Specimen collection and labeling are essential steps to assuring reliable results. The Joint Commission for Accreditation of Hospitals, CLIA, and other inspecting agencies require all specimen to have two patient identifiers. The following guidelines apply to all specimen, routine laboratory, microbiology, cytology, and anatomic pathology.
DO NOT label the specimen tubes prior to collection. 24-hour urine containers, however, should be labeled prior to giving the container to the patient for collection.
Write the patient’s full first and last name on the specimen.
Write the patient’s date of birth on the specimen.
Write the date and time of collection and your initials on either the specimen or the accompanying requisition.
Unlabeled or mislabeled specimen will not be accepted if labeling is not accurate and complete, as in the following scenarios:
First or last name or both on the specimen do not match those on the requisition.
The specimen is unlabeled, even though it arrives at the laboratory in a plastic specimen bag with the requisition.
The patient’s complete name is not on the specimen. Initials are not acceptable.
Irretrievable specimens may be an exception. These include spinal fluids and biopsy materials. In these cases, the physician or staff involved must sign the lab mislabeled/unlabeled documentation form before results can be reported.
NICL Laboratories is introducing new technology to Microbiology in May 2022. The new technology is MALDI-TOF or matrix assisted laser desorption/ionization-time of flight, and it will be performed on the Bruker Sirius ONE MALDI Biotyper® CA System.
This technology uses high mass spectrometric resolution to rapidly and accurately identify microorganisms in a matter of minutes after isolation of the organism.
RAPID IDENTIFICATION
Turnaround time for this method is equivalent to a gram stain, but unlike a gram stain it provides definitive identification (ID) of the microorganism with over 98% certainty. The accuracy of this methodology is comparable to nucleic acid sequencing, but it is more cost effective and easily accessible, as it doesn’t require nucleic acid specific testing materials or kits and a longer time to results. If the organism requires specific resistance classification the report will indicate so, and a preliminary identification will be reported, with the organism and resistance reported later.
Included in this method’s compendium are organisms such as Candida auris, a deadly yeast, which is primarily only identifiable via this method. Historically, Candida auris has been transferred to a reference laboratory for identification, adding up to 48 hours to turnaround time.
Blood Cultures and Sepsis
The MBT Sensityper® test will also be available, and when used with the Bruker MALDI Biotyper® allows for identification of the organism directly from a positive blood culture bottle. When the bottle is flagged as positive, this method will allow us to provide a sample for identification on the MALDI in 15 to 20 minutes. This will effectively reduce the turnaround time for organism ID from a blood culture by up to 48 hours.
NICL Laboratories also has a PCR method available for a small menu of organisms, to provide antimicrobial susceptibility test results within a few hours of organism isolation and identification, and it can now be performed in a more selective manner, based upon the organism identified.
Antimicrobial Stewardship
Rapid organism identification from a culture bottle or a culture plate will provide for focused antimicrobial treatment and intervention. Coupled with NICL Laboratories annual MASTR™ report, the Bruker MALDI Biotyper® will assist the Infection Surveillance personnel in appropriate antimicrobial utilization. It will also provide for early determination of contamination, reducing the use of needless treatments.
Use of Broad Spectrum Antimicrobials and intravenous (IV) antimicrobials is very expensive. The use of PIC line and Midline catheters adds to the cost. The cost of use of Daptomycin over the period of a month can cost $9-10,000 and other drugs can cost as much as $33,000 for a one-month Medicare A stay. There is also risk attached to the use of these IV methods as they relate to nosocomial infections.
Use of this technology has an added benefit in that the microtiter wells on the plates used for organism ID can now be used to add a larger menu of antimicrobials for each organism identified, and for some antimicrobials, to provide a greater range of microtiters. BRUKER MALDI Biotyper® will help us to provide you with improved antimicrobial stewardship and patient outcomes.
Sepsis impact on Reimbursement
Hospital Acquired Conditions (HAC) such as sepsis, may impact a facility’s reimbursement. Every year the worst performing 25% are penalized by losing up to 1% of their Medicare payments. Targeted treatment may assist in reducing sepsis, and early successful treatment of other nosocomial infections, which will not only improve patient care and outcome, but it can also significantly impact the financial bottom line.
https://nicl.com/wp-content/uploads/2022/05/Bruker-mbt-sirius-with-user-bruker-md-web-thumbnail.jpeg511512NICL/wp-content/uploads/2022/04/nicl-logo-300x86.pngNICL2022-05-24 11:24:002022-09-23 14:40:18Antimicrobial Stewardship and the War on Sepsis
NOTE: Wear a gown, gloves, mask (N95 preferred), and eyewear when collecting these specimen.
