# Petition for Writ of Certiorari — Bruch v. Florida (No. 07-358) > Briefs, arguments, decisions, and more. URL: https://www.frixlaw.com/law-library/documents/brief%3Amicro_IA40386009_1466%3A1 ## Record - **Collection:** Supreme Court brief - **Document type:** Petition for Writ of Certiorari - **Published:** January 1, 2007 ## Text Supreme Court, U.S. pe IL gus No.07- 07-35 8SEP13 2007 OFFICE OF THE CLERK IN THE Supreme Court of the United States RICHARD BRUCH, Petitioner, V. STATE OF FLORIDA, _ Respondent. On Petition for a Writ of Certiorari to the Fourth District Court of Appeal in the State of Florida PETITION FOR A WRIT OF CERTIORARI MICHAEL SALNICK * One Clearlake Centre, Ste 1203 250 S. Australian Avenue West Palm Beach, FL 33401 (561) 471-1000 * Counsel of Record Attorney for Petitioner ESATO RS. eg RUNS REY RETIRED tS ROPE E LAD LE LLIB CEE SEES WILSON-EPES PRINTING CO., INC. — (202) 789-0096 — WASHINGTON, D.C. 20002 QUESTION PRESENTED Whether the statutory jury presumption of impairment denied the petitioner fundamental due process when it in- volved the results of an expired alcohol blood testing kit and the prosecutor shifted the burden of proof to the defendant by arguing during closing that the jury could not consider the expired kit’s product insert indicating the results are not reliable if the kit is expired because the defense failed to introduce it into evidence, notwithstanding the fact that Florida Law prohibited its introduction? (1) il LIST OF PARTIES All parties appear in the caption of the case on the cover page. TABLE OF CONTENTS Page QUESTION PRESENTED. .-.-.....0.c.aO> * * * * [694] equipment used, she can he questioned about. MR. SALNICK: Judge, can I take that back? THE COURT: Yes. (Whereupon, the proceedings returned to open court.) MR. SALNICK: May | approach the witness, Judge? l4a THE COURT: Yes. BY MR. SALNICK: Q. For purposes of cross examination I want to show you this document and ask you if you would take a look at that, tell me what, after you take a look at that, had a chance to review it. What does that appear to be? A. It appears to be some documentation from Bectin Dickinson regarding usage of their blood collection tubes. Q. Allright. And where it says— MS. ROBERTS: Objection, improper predicate. THE COURT: | think you want to direct her attention to some other specific place on there. * * *£ * [767] Q. All right. Now is there also something within that document that talks about ideal storage and temperature, things of that nature? A. Ye. MS. ROBERTS: Objection, beyond the scope. THE COURT: Overruled. THE WITNESS: Yes. BY MR. SALNICK: Q. And does the author, does the Bectin Dickinson com- pany themself provide recommendations for storage, — of that nature? A. Ye. Q. All mght. And now when we talked about an expired _ kit, just so that we’re clear we’re not talking about an expired box, we’re talking about the tubes themselves, right? A. Yes. ~ Sa. Q. Okay. Expiration means the tubes that are used to test blood, correct? A. Yes. _Q. Okay. And Bectin Dickinson in fact recommends against using the tube beyond their expiration date, do they not? A. That is correct. * * * * [772] company personally to ask them what | their feelings were about the expiration date because of the answers that he told you, correct? - A. Yo. Q. Okay. And do you happen to have a notation as to when you called to the company? A. No. Q. Do you happen to have a notation as to who you spoke to in the company? a Q. That particular conversation, although you shared with us what they said, you don’t have notes of that, correct? A. That is correct. Q. Okay. But what they told you apparently agrees with the documentation that they printed out, correct? A. Yes. - Q. Now, if I’m understanding what it is you’re saying, any company that puts an expiration date on a product, they are talking about the reliability of the product,. are they not, sir? A. I would agree with that, yes. Q. And they are saying they can’t vouch for the reliability beyond a certain date? [773] A. Correct. Q. They can’t guarantee it? A. Yes. l6a Q. Now, you are familiar with Florida Department of Law Enforcement, the FDLE, correct? A. Yes. Q. And they have set rules out, correct? A. YO. Q. If FDLE doesn’t have a rule one way or the other concerning the use of an expired blood kit that would mean it wasn’t addressed by them, correct? A. Yes. Q. And for forensic purposes, you would certainly prefer to use a kit or a tube that had not expired, correct? A. Agree. Q. And that is because you can’t simply say any longer that the tube by itself stands as a good forensic example, correct? A. Yes. Q. Because with an expired kit you got to worry about the volume taken in, correct? A. That is correct. Q. You got to talk about stability of [774] chemicals involved, correct? A. Yes. Q. And with the tube that isn’t expired you don’t have to worry about those things, correct? A. That is correct. MR. SALNICK: Can I just have a moment, Judge? BY MR. SALNICK: Q. For all purposes then, if 1 understand Dr. Bidanset, the kits that have not expired would be better, is that correct? A. Thatiscorrect. — Q. Thank you, sir. 17a REDIRECT EXAMINATION BY MS. ROBERTS: Q. Dr. Bidanset, Mr. Salnick asked you about a—I believe how it would, alcohol would affect him hypo- thetically would you slam in the back of a motor vehicle stopped at a red light that at an intersection, brake lights illuminate on the vehicle that he struck? Would that be consistent with somebody that was impaired by alcohol? A. Yes. Q. And would that affect