D.13 Pathology and Laboratory Manual.pdf

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This is a Pathology and Laboratory Manual document that provides operational guidance and procedures for laboratory and pathology services. The manual establishes standardized protocols, testing procedures, quality assurance measures, and documentation requirements for pathology and laboratory operations within the VA North Texas Health Care System's community-based outpatient clinic (CBOC) network. The document serves as a reference guide for clinical laboratory personnel, pathologists, and support staff to ensure consistent, compliant service delivery for Veterans in the Grayson County, Texas catchment area and surrounding regions.

The manual likely covers specimen collection and handling procedures, laboratory testing methodologies, equipment operation and maintenance, result reporting standards, quality control and assurance protocols, safety and infection control procedures, and compliance with federal regulatory requirements for laboratory operations. As a supporting document to the CBOC solicitation, this manual establishes the baseline operational and clinical standards that potential contractors must be prepared to implement and maintain when providing outpatient laboratory and pathology services to the VA North Texas Health Care System.

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Pathology and Laboratory Medicine Service (P&LMS)

LAB MANUAL

VA North Texas

Health Care System rev September 2022

Shelby D. Melton, MD Chief, P&LMS

Sherman CBOC - RFP 36C25726R0018

TABLE OF CONTENTS PAGE

GENERAL LABORATORY INFORMATION:

1. P&LMS Telephone Listings

2. Guidelines for Laboratory Use

3. Specimen Collection and Labeling

4. Specimen Delivery

5. Sample Acceptability/Rejection Criteria

6. Reporting of Results

7. Accessing Test Results in Computer (CPRS)

8. Computer Downtime Protocol

9. Lab Test Downtime Menu

10. Medical Emergency Test List

11. Laboratory Critical Values, Alert Values

12. Laboratory Alert Values

13. Reference Laboratory

14. CSF and Other Sterile Body Fluids

15. Alphabetized List of Tests, “Yellow Pages”

16. Table of Reflexed Tests in VANTHCS

17. Quick Guide for Ordering Antibiotic Levels

LABORATORY SECTIONS:

Ancillary Testing (Waived Testing, Point-of-Care) Autopsy Blood Bank (Transfusion Medicine) Core Lab – Chemistry (Includes Urinalysis) Core Lab – Hematology (Includes Coagulation) Cytopathology Flow Cytometry (Immunophenotyping) Immunology Molecular Diagnostics (Viral Load & Genotyping) Microbiology (Includes Mycology/Mycobacteriology) Outpatient Phlebotomy/Ancillary Support Services Inpatient Phlebotomy/Ancillary Support Services STAT Lab – Operating Rooms Surgical Pathology Toxicology

OTHER SITES:

Arterial Blood Gas Labs Fort Worth Outpatient Clinic Sam Rayburn Memorial Veterans Center

PATHOLOGY AND LABORATORY MEDICINE SERVICE TELEPHONE LISTINGS

FREQUENTLY NEEDED NUMBERS:

Patient Sample Requirements or Questions (Client Services Unit) ....................... 70666/70714 Inpatient Phlebotomy Blood Bank (Transfusion Medicine) Pathology reports (Autopsy, Biopsy, Cytology) .................................................... 70677/70668 Pathology Resident on Call -- pager

(Fine Needle Aspirates, Frozen Sections, etc.) ....................................... 214-759-3341

ADMINISTRATIVE OFFICE

Chief, Pathology & Laboratory Medicine Service

Shelby D. Melton, M.D Administrative Officer

Nathan Irigoyen Secretary to Chief

Keleigh Garland Supervisory Management Assistant

Andreanna Taylor .................................................................................... 70684/70692 Laboratory Manager

Brian Ivey, MHA, MT(ASCP) Assistant Laboratory Manager/Education Coordinator

William Scott, MS, MLS(ASCP)cm Ancillary Testing Coordinators

Jacquelyn Gray, MT(ASCP) Tamara West, MS-CPM, MLS(ASCP)CM Christy Clemens, MLS(ASCP)CM

Laboratory Information Managers Glenn Vale, MT(ASCP) Haskell Ellis, MT(ASCP) Justin Ngo, MLS(ASCP)CM………………………………………………….70678

Safety Officer Diana Perez-Veliz, MLS(ASCP)CM

STAFF PATHOLOGISTS

Shelby D. Melton, MD ............................................................................ 70726 pgr. 214-786-4583 Ellen Araj, MD…………………………………………………………..70697 Bradford Barker, M.D. ............................................................................. 70712 pgr. 214-759-2232 Toby Gray, M.D. ..................................................................................... 70721 pgr. 214-759-4073 Mariam Mir, MD ..................................................................................... 70578 pgr. 214-759-4237 Daniel R. Nussenzveig, M.D., PhD. ........................................................ 71269 pgr. 214-759-1953 Roshan K. Patel, M.D. ............................................................................ 70325 pgr. 214-786-0322 Megan B. Wachsmann, M.D ................................................................... 70724 pgr 214-786-5531

On-Call/Frozen Section Pager ................................................................................ 214-759-3341 Pathology Resident Office ..................................................................................... 70679/71532/75244

ANATOMIC PATHOLOGY SECTION

AUTOPSY UNIT

Director: Bradford Barker, MD Supervisor: Shayla Powell, MLS (ASCP)CM Autopsy Suite Preliminary Autopsy Report ................................................................... 70677/70668

CYTOPATHOLOGY UNIT

Director: Mariam Mir, MD Supervisor: Shayla Powell, MLS (ASCP)CM Preliminary Cytology or FNA Report ....................................................... 70677/70668

SURGICAL PATHOLOGY UNIT

Director: Bradford Barker, MD Supervisor Histopathology: Shayla Powell, MLS (ASCP)CM Histology lab Preliminary Biopsy Report ......................................................................... 70677/74227/70668

