W81K00-24-R-0002_QandA (10 May 2024).pdf

Questions & Answers W81K00-24-R-0002

1. OR: Can we get the annual volume of the DaVinci cases separately from minimally invasive cases?

Response: Between 04-01-23 and 03-31-24, the total number of DaVinci cases amounted to 767 with operating 16 rooms. The requirement is to return to 24 operating rooms and expect the ratio to remain relatively consistent but will be dependent on case/grid requirements.

2. The industry standard for staf�ing is to provide the technician six months to be certi�ied.

Will that be the requirement for this solicitation?

Response: The requirement is in SOO Section 7.4. Certi�ication: In addition to Basic Life Support (BLS), a minimum of 50% of the contract personnel providing services shall have and maintain a current SPD certi�ication (at the start of the contract) as listed herein. Any non-certi�ied contract personnel shall acquire and maintain a certi�ication within six (6) months of their start date.

3. The Joint Commission standard for scopes processed by HLD must be reprocessed every seven days. Will that be the requirement? If so, this will have an impact on volume.

Response: No. Brooke Army Medical Center adopted the CDC guidelines for High Level Disinfection which does NOT have a mandated reprocessing time. However, in areas where the tempo doesn’t allow for a 10-day turnover, the requirement will be reprocess every 10 days.

4. Once awarded, how will orientation and in-servicing be handled for the vendor of choice? Will BAMC help with the engagement of all vendors making sure the awarded vendor’s team is properly trained on equipment and systems?

Response: Vendors will be required to coordinate with the Contracting Of�icer’s Representative (COR) for in processing and will be required to complete the training requirements as identi�ied in the PWS. IIt will be the vendor’s responsibility to train and document competency per BAMC requirements to ensure compliance with The Joint Commission TJC. This will be an inspectable item by the government.

5. What will be the process for repairing/replacing instruments, scopes, and equipment?

Who will be responsible?

Response: Vendor’s role in the repair/replacing process is for the vendor to identify which items need repair and replacement and to report this information to SPD. SPD will be responsible for repair/replacement. Vendor

6. Will the vendor of choice have access to the OR and clinic schedules?

Response: Yes

7. Are the current anesthesia scopes used in the facility single-use or reusable? If reusable, where will they be reprocessed?

Response: Anesthesia has both, reusable and single use bronchoscopes. TEE scopes are reusable. Any scopes anesthesia requires cleaning is currently being processed via SPD. At this time, there is no requirement for decentralized cleaning of scopes for anesthesia outside of SPD, however BAMC reserves the right to require cleaning within Anesthesia if conditions change (within the SOO)

8. We did not visit the urology clinic. Will that be covered? If so, how are those scopes decontaminated, processed, and stored?

Response: No. Urology is not within the scope of the contract.

9. Will you require repairs to be performed by OEM or a third party?

Response: It depends. After receiving notice from the vendor, SPD will determine how to proceed with the instrument.

10. Sterile Processing: Will vendor be allowed to operate both steam and low temperature sterilizers?

Response: Yes

11. Sterile Processing: What are the surge events- are only MIS instruments expected to be processed by the vendor or is it all specialties' instrumentation?

Response: Yes. Surge events for this contract vendor would only be MIS instruments.

12. Sterile Processing: Will the vendor have dedicated workspace in SPD?

Response: Yes, it will depend on workload of MIS instruments and other competing BAMC missions. Space availability will be coordinated between vendor and SPD leadership.

13. Sterile Processing: Please describe the repair process including the vendor's role in it.

Response: See response to question 5.

14. OR: Are there spine and/or ortho robots and are they covered by this scope of work?

Response: Currently there are no spine or orthopedic robots, however the vendor will be expected to process all MIS instruments for the life of the contract should spine/orthopedics be added.

15. OR: Are the ORs integrated and is the integration trouble shooting included in this scope of work?

Response: Yes, the ORs are integrated. The vendor will be responsible for the integration trouble shooting.