what happens to their eyes in that? ; 7 |. = s [840] beers. Well, the re is four beers left. How many are in a six pack? So, let’s soy after he left the bar that he consumed two more of the beers and what was two more? So, now we got him up to eight, don’t we? People don’t ride around with a cooler in their front seat with iced down liquor for the fun of it. He intended to drink it and he did because the proof is right here before you. Now, Mr. Salnick—getting back just a moment to the expired kit, Mr. Salnick kept showing this piece of paper to Susan Lewis and to Dr. Bidanset and would have them read from that piece of paper. Well, that piece of paper is not in evidence. MR. SALNICK: Objection, could we approach the bench? THE COURT: Yes. (Whereupon, there was a conference at the bench.) THE COURT: I didn’t hear what was said, something about a piece of paper? MS. ROBERTS: I talked about a piece [841] of paper. MR. SALNICK: Ms. Roberts talked about a piece of paper, that BD piece of paper. ~~ 18a MS. ROBERTS: It is not in evidence and it is a fair comment on the evidence. MR. SALNICK: It is not a fair comment on the evidence. State basically inferring that we somehow have the burden, the fact that it is not in evidence State knows better because the rules of evidence permit me to cross examine witnesses from a pamphlet hut now to say that it is not in evidence when, number one, it doesn’t have to be pursuant to the rules; number two, you ruled that I could use it for cross examination. It is a comment on the defense not presenting evidence. It is a step above a fair comment. She certainly could have said—Ms. Robert certainly could have said, well, it is not authoritative or how do we know who wrote it or maybe the cleaning lady wrote it but to say that it.is not in evidence makes it appear to the jury that [842] defense somehow has a burden. I have no other choice, Judge, because | believe that this is manifestly unjust based upon what has been stated so I move for a mistrial. MS. ROBERTS: Judge, he used two pieces of paper repeatedly through two witnesses. That’s all he did. The jury has the absolute right to know when they go to ask for that document that it is not in evidence. THE COURT: I agree with that. So we'll deny your motion, overrule it. (Whereupon, the proceedings returned to open court.) MS. ROBERTS: That piece of paper, ladies and gentle- men, we don’t know if the ‘janitor wrote it or we don’t know that. But it had to deal with the expiration of the tubes. Dr. ‘- Bidanset told you a little bit about sodium fluoride, the preservative and how there was no expiration date on it and that he had used expired tubes before and that it was, certainly didn’t affect the results to what he was working on. And then I asked him, I said, * * * * 19a APPENDIX E IN THE CIRCUIT COURT OF THE 15TH JUDICIAL CIRCUIT IN AND FOR PALM BEACH COUNTY, FLORIDA CASE NO. 02-013706 CF A02 CRIMINAL DIVISION “X” STATE OF FLORIDA, VS. RICHARD BRUCH, Defendant. MOTION TO SUPPRESS BLOOD ALCOHOL RESULTS COMES NOW the Defendant, RICHARD BRUCH, by and through his undersigned counsel, and, pursuant to Fla. R. Crim. P. 3.190, would hereby request this Honorable Court enter an Order suppressing the results from a blood kit which was utilized in the above-referenced cause to draw blood from the Defendant at the time of the accident. In support thereof, the Defendant would show as follows: 1. The Defendant is charged in a three count Information with DUI Manslaughter, DUI Causing Injury to Person or Property, and DUI Causing Injury to Person or Property. 2. According to the discovery provided to the under- signed counsel, the Defendant had blood drawn pursuant to 316.1933. 7 3. The blood was drawn by a Medic WALTER DILLIAN, employed by the Palm Beach County Fire Rescue as a Rescue Captain. According to Fire Rescue Officer DILLIAN, he was the only Medic on the scene at the time of the accident. He 20a drew the blood. He was requested to do so by one of the Jupiter Police Officers investigating the accident. 4. According to Mr. DILLIAN, he read the instructions on the blood kit and explained the Betadine swab and needle with a VAT vacuum tube. Although Mr. DILLIAN was not sure if the kit came with a tourniquet, he basically drew the blood, describing it as a pretty simple process. 5. Although Mr. DILLIAN, at the deposition, did not recall the number of vials of blood he drew, or whether he personally labeled all the tubes, he did recognize his signature when he reviewed at/from the Traffic Homicide Report supplied to the defense through discovery. 6. Through discovery, the State provided a copy of an inter-office Memorandum written by then Officer AMY WALLING' of the Jupiter Police Department. This Memo- randum, attached and incorporated by reference hereto, dis- cusses what is described as the “Dean fatality” on Novem- ber 23, 2003, and references the agency case number: “Dear ASA Roberts: “I am writing this Memo to advise you the blood kit used to draw blood from the driver of Vehicle 1, Richard J. Bruch, had expired October, 2002. The blood kit had expired by 23 days when I used it for the blood draw. Respectfully, Officer Amy Walling” 7. According to Palm Beach County Fire Rescue Medic: DILLIAN, at the time he used this blood kit, he did not know it was expired. 8. According to Officer WALLING-FOX’s April 14, 2004, deposition, she indicated that she got the blood kit out of her patrol car. Officer WALLING-FOX indicated that she had no idea how Jong the blood kit had been in her patrol car, ' Now Officer Walling-Fox. 2la but offered the opinion that the kit could have been in her car for a month, hut no longer than two months. 