Thursday, June 27, 2013

Barbara's Handmade Cookie Pies

Ah Cookies, cookies, and more cookies.  Who doesn't love cookies?  Crispy, sweet, crunchy, moist, delectable.  All adjectives that can be used to describe the little round baked products most of us crave so often.  One of my favorite cookies is Italian Bakery Cookies.  When I was little, the town I grew up in had many bakeries and some had the word "Italian" in their store name.  Rolls, Cannoli, Napoleons, and Eclairs among the items to be had on the shelves.  I used to love going to the Italian Bakery on Saturday morning with my Dad for rolls and treats. Around the holidays there were gingerbread men.  Oh the memories.

Anyway, these days I am hard pressed to find a bakery or a shop that sells anything close to the confectionery goodness I had as a little boy.  Until, well now.  Barbara's Cookie Pies has the most incredible butter cookies I have tasted in a long time.  These are just like the Italian Bakery favorites from long ago.  I have had butter cookies lately from several sources like warehouse clubs and supermarkets - the cookies are dry, lousy tasting, brittle, and not desirable.  Barbara's cookies are different!  The baked goodies are made fresh with all natural ingredients, no preservatives, from a family recipe; Barbara's family.

Let me tell you about these cookies.  They smell fresh and wholesome as soon as opening the package commences.  Visibly, they are yellow-white butter cookies decorated with cherries, nuts, sprinkles, jellies, chocolate dipped, and jelly filled.  My favorite is the Joey Joy Rainbow Sprinkle cookies.  All of Barbara's butter cookies are moist, soft, crumbly textured cookies.  The jellies are sweet, smooth, and not gummy like the lower quality cookies I have had recently; you know when you bite the cookie and the jelly sticks to your teeth like a gum drop - not good!.  No these are different. The jellies melt in your mouth leaving a fruity sweet taste with no preservative aftertaste.  The chocolate dips are delectable and compliment the buttery taste of the cookies so nicely.

If you have a desire for excellent, butter cookies ( I call them Italian Style Butter Cookies) then look no further than Barbara's Cookie Pies.  So convenient ordering on line.  Remember though - these cookies are preservative free and must be eaten right away or within 2 weeks stored in refrigerator 2-8 * C, or store for up to 6 months in a freezer.

They really are fabulous.
Scott Mayorga

Contact Barbara's Cookie Pies and order some for yourself or as a gift

Monday, June 17, 2013

2014 KIA Forte EX GDI Driving Experience Review

I love cars.  All kinds of cars.  There is nothing like cruising down the road in an open top T-Bird with wind in your face and Sun in your hair.  Burning gasoline at a ridiculous rate and a deep roar from the 430 cu in 4300 Lbs. monster,  but who cared - it was fun!  My first Toyota Celica GT was a great car as well.  All black inside and out.  Sun roof and pop-up head lights.  That was an awesome car - it's a shame rust got the best of it.  I hated selling that car.  Nowadays, I sport around in my 7th Gen Celica GTS.  6 Sp manual and tuned exhaust pumping out from a worked set of valves.  Rev-Rev-Rev always to a boiling 7,000+ RPM.  But back to this fellows car review...

I recently had the pleasure of driving the 2014 Kia Forte EX GDI (Gas Direct Injection) sedan supplied by STI - The Driving Experience people. Driving the Kia Forte for a week was most enjoyable.  The Forte is a small car that feels like a big car when your behind the wheel but it drives like a gas sipping luxury vehicle.  The Kia Forte is a special car offered by Car manufacturer KIA Motors.  Special I say, because it is small with big car comfort, loaded with standard features for safety, ergonomics, and electronics - very smart electronics.  With the additional options this tester car had, the Forte was equipped with many features found on cars 2-3 times the price.

I really enjoyed the Forte.  The styling was smart, the performance was agile, and the technology contained in the vehicle was smart without being "overly techy".  With a 2.0 ltr engine acceleration was smooth and brisk.  Attaining highway speed with confidence the car traversed the asphalt with grace, stability, and style.  Inside the cabin was lots of leather, heated seats front and back, and a heated leather wrapped steering wheel.  Comfort was a fist in the design phase of this vehicle.  Inside, the car gave this occupant the feeling that I was sitting in a much, much bigger car.  Lots of room with good support for back and legs in the seats.  Back seat occupancy was a pleasure too.  Ample leg room, more leather, a nice arm rest, and heated seats!

