4-Attachment B - Scope of Work.docx

ATTACHMENT B

SCOPE OF WORK

GENETIC TESTING

Article 1

DEFINITIONS

1.1 Definitions. In this contract, the following definitions apply:

(a) “AABB” means the Association for the Advancement for Blood and Biotherapies.

(b) “ASHI” means the American Society for Histocompatibility and Immunogenetics.

(c) “Parentage” means the state or fact of being the biological father of a particular child.

(d) “Phlebotomist” also called phlebotomy technicians means to work directly with the client to draw blood using venipuncture or skin puncture or buccal cells for laboratory Tests.

(e) “Records” means written or electronic genetic testing information and results.

(f) “Sample” means a small amount of material collected to provide information about its source. Collection commonly involves a buccal smear or may be collected by blood or other biological sources.

(g) “sFTP” means Secure File Transfer Protocol. It is the process to move files securely between DHHS and the Contractor.

(h) “Tests” means genetic Tests to determine Parentage.

Article 2

CERTIFICATION

2.1 Certification. The Contractor shall:

(1) maintain certification by the AABB or a successor of its functions or by the ASHI or a successor of its functions; and

(2) ensure its Phlebotomists have all certification required by Utah laws and regulations.

Article 3

REQUIREMENTS

2.1

3.1 General Requirements. The Contractor shall:

(1) provide a laboratory and genetic testing services to appropriately collect and test all Samples collected; and

(2) provide a level of service in strict compliance with AABB or ASHI guidelines for all Samples collected locally, nationally, or internationally.

1.1 2.1 3.1

3.2 Sample Collection Requirements. The Contractor shall:

(1) obtain Samples from all clients being tested;

(2) provide a certified Phlebotomist and the necessary phlebotomy supplies to collect Samples;

(3) ensure any Phlebotomist, person, or entity hired as a subcontractor by the Contractor is approved in writing by DHHS prior to the subcontractor providing services;

(4) ensure the Phlebotomist completes annual training provided by DHHS concerning data security;

(5) have Phlebotomists submit to and pass background screenings and security requirements, facilitated by DHHS, for direct access to DHHS clientele outlined in Utah Code 26B-2-120;

(6) provide a digital or instant camera to the Phlebotomist, photograph the Test subject, and attach the photograph to the chain of custody forms at the time of the Test;

(7) provide the client authorization and chain of custody forms necessary to schedule sampling locally, nationally, or internationally. Forms must include a way to designate correct DHHS billing codes;

(8) collect the type of Sample requested by DHHS. DHHS primarily relies on buccal cells. Blood cells or other cell sources may be used in limited circumstances which must be noted on the client authorization form in the special instructions box;

(9) comply with the chain of custody requirements set forth in Utah Code 81-5-504;

(10) verify client identity by the following procedures:

(A) requesting one form of government photo identification. This identification must be documented on the chain of custody form and used to verify the client’s and date of birth; and

(B) if the client does not have photo identification, the Contractor shall ask for two forms of government issued identification, such as a birth certificate and Social Security card. When no proper identification is available, the Phlebotomist shall contact the DHHS agent to obtain permission to proceed;

(11) obtain informed consent prior to Sample collection by asking the client to sign and date the form. In the case of a minor child, the informed consent form requires a signature from a parent or legal guardian;

(12) document attendance, noting who did and did not appear, for the Sample collection.

(13) verify the reason and notify the requesting DHHS office within five days of clients failing to attend their appointment when Samples are not received by the expected date;

(14) ensure that Samples are not interchanged at the time of sampling by:

(A) admitting only one client, and if needed with a guardian, to the sampling area at a time;

(B) preparing envelopes for the Samples specimens, recording the client’s name, relationship, date and time, racial background and the case number;

(C) affixing a label to each Sample that contains a unique identification for each Sample collected, collection date, and the initials of the Phlebotomist collecting the Sample;

(D) ensuring that the person who provides legal consent for the Sample collection verifies the accuracy of its affixed label in writing;

(E) ensuring all Samples are handled by the Phlebotomist and not allow Test participants to pack or transfer Samples; and

(F) ensuring Samples transported to the laboratory are sealed in a tamper proof package by the Phlebotomist;

(15) provide Tests locally, nationally, and internationally to establish Parentage for DHHS child support cases;

(16) coordinate with DHHS to prearrange the collection site, ensuring the location of Specimen collection is mutually known to the Contractor and DHHS;