9. Officer WALLING-FOX indicated that she had no idea at that time that the blood kit had expired some 23 days earlier, during the month of October. She further indicated that there are no procedures in place at the Jupiter Police De- partment concerning expired blood kits. Officer WALLING- FOX indicated that the Jupiter Police Department has never addressed this. 10. Based upon this, the Defendant ‘is requesting that the results from the blood kit be suppressed. In support thereof, the Defendant offers the following Memorandum of Law: MEMORANDUM OF LAW Blood test kits have expiration dates pertaining to the period that the vacuum in the vacutainer tube is warranted. Each tube contains a preservative and an anticoagulant. A specific vacuum exists in a vacutainer cube in order to assure a precise amount of blood will be drawn and mixed with chemicals in precise ratio. For example, if there was too much chemical and not enough blood, one’s test result could he affected because preservative and anticoagulant is what is referred to as “salting out agents.” If a vacutainer leaks, microorganisms can enter the sample. Fermentation is a con- cept which discusses combining blood with microorganisms. ETOH is a byproduct of fermentation, and there is no way to distinguish between alcohol consumed by a subject and alcohol created by fermentation. With an expired blood kit, there is a problem with respect to this occurring, which renders the results inaccurate. Addi- tionally, the Defendant would submit that: a. The administrative rule (Florida Administrative Code Rule 11D-8.012) for the collection of blood sam- ples are insufficient on their face and as applied in the instant cause. 22a b. The rule fails to require compliance and is not in accordance with the manufacturers’ procedures and methods for use of a blood kit. c. Manufacturers of blood kits, such as the one used in the instant cause, establish expiration dates for their blood kits. If a law enforcement officer knew a blood kit was expired prior to its use, it would not be utilized. d. As such, the rule is inadequate as it fails to provide for basic quality control in the collection of blood samples. e. An expired blood kit would only exacerbate these problems and would mislead a trier of fact as to accurate blood results. : In State v. Miles, 775 So. 2d 950 (Ha. 2000), the Florida Supreme Court held that the administrative rules concerning the collection, storage, transportation and testing of blood samples were inadequate and did not comply with the core policies of the Implied Consent statute as stated in State v. Bender, 382 So. 2d 697 (Ha. 1980). In response to Miles, the Department of Law Enforcement amended its rule regarding the labeling and collection of blood samples. The rule cur- rently states: “1 1D-8.012-—Blood Samples—Labeling and Collection. “(1) Before collecting a sample of blood, the skin punc- ture area must be cleaned with an antiseptic that does not contain alcohol. “(2) Blood samples must be collected in a glass evac- uation tube that contains a preservative such as sodium fluoride and an anticoagulant such as potassium oxalate or EDTA (ethytenediaminetetraaceticacid). Compliance with this section can be established by the stopper or label on the collection tube, documentation from the manufacturer or distributor, or other evidence. 23a “(3) Immediately after collection, the tube must be in- verted several times to mix the blood with the pres- ervative and anticoagulant. “(4) Blood collection tubes must be labeled with the following information: name of person tested, date and time sample was collected, and initials of the person who collected the sample. “(5) Blood samples need not be refrigerated if submitted for analysis within seven (7) days of collection, or dur- ing transportation, examination or analysis. Blood sam- ples must be otherwise refrigerated, except that refrig- eration is not required subsequent to the initial analysis. (6) Blood samples must be hand-delivered or mailed for initial analysis within thirty days of collection, and must be initially analyzed within sixty days of receipt by the facility conducting the analysis. Blood samples which are not hard-delivered must be sent by priority mail, overnight delivery service, or other equivalent delivery service. “(7) Notwithstanding any requirements in Chapter 11D- 8, F.A.C., any blood analysis results obtained, if proved to be reliable, shall be acceptable as a valid blood alco- hol level. “Specific Authority 316.1932(I)(a)2. (I)(f)1., 322.63(3)(a), 327.352( 1)( b)3., (1)(d) FS. “Law Implemented 316.1933(2)(b), 316.1934(3), 322.63(3)(b), 327.352(I)(e), 327.353(2), 327.354(3) FS. “History-New 10-31-93, Amended 7-29-2001.” Although the rule goes into various details of blood testing, the rule is fatally flawed when it comes to the manufacturers’ procedures and methods for collection of blood. 