03 GJVAMC Lab Remodel Request_20200511_Signed.pdf

Department of Memorandum

Veterans Affairs Date: May 11, 2020

From: Laboratory Manager (113)

Subj: Request for Priority Reconstruction of Laboratory

To:

Thru:

Facilities Management (138)

Chief of Ancillary Services

1. I request that the planned Grand Junction VA Medical Center project to remodel and expand the Pathology and Laboratory Medicine Services (Laboratory) be moved for first funding (design) from FY2023 to FY2021.

2. The current facilities have multiple space and condition deficiencies and do not meet the needs of the health care Providers and Veterans. If these issues are not addressed as quickly as possible, serious patient harm may occur that could have been avoided.

3. Justification: There are multiple categories of deficiencies which must be corrected.

a. Space is extremely limited with the Laboratory’s current location.

i. Due to the way laboratory contracts work, we have our major analyzers replaced every five years through NCO 19. This includes: Chemistry, Hematology, Coagulation, Urinalysis, Microbiology, and Blood Gases.

Every time this happens, the old and new analyzers must be run side-by-side (patients run on the old analyzer while validations are performed on the new analyzer).

ii. The current space is too small for the new Integrated Chemistry analyzers that are available to us when our current contract expires in one year; I can extend the contract one additional year, but no more than that. The new analyzers are larger and heavier than our current analyzers and require an external water purification system. Chemistry is our main department (running the most tests) and critical for the diagnosis and treatment of patients.

iii. If this renovation project occurs when originally planned for, the new Integrated Chemistry analyzers would have to be installed in the temporary location with the old analyzers and then they must be taken apart and reinstalled in the renovated area. Every time an analyzer is disassembled, moved, and reassembled there is a significant chance it will become non-functional and negatively impact patient care and cost the facility more money.

iv. Due to limited floor and counter space the Laboratory is unable to bring in new analyzers for critical testing and must therefore send specimens out to a local hospital laboratory for STAT testing. Just with Procalcitonin testing alone (a marker for infections and sepsis) the Laboratory spends an average of $1,300 a month and the turnaround time for this Emergency Department test is four times what it would be if run in-house. There would also be the benefit of being able to perform the test at a fraction of the price if space allowed for the addition of the required analyzer.

v. Current molecular testing is not being performed in an isolated area with its own biological safety cabinet, as is the current global standard, due to no space to add the necessary equipment and workspace.

vi. Individual refrigerators and freezers take up a great deal of the Laboratory’s footprint and their internal space is maxed out. The Laboratory is unable to add tests to existing analyzers because of the lack of refrigerator space for the required additional reagents. The installation of a large walk-in refrigerator would allow for some currently sent out tests to be brought in-house, saving both time and money.

vii. Federal and accrediting agencies require certain laboratory records and specimens be stored for incredibly long periods of time (e.g., up to 75 years for certain Transfusion Medicine records) and we are currently running out of space to store these items, as they must be kept separate from other materials and some items (such as anatomic pathology blocks) have temperature requirements.

b. The physical Layout of the rooms and benchtops creates several problems.

i. The Microbiology department must choose between appropriate operating temperatures and potential contamination due to vent locations. Due to the amount of obsolete ductwork in the ceiling, there are only so many options for the relocation of vents. Due to the amount of available space, there are only so many options for the relocation of required Microbiology processes.

ii. The Microbiology department does not have a work area to sit and read plates and perform the necessary specimen workups. Employees must currently stand for extended periods of time to perform these functions, creating unnecessary fatigue and pain.

iii. The current closed floor plan impedes efficient workflow during times of minimum staffing (please note that this is the majority of the Laboratory’s scheduled operations). Creating an open floor plan would improve efficiency and ensure more timely results for patient care decisions.

iv. There is currently not a dedicated specimen processing area for the receipt of specimens from outlying clinics and preparation of specimens being sent out to reference laboratories. The creation of this space will help streamline processes and ensure specimen trackability.

v. The current Laboratory layout does not allow for the flexibility or scalability of departments to change as technology and testing platforms evolve.