1. Obtain specimen using only the mini-tip swab provided in the kit. Due to supply shortages, please use one swab per patient, please!
When collecting just a SARS CoV-2 sample, you may use an anterior nasal swab.
All other viral pathogen tests require a thin-tipped nasopharyngeal swab.
Swab Type
Collection Procedure
Nasopharyneal (N/P) swab
Has a very thin swab end; diameter of swab end is not much larger than swab handle
Push forward using gentle downward pressure to keep the swab on the floor of the nasal cavity until the tip reaches the posterior wall of the nasopharynx. Gently rub and roll the swab, and leave in place for several seconds to absorb fluid.*
It is not necessary to swab both sides if the swab is fully saturated from one side, but if both sides are collected, use a single swab on both the left and right nasal cavity.
A single swab may be used for SARS-CoV-2 and Influenza/RSV or Respiratory Viral Panel.
Anterior nasal swab
Swab end resembles a Q-tip. Do not attempt to collect a nasopharyngeal specimen using this type of swab.
Insert the swab at least one-half inch inside the nostril (naris) and firmly sample the nasal membrane by rotating the swab and leaving in place for 10 to 15 seconds.
Sample both nostrils with the same swab.
This type of swab can only be used for SARS-CoV-2 testing. It cannot be used for Influenza, RSV or other Respiratory Viral Pathogen testing.
*For a demonstration of N/P specimen collection please go to http://www.youtube.com/watch?v=DVJNWefmHjE (NEJM | Collection of Nasopharyngeal Specimens with the Swab Technique).
2. Break the shaft at the molded mark so that it can be placed in the tube without restricting the cap, and replace the cap tightly to prevent leakage and specimen rejection.
3. Label the vial with patient information (Name, DOB, collection date & time, specimen source and the test requested). Refrigerate it immediately.
4. Store the specimen refrigerated, and send it to the lab as soon as possible.
5. Complete the requisition. Indicate the swab type, and if the patient is symptomatic or if testing is for preoperative procedures. Race and ethnicity are also required by Health and Human Services. This is essential!
The above are M4RT media and other Viral transport media (check the label to see if the media should be kept refrigerated prior to collection). They are appropriate for Influenza, RSV, Respiratory Viral Panels and SARS-CoV-2 testing. NICL requires the use Viral transport media for its viral pathogens testing.
NICL Laboratories performs D-dimer testing utilizing the INNOVANCE™ D-dimer assay.
The D-Dimer assay is intended for use as an aid in the diagnosis of venous thromboembolism (VTE) [deep vein thrombosis (DVT) or pulmonary embolism (PE)]. Non-elevated levels almost always indicate absence of VTE. Very rarely some patients with distal DVT may yield D-dimer results below the recommended cut-off of 0.50 mg/L FEU. Elevated levels are seen in VTE. However, elevated levels can be caused by other conditions so the results of this test should always be interpreted in conjunction with the patient’s medical history, clinical presentation and other findings.
D-dimer levels may be elevated in advanced age, coronary disease, cancer, hematoma, disseminated intravascular coagulation (DIC), diabetes, stress and hospitalization. D-dimer levels may be decreased in patients on anticoagulant therapy.
The measurement of D-dimer should NOT be used for the diagnosis of VTE in patients with:
Sepsis, severe infections, pneumonia, severe skin infections
Therapeutic dose anticoagulant therapy for more than 24 hours
Fibrinolytic therapy within previous 7 days
Trauma or surgery within previous 4 weeks
Disseminated malignancies
Aortic aneurysm
Liver cirrhosis
Pregnancy
Decision threshold: As an aid in the diagnosis of VTE (DVT or PE): Less than (<) 0.50 mg/L FEU
Please note that this test’s greatest diagnostic utility is its negative predictive value.
INNOVANCE™ D-Dimer is an immunoturbidometric assay employing a highly sensitive and specific monoclonal antibody for the quantitation of D-dimer in human plasma. It has a broad linear reportable range. The method has a high sensitivity of 97%, specificity of 42% and negative predictive value of 98%. The high sensitivity of the assay assures excellent accuracy and precision of D-dimer results. It has minimal susceptibility to interfering substances, particularly rheumatoid factor, lipemia and bilirubin.
3/5/2020 NICL Laboratories, Ltd All Rights Reserved
The keystone to the laboratory’s ability to provide accurate test results is the proper identification of the patient from whom the specimen is collected. Therefore it is crucial to ensure that the specimen being collected, processed and tested is correctly associated with a positively identified patient. Acceptable methods of positive patient identification are described below.