TRANSCRIPTION UNIT ...................................................................................... 70677/70668

CLINICAL PATHOLOGY SECTION

CLIENT SERVICES AND IMMUNOPATHOLOGY

Director Client Services: Megan Wachsmann, M.D Director Flow Cytometry: Daniel Nussenzveig, M.D., PhD Director Molecular Diagnostics: Megan Wachsmann, M.D Supervisor: Jennifer Wais, MLS (ASCP)CM Lead Technologist

Client Services Flow Cytometry Immunology (Serology) Molecular Diagnostics) Referral Testing

CORE LABORATORY UNIT

Co-Directors: Shelby D. MeltonM.D Daniel Nussenzveig, M.D………………………………...71269 Supervisor: Rochelle Hurd, MT(ASCP)

Chemistry/Special Chemistry .................................................... 70699/70700 Hematology ............................................................................... 70686/72689/72690 Coagulation Urinalysis

MICROBIOLOGY UNIT

Director: Toby Gray, M.D Supervisor: Bonnie Greene, MHA, MT(ASCP)

Bacteriology (Routine) Blood Cultures Specimen Processing Mycobacteriology Mycology Parasitology/Occult Blood

PHLEBOTOMY UNIT

Phlebotomy Supervisor: Selma Gomez Carney, MT(ASCP)CM ............. 70698/70719 Outpatient Phlebotomy Lead Technician:

Inpatient Phlebotomy Lead Technician:

Evening Shift Lead Technician:…………………………………………70736

TOXICOLOGY UNIT ........................................................................................... 70654/70665

Director: Shelby Melton, M.D Technical Director: Dwain Fuller, F-ABFT Supervisor: Whitney Kebenzikato, MT(ASCP)

TRANSFUSION MEDICINE UNIT ..................................................................... 70720/70725/70683 Medical Director: Daniel R. Nussenzveig, M.D., PhD Supervisor: Sun Y. Son, MT(ASCP)SBB

EVENING SUPPORT UNIT

Supervisor: Lois Tate, MT(ASCP)

MIDNIGHT SUPPORT UNIT

Supervisor: McKenzie Mrazek, MT(AMT)

FORT WORTH OUTPATIENT CLINIC LABORATORY

Supervisor: Walter Emholtz, MT(ASCP) ................................................. 817-730-0074 Laboratory .................................................................................................. 817-730-0347/0348/0349

SAM RAYBURN MEMORIAL VETERANS CENTER (BONHAM) LABORATORY

Supervisor: Taja Colbert, MLS (ASCP)CM ................................................ 903-583-6269 Laboratory .................................................................................................. 903-583-6268

PATHOLOGY & LABORATORY MEDICINE SERVICE

GUIDELINES FOR LABORATORY USE

I. LOCATION:

Pathology & Laboratory Medicine Service is located on the first floor of the Clinical Addition (South end).

II. HOURS OF OPERATION:

A. The main laboratory is open 24 hours per day, 7 days per week, with a Client Services Unit for the receipt of specimens. Regular working hours are from 8:00 a.m. - 4:30 p.m., Monday through Friday. A limited staff is on duty after regular hours, weekends and holidays.

B. The Outpatient Phlebotomy room (1B-220) is open from 6:00 a.m. - 4:30 p.m., Monday through

Friday and on a limited basis every Saturday from 6:00 a.m. – 2:30 p.m. Outpatient Phlebotomy services are not available on Sundays or holidays. Outside these hours, phlebotomy will be performed by nursing personnel or physicians.

C. The Inpatient Phlebotomy Section will provide collection of inpatient blood samples between the hours of 5:00 a.m. and midnight, seven days a week, including holidays. Early morning phlebotomy begins at 5:00 a.m. Regular collections are scheduled every two hours. Exceptions to the above are: MICU, SICU, TICU, Step Down Units, Dialysis (3A), Emergency Department, Surgical Recovery Room, Cardiac Catheterization & Electrophysiology Sections, Radiology Suites, and the Domiciliary.

III. CUSTOMER SERVICE:

The laboratory provides wide-ranging customer service regarding lab-related issues to our customers upon request. Please contact Client Services at extension 70666/70714.

IV. LABORATORY ORDERS:

Laboratory orders are entered into the computer (CPRS) using the WRITE ORDERS option in the ORDERS tab.

A. ORDER ENTRY:

All test requests except Anatomic Pathology and Blood Bank (Sect. C, page 7) must be entered into CPRS before the samples are delivered to the laboratory.

1. Collection Type:

a. Ward Collect - This option is used when blood specimens are to be collected by ward personnel. Order ward collect any time a patient has a PICC line and between the hours of midnight and 5:00 am.

b. Send Patient - This option is used for ambulatory patients who will be sent to the outpatient phlebotomy area for sample collection.

c. Lab Collect - This option is used when routine inpatient blood specimens are to be collected by P&LMS phlebotomy personnel.

d. Immediate Collect – This option is used when inpatient blood specimens are to be collected by P&LMS phlebotomy personnel and are designated as ‘STAT’ urgency or need to be drawn at a specified time.

2. A unique order number is automatically generated by the computer when a laboratory test request is entered into the computer.

3. The order number is in the electronic medical record (CPRS) next to the written order once it is entered and signed via computer. This will serve as the cross-reference for any future questions. This order number must also be written on the specimen labels from units where barcoded labels are not printed.

4. The order number is the only identifier and cross-reference the laboratory has to appropriately process the sample. Please ensure correct transcription of the number from the screen to the sample.

B. ADDING TESTS TO AN EXISTING ORDER:

Tests may be added to a previously collected sample by ordering the new test(s) in CPRS and notifying the Client Services Unit (CSU) at ext. 70666/70714. “Add-on” test(s) must match the original sample type.

To add a test(s) to a previously collected sample:

- Order the additional test(s) in CPRS.