vi. The size and location of the clean and non-clean storage rooms create problems with properly storing, locating, and managing supplies and other testing materials. The act of simply rotating reagents takes three to four times longer than it should.

vii. It is currently difficult for both employees and patients to have specimen collections performed when the Veteran is in a wheelchair due to the tight maneuvering of the wheelchair that is required in such narrow spaces.

viii. Forensic Urine Drug Screen (FUDS) and Forensic Urine Drug Testing (FUDT) collections are currently being performed in publicly accessible restrooms. This creates not only an inconvenience for other employees and Veterans when the restrooms are closed off for these collections, but also creates opportunities for adulteration of specimens. A legitimate FUDS/FUDT collection area requires a single-toilet room with a full-length privacy door and a water source for washing hands external to that room. In addition, the public restroom being closed with a “Urine Drug Screen Collection” sign can cause employees and applicants embarrassment and undue stress.

ix. While waiting to use the Laboratory’s restroom or in the draw rooms, patients can be exposed to other patients’ personal information. They are in eyeshot of others’ labels and/or earshot of Veterans verbally verifying their identification. While employees make every effort to prevent these inadvertent disclosures, the potential does exist due to the limited space and existing layout.

x. The locations of the facsimile machine and printers causes employees to cross in and out of clean/unclean areas and disrupt the work of others.

xi. The Microbiology and Blood Bank departments require a large amount of manual testing with detailed interpretation of results due to the nature of their work. The current layout introduces an enormous amount of background noise and distractions, which degrades job performance.

xii. Our accrediting agency requires restricted access to the Laboratory with controlled points of access. For our small laboratory there are six doors leading into the main areas, creating a serious risk to employee safety and patient information.

xiii. The Laboratory’s closed floor plan creates areas of risk for employees due to blocked sightlines. Fifty percent of the time there is only one person in our Laboratory and if they were to become injured or incapacitated our Police Officers would not be able to easily locate them.

A redesign must happen to create an open floor plan with windows installed in walls to create a safer (and healthier) environment for employees.

xiv. Due to the potential pathogens the Microbiology department works with, they should be in a negative pressure area within the Laboratory for employee safety.

xv. Due to the current layout, a patient has the potential to wander into either unsupervised areas with patient information or testing areas with biological and chemical exposure risks.

c. The utilities for the Laboratory’s current space have reached their limits. As with the size and weight of the newly available Chemistry analyzers mentioned above, their power requirements have also increased. However, the electrical panels for the Laboratory’s current space are maxed out and require an extensive upgrade.

d. Temperatures cannot be efficiently controlled. Precise temperature ranges are required not only to ensure patient and employee comfort, but to ensure we are providing accurate diagnostic test results and reliable blood products.

i. Temperatures sometimes get too warm for employee comfort. While OSHA regulations recommend room temperatures between 20.0°C and 25.5°C for employee working conditions, a number of variables affect Laboratory staff and their comfort. Although everyone has been repeatedly reminded and are aware of Standard Precautions and the Personal Protective Equipment (PPE) required to work in the Laboratory, some employees find that their only option to not overheat is to not wear a laboratory coat – right or wrong, this is a risk they are consciously accepting in order to deal with the heat. Twice in the past two years employees had to rotate in and out of the main work area to accomplish our mission while at the same time ensuring nobody suffered from heat exhaustion until portable air conditioning units could be installed.

ii. Patients, and the individuals accompanying them, have often complained about the high temperatures in the waiting room during the summer.

Due to our patient population, these high temperatures can lead to unwanted medical episodes and have led to patients passing out in the draw rooms.

iii. The combination of high temperatures, low humidity, required PPE and inconvenient access to drinking water has led to employees becoming dehydrated and feeling ill. This is a horrible combination when you need healthy individuals with clear mental focus to perform venipunctures on patients, manually perform tests, and interpret results; all of which contribute to information that will be used by Providers to diagnosis and treat Veterans.

iv. The use of three large portable air conditioning units during the summer creates physical obstacles in emergency evacuation routes and makes longer pathways to fire extinguishers, eyewash stations, and the emergency shower.

v. During April 1, 2019 to March 21, 2020, there were 82 instances in TempTrak of temperatures being too high and 167 instances of temperatures being too low in the Laboratory. A few of these instances exceeded several hours.

vi. Sixty-four of those instances were in Blood Bank (35 high and 29 low).