For patients capable of active communication and wearing arm bands, they will be asked to state their full names and date of birth. This will be compared to the information documented on the requisition form. If the information received corresponds with the information on the requisition form, the specimen collection will proceed. If the information received does not correspond with the information on the requisition form, Nursing staff will be sought to confirm the identity of the patient.
For patients NOT able to personally participate in the confirmation process and who are wearing arm bands, the information on the arm band (name and date of birth) will be compared to the information on the requisition form. If the information on the arm band corresponds with the information on the requisition form, the specimen collection will proceed. If the information on the arm band does not correspond with the information on the requisition form, Nursing staff will be sought to confirm the identity of the patient. The name of nurse confirming the identity of the patient will be documented.
For patients who are NOT able to personally participate in the confirmation process and NOT wearing arm bands, nursing staff will be sought to provide the identity of the patient. The name of the nurse providing the identity of the patient will be documented.
NICL Laboratories reserves the right to defer specimen collection if there is reasonable doubt in the proper identification of the patient or lack of support in attempting to confirm identity of patient.
Your cooperation in this critical patient safety concern is vital.
3/5/2020 NICL Laboratories, Ltd All Rights Reserved
Cultures of central venous catheter tips are frequently ordered to help determine the source of bacteremia. Correct collection and submission are essential for accurate results and personnel safety.
The intracutaneous segment and distal tip of long catheters should be submitted, but in practice the catheter tip is usually received and should be accepted. The catheter tip must be in a sterile container and must not remain at room temperature for more than 4 hours.
Catheter tips should be requested only if there are signs of infections, i.e. inflammation at the site of insertions, fever, signs of sepsis, or documented bacteremia in which source is not apparent. The routine culture of catheter tips without signs and symptoms is discouraged.
COLLECTION OF CATHETER TIP BY NURSE OR PHYSICIAN
Thoroughly cleanse skin around the insertion site with 70% alcohol. Allow to dry.
Using sterile forceps, carefully withdraw the catheter keep externalized portion directed upward and away from the skin surface.
Holding the distal end of the catheter over a sterile container, cut the tip with sterile scissors, dropping the last 2-3 inches into the sterile container. Avoid contact with the outside of the container. Avoid drying of the specimen.
Inspect the catheter exit site and note if any purulence can be expelled.
If pus can be expelled from the catheter exit site, swab drainage with a culturette swab and send to the laboratory requesting a routine wound culture. Label the source as: Drainage from (location of) IV exit site, (e.g. drainage from Right IJ exit site).
Send the catheter segment(s) to the laboratory requesting a routine culture. Label the source as: Location/type of IV catheter, (e.g. Right IJ swan).
Send the accompanying blood cultures to confirm bacteremia.
SPECIMEN STORAGE
Store in refrigerator (must not remain at room temperature for more than 4 hours). Must arrive within 24 hours.
REJECTION CRITERIA
Do not send Foley catheter tips.
Do not send catheter tips in saline or transport media.
Do not send the whole catheter line.
Catheter received in a nonsterile container.
Unlabeled specimen (always have Patient’s name, date of birth, and source)
References:
Linares J, Sitges-Serra, Grarav J, Percex JL, Martin R: Pathogenesis of catheter sepsis: a prospective study with quantitative and semi-quantitative cultures of catheter hub and segments. J Clin Microbiology 1985;21:357-360
Maki, D.G., Wise CE, Safarin H.W. : A semiquantitative culture method for identifying intravenous catheter-related infections. New Engl J Med 1977;296:1305-1309.
3/5/2020 NICL Laboratories, Ltd All Rights Reserved
Previously known as Flavobacterium meningosepticum, and more recently as Chryseobacterium meningosepticum, Elizabethkingia meningoseptica is a gram-negative bacterium found in soil and water. Although it is rarely isolated from clinical specimens, this organism is resistant to several classes of antimicrobials and is capable of causing infection in blood, cerebrospinal fluid, skin and soft tissue, the respiratory system, and other body sites. Nosocomial transmission of E. meningoseptica among immunocompromised adults in intensive care units has been reported. Further, long-term acute care hospitals with mechanically ventilated patients could serve as an important transmission setting for E. meningoseptica. This multidrug-resistant bacterium could pose additional risk when patients are transferred between long-term acute care facilities and other hospitals.
Please articulate and reinforce your established policies of infection control: handwashing and disinfection practices, isolation policies, the use of gowns and gloves, the proper disposal of body fluids and body fluid– contaminated items, and the use of sterile water for cleaning of respiratory equipment and any other devices that come into contact with mucous membranes or nonintact skin of patients. Additionally, adherence to the current CDC guidelines for prevention of Ventilator-Associated Pneumonia (VAP) is important for reducing these types of infections in the long-term acute care facility.
