Commonwealth v. Read — Trial ArchiveGary Faller - Direct/Cross/Redirect
260 linesMR. LALLY: [unintelligible] Dr. Gary Faller to the stand.
JUDGE CANNONE: Thank you.
COURT CLERK: Do you solemnly swear that the testimony you shall give to the court and the jury in the matter now pending shall be the truth, the whole truth, and nothing but the truth, so help you God?
DR. FALLER: I do.
COURT OFFICER: Sure.
JUDGE CANNONE: Good morning, doctor.
DR. FALLER: Good morning.
MR. LALLY: Good morning, Your Honor.
JUDGE CANNONE: All right, Mr. Lally, whenever you're ready.
MR. LALLY: Thank you, Your Honor. Good morning, sir.
DR. FALLER: Good morning.
MR. LALLY: Could you please introduce yourself to the jury, spelling your last name for the court?
DR. FALLER: My name is Dr. Gary Faller, F-A-L-L-E-R.
MR. LALLY: And what is your occupation?
DR. FALLER: I am a physician pathologist.
MR. LALLY: And where do you work?
DR. FALLER: I work currently at Signature Healthcare in Brockton.
MR. LALLY: How long have you worked at Signature and in what capacity, sir?
DR. FALLER: Signature — I started — it's probably been six months. I took a new job six months ago. I am the chief of pathology and the laboratory medical director at Signature.
MR. LALLY: And where did you work prior to your work at Signature, about six months ago?
DR. FALLER: Prior to that, I was at Good Samaritan Medical Center in the same capacity.
MR. LALLY: And how long did you work at Good Samaritan for?
DR. FALLER: Since 2015, late 2015.
MR. LALLY: And did you work in any capacity similar to that prior to working at Good Samaritan?
DR. FALLER: Prior to Good Samaritan, I worked at the Carney Hospital, which is in Dorchester. Started that job in 1996. I stayed on staff at Carney Hospital up until it actually closed six months ago. So I've been on staff at Carney for quite a long time.
MR. LALLY: Where did you go to school and what degrees did you receive?
DR. FALLER: I went to college at Tufts University in Medford. Graduated in '87. From there I went to Tufts Medical School and graduated in 1991.
MR. LALLY: And following your graduation, where did you go from there?
DR. FALLER: After medical school, I did a residency at Tufts Medical Center in 1991 to 1996.
MR. LALLY: And then where did you go following your residency?
DR. FALLER: Right from residency, my first job was at Carney Hospital, which I previously mentioned, so 1996.
MR. LALLY: And doctor, are you board certified?
DR. FALLER: I am board certified in anatomic pathology and clinical pathology.
MR. LALLY: And what is a board certification?
DR. FALLER: Board certification is something we need to show that we are actually qualified to perform our — the job that we need to do, both in anatomic and clinical pathology. It's a written exam that we take and we need to pass to demonstrate that we're competent and know what we're doing.
MR. LALLY: First, in just general terms, if you could explain to the jury — what is pathology?
DR. FALLER: Pathology — well, there are two basic branches of pathology: anatomic pathology and clinical pathology. Anatomic pathology is basically — an anatomic pathologist is a physician, an MD or a DO, trained to make diagnoses on patients by looking at tissue biopsies, organs, tissue fluids, and we're also trained in autopsy pathology as well. So basically an anatomic pathologist — we look at tissues via glass slides. Slides are made and we every day make the diagnosis of — somebody has a cancer or somebody doesn't have a cancer, benign — look at colon polyps, breast biopsies, pretty much anything that comes out of the operating room or a physician's office, any sort of biopsy.
DR. FALLER: Clinical pathology, on the other hand, is basically — a clinical pathologist is a physician, an MD or DO, who specializes in the clinical lab, which basically is any fluid specimen, including blood specimens. When you go to the hospital and you have your blood test and it gets sent to the lab, the clinical pathologist is ultimately responsible for the quality of your lab tests.
MR. LALLY: And so the time that you worked at Good Samaritan — did that cover the date of January 29th, 2022?
DR. FALLER: Yes.
MR. LALLY: And again, what was your title and what was your job at Good Samaritan in the month of January 2022?
DR. FALLER: I was the chief of pathology at the time and laboratory medical director.
MR. LALLY: And what did you do as the laboratory medical director?