24a In Bender, supra: “The trial court ruled that [a] defendant(’s] due process and equal protection rights were violated because the [rules] failed to ‘incorporate the procedures and methods of the manufacturers of the testing equipment for the maintenance and operation of the breathalyzers.’” Miles at 953. In reversing the trial court, the Florida Supreme Court reasoned that incorporation of the manufacturers’ procedures and methods were unnecessary when the rules were in fact in accordance with the manufacturer’s proce- dures. Jd. Unlike Bender, Rule 11D-8.012 neither incorpo- rates the manufacturers’ procedures and methods, nor are they in accordance with them. Manufacturers of blood kits, such as the one used in the instant cause, have established expiration dates for their blood kits and prohibit use of the kit after it has expired. As such, 11D-8.012’s failure to incorpo- rate this procedure/method, or he in accordance with it, renders the rule inadequate and in violation of Defendant’s due process and equal protection rights. The failure to require compliance with an expiration date violates the core policies of the Implied Consent statute as stated in State v. Bender, 382 So. 2d 697 (Fla. 1980). The Department of Law Enforcement has already estab- lished that compliance with expiration dates are required to assure accuracy in alcohol testing; thus, compliance with expiration dates are part of the core policies of the Implied consent statute. Florida Administrative Code rule 11D-8.0035 establishes the approval method for alcohol reference. solu- tions. Within said rule, the Department of Law Enforcement requires that manufactures of alcohol reference solutions “must have performed and documented tests that demonstrate that the alcohol reference solutions are reliable for at least two years from the date of manufacture.” Fla. Admin. Code Rule 1 1D-80035(1)(d). The Department of Law Enforcement goes on to require alcohol reference solutions “be used in 25a | agency or Department inspections within two (2) years of the date of manufacture.” Fla. Admin. Code rule 1 1D-8.0035(3). As such, the Department of Law Enforcement has established an expiration date of alcohol reference solutions and pro- hibited their use after the expiration date. Thus, compliance with an expiration date assures the accuracy of testing, while violation of the expiration date would raise legitimate ques- tions of the accuracy of any test, thereby violating the core policies of the Implied Consent statute as stated in Bender, supra. Due process and equal protection requires the Depart- ment of Law Enforcement to establish proper rules that ensure reliable. scientific evidence fin use in future court proceedings. The failure of the Department of Law Enforce- ment to incorporate the manufacturers’ use of expiration dates for blood kits denies the people of Florida front having reliable scientific evidence for future court proceedings, thereby violating the due process and equal protection clauses of the constitutions. The Defendant would submit that preservation of evidence, at all costs, goes to the heart of the criminal justice system. Preservation of evidence and following the rules which govern the obtaining of evidence depends on the integrity of these devices. In a DUI manslaughter prosecution in the State of Florida, the State must prove that at the time an individual was behind the wheel, his blood alcohol level was in excess of the legal limit. It would be difficult, if not impossible, for the State, with any degree of reliability, to present to a tner of fact evidence that an accused’s blood alcohol level exceeded _the legal limit when the very kit utilized to test this blood had already been expired at the time the test was administered. This is not a question of weight, but goes directly to admissibility. There can be no concept of substantial com- ? By Officer Walling-Fox’s own admission, the issue of an expired blood kit has not been addressed by her own policy agency. 26a pliance when the process wage with an already expired blood kit The Defendant had nothing to do with the expired blood kit. By virtue of the fact that it had expired; a certain life is put on it, which, by definition, ends at the date of expiration. To permit the use of results from an expired kit would mislead, confuse, and give a jury inaccurate results. If be- lieved, these results could result in the deprivation of liberty of an accused who had no participation or fault in the use of an expired blood kit. Based upon this, the Defendant would respectfully request this Honorable Court enter an Order suppressing results obtained from the expired blood kit. I HEREBY CERTIFY that a true and correct copy of the foregoing has been furnished by delivery to ELLEN ROBERTS, Assistant State Attorney, State Attorney’ s Office, 401 North Dixie Highway, West Palm Beach, Florida 33401, this Sth day of November, 2004. Respectfully submitted, LAW OFFICES OF SALNICK & FUCHS, P.A. One Clearlake Centre, Suite 1203" 250 South Australian Avenue. West Palm Beach, Florida 33401-5014 Telephone: (561) 471-1000 Facsimile: (561) 659-0793 /s/ Michael Salnick MICHAEL SALNICK, Fla. Bar #270962 /s/ Jack Fuchs JACK FUCHS, Fla. Bar #0036889 27a JUPITER POLICE DEPARTMENT Inter-Office Memorandum DATE: May 14, 2003 TO: ASA Ellen Roberts, SAO/Traffic Homicide Division FROM: Oft. Amy Walling, Jupiter Police Department SUBJECT: Dean Fatality on November 23, 2003 (54-02-037277) Dear ASA Roberts, I am writing this memo to advise you the blood kit used to draw blood from the driver of vehicle one, Richard J. Bruch, had expired October, 2002. The blood kit had expired by 23 days when I used if for the blood draw. Respectfully, /s/ Amy Walling OFC. AMY WALLING 28a APPENDIX F IN THE CIRCUIT COURT OF THE 1STH JUDICIAL CIRCUIT IN AND FOR PALM BEACH COUNTY, FLORIDA [Filed JAN. 14, 2005] CRIMINAL DIVISION X CASE NO: 02013706CF A02 STATE OF FLORIDA, | f RICHARD BRUCH, Defendant. ORDER RE: MOTION TO SUPPRESS THIS CAUSE came before the Court on Defendant’s Motion to Suppress. Based on the evidence presented the Court finds: Defendant Bruch was involved in an automobile accident at the intersection of AlA and Donald Ross Road. When Officer Fox of the Jupiter police department arrived at the accident scene a crowd of approximately 30 people were standing around. A Palm Beach Gardens Police Officer was already there. . The middle of Donald Ross Road is the dividing line between Palm Beach Gardens and Jupiter and a discussion ensued concerning which agency had jurisdiction. After it was decided that the case would be handled by Jupiter, Officer Fox began trying to determine which of the by- standers witnessed the accident or were involved. 