevator up to the roof of the building.  Most laboratory directors would say "not my staff - not my night shift, they don't do those sort of things". 

Let me tell you as one who worked many years on the off-shift in a terribly busy Level 1 trauma center; there must be some entertaining distractions or quality of the work will suffer, boredom and weariness set in.  Mostly the distractions clinical staff will employ to refresh themselves are harmless and rarely illegal.  One such distraction for our group of night shifters was what we called "Bocce-Bagel".  Day shift would often get goodies from vendors and often those goodies would consist of several large bags of bagels.  Bagels are cheap. They were plentiful.  It would tick us night shifters off when a dozen or more bagels would be left out open on a counter all day and were stale as a brick by 11 PM.  Oh yeah there would be a note on them "Enjoy", but enjoying them meant cracking your teeth down to bloody nubs! So, what do a dozen half baked scientists do with 2 dozen stale rock hard bagels?  You guessed it.  They throw them around and eventually come up with a systematic way to diffuse on the job stress - the Bocce Bagel way.  This is how you play.
Get your bagels and hand one to each player.  If they are all plain bagels name them with a lab pen.
Go down the hall; every lab has a long hallway of say 25-30 feet long ending at a wall.
Ante up with a quarter, dime, or for the money bags amongst you all, play for a dollar a toss.
One by one players toss their bagel down the hall towards the wall.
Player who comes closest to the wall wins the toss.
Repeat as necessary to relieve stress.

So what are some of the antics we resorted to, err I mean employed to diffuse stress, refresh, and otherwise widen our eyes?  Well of course Nap.  Cat nap that is.  Some of us learned to nap in a lab chair devoid of arm rests; that is quite a feat let me tell you.  Some labs have phlebotomy chairs.  Cushy, comfy chairs with arm rests just like Grandpa used to lay in on a Sunday afternoon and "Cat-Nap".  Oh yeah!  I worked in a hospital a short time that had a cot.  A real good cot padded heavily with accompanying blankets.  Uh well I am just saying it was a nice cot in case a patient was feeling ill during phlebotomy procedures.  Other means for a quick cat nap often make you look like your are actually doing work! Imagine that.  You walk into the lab and see Charlie over their working his heart out at the microscope.  He's reading gram stains and cell counts on that spinal fluid that came down from the ER.  NOT!  Charlie is sleeping.  He looks like he is working.  His forehead is resting on the microscope oculars and he is lights out.  10 minutes, 15, 30 minutes go by...maybe someone should go wake up Charlie; he has been reading that same gram stain for the last half hour.  Nah - let him sleep.  An hour goes by.  A code is called over the public address system.  Charlie wakes up and oh yes he has the tell tale signs of "Ocular Narcosis".  Hard circles embedded so deep into the skin of his forehead they barely go away by the time the day shift starts showing up.  "Sleep is a beautiful thing", I think some mattress company once said.  Anyway.  What else did we do.
Lab Scientist Ocular Narcosis

Exploring - Yes we were like Magellan and Christopher Columbus going where we never went before.  Up the elevator, down to the basement, out the back door, we would have gone to the moon and back if we had a space ship!  One such jaunt was scary as hell.  It was winter, dead winter and January cold.  Windy, blustery, and freezing.  Let's go to the roof! Yes lets get on top of the building and look out over the land.  With only our lab coats to protect us up the elevator we went to the 19th floor.  We searched for a way out and the way out we wanted was in the vertical direction.  Yes we found it.  It looked like a broom closet door.  After we pried it open, alas there was a cat walk and narrow metal grate stairway going up.  After climbing up the the narrow stairs another door but it was unlocked this time.  We did not mean to fling the door open but it sort of pulled out of our hands.  You see the wind created a draft so strong the door flung open viciously as soon as it cleared the latch mechanism.  Oh wow.  Look at that.  You could see for a great distance up here.  It was dark, it was very windy, it was shiverrrrring cold, our teeth were chattering.  There were no safety bars, no fence, nor any other safety mechanism from keeping us on that roof and not flying away like the "Flying Nun".  Ok lets go back down now - yeah lets its cold up here!