(17) provide Specimen collection services in institutional settings;

(18) perform Tests for clients requested by the DHHS agent at the ORS designated office;

(19) collect the majority of Samples at the following DHHS offices:

(A) Office of Recovery Services 2540 Washington Blvd, 4th Floor Ogden, UT 84401

(B) Office of Recovery Services 150 E Center STE 2100 Provo, UT 84606

(C) Office of Recovery Services 4315 S 2700 W, 1st Floor Taylorsville, UT 84129

(D) Office of Recovery Services

33 N 100 W, STE 100

St. George, UT 84770;

(20) provide genetic Sample collection services at other locations throughout Utah when DHHS office locations are not practical;

(21) provide genetic Sample collection for incarcerated individuals both inside and outside the State of Utah;

(22) schedule all clients residing in the state of Utah to be tested and coordinate the time and place of Tests with the DHHS agent;

(23) make every effort to arrange Sample collection to ensure that, whenever possible, all client Samples arrive at the laboratory at the same time. In cases where this is not possible, or does not occur as scheduled, the Contractor shall test Samples received and rescheduled the clients not yet sampled;

(24) notify DHHS within 48 hours of the date, time, and location of scheduled appointments when scheduling testing appointments outside the state of Utah;

(25) notify DHHS of all clients who reside within the State of Utah who fail to attend their scheduled appointments;

(26) provide overnight courier service between the collection sites and the laboratory; and

(27) inform DHHS of all nonviable specimens collected within 48 hours of arrival at the laboratory.

(a) (b) (c) (d) (e)

3.3 Tests Requirements. The Contractor shall:

(1) provide Tests using polymerase chain reaction;

(2) use a Test battery with a minimum of 15 DNA systems for each case at no additional cost to DHHS;

(3) perform an amelogenin Test on each client tested and send findings to the requesting DHHS office in the case of fraud, or unusual genetic findings which may have the potential to hinder the paternity proceedings;

(4) provide a probability of paternity of at least 99% for inclusionary cases as calculated by using the combined paternity index obtained in the testing;

(5) ensure genetic testing adheres to the following:

(A) presumption of natural fatherhood if the genetic Parentage testing results in a Parentage index of 100 to 1;

(B) findings of non-Parentage must be based on a minimum of three DNA inconsistencies; and

(C) Double Blind Testing must be performed upfront on every client case, regardless of results;

(6) ensure laboratory Test results are interpreted by two qualified technical staff members and certified by a qualified, experienced expert holding a Ph.D. in a biological or biomedical science field;

(7) have the ability to perform motherless paternity calculations and Test various types of specimens, including tissue from deceased individuals, or any other unusual cases;

(8) have the ability to crossmatch Samples from various testing laboratories; and

(9) provide Tests to the following individuals when a Test specimen is not available from an alleged father and if ordered by the court:

(A) the parents of the alleged father;

(B) brothers or sisters of the alleged father;

(C) other children of the alleged father and their mother(s); and

(D) other relatives of the alleged father necessary to complete genetic Parentage testing.

3.4 Tests Results and Invoicing. The Contractor shall:

(1) present professional certified laboratory Test results, signed and notarized by a designee of the testing laboratory, to the DHHS office in a scientifically meaningful format, ensure the Test results are useful to non-technical readers, and maintain all genetic reports on accreditation standards;

(2) transmit genetic Test results as PDF documents via sFTP to the DHHS sFTP server, using Domain Name Services address orssftp.dhhs.utah.gov, within 24 hours of completed Test results;

(3) transmit the PDF documents using the DHHS case number as the file name;

(4) transmit all Test results via sFTP and include an attached invoice;

(5) resubmit any electronic Test result that is corrupted in the transmission within 24 hours of notification by DHHS;

(6) submit to DHHS clear photographs of alleged parents;

(7) submit photographs of sufficient quality and clarity to allow anyone viewing the photograph to clearly identify the person depicted;

(8) ensure unrecognizable photographs are not submitted for payment to DHHS and acknowledge they are ineligible for payment;

(9) send original invoices electronically via email to DHHS Financial Services at leastorsfinance@utah.gov once per month and no later than 10 to 15 days following the end of the month in which the services were performed;

(10) submit original invoices by email as PDF attachments. Invoices must be separated by DHHS office location and grouped by billing amount for each office as follows:

(A) Ogden

(B) Provo

(C) Taylorsville

(D) St. George;

(11) ensure each invoice contains the following:

(A) invoice Number;

(B) regional office location, team number and agent;

(C) DHHS case number;

(D) mother’s name;

(E) child’s name;

(F) alleged father’s name;

(G) names of all participating case participants and note any previously billed participants;

(H) date of report;

(I) dates Samples received;

(J) price per Sample; and

(K) amount due; and

(12) ensure all communication between the Contractor and DHHS regarding billing, unpaid invoices, insufficient instructions or cooperation from the ORS agents, problems with facility personnel, or corrective action issues are directed to the ORS Contract Analyst.

