ATTACHMENT - CATEGORY 1_ Minimum Technical Requirements- LPTA Items.pdf

CATEGORY 1 - LOWEST PRICE TECHNICALLY ACCEPTABLE

GROUP 1 - CATEGORY 1 – FOOT AND ANKLE (CLINS 001 – 099)

LOWEST PRICE TECHNICALLY ACCEPTABLE (LPTA)

• Group 1 Foot and Ankle CLIN #s 001-099

• Group 2 Knee CLIN #s 100-199

• Group 3 Spinal CLIN #s 200-299

• Group 4 Upper Extremity CLIN #s 300-399

• Group 5 Compression Therapy CLIN #s 400-499

• Group 6 Prosthetic Socks CLIN #s 500-599

CLIN 001-GROUP 1 - CATEGORY 1 LPTA

DESCRIPTION: ZERO COMPRESSION NEUROPATHIC FOOT PROTECTIVE INTERFACE (VA125)

Need total: 1 product

Indications:

• Neuropathy

• Skin pathology as a protective interface

• Protective interface against orthotic fitting pressures

Minimum Technical Requirements: Item must have all of the below features.

• Type: Below the knee, non-constrictive proximal end, less constrictive than remaining stocking.

• Size: Must be clearly marked on product

• Equivalent shoe sizes on or visible through packaging

• Range Fits:

• All commercially available sizes

• Clearly indicate relative shoe sizing

• Height: Crew or above

• Seams: Non-prominent seams.

• Closure: Closed toe

• Material: Multi-fiber excluding cotton

• Colors: A minimum of 2 colors to include the following:

• White

• Black

• With or without antibacterial, antifungal finish

• Packaging

• Minimalist packaging to reduce waste and space

• Sizing to be listed on the package or visible through packaging.

CLIN 002 – GROUP 1 - CATEGORY 1 LPTA

DESCRIPTION: GEL HEEL CUPS (L3170)

Need total: 1 product

Indications:

• Heel Spur

• Heel Pain

• Bursitis

• Achilles tendonitis

Minimum Technical Requirements: Item must have all of the below features.

• *Medical Grade Silicone (Hypoallergenic)

• Sold in Pairs

• Sizes:

• Small (S)

• Medium (M)

• Large (L)

• Extra-Large (XL)

• OR EQUIVALENT SIZES

CLIN 003 – GROUP 1 - CATEGORY 1 LPTA

DESCRIPTION: ELASTIC PULL-ON ANKLE ORTHOSES WITH GEL MALLEOLI SUPPORT (L1902)

Need total: 2 products

Indications:

• Stabilizes the ankle muscles and joints for healing and pain relief following injury or surgery.

• Mild ankle sprains

• Mild instabilities

• Ankle arthritis

• Ankle pain

• Ankle swelling

Minimum Technical Requirements: Item must have all of the below features.

• Available in right and left

• Two-way stretch, Compression Reduced Along Distal & Proximal Edges of Support

• Minimum 1/8” gel pads imbedded between fabric, positioned over each malleoli for malleolar relief/protection

• May or may-not contain spiral stays within material (not exposed)

• Breathable, elastic fabric, (latex free)

• Sizes range from:

• Extra- Small (XS)

• Small (S)

• Medium (M)

• Large (L)

• Extra- Large (XL)

*Salient Characteristics for Medical Grade Silicone (Hypoallergenic): Provides support and comfort, shock absorbing properties, able to withstand extreme temperatures, soft and pliable, making it ideal for contact with human skin, hypoallergenic, non-toxic, non-flammable and odor free, has even pressure distribution providing relief from heel pain, the products shall be compressible and be of one density, washable and transferable between footwear, will not get warmer than body temperature, will not deform or degrade with use.

If an equivalent product is being offered, documentation that demonstrates that the offered product meets the salient characteristics, as shown above, must be included with the technical proposal.

CLIN 004 – GROUP 1 - CATEGORY 1 LPTA

DESCRIPTION: HEEL LIFT (L3332)

Need total: 2 products

Indications:

• Adjust for leg length inequality

• Allow for temporary contralateral orthotic interventions

Minimum Technical Requirements: Item must have all of the below features.

• Extra firm sponge rubber or equal (non-compressible)

• Tapered toward distal edge

• Size:

• Small (Narrow)

• Medium (Medium)

• Large (Wide)

• OR EQUIVALENT SIZES

• Height:

• 1/8”

• 3/8”

• 1/2”

CLIN 005 – GROUP 1 - CATEGORY 1 LPTA

DESCRIPTION: PREFABRICATED IN-SHOE FOOT ORTHOSES (L3040)

Need total: 2 products

Indications:

• Foot Pain, discomfort.