29a She was immediately informed that the woman in one of the vehicles was dead. She followed this person to the Mitsubishi vehicle and confirmed that fact. She noticed Mr. Bruch and asked if he was a witness or involved. He said, “I was driving the Isuzu Trooper.” Mr. Bruch was stumbling around and smelled of alcohol and his speech was slurred. She placed Mr. Bruch in the back of her patrol car. She did not read him the Miranda Warning at this time. She asked for his drivers license and he said, “It’s in the car”. This question and answer concerning the whereabouts of the driver license is therefore inadmissible because this was an in custody interrogation. He later asked, “What’s going on?” What’s the big deal anyway?”. Officer St. Lauren of the Jupiter Police Department arrived and conducted a traffic homicide investigation. He questioned Mr. Bruch while he was in the back of the patrol car and obtained all necessary information to complete the accident report which is sent to Tallahassee. These questions and answers are protected by the accident report privilege. During a period of time when he was seated in the back seat of the car the car’s audio and camera were turned on. While he was alone Mr. Bruch made several comments picked up by the recording device. The comments were, “Holy Shit” and “Oh, my God.” These comments are ad- missible as they are not the result of any interrogation. The police say he also said, “I should have stayed home this week end.” He asked, “What happened to my vehicle. Will it be safe, I have a lot of stuff in there”. These statements are admissible as they are not in response to any questions. Later a sample of Mr. Bruch’s blood was taken by a fire rescue EMT. Officer Fox gave the EMT a blood draygng kit she kept in her car to use for that purpose. The blood collection vacuum tube used had an expired expiration date. 30a The Court concludes, based on the testimony of Dr. Bidanset that the age of the tube did not effect the accuracy of the blood alcohol. Based on the evidence the Court concludes that Officer Fox did not question the Defendant in order to complete a crash report. Officer Fox did not require the person involved in the accident to answer questions. Officer Fox did not indicate to Mr. Bruch that he must respond. The statements made by Bruch to the effect that he was the driver of the vehicle involved was not and in custody interrogation. This statement is admissible. The Court further concludes that the results of the blood tests are admissible. Whether the fact that the vacuum tube used was past it’s expiration date can of course, be used to question the accuracy of the results but it does not render the results inadmissible. Wherefore, it is ORDERED AND ADJUDGED that the Motion to Suppress is granted in part and denied in part. DONE AND ORDERED in West Palm Beach, Palm Beach County, Florida this the 14th day of January 2005. /s/ Stephen A. Rapp STEPHEN A. Rapp, Circuit Judge copies furnished: Ellen Roberts, ASA Michael Salnick, Esq. 250 Australian Ave., ste 1203 West Palm Beach, FL 33401 3la : d 5 © BD Vacutainer® Evacuated Blood Collection System For in Vitro Diagnostic Use. INTENDED USE AD Vacutaines® Tubes. Needles and Hriters are ised togethor as a system for the collection af venous blood. BN Var tlainer® Ties are used (0 transport and process blood fiw testing serum, plasma or véale blood yw the clnical laboratory PRODUCT DESCRIPTION 8D Vacutainer? Tubes ate evacuated ‘hes wath cv or-coddeul (ser tLibke below) conventional slopipers of AD) Hemogaid”™ Clounes. BD Vaaita ner’* Plus Tubes are plustic tribes. Both tube Types (oataln additives in varainy concentrations dependent ujiew the amount ui vacuum and the required addirive to hina ratin fn the tube See each shelf package or case label tor specific xiditeve quantity and apmrownate ‘hav walume. Advitive Choice dene ids on the awalyt test method. 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Heer uthivales anuthrombins, thus olocking the cong alation cascane and producing « whole bood/plans se nple nsiead of ciated hynod pins sermn. & barrier po ymer |S present at the tube potion Tne density of this matenat Causes it (o move upward during centrihuyation to the plasew cell intedace, edvere it forms. a harier separating plasma fram cells. Sepematent plisina may he aspirated direc ity horn the collection tube, eliminating the need for manual transfer to another container. Plasma nbtamned! im BD PST" Tubes should be tested or temeved from the tube withn 2 hours of collection. Sec Linntations of Systam, P ecautions, Specimen Collection aid Hundang Sections. 