MOD | 65 | Home Telehealth Technologies

FBO DAILY ISSUE OF JANUARY 10, 2010 FBO #2969
MODIFICATION

65 -- Home Telehealth Technologies

Notice Date: 1/8/2010
Notice Type: Modification/Amendment
NAICS: 339112 — Surgical and Medical Instrument Manufacturing
Contracting Office: VA National Acquisition Center - Department of Veterans Affairs National Acquisition Center
ZIP Code: 00000
Solicitation Number: VA-797-10-RI-0015
Response Due: 1/22/2010
Archive Date: 3/23/2010
Point of Contact: Cheryl Simmons or Willie AnthonyContracting Officer
E-Mail Address: Contracting Officer
(cheryl.simmons@med.va.gov)
Small Business Set-Aside: N/A
Description: q. If two product models meet the basic requirements for this device, can the two products be bid in one response or is two responses required?a. Two q. Since each vendor supplies their own server rack is the restriction stated for "racks" or "servers"? Please Clarify a. This was a typo and will be removed q. Recommend sub sections 1.g thru 1.j be added for this item. a. VA desires IP connectivity for video and will consider adding further break downs q. Please clarify how vendors are to bill for 2nd and additional years for the software license fee. This appears to be different than what is stated at Section 14.0. a. VA will reconsider and clarify this item in the solicitation q. Will the VA provide all possible telecommunications connectivity modalities, ie Satellite connectivity, POTs, wireless etc? Please clarify. a. During vendor presentations at the VA National Acquisition Center VA will provide analog phone lines and Ethernet wired internet access. q. Please define and provide an example for "clinical data other". a. VA will delete this item q. Please change to read: Regular delivery shall be made within seven (7) business days after receipt of a delivery order, Expedited delivery within 3 days business and emergency delivery within 24 hours. a. VA will modify this component q. Please clarify, we understand that any new technology must support units purchased under the award for a period of five years. Is this period five years from contract award? a. Five years from date of purchase q. Please delete "and for any changes or upgrades to equipment or software". Recommend training for changes or upgrades to equipment or software be provided via "web-based training or video conferencing" at each facility - versus on-site. VA will remove the "on-site" requirement for training for upgrades. a. Web training for upgrades is acceptable q. Recommend that the Service Data Manual be provided only with the first purchase by a facility rather than with each purchase. a. VA will remove the requirement for 2 copies of SERVICE manuals with every device. One copy of a USER manual is also required for each device q. Recommend a specific line item in the Schedule of Supplies Associated with Equipment Purchase be established for a Multi-User System as described. a. No, the option for use by multiple patients is desired but not required. q. Recommend a specific line item in the Schedule of Supplies Associated with Equipment Purchase be established for the Clinical Coordinator Video System. a. A specific line item will be added q. Please clarify "data base format", request further definition of format desired. a. New Attachment M detailing the data base format will be provided with solicitation q. Recommend further clarification of COTS products. Statement should include for example the weight scale is not required to have Pre-Market Approval; also a number of devices used with the video such as camera, microphone, speakers, and other similar products should be included as they do not require Pre-Market approval. a. Clarifications will be added to solicitation document. FDA approval is required for all medical devices such as weight scales, but not for speakers, microphones and cameras. q. Please modify: Capture of these measurement data must be automated and directly uploaded via USB/wireless from approved peripheral measurement devices. To Include Serial interface. a. No q. Recommend the requirement for differentiation between machine and manual data entry be deleted. a. No q. Please provide the business rules for displaying contiguous patient data to include example when patients are de-activated or dis-enrolled or on vacation. a. The requirement is for the display of patient data over the whole enrollment period. There is no requirement to display status of deactivation or vacation time. q. Please define and give -section examples of "includes the capability for modular algorithm building or modification for patients with special circumstances. a. Example: DMP question asks patient if he/she has inspected feet today - but patient is amputee and question requires modification or deletion for that patient q. Please clarify and provide further definition of the type of reports needed for "category of care:" and "in ad hoc reports". a. Availability of ad hoc reports is subject to proposal evaluation process. An example of an ad hoc report might be a trending of responses for a specific DMP item for a patient and for a group of patients. q. Please clarify and provide specific examples of "a format that supports standard and 'ad hoc' queries by the Care Coordinator". a. An example of an ad hoc report might be a trending of responses for a specific DMP item for a patient and for a group of patients. q. Recommend that this statement be changed to read "offerors must provide clinically validated documentation regarding their accuracy". a. VA will modify q. We understand this as referring to the zero out function, which must be done at the beginning of each measurement to ensure the accuracy of the reading. a. Correct q. Please clarify what "measurement solutions" a. Devices that provide measurements q. Please define "high definition picture clarity". a. We will delete this requirement q. We understand this to mean that the clinician has a means to control the incoming audio volume, please clarify. a. Correct. We will modify q. We understand this to mean that the clinician has a means to control the local video camera picture quality, please clarify. a. Correct. We will modify q. We understand this to mean to cover the cost of integrating "new or revised standardized VA Disease Management Protocols -- and not the fact that the vendor develops the DMP a. Correct. VA develops the DMP content in this case. q. Recommend "within 7 days" be changed to "within 7 business days" to enable verification and validation testing to be adequately completed. a. No. Patient safety requires this time frame. q. Please clarify what is meant by "that patients should be required to respond to each DMP item"; Please provide the appropriate business rules. a. Business rule is that VA desires that patients must respond to the questions education items or other items that are assigned on any given day and should not easily be able to 'skip' those items. q. Recommend the time be extended to at least 90 days to allow adequate time for development, integration, verification and validation testing, and