• Plantar Fasciitis

Minimum Technical Requirements: Item must have all of the below features.

• Female 5-13

• Male 7-15

• Full Length

• Deep heel contour

• Fabric top-cover - Sheer or non-abrasive texture

• PDAC approved.

• Multi-layer cushioning construction

CLIN 006 – GROUP 1 - CATEGORY 1 LPTA

DESCRIPTION: HEEL OFF-LOADING SHOE (A9283)

Need total: 2 products

Indications:

• Reduce weight bearing pressure on the heel postoperatively, post-trauma or when heel wounds or ulcerations are present.

Minimum Technical Requirements: Item must have all of the below features.

• Fits right or left

• Breathable Fabric Upper

• Top layer of shoe should be lightweight, non-toxic, odorless, nonabsorbent, washable, able to be disinfected and wiped clean and resilient

• Adjustable Closures at instep & forefoot

• Surgical Opening

• PDAC approved.

• Wedge Sole (In Plantarflexion) with good plantar traction

• Range Fits:

• All commercially available sizes

• Clearly indicate relative shoe sizing, visible on or through packaging

CLIN 007 – GROUP 1 - CATEGORY 1 LPTA

DESCRIPTION: FOREFOOT OFF-LOADING SHOE (A9283)

Need total: 2 products

Indications:

• Reduce weight bearing pressure on the forefoot post operatively, post-trauma or when forefoot wounds or ulcerations are present.

Minimum Technical Requirements: Item must have all of the below features.

• Fits Left or Right

• Breathable Fabric Upper

• Removable insole or adjustable pressure relief system

• Top layer of shoe should be lightweight, non-toxic, odorless, nonabsorbent, washable, able to be disinfected and wiped clean and resilient

• PDAC approved

• Adjustable Closures at instep & forefoot

• Surgical Opening

• Wedge Sole (In Dorsiflexion) with good plantar traction

• Equivalent shoe sizes on or visible through packaging

• Range Fits:

• Women’s size 5 to Men’s size 14

• Clearly indicate relative shoe sizing visible on or through packaging

CLIN 008 – GROUP 1 - CATEGORY 1 LPTA

DESCRIPTION: NIGHT SPLINT- PLANTAR SURFACE DESIGN, CLOSED CELL FOAM, DORI-

ASSIST ADJUSTABLE HOOK AND LOOP STRAPS (L4396)

Need total: 2 products

Indications:

• Plantar Fasciitis

• Achilles Tendonitis

Minimum Technical Requirements: Item must have all of the below features.

• Design: Non-ambulatory splint

• Size Range:

• Small (S)

• Medium (M)

• Large (L)

• Extra-Large (XL)

• Or Equivalent Sizes (between men’s 6 to 15)

• Calf Circumference: must accommodate minimum calf 12 inches

• Length: Full - foot length

• PDAC approved

• Closure: Hook & Loop Closures - calf, instep, and forefoot straps

• Material: Removable washable liner

• Semi-rigid frame with non-slip plantar sole

• Universal (fits Left or Right lower extremity)

CLIN 009 – GROUP 1 - CATEGORY 1 LPTA

DESCRIPTION: ANKLE ORTHOSIS, STIRRUP STYLE (L4350)

Need total: 2 products

Indications:

• Acute ankle injury (ankle sprains/strains)

• Chronic ankle instability

Minimum Technical Requirements: Item must have all of the below features.

• Stirrup design

• Size: Universal

• Closure that is reinforced and securely attached to plastic facilitating multiple donning and doffing

• Gel, pneumatic padding or foam material within a plastic shell adhered with Hook & Loop closure

• Adjustability:

• Medial/Lateral width of heel

• Circumferentially around ankle

• PDAC approved

• Height: Minimum 6”

GROUP 2 KNEE (CLINS 100 – 199)

CATEGORY 1: LOWEST PRICE TECHNICALLY ACCEPTABLE (LPTA)

CLIN 100 – GROUP 2 - CATEGORY 1 LPTA

DESCRIPTION: KNEE IMMOBILIZER (L1830)

Need total: 2 products

Indications:

• Post-Op or Post-Injury knee immobilization for mild to severe knee injuries when full knee extension is desired

Minimum Technical Requirements: Item must have all of the below features.