References:
Weaver, KN et al. Acute Emergence of Elizabethkingia meningoseptica Infection among Mechanically Ventilated Patients in a Long-Term Acute Care Facility. Infection Control and Hospital Epidemiology 2010, Vol. 31 (No. 1), pp. 54-58.
Walkey, AJ et al. Epidemiology of Ventilator-Associated Pneumonia in a Long-Term Acute Care Hospital. Infection Control and Hospital Epidemiology 2009, Vol. 30 (No. 4), pp 319-324.
Tablan OC, et al.; Centers for Disease Control and Prevention (CDC); Healthcare Infection Control Practices Advisory Committee. Guidelines for preventing health-care–associated pneumonia, 2003: recommendations of CDC and the Healthcare Infection Control Practices Advisory Committee. MMWR Recomm Rep 2004; 53(RR-3):1-36.
3/5/2020 NICL Laboratories, Ltd All Rights Reserved
Frequently, physicians order laboratory procedures that require the collection of testing samples at specific times. These are referred to as ‘timed’ tests. Due to the importance of the time the specimen is collected in relationship to the drug dosing, it is very important that the laboratory be contacted a minimum of 12 hours prior to the desired collection time, though 24 hours lead time is preferred, to assure that personnel are available to collect the specimen.
Certain antibiotic levels such as Amikacin, Gentamicin, Tobramycin and Vancomycin are often ordered at specific times before and/or after the administration of the drug to monitor the drugs peak and trough levels. Trough levels are drawn prior to the drug administration, and peak levels are drawn after the drug has been administered. Since drug administration should occur at specific times, laboratory personnel do their best to work around the administration schedule.
When contacting the laboratory, please ensure that the time of the dose administration is provided to the dispatcher.
COLLECTION GUIDELINES
In the event that facility staff are collecting the timed specimens, strict adherence to the following guidelines is essential to ensure appropriate reporting:
Complete a separate laboratory requisition for each timed specimen
Indicate clearly on each requisition the type of drug being monitored (ex. Amikacin, Vancomycin)
Indicate in the box provided, the dose quantity, dose time, and the type of administration (IV, IM, etc.)
Indicate the type of level, peak, trough or random
Obtain the blood sample as near to the requested time as possible (collection times are noted in the NICL Laboratories LTC manual)
Label each specimen with the following: Patient Name, Patient’s date of birth, collection date and time
Place each specimen in a separate collection bag accompanied by the corresponding laboratory requisition
Failure to follow these collection guidelines may result in rejection of the specimen as unsuitable for testing.
Consult your Customer Service Representative with any questions on this topic.
3/5/2020 NICL Laboratories, Ltd All Rights Reserved
Vancomycin level monitoring is a topic under constant consideration.
Vancomycin trough levels are the preferred test, though Vancomycin peak levels (drawn 3 hours after the dose), may be useful in rare situations when calculation of kinetic parameters are necessary. Vancomycin trough levels should be collected just prior to the 3rd or 4th dose (within 30 minutes prior to administration). Baseline creatinine levels should be measured prior to the start of therapy and weekly during therapy, unless renal function indicates more frequent testing.
Indications for Monitoring
Indications for monitoringinclude patients with therapy anticipated to be greater than three (3) to five (5) days, infants and children with serious infections, cerebrospinal fluid shunt infections, meningitis, patients with rapid clearance of drug, in selected dialysis patients, and in cases of deteriorating or unstable renal function. In these patients a trough level is recommended, rather than a peak level, as vancomycin is distributed slowly into the peripheral tissues, making it difficult to determine a true peak level.
Therapeutic Ranges
Therapeutic ranges for Vancomycin differ dependent upon the infection.
In those circumstances where levels between 15 and 20 mg/L are indicated, renal function must be monitored closely. The pharmacist should be consulted whenever levels exceed 20 mg/L.
Risk Factors
Risks factors of supratherapeutic dosing (levels over 20 mg/L) are the incremental risks of nephrotoxicity and ototoxicity. Levels below the therapeutic range increase the risk of treatment failure as well as the risk of resistance to the drug.
Reference: Rybak, Michael, Lomaestro John, Rotschaer, John C, Moellering Jr, Robert, Craig, William, Billeter, Marianne, Dalovisio, Joseph R, Levine, Donald P, Therapeutic monitoring of vancomycin in adult patients: A consensus review of the American Society of Health-System Pharmacists the Infectious Diseases Society of America and the Society of Infectious Diseases Pharmacists. Am J Health Cyst Pharm – Vol. 66 Jan, 2009
3/5/2020 NICL Laboratories, Ltd All Rights Reserved
