DEPARTMENT OF HEALTH AND HUMAN SERVICES CENTERS FOR MEDICARE & MEDICAID SERVICES OMB No. 09380581 CLINICAL LABORATORY IMPROVEMENT AMENDMENTS OF 1988 (CLIA) APPLICATION FOR CERTIFICATION I. GENERALINFORMATION Initial Application CLIA Identification Number Change in Certification Type (If an initial application leave blank, a number will be assigned) Facility Name Federal Tax Identification Number Telephone No. (Include area code) Fax No. (Include area code) Facility Address — Physical Location of Laboratory Mailing/Billing Address (If different from street address, include (Building, Floor, Suite if applicable.) attention line and/or Building, Floor, Suite) Number, Street (No P.O. Boxes) Number, Street City State ZIP Code City State ZIP Code Name of Director (Last, First, Middle Initial) II. TYPE OF CERTIFICATE REQUESTED (Check one) Certificate of Waiver (Complete Sections I – VI and VIII – X) Certificate for Provider Performed Microscopy Procedures (PPMP) (Complete Sections I – X) Certificate of Compliance (Complete Sections I – X) Certificate of Accreditation (Complete Sections I through X) and indicate which of the following organization(s) your laboratory is accredited by for CLIA purposes, or for which you have applied for accreditation for CLIA purposes. JCAHO AOA AABB CAP COLA ASHI If you are applying for a Certificate of Accreditation, you must provide evidence of accreditation for your laboratory by an approved accreditation organization for CLIA purposes or evidence of application for such accreditation within 11 months after receipt of your Certificate of Registration. According to the Paperwork Reduction Act of 1995, no persons are required to respond to a collection of information unless it displays a valid OMB control number. The valid OMB control number for this information collection is 0938-0581. The time required to complete this information collection is estimated to average 30 minutes to 2 hours per response, including the time to review instructions, search existing data resources, gather the data needed, and complete and review the information collection. If you have any comments concerning the accuracy of the time estimate(s) or suggestions for improving this form, please write to: CMS, Attn: PRA Reports Clearance Officer 7500 Security Boulevard Baltimore, Maryland 212441850 III. TYPE OF LABORATORY (Check the one most descriptive of facility type) 01 Ambulatory Surgery Center 02 Community Clinic 03 Comp. Outpatient Rehab. Facility 04 Ancillary Testing Site 05 End Stage Renal Disease 06 Health Fair 07 Health Main. Organization Health Service 08 Home Health Agency 09 Hospice Facility/Nursing Facility 10 Hospital 11 Independent 12 Industrial 13 Insurance 14 Intermediate Care Facility 15 Mobile Laboratory 16 Pharmacy Health Center 17 School/Student 18 Skilled Nursing 19 Physician Office 20 Other Practitioner (Specify) 21 Tissue Bank/Repositories 22 Blood Banks in Health Care Facility for Mentally Retarded 23 Rural Health Clinic 24 Federally Qualified Dialysis Facility 25 Ambulance 26 Public Health Laboratories 27 Other_____________________ Is this a Medicare/Medicaid certified facility? Yes No If yes, indicate Medicare provider number_______________________ Medicaid number _________________________ IV. HOURS OF LABORATORY TESTING (List times during which laboratory testingis performed) SUNDAY MONDAY TUESDAY WEDNESDAY THURSDAY FRIDAY SATURDAY FROM: AM PM TO: AM PM (For multiple sites, attach the additional information using the same format.) V. MULTIPLE SITES (must meet one of the regulatory exceptions to apply for this provision) Are you applying for the multiple site exception? No. If no, go to section VI. Yes. If yes, provide total number of sites under this certificate________ and complete remainder of this section. Indicate which of the following regulatory exceptions applies to your facility’s operation. Is this a notforprofit or Federal, State or local government Is this a hospital with several laboratories located at contiguous laboratory engaged in limited (not more than a combination buildings on the same campus within the same physical of 15 moderate complexity or waived tests per certificate) location or street address and under common direction that is public health testing and filing for a single certificate for filing for a single certificate for these locations? Yes No multiple sites? Yes No If yes, list name or department, location within hospital and If yes, list name, address and tests performed for each site below. specialty/subspecialty areas performed at each site below. If additional space is needed, check here and attach the additional information using the same format. NAME AND ADDRESS / LOCATION TESTS PERFORMED / SPECIALTY / SUBSPECIALTY Name of Laboratory or Hospital Department Address/Location (Number, Street, Location if applicable) City, State, ZIP Code Telephone Number Name of Laboratory or Hospital Department Address/Location (Number, Street, Location if applicable) City, State, ZIP Code Telephone Number Name of Laboratory or Hospital Department Address/Location (Number, Street, Location if applicable) City, State, ZIP Code Telephone Number VI. WAIVED TESTING Indicate the estimated TOTAL ANNUAL TEST volume for all waived tests performed __________________ VII. NONWAIVED TESTING (Including PPMP testing) If you perform testing other than or in addition to waived tests, complete the information below. If applying for one certificate for multiple sites, the total volume should include testing for ALL sites. Place a check in the box preceding each specialty/subspecialty in which the laboratory performs testing. Enter the estimated annual test volume for each specialty. Do not include testing not subject to CLIA, waived tests, or tests run for quality control, calculations, quality assurance or proficiency testing when calculating test volume. (For additional guidance on counting test volume, see the information included with the application package.) If applying for certificate of accreditation, indicate the name of the accreditation organization beside the applicable specialty/subspecialty for which you are accredited for CLIA compliance. (JCAHO, AOA, AABB, CAP, COLA or ASHI) SPECIALTY / ACCREDITING ANNUAL SPECIALTY / ACCREDITING ANNUAL SUBSPECIALTY ORGANIZATION TEST VOLUME SUBSPECIALTY ORGANIZATION TEST VOLUME HISTOCOMPATIBILITY Transplant HEMATOLOGY Hematology Nontransplant IMMUNOHEMATOLOGY MICROBIOLOGY ABO Group Bacteriology & Rh Group Mycobacteriology Antibody Detection Mycology (transfusion) Parasitology Virology Antibody Detection (nontransfusion) Antibody Identification DIAGNOSTIC Compatibility Testing IMMUNOLOGY Syphilis Serology PATHOLOGY General Immunology Histopathology Oral Pathology CHEMISTRY Cytology Routine Urinalysis RADIOBIOASSAY Endocrinology Radiobioassay Toxicology CLINICAL CYTOGENETICS Clinical Cytogenetics TOTAL ESTIMATED ANNUAL TEST VOLUME VIII. TYPE OF CONTROL VOLUNTARY NONPROFIT 01 Religious Affiliation 02 Private 03 Other _______________ (Specify) FOR PROFIT 04 Proprietary GOVERNMENT 05 City 06 County 07 State Enter the appropriate two digit code from the list below ________ (Enter only one code) 08 Federal 09 Other Government (Specify) IX. DIRECTOR AFFILIATION WITH OTHER LABORATORIES If the director of this laboratory serves as director for additional laboratories that are separately certified, please complete the following: NAME OF LABORATORY ADDRESS CLIA IDENTIFICATION NUMBER X. INDIVIDUALS INVOLVED IN LABORATORY TESTING Indicate the total number of individuals involved in laboratory testing (directing, supervising, consulting or testing). Do not include individuals who only collect specimens or perform clerical duties. For nonwaived testing, only count an individual one time, at the highest laboratory position in which they function. (Example: Pathologist serves as director, technical supervisor and general supervisor. This individual would only be counted once (under director).) A. WAIVED TESTING B. NONWAIVED TESTING (Including PPMP testing) Total No. of Individuals _____ Total No. of Individuals Technical supervisor Director General supervisor Clinical consultant Testing personnel Technical consultant Cytotechnologist Any person who intentionally violates any requirement of section 353 of the Public Health Service Act as amended or any regulation promulgated thereunder shall be imprisoned for not more than 1 year or fined under title 18, United States Code or both, except that if the conviction is for a second or subsequent violation of such a requirement such person shall be imprisoned for not more than 3 years or fined in accordance with title 18, United States Code or both. Consent: The applicant hereby agrees that such laboratory identified herein will be operated in accordance with applicable standards found necessary by the Secretary of Health and Human Servicesto carry out the purposes of section 353 of the Public Health Service Act as amended. The applicant further agrees to permit the Secretary, or any Federal officer or employee duly designated by the Secretary, to inspect the laboratory and its operations and its pertinent records at any reasonable time and to furnish any requested information or materials necessary to determine the laboratory's eligibility or continued eligibility for its certificate or continued compliance with CLIA requirements. SIGNATURE OF OWNER/DIRECTOR OF LABORATORY (Sign in ink) DATE THE CLINICAL LABORATORY IMPROVEMENT AMENDMENTS (CLIA) APPLICATION (FORM CMS116) INSTRUCTIONS FOR COMPLETION CLIA requires every facility that tests human specimens for the purpose