• Universal Tri-panel

• Hook & Loop Closures

• Minimum 4 Straps

• Minimum 2 straps (1½” or 2” width) proximal to the knee

• Minimum 2 straps (1½” or 2” width) distal to the knee

• Elastic strap providing compressive force to patella-minimum 1” width

• Malleable medial, lateral and posterior stays

• PDAC approved

• No sharp edges

• Non-Latex open celled foam

• Provide a range of sizes to include the following sizes:

• 16” Length

• 18” Length

• 20” Length

• 24” Length

• OR EQUIVALENT SIZES

• Must cover calf: 12” to 18”

• Must cover Thigh 14” to 25”

CLIN 101 – GROUP 2 - CATEGORY 1 LPTA

DESCRIPTION: IMMEDIATE POST-OP ROM KNEE ORTHOSIS-ADJUSTABLE LOCKING KNEE

JOINTS, POSITIONAL ORTHOSIS, RIGID SUPPORT, BREATHABLE OR OPEN

STYLE (L1832)

Need total: 2 products

Indications:

• For swollen or tender knee resulting from sprains, strains, sports injuries, ligamentous injuries, arthritis, chondromalacia, patellar tracking abnormalities and tendonitis or post-operative rehabilitation.

• Size:

• Universal (Will accommodate mid-thigh circumference of at least 27” or above)

• Length: Adjustable/telescoping- Minimum 18 1/2” or less; Maximum 27” or more

• Closure: hook & loop closure or equivalent. Must have two straps proximal to knee and two straps distal to knee.

• Material: Must come in “cool version” which has foam only under the straps. Open Cell Foam or equivalent material. No Latex.

• Knee joint component: Must have the ability to control range of motion with the ability to lock motion in 10 degree increments. Total range available must have Extension starting: -10 degrees to at least 110 degrees of Flexion. Range of motion increment stops should be clearly labeled according to the degree of measurement. Knee joint componentry must have the ability lock both the Extension limit and Flexion limit to be utilized to limit range of motion or fixed at a single ROM (e.g. 0 degrees).

• PDAC approved

• Special features: Contourable bars (aluminum)

CLIN 102 – GROUP 2 - CATEGORY 1 LPTA

DESCRIPTION: IMMEDIATE POST-OP ROM KNEE ORTHOSIS-ADJUSTABLE LOCKING KNEE

JOINTS, POSITIONAL ORTHOSIS, RIGID SUPPORT, FULL FOAM WRAP-

AROUND STYLE (L1832)

Need total: 2 products

Indication:

• For swollen or tender knee resulting from sprains, strains, sports injuries, ligamentous injuries, arthritis, chondromalacia, patellar tracking abnormalities and tendonitis or post-operative rehabilitation.

Minimum Technical Requirements: Item must have all of the below features.

• Size:

• Universal (Will accommodate mid-thigh circumference of at least 27”)

• Length: Adjustable/telescoping- Minimum 18 1/2” or less; Maximum at least 27”)

• Closure: hook & loop closure or equivalent. Must have two straps proximal to knee and two straps distal to knee.

• PDAC approved

• Material: Must come in full foam which has full foam circumferential wraps. Open Cell

Foam or equivalent material. No Latex.

• Knee joint component: Must have the ability to control range of motion with the ability to lock motion in 10 degree increments. Total range available must have Extension starting: -10 degrees to at least 110 degrees of Flexion. Range of motion increment stops should be clearly labeled according to the degree of measurement. Knee joint componentry must have the ability lock both the Extension limit and Flexion limit to be utilized to limit range of motion or fixed at a single ROM (e.g. 0 degrees).

• Special features: Contourable bars (aluminum)

GROUP 3: SPINAL (CLINS 200-299)

CATEGORY 1 LOWEST PRICE TECHNICALLY ACCEPTABLE (LPTA)

CLIN 200 – GROUP 3 - CATEGORY 1 LPTA

DESCRIPTION: LUMBAR-SACRAL ORTHOSIS (L0626, L0641)

Need total: 2 products

Indications:

• Low back pain/strain

• Lumbar disc injury

• Post-operative discectomy/fusion (L1-5)

• Disc herniation and degeneration

• Spondylolisthesis

• Spondylolysis

• Breathable fabric (Latex Free)

• Universal sizing – Adjustable to fit a waist circumference range from at least 28” – 60”

• Low Profile, Minimum L1 to L5

• Hook & loop closure

• Single or double pulley system (or similar) for abdominal cavity compression

• Semi-rigid posterior panel or stays within soft covering

• No exposed metal or plastic

CLIN 201 – GROUP 3 - CATEGORY 1 LPTA

DESCRIPTION: LUMBOSACRAL ORTHOSIS - WITHOUT POSTERIOR INSERT (L0628)

Need total: 2 products

Indications:

• Lower back pain

• Post-operative care

• Facet Syndrome

• Muscle spasms.