Another pass time came from necessity.  You see at the back hallway of the laboratory was an exit door leading to the outside out to the back of the hospital.  Just outside the exit door there was the new MRI building.  MRI was new back then.  MRI was a mysterious machine housed in a closed off building.  No Metal Objects Allowed the signs all said.  Well we kept away alright.  But there were others that were brave enough to get close to that building.  Flies.  Insects of the black Fly kind.  I swear I never saw flies so big almost the size of a quarter.  They would come into the building from the back door out by the new MRI building.  Those incredibly strong magnets were growing flies so big they could take down a small dog.  Into the lab they would fly those flies.  They were hungry flies.  You know what they liked to eat?  Blood smears.  They would land on the freshly made blood smears in Hematology lab and suck up the drying blood on the glass slides.  How disgusting is that.  After their meal they would fly up to the ceiling and warm themselves around the fluorescent lights.  I had to do something about this.  That back door was used as an employee exit so it was constantly letting flies into the building.  We had patients up stairs for goodness sakes.  So here comes Hemabond to the rescue.  Hemabond was the ultimate laboratory multi-tasker.  Hemabond carried a gun - a very nasty rubber band gun.  Loaded with discarded rubber tubing from the coagulation analyzer and adeptly handled by the likes of Hemabond those flies did not have a chance.  I kept the gun inside my lab coat.  Down my sleeve it would sit at the ready.  It was big enough to stretch the rubber tubing 10 inches!  It had a real trigger mechanism.  It was a real beauty of hard wood and metal parts from a hanger used to hang slacks in my closet.  Doctors would walk into the lab and not have a clue they were talking to a super-hero of sorts, carrying a high powered rubber band gun.  Legend has it that I was on the phone calling a critical lab result, sitting in a lab chair at the front of the lab.  Another scientist walked in and pointed up at the ceiling.  I pulled out my weapon of mass fly destruction, aimed with one arm while giving report to a nurse, BLAM! Down that fly came.  Charlie was impressed! He laughed all the way back to Chemistry lab.  I even went out front of the hospital to the traffic circle, sat on the benches, concealed carrying my weapon under my lab coat.  Oh what fun!

Then there was the cafeteria.  Oh the joy of the cafeteria at 2 in the morning.  The grand eatery would open to a narcolepsy afflicted crowd.  One notorious morning, we ventured up to the cafeteria cause this was a typical laboratory down in the basement, two floors below ground, except for the exit out back by the MRI building.  We were bored almost to death.  The usual cafeteria fare was abundant like burgers, eggs any style, toast, day old wrapped sandwiches and other nutritionally challenged offerings.  Peering down into the wells in front of the "Chef"; well she had chef clothes and a chef hat  so we assumed she was a chef.  Who were we to challenge her - who cared?  One of us was bold enough to ask what the green stuff was in the smoldering stainless steel bin with green crud caked up on the sides an inch thick.  As it turns out that was "Split Pea Soup".  Your head had to be split open with a hatchet before eating that stuff.  "What you got to go with that brown gravy" was asked of the esteemed chef?  She looked at the offerings in front of her and said "nothing?".  She had gravy, brown gravy.  No mashed, no french fries, no biscuits, no roast beef.  Nothing to go with the gravy!  Such was the grand experience of the cafeteria at the big hospital at 2 AM.

What else did we do.  Let me see...  Oh yes, Cards.  We played poker in the big conference room.  We had seating for 20 or so.  Sometimes it got cut throat. I did not play much.  I hated to part with my money that way back then.  So I just watched and was glad I was not involved in the sham of it all.  I guess sitting there at the table watching was almost as bad as participating directly as far as management was concerned.  I did like Boccie-Bagel though.  And I always had the Hemabond gun in case things got out of hand.

Well you see working night shift is tough.  You constantly feel like you are sleep walking, everything is "fuzzy", your eyes are tired and blood shot, always weary.  Distractions were just a way to cope with the stresses of the job.  Coffee, lots of coffee helped.  We really did not need the cafeteria though because when we got together for holiday celebrations we really had a feast.  We had a whole turkey dinner once.  All the fixings and deserts abound.  We really lived it up on the night shift.  The work got done.  We did our jobs. We were saving lives.  Level 1 trauma lives.

Well take care my Lab friends.  Don't wake up with Ocular Narcosis.  Your reading glasses will not cover those deep circles.

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

Wednesday, September 18, 2013

Help! My Fish Tank Is Leaking Water-Petco to the Rescue

Leaking fish tank led to the most positive customer service experience from my local PETCO store 

Recently, I had to endure what I would call a family tragedy.  If your family had its domicile destroyed and you had to move into temporary quarters until your home was replaced then you know what kind of tragedy I am talking about.  The loss of ones home can be devastating.  If you are part of a family of fish, Cichlids that is; then the loss of the family home can be treacherous and deadly.  Recently, a tragedy is what happened to my fish tank I called Cichlidae Lagoon.  A 37 gallon fresh water fish tank with a small family of Cichlids named Pancake, Dexter, Elvis, and Lilly.  One Friday evening at about 11 PM Cichlidae Lagoon started leaking water fast.  My wife heard the filter system splashing water into the tank, looked over, and said "Oh my gosh - what is wrong with the fish tank?"