16. OR: What support is needed for Anesthesia outside �lexible scope processing? Are reusable laryngoscopes used and would vendor be expected to process them?

Response: See response to Question #7

17. OR: What are the expected duties for the Airway management carts other than scope processing?

Response: The expected duties for Airway management carts other than re-processing is to transport them to and from the OR and SPD.

18. OR: When building case carts, are vendors required to build all portions of the carts including soft goods disposables and instrumentation?

Response: No, vendors will not be responsible for pulling soft goods for case carts.

19. OR: What is the OR case volume for the past twelve months, including: Room In/Out, procedure type, date?

Response: Over the last 12 months, the volume of cases in the OR reached 18,565 which include �luctuations in OR rooms from 12-18. On average we average 2.5-3.0 cases per room per day. The requirement is to return to 24 operating rooms

20. HLD: Are all �lexible scope cabinets being replaced?

Response: Don’t know at this time. It depends on the discretion of clinic and funding availability.

21. HLD: Do the estimated HLD volumes include expired reprocessing events or patient usage only?

Response: No. Brooke Army Medical Center adopted the CDC guidelines for High Level Disinfection which does NOT have a mandated reprocessing time. However, in areas where the tempo doesn’t allow for a 10-day turnover, the requirement will be reprocess every 10 days.

22. HLD: Will vendor be required to provide in OR/procedure suite point of care cleaning for �lexible scopes? If so, does this include bronchoscopies performed at the bedside on the �loors?

Response: For HLD, the vendor’s responsibility is from HLD process site to storage cabinet.

Depending on clinical setup (which varies) Point of Use cleaning may be required if proximity allows. For OR operations the requirement is comprehensive management.

23. General: Outside of Symplr, what are the other hospital speci�ic credentialing requirements?

Response: See response to question 2.

24. General: Can we get a 12-month MIS case volume and �lex scope data set? To include procedure date, type of procedure, in and out room times, OR number and surgeon specialty.

Response: There are no pre-con�igured reports accessible for extracting data on speci�ic procedures.

25. MRCO-W: At the end of our proposal, can we include an executive summary?

Response: Yes but it will count against the page limit.

26. General: 4. Place of performance. Were there any other associated medical facilities that we were not shown on Monday 4/29?

Response: No

27. OR: Is the expectation to pull instruments and build out case carts or just facilitate the movement of clean/dirty carts?

Response: The expectation is to pull instruments, build carts, move carts, support/trouble shoot in the OR, validate equipment and point of use cleaning post case.

28. OR: 6.5.1.11. Please expand on anesthesiologist support. What types of scopes/equipment support is needed?

Response: See response to Question #7 Please see response to question 7.

29. Sterile Processing: 6.9. What do you classify as a defect?

Response: Per SOO Section 6.9 – “Defects are de�ined as Missing, damaged, or dysfunctional equipment and/or instruments, clamped, and positive hemo-checks.”

30. Sterile Processing: 6.4. Are the expectations to run the sterilizers and perform any of the necessary tests?

Response: Yes, in accordance with BAMC policies.

31. Rapid Surge: 6.4. Are the expectations to run the sterilizers and perform any of the necessary tests?

Response: Yes, in accordance with BAMC policies.

32. HLD: 6.6. Can you please expand on the expectations regarding �lex scope in room set up? Also is the point of use/bed side cleaning of �lexible scopes to be completed by staff or Vendors prior to it being sent for hand wash and HLD?

Response: For HLD, the vendor’s responsibility is from HLD process site to storage cabinet.

Depending on clinical setup (which varies) Point of Use cleaning may be required if proximity allows.

33. HLD: Are there any expectations around preventative maintenance of HLD equipment including �ilter change outs, cleaning solutions ordering/logistics)

Response: Yes, vendors are to conduct preventative maintenance activities and checks per IFU (inspection of hoses/connectors, AER �ilter changes, etc.), as well as loading consumables for AER (disinfectant, detergent, alcohol, etc.). If vendor Vendornotices that consumables are not being restocked or are running low, vendor is responsible for notifying the section lead.