DR. FALLER: The laboratory medical director is basically responsible for the ultimate quality of any — whether it's a biopsy, somebody's biopsy, or lab result — the laboratory medical director has to make sure that the final result is of excellent quality. So there are many different things that we need to make sure are in place. as far as we need to make sure we have the correct amount of workers. You know, you want to have enough workers. You want to make sure they're competent. So there are many policies for competency for all the lab techs and phlebotomists and even pathologists. Basically, the laboratory medical director — if something goes wrong — it's ultimately his or her fault.
MR. LALLY: And the lab at Good Samaritan — was that lab, is that lab accredited?
DR. FALLER: Yes it is.
MR. LALLY: And by what body?
DR. FALLER: We are accredited — Good Samaritan is accredited by the — we call it the CAP. It's the College of American Pathologists. They are considered the preeminent accrediting body for hospitals. They've been around for probably 70 plus years or so.
MR. LALLY: What is accreditation? What does that mean?
DR. FALLER: Accreditation is basically something that says that your laboratory is following guidelines and providing excellent quality. To be accredited with the CAP, every two years we have a laboratory inspection. They don't tell you when they're coming. They will give you a 3-month window and they'll come and inspect you to make sure we have a good quality lab. Each section of the lab — pathology, the clinical lab, microbiology, chemistry, hematology — the CAP has a checklist with numerous requirements that one needs to fulfill. There are probably over 3,000 items that they look at.
MR. LALLY: And was your laboratory at Good Samaritan — was the accreditation up to date on January 29th, 2022?
DR. FALLER: We were accredited, still are.
MR. LALLY: Now, at Good Samaritan Medical Center, when a blood test is ordered, what types of things is the lab testing for?
DR. FALLER: I think the most common tests that are performed when you go and you have your blood test — one is chemistry, a chemistry test where we look at sodium, potassium, chloride, glucose. We also — a common test is a CBC, or a complete blood count, where we look at your red blood cells and your white blood cells and your platelets. Those are the two most common tests.
MR. LALLY: And why is blood testing ordered in the course of medical treatment at a hospital?
DR. FALLER: When you're admitted to the hospital, usually you're sick. So the physician is usually ordering, as a standard, chemistry and CBC to see if there are any clues in those tests that could help the doctor take care of you. If they look at a BUN and creatinine — maybe if they're elevated, you could be dehydrated or have renal failure. If you look at liver function tests, maybe there's something wrong with your liver. So it's just a general good look at the patient to see if there are any clues that could help them.
MR. LALLY: And as far as the blood testing results are concerned, how does that assist either a doctor or clinician in treatment and diagnosis?
DR. FALLER: Basically, if the results are normal, that sometimes helps to rule things out. If they do a CBC and look at the hemoglobin and it's low and the patient's anemic, maybe the patient might need a transfusion. So there are many different case scenarios where the results can help the provider, the clinician.
MR. LALLY: Now, with reference to alcohol — does Good Samaritan Medical Center also test alcohol within the blood?
DR. FALLER: Yes, we do.
MR. LALLY: And why would that assist medical treatment and diagnosis?
DR. FALLER: If a physician is wanting to know if somebody's been drinking or has alcohol on board — or maybe a patient has ingested drugs of abuse — they'll test for alcohol to see, one, if it's positive. And if it is, then it helps confirm that the patient has been drinking.
MR. LALLY: Now, are there any policies and protocols at Good Samaritan Medical Center with reference to how blood is taken and how blood is tested?
DR. FALLER: Yes, we have numerous policies. We have one policy specifically for phlebotomists. Those are laboratory technicians who draw the blood. So we have a policy for them to explain exactly what they need to do. And also in the laboratory we have numerous policies basically for any tests that we provide, and so we have a policy for alcohol testing as well.
MR. LALLY: May I approach the witness, your honor?
JUDGE CANNONE: Yes.
MR. LALLY: Doctor, I'm placing before you two sets of documents. Just ask you to review those generally and look up when you're finished. And do you recognize what those are, sir?
DR. FALLER: Yes.
MR. LALLY: And can you explain to the jury what is contained within each of those two sets of documents?
DR. FALLER: Okay. The first one is a patient preparation for specimen collection. This is the policy that I was mentioning, specifically designed for our phlebotomists, to detail the procedure of the blood draw. Basically it goes through — one of the most important parts of the process is correct patient identification, where we need to correctly identify the patient. We have the patient state his or her first and last name and state it out loud, to make sure it matches the patient that we're trying to draw, and then we also match up the bracelet to the medical record number on the patient's bracelet. So one of the most important things is correct patient identification.
