IHS1525032 QnA.docx

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WRSU – Biohazard Waste Removal Services
Solicitation number
IHS1525032
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About this file

This is a Questions and Answers (Q&A) document clarifying requirements for the IHS Whiteriver Service Unit biohazard waste removal solicitation (IHS1525032). The document addresses operational logistics, waste stream specifications, compliance documentation, and service parameters for the one-year base contract with option years.

Key clarifications include: pharmaceutical waste removal (four times annually) may occur concurrently with weekly biohazard pickups; trace chemotherapeutic waste has separate estimated quantities beyond the 22 weekly 43-gallon containers; pharmacy formulary characterization (twice yearly) requires on-site physical characterization and sorting by contractor personnel, not desktop audits; key personnel need only standard DOT hazardous materials certification; Certificates of Destruction are requested for RCRA incineration loads (up to 150 lbs annually) in addition to standard waste manifests; pickup reliability is critical due to remote location with pickups occurring Tuesdays (time flexible due to weather/traffic, acceptable if after 8:00 AM window); facility prefers 43-gallon containers due to existing red bag volumes from laboratory operations and will not accept 32-gallon alternatives; P-listed and U-listed pharmaceutical waste codes include chemotherapy agents, controlled medications, and hazardous commercial chemicals; average historical pickup is 22 containers weekly with 15-20 extra containers depending on patient census; emergency pickups have not been historically required; the facility requests on-site pickups only (no mail-order programs); control medications and hazardous pharmaceuticals are included for destruction; the facility provides trace chemotherapy and sharps containers; training for waste handling staff is currently conducted through new employee orientation with additional training desired; and line-item charges on an as-needed basis are acceptable.

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Q. Pharma Waste Logistics and Pricing: SOW Section C.12 specifies weekly biohazard pickups, while Section C.3 requires pharmaceutical waste removal four times per year. Given the remote location of the facility, could the Government clarify if the four annual pharmaceutical waste removals are intended to occur concurrently with a scheduled weekly biohazard pickup, or if they require separate, dedicated transport missions?

A. The pharmaceutical waste removal can be done concurrently with a scheduled biohazard pickup.

Q. Waste Container Composition: SOW Section C.11 estimates a weekly removal of 22 containers (44/45 gallons each). Do these 22 containers represent the total for all waste streams combined, or is there a separate estimated quantity for the trace chemotherapeutic waste containers mentioned in Section C.7?

A. There is separated estimated quantity for the trace chemotherapeutic waste.

Q. Formulary Characterization Scope: SOW Section C.5 requires the Pharmacy Formulary to be characterized twice per year. Does the Government intend for this to be a desktop audit performed by the Contractor based on a provided list of pharmaceuticals, or does this requirement involve on-site physical characterization and sorting of waste by Contractor personnel?

A: On-site physical characterization and sorting of waste by Contractor personnel.

Q. Key Personnel Qualification Standards: The Instructions to Offerors (FAR 52.212-1 Addenda) require a list of "qualified key personnel". Aside from standard DOT hazardous materials and OSHA 29 CFR 1910 compliance, are there specific professional certifications or minimum years of experience the Government requires for these individuals to be deemed "qualified" under the technical evaluation factor?

A. Currently the staff are qualified with the standard DOT hazardous materials which has been the basic requirement for handling the hazardous waste.

Q. RCRA Disposal Documentation: SOW Section C.4 requires high-temperature incineration for up to 150 lbs of RCRA waste annually. Will the Government require a Certificate of Destruction from the final disposal facility for these specific loads in addition to the standard waste manifests mentioned in the QASP?

A. It will be helpful if a Certificate of Destruction be provided along with the standard waste manifests.

Q. Pickup Window and Contingency: The QASP identifies "pickup reliability" as a critical performance area due to the facility's remote location, and SOW Section C.12 mandates a strict 6:00 AM to 8:00 AM window. Does the Government have a maximum allowable "wait time" for the driver if the secured storage area is not immediately accessible upon arrival during this window?

A. Currently the biomedical waste are picked up on a Tuesday and the time varies due to traffic, weather conditions, etc; therefore, some pick ups are after 8am. As long as the biohazard waste is picked up on the agreed day of the week.

Q. What is the historical maximum number of containers (you estimated 22) picked up per week? Would the facility consider 32-gallon containers for the duration of the contract?