- Contact CSU with the “add-on” request at ext. 70666/70714.

- Provide the following information to CSU:

Patient’s full name and complete SSN Additional test(s) Old order number New order number Provider name and a contact number (phone or pager)

C. LAB SECTIONS NOT ON WARD ORDER ENTRY:

1. Surgical Pathology Orders – A fully completed tissue examination form (SF-515) must be submitted with each sample. The Histology section will accession the requests into VistA.

The Transcription Section will enter the results into VistA. Surgical pathology results can be accessed through CPRS using the ‘Reports’ tab. Click on the ‘Anatomic Path Reports’, then choose ‘Surgical Pathology,’ ‘Cytopathology’, ‘Autopsy,’ or ‘Electron Microscopy.’

2. Cytology Orders - A fully completed tissue examination form (SF-515) must be submitted with each sample. The Cytology Section will accession the specimens into VistA in the laboratory. The Transcription section will enter the results into VistA. Cytology results can be accessed through CPRS using the ‘Reports’ tab. Click on the ‘Anatomic Path Reports’, then choose ‘Cytopathology’.

3. Autopsy Requests – a completed autopsy permit consisting of a SF-523 “Authorization for

Post-Mortem Examination” must be appropriately filled out, bearing the signatures of the legal next of kin, the physician and two witnesses who are medical center employees. See VANTHCS Memorandum 11-15 Post-Mortem Examination for complete details.

4. Transfusion Medicine Orders -

a. Select “Blood Bank Orders” on left side of screen, click to open.

b. The following options are displayed: Type and Screen only, Blood Bank Transfusion

Orders, Pre-Op Orders (includes inpatient orders and outpatient orders), Intra-Op Orders (used only by surgical staff for patients currently in the Operating Room), Large Volume Transfusion Protocol for Life Threatening Bleed, and Transfusion Reaction Work-up.

c. Select the appropriate order and click to open page.

d. Fill in applicable information.

e. Type and Screen and Blood Component orders are for inpatients currently admitted to the hospital. Do not order for outpatients.

f. Refer to the Blood Bank (Transfusion Medicine) section in this manual for more information.

A completed SF-518 (Blood or Blood Component Transfusion Form) and a 7 mL pink top or 10 mL purple top (EDTA) tube labeled with patient identification (full name, full SSN), date, time, and initials of collector must be submitted directly to the Transfusion Medicine Unit (room 1B-306) for Type and Screen and/or Blood Transfusion orders.

The completed SF-518 must include the patient’s full name, full SSN, component requested, type of request, date and hour requested, requesting physician, diagnosis, collector’s signature, verifier’s signature, date and time verified.

Laboratory staffing between 4:00 p.m. and 8:00 a.m., weekends, and holidays, is for emergency transfusion services only.

NOTE: UNCLEAR ORDERS. Test orders that may be unclear (non-standard, non-specific terminology, etc.), must be clarified prior to continuation of testing by contacting the provider or other health care professional who placed the order. Specimens will be processed to maintain sample integrity if there is a delay in clarification of test orders.

V. SPECIMEN TESTING PRIORITY: - Three testing priorities are available:

Routine:

Results for most tests will be available within 2-8 hours from time of receipt in laboratory. Most tests are defaulted to this priority in the computer.

STAT:

Results will be available within 1-2 hours of receipt. This priority is used in lieu of Medical Emergency, if the survival of the patient is not dependent upon expeditious results.

Medical Emergency:

Results will be available within 1 hour of receipt. This priority is reserved for use when the survival of the patient is dependent upon test results. Please refer to Specimen Delivery (Section VII, D) for further information on Medical Emergency requests.

VI. PHLEBOTOMY SERVICES:

Pathology and Laboratory Medicine Service will be responsible for collecting blood samples for patients of local outpatient clinics and specified inpatient units as per Section II. For Hours of Operation, see II B and C above. For additional information, see the Phlebotomy Section of this manual.

VII. SPECIMEN COLLECTION, LABELING, AND DELIVERY TO THE LAB:

To ensure that patient samples are in no way compromised due to improper collection or handling, and to be in compliance with the Joint Commission, CAP, and VHA laboratory testing standards, the guidelines below must be followed when submitting specimens to the laboratory:

A. COLLECTION LISTS:

1. LAB COLLECTION DRAW LIST – Collection list printed by the inpatient phlebotomy team prior to being dispatched to the various units for scheduled sample collections. The draw list includes all ‘Lab Collect’ orders that have been placed on patients on the ward. As patient samples are accessioned into the lab, the orders will drop from the list.

2. The WARD COLLECTION SUMMARY LIST option (on all ward personnel menus in

VistA only) will provide the user a list of all WARD COLLECT and SEND PATIENT orders placed for a given day.

3. The WARD COLLECTION SUMMARY LIST is printed by MAS clerks daily and placed in an accessible area, so that in the event of an unscheduled computer downtime it can be immediately referenced.

4. The LAB COLLECTION list is printed at designated times throughout the day by inpatient collection personnel and placed in an accessible area, so that in the event of an unscheduled computer downtime it can be immediately referenced.

B. SPECIMEN COLLECTION AND LABELING:

1. UNLABELED SAMPLES are not accepted for laboratory testing. Every effort is made to notify the collector or attending physician if an unlabeled sample is submitted, to allow for timely recollection.

2. An accurate laboratory work-up begins with the proper collection and labeling of patient specimens. Samples should be of adequate quantity, in an appropriate in-date container, and properly labeled. Requirements for most types of specimen collection, types of tubes, and special precautions are listed under the INDEX OF LABORATORY TESTS in this manual.

Detailed information can also be accessed in CPRS using "Lab Test Information” in the “Tools” bar. Please contact the laboratory Client Services Unit (ext. 70666) with any questions regarding special collection or handling procedures.