DR. FALLER: The rest of this policy goes on and just pretty much details what to do next, including finding the veins, cleaning the site, has some information on if there are any complications. So it's basically the entire process of the blood draw. The second one is our alcohol policy, which pretty much details in detail what goes on behind the scenes for an alcohol blood test in our hospital.
MR. LALLY: May I approach again?
JUDGE CANNONE: Yes. Counsel, proceed to introduce and admit the next two exhibits.
MR. JACKSON: No objection.
JUDGE CANNONE: All right. Thank you. For the record, it would be the patient preparation for specimen collection — the next exhibit in line. All right. 35.
MR. LALLY: And the ETOH policy would be the next exhibit. 36.
JUDGE CANNONE: Excuse me. Okay.
MR. LALLY: Now, doctor, what types of precautions are in place at Good Samaritan with respect specifically to alcohol testing in the blood — I should say, taking the blood sample from the patient?
DR. FALLER: Yes. One of the major things we need to do when taking somebody's blood for alcohol is to obviously not use an alcohol swab. Normally when you have your blood test, they cleanse the area with a swab that contains alcohol. So in our policy there is a specific statement that says do not use an alcohol swab, because potentially, when you're drawing the blood, if you suck up some of that residual alcohol, you could cause a false positive. So we have in our policy — and it's a policy every hospital should have — where we use a swab that has no alcohol. We call them a moist towelette. That's what we refer to them as. Also, in the emergency room, my supervisor pretty much removed probably 95% of all the alcohol swabs.
DR. FALLER: So just in case a phlebotomist forgets to not use an alcohol swab, they are hard to find. We need to keep a few there because we need to use alcohol wipes on certain tests like blood cultures and things like that.
MR. LALLY: So when were the alcohol swabs removed from the emergency department?
DR. FALLER: It was before my time.
MR. LALLY: So fair to say prior to January 29th, 2022.
DR. FALLER: Correct.
MR. LALLY: What is a phlebotomist and what do they do?
DR. FALLER: A phlebotomist is a healthcare professional who specializes in drawing blood. They're the ones who are trained, competent, and know what to do when they draw a patient's blood.
MR. LALLY: What kind of training do phlebotomists receive at Good Samaritan?
DR. FALLER: We try to hire phlebotomists who have been trained — it's just easier. They can have a high school background, but if we train on site, they just need to be trained on the proper protocol, proper procedures, and demonstrate competency.
MR. LALLY: Is there any sort of proficiency testing related to phlebotomists at Good Samaritan?
DR. FALLER: There is no proficiency testing for phlebotomists, but there are competency assessments. With phlebotomists, or any laboratory technician or even pathologists, there are strict guidelines for competency. We have to always make sure people know what they're doing — it's a CLIA, or a federal government regulation or requirement. So when anybody first starts in a hospital, the requirements are: one, initial training. You can't let anybody come in without knowing what they're doing. So we have to document that they have the initial training and they're competent. Then the law says 6 months from that, we do another competency assessment where we look at six elements of competency defined by CLIA.
DR. FALLER: And 6 months from that — one year from the start date — is another competency, and then after that it's annual thereafter. And that goes for phlebotomists and it goes for any laboratory technician.
MR. LALLY: Doctor, once the blood is drawn by the phlebotomist, what happens then?
DR. FALLER: The phlebotomist will draw it, and at that time they need to have the specimens labeled in the patient's room, because you don't want the phlebotomist to mislabel. So everything is labeled at the patient's bedside, with a an initial and with a phlebotomist's initial and date and time, that blood test will then be sent to the lab. In this case, blood was drawn in the emergency room, so it gets packaged into a plastic bag and sent in a pneumatic tube up to the laboratory.
MR. LALLY: And once it's sent to the laboratory, what happens with the sample from there?
DR. FALLER: Once we receive it — it's called receiving the specimen — there will be a technician who then goes into the computer, enters the phlebotomist's name from the tube into the computer system, enters the time, and the technologist will look and see what was ordered and then do the appropriate next step based on what was ordered.
MR. LALLY: And in a case in which alcohol is one of the items that are ordered, what is the next step as far as the testing goes?