8D Vacutainer” Tubes for BD Vacutainer* Mus K2FDTA and Plus Serum Tubes as well as the BD Vacutamer* Glass Serurn cad Gass KZEOTA Tubes may be used for routine Immunohematolagy testing yuch 4s red cell grouping, Rb typing and anubudy screening. BD Vacutaines® Plus Serum Tubes and Glass Serum Tunes nay atso be used fer ied cell phenoryping and DAT testing Tubes must be fled to canacny (until vacuum 1s echausiod) Additive tubes (K) ar X;) must be inverted & tu IC times to assume compicte mining with blond, as erronenus results may ovcur. See Lmiiahions of System, Precautions, Specimen Collection and Handing Sectiuns. 8D Vacutainer* CTAD Tubes ‘tee CTAD sube 1s used for the collection and transport of specimens for hemostaus iesting The CTAD sotution is a nrecture of sodium ciate, theephyltine, adenosine und dipyndamole. The aurpose of the anditive +s to anacoaqulaie the saecemen and te mannuze wt wtio pivclet autivation See Limitations ot System, Mocautions, Specimen Collection and Hunuiny Sechons 8D Vacutainer* Plus Citrate Tubes The tube component is Compsed uf two plastic tubes assembled together to maintain the chaw valunve and liqud additive. Phe tthe contumes ©. 199M (3.2%) buffered sede citsate adehteve, All (ube configurations ae “hull draw’ and utilize BC Homagad™ dosures. See Unwtaliors ul System, Precautions, Specimen Collection and Handling Sections. ihe product performance has heen compared a the 4.5ml glass tube for towtine coagulation assays on a vanety of danor popula: linws with clinically equivalent results obtained Mote” all studies were potlonned on donors with hematoc is between 2S and 55%. BD Vacutainer" Blood Collection Needles 8D Vacutainer® Rinad Collection Nvedies are single use, deninie-ended, slawiess see needirs. They have a threaded hub that his mio the threads of all AD Vacutainer” Needle Holders The venapiacture ead of the necdie nas a point specially designed to cater the skin easily during verininctive The note 6 lubricated with silicone, AY) Variitaine' Muluple Sample Neadles have a nithe’ siceve cuvenng the non-patient end Of the neerile that prevents legkaye of bidod wte the holder duciwy vermpunccure. This Prochict Contains Pry Nitra Rubber. The tubes she into the hekler and are pushes anto the back end of the needa, allowang the vaca mn the tube tv draw blood ta a precetermuned evel The needles are avadable m | andl 1-1/2 wich bengtins, in 20, 21, and 22 gauge. MeceBe size and Lot umber are printed on each incivelsal needle assembly. LIMITATIONS OF SYSTEM the quastity of blood draw vanes with alvturte, aubrent icmyperaty’e, narametnc pressine, tube aye, verous pressas Pond tiliag technique Tubes with draw volume cralies than the /PPATeNE OMENSIOS NCCE fparted draw tubes) my ill More slowwy than tubes of the Source wee walt greater mraw volume for those lubes sulyjected 10 centrifugation te generate prasma or serum for resting, Standlard processing Candiuons do net per essary completely sediment all cel, whether or DoF barnes gets present. Accordingly. Cell-naséri metabolism, as well a5 natural dagradabon ex vivo affects scrunvplusina analyte cor jactumies beyond aceltular charges. 't 6 recommended inal testing for glucose, unc acid und lactate dehydrogenase (LD} he perlonned us sunn after collection anc separation os yoswible. Due to natural deqsadation, olay 1 separatun of the serum oF plasma have the cellular mass or in testing after Separation wail rest mi enoneous results lor thay: anatytes. 32a Pring fo ising CLAD tubes to collect specimens fant wert patents ter PT deteiminatinns wath Citrate cansitive reage's, plorse contact the BD igclevcal Scrvaes Deparineat ar 1800-65) .0074, BD Vacutainer® SST" Tubes, PST * Tula, and Phiy Scrum Tubes are mot recommender! fre collectan of samples for hind banving procedures. Glass EDTA and glass Semm Tubes ave accéptabile for hood hankiay prucedeecs. BD Vere istainer® SST" Glusy Tides and PST Tubes age nat cecomanended fon collecting of simples lor therapeutic diiig meantoeny (TOM) uSSiys. BD Vocutvaner® SS¥™ Plus Tubes «an be usad far certain TOM assays. Please Cantal BD Techincal Services Dxparinent at | 900 631 0124 for detars. Oo 9nt ese RD Varutamer® Fibes contaning lithium heparin for lithaan hepa easement For enagaslatinn tests, df patign? hematoet & abeew 55%, the final ulate concenwation in the specieten shan’ be cachprstent PRECAUTIONS +. Storage of glats-tuhes containing blond at or betray °C may wsidt in tue brestage. 2. Da not semowe ronventinnal nuhber stanpers by milling with thuinly tenove stanpers vaith a Past anet pall motion ; ° Drv nat ese tubes, oF needs if fovesign wate 5 present. 4. The paper label covenny the comnccieon of the anette simelds wil fear when the nestle is apencd. Dyno use needle it fabel hag Loess tora belure venipuncture. >. CTAD thes musi be protected from anihoiai ane natural light during steaxge. Accunmated light exposure in excess ol 12 hours can cause additive Inactivation. 6, BD Vorutaincr® Plus Serum Tubes with (ot Aghwater are mot t0 De used as acfiwcai tune lor coagulation shaces, 7. Separation of serum ar plasma from the colts shoud take place veuthin 2 linet of a poe CAUTION: .