Thursday, July 28, 2011

The Laboratory 5

“Curmudge, at the start of our tour you said that laboratories of all sorts tend to have common characteristics, such as their need for accuracy, responsiveness, communications with clients, and keeping methods up to date.”

"That’s right, Jaded Julie, but there’s one more thing. Stress is endemic in laboratories, especially among lab managers. That’s why I appear to be in my 70’s but am only 50 years old.”

“Don’t give me that, Curmudge. You are really in your 70’s, but you appear to be 90; and you never worked in a clinical lab. In labs like the one we just visited, it’s certainly less stressful when one can be confident that results are correct and will be available when needed. How can they do that, day in and day out?”

“It’s dedicated people and good systems just like we teach in Lean. Well-trained professionals and technicians performing standard work. If a lab has those, the manager’s stress level is reduced considerably. And of course they have strict quality control protocols, which Mary Dikeman will describe to us. ‘Please tell us, Mary, how you make certain that your results are correct.’ “

“Each test has quality control (QC) samples that are run every day. These have known value ranges and that value must be produced each time, or we must find the reason for the aberration. Patient results are not reported unless the QC sample results are in the proper range. Some instruments also have calibrator samples that also assure that the instruments are working properly and the results are correct.

We also have to do proficiency testing for every test we do. We purchase sets of unknown samples 2-3 times a year and run them exactly like we run patient samples. Then we send in our results and they are graded and compared to others who perform the test. The results are reported to the Centers for Medicare & Medicaid Services (CMS), so they know we are proficient at what we do. If there are failures in any testing event, we have to make changes and improve for the next time, or they may take away our ability to do that test for Medicare patients.

In addition, every instrument has maintenance and monitoring procedures that are performed according to an established schedule of daily, weekly, monthly, and semi-annually. These maintenance tasks keep the instruments working well, prevent breakdowns, and maintain accuracy.”

“Years ago in my environmental lab we had to run proficiency tests, similar to what you do, for the EPA. We were always eager to learn how well we had done. One of our chemists, who happened to be of foreign origin, would complain vehemently when I didn’t share our results the moment they arrived in the mail. I think she learned her English from a drill sergeant. ‘In addition to QC, Mary, perhaps you can tell us about your sample workloads and typical turnaround times.’ “

“We average 2600 tests per day—that’s about 2000 samples. Some have multiple tests per sample. They come from inpatients, outpatients, clinics and other hospitals. Many tests are done within an hour of receipt in the lab. Some take several hours. Some noncritical tests can wait for a batch to accumulate and are run 2-3 times per week. Cultures may take 2-7 days, although TB and fungus cultures are held for 6 weeks. So you see, sometimes ASAP is dictated by how fast something is technically feasible.

The lab is staffed around the clock, with about 42 people in the various departments during the day Monday through Friday, 5-6 people working evening shift, and 2 people working night shift. However, there are fewer people in the laboratory on weekends.”

“So, Jaded Julie, do you have any questions for Mary?”

“I certainly do. If I were starting out in health care and wanted to work in a lab like yours, what sort of education and training would I need?”

“For detailed career information for Phlebotomist (6-12 months), Medical Technologist (BS degree), Medical Technician (associate degree), Cytotechnologist (BS + I yr), Histologist (associate degree + 1 yr), Pathologist (MD +specialty), visit the website of the American Society of Clinical Pathology or the College of American Pathologists.”

“We really appreciate your tour and discussions, Mary, and we now have a better understanding of the lab’s capabilities and complexity. Patients can certainly feel confident in the laboratory’s results. Nevertheless, I’ll try not to be the source of submitted specimens. Okay Julie, shall we go out for a jog?”

“Get real, Curmudge. How about a brisk walk up the stairs?”

Affinity’s Kaizen Curmudgeon

Thursday, July 21, 2011

The Laboratory 4

“Today we’re going to visit Pathology, Jaded Julie. One has to be impressed with what they do here, with the pathologists dealing with life-or-death issues on a daily basis.”

“C’mon, Curmudge, you know it’s not strictly life or death. The ultimate mortality rate is 100%; everyone dies eventually. It’s more correct to say, ‘death sooner or death later.’ “

“Thanks for making my day brighter, Julie. Shall we continue our tour of the laboratory with Mary Dikeman?”