DR. FALLER: So the next step with alcohol testing — we use a specific tube, so the phlebotomist would know what tube to use. It would be a light green tube that has lithium heparin in it, which is an anticoagulant. We don't want the blood to clot, so that's why we use an anticoagulant. So the first step when testing for alcohol is that the test is designed to be performed on serum or plasma, and to get that, the next step would be to centrifuge the blood. A centrifuge is a machine that spins the blood rapidly. We spin it at around 3,300 RPMs — rotations per minute — which is pretty fast. And the reason why we spin it is because centrifugation will separate the blood components based on density.
DR. FALLER: So the heavier stuff, like the red blood cells, will go to the bottom, and the lighter stuff, like the watery component of the blood, will go to the top, and some of the white cells go into the middle. But for alcohol testing we are targeting the top part of the blood component, which would be plasma.
MR. LALLY: And then once it goes through the centrifuge process, what happens then?
DR. FALLER: So once it's centrifuged, we have the separation of the blood components. We have the plasma ready to be tested, so the technologist will walk the specimen over — it's probably 10 feet from there — and put it onto our Roche Cobas machine. That's our machine that performs our chemistries as well as alcohol testing. It goes onto a machine. All the testing is basically inside of a black box. And the label present on the blood tube will dictate what the Roche Cobas machine will test. So based on the barcode label, once it's on our machine, it knows what test to do and it will perform an alcohol test.
MR. LALLY: And Doctor, for the stenographer, do you know how to spell that Roche Cobas machine that you were just referencing?
DR. FALLER: Oh, R-O-C-H-E, Roche. And Cobas, C-O-B-A-S.
MR. LALLY: Thank you, sir. May I approach?
JUDGE CANNONE: Yes.
MR. LALLY: Doctor, showing you another series of documents. You can just look at that and look up when you're ready. Do you recognize those records, sir?
DR. FALLER: Yes.
MR. LALLY: And what do you recognize those to be?
DR. FALLER: These are the medical records of Karen Read.
MR. LALLY: And sir, is there an indication within those records as far as the date of treatment for Miss Read?
DR. FALLER: Yes, there's a bunch of dates in here.
MR. LALLY: As far as the treatment is concerned, sir, what is the date of treatment?
DR. FALLER: Oh... sorry. Is that 1/29/22? That's what it says on the admit date. It says 1/29/22.
MR. LALLY: Thank you, sir. That's fine. Doctor, if I could direct your attention further into the document to a previously tabbed portion. Do you see any indication in there as far as a result for alcohol testing?
DR. FALLER: Yes, I do.
MR. LALLY: And with respect to that result, have you reviewed these records prior to today?
DR. FALLER: Yes, I did.
MR. LALLY: And if you could explain to the jury the timeline of this blood sample — let's start with first when it was ordered.
DR. FALLER: So when it was ordered, it was 9:03 in the morning.
MR. LALLY: Okay. And when was it taken, sir?
DR. FALLER: The blood test was taken 5 minutes later. So 9:08.
MR. LALLY: And then what happened, or what is the next time that something of any significance happened with it?
DR. FALLER: 5 minutes from that — 9:13 — we received it, and 9:53 in the morning the result was entered into the computer. So it was ordered at 9:03 and the results were in the computer at 9:53.
MR. LALLY: May I approach again?
JUDGE CANNONE: Yes.
MR. LALLY: I'm going to seek to introduce and admit as the next exhibit.
JUDGE CANNONE: Any objection, Miss Little? All right. Thank you.
MR. LALLY: May I return to the witness?
JUDGE CANNONE: Yes.
MR. LALLY: And Doctor, what was the result of the testing for alcohol in the defendant's blood when it was taken shortly after 9:00 a.m. on January 29th?
DR. FALLER: 93 milligrams per deciliter.
MR. LALLY: Okay. Nothing further.
JUDGE CANNONE: Okay. Miss Little.
MS. LITTLE: Thank you. Good afternoon, Dr. Faller.
DR. FALLER: Good afternoon.
MS. LITTLE: The Good Samaritan Lab is a clinical lab, not a forensic lab. Is that right?
DR. FALLER: Correct.
MS. LITTLE: And hospitals are not in the legal business of calculating an individual's blood alcohol concentration. Is that right?
DR. FALLER: I would say 99.9% of the time we are not in the legal business. We are testing alcohol for the diagnosis of alcohol intoxication. But occasionally a case may come — very rarely — to a hospital and it ends up being a legal case. It's not common. Uncommon.