3. Patient Identification Procedures:

a. Pre-Collection Identification: Two identifiers must be used when confirming patient identity. The identifiers must match exactly.

1) Inpatients: Inpatients will have wrist (or ankle) identification at all times during their hospital stay. Staff members will look at the identification band and verify the patient’s full name and date of birth (DOB) – with either the patient’s verbal response, or paperwork when applicable. Full social security number (SSN) will also be verified visually by comparing the specimen label(s) with the patient ID band.

2) Outpatients: Clinic and Home Care patients are asked to show their Veterans Health

Identification Card (VHIC) each time service is provided. Staff members will look at the card and verify the patient’s full name and at least one other identifier with the patient’s verbal response. The patient is asked to state full name (first, last) and date of birth (DOB). The patient’s response must be identical to the information listed on the request form and/or specimen label. If the identification card does not have a unique VistA compatible barcode or the full SSN, the patient is asked to complete a P&LMS provided fill-in card (full name, DOB, and full SSN) to compare for complete verification.

3) Comatose, disoriented, or incoherent patients: Ask family member/legal guardian or accompanying adult to identify the patient, or use picture identification, and compare the information given to that listed on the wristband (inpatients) or VHIC card (outpatients). Verbal identification is confirmed by comparison with written documentation when possible.

4) Visually impaired patients: Ask the patient for a form of Identification that includes their SSN. If the patient is unable to provide a SSN, the patient is instructed to whisper the SSN to the phlebotomist.

b. Patient Sample Labeling:

1) Ensure that the patient’s full name, full DOB, and full SSN as listed on the sample(s) exactly matches the identification listed on the electronic (order number) or paper requisition.

2) Specimens must be fully and appropriately labeled immediately upon collection in the presence of the patient. If laboratory barcode labels are not used, the patient's identification card may be used to prepare a stamped/written label to provide the following:

Complete legible name of patient Complete social security number Date and time of collection of the specimen (especially for time sensitive test) Initials of the person who collected the specimen Source, body site, or specimen type for samples other than peripheral blood

(i.e., right femoral artery, left pleural fluid, abscess left groin)

3) The identifying label is placed on the sample container(s) at the time of collection in front of the patient. Outpatients are asked to visually verify the label information on their samples.

4) Containers and test packets for tests requiring patient self-collection (i.e., fecal occult blood samples, urine containers) may be pre-labeled, but require verification with the patient to confirm complete identifiers (full name, full SSN) prior to hand-off of the collection container.

5) Place specimens for each unique patient in a single biohazard transport bag. DO

NOT place specimens (or labels) from more than one patient in a single biohazard transport bag. Samples from more than one patient in a single biohazard transport bag are rejected.

Additionally, the computer-generated order number, when applicable, should be noted on the label. Do not place identification labels over the barcodes on bottles or tubes.

4. Feedback to phlebotomists regarding specimen quality (GEN.40499) is performed by the discovering technologist, inpatient phlebotomy lead technician, and/or phlebotomy supervisor/supervisor if specimen quality has been decreased or compromised due to hemolysis, insufficient sample, clots, etc. Records of phlebotomy feedback are documented and education/counseling is conducted as appropriate.

C. PAPER REQUISITIONS:

The demographic information on the requisition must match that of the sample label:

Complete and legible name of patient Complete social security number Date of birth Complete name and signature of requesting physician and pager number. Referral tests will require the physician's signature and pager number and/or extension where physician can be reached.

Location of patient Sex Name of the tests requested

Date and time of collection of the specimen Specimen type, source and/or anatomic site with laterality when indicated, i.e., joint fluid

(right or left knee), throat culture, pulmonary cytology, etc.

Computer generated order number (when applicable).

D. SPECIMEN DELIVERY:

1. All patient specimens, except those for Transfusion Medicine, must be delivered to the Client Services Unit (CSU) as soon as possible after collection. Samples must be placed in a sealed plastic transport bag bearing a biohazard symbol. Samples from only one patient per biohazard transport bag are acceptable. Samples from more than one patient in a single biohazard transport bag are rejected. Place requisition in the outer pocket of the bag to avoid contamination. Samples are brought directly to the CSU window (1B-311), the pneumatic tube system (below), or sent by the ABC Transport System (below).

2. Transfusion Medicine (Blood Bank) samples must be delivered directly to the Transfusion

Medicine window, room 1B-306 in the Clinical Addition. This window is staffed 24 hours per day, 7 days per week. Samples for Type and Screen/Blood Component Orders requiring Type and Screen (T&S) must be accompanied by a complete, legible, and properly labeled SF-518 form. Samples are rejected without the complete, properly labeled SF-518 form.

Refer to Blood Bank, Transfusion Medicine Section, IV. REQUEST FOR BLOOD COMPONENTS: A.2. of this manual for detailed information on sample collection, delivery, and acceptability.

3. Each “Medical Emergency” test request must be assigned a separate and unique order number. These requests require special handling and processing procedures to ensure timely results. Medical Emergency samples are delivered directly to CSU. Kindly alert Client Services personnel verbally when submitting “Medical Emergency” samples at the CSU window.

E. ABC TRANSPORT SYSTEM:

Non-emergent (“routine” urgency) patient samples are delivered to the clinical laboratory using the ABC Transport System (“the train”).

1. Only designated ABC lab cars are used to transport patient samples. These cars are clearly labeled “Biohazard” and “Lab Samples Only.” Unlabeled cars are used for all other materials, such as patient files, paperwork, or SPS supplies.

2. Patient samples must be placed in sealed biohazard bags with any accompanying paperwork placed in the outside sleeve. Only one patient’s samples per biohazard transport bag. The bags must be placed in one of the two metal baskets hanging in the train car. Please ensure that all urine, sputum, and stool sample caps are securely tightened before placing in biohazard transport bags.