Driver controls are well placed in this vehicle with smart ergonomics easy to operate from the steering wheel. Steering wheel action can be adjusted from sport, regular, and comfort with the touch of a button giving different feels in the driving experience and control.  Radio/nav/and telephone control can all be achieved with the steering wheel controls within fingers reach at any moment.  A full array of nicely colored contrasting gauges complimented the information screen right in front of the driver where they belong.  Two really nice features on the Forte were the 2-driver seat memory settings and video back up camera - Wow!  The Kia Forte delivers comfort, confidence, and safety in this reviewers driving experience.  Not only that but minute details of the ergonomics controls can be adjusted like right from the steering wheel controls and the info center display.

 I found very useful the navigation display placed right in front of the driver set in-between the speedometer and tachometer.  That display was so handy and visible.  The bright colors of the navigation direction graphics were visible with my peripheral vision without having to look down all the time.  It was great function and very safe to use while driving instead of having to look over at the main screen on the middle of the console for navigation.

Driving the Forte gave me a feeling of confidence and flare.  The smart remote key less entry and engine start enhanced my driving experience.  Walking up to the Forte, the side view mirrors would pop out slowly as if to say "hello".  Braking was strong, smooth, and gave me great confidence.  Visibility looking outside the cabin was wide open unobstructed and with the small forward aft windows just below the windshield, I could actually see curbs and other obstacles as turns were negotiated.  Fuel economy was good making frequent short trips around town, highway economy was great! Fuel economy is tracked constantly by the on board computer and displayed instantly with data and graphics to the driver to help train driver habits for economy.

In all, the 2014 KIA Forte is a nice package, comfortable, and nicely appointed with features and equipment that are useful, ergonomically placed, definitely desired, and especially advanced for a small import vehicle.

Try the Forte on for size.  I bet you will be glad you did.

Thanks STI for the opportunity to experience the Kia Forte
Scott Mayorga

Saturday, June 15, 2013

Laboratory Inspections, Audits, Trains and Ridiculous Questions

Medical Technology is not always the lab bench, automation, staining slides, or reviewing quality control data for testing procedures, although these are some of the activities this Clinical Laboratory Scientist enjoys doing in my line of work.  Sometimes there are other duties as assigned just like in all work activities, professions, and positions held by productive citizens across this great nation.

One of the most challenging activities I have had in my experience as a laboratory manager has brought both vast enjoyment and disdain although at different times.  As a Laboratory Manager at a large laboratory servicing the pharmaceutical industry, part of the job was to tour the laboratories with auditing teams from pharmaceutical companies then field the questions as they inspected procedures, documents, and assorted lab data.  The laboratory was a show place and was on display for everyone and anyone who wanted to take a look-see.  During an audit of the laboratory, anything was game, nothing was off limits, and no question was too stupid or complex to answer.  Sometimes auditors had great questions to ask, then follow up questions, assertions, inquisitive speculation either refuted or validated.  Sometimes the questions were ridiculous or off base.  An audit is different from an inspection for a laboratory.  The most common type of inspection for a laboratory is a CAP inspection; [College of American Pathologists].    This is where an inspection team is put together with clinical laboratory experts and standardized established check lists are used to inspect each section and department of a laboratory facility.  The CAP inspection team shows up on a random day within a 3-month window.  Department of Health inspections are even less fun.  A representative from a state run DOH like New York State, visit the laboratory for 1-3 days and pour over everything and question everything that is done as if it is incorrect and you have to prove otherwise.  Audits are neither inspections or certification processes.  They are wild games of show me this , show me that, why did that happen...and also everything and anything the auditor wishes to ask and see.  Nothing is off the table.  Audits are done by customers at the facility of the vendor.

I have had the pleasure of sitting on each side of the table as an auditor and as the one being audited.  Both positions are tedious hard work requiring exact attention to detail and exhaustive attention to the matters at hand.  There are no winners or losers from an audit process.  The amount of background data or backup info required to satisfy the auditor can be minimal or downright horrendously voluminous.  The end result of a good audit or inspection is the sharing of ideas, gained expertise and possibly a better way to do something in your own lab.  Give and take of experience between auditor(s) and the vendor lab can be rewarding.  Sometimes it can be awful and just plain stupid!  One example of an audit from hell that I can give is a two person female audit team from a well know old school pharma company which visited for two days.  One lady was pleasant, did not talk much but assisted the other nasty one to help explain what the crazy one was trying to get across.  Anyway, I was called into the audit room to field questions which I frequently did for many audits.  Outside the audit room was the Metrologist and his manager; unhappy they looked after being grilled over nonsense and abstract questioning.  Next it was my turn, they both said "Good Luck" before I opened the door.  Entering the room I was looked up and down by the crazy one like I was being matched up against a suitable sized Lion just big enough to overtake me but small enough that I could last a few minutes before being devoured.  Or something like that - I knew I was in for it.  One thing of a cardinal rule though; the auditor is always right and you must remain calm and collected at all times.
  1. They can smell blood and attack when vulnerable
  2. Your boss will be after you for smart mouthing the auditor and you will be in hot water as the amount of necessary documentation to satisfy the auditor(s) grows exponentially when they are on a mission to hurt you.