documentation. a. No. q. Please define the business rules and give an example of how the contractor must cease to allow enrollment of new patients into the original DMP, once the VA standardized DMP is released. a. If VA develops a new standardized CHF DMP, enrollment should not be allowed for any previous CHF DMP or any co-morbid DMP that includes previous CHF DMP content. q. Since the standardized DMPs have not been designed it is difficult to respond to this requirement unless it is assumed that these DMPs will be similar to the vendor developed CORE DMPs. Please Clarify a. Standardized DMPs for weight management, TBI and substance abuse disorder have all been completed, released and are attached. q. Please add that VA will provide direction and business rules for this process in advance to enable compliance. a. VA will add. q. Recommend that the license fee be simplified such that once a unit is placed into service by the VA the service fee is charged on a quarterly basis thereafter. a. VA will reconsider this item and modify if indicated q. Please verify the MS Internet Explorer version to be supported and that if other MS Internet Explorer versions are to be supported that the VA will notify vendors and allow 45 business days for implementation. a. VA will migrate to newer versions of the software over time and it is the vendors' responsibility to remain compatible with newer versions. q. Will the VA provide a standard format for this report? If so, please give an example. Recommend the report be on a "monthly" basis. a. VA will clarify in the solicitation q. VA Clinical Guideline for COPD is missing; please add a. Will add web link q. Are the attached VA Clinical Guidelines current to all national standards and standards of accepted evidence bases practice? a. VA Guidelines are current to VA standards q. For blood pressure monitors that are not designed for home use, offerors must provide documentation regarding their accuracy. Our monitors have clinical validation papers that were done by an independent third party of clinicians backing up the accuracy of the algorithm. I don't think it is fair for companies who use a bp module to "provide documentation regarding their accuracy" which will most likely be internally generated data. a. VA will change to require documentation showing that the units are clinically validated for accuracy. q. Weight scales must include a mechanism for standard calibration within the units. I understand this as referring to the zero out function. I want to have it also state that this needs to be done at the beginning of each measurement to ensure the accuracy of the reading. If this function is done after the measurement, like a lot of other scales on the market, then how can they claim that the reading that was just taken is accurate? If the scale was moved then the reading may not be accurate if the zero out function is done after the measurement has been taken. a. VA will change the specification to clarify. Weight scales must include a mechanism that allows the user/patient to easily set the "zero out" setting. The patient is not expected to be able to adjust the weight calibration of the scale against a weight standard. q. The RFI lists 350 mmhg as the upper range for the bp monitor. The industry standard is 280mmhg for the upper range for all bp monitors. Please ask that this be changed to 280mmhg. a. For cuff inflation pressure the industry standard is 300 mmHg as referenced in AAMI/ANSI SP10:2002. VA will modify this item. q. As for the remaining DMPs by national, will the vendors continue to have the ability to charge for engineering, testing and clinical time for development? a. No q. For blood pressure monitors that are not designed for home use, offerors must provide documentation regarding their accuracy. The provider we use has a B/P module that is clinically validated for accuracy which should be the metric for validation. The statement is vague and needs clarification. a. Will clarify - VA will change to require documentation showing that the units are clinically validated for accuracy. q. Weight scales must include a mechanism for standard calibration within the units. This reads as referring to a zero out function. Is this correct? a. Correct - VA will change the specification to clarify. Weight scales must include a mechanism that allows the user/patient to easily set the "zero out" setting. The patient is not expected to be able to adjust the weight calibration of the scale against a weight standard. q. The RFI lists 350 mmHg as the upper range for the B/P monitors. The industry standard is 280mmhg for the upper range for all B/P monitors. a. For cuff inflation pressure limits, the industry standard is 300 mmHg as referenced in AAMI/ANSI SP 10:2002. VA will modify this item. q. Development and IT, SCOPE OF CONTRACT AND STATEMENT OF WORK, Section 2.7, Section 3.2 requirement 2f and 2g, and Attachment I: Transfer of the data from financial data system to VA via Census-like interface is unrealistic. This would require either opening the VA Census interface to the outside world and doing a secure ERP integration to this external interface, or integrating an ERP system into system in the VA, replicating ERP data in the tele-health database, then transferring it from our system via a Census-like interface. a. VA requires a timely way to track the inventory of individual devices sold, delivered or exchanged to VA facilities from all vendors. VA has outlined a viable mechanism to obtain that data. part of the RFP review process q. The same issues from 1. apply to the server and performance monitoring applications that run at Navisite and would somehow have to be integrated from Navisite to the VA or from Navisite to our system. a. VA has outlined a viable mechanism to obtain the required data q. The same issues from 1. apply to the tracking systems we use. a. VA has outlined a viable mechanism to obtain the required data q. Need more specifics on what exact data is required with a focus on data that can be reasonably acquired and transferred. A PDF report delivered manually once monthly should be considered as opposed to some multi-system, multi-site integration with a large development and validation cost and ongoing maintenance. a. VA has outlined a viable mechanism to obtain the required data. q. Section 3.2 requirement 2b: Transfer of survey responses to the VA needs to be clarified with respect to subjective and objective responses. Our system permits thousands of different subjective questions with thousand of different text or numeric responses to these questions. While our system can handle these, the current VISTA integration of the VA cannot. These are major extensions to VISTA and VISTA integration at the VA to handle these subjective questions. We have done this with other customers so we know our system can handle this, if the VA systems can. While objective responses are supported today, subjective responses will likely take at least 1 year to integrate and validate assuming both the VA and we modified their sides of the interface. a. VA