3. Send the train cars to laboratory stations #28 or #29.

4. Empty lab cars are called to the sender’s station by pressing “Special Call” on the keypad.

5. The status of all cars sent to the lab can be checked at any time by pressing the

“INFORMATION” on the keypad. Pressing INBOUND will list the car number and sending station. Pressing OUTBOUND will list the car number and destination station, Pressing ARRIVALS will display the history list of all cars that have arrived at that station.

6. “Medical Emergency” and “Transfusion Medicine/Blood Bank” samples should be hand-delivered to the laboratory, as the patient’s survival depends on the timeliness of results. The ABC System should NOT be used for these samples.

7. Some patient samples should never be transported by the ABC system. These include 24-hour urine jugs and jars of alcohol that contain patient smears on glass slides. Other unique, non-re-collectable samples (CSF, joint effusion, etc.) should be similarly hand-delivered by collecting personnel or delegate, to ensure that the specimen is accessioned and processed without delay. The ABC System should NOT be used for these samples.

8. For all operational problems with the ABC system, call the ABC Transport office at ext.

71062 (weekdays) or the Energy Center at ext. 71139 (nights, weekends, and holidays).

F. Pneumatic Tube System:

Samples from the Emergency Department (ED), Clinical Decision Unit (CDU), and Spinal Cord Injury (SCI), Cardiac Care Unit (CICU), Medical Intensive Care Unit (MICU), Surgical Intensive Care Unit (SICU), Thoracic Intensive Care Unit (TICU) center may be delivered to P&LMS Client Service Unit (CSU) utilizing the pneumatic tube system. Under normal operating conditions, samples will arrive in CSU within two minutes of leaving the sending station.

1. Samples must be placed in sealed biohazard bags with any accompanying paperwork placed in the outside sleeve of the bag Only one patient’s samples per biohazard transport bag.

Then the bags are placed in the foam insulated pneumatic tube carrier (bullet). Do not overfill the individual biohazard bags because this may prevent proper sealing of the biohazard bag. Do Not use the bullet without foam insulation.

It is imperative that samples are securely bagged and tightly sealed to prevent any spillage within the pneumatic tube system. Spillage may cause electrical shorting of circuitry which would shut down the system.

Blood culture bottles are susceptible to breakage if not properly handled, so only one set is placed in a biohazard bag at a time for transport in the pneumatic tube.

Urine, sputum, and stool samples must have the container lids securely tightened and double bagged. Ensure that both bags are tightly sealed.

Do not place glass alcohol jars containing glass slides or 24-hour urine jugs in the pneumatic tube system. These samples must be hand delivered to the laboratory.

2. Place the biohazard bags in the bullet. Make sure the biohazard bags are not protruding from the bullet before locking the safety latches at each end of the bullet. Do not overload the bullets (keep <5 pounds). Send samples that are too large or too heavy for the bullet in the ABC transport system or hand deliver.

3. Place the securely locked bullet into the vertical sleeve and type in the station number on the touchpad (on the front of the pneumatic tube station) that samples will be sent to. The stations and their station numbers are:

Clinical Decision Unit (CDU) (#100) Client Services Unit (#101)

Spinal Cord Injury (#102) Emergency Dept (ED) (#103) Medical Intensive Care Unit (MICU) (#151) Cardiac Care Unit (CICU) (#152) Surgical Intensive Care Unit (SICU) (#153) Thoracic Intensive Care Unit (TICU) (#154)

4. Select the location under the Directory button. Push the “Send Normal” pad to activate the system and to send the bullet to the selected station.

5. When the bullet arrives at the selected station an audible alarm will sound to alert staff that a bullet has arrived. Press the “Silence Alarm and then “Yes” to turn off the alarm and then remove the bullet.

6. Open the safety latches at each end of the bullet and remove samples.

7. Close safety latches and place empty bullet back into the vertical sleeve. Select the location under the Directory button. Push the “Send Normal” pad to activate the system and to send the billet to the selected station.

8. Do not keep more than four bullets at each station. Keeping more than four bullets could cause the system to shut down.

9. Call the Energy Center (71139) during for all pneumatic tube operational problems.

VIII. SAMPLE ACCEPTABILITY/REJECTION CRITERIA:

Unlabeled samples are rejected, and recollection will be required (refer to Section VII B, “Specimen Collection”). More than one patient’s samples (or labels) in a single biohazard transport bag are all rejected.

It is essential that the samples are delivered immediately upon collection for quality analytical results.

The optimum time to physically separate serum/plasma from cell contact is within 2 hours after collection.

Specimens inappropriately preserved, leaking or cracked tubes or containers, grossly hemolyzed blood samples, clotted samples drawn in an anticoagulant, blood specimens contaminated with I.V.

fluid, or insufficient amounts of blood (e.g., less than 1 mL for chemistry profiles) are unacceptable.

Refer to the Index of Tests (yellow pages, this manual) or the Lab Test Information (CPRS) for specific sample requirements. The ordering provider/ward charge nurse will be notified, and a new specimen will be requested.

A. Hematology: Sedimentation Rate should be analyzed within 4 hours after collection. Samples for

CBC with Auto diff. are stable up to 24 hours at room temperature, and 48 hours if refrigerated.

Clotted or under-filled (<2mL) EDTA (lavender top) tubes are unacceptable. Fluid samples for cell counts submitted in syringes are unacceptable. Blue top for platelet is stable at room temperature for 24 hours. Do not refrigerate.

B. Coagulation Studies: Sodium citrate (light blue top) tubes must be filled to “draw capacity”

(blue bar on tube label). Clotted samples, hemolyzed plasma, and specimens drawn from a heparin lock are considered unsuitable for analysis. Coagulation samples for PT testing can be analyzed up to 24 hours after collection if the tube is at ambient temperature; however, samples for PTT, D-Dimer, and Fibrinogen must be assayed within 4 hours of collection. PTT Heparin samples must be spun within 1 hour of collection.

