10/7/ Immediate Action, Quest Diagnostics Nichols Institute, Valencia

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1 REDIRECTS Please Not all test codes assigned to each assay are listed in the table of contents. Please refer to the complete listing on the page numbers indicated. Test Code Test Name Effective Date Page # S52243 HLA-A,B Low Resolution Typing 10/9/ S51545 HLA-A,B,C Low Resolution Typing 10/9/ S52431 HLA-A29 Determination 10/9/ S51544 HLA-B27 Determination 10/9/ S52371 HLA-B51 Determination 10/9/ S51549 HLA-C Low Resolution Typing 10/9/ S51407 HLA-DQB1 Low Resolution Typing 10/9/ S51546 HLA-DR/DQ Low Resolution Typing 10/9/ S51550 HLA-DRB1 Low Resolution Typing 10/9/ DISCONTINUED TESTS Please Not all test codes assigned to each assay are listed in the table of contents. Please refer to the complete listing on the page numbers indicated. Test Code Test Name Effective Date Page # S51617 HLA A,B,C, DR-Quest Valencia- HLA Profile I 10/9/ S51552 HLA Typing for Narcolepsy 10/9/ S52122 HLA-B*1502 Typing 10/9/ S51551 HLA-B*5701 Typing 10/9/ SEND OUTS Please Not all test codes assigned to each assay are listed in the table of contents. Please refer to the complete listing on the page numbers indicated. Test Code Test Name Effective Date Page # HLA Typing for Narcolepsy 10/9/ HLA-B*15:02 Determination with Reflex to HLA-B High Resolution HLA-B*57:01 Determination with Reflex to HLA-B High Resolution 10/9/ /9/ Due to the background information related to these changes, we are unable to use our normal method of communication. These changes listed in this document are effective in less than 30 days. Please note the individual effective dates below, as some of these changes require IMMEDIATE ACTION. Announcement Effective October 9, 2104, Quest Diagnostics will no longer perform HLA (Human Leukocyte Antigen) testing in our Chantilly, VA Esoteric Laboratory. This change will affect only the immunogenetics and histocompatibility testing previously performed in Chantilly. It will NOT affect our HLA flow cytometry services, which will continue to be performed as usual throughout the company. All immunogenetics and histocompatibility testing previously performed at Chantilly will still be available through Quest Diagnostics but will be performed at BloodCenter of Wisconsin, in Milwaukee, WI. BloodCenter of Wisconsin has extensive experience with HLA typing for bone marrow and solid organ transplantation, as well as for non-transplant related areas such as platelet transfusion, transfusion related acute lung injury Page 1 of 11 The CPT Codes provided in this document are based on AMA guidelines and are for informational purposes only. CPT coding is the sole responsibility of the billing party. Please direct any questions regarding coding to the payor being billed. Any Profile/panel component may be ordered separately. Reflex tests are performed at an additional charge.

2 (TRALI), and disease association. HLA Typing for Celiac Disease, previously redirected to the UCLA Immunogenetics Center in Los Angeles, CA (as communicated in a recently prior laboratory update) will continue to be performed there. This decision to temporarily discontinue this testing was driven by our commitment to providing the best possible quality of testing for both our patients and our clients. Our full intention is to bring this testing back up within Quest Diagnostics in the future and we will update you as needed along the way. We deeply regret the short notice of this change and any temporary inconvenience this might have to your business. If you have any questions please do not hesitate to call either Katie Bishar, Vice President, Esoteric Operations at or David Murawski, Marketing Director, Infectious Disease & Immunology Clinical Franchise at Redirect HLA-A,B Low Resolution Typing HLA-A,B DNA Typing, Low Resolution S52243 Test Code HLA-A,B Low Resolution HLA-A,B,C Low Resolution Typing Page 2 of 11

3 HLA-A,B,C DNA Typing, Low Resolution S51545 Test Code HLA-A,B,C Low Resolution HLA-A29 Determination HLA - A29 DNA Typing S52431 Test Code Page 3 of 11

4 16773 HLA-A29 Determination HLA-B27 Determination HLA - B27 DNA Typing S51544 Test Code HLA-B27 Determination HLA-B51 Determination Page 4 of 11

5 HLA -B51 DNA Typing S52371 Test Code CHY Report available: 7-9 days HLA-B51 Determination HLA-C Low Resolution Typing HLA-C DNA Typing, Low Resolution S51549 Test Code Page 5 of 11

