NMC_Portsmounth_JEFO_Philips_Fetal_Monitors_Redacted.pdf

JUSTIFICATION FOR AN EXCEPTION TO FAIR OPPORTUNITY

(JEFO)

PHILIPS HEALTHCARE

CONTRACT SPM2D1-09-D-8349

Fetal Monitor Equipment

(1) Defense Logistics Agency (DLA) Troop Support, Medical Supply Chain, Capital Equipment Division, is the contracting activity.

(2) The action submitted for approval is a JEFO for an acquisition from Philips Healthcare Patient Monitoring Capital Equipment (PMCE) contract SPM2D1-09-D-8349, valid through March 29, 2019.

(3) The items to be acquired are twenty-six (26) Avalon FM50 Fetal Monitors and fifteen (15) Avalon CL Basestations, transducers, and other accessories for Naval Medical Center (NMC) Portsmouth. The Avalon CL Basestations work in tandem with the Avalon FM50 Fetal Monitor to allow for wireless monitoring of up to three fetal and one maternal vital signs using cableless transducers that transmit patient information via the Avalon CL Basestation to the Avalon FM50 Fetal Monitor. The Avalon FM50 Fetal Monitor can only work with Philips products. The Avalon CL Basestation can only function with the Avalon Fetal Monitor as other manufacturer monitors are unable to process the transmitted signals from the Basestations. The total estimated dollar value of this action is

(4) The authority waiving the competition requirements is FAR 16.505(b)(2)(i)(B), only one awardee is capable of providing the supplies or services required at the level of quality required because the supplies or services ordered are unique or highly specialized. The Avalon FM50 Fetal Monitors and Avalon CL Basestations identified above from Philips Healthcare are essential to NMC Portsmouth’s requirements.

NMC Portsmouth’s requirement is for twenty-six (26) Fetal Monitors and fifteen (15) Basestations, which shall be able to continuously monitor and display information listed in the table below. The intrapartum monitors shall also be able to display patient identification information, date, time, alarm information, recorder status, and prompt/error messages at the bedside and at a central nurse station and be able to work wirelessly when connected with the basestation.

Patient to be Monitored Measuring Parameters

Fetus/Fetuses - Fetal Heart Rate (FHR)

- Electrocardiogram (ECG)

- Uterine activity/fetal movement and development

Maternal - Maternal Heart Rate (MHR)

- Non-invasive blood pressure (NIBP)

- Pulse oximetry (SpO2)

- Electrocardiogram (MECG)

PHILIPS HEALTHCARE

- Intrauterine pressure (IUP)

- Maternal Uterine Contraction during labor and birth

The units shall be able to monitor FHR over a minimum range of 50 to 210 beats per minute (BPM). The units shall be able to accurately distinguish between the MHR and FHR. The units shall be able to distinguish between multiple FHR in the case of multiple fetuses using transducers and the monitor. The units shall be able to monitor triplets utilizing a single monitor.

This clinical requirement is supported as NMC Portsmouth has on average ten (10) deliveries per year involving pregnancies with triplets.

Market research was conducted which included a search of the Internet using Google, Bing, searching GSA Advantage, and reviewing the ECRI Sourcebook. Vendors that provide a fetal monitor on the DLA PMCE contract are GE Healthcare, Philips Healthcare and Spacelabs. GE Healthcare and Spacelabs can provide fetal monitors

. Wireless is an important feature in cases where transferring patients to the operating room (OR) for reasons such as when a C-section is required. Having the ability to continue monitoring of a fetus that may already be exhibiting signs of distress while enroute to the OR and getting the mother transferred onto the OR table would be beneficial from the perspective that the surgeon could determine what type of incision to make and anesthesia could determine the type of medications needed based on the urgency.

Additionally, Because of the significant additional challenges associated with using multiple monitors for multiple births, using two separate monitors for triplets adds risks to those pregnancies. The additional challenges presented by using multiple monitors include: 1) Increased maternal stress and discomfort during labor due to the greater amount of wires and cables attached to the mother; 2) Additional limitations on the mother’s mobility when connected to additional monitors; 3) Slower clinician interpretation of multiple data strip printouts provided by multiple monitors and the inability to integrate two separate data strips into a fetal record keeping system;

4) When multiple monitors are used for triplets, it is difficult for a clinician to confirm that all three of the fetal hearts are being displayed and that none of the displayed fetal heartrates are “duplicates” of one fetus’s data being displayed multiple times.

PHILIPS HEALTHCARE

(5) The Philips Healthcare items required are available on the Philips Healthcare contract SPM2D1-09-D-8349. The contract pricing has previously been determined fair and reasonable via comparison with commercial pricing and other than certified cost or pricing data. In view of this earlier determination, the Contracting Officer has determined that the anticipated cost will be fair and reasonable to the Government, and that the subject procurement represents the best value.

(6) There are no other facts supporting the use of this JEFO.

(7) Vendors with PMCE contracts have the opportunity to add products that fall within the scope of the PMCE program at any time, including new models of fetal monitors. The ongoing addition of new products to the PMCE program will enhance competition for future acquisitions.

(8) As the Contracting Officer, I hereby certify that the information contained in this justification is accurate and complete to the best of my knowledge and belief.

I hereby certify that the requirements which form the basis of this justification are accurate, that these supplies meet the Government’s minimum needs and that this justification is accurate and complete to the best of my knowledge.