A. The average pick up is 22 on 43-gallon containers. I would like to stay with 43-gallon containers because we have red bags from lab department that take most of the containers.

Q. Can you please break down historically the type of Hazardous Pharmaceuticals you have disposed of? P/U Listed medications

a. P-Listed Pharmaceutical Waste Codes (inhalers, alcohol, idodine etc.)

1. P-listed = acutely hazardous waste. These generally require stricter segregation and disposal controls.

1.

PU Code
Pharmaceutical / Ingredient
Common Examples
P001
Warfarin and salts, greater than 0.3%
Coumadin, Warfarin
P012
Arsenic trioxide
Trisenox
P042
Epinephrine
Adrenalin, EpiPen, epinephrine injectables/inhalants
P046
Phentermine
Phentermine
P075
Nicotine and salts
Nicotine e-cigarettes, vape juice, prescription nicotine products
P188
Physostigmine salicylate
Eserine salicylate
P204
Physostigmine
Eserine

1. Note: FDA-approved over-the-counter nicotine patches, gums, and lozenges are federally excluded from the P075 listing, but confirm state adoption before treating them as non-hazardous.

1. U-Listed Pharmaceutical Waste Codes

1. U-listed = hazardous waste, but not acute like P-listed waste.

1.

PU Code
Pharmaceutical / Ingredient
Common Examples
U010
Mitomycin C
Mitomycin, Mutamycin
U015
Azaserine
Leukemia chemotherapy
U034
Chloral hydrate
Chloral hydrate
U035
Chlorambucil
Leukeran
U044
Chloroform
Chloroform
U058
Cyclophosphamide
Cytoxan, Neosar
U059
Daunomycin / Daunorubicin
Cerubidin, DaunoXome
U089
Diethylstilbestrol
DES
U129
Lindane
Lice/scabies treatment
U132
Hexachlorophene
Phisohex-type disinfectants
U150
Melphalan
Alkeran
U151
Mercury
Mercury-containing compounds
U182
Paraldehyde
Paraldehyde
U187
Phenacetin
Acetophenetidin
U188
Phenol
Phenol, liquified phenol
U200
Reserpine
Reserpine
U201
Resorcinol
Resorcinol
U205
Selenium sulfide
Selsun-type dandruff shampoo
U206
Streptozotocin
Zanosar
U237
Uracil mustard
Uramustine
U248
Warfarin and salts, less than or equal to 0.3%
Warfarin

1. P and U codes apply to unused commercial chemical products that become waste and contain the listed chemical as the sole active ingredient. EPA identifies P-list wastes as acute hazardous wastes and U-list wastes as toxic hazardous wastes under 40 CFR 261.33.

Q. Please provide an estimate of how many containers you would utilize weekly for pickup.

A. Average containers picked up are 22 per week with 15-20 extra containers. The amount of containers used depends of the patient census in the in-patient areas. Note we are currently using 43-gallon containers.

Q. Would the facility request a specific day per week (barring holidays)?

A. Tuesdays

Q. Will this be for only 1 location?

A. Yes, just one location Q. Will the current construction of the hospital impact pickup/delivery in the future on this contract?

A. Yes

Q. Historically, have there been any emergency pickups needed (if so, how many and how far in advance was the contractor notified) A. No. We had cases when our pickups were missed therefore our biohazard bags started piling up because we utilized all the containers.

Q. Will a mail-order hazardous waste program be acceptable instead of onsite pickup?

A. Onsite pickups Q. Will any control medication be included in the destruction?

A. Yes

Q. Will the facility provide its own Trace Chemotherapy containers?

A. Yes

Q. Will the facility provide its own sharps containers?

A. yes Q. In the above estimate of the number of containers needed per week, does this include sharps volume?

A. yes

Q. You stated that historically, around 150 lbs of pharmaceuticals were used annually. Could you please provide the records for this?

A. yes Q. Could you provide insight into whether anything previously on a contract could be improved upon, as suggested for this contract?

A. No missed pickups. Due to the missed pickups and the over flow of the biohazards bags; it attracted some pests.

Q. Could you please provide insight into what is meant by: "pharmacy formulary, an official website of the United States government, characterized twice annually"- This is public to the people, but what is the contractor expected to provide here?

Q. Will the facility require training for waste? Is this expected to be included as a line item A. Currently the staff involved with hazardous are trained and included in our new employee orientation. More training would be great as well.

Q. Will the facility accept line-item charges on an as-needed basis?

A. Yes

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