Minimum Technical Requirements: Item must have all of the below features.

• Design: Lumbar-sacral orthosis

• Size Range:

• Universal sizing – Adjustable to fit a waist circumference range from at least 25” – 60”

• Length: extends from sacrococcygeal junction to T-9 vertebrae)

• Closure: Hook & Loop Closure (adjustable side pull straps)

• PDAC approved

• Material: Drytex®, Koolflex® or equal (no latex)

• Support: Intra-abdominal support and posterior stays, Without posterior insert

*Salient Characteristics for Drytex®: Constructed of a nylon core and polyester/lycra fabric, breathable, provides compression, hypoallergenic and able to draw moisture away from the skin.

*Salient Characteristics for Koolflex®: Constructed of a polyester/nylon core with a polyester spandex outer cover. Breathable, has good stretch and memory and able to draw moisture away from the skin.If an equivalent product is being offered, documentation that demonstrates that the offered product meets the salient characteristics, as shown above, must be included with the technical proposal.

CLIN 202 – GROUP 3 - CATEGORY 1 LPTA

DESCRIPTION: ABDOMINAL BINDER (A4467)

Need total: 2 products

Indications:

• Lower back pain

• Control pendulous abdomen

• Muscle spasms

Minimum Technical Requirements: Item must have all of the below features.

• Design: abdominal binder, elastic wraparound

• Size Range Fits:

• Single sizes (not height) that fit a waist circumference range from 26” – 60”

• Length: extends from sacral-coccygeal junction to Thoracic vertebrae)

• Closure: Hook & Loop Closure

• PDAC approved

• Material: Lined elastic (No latex)

• Support: Intra-abdominal support, may include support stays within soft closure

• Height:

• 8”

• 10”

• 12”

CLIN 203 – GROUP 3 - CATEGORY 1 LPTA

DESCRIPTION: SEMI RIGID CERVICAL ORTHOSIS (L0172)

Need total: 1 product

Indications:

• Post-operative care

• Severe spinal arthritis

• severe cervical syndrome

• slipped cervical discs

• Stable cervical fractures

Minimum Technical Requirements: Item must have all of the below features.

• Universal Sizing – Circumference & height adjustments with secure locking feature

• Hook & Loop Closure (both sides)

• Anterior and Posterior Sections

• PDAC approved

• Adequate Tracheal Access

• Semi-rigid thermoplastic with removable & replaceable, washable, soft-lined padding.

• Must include 1 additional replacement set of pads

CLIN 204 – GROUP 3 - CATEGORY 1 LPTA

DESCRIPTION: CERVICAL COLLAR (L0120)

Need total: 2 products

Indications:

• Neck Extension Injuries (Whiplash)

• Cervical Spondylitis

• Cervical Spondylosis

• Rheumatoid Arthritis (R/A) & Osteoarthritis (OA) Cervical Spine

• Herniated Cervical Disc

Minimum Technical Requirements: Item must have all of the below features, and sizes.

• Design: Soft foam design

• Size: Universal

• Length: N/A

• Closure:

• Hook & loop

• Minimal length of strap should be 6 inches pile hook & loop closure for adjustability

• Minimum 2” hook & loop closure sewn on collar

• Strap extension to cover any exposed hook & loop closure for all sizes

• Minimum 1 Additional stockinette covering for hygiene

• PDAC approved

• Material:

• Medium density foam

• Contoured shape

• Soft tubular stockinet covering

• Height:

• 2 ½”

• 3”

• 4”

GROUP 4: UPPER EXTREMITY (CLINS 300-399)

CATEGORY 1 – LOWEST PRICE TECHNICALLY ACCEPTABLE (LPTA)

CLIN 300 – GROUP 4 - CATEGORY 1 LPTA

DESCRIPTION: HAND FINGER ORTHOSIS – THUMB SPICA; HFO WITHOUT JOINTS (L3923)

Need total: 2 products

Indications:

• De Quervaiin’s syndrome

• Sprains

• Strains

• Carpal tunnel syndrome

• Gamekeeper’s thumb

• Scaphoid injuries

• Design: Thumb Spica

• Size Range:

• Multiple Sizes that fit a wrist circumference measurement range from 5” to 12”

• 5” – 6”

• 6” – 7”

• 7” – 8”

• 8” – 9”

• 9” – 10”

• 10 1/2” – 12”

• OR EQUIVALENT SIZES

• Closure: Hook & Loop Closure

• Material: *Drytex®, *Koolflex® or equal (no latex)

• Thumb, Palmer and Dorsal stays that are Removable/Malleable

• PDAC approved

• Allows full ROM of digits 2-5

• Sides: must have both sides in various sizes

• Right

• Left

CLIN 301 – GROUP 4 - CATEGORY 1 LPTA

DESCRIPTION: HEEL/ELBOW PADS (E0191)

Need total: 2 products

Indications:

• Provides pressure relief for ulcerations at heel or elbow

• Protects against excessive pressure or contusion to heel or elbow

Minimum Technical Requirements: Item must have all of the below features.

• Pressure relief provided through elastomer gel or equivalent

• Breathable elastic, latex-free material that is machine washable

• Sleeve-type design to ensure proportional fit, minimizing migration

• Sold in pairs

• Minimum range of sizes to include:

• Medium (M)

• Large (L)

• Extra- Large (XL)

• Or Single Universal Size

• Universal for both heel and elbow

CLIN 302 – GROUP 4 - CATEGORY 1 LPTA

DESCRIPTION: ELBOW IMMOBILIZER – CUBITAL TUNNEL TYPE (L3762)

Need: 2 products

Indication:

• Cubital Tunnel Syndrome Minimum Technical Requirements: Item must have all of the below features.

• Provide elbow immobilization in a slightly flexed position (from full extension) around 122 degrees, prevent hyperextension.

• Hook & Loop Closure – adjustable length, minimum 1 ½" wide for comfort

• Soft breathable interface – removable for washing.

• Universal side – Left or Right

• Available in short, medium and long lengths, or all commercially available sizes.

GROUP 5: COMPRESSION THERAPY (CLINS 400 – 499)

CATEGORY 1 – LOWEST PRICE TECHNICALLY ACCEPTABLE (LPTA)

CLIN 400 – GROUP 5 - CATEGORY 1 LPTA

DESCRIPTION: LOW COMPRESSION NEUROPATHIC FOOT PROTECTIVE INTERFACE WITHOUT

ANTIBACTERIAL (A4467)

Need total: 1 product

Indications:

• Minimal edema

• Mild varicosities

• Neuropathic management

• Protective interface

• Type: Below the knee, non-constrictive proximal end, less than remaining stocking.

• Pressure: approximately 8-15 mmHg. Gradient/graduated pressure

• Size: Must be clearly marked on product

• Equivalent shoe sizes on or visible through packaging

• Range Fits:

• Women’s size 5 to Men’s size 14

• Clearly indicate relative shoe sizing

• OR EQUIVALENT SIZES

• Height: knee high

• Seams: Non-prominent seams.

• Closure: Compression relieved closed toe

• Material: Acrylic/multi-fiber

• Colors: at least 2, including

• White

• Black

• Without antibacterial, antifungal finish

• Packaging

• Minimalist packaging to reduce waste and space

• Sizing to be listed on the package or visible through packaging

CLIN 401- GROUP 5 - CATEGORY 1 LPTA

DESCRIPTION: LOW COMPRESSION NEUROPATHIC FOOT PROTECTIVE INTERFACE WITH

ANTIBACTERIAL (A4467)

Need total: 1 product

Indications:

• Minimal edema

• Mild varicosities

• Neuropathic management

• Protective interface

Minimum Technical Requirements: Item must have all of the below features.

• Type: Below the knee, non-constrictive proximal end, less than remaining stocking.

• Pressure: approximately 8-15 mmHg. Gradient/graduated pressure

• Size: Must be clearly marked on product

• Equivalent shoe sizes on or visible through packaging

• Range Fits:

• Women’s size 5 to Men’s size 14

• Clearly indicate relative shoe sizing

• Height: knee high

• Seams: Non-prominent seams.

• Closure: Compression relieved closed toe

• Material: Acrylic/multi-fiber

• Colors: at least 2, including

• White

• Black

• With antibacterial, antifungal finish

• Packaging

• Minimalist packaging to reduce waste and space

• Sizing to be listed on the package or visible through packaging.

List all advanced features: examples include but not limited to the following features:

• With antibacterial, antifungal treatment

• Moisture -wicking materials to include but not limited blends of cotton, wool and synthetic fibers