After being sized up and exchanging niceties, names, credentials, and brief discussion of what I did at the lab, then the games began.  At first, the questions were general about procedures being followed, equipment maintenance procedures, quality control and such.  Then a question or two from the quiet one.  Good questions following up on the QC and maintenance theme.  Then crazy one started rolling her eyes, a blank stare on her stone face, I thought she was going to turn green and spit pea soup on the wall! "Tell me about calibrations of your equipment" she quipped?  I proceeded to tell her about frequency and procedure to calibrate a hematology analyzer and she started to smile.  A strange smile.  It was weird.  Finally after 15-20 minutes of banter she smiles and out of her mouth comes the ridiculous.  She says, "Tell me, who does the calibrations or better yet who is qualified to do the calibrations?".  I tell her I have two techs who regularly calibrate the equipment every 3 months and that I am also experienced and qualified to perform the calibration procedure.  Next was the knock down drag out of all follow-ups. She interrupts me mid sentence to ask, "So- suppose you are on your way to work one day and it is the day the instruments are scheduled to be calibrated, and you come up to a railroad crossing and BAM! a train smashes into your car and your splattered all over the are you going to insure the equipment gets calibrated the right way?"  I look over at quiet one and she is holding her head down with a grin on her face.  I look at crazy and say, "If I am splattered by a train I guess it doesn't really matter, but in my absence there are still several very capable laboratory scientists here that can perform without me".   A couple more scientific related questions and I was dismissed by the quiet one.  Later that day she called me back for some more "abuse" and then again the next morning before their half-day exit.  By God that was the weirdest off base, asinine  auditor question ever asked of me.

Most audits were enjoyable though with our visitors asking good questions with a flavor of respect and admiration.  You don't mind responding to those types of people all day long.  Probably one in six auditors thought they had something to prove - A "Hired Gun" sort of attitude.  Some of them gave the impression that they were paid well and they had to bring back to their customer lots of damage.  The auditors that were actually employed by the pharma companies were for the most part respectful and not on a mission of seek and destroy.  "Quiet one" and her partner "Crazy Lady" were not hired guns.  Crazy was just a nasty B*otch.

On the other side of the table, a most memorable audit I conducted at another lab was at a lab conducting esoteric testing.  I had three days with a manager from my own QA dept. to review this lab.  What fun I had.  I did not go there with the idea of seek and destroy but sometimes either at an audit or CAP inspection, you will see something wrong and so you dig and dig and dig, follow the trail, and dredge up everything wrong in its path.  Well that is what happened to this poor highly respected, well known specialized testing laboratory in the mid-west.  Some problems I observed right at the start even during greetings and the tour of the facility; eating in the specimen prep areas, CO2 tanks not secured, and staff carrying specimens uncovered in the elevator with us as we rode down to the lower level where specimen receiving was located.  Open plates of food like a party was going on just steps away from open specimens on lab benches.  That was just the first 20 minutes during introductions.  My job was to look over SOP's for the lab procedures, look over safety issues, analyzer maintenance and testing, and anything related to such subject matter.  The QA manager was to review facility general, general SOP's, business practices as it pertained to our contract and so forth.  I started with the analyzers performing the bulk of the work this lab did for my organization.  Record keeping was sloppy, maintenance documents not identified with each unique instrument ID so I could not tell what document belonged to which instrument  nor what maintenance and care was done to each instrument.  Then onto the DI water used for the assays.  The water quality testing was spotty at best and not completely up to CAP standards.  Then the pipettes which had not been calibrated/checked in over a year.  I reviewed documents for the last 5 years!  Unlabeled reagent bottles and undated open containers of reagent, water, and supplies out in open visibility on lab benches.  These are big No-No's.  Right then I had enough documentation to suspect that every lab result this lab supplied for my organization was in doubt at best and not to be trusted at worst.  I had people very upset. A lab supervisor retreated into the ladies room for a good cry.  The QA person hosting us tried to explain away the pipette calibration as a mis-identification of the pipettes themselves like the analyzer maintenance records.  Then, I checked for software upgrades for the analyzers and what was done post upgrade to validate the equipment back into service? Nothing was done? I was questioned why this was important.  I then got a visit from the Lab Director.  All of this was before lunch the first day.  During lunch in a common break room I was introduced to various company principles and got lots of stink-eye from employees.  I guess I will never be invited back.  After lunch I ventured into more scrutiny of the water quality procedures, analyzer maintenance, and training records of the staff performing the testing.  More insufficient data, incomplete data, missing data which was promised by next day.  In all, I cataloged 67 issues requiring backup data or supporting documentation to prove that this lab was not the shoddy appearance I was getting in a two day visit.  Yes, some issues were minor but when you add water quality, pipette maintenance, and shoddy analyzer records together that is very bad laboratory practice.  My laundry list of issues took almost 6 months for this lab to come up with supporting documentation and some issues just could not be satisfied.  Responses addressing the issues consisted of staff training, more detailed documentation, and timely adherence to maintenance procedures.  The most common explanation given in response by this lab was "Absence of Supporting Documentation".