Before we knew what was happening about 15 gallons of water had leaked out of a bottom seam of the fish tank onto my carpet flooring.  I had a big mess going on but worst of all my Cichlids were in serious trouble.  What to do?  What to do first?  My wife was going to grab a vase.  I remembered I had a small fish tank in storage in the basement.  She screamed "Go get it fast".  I quickly got the small tank cleaned up and netted my Cichlids into their temporary overnight accommodations.  Then began the 5 hour task of emptying Cichlidae Lagoon before it emptied onto my floor, carpet cleaning, and setting up the small tank with air, heat, and filtering.  What a disaster.  With everything stable we went to bed at about 4:30 AM...

After awakening from slumber, my four Cichlids were ok on the kitchen counter in a real small tank  but they were in trouble.  The filter was not enough, there was not enough water for them, and they were cramped.  I had to do something!  I made a call to a local Aquarium store to see if I could board the Cichlids for a few days.  No answer that Saturday morning.  They were not open yet.  I then called Petco in Buford GA.  I explained my situation to the person who answered the phone and was immediately transferred to the stare manager "Chris".  Chris listened to my issue and then said  the kindest words I could here that day.  He said, "all was going to be alright, bring your fish into the store and we will take care of them until you figure out what to do about replacing the fish tank".  I thanked him over and over again as my main concern was the health and well being of my fish.

My Cichlids are family to my wife and I 

My wife calls them by name and they come to the front of the glass.  I feed them lovingly and take care of their ecosystem of water, air bubbles, temperature control, and filtering system.  I have a sound speaker I put in a plastic bag and submerge to play music for them...The store staff at Petco in Buford, GA were caring and took care of my Cichlids expertly until I got a new tank set up and ready for them to come back home.  From that Saturday afternoon that I took the Cichlids to Petco, leaving them with Store Associate DeeDee, to the evening I picked them back up to come home the staff at Petco looked after my fish and kept them healthy.  The fish seemed to be happy at Petco in a beautiful display tank full of fresh plants with a waterfall and two little Cichlid friends they met who were already there.  It was like the Cichlids went to summer camp!  My wife and I visited them several times that week, spoke with the store staff, and answered questions about the Cichlids they were holding for us.  There were many inquiries from customers wanting to buy my Cichlids but the store staff placed a big sign on the display tank that said "Fish for observation only - Not for Sale".  When we visited, customers often said what beautiful fish they were, asked what kind of fish they were, and how much they were.  You see they are beautiful Cichlids; Pancake is about 2 years old and 5 inches; bight baby blue.  Dexter is just under 2 years old and is 6 inches; yellow and black like a bumble-bee.  Elvis is about 1.5 years old and almost 5 inches; black with blue stripes.  Lilly is about a year old and almost 3 inches; albino pink with ruby red eyes.
Pancake and Dexter going to Summer Camp

What Happened?

As it turns out I purchased the 37 gallon fish tank from the Buford GA Petco store in Jan. 2012.  Fish tanks rarely develop leaks as serious as my tank did and certainly not so soon after purchase.  Usually, fish tanks can last 10-20 years with good care placed in a stable environment.  Chris, the store manager was very concerned about the tank leaking.  I was too and I was afraid that another tank would also leak prematurely. After all one does not expect a tank to leak so badly.  Chris and several store associates all reassured me that such an occurrence is rare.  I email contacted the manufacturer that Saturday but it was Labor Day weekend and the manufacturer runs M-F, 9-5.  I waited till almost Wednesday after Labor Day before getting an email response.  Basically, I was told by email "let us know if the store does help you and what they did for you".  The email came from someone with a title indicating they worked for a company other than the manufacturer, like a customer service triage representative.  Anyway, hearing nothing else I spoke with store staff that week including managers Becky and Sean who assured me Petco would stand behind the product.  After speaking with Chris by telephone again that week, it was agreed that I should return the leaking tank to the store for store credit with which I could use to purchase a new tank for my Cichlids.  I was so thankful and grateful.  At this point I was in awe of the way I was being treated by Chris, Sean, and Becky the store managers; the rest of the staff who looked after the Cichlids while there at "Summer Camp" were also pleasant, cheerful, and concerned for the Cichlids.  Petco really came through for me and the Cichlids.  They really cared about the fish and made sure they were going back home in excellent condition.  With the store credit I was issued I was able to get a new tank, some replacement supplies, new live plants, and the two little Cichlids that spent Summer Camp together with my Cichlids.  I brought them home a week later.  When I picked up the Cichlids originally, the store staff did not want to sell me the little Cichlids because they were not tagged for sale yet.  That happened after my Cichlids went home.  So now they are all together in Cichlidae Lagoon II.

