Independent Diagnostic Testing Facilities-Site Investigation {CMS-10221}

DEPARTMENT OF HEALTH AND HUMAN SERVICES CENTERS FOR MEDICARE & MEDICAID SERVICES Form Approved OMb No. 0938-1029 Independent dIagnostIc testIng FacIlItIes--sIte InvestIgatIon 42 cFR § 410.33 Date Ordered: _________________________ Date of First Visit: ______________________ Date of Second Visit: ______________________ Time: ______________________ Time: ______________________ 1. Reason FoR vIsIt Initial/Change Revalidation Hearing & Appeal Ad Hoc 2. FacIlIty InFoRmatIon Facility Name National Provider Identifier (NPI) Name of Authorized Representative(s) or Interviewee(s) Name of Authorized Representative(s) or Interviewee(s) Practice Location (Physical Street Address) City State Name of Authorized Representative(s) or Interviewee(s) Name of Authorized Representative(s) or Interviewee(s) Zip Code business Telephone Number 3. FacIlIty InspectIon a. peRFoRmance standaRd #3 performance standard #3 requires IDTFs to maintain a physical facility on an appropriate site. (photogRaph RequIRed) Office Suite-Mall Office Suite-Office building Private Residence Warehouse Other. Please describe: _____________________________ 1. Is the ITDF located on an appropriate site? If no, describe: Yes No ___________________________________________ ___________________________________________ ___________________________________________ 2. Is the IDTF handicap accessible? If no, describe: Yes No 3. Were there patients in the facility during the inspection? If no, describe: Yes No 4. If this IDTF is at a fixed location, does the facility contain adequate space for testing, including all tests listed on the enrollment application, facilities for hand washing, adequate patient privacy accommodations, and storage of business and medical records? If no, describe: Yes No N/A ___________________________________________ 5. If this IDTF is a mobile facility, does the mobile unit have access to facilities for hand washing, adequate patient privacy accommodations, and a home office location for the storage of business and medical records? If no, describe: Yes No N/A ___________________________________________ Form CMS-10221 (08/12) American LegalNet, Inc. www.FormsWorkFlow.com 1 B. peRFoRmance standaRd #4 performance standard #4 requires IDTFs to have all applicable diagnostic testing equipment available at the physical site (excluding portable diagnostic testing equipment). 1. Does the IDTF maintain a catalog of portable diagnostic equipment, including diagnostic testing equipment serial/registration numbers, at the physical site? If no, describe: Yes No N/A ___________________________________________ 2. Did the IDTF make the portable equipment or mobile unit(s) available for inspection? If no, describe: Yes No N/A ___________________________________________ ___________________________________________ 3. Does the IDTF maintain a current inventory of diagnostic equipment, including diagnostic testing equipment serial/registration numbers? If no, describe: Yes No 4. Has the IDTF provided updates to the MACs regarding equipment changes in accordance with existing regulation? If no, describe: Yes No ___________________________________________ c. peRFoRmance standaRd #5 performance standard #5 requires IDTFs to maintain a primary business phone under the name of the business. 1. Is the business telephone located at the IDTF or within the home office for the mobile IDTF? If no, describe: 2. Is the business telephone number listed in local telephone directory or is it available through directory assistance? If no, describe: Yes No ___________________________________________ Yes No ___________________________________________ d. peRFoRmance standaRd #6 performance standard #6 requires IDTFs to have comprehensive liability insurance in the amount $300,000 per facility. 1. Did the IDTF provide proof of insurance upon request? If no, describe: Yes No ___________________________________________ e. peRFoRmance standaRd #7 performance standard #7 states that IDTFs must agree not to directly solicit patients; this includes, but is not limited to, a prohibition on telephone, computer, or in-person contacts. How does the IDTF solicit new business? Describe: __________________________________________________________________________________________________________ __________________________________________________________________________________________________________ __________________________________________________________________________________________________________ F. peRFoRmance standaRd #8 performance standard #8 requires IDTFs to maintain a protocol regarding beneficiaries' complaints. 1. Does the supplier have a written complaint resolution procedure Yes No established? If no, describe: Form CMS-10221 (08/12) ___________________________________________ American LegalNet, Inc. www.FormsWorkFlow.com 2 g. peRFoRmance standaRd #9 performance standard #9 requires IDTFs to post these standards for beneficiary review. 1. Has the IDTF posted the standards found at 42 CFR § 410.33 in the IDTF or home office for a mobile IDTF? If no, describe: Yes No ___________________________________________ h. peRFoRmance standaRd #11 performance standard #11 requires IDTFs to have their diagnostic equipment calibrated and maintained per manufacturer's equipment instructions and in compliance with applicable manufacturer's suggested maintenance and calibration standards. 1. Does the IDTF have proof that diagnostic equipment has been calibrated and maintained per equipment instructions in accordance with manufacturer's instructions? If no, describe: If no, describe: Yes No ___________________________________________ ___________________________________________ 2. Did the IDTF provide a copy of the maintenance log upon request? Yes No I. peRFoRmance standaRd #12 performance standard #12 requires IDTFs to have technical staff on duty with the appropriate credentials to perform the tests. 1. Can the IDTF furnish the applicable Federal/State licenses and/or certifications for the individuals performing these services? If no, describe: Yes No ___________________________________________ Yes No 2. Can technical staff identify the supervising physician(s)? If yes, list name(s) of supervising physician(s) that was provided by the technician. _______________________________________________ If no, describe: ___________________________________________ ___________________________________________ ___________________________________________ 3. Is the supervis