C. Chemistry: Samples for chemistry testing and therapeutic drug monitoring should be analyzed within 8 hours after collection. Samples that must be placed on ice (lactate, ammonia-delivered within 30 minutes of collection, fluid pH, and ionized calcium) are to be delivered immediately.

Disclaimers are included with the final patient report on hemolyzed samples.

D. Urinalysis: The optimum time to deliver urinalysis samples to the laboratory is within 1 hour of collection. If unable to deliver within one hour of collection, refrigerate and deliver as soon as possible during the shift.

E. Bacteriology, Mycology, and AFB specimens should be processed as soon as possible. Deliver specimens submitted for microbiological cultures to the laboratory as soon as possible after collection. Urine and sputum samples may be temporarily refrigerated if delivery to the lab will be delayed. Failure to properly collect specimens or delays in transport could lead to compromised specimens and erroneous culture results.

Blood Cultures -Myco/F Lytic bottles (for AFB and/or fungus cultures) must contain at least 1-5 mL of blood per bottle. Those collected with less than 1 mL per tube are processed; however, a

"short draw" disclaimer will be reflected in the report

Blood culture bottles submitted for bacterial culture must contain at least 8 - 10 mL of blood per bottle. Optimally, 20 mL of blood per culture set (2 bottles) is collected. Larger volumes of blood increase the yield of true positive cultures. Samples containing less than 8 mL per bottle are processed; however, a "short draw" disclaimer will be reflected in the report.

Sputum specimens submitted for culture on swabs are not accepted.

Swab specimens submitted for anaerobic cultures are not accepted.

Stool specimens submitted for ova & parasite examination must be free of interfering substances (barium, magnesium, kaolin, bismuth compounds, castor and mineral oils, etc.).

Formed stool specimens submitted for Clostridioides difficile PCR testing are rejected.

Cerebrospinal and Other Body Fluid Specimens: When an inadequate sample volume is submitted, the report will note that the culture results may be compromised due to the limited sample volume received.

F. Cytology/Histology specimens should be delivered as soon as possible.

Tissue Examination Request Forms (SF-515) - Samples for cytology and surgical pathology that are submitted without requisitions, or incomplete or illegible requisitions, are unacceptable and will require correction or completion of the requisition by the clinical staff before results can be made available.

G. Flow Cytometry: CD4/CD8 Samples: Clotted, hemolyzed, frozen, shipped on ice, or under-filled (<1 mL) small EDTA (4mL) tubes are rejected and a redraw requested. Specimen must be at room temperature. NOTE: Samples are stable up to 4 days at room temperature.

H. Molecular Diagnostics: HBV/HCV/HIV-1 Quantitative Viral Load testing and: Whole blood samples >24 hours old, frozen samples stored in primary tubes, and plasma samples improperly collected, stored, or exceeding stability will be rejected and a redraw requested. Highly soiled rectal swab specimens for CT/NG testing are rejected and a recollect is requested.

I.

J. Immunology: Samples for immunology testing should be analyzed within 8 hours after collection.

Vaginitis testing: Vaginal samples improperly collected, stored, or exceeding stability are rejected and a recollect requested.

J. Toxicology: Urine samples may be delivered directly to the secure, access restricted Toxicology section (room 2C-403) until 3:00 p.m. Monday-Friday. After 3:00 p.m. and on weekends and holidays deliver urine samples to the Client Services Unit within 2 hours of collection or refrigerate and deliver as soon as possible.

K. Transfusion Medicine (Blood Bank): All samples submitted for “Type and Screen” (T&S) or

“Blood Component Orders” requiring T&S must be accompanied by a complete, legible, and properly labeled, SF-518 form. If either the sample or the SF-518 is unlabeled, incompletely labeled, or illegible, both the sample and the SF-518 form will be rejected by the Transfusion Medicine Unit staff and recollection requested.

L. Referral Testing: Please call the Referral Testing section at extension 70691 regarding specific referral testing information. P&LMS provides referral laboratory service for patient specimens when specific tests are not performed in-house. The user of this manual should assume that tests not listed may fall into the category of a "fee basis referral test." It is recommended that the CPRS user option, LAB TEST INFORMATION, located in the TOOLS dropdown menu, be utilized as a resource for information related to any test a provider may desire to have performed. The Client Services Unit (ext. 70666) will assist users with this information.

A laboratory e-Consult request is required for referral tests that are not orderable in CPRS. The laboratory e-Consult is ordered in CPRS as “Miscellaneous Lab Test Request” under the Dallas Consult Services, Pathology and Laboratory Medicine. Consults requested for tests that are orderable in CPRS will be closed without action.

Only VA paid staff providers are authorized to spend federal funds (i.e., order reference lab tests).

Refer to VANTHCS Memorandum 141-02 for responsibilities in utilizing consults.

A laboratory Pathology Molecular Test consult is required for referral testing associated with the National Precision Oncology Program. Consults are reviewed by a pathologist prior to being sent for testing. The e-consult is ordered in CPRS as “Pathology Molecular Testing Request” under the Dallas Consult Services, Pathology and Laboratory Medicine.

IX. REPORTING OF RESULTS:

A. PRINTED REPORTS FOR THE MEDICAL CHART:

1. All test results are immediately available to the provider as soon as the data is verified in

VistA. The provider may, at any time, determine the progress of a given order by going to the ‘LAB’ tab computer option in CPRS, then selecting the LAB STATUS tab.

B. CRITICAL VALUES/RESULTS

Critical (“Panic”) Values/Results are those results that fall so significantly outside of normal test ranges that, if they are not acted upon, may present significant risk to the patient (Refer to Medical Center Memorandum 11-14, “Communicating Test Results to Providers and Patients”).