34. SPD: Instrument Tracking/Documentation: Do you have the capability to document scope processing within Censitrac? (ScopeTrac)

Response: Yes, but SPD has scopes listed under containers within CensiTrac for tracking purposes only.

35. SPD: Instrument Tracking/Documentation: Who is responsible for managing the current manual documentation forms?

Response: Vendor. The vendor will be responsible to Level 1/end user maintenance documentation of equipment. The vendor will also be responsible for tracking equipment to the patient and all associated logs.

36. SPD: Instrument Tracking/Documentation: What is the current IFU database in use?

Response: One Source is the government-provided resource for IFU’s.

37. SPD: MIS Current Work�low: Currently, are MIS instruments being processed separately than the remainder of the SPD instrumentation? (excluding HLD items)

Response: The requirement is for the vendor to process all MIS instruments from end to end.

38. SPD: Policy Review: Can we obtain copies of the current HLD/SPD policies in place?

Response: See Sam.gov Amendment #3

39. SOO: Work�low support: Will the MIS teams be responsible for case cart & soft good picking?

Response: No

40. SOO: Work�low support: Will the MIS teams be responsible for ordering, receiving, stocking soft good supplies?

Response: No

41. SOO: Is power equipment included in this SOW?

Response: Yes, but limited to only power equipment in the OR.

42. SOO: Will any vendor instrumentation be included in this SOW?

Response: Yes

43. SOO: Will the MIS teams be responsible for managing back up instrumentation, replenishment, new items, and managing service/repair contracts?

Response: Yes the vendor is responsible for managing the right case at the right time on the right patient. If a defect is determined, it will be on the vendor to ensure a backup set is primed to not delay the case. Vendor’s role in the service/repair process is for the vendor to identify which items need repair and replacement and to report this information to SPD.

SPD will be responsible for repair/replacement.

44. General: What type of sonics do you have & do they have DaVinci processing capabilities?

Response: 2 Getinge Triton 72, DaVinci capable. Per the SOO Section 6.1.1. – Equipment on-site is subject to change or supplementation.

45. General: Does the facility have RO/DI water for their critical instrumentation?

Response: SPD is supplied with RO water at decontamination sinks. DI water is not currently available in SPD.

46. General: What is the work�low of dirty to clean for HLD items?

Response: This is dependent on the clinic setup and vendor’s proposed PWS.

47. MRCO-W: Is an incumbent Vendor currently performing this work? If so, what is the Vendor’s name and the contract number?

Response: There are no other Vendors performing this speci�ic contract requirement.

48. MRCO-W: How many FTEs are currently performing on this effort?

Response: There are no other Vendors performing this speci�ic contract requirement.

49. MRCO-W: Are current workload requirements equal to that in the SOO for this effort?

Response: The SOO is a projection and will be dependent on patient complexity, changing clinical standards, and OR grid determination. The MIS workload may change day to day dependent on numerous factors discussed. The requirement is support to 24 ORs.

50. MRCO-W: Are productivity levels currently being met?

Response: Not currently

51. MRCO-W: Are acceptable defect rates currently being met?

Response: Yes

52. MRCO-W: Is there currently a Program Manager assigned?

Response: No

53. Is there designated office space for the Program manager?

Response: Yes

54. MRCO-W: Will there be any integration between the SPD services provided under this procurement with the SPD services recently procured under contract #W81K00-23-C- 0012?

Response: No

55. Will the awarded Vendor be supported by BAMC for equipment repair for HLD and sterilization?

Response: Vendor’s role in the service/repair process is for the vendor to identify which items need repair and replacement and to report this information to SPD. SPD will be responsible for repair/replacement.

56. Define perioperative services as used in the SOO.

Response: The team should have knowledge of sterile technique and be able to enter the OR, open instrumentation, troubleshoot equipment, and deliver important information to the surgical team without compromising the sterility of the OR suite.

57. Please confirm only 20 Operating Rooms are receiving cases with the intent to open 4 additional rooms (20% increase).