-- 0... oo 4. Pacer cin Pecantions, Uhe ghar, am, ee protein, anepend | pratective eqpipment, and enginerriag cotiets to protect Gare ploud splatter, akon __ eakage, and patemtiat posure tn Moodhurne pathouens 2 0. All glass hie the potential for leakage. Examine all glass lor catentiat damnage (ens before use, andl ke precanbanary measures during Fainifing, 3 Hanlte lf Dielogyic sonnpates cmd baad cokection “sharps” (bncets, weedies. het anaplers, anal blood collection vers) arconfing tn the pntiens vad procedures of your 1 favilny, Obtain agquopriate merical anention in the event of aay exposure tu uolagic ' j saan ples (ken example, Mingteyh a puna tare weary), nce they sncy ts omesawl viral ' hepatitis, HIV (AIDS), oF ether valentines hem ases. Uidize avy built-in isetnerdie | protector, if the nload collection deve e premier One BD dens nut Hes cmencmed teshtelcing iced needles. Hravever, he policies and nrncedates af yeut hulity may Giler and mst alvays tie folloeed 4. Discard al binnd eetiection “sharps” iv hiohazard cuntaness opprawed for tein dispnsal, 5. Transterring 9 sampte coPecter! many syringe and newlie t9 a tube ty At . fecommended Additional maniqudation'at sharps. sinh as hollow bine nendtes. j { increases the potential tn needdlestick ingury ! | & Trasesterring campos bom syringe ti anezacvated tube using anon deny deve > Shaul hepertoemedt veitl caution bor the reasons described below, « Dejmessing the | Sytinge plunger duting trandler can create a positive prevsvan foncobaily ubsystaciny tine) Stn pper and sample, canning slater atin polenta’ blot expesim: © Ung a syringe | | few bined wanster may also cause over or wder filing of tubes, resulting in an i + nconect bined to-aciditive rain and potentiay incorrect analytic rern'ts * Cyacuated | j ! | tubes, are designed to diary the volume vmlicated, Filling +s Complete rae vac uurt no Jonger continues to diay, thouqn same tubes my partially till due to plenger : teoviane eaten filled hom a sytinge. The laborainry shoe be consuited ‘exgarelingy the use of these saagtes 7H btond és collected through un intravenous 0.¥) fine, enowe that fine has heen cleared of LV. salution betuee hequnning co fi blood collection tubes. This 1s crithcal to avid enonnorts bibe-atury Cabs bern LV. {lng contarmenation, 8B. Overlileny or under fiiry of tubes wall resuit sn ad inconect hiaiut-ta-adeiteve ratio & ond a7 bead Wo incorte Ce analy ic tr suet OF Pet provtuct partormvanee ee a eerre oe Store, tubes at 4-25°C G9-77°F), unless nthenvise natert nr the pack age labet. 4! iguicl preservatives and anticoagiants are clear andcolaite tunes. overt Cinate w CTAD tubes 3-4 wines. ‘overt all other fillerl additive tubes B-14) times. Du not shake. Vigorous m cing may carise ‘naming of hemo ysis. insuflaent mixing oF deiayed muning m serim tubes may reselt wm delayed clatter and nncorrect test iesults. Im tubes wath antcoagulants, imatlequate mining nay -esui «1 platelet clumping clottiny andlor incorrect test resiats 14. As snon as blood stops flowing wn the Last tube, rewrove needle from vein, applying pressure lo purciure ste wath diy siete seals unul bleeding stops. 15. Once clotting has occurred, angay bandage if dosined. 16. After venipuncture, the fop af the stopper may conta resin b'aod Take proper prec auitions when handbag tubes te averd contact with this blood, 17. Dispose of needle and hulder per your faclity’s policy and qpidelines Clotting Instructions Allows blond to cin! tharnughly helyre cert tugation, The faliawarg toble ques We recomuneaded miniauin dotting times for speci'tc tube types oF acd tives: BD SST Tunes, and Plus Serum Tubes should be inveried five tines. - Mien Cling Tie Necormendatons ee 5 ——fatt fet j ———y % ] Recommended times are based upon an intact clotting process Pafiewts wat 2 voewanad clutting dite to disease, or those recenving anticoaquiant Hherapy rAquive Mewes tne for complete clat formation Separation of senim or plasina how celle sho ala Lake place wathan 7 hows of collechon to prevent eroneous lest results according 10 NCCLS quidelines. See Limitations of System, Precautions, Speamen Cottection and Handling Sechons. Centrifugation Caution; Do aot centrifuge glass tubes at forces above 2200 RCF in a hori- zontal head (swinging bucket) breakage may occur, Glass tubes centrifuge as may break if centrifuged above 1300 RCF in fixed angle centrifuge heads BO Vacutane® Pus Taba wl wittand up 10,090 CF 8 a bance centrifuge. Always use appropriate carriers or inserts. Use with cracks or chips of excessive centrifugation speed may cause tube breakage, with release of sample, droplets, and an aerosol into the centsifuge bowl. Release of these potentially hazardous materials can be svoided by using specially designed sealed containers in winch tubes are held during centrifugation. Centrifuge carriers and inserts should be of the size specific to the tubes used. Use of Carriers too large or too small for the tube may result in breakage. ACE is related to contitunge speed setting (pm) usmy the fofuwiny equation: where “r*, expressed in cm, is the racial clistance how the ceiter of the centrifuge head to the bottom of the tbe. the fullowing lable gives recommender centriftune RCF andl tine. Centritugation RCF and Time pee paoouct a oa “a 1000.) ' BD SST™~ Plus and BOPST™ Plus Tubes - ‘3am {1100 1300 w 1 BD SST Plys and BD PST™ Plus Tubes = ‘6mm 1000-1907 jy LBD SST" Transport Tubes... 190022900 5 1 Ad non oct 5 ee ee + = ae at ies ee eee ‘Cala Vubes* 1500 1§ 15 minutes for ali gel tuies in a fixed! angie ceaturdige RCE ~ Retative Cemtifugai Force, y's “Crane times aunt bee veut hovel at speed ord bere to ceremony mogmc plete gen phrora ysotaet cot «VORA par CCS Gurdetines, Ensure that hes are property seated in the contiluge carner. Incomplete seating could result in separation of the BD Homogard™ Clusure from the tube or extension af the tube above the caruct Tubes extending above the carrer cotiid catch on contriluge head, tesuilting om breakage Bulunce (ubes to minimize the chance of ylass breakage Match tubes to hibes of the same fll tevel, ghiss (ubes to lass. tubes vith BD Hemogan!