“The next three rooms are the offices of our pathologists, each with a microscope on the desk. They work closely with Histology and Cytology, and they oversee the technical aspects of the entire lab. Their normal day includes examining and describing each tissue specimen, examining slides prepared from the tissue specimens for evidence of malignancy or disease, performing analysis of frozen sections of fresh tissue sent from the operating room, conferring with surgeons and oncologists about reports, reviewing Pap smears, reviewing new and changed technical procedures. They also perform autopsies when required.

Now we will walk into the histology department. Histology is the study of the microscopic structure of organic tissues. A tissue sample, such as a gallbladder, is removed during surgery, put in a fixative and send to Histology. There the next day the pathologist examines it and describes its appearance at the large stainless steel grossing station in Histology. Then he will cut portions of it to have microscopic studies. These sections are processed overnight in two instruments that move the tissues through various solutions to prepare them to be cut into very fine slices and put on a slide. There are four microtomes at the center table in this area that are used by the histotechnicians and histology assistant to cut the tissue into fine slices for slides. Once they are affixed to the slides, they are moved to an instrument where they are stained and a glass coverslip is put over the tissue. These are the same as the bright colored tissue slides they show on the CSI or Medical Examiner TV shows. Then they are taken to a pathologist for him to examine. They look at what kinds of cells and structures are present on the tissue slide and what characteristics they have. When fresh tissue is sent to Histology for a frozen section during surgery, a portion of the tissue must be quick frozen in a cryostat and then thin slices are cut and placed on a slide. After it is stained, the pathologist examines it and calls the results to the operating room. The surgeon will then decide how to proceed with his surgery. You will notice that there are two cryostats, so there is always one available in case one is in auto defrost at the time it is needed. The histotechnicians also perform other special stains and immunohistochemical stains on tissue to help the pathologists make disease diagnoses from these slides.

Now let’s go across the hall to the Cytology processing area. Here is another laminar flow hood to protect the users when they set up possibly infectious samples. Watch the cytology assistants take the Pap smear vials and run them through the processor to make a thin layer of cells on a slide. Then they spin down body fluids in the centrifuge and process them to make a slide. The slides are stained and coverslipped on the instrument in Histology. Then the slides are put on the computerized imaging system that will survey the slides and pick out 22 fields of interest that need to be reviewed. In another room with microscopes at 3 work stations, the cytotechnologists look at and determine if there are suspicious cells present on the 22 areas or anywhere on the slide. This uses both computerized and human expertise to provide a high level of detection. Any slides that have suspicious cells are taken to the pathologists to review and diagnose.”

“I remain totally impressed, Julie. So much of this requires painstaking work by the technicians and experience and judgment by the pathologists. Diagnosis of diseases by microscopic examination of tissue specimens can be very difficult, as is the case with interstitial lung disease. Different areas of the same specimen can look different, and even experienced pathologists can disagree.”

“With your poor eyesight, Curmudge, it’s a good thing that you didn’t become a pathologist. ‘It looks as if we are nearing the end of our tour, Mary.’ ”

“ Almost, Curmudge and Julie. Across the hall is a room where there is an industrial dishwasher, large sinks and an oven. Here the lab glassware is washed and equipment kept clean by the lab aide, who also orders supplies and fills orders for lab supplies.

Near the main lab is the Point of Care office. The POC staff maintain and oversee all the bedside testing that is done across the system. Also located in this area are the MT school coordinator, the student lab and classroom. Our technologists and pathologists support a school to provide a clinical year experience for 4th year medical technology students. They receive lectures and training in the student classroom and student lab, and then are integrated into the laboratory to learn about performing tests in most areas of the lab.”

“Although our formal tour is over, let’s get together next week and do a post mortem (oops, that might not be the best term to use here) on what we have seen.”

Affinity’s Kaizen Curmudgeon

Thursday, July 14, 2011

The Laboratory 3

“Here we are, Jaded Julie, back in Microbiology to continue our tour of the laboratory.”

“Before you forget everything, Curmudge, please tell me some of the things that you have already learned from the tour.”

“Do you remember the 1967 movie, The Graduate, in which Dustin Hoffman was advised to go into ‘plastics’?”