Response: Currently BAMC operational OR has varied from 12-20 over the last 24 months.

The requirement is to support 24 ORs.

58. Does the Government expect that offered pricing would include the workload of 4 additional operating rooms.

Response: See response to question 57.

59. Who maintains/replaces consumables for decontamination such as cleaning tools, Prolystica, etc…

Response: BAMC Logistic maintains and replaces consumables within the Pyxis. The vendor will be responsible for the end user maintenance with supplies provided per the manufacturing guidelines.

60. MRCO-W: When will floor plan(s) be made available.

Response: See Sam.gov Amendment #3

61. Please further define the “60 minute” requirement for scope/device preparation.

Response: Reprocessing of �lexible endoscopes are intended to be performed without time delays. If there is a delay of 1hr or greater between pre-cleaning and manual cleaning, and between manual cleaning and high-level disinfection the endoscope will undergo delayed reprocessing. Delayed reprocessing includes the soaking of the endoscope for longer periods in the detergent not to exceed a speci�ied time per IFU.

The vendor will be responsible for the identi�ied locations during business hours (per the attached sheet), however the vendor has the responsibility to provide 24/7/365 MIS support.

62. What is the current HLD time for a GU CL Flex Cystoscope from decontamination to hanging?

Response: At this facility, GU scopes are sterilized using Sterrad and are subject to sterilization event-related reprocessing guidelines.

63. MRCO-W: Does the 65-page limit on the Performance Work Statement Doc include the 50 pages that are already in the provided work document, or is the 65-page limit additional to the template?

Response: The total page count for the PWS is 65 pages to include 50 pages that are in Attachment 8 BAMC PWS Template.

64. MRCO-W: We are working diligently to compile the requirements for the above referenced RFP submission. At this time, we respectfully request an extension of 2 weeks from the current due date of May 14th in order to provide accurate response and quotation.

Response: See Sam.gov for Amendment #2 extending the proposal due date.

65. Is there designated office space for the Program manager?

Response: Yes

66. This effort requires end-to-end performance by the awardee. Is the awarded vendor responsible for:

a. Initiation of background investigations through NBIS to include eAPP and fingerprinting for technicians?

Response: Yes, Vendors will be required to coordinate with the Contracting Officer’s Representative (COR) for in processing

b. Processing technicians for CACs and base access?

Response: Yes, Vendors will be required to coordinate with the Contracting Officer’s Representative (COR) for in processing.

c. Conducting BAMC centric orientation/integration?

Response: Yes, Vendors will be required to coordinate with the Contracting Officer’s Representative (COR) for in processing.

d. Training on BAMC systems and platform such as scheduling, DHMIRSi; annual training such as SHARP, iWatch, etc.?

Response: Yes, See response to question #6

67. Statement of Objective (SOO) para 6.3 states “At the onset of this contract, the vendor will implement a “surge” event to clear all backlog MIS sets. The vendor will maintain the capability to surge throughout the term of this contract, no greater than 18 surge events per year.” Would the Government please confirm that the surge event at the onset of the contract is considered one or the 18 surge events and that the vendor will be able to invoice the onset surge event against the surge CLIN?

Response: No, vendor will provide a solution to the backlog of MIS sets at the onset of contract while using CLIN 0001 (SPD/HLD Support services).

68. When can we expect DaVinci case volumes and revised MIS volumes?

Response: Over the last 12 months, the volume of cases in the OR reached 18,565 which include fluctuations in OR rooms from 12-18. On average we averaged 2.5-3.0 cases per room per day. The anticipation is that the contract will support BAMC target of 24 ORs.

The SOO is a projection and will be dependent on patient complexity, changing clinical standards, and OR grid determination. The requirement is to support 24 ORs.

69. How long do cases run in each care site/clinic each day? How many days each week do cases run in each care site/clinic?

Response: See attachment for business hours of each clinic. However, the vendor will be responsible for the identified locations during business hours (per the attached sheet), however has the responsibility to provide 24/7/365 in house support.