I have also participated as an inspector on a CAP inspection team many times.  Those types of inspections are tedious and sometimes very sad.  The Lab being inspected must respond to each finding documented. Findings are items not meeting the specification as per the checklist for each section of the lab facility.  It is rare but possible that a lab can lose CAP Certification status because of egregious or numerous findings.  I have never had the displeasure of being inspected by the FDA and wish never to be under that type of serious scrutiny.  FDA can shut down a lab on the spot or impose serious sanctions and severely limit services a lab can provide.  Not fun!

Anyway - Inspections are a great tool to maintain quality in lab work for the industry as a whole.
If you are going to be inspected here are some tools to help you get through a trying experience...

  • Plan ahead - Review all your procedures months in advance of the open window for your inspection.
  • Get your documentation in order and have it readily available.  Being able to supply documentation quickly and in presentable fashion raises the confidence of the inspector/auditor that everything is mostly ok instead of mostly in shambles.
  • Review checklists or frequently asked questions and have that documentation ready such as calibration data, temperature records, maintenance records, etc.  Frequently, inspectors will ask to see INR/Prothrombin calculation data.
  • Get training records organized and ready.  The inspectors get to choose what/whose records they want to see so they all better be in order.
  • In the weeks before you CAP window opens, tour the lab yourself, ask your staff question like you are the inspector...this will help prepare them for the event instead of them running to the bathroom when the inspection team shows up.
  • Check, check, and double check your documentation, your lab signage, and your reagents.  Check to make sure everything is labeled as appropriate per regulation.
  • Come up with an action plan before the inspection happens.  I would sit with my staff and assign duties to each for when the inspectors showed up.   I knew I could count on them to quickly review maintenance and temperature charting for that morning, reagent labeling, and general clean up around the lab.  Printouts of critical calibration data like PT/INR would be printed and ready to show. Anything that could frequently be asked for - have it ready or set to be ready when the inspection team arrives.
  • Don't panic - stay calm - and be friendly.  More conversation = less time the inspectors have to run through your stuff and be all up in your grill with issues.  Be assertive but don't offer "extra" information.  Answer questions like you are a witness on the stand.  Answer exact and to the point.  Nothing extra.  Don't be responsible for leading an inspector into your hidden problems.
  • Don't cheap out on lunch.  These people are taking time to volunteer to do an inspection of your lab.  There is a great amount of required training and prep work the inspectors must go through to prepare to inspect your lab.  Treat them well.
  •  Treat every workday like a potential inspection day.  Get your staff in the habit of being prepared for an inspection at any time not just at that time of the year.  This will help your staff cope with the event and prepare them to be calm and poised to answer questions confidently and interact with the inspection in a positive way. 
Good day my friends ~ take care ~ be prepared for success.
Scott Mayorga BS MT(ASCP)H

Friday, June 14, 2013

Kroger Great Summer Products

Kroger and BzzAgent have teamed up to get the word out about the great summer grilling products available at Kroger grocery stores.  I picked up #GotItFree with the help of BzzAgent many items for a nice bar-b-Que grill out.  Tasty products like Slider size beef burgers and buns, Big K Soda, frozen fruit, potato chips, frozen yogurt bars, and fresh veggies for a nice dinner salad.  Nutritious, wholesome, and tasty.  These products are also available at a great price at your Kroger.  Save even more with a plus card!  Sign up and get excellent high value coupons and free item coupons delivered almost weekly in your mailbox.

Tonight, after a hard day in the Laboratory interfacing a new clinical chemistry analyzer, I made a dinner salad with cucumber, grape tomatoes, orange bell pepper, and fresh bagged romaine lettuce as a side dish for me and sweetie.  I made slider-sized beef burgers with matching Kroger slider buns for me and veggie hot dogs for sweetie (vegetarian), Kroger chips, and Big K Diet Cola.  For desert we had Kroger frozen yogurt bars.  Dinner was fresh and delicious.  Best yet - with BzzAgent I got all that for free! 