MS. LITTLE: And you'd agree that there are differences between screening tests that are conducted at hospitals and forensic tests that are conducted by law enforcement. Right?
DR. FALLER: Yes.
MS. LITTLE: The purpose of testing in a clinical setting is to assist in the diagnosis and treatment of a patient. Right?
DR. FALLER: Correct.
MS. LITTLE: And physicians need to analyze blood quickly. They need to get the results so they can see what's in a patient's system and then effectively and efficiently treat that patient. Right?
DR. FALLER: Correct.
MS. LITTLE: Whereas in a forensic setting, tests for blood alcohol concentration are designed to produce results that are reliable and credible for use in court.
DR. FALLER: Correct.
MS. LITTLE: You testified earlier today that your lab is accredited by CAP, which is the College of American Pathologists. Do you recall that testimony?
DR. FALLER: Yes, I do.
MS. LITTLE: But CAP is a clinical laboratory accreditation, not a forensic accreditation. Right?
DR. FALLER: We don't have the forensic accreditation for Good Samaritan.
MS. LITTLE: In fact, Good Samaritan has never been investigated or accredited by any forensic accreditation team to ensure that you perform all of your tests with the integrity necessary to support results in court. Right?
DR. FALLER: We've never had the forensic accreditation, but we have very good quality lab results, which I could go into further.
MS. LITTLE: But you've never been accredited by a forensic accreditation team, right?
DR. FALLER: Nope.
MS. LITTLE: And the lab at Good Samaritan has never been accredited by ANAB, the ANSI National Accreditation Board. Are you familiar with that organization?
DR. FALLER: No.
MS. LITTLE: Are you aware that ANAB is the forensic accreditation body in the United States that ensures that a laboratory's procedures meet the minimum standards necessary to ensure results are reliable and credible for use in court?
MR. LALLY: Objection.
JUDGE CANNONE: Sustained.
MS. LITTLE: Now, the most reliable method of forensic ethanol testing is called headspace gas chromatography, or HSGC. Are you familiar with that process?
DR. FALLER: Yes.
MS. LITTLE: And HSGC is the method that's used by forensic labs to test for blood alcohol content. Right?
DR. FALLER: Correct.
MS. LITTLE: And that's because forensic tests require the testing of whole blood for the presence of alcohol. Right?
DR. FALLER: Correct.
MS. LITTLE: Can you briefly, just for the jury, describe the difference between a whole blood test and a serum test?
DR. FALLER: Sure. So whole blood — to put it simply — when you have your blood drawn, you see the fluid coming out all red. That's whole blood. We don't do anything to it. We don't spin it down. We don't centrifuge it. That is whole blood. That is the specimen of choice for forensic blood ethanol testing. Hospitals, on the other hand — our methodology, which is just as good as the forensic headspace gas chromatography — is based on looking at the serum or the plasma. So we centrifuge it and take the liquid portion off the top. So in the hospital we test it on the serum or the plasma. Now, did you ask me the difference? Do you want me to go into the difference?
MS. LITTLE: That's enough, Doctor. Thank you. I'll ask some additional questions to clarify. And in a forensic lab, they actually require the testing of whole blood. Correct?
DR. FALLER: Correct.
MS. LITTLE: And HSGC directly measures ethanol in the blood. Correct?
DR. FALLER: Correct.
MS. LITTLE: And this method is designed to be accurate and reliable for forensic purposes, for use in legal proceedings. Correct?
DR. FALLER: Correct.
MS. LITTLE: But the testing in this case was performed using the hospital's clinical chemistry machine instead of a forensically defensible method like HSGC. Right?
DR. FALLER: Correct.
MS. LITTLE: And that clinical chemistry machine performs — what you just testified to — a serum test. Right?
DR. FALLER: Serum or plasma.
MS. LITTLE: Serum or plasma. And hospitals use serum or plasma testing because it's actually quicker and more efficient than HSGC, ...right?
DR. FALLER: Uh, yes. It's less labor intensive. It's easy to automate, but at the same time very, very good and very accurate.
MS. LITTLE: But serum testing does not actually measure alcohol directly. It instead measures the presence of what's called — what's called NADH. Right?
DR. FALLER: Say that again.