70. Will specific ultrasonic /machine be assigned? If so, will the awarded vendor be responsible for daily systems tests?

Response: Yes, to daily system tests in accordance with BAMC policies. However, the specific number and/or which machine will vary depending on dual mission requirements.

71. Will there be an assigned Sterrad system? If so, will the awarded vendor be responsible for daily systems tests?

Response: Yes, to daily system tests in accordance with BAMC policies. However, the specific number and/or which machine will vary depending on dual mission requirements.

72. Will there be any displacement of civilians in SPD once awarded?

Response: No

73. Will we have permission to interview civilian SPD personnel?

Response: Not during duty hours and/or on the installation.

74. Please provide clearly defined end-to-end steps and process for OR and SPD.

Response: The Government is requesting the vendor to propose a solution. Below is the government’s definition of end-to end for this requirement.

Per SOO, “A self-contained workflow encompassing the autonomous management of designated medical instruments, starting from decontamination, assembly, sterilization, utilization in the operating room or clinic, and concluding with the return through the decontamination phase. This process operates independently of external government intervention or direction, ensuring efficiency and quality control within the Sterile Processing workflow in a hospital setting.”

75. Please provide clearly defined end-to-end steps and processes for Clinics.

Response: The Government is requesting the vendor propose a solution. Below is the government’s definition of end-to end for this requirement.

Per SOO, “A self-contained workflow encompassing the autonomous management of designated medical instruments, starting from decontamination, assembly, sterilization, utilization in the operating room or clinic, and concluding with the return through the decontamination phase. This process operates independently of external government intervention or direction, ensuring efficiency and quality control within the Sterile Processing workflow in a hospital setting.”

76. Solicitation Document – Page 1 – “8. OFFER DUE DATE/LOCAL TIME 12:00 AM 14 May 2024” – Does BAMC intend for proposals to be due at midnight? Will BAMC please extend the proposal submission deadline to ten business days past when questions are answered?

Response: See Sam.gov for Amendment #2 extending the proposal due date.

77. Solicitation Document – Page 8 – Can you please clarify award date, credentialing period/ramp time, and desired performance start date? How much flexibility is in these dates? Among the timing concerns, background checks alone can take more than a month.

Also, credentialing at a military base sometimes takes months, and a vendor has little control over this part of the process.

Response: Security on-boarding can take 30-60 days for approval (on average). For this requirement, it would be considered as 30 days from receipt of award, plus 30 days from start of POP. These individuals will not be “formally credentialed” like providers/nurses however the vendor will need to validate the certification is valid/updated. Most of the security delays are historically on candidates completing the documents and returning it to the security office.

78. PWS – Will BAMC please revise all 30-day requirements related to staffing to be 90 days? his includes initial onboarding of team, background checks, training, and personnel replacements. Key sections include PWS 1.20, 1.23, 1.24.

Response: Security on-boarding can take 30-60 days for approval (on average). For this requirement, it would be considered as 30 days from receipt of award, plus 30 days from start of POP.

79. PWS doc. sec. 1.6.2, Contract Personnel Security Clearance Requirements – T1 Security Clearance, what is the estimated time to obtain this clearance from BAMC from the date when contract employee names are submitted after award?

Response: Security on-boarding can take 30-60 days for approval (on average). For this requirement, it would be considered as 30 days from receipt of award, plus 30 days from start of POP.

80. PWS doc. sec. 1.6.4, Background Checks, what is the estimated time to obtain clearance from the date of submission? This section also requires that we replace any employee that is found to have an unfavorable background check with another employee within 30 days.

Please confirm that should we submit a new employee, that all clearances from BAMC will be performed within this 30-day window.

Response: Security on-boarding can take 30-60 days for approval (on average). For this requirement, it would be considered as 30 days from receipt of award, plus 30 days from start of POP.

81. PWS doc. sec. 1.10. a., Key Personnel, Special Qualifications – This section states that “There shall be no more than two (2) substantiated complaints per contract employee within a 12-month period.”

a. Please clarify more detail about the types of “substantiated complaints,” e.g., personality difference, productivity issue, or something more egregious.