A yummy dinner and look at all the products  #GotItFree and #KrogerSummer thanks to BzzAgent and Kroger food stores.

Happy grilling!
Thanks BzzAgent
BzzAgent Hematech

Saturday, June 1, 2013

What is the INR Calculation - What should a Coumadin Patient know
What does INR mean and why should patients trust this test result
While the Prothrombin Time (PT) test was developed in 1935, the INR value was developed in early 1980's.  The need to standardize the PT test result so that coumadin dosing could be done with accuracy and confidence by health care providers was most important. Most patients on coumadin oral anti-coagulent therapy are familiar with the terms PT or Prothrombin Time and INR but very few understand the concept of why the INR is so important and critical to the dosing of this important plant derived medication.

Prothrombin Time tests are performed in clinical laboratories all across the globe on sophisticated laboratory analyzers or in the point of care setting using a small device the size of a tablet computer.
The test was developed with the use of purified biological material made from the brain tissue of rabbits. As technology and manufacturing practices evolved, Prothrombin Complex reagent production was developed with recombinant manufacturing methods without sacrificing the bunnies. Yeh! In early years before INR, the PT result was expressed in several variations to give the physician a better idea of the anti-coagulent effect of coumadin on his patient. The PT result was reported with a normal range which represented normal for the non-anticoagulated patient, other expressions of the PT result also combined a ratio value of test PT to Normal control, and also an established normal range ratio. However, due to variances in the many different test methods, reagents available, and sometimes technique of the person performing the test, the patients were at great risk of being over medicated or worse under medicated and even worse still overdosed. Hence the INR value was developed to provide the physician with a stable and reliable test result that was safe to use to dose patients with coumadin. Eventually, the WHO would get involved in the process of developing standards used to this day for manufacturing reagents, assigning a numerical value to the reagents [talk about this later] and test procedures.

INR stands for International Normalized Ratio which is a test result reported from the mathematical calculation of three parameters; PT result, Geometric Mean of the Normal PT, and ISI value of the reagent used. Ok I know – not another acronym!

ISI stands for International Sensitivity Index. This is the crucial component that makes for reliable INR results for all patients no matter what lab or device performs the PT test. The ISI value of every reagent manufactured for coagulation testing is assigned to that reagent based upon comparison of performance characteristics set up by WHO ~ World Health Organization. The ISI is much like the Octane rating of gasoline. The octane rating is the product of a calculation provided to consumers to assure gasoline meets certain performance standards. ISI is much the same thing. Reagents of different ISI values perform differently depending on the instrument system and the coag status of the patient; meaning deficiencies of coag factors, medications ingested, and testing conditions. Generally, the lower the ISI value of a reagent the more sensitive the reagent is to coag deficiencies which indirectly reflects effects of coumadin therapy.

The INR calculation is a brilliant mathematical process that helps to standardize a result used to directly adjust dosing of oral anti-coagulent. No matter where the specimen is analyzed, if laboratories follow procedures correctly the same blood sample can test very accurately between different Labs.

Here is the calculation:

How does this all work?
  • Coagulation Reagent manufacturers produce lots of Prothrombin Time reagent with a posted certified ISI rating.
  • Laboratories purchase this reagent for use with the laboratory instrumentation used for coagulation testing.
  • After validation testing including quality control, lot to lot comparison, and geometric mean calculation, the ISI value and geometric mean value is entered into the instrumentation data base for the INR calculation process.
  • Patient specimens are tested on the instrument for Prothrombin time which is measured in seconds.
  • The instrument automatically calculates the INR with the 3 components of the calculation.
  • The Prothrombin time result and INR calculated result are transmitted or entered into the laboratory computer system or otherwise given to the physician.
  • Patients on coumadin therapy must be evaluated by their physician for along with the PT and INR value to regulate the correct dose of coumadin for each patient.
With the advances in electronics, robotics, automation, and technology in the clinical laboratory along with a laboratories own Quality Assurance program to monitor the assay performance, the INR test result has become a reliable standard to monitor anti-coagulent therapy for the patient.

If you are a patient undergoing anti-coagulent therapy, or just frequent trips to a laboratory for monitoring testing contact the laboratory directly to ask to tour the facility.  You can gain assurance and confidence in your test results provided to your doctor for your care and treatments.  Laboratorians love to show off their labs, their work, and talk about the quality systems built into their laboratory to assure quality and accurate data for their patients. 

Scott Mayorga  MT(ASCP)H
Clinical Laboratory Scientist
Medical Technologist
LIS Manager

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