of providing information for the diagnosis, prevention or treatment of any disease or impairment of, or the assessment of the health of, a human being to meet certain Federal requirements. If your facility performs tests for these purposes, it is considered, under the law, to be a laboratory. CLIA applies even if only one or a few basic tests are performed, and even if you are not charging for testing. In addition, the CLIA legislation requires financing of all regulatory costs through fees assessed to affected facilities. The CLIA application (Form CMS-116) collects information about your laboratory’s operation which is necessary to determine the fees to be assessed, to establish baseline data and to fulfill the statutory requirements for CLIA. This information will also provide an overview of your facility’s laboratory operation. All information submitted should be based on your facility’s laboratory operation as of the date of form completion. NOTE: WAIVED TESTS ARE NOT EXEMPT FROM CLIA. FACILITIES PERFORMING ONLY THOSE TESTS CATEGORIZED AS WAIVED MUST APPLY FOR A CLIA CERTIFICATE OF WAIVER. THE GENERAL INFORMATION SECTION AND ALL APPLICABLE SECTIONS MUST BE COMPLETED. INCOMPLETE APPLICATIONS CANNOT BE PROCESSED AND WILL BE RETURNED TO THE FACILITY. PRINT LEGIBLY OR TYPE INFORMATION. I. GENERALINFORMATION For an initial applicant, the CLIA identification number should be left blank. The number will be assigned when the application is processed. Be specific when indicating the name of your facility, particularly when it is a component of a larger entity; e.g., respiratory therapy department in XYZ Hospital. For a physician’s office, this may be the name of the physician. NOTE: The information provided is what will appear on your certificate. Facility street address must be the actual physical location where test ing is performed, including floor, suite and/or room, if applicable. DO NOT USE A POST OFFICE BOX NUMBER OR A MAIL DROP ADDRESS FOR THE NUMBER AND STREET OF THE ADDRESS. If the laboratory has a separate mailing or billing address, please complete that section of the application. II. TYPE OF CERTIFICATE REQUESTED When completing this section, please remember that a facility holding a: Certificate of Waiver can only perform tests categorized as waived;* Certificate for Provider Performed Microscopy Procedures (PPMP) can only perform tests categorized as PPMP, or tests categorized as PPMP and waived tests;* Certificate of Compliance can perform tests categorized as waived, PPMP and moderate and/or high complexity tests provided the applicable CLIA quality standards are met; and Certificate of Accreditation can perform tests categorized as waived, PPMP and moderate and/or high complexity tests provided the laboratory is currently accredited by an approved accreditation organization.** *A current list of waived and PPMP tests may be obtained from your State agency. Specific test system categorizations can also be reviewed via the Internet on www.cdc.gov/phppo/dls/. **If you are applying for a Certificate of Accreditation, you must provide evidence of accreditation for your laboratory by an approved accreditation organization for CLIA purposes or evidence of application for such accreditation within 11 months after receipt of your Certificate of Registration. III. TYPE OF LABORATORY Select the type of laboratory designation that is most appropriate for your facility from the list provided. If you cannot find your designation within the list, contact your State agency for assistance. IV. HOURS OF ROUTINE OPERATION Provide only the times when actual laboratory testing is performed in your facility. V. MULTIPLE SITES You can only qualify for the multiple site provision (more than one site under one certificate) if you meet one of the CLIA regulatory exceptions outlined on the form. VI. WAIVED TESTING Include only the estimated annual volume for those tests that are waived. VII. NONWAIVED TESTING (Including PPMP) Follow the specific instructions on page 3 of the Form CMS-116 when completing this section. (Note: The Accrediting Organization column should reflect accreditation information for CLIA purposes only; e.g., JCAHO, etc.). VIII. TYPE OF CONTROL Select the code which most appropriately describes your facility. Proprietary/for profit entities must choose “04”. IX. DIRECTOR AFFILIATION WITH OTHER LABORATORIES List all other facilities for which the director is responsible. Note that for a Certificate of PPMP, Certificate of Compliance or Certificate of Accreditation, an individual can only serve as the director for no more than five certificates. X. INDIVIDUALS INVOLVED IN LABORATORY TESTING Self explanatory Once the completed Form CMS-116 has been returned to the applicable State agency and it is processe d, a fee remittance coupon