I can't say thank you enough to Becky, Sean, DeeDee and Chris at the Buford GA Petco store for turning a disaster into a positive experience but mostly for saving my fish from a stressful situation or possibly death.

Let me tell you about my Buford Petco Store. The fish tanks at are beautiful.  I have 6 Cichlids now and 5 of them were purchased from Petco.  They have a vast selection of fresh water fish, salt water fish, turtles, and other aquatic animals and plants.  Numerous aquatic supplies and decorations abound in the aisles.  See my pictures below I took during visits to the store while the Cichlids were at summer camp.  The store is well organized, CLEAN - Spotlessly clean, with open aisles and vast selections of whatever your pet needs are.  Prices are just right and Petco Pals prices are even better with a Petco Pals customer loyalty card.  Petco even has a Unique on-line information community board called PTP - Petco Talk Place.  The Talk Place has different areas for Dogs, Cats, Birds, Fish, small land animals, and even snakes.  The staff at Buford Petco are just wonderful and knowledgeable.  While there at the store visiting the Cichlids I observed customers perusing aisles, looking over the fish tanks, and selecting new family members to go home with them.  I watched as the store staff cheerfully answered questions, advised, and carefully retrieved fish from tanks for the customers.  I observed a happy cheerful environment every time I visited that week which was almost everyday for a week - I missed my little Cichlids!

I have a special place in my heart for Buford Petco and the loving staff that took care of my Cichlids.  I know that this is not normal practice for Petco but under extenuating circumstances Petco did what had to be done and did it cheerfully and professionally.  It is now several weeks later and the Cichlids are all doing well adjusting to their new home "Cichlidae Lagoon II".

See below for links to Petco, Petco (PTP) Information Community, the Petco Pals program, and  Petco Foundation -  Helping to support companion animals with $15 million per year in donations.

Thanks Petco - you saved the life of 4 little Cichlids that mean so much to my wife and I.

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

United Pet Group has since contacted me and offered to reimburse for full purchase price of the leaking fish tank.  Thank you United Pet Group for stepping up and completing a postive customer service experience in full manner with concerns and well wishes for the Cichlids.

Petco web site
Petco Fish on line Community
Petco Pals Club - Customer Rewards
Petco Foundation
Petco on Pinterest
Petco on facebook
Connect with Petco on twitter; @Petco

Petco Buford - Mall of Georgia

Wednesday, September 11, 2013

Excuse me - How cold is the Dry Ice in that Cooler?

 Dry ice maintains a temperature of -80ºC which makes it a perfect shipping medium for blood products, frozen foods, and other temperature labile items

If you are a manager, supervisor, head, chief or otherwise known as leader in your organization you know full well being placed in the "Hot-Seat" becomes a comfortable position par for the course that comes with said titles.  Eventually, being looked upon as the leader can have its trying moments.  I have explained in previous posts about representation of a laboratory facility in an inspection or audit role.  In a less stressful situation such as interaction amongst staff of your own facility things can still get dicey.  Decorum, tact, and Witt will always prevail in every situation or interaction.  As the leader you are relied upon to give sound judgement, smart opinion, astute evaluation, and complete answers to questions.  As the leader, sometimes it is hard not to get "Fed-Up" with ridiculous questions or challenges that sometimes challenge not only reasoning skills but also patience.  Working in a large facility with hundreds to thousands of fellow staff members it is only a matter of time before one of those staff members really tries your patience.  Here is one such observation that although I gave a good observation and astute answer to a ridiculous question I ran the risk of running myself under hot water.  Every situation is different.  Whenever patient care is involved you always have to give 100% attention and serious response.  When the same issue is bantered about over and over again sometimes it is best to stop the BS and say it straight - Straight Talk From The Hematech.

Dry ice is nothing more than solidified carbon dioxide with some impurities mixed in.  As such, this substance is very efficient at keeping materials in close proximity in a frozen state.  Dry ice maintains a constant temperature of -80ºC which is very, very cold.  Laboratorians know that in order to keep blood specimens stable for long periods of time -80ºC is the temp required inside a frost-less freezer or dedicated laboratory grade freezer.  If specimens are going to be shipped across the state, overnight, or across the globe the only way to do that is with a well insulated cooler box full of dry ice to keep the specimens in a frozen stable state.  Well everything works great when there is enough dry ice packed in the box, the box is sealed properly, and the shipping is prompt and on time.  A small cooler box with 1-2 lbs of dry ice sealed appropriately will keep contents frozen for up to 5 days.  Add more dry ice such as 2+ lbs and you can insure stability of contained specimens for up to 7 days.  

