UPDATE…UPDATE…UPDATE…UPDATE ... - Interpath Labs



As an Interpath customer who receives electronic results or sends electronic orders you may need to be notified when we update our Service Manual. Although we try to keep these changes to a minimum, laboratory medicine is an evolving industry requiring changes to our technology from time to time. Depending on the requirements of your EMR or Hospital Information System you may be required to make similar changes to your system in order to correctly process inbound electronic results and create outbound electronic orders.

If you are uncertain that you are required to update your system we recommend that you contact your vendor for more information. As your laboratory service provider we are available to participate in the discussion with your vendor so that you clearly understand the impact of these changes.

Included in this email:

• This cover letter with a summary of the changes

• Microsoft Word® Document with the detail of these changes to our Service Manual

Additional information including our most recent Service Manual and additional contact information can be found at

Effective Date: May 18, 2017

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On 17 May 2017, the Food and Drug Administration (FDA) issued a safety communication warning about venous blood lead testing on the Magellan Diagnostics’ LeadCare® analyzers. Specifically, the FDA stated, “FDA is now advising that Magellan Diagnostics’ LeadCare® analyzers should no longer be used with venous blood samples.” In response, Interpath Laboratory immediately ceased in-house testing and is now sending all venous testing to ARUP Laboratories.

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|Specimen: |

| |Collect: |One Royal Blue (EDTA)   |

| |Submit: |6 mL (Min:0.5 mL) Whole blood in Royal Blue (EDTA). Submit Ambient.   |

| |Special |Stability: If the specimen is drawn and stored in the appropriate container, the trace element values do not change with time. |

| |Handling: |Ambient: Indefinitely; Refrigerated: Indefinitely; Frozen: Unacceptable   |

| |Rejection |Clotted Specimen |

| |Criteria: |Heparinized specimens |

| | |Serum  |

|Methodology: |Quantitative Inductively Coupled Plasma-Mass Spectrometry   |

|Performed: |Sun-Sat  |

|Reported: |2-3 Day(s)  |

|CPT Codes: |83655 |

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2016      Lead, Blood, Children DC

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|90300      Lead, Capillary NT |

|Specimen: |

| |Collect: |One Lavender (EDTA)   |

| |Submit: |0.5 mL (Min:0.3 mL) Whole blood in Lavender (EDTA). Submit Ambient.   |

| |Special Handling: |Patient Preparation: Clean puncture site well with soap and water before collection procedure begins. |

| | |Specimen Preparation: Invert specimen 10 times to prevent clot formation. |

| | |Stability: If the specimen is drawn and stored in the appropriate container, the lead values do not change with time.   |

| |Rejection |Frozen Whole Blood |

| |Criteria: |Heparin Anticoagulant  |

|Methodology: |Quantitative Inductively Coupled Plasma-Mass Spectrometry   |

|Performed: |Sun-Sat  |

|Reported: |2-3 Day(s)  |

|CPT Codes: |83655 |

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|5215      PAP with HPV AOE |

|Specimen: |

| |Collect: |Gynecological Sample in ThinPrep PreservCyt Media |

| | | |

| | |Also Acceptable |

| | |Gynecological Sample in SurePath Liquid Pap Media  |

| |Submit: |ThinPrep PreservCyt Media. Submit Ambient. |

| | | |

| | |Also Acceptable |

| | |SurePath Liquid Pap Media. Submit Ambient.   |

| |Special Handling: |State Source |

| | |Follow manufacturer's guidelines for sample collection. |

| | | |

| | |SurePath Stability: Refrigerated: 14 Days, Ambient: 14 Days.   |

| |Rejection |Specimen collected in an improper storage container.   |

| |Criteria: | |

| |Stability: |Ambient: 1 Month(s); Refrigerated: 1 Month(s); Frozen: Unacceptable; Incubated: Unacceptable  |

|Methodology: |Target Amplified Nucleic Acid Probe; ThinPrep processing system / Surepath processing system  |

|Performed: |Mon-Fri  |

|Reported: |3-6 Day(s)  |

|CPT Codes: |87624 |

| |88175 |

| | |

|Components: |5211 - PAP, Liquid |

| |93657 - HPV, HIGH RISK |

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Please add Ask on Order Entry Questions, see the attached compendium.