requires that VA survey responses be sent to the VA shortly after the Veteran submits them to the vendor. Please see attachment E. The VA Survey data transfer requirement only applies to VA nationally standardized surveys. It does not apply to other non-national survey responses. q. Section 5.2 subsection E: It has been the case in the past that it is almost impossible to get access to the VA datacenters in Austin and particularly Hines outside of normal business hours. This is due to lack of available escorts to supervise our resources. We need the 24/365 access described herein and the VA needs to strongly commit and budget to making this available otherwise we cannot commit to the service levels we are being asked to deliver. a. Your proposal should include any important conditions you feel you are required to include (i.e. vendor access to vendor's equipment on VA property is required within one hour of arrival at the DPC assuming advance security clearances have been completed). q. Section 9: We provide the field service manual as an electronic download from our website. It is not shipped with each order. a. This is acceptable q. Section 14.1: We have almost 1TB of data in our system Oracle database. This is expected to double or triple over the next 4-5 years. The VA needs to provide more specifics on how they expect to take a copy of this each month. Trying to deliver even a portion of this data through a web interface is unreasonable. Trying to send multiple terabytes each month over the LAN/WAN of the VA to do some form of backup is also unscaleable. A recommended approach would be to provide each vendor a secure fiber channel on a VA SAN to which we could copy a standard Oracle RMAN backup each month. Please provide more specifics of what is desired and how it could be implemented given the volume of data being expected. a. Please see a new Attachment M in revised solicitation. Local data transfer is preferred (vs. transfer across the WAN). Copying data to a local drive that could be removed by VA operations staff is also an alternative. Draft content of Attachment M: As part of the contingency planning process, the VA must have a procedure for accessing the veteran data from contractor systems under the unusual situation where the contractor systems were to become permanently unavailable for any reason. In order to meet this need, the VA will create and maintain a system that can import, and store a copy of all veteran Home Telehealth data from each of the contractor data bases. This data will be in a data base format that will allow the data to be searched and read by VA staff. In order to meet this need, each Home Telehealth contractor must generate a file that exports all patient data. This file will be used to recreate the contents of the data collected in behalf of the VA. The VA will use the file to populate a Microsoft SQL Server 2005 database. The VA is able to use data exports from Microsoft SQL Server, Oracle, and MySQL. The VA could also import a generalized formatted file such as CSV or XML. The structure of the file will be defined by mutual agreement. The VA requires that the file be generated monthly on a regular schedule defined by mutual agreement. The file will be electronically transferred in a secure manner to a directory of a secured VA system using a simple process defined by mutual agreement such as secure FTP. This does not replace any other system backup requirement. q. SPECIFICATIONS, Section 2.6: What is expected for cross-coverage of patients by care coordinators at different facilities? Is it required for the Care Manager to have a single user login which allows them to see patients of another Care Manager in another facility? If the care Manager can login into each facility using their login for that facility, is it acceptable? a. This question appears to refer to specification 2.2 and not to 2.6. Specification 2.2 is for provision of a mechanism for review and management of patient data at another facility/location by an alternate care coordinator (specifically assigned at the time of need by the VISN Lead or designee) in event of emergency/disaster or loss of key personnel. Offered mechanism and ease of use will be subject to evaluation. q. Section 2.12 and 2.16: Providing Ad-Hoc Queries is a very costly feature to develop and validate. Moreover the scope of the Ad-Hoc Query data set has to be defined, as does the scope of reporting elements to be added. Is this a database query type interface (SQL) or a reporting type interface or both? Integrating a third party reporting tool such as Crystal Reports or Actuate Reports is possible, but typically comes with a per user license costing $1000s. Please specify the scope of the dataset, query set and data report types. Even if the requirement is a simpler Excel CSV dump of a chosen data subset, please provide more detailed specs. a. VA will review and clarify q. Section 2.20: Providing a role to allow viewing of VA patient data across the entire VA is a dangerous concept from a patient security point of view. Is this limited to a few? How are these few authorized and setup? What is the process for doing this? Today each account (facility) can manage its users and roles. What is the analog for a VA wide user? Assuming we have this setup then we get more questions. What is the scope of data they should be able to see? What are they allowed to do with this data? It is unclear if this is something within the scope of the vendor viewer, which is primarily a viewer for a patient panel related to a care providing team. So do we need a new tool to do this? When would this be expected? Specs? a. Specification 2.2 is for provision of a mechanism for review and management (as per usual processes, utilizing the vendor viewer) of all patient data at another facility/location by an alternate care coordinator (specifically assigned at the time of need by the VISN Lead or designee) in the event of emergency/disaster or loss of key personnel only q. Section 2a: Refurbishment needs more specifics. What if we receive an unrefurbishable unit that is damaged - send a new unit and bill the VA? What if the cosmetics are bad - replace the plastics and bill the VA? What about the VA labeling - it is sometimes unremovable? What are the cosmetic standards we are agreeing to avoid follow-on customer concerns the unit is "scratched"? How is the unit returned by the VA - in the original packaging or loose bubble wrapped? Are the accessories included or are we replacing? By FDA guideline we have to return complete and tested units, including accessories and IFU, properly packed to our specs. a. Refurbishment would include repair of cosmetics. We will modify the specification. q. Section 3.0 - Cellular communication option: Is an external cellular modem acceptable? Using a patient's cell phone is truly an integration nightmare, and building a cellular modem into a patient appliance is costly and complex. a. The specification is for a device either included within the hub device or as an external add-on device to the hub. q. Attachment A - HL7 Integration: The VA Integration specification lists 3 phases. What phases of the VA Integration spec are required from the start as not all have yet been implemented with the VA? What is the schedule for development and deployment of the other phases? The 3 phases of VistA Integration testing include Emulator, Integration Test Lab and Limited Field testing. a. All of these testing phases are currently available and operational. q. Attachment A states that VA will provide 60 days advance notice to make the required software changes for any changes to the VA Integration software. Does this mean that we have to design, implement, test and release within 60 days? This is not possible in a medical regulatory compliant design/validation process. It also varies by scope of the requested change. Some requested changes may not even be possible. Perhaps this should be 30 days to understand the required changes, seek clarification and commit a target delivery date. a. The desire is to contract with vendors who have quality products and are responsive. Simple vendor server to VA enterprise reporting modifications are expected to be completed in 60 days. As future changes are more clearly defined, their timelines will need to be discussed. q. Attachment B - HTH Server Environment: Fault tolerant servers with clustering as a means being specified. While it is common to purchase servers with redundant disks and power supplies to increase uptime, clustering servers significantly increases the costs of operations. For example, to run a clustered database requires two database servers running on a common SAN using a set of Oracle database clustering licenses and SAN clustering software options. This more than doubles the cost of the database systems required in both sites compared to what is in place now. The same applies to application servers and integration servers, where we would need to provide load balancing, twice as many servers and additional application licenses. If all of these need to be clustered then we will have to double the size and cost of our datacenter in both Austin and Hines. Please remove the expectation of clustering or expect to double IT costs and double the VA power and rack requirements. a. Each vendor needs to evaluate their tradeoffs between the additional hardware and software costs, their system monitoring and repair costs and their system uptime impacts. VA will change the specification to state that local clusters are a desired option q. The current mechanism being used by the VA to measure responsiveness is inadequate to measure the various types of page performance listed. We need to measure not only time to hit the home page but also login time, worklist display time, and some agreed upon page to page time. This requires proper, commercial web application monitoring tools, with application login capabilities, that are agreed upon by both parties, purchased by both parties, and setup both on the VA and our networks so we have independent data collection for dispute resolution. Please specify the desired commercial application. a. VA has no written program office request or budgeted initiative to enhance the existing response time monitoring tool. It is the vendor's responsibility to monitor system response time and upgrade their systems as required. VA collects basic data to help the VA and the vendor identify and verify that a problem may exist. q. The 98% uptime needs to exclude outages caused by VA network or facility issues or maintenance which today is the lion's share of the issues we see. The 98% must be w.r.t. issues caused by vendor controlled system elements. Moreover the uptime should exclude downtime required to do VA required upgrades or patches. Is this acceptable? a. The vendor is required to record and report uptime as described in the specification. Any variations, unusual situations, exceptions or event explanations could be included in the report. q. The banks of VA phone lines provided needs to span multiple phone numbers in multiple locations with a high degree of redundancy. We currently have over 300 lines just for our system distributed in two different geographic locations and over 8 different systems to be sure that we can meet the demand and connection reliability. Can the VA provide more specifics of the number of lines and their redundancy approach? We also need the specifics of the PPP access protocol used and authentication method to configure in our appliances. a. The VA assigns multiple phone lines (or T3 channels) to an 800 phone number. Currently there are 3 availed 800 numbers and 450 free channels or phone lines available to be allocated. There are separate phone banks at 2 geographically separated locations. You should include any special requirements in you proposal and it will be evaluated as part of the Proposal review process. VA provides the 800 number and the hardware to pick up the call only. The VA hardware does not authenticate nor does it set the communication requirements. The equipment is merely a relay unit. The Vendor will supply the hardware and specs for the setting the VA hardware, The vendor server will authenticate that call, validate the traffic and relay the patient data to the receiving server. The hardware currently in place is a Cisco AS5350. Please referrer to the Cisco specs for compatibility with your implementation. q. Attachment C - Security: The VA expectation is that we remain in compliance with the evolving security requirements of the VA as documented in a number of policies and procedures outlined. Does the VA agree to pay for the cost of additional software or equipment necessary to remain in compliance with these standards as they evolve over the contract? For example the policy could change to add intrusion detection in our rack, as opposed to at the VA level, and this would cost us an additional $40,000 to purchase and install intrusion detection devices or firewall upgrades. This has happened in the past. a. Any requests for an equitable adjustment to the contract for compliance with mandatory VA security changes would need to be submitted to the contracting officer. q. Attachment J - Date/Time and Measurement Rules: It is important to note that no data from a peripheral medical device can ever be considered "accurate" as it cannot be reliably associated with the patient who created it. In the clinical setting this association is done by the care provider taking the measurement. In the home environment anyone with access to the medical device could take a reading and add it into the memory of the device. The medical devices themselves provide no biometric or even username/password to authenticate the user. We typically see the medical device data having a mix of data from the patient and their spouse, which could be approximately the same but trending differently. If the VA insists on the vendor having liability for "accuracy" then we should tag all medical device data as inaccurate on this basis alone. It is always a requirement that upon noting a trend in the telehealth reported data that the