will be issued. The fee remittance coupon will indicate your CLIA identification number and the amount due for the certificate, and if applicable the compliance (survey) or validation fee. If you are applying for a Certificate of Compliance or Certificate of Accreditation, you will initially pay for and receive a Registration Certificate. A Registration Certificate permits a facility requesting a Certificate of Compliance to perform testing until an onsite inspection is conducted to determine program compliance; or for a facility applying for a Certificate of Accreditation, until verification of accreditation by an approved accreditation organization is received by CMS. If you need additional information concerning CLIA, or if you have questions about completion of this form, please contact your State agency. TESTS COMMONLY PERFORMED AND THEIR CORRESPONDING LABORATORY SPECIALTIES/SUBSPECIALTIES HISTOCOMPATABILITY HLA Typing (disease associated antigens) SYPHILIS SEROLOGY RPR FTA, MHATP GENERAL IMMUNOLOGY Mononucleosis Assays Rheumatoid Arthritis Febrile Agglutins Cold Agglutinins HIV Antibody Assays (hepatitis, herpes, etc.) ANA Assays Mycoplasma pneumoniae Assays PARASITOLOGY Direct Preps Ova and Parasite Preps Wet Preps CHEMISTRY Routine Chemistry Albumin BUN Ammonia Uric acid Bilirubin, Total ALT/SGPT Bilirubin, direct AST/SGOT Calcium SGGT Chloride Alk Phos Cholesterol, total Amylase CO2, total CPK/CPK isoenzymes Creatinine CKMB Glucose HDL Cholesterol pH Iron pO2 LDH pCO2 LDH isoenzymes Phosphorous Magnesium Potassium Ferritin Protein, total Folic Acid Sodium Vitamin B12 Triglycerides PSA Urinalysis Automated urinalysis Urinalysis with microscopic analysis Urine specific gravity by refractometer Urine specific gravity by urinometer Urine protein by sulfasalicylic acid BACTERIOLOGY Gram Stains Cultures Sensitivities Strep Screens Antigen assays (chlamydia, etc.) H. pylori MYCOBACTERIOLOGY Acid Fast Smears Mycobacterial Cultures Sensitivities MYCOLOGY Fungal Cultures DTM KOH Preps VIROLOGY RSV HPV assays Cell cultures Endocrinology TSH Free T4 Total T4 Trilodothyronine (T3) T3 Uptake Ferritin Folate PSA B12 SerumbetaHCG Toxicology Acetaminophen Primidine Blood alcohol Procainamide Carbamazephine NAPA Digoxin Quinidine Ethosuximide Salicylates Gentamycin Theophylline Lithium Tobramycin Phenobarbitol Valproic acid Phenytoin HEMATOLOGY WBC count RBC count Hemoglobin Hematocrit (Other than spun micro) Platelet Differential MCV Activated Clotting Time Prothrombin time Partial thromboplastin time Fibrinogen Reticulocyte count Manual WBC by hemocytometer Manual platelet by hemocytometer Manual RBC by hemocytometer Sperm count RADIOBIOASSAY Red cell volume Schilling’s test IMMUNOHEMATOLOGY ABO group Rh(D) type Antibody Screening Antibody Identification Compatability testing PATHOLOGY Dermatopathology Oral pathology PAP smear interpretations Other cytology tests Histopathology CYTOGENETICS Fragile X Buccal smear GUIDELINES FOR COUNTING TESTS FOR CLIA For histocompatibility, each HLA typing (including disease associated antigens), HLA antibody screen, or HLA crossmatch is counted as one test. For microbiology, susceptibility testing is counted as one test per group of antibiotics used to determine sensitivity for one organism. Cultures are counted as one per specimen regardless of the extent of identification, number of organisms isolated and number of tests/procedures required for identification. Testing for allergens should be counted as one test per individual allergen. For chemistry profiles, each individual analyte is counted separately. For urinalysis, microscopic and macroscopic examinations, each count as one test. Macroscopics (dipsticks) are counted as one test regardless of the number of reagent pads on the strip. For complete blood counts, each measured individual analyte that is ordered and reported is counted separately. Differentials are counted as one test. Do not count calculations (e. g., A/G ratio, MCH, and T7), quality control, quality assurance and proficiency testing assays). For immunohematology, each ABO, Rh, antibody screen, crossmatch or antibody identification is counted as one test. For histopathology, each block (not slide) is counted as one test. Autopsy services are not included. For those laboratories that perform special stains on histology slides, the test volume is determined by adding the number of special stains performed on slides to the total number of specimen blocks prepared by the laboratory. For cytology, each slide (not case) is counted as one test for both Pap smears and nongynecologic cytology. For cytogenetics, the number of tests is determined by the number of specimen types processed on each patient; e.g., a bone marrow and a venous blood specimen received on one patient is counted as two tests.