Critical values will be called/paged to ordering provider within one hour of test completion. The notification cascade will be followed as per Medical Center Memorandum 11-14: notify initial individual on cascade, if unable to reach within 15 minutes proceed to notify next individual on cascade, etc. All critical results communicated will require write-down/read-back (see VANTHCS Memorandum No. 00-07, Read-Back Requirements) to ensure the result is communicated accurately. For all testing services, the communicating physician, therapist, or technologist will document in VistA the name of the Authorized Licensed Professional (ALP) who received and read back the critical value, and the time the message was communicated.

1. Inpatient Cascade:

a. Regular work week (8:00 a.m. to 4:30 p.m., Monday through Friday): notify ordering

ALP, Attending for ordering ALP’s team, Section Chief, Service Chief.

b. 4:30 p.m. to 8:00 a.m. during the workweek, holidays, and weekends: notify ordering

ALP, Cross-cover ALP, Attending for cross-cover team, Service Chief.

2. Outpatient Cascade:

a. Regular work week (8:00 a.m. to 4:30 p.m., Monday through Friday): notify ordering

Authorized Licensed Professional (ALP), Critical Results Pager (CRP) for section, Chief of Section, if applicable, Chief of Service.

b. Regular work week after hours (4:30 p.m. to 8:00 a.m., Monday through Thursday), holidays, and weekends (Friday 4:30 p.m. through Monday 8:00 a.m.). If a holiday falls on Tuesday, after hours will be 4:30 p.m., Monday, to 8:00 a.m., Wednesday. Notify ordering ALP, Emergency Department (ED) – The Medical Officer of the Day (MOD) may be contacted at extension 71975.

3. Exceptions – Inpatient Intensive Care Units (MICU, CCU, TICU, and SICU):

a. At all times: Critical results may be called to any available physician in the ICU.

b. At all times: if the critical value/result is a PTT for a patient who is on an anticoagulation (Heparin drip) protocol, the critical result may be communicated directly to the RN who is taking care of the patient.

c. At all times: if the critical result is a blood glucose value for a patient who is on an insulin drip protocol, the critical results may be communicated directly to the RN who is taking care of the patient.

d. In all the above cases, the receiving party will perform write-down/read-back.

e. ICUs may be contacted at the following numbers:

1. CCU: 72181, 72182, or 72184

2. MICU: 71659, 71660, or 71661

3. SICU: 71619 or 71620

4. TICU: 71624 or 71625

4. Exception: Protime Clinic:

a. Normal duty hours, 8:00 a.m. to 4:30 p.m.: Anticoagulation Clinic will be notified of critical lab results via the Critical Results Pager at (214) 749-2215. A second method is to contact a clinic provider at extension 71963. Write-down/read-back must be done.

b. After normal duty hours, 4:30 p.m. to 8:00 a.m. and weekends: Call the ED – The Medical Officer of the Day (MOD) may be contacted at extension 71975.

Note: The ordering physician can also choose to receive critical values alerts in CPRS by going to the TOOLS option and turning on the notification setting. However, use of this option will not replace the telephone notification.

C. ALERT RESULTS:

Alert values are those lab values above or below the reference or therapeutic ranges that are very abnormal and for which notification of the ordering provider is appropriate. Notification is made by telephone within four hours of test completion.

D. ABNORMAL RESULTS ALERTS:

If the ordering physician would like to receive notification of abnormal laboratory test results in CPRS (excluding microbiology and anatomic pathology), the Abnormal Results Alert option is activated by selecting the TOOLS/OPTIONS tab and turning on /off any of the notifications listed except those denoted as mandatory. Be mindful that if ‘Abnormal Lab Results’ is chosen; all abnormal lab test results will result in a notification sent. The option cannot be set to receive only specific lab test results.

E. TELEPHONE RESULTS:

Requests for laboratory results by telephone are discouraged. The Privacy Act of 1974 and HIPAA places specific restrictions on the dissemination of private patient information. All verified data is immediately available via the computer and can be printed out as needed.

F. CORRECTION OF ERRONEOUS RESULTS:

If erroneous lab results have been verified on a patient, the correct results must be reported. The ordering physician is notified of the correction by a notification comment entered into the computer system.

The entry of “Comment” (#) in the results field or change in a result will automatically cause a comment, “___ incorrectly reported as ___” to appear in the computer for each test. This computer-generated comment must not be deleted. This comment is automatically generated every time there is a change in a previously verified result (in sequential order). The comment indicates the person making each change and the date and time each change was made. A supervisory report, “Audit of Deleted/Edited Comments,” is run each month to assure that these comments have not been deleted.

The supervisor may also use the option “Changes in Verified Lab Data” to periodically track any verified result changes by employees. This process applies to all section of the Clinical Laboratory except Microbiology. Manual entry of culture corrections are entered by the technologist.

All comments (computer-generated and those manually entered) are displayed when reviewing results on the computer screen or when a lab report is printed.

NOTE: Any time test results are verified, whether it be initial verification, or when results are corrected and verified, new lab reports are automatically generated.

Erroneous results of significant deviation will initiate provider notification by phone. A result of significant deviation is one that changes the result from a normal result to an abnormal result, or an abnormal result to a normal result. Refer to individual section policies for further information.

X. ACCESSING LABORATORY TEST RESULTS IN CPRS:

A. Laboratory test results are contained in CPRS, the VA’s clinical computer system. All staff and house staff are encouraged to become familiar with CPRS and use it to facilitate their interaction with the laboratory. Pathology & Laboratory Medicine Service will provide assistance to any provider desiring assistance in its use.

Computer operations are not under the authority of Pathology & Laboratory Medicine Service;

therefore, all operational problems should be referred to Information Technology (IT) Help Desk.