care provider assess the patient directly themselves, independently of the telehealth data, to vet the accuracy of the readings and the association of the readings with the patient prior to providing any change in course of treatment. Failing to do so is the care provider's liability. a. The requirement addresses the accuracy of the measurement date/times and the accuracy of the measurement values, and not user authentication. Accuracy is vitally important and is very different from the issue of use authentication. It is the vendor's responsibility to deliver systems that deliver accurate measurements and date/time stamps. VA marks Home Telehealth data so that clinicians can consider the variabilities in the home environment when evaluating the clinical significance of the data. If your corporate position is that all data gathered in the home is inaccurate related to measured values and date/times, then you need to state that position in your proposal. q. Not all medical devices used in the VA have a clock or allow setting of the clock. For those that do if we set the clock in the device based on a mandatory zip code entry for the patient in the database this does not really guarantee accuracy. The zip code could be incorrect (we will have to log the changes the care provider makes to this for liability) or the patient could be traveling with the device and have taken readings in a different time zone. This is particularly important for glucose meters where the patient could have been told to take readings at specific times in the day. Most medical devices do not have time zone capability and are just local time and date. It is not recommended to set the clock for devices that have manual entry of the clock, as the user will be frustrated that the clock is set with a local time for a different time zone from where they actually are while traveling, the user will therefore change it to the correct local time, and then keep having it reset by the appliance. Moreover setting this clock has little value since the readings are still tagged as inaccurate. Is this acceptable? a. Currently, VA has observeddate/times that are inaccurate by years. Sometimes these dates are years in the future. While there may be inconvenience for patients who travel, the goal of the requirement is to improve on the current situation. The VA requirement is to set the time to the time zone of the address of record. The vendor is responsible for testing their entire systems, including peripheral measurement devices to validate that the entire systems will produce valid data. Offered solutions are subject to evaluation. q. For devices with manual clock entry we can tag all readings as unreliable as we cannot know that the user did not change and then change back the time prior to connect. At present this means that many of the devices used by the VA will have their readings tagged as inaccurate. All currently supported glucometers and wired blood pressure devices in use allow manual clock entry. Only the A&D Bluetooth medical devices have an internal clock that cannot be user set and that can be system set. The other option is to only allow in session readings, but although this is viable for weight, blood pressure and pulse oximetry devices, it is likely unattractive for glucose which is undesirable to take in session and is typically taken multiple times per day. Glucose meters are a major issue for accuracy and we would like the VA to discuss this with the Glucose meter manufacturers. a. Constructive vendor suggestions and support is desired so that together we can improve on the current unacceptable situation. These changes may mean that some current conveniences are no longer available. q. Can we use GMT in the medical devices as the time base, and adjust the time zone at the system level? This is easier for medical devices without a time zone concept. a. Generic statements are difficult to evaluate but the described solution may be viable for some devices. It would not be appropriate if the device displays the time to the user that is many hour different from local time, q. One general concern related to tagging measurement readings based on rules such as "weight has changed by 100 pounds" is that the system is starting to exercise medical judgment that is generally not allowed within the indications for use of a Physiological Data Gathering device. This is a liability for the vendor. As an alternative we have provided a means for the care provider to tag suspect readings using their judgment after consultation with the patient. Is this acceptable as an alternative? a. The current systems alert care coordinators when values fall outside specified limits and this is a beneficial function. Additional types of data review to send alerts to the care coordinators would be valuable and will be considered in the evaluation. q. Clinical Content, Section 12 Optional Supplemental Special Services FEE VA Standardized Disease Management Protocols for Messaging (HUB Device or IVR): "This pricing covers the cost of developing new or revised standardized VA Disease Management Protocols (DMP) that have incorporated the required standardized VA content and meet VA's pre-acceptance testing requirements. " Please define for us the "pre-acceptance testing requirements". a. This is an internal VA process utilizing clinical Subject Matter Experts. q. How will translation fees of the DMPs be addressed? a. All vendors will be required to review the specifications for new DMPs and submit development pricing for VA to review. q. 5th Bullet: "DMPs for co-morbid diseases or conditions may be made available by contractors, subject to all other requirements." Please clarify "all other requirements." a. As contained in 2.4 and Specification #12 q. 6th Bullet: "The contractor must have a mechanism to ensure that rapid change (within 7 days) can be made to the content of all of the affected DMPs (core or standardized) in the event of a patient safety issue arising due to changes in accepted clinical practice or a problem with existing content. These changes will be made at no additional cost to the VA" Please define patient safety issue and distinguish between patient safety issues and non-patient safety issues. a. This will be as interpreted by VA clinicians and administrative staff in the specific circumstance q. How/Who determines what is and is not a patient safety issue? a. VA clinicians and program office staff determine this. q. 2nd Bullet: "Once VA standardized DMP content for a disease or condition is released to contractors, each contractor must make available the standardized DMP content for pre-acceptance testing by the VA within 45 days." What is the process for pre-acceptance testing for minor changes? a. Internal VA review process utilizing Subject Matter Experts. q. Attachment K: Since the VA has created and is currently testing their own Substance Abuse DMP, why are the current Substance Abuse Guidelines included? a. Will delete. q. The COPD Guidelines seem to be missing as a part of Attachment K. Please forward the current COPD Guidelines. a. Will be attached to solicitation or web link provided. q. Measurement Device Manufacturer Section 2 Specifications, Subsection 3.0 Measurement Solutions for Messaging and Measurement Hub Device. 