This is the story of a physician office that would just not follow directions for shipping frozen specimens.  If you put a couple of pebbles of dry ice in a box you can't expect to have stability for very long.  That will not last more than an hour or two.  Well, delivery after delivery, specimens from this one physician office arrived devoid of dry ice and warm as the ambient temperature.  After several failed attempts to ship specimens to the core lab something was just plain wrong and the responsible people for packing and shipping were failing in their duties.  Project management type staff members are responsible for well managing the project and the customer.  I had had it by now.  After many emails back and forth, phone calls, disputed state of arriving cooler boxes it was time to educate the project manager.  One such day, a cooler box was expected from said physician office with supposed frozen specimens.  I notified the project manager to come to the lab to visually inspect the cooler box as it was opened.  The project manager ran right over.  As several of us, me the lab manager, several technical staff members, the project manager who was in a new position, and an assistant we all observed the opening of the box.  What would we find?  A box full of dry ice and specimens or another failed attempt at shipping specimens.  Well, after anticipation of the physician staff finally getting it right - No, just a box of warm specimens and no sign of dry ice.  What could possibly be wrong?  Why is this happening?  "Something is terribly wrong" said the project manager.  I said, "yes something is wrong - if they placed the required amount of dry ice in the box we would have frozen specimens today?"  Some banter went back and forth with the project manager; yes they were putting in dry ice, yes it was the right amount, then the ridiculous started.  Assertions flew about the cooler box and how faulty it was.  That was hog wash; it is a styrofoam box used for hundreds of shipments each day to that facility.  Then the "Piece de resistance" came out of the mouth of the intrepid project manager.  She asked, "So- how cold is the dry ice is those boxes over there?"  I replied, "they are full of dry ice and dry ice is -80ºC."  Then she asked, "Well how do you know that dry ice is cold?"  I looked at her dumb founded.  Devoid of an astute smart complete response I said the following; "Well,... stick your hand in a box of dry ice for 30 minutes, take your hand out, then smash your hand on that table over there."  "If your had shatters into a million pieces you know that dry ice is cold."  Of course that elicited a dumb chuckle from the assistant and some smiles from my staff in attendance. Blank stare from the project manager was followed by more dumb inquisitive banter.  Now the morale of the story is I might have felt better after I said what I said and it really needed to be said at that point in the situation - but that banter would come back to bite the lab.  As it turns out that project manager started dating the medical director of the laboratory.  Over head pages from the project manager emanating from the sound system through out the facility complex were heard beckoning the medical director by his pet name which we all promptly heard for the first time and only time.  I guess she got the smack-down because she never over-head paged the man again.  Anyway, might I digress?  She suggested to the medical director probably over sultry pillow talk that the cooler boxes used for transporting frozen specimens were faulty.  It could not be the staff of the physician office not placing enough dry ice in the boxes; No it had to be the cooler boxes.  Well that prompted a very scientific, thorough, and painstaking review of so said boxes.  The result of that validation found that not only were the boxes doing their job the specimens were perfectly safe for a very long travel.  

Here is the validation overview:
A handful of specimens were packed in a standard styrofoam cooler box ( approx 8" x 8" by 12") with 2.2 lbs of dry ice. In with the specimens was a very expensive temperature recording device that was capable of recording the environment temperature for over a weeks time.  The box was packed and shipped exactly as instructions were given to all physician offices shipping samples to the core lab.  The package was shipped over 1200 miles to an office then without opening the box it was return shipped back to the lab.  Well, low and behold, the temperature inside the box never wavered, dry ice was still in the box upon its return to the core lab, and specimens maintained frozen state the whole way.

Yes, dry ice is cold, very cold.  It makes for an efficient medium to pack and keep frozen all sorts of items such as foods, chemicals, and blood.  The validation was a success.  Eventually, the physician office caught on and thawed specimens were seen no more.  Good for patient care - good for my sanity.

So, think about that wise crack before you let it fly.  You never know if the receiving person is going to sleep with your boss and cause you grief.

Take care my laboratory friends.  Be careful what you overhead page.  
Another tip! Be careful of the email you send.  How embarrassing it is to be in a room observing a presentation from a managers laptop, projected on the wall for all to see.  Then in the lower right hand corner MS-Outlook flashes the subject line of an incoming email and the senders name.  Whoops, there flies another pet name!  From another Medical Director to the underling.  How true, how sad, how true.

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

Monday, September 9, 2013

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!

 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


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