MS. LITTLE: Yes. I'll repeat that. That was my fault. Serum testing does not actually measure alcohol directly. Instead, it measures the presence of NADH. Is that right?
DR. FALLER: Almost. Well, NADH is a byproduct of alcohol, right?
MS. LITTLE: Uh, correct.
DR. FALLER: I can go into the testing methodology that we use to explain it, if you want me to.
MS. LITTLE: Well, serum testing measures the presence of
DR. FALLER: NADH.
MS. LITTLE: Correct.
DR. FALLER: It measures the rate of change of NADH production. So it doesn't actually look at just NADH — it measures the rate of production, and I can go into more detail on that. Alcohol testing in the lab is correct.
MS. LITTLE: I'll ask you some additional questions about NADH and we'll get there.
JUDGE CANNONE: Yeah. So you can do this now, but let the doctor answer his question fully. Next question. Okay. And the following questions. Doctor.
MS. LITTLE: The higher the NADH in a patient's system, the higher the serum test result.
DR. FALLER: Correct. That may not be correct. You know, it's a rate of change of NADH production based on our methodology. I can go into that. So our test system is a little bit different than the forensic testing system, but it's also very good and very accurate, and almost — when we compare our methodology to the headspace, we get almost the exact same results, and when we compare with peer laboratory comparisons. But what we do — and I think the jury needs to know this, maybe some of you might understand the chemistry behind it — is we take the patient's sample, and it's based on — because when there's alcohol in the specimen, we add alcohol dehydrogenase to the test system — the same enzyme that's in the patient's body. In addition, we add a surplus of NAD to it.
DR. FALLER: NAD is similar to NADH; they get converted back and forth. So when we put it on our test system, alcohol dehydrogenase is in there. And what happens is when there's alcohol, it combines with the NAD that we add to it and creates NADH. And then in our machine, there's a spectrophotometer which can monitor the rate of NADH production over baseline. And we use — there's something that measures — a photometer that measures the NADH production. It looks at light — in physics — and looks at 340 nanometers, and it's pretty accurate. It will tell the system how much NADH is produced, and that amount is directly proportional to the alcohol in the patient sample. So it's a very, very accurate test, but there are some limitations that I can go into.
JUDGE CANNONE: So wait for another question. Okay, next question, Little.
MS. LITTLE: Yes. So serum testing can be subject to errors, right?
DR. FALLER: And there are limitations. There are some limitations that I can explain, just like headspace gas chromatography may have some limitations — but I can go into them.
MS. LITTLE: What are some of the limitations of the serum testing?
DR. FALLER: Okay. So the serum test — as with many tests in the laboratory — different things can interfere with our laboratory tests, and the three most common ones, which are unlikely to affect ethanol testing, are what we abbreviate H-I-L. We want to look at those three things. One is hemolysis, which is H — in our mnemonic. The other one is icterus, which is high bilirubin. And the third is L for lipids. High lipids will interfere with alcohol testing, or with any testing based on that same methodology. Our machine — the Roche Cobas machine, and all the machines out on the market today — are very sophisticated. If we have elevated levels of H or I or L, it will flag it and raise the potential for a problem.
DR. FALLER: The next thing on the list is that our alcohol testing is not absolutely specific for ethanol. There are two possible other alcohols that can cross-react: one is propanol and butanol. But then it goes to clinical history — did the patient ingest those two alcohols? And third is some unusual hematologic malignancies, like Waldenström's macroglobulinemia, that can interfere. So it's — — always have to correlate with the clinical situation. The next one — sometimes, you know, there can be patients who make endogenous — make their own — alcohol. So very rarely, some patients may truly have a positive result that could be from our test or headspace — they make their own. So we have to rule that out. It's a rare condition.
DR. FALLER: And the next one is one that's in the literature, which is LDH and lactic acid. If a patient has a markedly elevated LDH or lactic acid — one is an enzyme and the other is an acid — that can cause false positives. Now, if I can stop you there,
MS. LITTLE: Doctor, I think those were the four that you identified — the four limitations — the lactic acid, the hemat— If I could ask you a few more questions about LDH and lactic acid. You're aware, Dr. Faller, of the medical literature establishing that the presence of LDH and lactic acid can lead to falsely elevated serum readings. Correct?