4th Bullet: "For blood pressure monitors that are not designed for home use, offerors must provide documentation regarding their accuracy." This is a big issue as it could allow certain companies to participate. These companies use a BP module that is not clinically validated for accuracy. Our monitors have clinical validation papers backing up the accuracy of the algorithm. I don't think it is fair for companies who use a BP module to "provide documentation regarding their accuracy" which will most likely be internally generated data. a. Noted. VA will modify the specification to require devices that are clinically validated q. 5th Bullet: "Weight scales must include a mechanism for standard calibration within the units." We understand this as referring to the zero out function. We would like to have it also state that this needs to be done at the beginning of each measurement to ensure the accuracy of the reading. If this function is done after the measurement, like a lot of other scales on the market, then how can they claim that the reading that was just taken is accurate? If the scale was moved then the reading may not be accurate if the zero out function is done after the measurement has been taken. a. The VA will modify the specification to indicate a zero out function. q. Blood Pressure: The RFI lists 350 mmhg as the upper range for the bp monitor. The industry standard is 280mmhg for the upper range for all bp monitors. We would request this be changed to 280mmhg to accurately reflect industry standards. a. The industry standard for cuff inflation pressure limit is 300 mmHg as specified by AAMI/ANSI SP10:2002. VA will modify this element. q. Data Services SCHEDULE OF SUPPLIES1.c: How is this defined. Is it equivalent if not precisely the same as the current Census data or does it extend to export for research types of ad hoc requests? I think later references are more clear but still not entirely clear. a. See the related Specifications q. Data Communication And Reporting: Are these 2 the current VA integration functionality or something new? a. The specifics of the requirement are included in the RFP specification. There are some new requirements q. Please provide more information regarding the monthly data connectivity reports. a. The specifics of the requirement are included in the RFP specification q.14.0 DATA OWNERSHIP AND ACCESS: Is this a change in policy? This seems far more stringent than before. a. VA policy is as written q. Customer Service, 2a.MESSAGING AND MEASUREMENT HUB DEVICE REPROGRAMMING AND REFURBISHING FOR RE-USE BY NEW PATIENT: Is the refurbished unit sent back to the VISN required to have the same serial number as the unit sent in for refurbishment? a. No q. How should units with etched or permanently marked devices be handled? a. The requirements for refurbishment will be clarified to include cosmetics q. Customer Service Requirement for In Home Telehealth Devices for clinicians: These hours are extended from current operations and will require a significant expansion of staff. a. Required for adequate customer service for a very large program. q. In the last RFP it basically said that we could not contact patients. It did not say that patients could not contact us. It is not unusual for: a. VA CM to have a patient contact us. b. VA patients find our contact information on the internet and contact us of their own volition. a. Noted q. Finance/Logistics, Schedule of Supplies: For Item 1(e) are we required to ship or to only support a Glucose meter? Currently we have no reseller agreement. a. VA will clarify the language. q. Section 1.4 Contract effective date: " These licenses will have an effective period for a full year" The contract period is only for one year at time. I would state that the licenses will have an effective period until the end of the current contract period. a. VA will clarify the language q. If the license is for one year, why do we have to bill quarterly? a. VA will clarify the language q. "In the event patients are managed for less than a complete year". Unclear. What is the definition of provision of care? Being enrolled and assigned to a device? a. Yes q. Section 2.8 Delivery Requirements: "Regular deliver shall be made within seven (7) days after receipt of a delivery order." There might be issues with holidays for remote areas. Please exclude holidays counting as days. a. VA will clarify q. Section 2.9, Weekly report of sales: What is the format requirement for this report? a. Attachment I includes the current description of the report format. q. Section 9.0 Service Data Manual Device: This states that we need to provide TWO manuals for each purchase. We recommend that service data manuals are supplied in electronic version or are ordered as part number. a. VA will clarify q. 2.0 SPECIFICATIONS, Section 2a. Messaging..refurbishment and : We need to add a clause stating "The equipment must be sent back in original packaging or Contractor provided retrieval packaging. Any equipment returned in unapproved packaging will not have any work completed that is warranted by the Contractor." Unfortunately, our appliances are regularly returned with little or no padding which causes significant damage during shipment. a. Noted. q. Section 14.0 Licenses/Associated Services Fee: Are we charging a yearly fee or quarterly? It stated earlier that licenses will have an effective period for a full year (Section 1.4 Contract Effective Date) "purchaseswill be made at a local level." From 2.3. I would request that for Quarterly billing of Licenses, the payment is due 45 days from the date that the data is sent to each "local level". Currently it takes far more than a quarter to collect the money. Some facilities say they have to bill on a patient level, this assumption should be cleared. a. VA will clarify q. What is meant by "The level of fee will vary according to the technology and the components"? a. VA will clarify q. "VA will calculate the number of patient days of actively deployed device/service every 3 months." Is the definition of actively deployed device/service equal to enrolled and assigned device? As soon as a device is active it is calling in on a daily basis. a. VA will clarify q. Attachment L - Warranty, Section 6. Original: The warranty shall include parts, labor and shipping to and from the contractor. Contractor will provide a replacement within 5 business days of notification. (contradiction with 4.3?). Proposed: The warranty shall include parts, labor and shipping to and from the contractor. Contractor will provide a replacement within 10 days of receipt of the allegedly defective equipment after a test is performed that confirms the defect. If the allegedly defective equipment is confirmed to be functioning as originally intended, the unit will be sent back to the VA. a. VA will review this item q. Account Management, SCOPE OF CONTRACT AND STATEMENT OF WORK, Section 2.3: What constitutes "VA requires Veteran patients in CCHT programs to exchange clinical and administrative data bi-directionally with VA clinicians on a daily basis."