6 Set up: Mon-Sat; Report available: 5-7 days HLA-C Low Resolution HLA-DQB1 Low Resolution Typing HLA-DQB1 DNA Typing, Low Resolution S51407 Test Code Set up: Mon-Sat; Report available: 5-7 days HLA-DQB1 Low Resolution Page 6 of 11

7 HLA-DR/DQ Low Resolution Typing HLA-DRB1, DQB1 DNA Typing, Low Resolution S51546 Test Code CPT Codes HLA-DR/DQ Low Resolution HLA-DRB1 Low Resolution Typing HLA-DRB1 DNA Typing, Low Resolution S51550 Test Code Pediatric volumes: Page 7 of 11

8 If requesting more than one panel for HLA Transplant Testing, no more than 14 ml whole blood collected in an EDTA (lavender-top) tubes is required. If requesting more than one panel for HLA Transplant Testing, follow drawing instructions according to age as specified above. No more than what is specified by age is required HLA-DRB1 Low Resolution Discontinued Tests HLA A,B,C, DR-Quest Valencia- HLA Profile I Test Code S51617 The recommended alternatives are: HLA-ABC Low Resolution Typing HLA-DR/DQ Low Resolution Typing HLA Typing for Narcolepsy Test Code S51552 The recommended alternative is test code HLA Typing for Narcolepsy, in the Test Send Out (Referrals) Section. HLA-B*1502 Typing Test Code S52122 The recommended alternative is test code HLA-B*1502 Determination with Reflex to HLA-B High Resolution, in the Test Send Out (Referrals) Section HLA-B*5701 Typing Test Code S51551 The recommended alternative is test code HLA-B*57:01 Determination with Reflex to HLA-B High Resolution, in the Test Send Out (Referrals) Section. Test Send Out (Referrals) Page 8 of 11

9 Due to these assays being performed by outside vendors, we are unable to use our normal method of communication. Some of the changes listed in this document may be effective in less than 30 days. Please note the individual effective dates below, as these changes may require IMMEDIATE ACTION. HLA Typing for Narcolepsy Test Code CPT Codes 81377, (x2) Transport Temperature Specimen Stability Methodology Room temperature Room temperature and Refrigerated: 7 days Frozen: Unacceptable Sequence Specific Oligonucleotide Probes, Polymerase Chain Reaction HLA-Narcolepsy HLA-B*15:02 Determination with Reflex to HLA-B High Resolution Test Code CPT Codes Page 9 of 11

10 If requesting more than one panel for HLA Transplant Testing, no more than 14 ml whole blood collected in an EDTA (lavender-top) tubes is required. If requesting more than one panel for HLA Transplant Testing, follow drawing instructions according to age as specified above. No more than what is specified by age is required. Transport Temperature Specimen Stability Methodology Room temperature Room temperature and Refrigerated: 7 days Frozen: Unacceptable CHY Report available: 7-9 days Sequence Specific Oligonucleotide Probes, Polymerase Chain Reaction HLA-B*1502 w/rfl HLA-B High This is a true reflex. Please build the unit code below separately. Orderable Reflex: HLA-B High Resolution HLA-B High Resolution If HLA-B*15:02 is positive, then HLA B-High Resolution will be performed at an additional charge (CPT code (s): 81380). HLA-B*57:01 Determination with Reflex to HLA-B High Resolution Test Code CPT Codes Page 10 of 11

11 Transport Temperature Specimen Stability Methodology Room temperature Room temperature: 7 days Refrigerated: 7 days Frozen: Unacceptable Sequence Specific Oligonucleotide Probes, Polymerase Chain Reaction HLA-B*5701 w/rfl HLA-B High This is a true reflex. Please build the unit code below separately. Orderable Reflex: HLA-B High Resolution HLA-B High Resolution If HLA B*5701 is positive, then HLA B-High Resolution will be performed at an additional charge (CPT code (s): 81380). Page 11 of 11 Quest, Quest Diagnostics, the associated logo, Nichols Institute and all associated Quest Diagnostics marks are the trademarks of Quest Diagnostics Quest Diagnostics Incorporated. All rights reserved.

12/10/ Immediate Action, Quest Diagnostics Nichols Institute, Valencia

12/10/ Immediate Action, Quest Diagnostics Nichols Institute, Valencia NEW TESTS Please Note: Not all test codes assigned to each assay are listed in the table of contents. Please refer to the complete listing on the page numbers indicated. Test Code Test Name Effective Date