DR. FALLER: Correct. And that's because lactic acid or LDH actually forms NADH. Lactic acid — I'll have to go into a little bit of chemistry. Lactic acid and LDH — lactate dehydrogenase — they both act on each other. And LDH and lactic acid need NAD+ to break it down. So in theory, when you're testing a serum, a plasma, for blood alcohol, if there's extra LDH or high levels of LDH, high levels of lactic acid, you add it to the test system — and then Roche throws in, or Siemens throws in, the NAD — it will form NADH. That was first documented, I think, back in the older versions of these ethanol testings, back in the 1990s, when they stumbled on it — they were looking for biomarkers or reasons in kids with SIDS, little babies — and they found that two of these babies had a positive alcohol.
MS. LITTLE: Doctor, if I could just ask the next question, if that's okay. Sorry. So in other words, NADH — studies have found — can actually be formed by certain biochemical processes other than the presence of alcohol. Right?
DR. FALLER: Yes.
MS. LITTLE: Are you aware that the National Institutes of Health has found that liver diseases, kidney diseases, muscle injury, trauma, and even anemia are some of the health conditions that can lead to a rise in serum LDH levels?
DR. FALLER: Yes.
MS. LITTLE: Are you aware that Miss Read was severely anemic in January of 2022?
JUDGE CANNONE: Sustained.
MS. LITTLE: Are you aware that the medical literature has also found that patients suffering from multiple sclerosis have a two-fold increase in NADH levels as compared to controls?
JUDGE CANNONE: I'm going to allow that.
DR. FALLER: I haven't read anything specifically related to the NADH level, but I want to go back to the point where our laboratory — our testing is not based—
JUDGE CANNONE: Let him finish his answer.
DR. FALLER: It's not — it's the rate of change of NADH. So if somebody has NADH on board, I believe it's not going to affect the result. It's the rate of change. And it basically — back to the anemia, I haven't read or heard of that.
JUDGE CANNONE: That was stricken.
DR. FALLER: It all goes back to the lactic acid and the LDH — the NADH doesn't matter. So looking at multiple sclerosis patients, they can have elevated LDH and lactic acid, but it's not to the extent that it can interfere with the alcohol levels. There was a study, maybe seven to ten years ago.
MS. LITTLE: Your Honor, there's no question pending.
JUDGE CANNONE: You asked him about a study — if he was aware of the studies.
MS. LITTLE: I asked, and that's a yes or no question.
JUDGE CANNONE: He's all right. Doctor, we're going to hold that there for you and ask the next question. Can you do that again and slow down, please?
MS. LITTLE: Sure. Doctor, have you reviewed the August 21st, 2013 peer-reviewed article entitled "Serum NAD levels through disease course in multiple sclerosis," which was sponsored by the Center for Healthy Brain Aging by the School of Psychiatry at the University of New South Wales in Sydney, Australia, which specifically found that patients suffering from multiple sclerosis have a two-fold increase in NADH levels as compared to controls?
JUDGE CANNONE: I'll strike the part of what the article held. Is he aware of the article?
DR. FALLER: No, I'm not, to be honest. No.
MS. LITTLE: Dr. Faller, did you consider Miss Read's anemia and multiple sclerosis condition when you conducted the alcohol test on January 29th, 2022?
DR. FALLER: No, no, we don't. No.
MS. LITTLE: And again, serum tests like the ones conducted in this case don't test for ethanol — they only test for NADH, right?
DR. FALLER: Uh, we test for the rate of change of NADH production.
MS. LITTLE: And Doctor, you did a number of other tests on Miss Read on January 29th, 2022. You tested for additional drugs, not just alcohol. Correct?
DR. FALLER: Correct.
MS. LITTLE: And all of those results were negative.
DR. FALLER: Correct.
MS. LITTLE: Thank you. No further questions.
JUDGE CANNONE: Okay.
MR. LALLY: Doctor, are you aware — uh, I know your lab at Good Samaritan did not do this process, but are you aware through your training and experience of any sort of mathematical conversion that can be done from a serum reading in milligrams per deciliter to a blood alcohol concentration of whole blood?
MS. LITTLE: Objection.
JUDGE CANNONE: I'm going to allow it. The door is open. Go ahead, sir.
DR. FALLER: Um, yes, I am aware.
MR. LALLY: And please describe what you're aware of with reference to that.