Response: Primarily relates to performance and/or productivity issues, however there are often behaviors that can be unacceptable. Coordination with the assigned COR will be necessary to determine the gravity of each situation, as they occur.

b. Please explain the expected remedy process should this occur, e.g., formal corrective action, termination etc.

Response: All concerns are presented to the Vendor for resolution and/or remedy.

Coordination with the assigned COR will be necessary to determine the gravity of each situation, as they occur.

82. PWS doc. sec. 1.10, Key Personnel – “The Vendor shall not employ contract personnel to provide services under this contract that are currently employed by the U.S.

Government, either as active military or civil service. Such employment would be considered as a conflict of interest, in accordance with DoD 5500.07-R.” Does this mean that Vendor may not employ contract personnel for this contract who are members of the National Guard?

Response: No, this restriction refers to active military or civil service only.

83. PWS doc. sec. 1.20, Phase-In/ Phase-Out Period – In order to meet the requirements for starting services efficiently, please confirm that it is acceptable to initiate services with an implementation/launch team. This team would be phased out over a period of 3 to 6 months as permanent staff are onboarded. If a transitional team is not acceptable, please confirm that the Government is willing to delay commencement of services 3 to 6 months to provide time for recruitment/credentialing of vendor’s permanent team of employees to be deployed to BAMC.

Response: See Sam.gov updated Attachment 8 BAMC PWS Template dated 7 May 2024.

84. PWS doc. sec. 1.20, Phase-In/ Phase-Out Period – “The vendor shall have 100% personnel on board, within 30 days of award of the contract.” Please confirm the lead time needed by the Government to issue background and security checks and any training (ref PWS 1.23.1 – 1.24.2), needed before placing a contract employee “on the job”.

Response: Security on-boarding can take 30-60 days for approval (on average). For this requirement, it would be considered as 30 days from receipt of award, plus 30 days from start of POP. The limiting factor is historically completion of the security documents. If completed within a week, this is a feasible timeline. BAMC COR in coordination with our security team can assist applicants by answering questions. See Sam.gov updated Attachment 8 BAMC PWS Template dated 7 May 2024.

85. PWS doc. sec. Technical Exhibit A (page 34) – This references CDC guidelines for Environmental Cleaning, as well as this RFP’s SOO 6.9. The CDC document (see attached:

Sec 4.6.3 refers to Sterile Service Departments) is associated with SPD room cleaning.

Please confirm that evaluation of room cleaning would be limited to the contract MIS teams’ work areas and not areas not under the direct supervision of the MIS team.

Response: Vendor is only responsible for MIS services.

86. PWS doc. Technical Exhibit A (page 34) – “Fill rate of 80%” – Does this refer to the # of staff or the # of hours covered? Is the fill rate considered “filled” even if the hours are covered with overtime? Can implementation team members be considered part of the “fill rate?”

Response: This Technical Exhibit is not relative to this contract, as it was not established to be FTE-driven, but as a required service. The Vendor is free to determine how many personnel are needed, as long as all contract requirements are being met. See Sam.gov updated Attachment 8 BAMC PWS Template dated 7 May 2024.

87. PWS doc. sec. Technical Exhibit A (page 34) – Turnover rate is referenced with an acceptable rate of 20%. Should the turnover rate exceed this amount, what is the resolution assuming that staffing levels meet the required fill rate of at least 80%?

Response: This Technical Exhibit is not relative to this contract, as it was not established to be FTE-driven, but as a required service. The Vendor is free to determine how many personnel are needed, as long as all contract requirements are being met. See Sam.gov updated Attachment 8 BAMC PWS Template dated 7 May 2024.

88. If Vendor is to sterilize both steam and low temp, what is the requirement for Vendor to operate the equipment? Would BAMC sign off on equipment use and internal process/ procedure for documenting and tracking loads?

Response: Vendor personnel will be required to have competency with assigned equipment, in accordance with BAMC policies.