? a. VA desires that patients respond with the requested data/response items daily as assigned by the care coordinator q. Page 11 Regarding page load times: Must patient panels be limited to 150? a. No upper limit q. May the load times be longer if the panels have more than 150 patients? a. No q. 4.3.g: If we replace a unit and the "defective" unit is not returned, when should we bill for it? After 30 days? a. Replacement units should be sent once the defective unit is returned q. Specifications, 12.0 "Within one year after contract award,": Please include more detail about data elements being requested. a. As noted, this is yet to be specifically determined. Details and instructions would be provided with advance notice to afford implementation. q. Will a device?free, IVR platform approach to telehealth should be given a separate award for at least one vendor under the same procurement vehicle currently under consideration. a. The SOW does include the option for separate award for a stand- alone Interactive Voice Response system. We will clarify the wording under 1.0 Schedule of supplies, paragraph 2: "Line item 6 can be considered a separate option from the required items 1-1e." q. Section 1.0 Schedule of Supplies (page 2): What is the specification for a server? For example, is this an individual rack of multiple CPUs or a single CPU? a. The RFP contains the server specifications, i.e. section 6.2 and attachment B. Using multiple computer systems containing multiple CPUs is a common way to meet the requirements. It is desirable to limit the physical space requirements for the servers at one site, so a one rack solution is desirable. q. Section 1.0 Schedule of Supplies, 3e (page 4); A stethoscope is listed as a mandatory device in the Messaging/Measurement/Video Telemonitoring Measurement Solution category. For a vendor that has a telehealth solution with video conferencing capability, but does not support a stethoscope as a peripheral device, would the VA consider modifying the RFP so that the stethoscope is a desirable rather than mandatory requirement? If not, would the VA consider a vendor proposal that did not have a stethoscope but met all other requirements? Would the vendor be allowed an implementation period after contract award to meet this requirement? Or, is the vendor disqualified from award consideration if they don't meet this requirement at the time of submission of a proposal? a. VA will consider making this an optional feature. Availability of this feature and any timeline for availability will be considered during the proposal evaluation process. q. Section 1.2 Purpose and Objectives (pages 6-7): If a vendor has a specific new product feature (one that is listed as desired, but not mandatory in the RFP) that is currently on the product development roadmap but is not commercially available at the time of writing a proposal in response to the VA RFP, should the vendor include the product and/or feature description in their proposal with an understanding it will be available in the product within a certain period of time after the award? a. No q. Or, should the vendor leave that feature or product offering out of the proposal completely? a. Yes q. If left out, once a vendor has received an award on this contract, are there opportunities outside of the new contracting period to add new features and/or products to the vendor's contract with the VA under this award? a. Upgrades, new accessories or software may be submitted for consideration under technology refresh guidelines q. Along the same line of questioning, if there is a mandatory specification that the vendor doesn't currently meet but has plans to release that specification commercially within the next 12 months, can the vendor still apply for the contract award or would missing a mandatory specification automatically disqualify the vendor from consideration? a. Disqualify q. Are the vendors managing the servers in the VA data centers, or are the servers managed by VA IT personnel, or both? a. The vendors are responsible for managing their servers in the VA data centers. If the vendor does not have that capability, the vendor could contract with another entity to manage the servers. q. Section 1.4 Contract Effective Date (page 7): Is the 12 month licensing fee for a product only billed at purchase or can the license fee be billed quarterly? a. VA will clarify this item q. Please clarify the requirement for setting up the backup datacenter: is it 115 or 120 days? If a vendor's system does not currently support data center mirroring, is the VA willing to work with the vendor for a period longer than 120 days to set up the backup data center in the event that problems arise and the vendor is not able to complete the work within the specified period of time? a. Section 4.4 states that "This testing is to be accomplished within 120 days of the award." Section 1.4.1 b will be changed from 115 to 120 days. q. Section 2.3 Home Health Technologies (pages 10-11): If a vendor's product does not currently delineate whether data was entered by the patient vs. data captured by medical peripheral devices, is this a requirement that the VA is willing to make optional rather than mandatory? a. No q. Or, is the VA willing to give an implementation period for the vendor to meet this requirement after contract signing? a. The vendor should propose the features they currently have in production and propose specific timeframes for delivery of additional features. q. Is VistA HL7 integration a mandatory requirement that must be available at contract signing? a. Attachment A states "At a minimum, contractor systems must have HL7 messaging capability in field testing by the end of the first 6 months or the contract would be terminated. q. If a vendor has release plans to support this capability within the calendar year, but it is not commercially available at the time of the vendor's proposal, would this disqualify the vendor from consideration for an award in response to the RFP? a. No q. Or is the VA willing to provide an implementation period after contract award for the vendor to support this capability? a. Yes, but the vendor must have the feature available for testing and implementation in the timeframes required in the specifications q. Can you provide a technical specification on the HL7 application interfaces the VA has implemented? a. The RFP contains the VA Home Telehealth HL7 implementation specification as an embedded document in "Attachment A- HL7 Messaging Capability" q. Section 2.7 Data Communication and Reporting (page 13): Is the VA willing to provide an implementation period after contract award for vendors to add VA specific data elements to standard reports or to create any custom reports required by the VA? a. Yes, give specific timelines in your proposal. An acceptable timeframe would be within 3 months of award. q. Section 3.1 