DR. FALLER: Well, with blood alcohol — concentrations — when it's in your blood, it goes more to the watery components of your blood. So when I described the process earlier, whole blood is before we spin it. And when we test, we test the plasma, which is specifically testing the watery component. Now, people have done studies on what percentage of water is in serum versus whole blood. Basically, to put it simply, there's a higher percentage of water in the serum versus whole blood. So a hospital result will always be a little bit higher than a test on whole blood. The conversion factor is anywhere from 1.1 to 1.18 — it could be 18% or 11% higher in serum versus whole blood — but we don't do it. That's what I read. I will defer that to the experts. Now, doctor, you were referencing in
MR. LALLY: Now, doctor, you were referencing in your cross-examination about a study that you were aware of about 10 years ago or so regarding MS and alcohol testing. Is that correct?
DR. FALLER: It was more on MS, looking at the results of lactic acid and LDH to see how high the levels of lactic acid can go in a group of multiple sclerosis patients. When reviewing that, we found that the range went — some normal range — 16% of the multiple sclerosis patients had normal lactic acids, but the remainder had elevated levels. But those levels were not anywhere near the required levels to produce a false positive. Our package inserts for the Roche testing system. The Roche — it's an FDA-approved test, and they have to do in-depth detailed testing before they allow any hospital to do a test, and they have listed levels of lactic acid beyond which the test would not be reliable.
DR. FALLER: But the results, based on this study of 600 multiple sclerosis patients — two big centers in Italy and one in the Netherlands — show that the highest level of lactic acid in the MS patients did not achieve — didn't get close. Usually patients with MS that are asymptomatic can have normal or low-normal levels, slightly elevated. It was the ones that had more symptoms that had elevated levels up to I think the highest was 6.5 millimoles per deciliter, which is not high enough to interfere with our result.
MR. LALLY: Now, with respect to the lab at Good Samaritan Medical Center, the interference that you were speaking about earlier on cross-examination — what would happen if any of those types of interference were to occur during the course of the testing?
JUDGE CANNONE: No, I'll allow it.
DR. FALLER: The three main ones, which I detailed earlier, are hemolysis, icterus, and lipemia. Our machines are sophisticated — they will detect it and flag it and say please do not result it, or we'll have a disclaimer saying interpret this result with caution — the results may not be accurate. And it hardly ever happens with alcohol testing. But if it did, we would get a result like that and we probably wouldn't report it.
MR. LALLY: And from your review of the defendant's medical record, specifically her testing from January 29th, did you notice any interference or any reports like that in her record?
DR. FALLER: No.
MR. LALLY: Now, the testing that you're doing at Good Samaritan is in relation to patients that might have cancer or heart disease or something like that. Correct?
DR. FALLER: Correct.
MR. LALLY: Now, you were talking — or started to speak on cross-examination — about the quality of lab results that you have from your lab, and you wanted to go into that further. Could you please expound upon that for the jury?
DR. FALLER: Now — we have — you mentioned proficiency testing before. So all hospital laboratories are accredited by the CAP, or have to participate in proficiency testing. What that means is that every — it's three times a year — they give us five unknown samples, and we have to test them, report it back to CAP, which also reports back to the government, and we have to basically get the correct answers. And with alcohol testing, it's probably one of the best tests in the laboratory — always right on the money results. But at the same time, we're also able to look at results of all the other labs that participated in this proficiency testing. So we can look at different methods. We can look at labs that had the same method as us to see how we're doing.
DR. FALLER: And usually with this proficiency testing, we have 3,000 labs across the nation that have the same methodology as us, so we can compare to them. And also interestingly, we can see the labs that are using headspace gas chromatography. And out of interest, we can see how we compare, and we have exactly the same results on these proficiency testings. We also look at some statistics as well — not going into them, but we can look at stats like standard deviations and SDs. And actually, the hospitals with enzymatic testing have slightly better stats compared to headspace — pretty close, but a little bit better.
MR. LALLY: And, doctor, from your review of the defendant's medical records and the blood testing in this case, was that done in conformity with the policies and protocols at Good Samaritan?
DR. FALLER: Every — we have policies in place to be followed, and there's no reason not to think that somebody didn't follow policy.
MR. LALLY: Thank you, sir.
JUDGE CANNONE: Anything else, Miss Little?
MS. LITTLE: No questions.
JUDGE CANNONE: All right, doctor. You are all set, sir. Thank you. Do you have another witness, Mr. Brennan?
MR. BRENNAN: I do.
JUDGE CANNONE: Okay.