APPENDIX C

KEY to REGISTRATION CERTIFICATES

Certificate for Minimally Complex Testing

Testing limited to: Non-automated urinalysis (dipstick/tablet reagent); fecal/gastric occult blood; visual color ovulation and urine pregnancy tests; blood glucose by devices cleared by the FDA for home use; non-automated ESR; non-automated hemoglobin; spun hematocrit; hemoglobin by single analyte instruments; Group A Strep tests; H. pylori tests; rapid cholesterol tests.

Personnel Requirements: No defined educational level requirement

Proficiency testing: None required

Inspections: As required

Reference: Chapters 2 & 3, TM 8-XXX/NAVMED P-XXXX/AFI 41-XXX

Certificate for Provider-Performed Microscopy

Testing limited to: Wet mounts; KOH preps, fern tests; post-coital direct exams of vaginal/cervical mucous; pinworm exams; urine sediment; nasal smear for granulocytes; fecal leukocyte exams; qualitative semen analysis.

Personnel Requirements: Must be performed by physician, Nurse Practitioner, Nurse Midwife, PA or Dentist at time of patient visit

Proficiency testing: Required where available

Inspections: As required

Reference: Chapters 2 & 4, TM 8-XXX/NAVMED P-XXXX/AFI 41-XXX

Certificate for Moderate Complexity Testing

Testing includes: Waived tests; provider performed microscopy, plus: automated chemistry; basic bacteriology; automated hematology; non-transfusion related Immunohematology.

Proficiency Testing: All named analytes

Inspections: Every 2 years

Reference: Chapters 2 & 5, TM 8-XXX/NAVMED P-XXXX/AFI 41-XXX

Certificate for High Complexity Testing

Testing Includes: All in moderately complex, plus: Parasitology; transfusion related Immunohematology; manual procedures; microbiology; histopathology; cytology

Personnel Requirements: Must satisfy requirements for: Director, Clinical Consultant, Technical Supervisor, General Supervisor and Testing Personnel

Proficiency Testing: All named analytes

Inspections: Every 2 years

Reference: Chapters 2 & 5, TM 8-XXX/NAVMED P-XXXX/AFI 41-XX

APPENDIX D

INSTRUCTIONS FOR COMPLETING REGISTRATION FORMS

The DOD CLIP Registration Form (DD Form XXXX) is a six-page document that covers all the registration types. You need only complete those portions that apply to your laboratory.

Minimally Complex Testing - Sections I, II, III, IV, V

Provider Performed Microscopy - Sections I, II, III, IV, VI

Moderate or High Complexity - Sections I, II, III, IV, VII (multiple sites only), VIII, IX, X

Section I. General Information

The requested information is self-explanatory. Mail the completed form to the address in the upper right-hand corner.

Section II. Type of Certificate

Circle only one selection per registration form. The differences between a certificate for a single site and one for multiple sites are:

A. Single Certificate at Each Site:

1. Each site requires a director. One director may direct a maximum of 5 highly complex or moderately complex labs.

2. Certificate must be for highest level of testing performed.

3. Director must assure personnel, quality control, and proficiency testing requirements are met for each site.

4. Proficiency test program required for each site (failure does not affect other sites).

5. Separate accreditation required for each site.

B. Single Certificate for Multiple Sites:

1. Same director for all sites. Director must assure personnel, quality control, and proficiency testing requirements are met for each site under certificate. Certificate must be for highest level of testing performed.

2. Single proficiency testing program for primary method; failure of primary method affects all sites; secondary methods must be validated with primary method every 6 months.

3. Accreditation must include inspection of all sites under certificate.

The appropriate chapters of the Technical Manual discuss the different types of testing in detail.

Section III. Type of Laboratory

Circle one selection from each column to accurately define the type of laboratory that this registration form is being completed for.

Section IV. Laboratory Accreditation

If your laboratory is currently accredited by a non-Federal laboratory accrediting organization, indicate your accreditation number in the appropriate space.

The names and signatures of the Laboratory Director and Facility Commander are required on the bottom of the page along with the name of the individual completing the form.

Section V. Sites Performing Minimally Complex Tests Only

The name, SSAN, level of education and status must be indicated for the person assuming responsibility for the minimally complex sites being registered. This section has blocks for registering up to 3 sites per page. Make copies of the page to register more sites. Check the blocks for the minimally complex tests to be performed at each site along with the number of personnel in each category that will be performing testing. This is as far as you need to go to register your laboratory(s) as minimally complex. Mail the form to the address indicated.

Section VI. Sites Performing Provider Performed Microscopy Tests Only

The name, SSAN, level of education and status must be indicated for the person assuming responsibility for the provider performed microscopy sites being registered. This section has blocks for registering up to 3 sites per page. Make copies of the page to register more sites. Check the blocks for the provider performed microscopy tests to be performed at each site along with the number of personnel in each category that will be performing testing. This is as far as you need to go to register your laboratory(s) as provider performed microscopy sites. Mail the form to the address indicated.

Section VII. Multiple Sites (Moderate/High Complexity Registration)

If in Section II, you circled Moderate or High Complexity for Multiple Sites, you must fill out the information on this page for each site that you are registering under this certificate. You can register the maximum of 5 moderately complex or 5 highly complex sites per director on this page. When finished, go to Sections VIII/IX/X.

Section VIII. Sites Performing Tests of Moderate or High Complexity

For each site you indicated in section VII, or for a single Moderate or High Complexity lab that you are registering, provide the information indicated. The explanation of the codes used for personnel qualification can be found in appendix E. You should have one section VIII completed per site being registered.

Section IX. Test Volume Information - Moderate and High Complexity Testing

For each site you indicated in section VII, or for a single Moderate or High Complexity lab that you are registering, provide the information indicated. Indicate which of the specialty/ subspecialty tests you will be performing in each lab and the test volume for the specialties. You should have one section IX completed per site being registered.

Section X. Laboratory Test Information - Moderate and High Complexity Testing

For each site you indicated in section VII, or for a single Moderate or High Complexity lab that you are registering, provide the information indicated. If your laboratory is CAP accredited, you do not need to complete this section, the information is provided to CAP when you apply for your accreditation inspection. You should have one section X completed per site being registered.

When finished, insure the form is signed by the Laboratory Director and Facility Director and send it to the address in the upper right hand corner of page 1.