“The movie was before my time, but everyone knows the story.”

“Well Julie, this tour is teaching me that appropriate advice for today’s graduate would be to go into biology or perhaps automation. I’m becoming convinced that microbiology is an extremely powerful science. ‘So, Mary, continue the tour and teach me more.’ “

“Let’s move to the next area in Microbiology and see on the left an instrument that is used for Lyme disease testing. On the right is a small instrument for fetal fibronectin testing that helps tell whether a mom is at risk of early labor. You may also see the Newborn Screen cards that are sent to the State Lab to help detect more than 25 congenital conditions on all newborns, before they can affect the child. Ahead is a large table with four technologists looking at the culture media plates that were set up the day before and put in that CO2 incubator. They check each plate for growth and if there is something, they must decide whether it is important to know what it is. (Some bacteria are normally present in some areas, so they are not the 'bad guys' or pathogens.) If they need to identify some possible 'bad guy' bacteria, they might do some quick biochemical tests, or they might put the bacteria on the Vitek instrument that can perform a whole panel of tests and produce the name of the organism. This instrument will also put the bacterial organism with some dilutions of antibiotics and test what antibiotics will likely be effective in treating that infection. These identification and antibiotic results may be available in 5-12 hours. The results are passed to the Meditech computer system by an interface from the instrument. You will notice several microscopes in this area, since determining if bacteria are gram positive ( blue) or gram negative(red), or shaped like rods or round cocci is the important first step toward identification.

Across the room is another large incubator to keep the culture media and other tests warm for 2-7 more days. Next to that is a large Plexiglas box with a side chamber and access door. This is the anaerobic chamber. Some important bacteria called anaerobes are unique from other bacteria and do not like to be in the presence of oxygen. This chamber removes most of the oxygen and replaces it with a high nitrogen gas mixture that makes them happy. Cultures from deep systemic areas of the body may be checked for anaerobic bacteria. The specimens are put to special culture media and incubated in the anaerobic chamber for many days. The technologist puts their hands into the box through portholes with sleeves and examines the cultures. If anaerobes are present, they have certain growth characteristics that help identify them.

Off to the back is a small closet-like room, called the dark room. There is a fluorescent microscope in there, which is best used in a dark surrounding. Special fluorescent stains are used here to detect ANA antibodies, Cryptosporidia, and Giardia.

Let’s go out the back door and across the hallway to the very clean (smell the bleach) Molecular room. Here is where DNA amplification and target signal amplification are used to detect Chlamydia, Gonorrhea and HPV. In the next room is the area where Parasitology and Mycology (fungus) work is done. There is also a large laminar flow hood in this area for the fungus culture work to keep the fungus spores away from the people. So that fungus is not among us! A smaller incubator contains the fungus cultures; they require a lower temperature and special media for optimal conditions to grow.”

“As I was saying, Julie, microbiologists do really important work. They are certainly more than ‘little biologists.’ When I was a kid, microbiology might not have been part of a clinical lab, if such labs even existed then. Of course, it didn’t require a microbiologist to diagnose the ugly impetigo sore on my knee.”

“You told me that years ago engineers in industry used simple microbiology to identify the filamentous bacteria that hampered the operation of waste treatment plants. The science has come a long way since then.”

“And we’ll go a short way out the door and to the right. The next room on the right is the pathology transcription area. You will find two transcriptionists who handle the clerical work for the Cytology and Histology departments. They transcribe dictated reports from the pathologists, register client patients, and order tests.

The next room is the office for the two laboratory information system coordinators. They handle problems and changes to the lab computer module, some lab billing issues, and lab quality matters across our lab system.”

“Speaking of pathology, that’s the part of the lab that we’ll visit next week. Don’t forget to come, Julie.”