™ Closure to others with dhe Closure yet tubes 1a qe! thes, BD Vacuta ner Plus Tubes wath Phis Tubes, aud tube size to tube size. Abvays allow contuiluge to caine to 2 complete ston heloe aticmptiny tu remove tubes. When centifuge ead has siupped open the kd and exanune for possible broken whes if treakaqe 15 indicated, use mechanical device such as forceps oF hemostal to remove nibes. Caution: Do not remove broken tubes by hand. See cenretuge instaict on manual fur disielec ion instructions Barrier information The flow properties ot the harrier material are temperatuae-celated. Hows way be impeded if Chitled bela? oe caning centifagation. Lo egeew2e Now and prevent hooting during Centrifugation, set refrigerated contfuyes wv 25°C (77°F). Gel separanion tubes should be centriluged no !ier than 2 hows after collection. Tubes should rot pe re-cont tuged once harner has farmed, Baniers we more stable when lubes are spain in centrifuges with hutizuntal (sanding dur ket) heals thi those with fed angie hearte Note: Some push-duwn liters may not be compatole will plastic (des due ta the Lapered mer chamerey of the Whe. Separated see im or olasina +s ready tor use, The tubes may be placed sireetty on the wstrumen| Caries 0” seeunvplasma may he papetted my an analyzer cup. Some inytruments can sample duectly trom a separator tube wath the stopper in place. Follow the instrument mamelocturer’s instructions. ANALYTIC EQUIVALENCY Evaluations of RD Vacutaincr Tubes have been performed for an anay uf analytes over a variety of text metharls and time penods. The BD Techical Servi es Department 15 available Jo answer questions regarding these studies. Please comact them to obtain teterences and techincal reports on these evaluations and any otlver infurmation regarding the use of BD Vacuiaines* Tubes wath your instrumentecagent system. BO Technical Seraces may be reached at 800-631-0174. You may write to BD D:agnostics for wharmityn at BD Technical Services BD, Franklin Lakes, NP 07417 wenn. bd.com Wheneve: changing ary manutacturer’s olood collection lube type, size or storage condition foro particular lavoraliory assay, the laboratory personnel shoukt review the tube incu lacturer’s cata and theit own data tn establishrver ify the reference range for a specific instrumentieagent sysiem. Based on such ilormation, the laboratory can then decide if changes are appepnate. REFERENCES NCCLS Document 15 AS. Evacuated Cobes and Add:tives for Btoed Specumon Codinetion. apmewad suamehad SAD ork Wayne, PA: National Comm ttee foe Chaveal | eharatory Standards: 2003. NCCLS Docuineert KI-AS. Procedures far the Coleetion of Diagnostic Blood Specuntns by Venipuncture: op rOwed Manel id, Sth ed Wayne PA tanonal Commitee for Clieid (ihorstory Standards, 2003. Lavelt M, Sort CH ond Hurtin GL Evaluation of evacuated blond cnitnetion tudes: tHects of dace af polymere seoaralors on Thasapeitie chug enanitonag specimens Che Chom 1993, 19:17) 1717. Quequpla &, Dear R, Salona S. Mingman Cad fic auton RYE Abscnption of therape mic drugs by DAMIR QS IR Sern separator hoor conection tuber. An J Cio Rath 1994: 1012456461. Yaw HP, (qe C and Dale |. Prothordber tne, one tule: or two? Am 1 Ci Path 1996: 105:794.97, Gotthard, EL ord Aciach:, WIM Prothrombin tre (PT) amet actecated partial prodwomiia were (APTT) can be nevfoarad on the fi st tube, Ary 1Cia Park 1997, 107-681 683 NCCLS Doewre-4 H2T-Ad Collectien, Treaigpent, ant Peecets vg of Bivod Specinnens for Conrpéntion ievting ren Fertormance Gt Coagulation Assays: acpieved quick Fw, duh rd Wearyne, PA: Harkina Comanittee fea Cum ctl Laboratory Standeds 2009 Instructions for Removal of lnstructions for Reinsertion of 00 Nemogard™ Closure 8D Hemogard” Closure a | eee Re Ae tp the BD Vsauiawier® Take with eae ned. pil ng chee (Mand winder toa, BO ~~ a” fe a “s ae ‘ i PF ’ Heupel * Chisute. Sur aeitedt ctabiliny, place em an sobid surtace) With the cties I rt a bide bi ie. t 5 hared, tae sc the MRD biewrenepscn’ Choome while siemabaniecnsta pr! icy abs ath he thayonds ‘ee oi}. seedy 7 | | | oh the ober haru OMY LINE THE TURE STOPPER i$ LOUSE MEO ' | ’ 12 Nove thumb away iden: fitone: cfm, 00 HOT se Drum lo pst cloner 0! tate. beaks ef OR ‘2 \3 Caution: Any ylis lube has the potential to crack or break. 17 the tube . Ons ~- - + contains bivod, an exposuer hazard caists Fo help peer ues dueiy Certecetee s+» 0.» area tlowute heme, ("9 anpestant inal the thyen wed te jars unerea oF Ihe clo we Ue | Replace cian aver whe. romuved farm vemtaut wth the tue ar sham a the BD tlemanzig Clo iute +5 kaqeeved 2 Tat act pe dows Firenly until stopper 1s fully seseancd J. UM dasune off babe, (9 aoe unite t, cven! oa the plastic shatd separating; “rctn the euler Compact: reneertion of the stopper 1s necessary tor thy stegipe, DO WOT REASSESARIE CA OSIME. Conrfuity vetiarve tuber stegisys fram (ut Clenere to remam seccaely ca the tube during haunllang, rn Symbol Key: . ’ D worm wad Mosnewe 0 Me eo oe ee TIE cared tecwrgt ne ion ioe ! toeyh thy he Wh Cae fee oe tnreaon | 9 te 2 ont REF CrAgttmine SHURE] AT Methoe co Ger lee oe ade ge darn Teal Polemgwe tori ty beep Pan; hee “enlghn i et arto? Naseer ons HE] hive {itaar) ew Tah, Meetat mm wertome ing Sor my Mert Ga fovn Lngyrens «orl Nie ae it ‘ea tnd yo Separ bint ¢ Teper i ' ce) Herr dared oe (EPR) ther vo roe icra A CRs Ci Re Oe ah terndbt bey ! AGie*, 80, ReMiver inetentriad Eptate Phrrayt! Pe TERK aad OY, Frgedtio pabes, i OMI LISA BD. GD Gaye od caer W ederests mae prnmenty Co ete Ub uinges, and Lorpery C2008 UE Pate Sea = T0626, 299198 cry rege yt Ao oi et wih»