B Laboratory test results can be accessed in CPRS in the following ways:

1. COVER SHEET: Recent laboratory test data is listed in the lower left-hand corner of the cover sheet.

2. ORDERS TAB: Select ‘Lab Tests” under the ‘Write Orders’ column on the left side. An alternative is to select ‘Quick Orders’, proceed to the appropriate menu, then select either the lab order menu or ‘Other Lab Tests.’ Under the lab order menu, there are tests already set up (quick orders) that require minimal input from the clinician to complete the order; however, the order, including test urgency, can be changed to fit the individual clinician’s needs.

Under ‘Other Lab Tests’, the clinician must input all the pertinent information into the order.

3. REPORTS TAB: Laboratory test results are contained in the ‘Clinical Reports’ area. Click on the + Lab to expand the tree structure. Once expanded, the following options are available:

- Blood Availability – Lists what is currently cross-matched for the patient.

- Blood Transfusion – Lists the component type and number of all blood products transfused.

- Blood Bank Report – Lists the current and previous blood product requests with the patient’s blood type and antibody screen/identification. Lists the blood products currently available or issued in the past 24 hours, if applicable.

- Surgical Pathology Report – Lists all surgical pathology reports for that patient.

- Cytopathology – Lists all cytology and FNA reports for that patient.

- Lab Orders – Lists all lab orders for a specific date range.

- Chem. & Hem – Lists lab orders for a specific date range that can be sorted (click heading to sort).

- Microbiology – Lists all microbiology reports. Select ‘Most Recent Test’ to locate

Occult Blood, C. difficile toxin, Lactoferrin, Carba-R PCR,-MTB/Rif, Respiratory Panel, BCID results, and SARS-CoV-2 PCR (Cepheid).

Laboratory test results are also contained in the ’Health Summary’ area. Click on Health Summary to expand the tree structure. The following options are available upon expansion:

- Lab Status – Same as Lab Tab (below)

- Blood Bank Status – Same as Lab Tab (below)

Various Anatomic Pathology reports are contained in the ‘Anatomic Pathology’ area. Click on + Anatomic Pathology to expand the tree structure. The following options are available upon expansion:

- Surgical Pathology – Surgical pathology reports.

- Cytopathology – Cytology and FNA reports.

- Autopsy – Autopsy reports, when available.

Laboratory test results are also available in the Daily Order Summary area. Click on + Daily Order Summary to look at all the orders for today. This report gives the order summary within the date range. To print a chart copy summary, select the device and print the needed report.

4. LAB TAB – Under the left column (‘Lab Results’) there are several options to choose from:

- Most Recent – Lists the most recent laboratory test data (cannot print from this option)

- Cumulative – Lists laboratory test data in a cumulative format for easy comparison

(cannot print from this option)

- All Tests By Date – Lists all tests for date range indicated in lower left corner.

- Selected Tests By Date – Select only the relevant tests desired. Type in the test, click on

‘Add’, then ‘OK’ when the list is complete.

- Worksheet – Predefined test groups can be displayed. These tests can be arranged by specimen and by the order in which they will be displayed.

- Graph – Lab test data can be graphed for easy comparison over a period of time.

- Microbiology – Lists microbiology reports for the date range indicated.

- Anatomic Pathology – Lists Anatomic Pathology reports for the date range indicated.

- Blood Bank – Lists Blood Bank reports.

5. LAB STATUS: Shows patient specimen status in real time, so that the clinician can track the progress of the sample to and through the laboratory.

XI. COMPUTER DOWNTIME PROTOCOL:

Pathology & Laboratory Medicine Service does not have an independent computer system and is dependent solely on the hospital (VistA) mainframe computer. Therefore, any interruption in computer service significantly impacts the laboratory, as well as the other clinical services. Please refer to VANTHCS Memorandum No. 113-05, Laboratory Computer Downtime Procedure [viewable on VANTHCS Intranet] for detailed information.

A. For scheduled computer downtime, the following procedures must be followed.

1. One hour prior to downtime, all specimens submitted to the Client Services Unit (CSU) or the laboratories must be accompanied by a manual 5-part laboratory requisition that includes the computer order number as well as full patient name, full patient SSN, sex, priority, unit/clinic location, physician name, and pager. This enables the laboratory to know which unit/clinic is to receive the hardcopy results, as well as whom to notify in case a critical value is determined.

2. As much as possible, test requests are consolidated by specimen type (color of collection tube cap -- refer to the Lab Test Menu for Computer Downtime on the following page) during downtime. A separate request slip must be completed for each sample tube if a manual 5-part laboratory requisition form is unavailable. This is to ensure that no samples are mis-placed, or tests not run, since tests are routinely run in several different areas of the lab. A full color copy of the Downtime Menu should also be available in each ward/unit/clinic as part of that area’s computer downtime protocol.

3. Medical Emergency and STAT orders will be handled with first priority during this time. The test urgency must be indicated on the requisition.

4. All Medical Emergency test results will be called to the nursing unit. All critical results are called as per the Critical Results Policy – VANTHCS Memorandum 11-14.

5. All ICU and ED results are faxed to the appropriate area upon completion. The ICUs and ED are responsible for identifying the fax number to be used, and for ensuring that the fax machines function properly. Other services may pick up test results from the Client Services Unit window of P&LMS. Additionally, P&LMS will provide delivery of test results during normal duty hours approximately every two hours as staffing allows.

6. Each ward/unit/area has one PC that is designated the contingency PC. Staff may access patient information using these specific PCs. Patient information is backed up daily, but updated lab results will not be received until the main computer system is back up.

VistA-RO, a “Read Only” system is available via the Intranet webpage. VistA-RO contains the latest patient information prior to the downtime.

7. Telephone calls to the laboratory for test results should be limited to emergency needs only.

B. In the event of an un-scheduled computer downtime, the laboratory will immediately go into an emergency mode. This is characterized by the following:

1. All Medical Emergency test results are faxed to the nursing unit. All critical results are called as per the Critical Results Policy – VANTHCS Memorandum 11-14.

2. All routine testing already requested through the…

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