When temperatures are out of range, we are prohibited from storing platelets for patient transfusions. These products are used for the prevention and treatment of bleeding, including patients with hematologic malignancies. AABB regulations state platelets must be stored between 20°C and 24°C.

vii. Kit tests require reagents be stored at, and reactions occur at, specific ambient temperatures (normally 20-25°C) per manufacturer instructions.

When the Laboratory’s temperature is outside of these temperatures the tests cannot be performed and therefore Providers cannot make informed clinical decisions.

viii. During the past several summers three large portable air conditioners were required on an emergency basis in the Laboratory to keep temperatures within acceptable limits. These units took up valuable space and sometimes created worse temperature fluctuations when not properly overseen.

ix. Wide temperature variations can affect equipment used in different areas of the Laboratory, to include analyzers and incubators. When this equipment is affected, test results must be invalidated, repeated, and/or reported with annotations that results may not be accurate. Sometimes specimens cannot be recollected for reanalysis, especially for Microbiology.

x. At times in the Laboratory one area of the Laboratory is too hot while another area is too cold. A common example of this is when the temperature in Blood Bank is over 24°C while at the same time the temperature in the Microbiology department is under 20°C.

xi. Twice in the past four years temperatures were so high in the Laboratory that analyzers used for testing patient specimens necessary for critical diagnosis and treatment decisions had to be shut down to prevent damage to the equipment or spurious results.

xii. Certain Laboratory reagents and testing materials require storage in specific temperature ranges. Temperatures in the Laboratory have exceeded storage requirements to such extremes at times that materials had to be disposed of, delaying tests and wasting money. An area of focus right now is COVID-19 testing, and many of the specimen collection and testing materials related to this pandemic have an upper storage limit of 25°C; a temperature sometimes exceeded.

xiii. Currently, our Chemistry analyzers have exhaust ducts connected to the main return air duct to prevent an uncontrollable increase in the Laboratory’s ambient temperature. However, our Chemistry analyzer contract expires in less than a year and every new Chemistry analyzer option vents heat into the Laboratory without an exhaust duct. When this occurs, the Laboratory will need even more responsive and precise temperature controls.

e. Humidity cannot be efficiently controlled. Like with temperatures, exact humidity ranges are required to ensure we are providing accurate diagnostic test results.

i. During April 1, 2019 to March 21, 2020, there were 11,031 instances in TempTrak of humidity being too low in the Laboratory.

ii. Of those instances, 4,446 were in Blood Bank, which affects the gel cards the Laboratory uses for testing patients’ specimens, retyping blood products, and performing crossmatches. Negative effects on testing in this department create true life-or-death situations.

iii. On numerous occasions the humidity has been so low in the Laboratory that static electricity built up on the cuvettes in the Chemistry and Immunoassay analyzers and caused them to jam in the chutes. This results in analyzer downtime and a significant delay in test results.

iv. OSHA regulations recommend room humidity between 20% and 60% for employee working conditions and most of our analyzers have humidity requirements between 20% and 80%. We are very frequently below 20%.

v. Analyzers often give low humidity flags, which must be investigated to ensure accurate test results, taking time away from other crucial tasks.

4. As I hope this memorandum shows, it is urgent that the scheduled Laboratory remodel and expansion project start design next fiscal year (FY 2021). The completion of this project without delay will ensure more reliable, accurate, and timely results and help prevent serious patient harm.

Respectfully, Charles L. Faingnaert, MS, MLS(ASCP)CM MBCM

Laboratory Manager

Concur / Non-concur

Marshall Gallant, DMD Chief of Ancillary Services