Affinity’s Kaizen Curmudgeon

Thursday, July 7, 2011

The Laboratory 2

“Here we are, back in the basement of St. E’s. Whenever I come down here I fear that some day I’ll ask about you and the answer will be, ‘Oh, Curmudge is over there in the morgue.’ “

“Don’t worry, Jaded Julie. If I’m there I’ll be in good hands. I have a friend who drives a hearse for a local funeral home. She often comes down here to pick up ‘clients.’ Shall we continue our laboratory tour with Mary Dikeman?“

“Now we leave the Blood Bank and head into the area where urines are examined, fecal occult blood tests and pregnancy tests are done. Good thing they keep it so clean or it could become very odiferous very easily! In the back aisle is the large Coulter instrument that does the CBCs—Complete Blood Counts—and also the microscopes used when a manual differential is required. And there is another smaller instrument that serves as backup to the CBC instrument; so important to have a backup so that CBCs can still be done even if the Coulter is having a time out to have maintenance done. There are an average of 100 CBCs done each day. Across the aisle are the two instruments that are used for Coagulation tests, such as PT, PTT; again there is a backup for the testing.

We continue around the corner and see a large screen that lists pending stat tests and how long they have been waiting. Turn to the right toward the Chemistry Department and see the two blood gas instruments where arterial blood gases are run. Straight ahead are the workhorses in the lab, the chemistry instruments that do the chem panels. The instruments are each the size of a small VW Beetle. Again there is two of each instrument that run different tests, but they can be the backup to each other in case one is not working. On average, about 200 chem panels are run each day. There are also two very large instruments that do hormone testing, cardiac testing, thyroid testing, and other specialty tests. These instruments pass the results to the lab Meditech computer via an electronic interface.”

“You must have noticed, Curmudge, that the lab seems to have two of each of the most critical instruments. They can’t afford to have a request for an essential test ‘stat’ and have to respond that the instrument is ‘down’ for maintenance.”

“ ‘Stat’ is another one of those medical terms that is not obvious to every layperson. It’s like ordering a gelato in Italy, and the waiter says ‘subito’ and brings the ice cream immediately.”

“Around the back corner there is the ECI instrument that does troponins (to diagnose a suspected heart attack), hepatitis and HIV testing. Also in that area are the Variant instrument that does hemoglobin A1C testing (to diagnose and manage diabetes) and the protein electrophoresis instrument that uses electric current to separate proteins in serum or spinal fluid. Testing for lead in patient’s blood takes place on the back counter in this area. Lead poisoning is still a problem in our community. You also notice the Plexiglas-covered instrument that is used for vitamin D, varicella, mumps and rubeola testing. The medical technologists and technicians (also ASCP certified) rotate through the operation of these instruments. You will notice the wall is completely covered by refrigerators and freezers that store reagents for the chemistry tests.

Now let’s walk past the lab office, which is the central area for clerical business and the lab secretary, and into the Microbiology area. On the left is the blood culture instrument that incubates the BC bottles and takes a reading every 10 minutes. It looks for an increase in CO2 production that would indicate the presence of bacteria. On the right are a long counter and a Plexiglas front cabinet. Watch the technologists put their hands under the opening to the cabinet and put the culture specimens onto the culture media. There is airflow that will capture any stray bacteria and pull them away to a filter, so the technologist/technician is protected from infection. Once the culture media is inoculated with the specimen (such as urine, sputum, wounds, throat), the media is placed into the large refrigerator-like box. This incubator is kept at a temperature of 35 degrees Celsius, which is close to the human body temperature that bacteria like to grow in. It also has 5% CO2 gas pumped into it to really make the bacteria happy so they will replicate while in the incubator. In 8-24 hours they will have multiplied hundreds of times and formed colonies of bacteria that are 1-2 mm in size. In this room, the rapid tests for influenza, RSV (respiratory syncytial virus), strep, rotavirus and Clostridium difficile are performed, and there is a microscope for looking at gram stains of the specimens that came in.”

“I must admit, Julie, that many of the tests performed in Mary’s lab are new to me; and they might be fairly new to the lab. For example, their vitamin D testing was started in the fall of 2010. Not only must a hospital lab be responsive and accurate; it must stay up to date. When a test is developed that can answer a critical diagnosis question, the laboratory needs to be able to do it. Of course, if the test is not requested often and the results not needed ‘stat,’ it can be sent out to a so-called reference lab.”

I’m impressed by the measures taken by the lab to protect the technicians from infection. We wrote about C. difficile on February 5, 2009, and I still shudder when I think of it.”

“You can shudder for a whole week, Julie. Mary has other work to do, so let’s continue our lab tour in the next posting.”

Affinity’s Kaizen Curmudgeon