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|5217      PAP with HPV reflex to Genotyping AOE |

|Specimen: |

| |Collect: |Gynecological Sample in ThinPrep PreservCyt Media |

| | | |

| | |Also Acceptable |

| | |Gynecological Sample in SurePath Liquid Pap Media  |

| |Submit: |ThinPrep PreservCyt Media. Submit Ambient. |

| | | |

| | |Also Acceptable |

| | |SurePath Liquid Pap Media. Submit Ambient.   |

| |Special Handling: |State Source |

| | |Follow manufacturer's guidelines for sample collection. |

| | |Positive HPV will reflex to HPV 16 & 18/45 Genotype (test#93697). Additional charges will apply. |

| | | |

| | |SurePath Stability: Refrigerated: 14 Days, Ambient: 14 Days.   |

| |Rejection |Specimen collected in an improper storage container.   |

| |Criteria: | |

| |Stability: |Ambient: 1 Month(s); Refrigerated: 1 Month(s); Frozen: Unacceptable; Incubated: Unacceptable  |

|Methodology: |Target Amplified Nucleic Acid Probe; ThinPrep processing system / Surepath processing system  |

|Performed: |Mon-Fri  |

|Reported: |3-6 Day(s)  |

|CPT Codes: |87624 |

| |88175 |

| | |

|Components: |5211 - PAP, Liquid |

| |93657 - HPV, HIGH RISK |

| | |

Please add Ask on Order Entry Questions, see the attached compendium.

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|5219      PAP with Neisseria Gonorrhea and Chlamydia RNA AOE |

|Specimen: |

| |Collect: |Gynecological Sample in ThinPrep PreservCyt Media |

| | | |

| | |Also Acceptable |

| | |Gynecological Sample in SurePath Liquid Pap Media  |

| |Submit: |ThinPrep PreservCyt Media. Submit Ambient. |

| | | |

| | |Also Acceptable |

| | |SurePath Liquid Pap Media. Submit Ambient.   |

| |Special Handling: |State Source |

| | |Follow manufacturer's guidelines for sample collection. |

| | | |

| | |SurePath Stability: Refrigerated: 10 Days, Ambient: 10 Days.   |

| |Rejection |Specimen collected in an improper storage container.   |

| |Criteria: | |

| |Stability: |Ambient: 1 Month(s); Refrigerated: 1 Month(s); Frozen: Unacceptable; Incubated: Unacceptable  |

|Methodology: |Target Amplified Nucleic Acid Probe; ThinPrep processing system / Surepath processing system  |

|Performed: |Mon-Fri  |

|Reported: |3-6 Day(s)  |

|CPT Codes: |87491 |

| |87591 |

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| |88175 |

| | |

| | |

|Components: |5211 - PAP, Liquid |

| |1132 - N. GONORRHEA AND CHLAMYDIA RNA |

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Please add Ask on Order Entry Questions, see the attached compendium.

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|5223      PAP with Neisseria Gonorrhea, Chlamydia, and Trichomonas RNA AOE |

|Specimen: |

| |Collect: |Gynecological Sample in ThinPrep PreservCyt Media   |

| |Submit: |ThinPrep PreservCyt Media. Submit Ambient.   |

| |Special Handling: |State Source |

| | |Follow manufacturer's guidelines for sample collection.   |

| |Rejection |Specimen collected in an improper storage container.   |

| |Criteria: | |

| |Stability: |Ambient: 1 Month(s); Refrigerated: 1 Month(s); Frozen: Unacceptable; Incubated: Unacceptable  |

|Methodology: |Target Amplified Nucleic Acid Probe; ThinPrep processing system / Surepath processing system  |

|Performed: |Mon-Fri  |

|Reported: |3-6 Day(s)  |

|CPT Codes: |87491 |

| |87591 |

| | |

| |87661 |

| |88175 |

| | |

|Components: |5211 - PAP, Liquid |

| |2826 - N.GON./CHLAMYDIA/TRICHOMONAS RNA |

| | |

Please add Ask on Order Entry Questions, see the attached compendium.

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|5225      PAP with HPV, Neisseria Gonorrhea, Chlamydia, and Trichomonas RNA AOE |

|Specimen: |

| |Collect: |Gynecological Sample in ThinPrep PreservCyt Media   |

| |Submit: |ThinPrep PreservCyt Media. Submit Ambient.   |

| |Special Handling: |State Source |

| | |Follow manufacturer's guidelines for sample collection.   |

| |Rejection |Specimen collected in an improper storage container.   |

| |Criteria: | |

| |Stability: |Ambient: 1 Month(s); Refrigerated: 1 Month(s); Frozen: Unacceptable; Incubated: Unacceptable  |

|Methodology: |Target Amplified Nucleic Acid Probe; ThinPrep processing system / Surepath processing system  |

|Performed: |Mon-Fri  |

|Reported: |3-6 Day(s)  |

|CPT Codes: |87491 |

| |87591 |

| | |

| |87624 |

| |87661 |

| | |

| |88175 |

| | |

| | |

|Components: |5211 - PAP, Liquid |

| |93657 - HPV, HIGH RISK |

| | |

| |2826 - N.GON./CHLAMYDIA/TRICHOMONAS RNA |

| | |

| | |

Please add Ask on Order Entry Questions, see the attached compendium.

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