Information Technology (IT) Requirements, 1e (page 14): If a product does not currently support Clinical Context Object Workgroup (CCOW), is the VA willing to give an implementation period after contract award for the vendor to implement this capability? a. Yes, attachment D states "Within 3 months of award, the new contractors will submit CCOW compatible clinical data management software to the VA for testing" q. Section 3.1 Information Technology (IT) Requirements, 2b (page 15): What is the specific time requirement for "immediate" delivery of individual patient survey responses electronically transferred to VA system? (ie. what is the VA's definition/specification for "immediate"?) a. The VA goal is to receive the responses in real time. The transmission of the survey responses should be sent to the VA when the completed responses are received from the veteran. They should not be bundled and batched for later transmission. Short delays due to traffic congestion are acceptable. q. Section 1.0 Messaging and Measurement "Hub" Device Hardware (pages 20-21): 1.4 Is Verdana an acceptable sans serif font? a. Verdana is acceptable q. 1.8 If a vendor's telehealth product is not self configuring, is this a requirement the VA would be willing to make desired rather than mandatory requirement? a. No, the home devices must be easy to install and use q. Or, would the VA be willing to allow an implementation period for the vendor to deliver this capability after contract award? a. The vendor must be able to produce documentation and to demonstrate the proposed self configuring device when their proposal is submitted and when the product is demonstrated during the evaluation. For any capabilities that are not immediately available, the vendor should propose specific timelines for the delivery of these capabilities as commercially available products. This will be considered during the proposal evaluation process. q. Section 2.0 Software that Supports the HUB Device and the Servers in the VA Data Center (Attachment B) (pages 22-23): 2.8 The ability to add custom fields to support the VA's categorization of patients is work that would need to be done by vendors after a contract is awarded. Is the VA willing to consider making this an optional requirement or allowing for an implementation period after contract award for vendors to meet this requirement? a. The vendor must document and demonstrate any required and defined capabilities that are part of the patient or care coordinator interface, i.e. levels of care. The vendor should propose specific timelines the delivery of any other capabilities (or features that are only generally defined) that are not immediately available. This will be considered during the proposal evaluation process. q. 2.12 If a vendor does not provide all of the sorting and aggregating patient data displays and reports exactly as described for the VA, is the VA willing to allow for an implementation period after contract award for a vendor to implement these requirements? a. The vendor must document and demonstrate any required and defined capabilities that are part of the patient or care coordinator interface. The vendor should propose specific timelines the delivery of any other capabilities (or features that are only generally defined) that are not immediately available. This will be considered during the proposal evaluation process. q. 2.17 Having two fields available for customer assigned patient identification numbers is another custom feature for the VA that vendors would need to enable if a contract was awarded. Is the VA willing to allow for an implementation period for a vendor to enable this capability after contract award? a. The vendor must document and demonstrate any required and defined capabilities that are part of the patient or care coordinator interface The vendor should propose specific timelines the delivery of any other capabilities that are not immediately available. This will be considered during the proposal evaluation process. q. 2.19(c) Is it acceptable to provide the archive for threshold history and individual identity in a separate database from the telehealth system? Does the VA implement a separate database to archive this historical information? a. The specific intent of this question is not clear to the reviewers. The vendor should propose specific details of any archiving plan as well as timelines for the delivery of any archiving capabilities that are not immediately available. This will be considered during the proposal evaluation process. q. Section 6.0 REQUIREMENTS FOR THE MESSAGING/MEASURING/VIDEO TELEMONITORING DEVICE INCLUDE (page 26): 6.6 What is the specification for high definition picture clarity? a. This requirement will be clarified. The intent was not to obtain HDTV, but to avoid very poor quality video clarity q. Will this specification be a mandatory or optional requirement? a. Adequate video quality will be defined and will be mandatory. q. Section 12.0 OPTIONAL SUPPLEMENTAL SPECIAL SERVICES FEE VA STANDARDIZED DISEASE MANAGEMENT PROTOCOLS FOR MESSAGING (pages 32-34): Would reporting DMP revision changes via system log files be an acceptable method to support this requirement? a. The VA standardized DMPs will not change frequently (i.e. once or twice a year versus weekly). For these DMPs, log file changes would not be sufficient. q. Does the VA have a separate system to archive this data or is this a requirement of the telehealth system database? a. The VA currently has a system that stores all versions of surveys and all the patient responses. For DMPs, the VA has plans to develop a system or expand the existing survey system in order to store all versions of VA standardized DMPs and selective responses. The vendor must also maintain a correlation between the patient responses and the DMP questions that were current at the time the veteran submitted their responses q. Attachment B - Home Telehealth Server Environment (page 39): Can you provide the list of approved VA virus protection software? a. Yes. McAfee AV and ISS Proventia HIPS protection are currently both used for signature virus protection and Intrusion prevention. Other packages are acceptable but each vendor must request and receive approval to use their proposed virus protection software. q. Attachment E - Patient Survey Response Transmission Specification (page 47): Is it mandatory or optional for vendors to support the electronic delivery of these surveys? a. Mandatory q. If a vendor's system did not support the delivery of these surveys because of the length of some of the specific questions or the numbers of responses to choose from (6 possible answers), would the vendor be disqualified from consideration for an award under this RFP? a. Yes, they would be disqualified q. Can IVR and/or Video Conferencing hardware (telco and servers) be located outside the VA firewall? a. No, any system that includes/stores any patient specific information cannot be located outside the VA firewall.
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65 -- Home Telehealth Technologies