3.5 Payment Information.

(a) The Contractor shall:

(1) be responsible for any charges incurred by the other facility when Samples are not collected at the local ORS office and the Contractor uses an alternate location for collection;

(2) not charge an additional cost for the mother and child when an alleged father is excluded and DHHS refers another alleged father for testing;

(3) incur the cost of any re-collections and must send DHHS verbal and written notification, including the reason for re-collection within two weeks;

(4) not impose fees upon clients unless authorized by DHHS;

(5) send invoices to the initiating state when tests are initiated by a state other than Utah;

(6) bill for the number of people tested at that time when testing of a trio cannot be completed concurrently and once the final party has been tested; and

(7) include the names of all previously tested participants on the invoice for subjects tested separately and clearly mark the invoice with the notation of “previously billed.”

(b) DHHS shall pay the Contractor in accordance with the rate outlined in Attachment D: Cost Sheet. The rates include all fees or costs associated with the genetic testing procedures.

3.6 Miscellaneous Provisions. The Contractor shall:

(1) provide DHHS with a toll-free telephone number for customer support and access to key lab personnel;

(2) provide DHHS with a secure web-based method of reviewing the status of all tests;

(3) at the request of the court or DHHS, provide depositions, responses to interrogatories, written affidavits, and courtroom testimony at no additional cost to DHHS;

(4) provide responses by the director of the laboratory or the director’s designee with minimum qualifications of an earned Ph.D. in a relevant biological or biomedical science who is directly familiar with the processes and procedures used in the laboratory;

(5) ensure client Records produced by the Contractor are the property of DHHS;

(6) not release client Records to any other entity;

(7) deliver client Records to DHHS within 30 days of request, except as otherwise required by law or the AABB; and

(8) provide each DHHS office access to all DHHS client Records and Samples and to all DHHS genetic testing Records.

Article 4

REPORTING

4.1 Reporting. The Contractor shall maintain, track, and report all operational, performance, and compliance activities associated with genetic testing by:

(1) maintaining all genetic testing reports based on accreditation standards;

(2) submitting monthly performance reports to DHHS within 10-15 days after the end of each reporting period;

(3) including in monthly reports the total number of cases received, scheduled, completed, and pending;

(4) reporting Sample collection metrics, including successful attendance rates, no-show rates, and rescheduled appointments;

(5) tracking and reporting turnaround times for Sample processing and delivery of test results;

(6) documenting compliance with chain-of-custody requirements and delivery of test results;

(7) reporting all data transmitting activities, including sFTP success rates and any transmitting errors;

(8) providing detailed billing and invoicing summaries, including submission timelines and accuracy rates;

(9) identifying and reporting any operational issues, delays, or service disruptions, including correct action taken;

(10) submitting quarterly performance reports that include trend analysis, performance comparisons, and continuous improvement efforts;

(11) retain all reports and related documentation in accordance with AABB, ASHI, and applicable state and federal requirements; and

(12) make all reports and Records available to DHHS for audit, review, or legal purposes.

Article 5

OUTCOMES

5.1 Outcomes. The desired outcome of this contract is to ensure the legal and biological integrity of the genetic Test process. DHHS and the families they serve are positively impacted when maintaining high accuracy and regulatory compliance and the results of genetic testing provide legally defensible provisions that ensure the correct establishment of paternity and support obligations. These objectives are realized through the following outcomes:

(1) Sample Collection and Chain of Custody. All Samples are collected, labeled, transported, and documented in full compliance with chain-of-custody standards set forth in Utah code 81-5-504;

(2) Test Processing Services and Reporting. All Test results and deliverables are completed and transmitted within the required timeframes;

(3) Secure and Compliant Data Handling. All genetic testing data is securely transmitted, stored, and managed in full compliance with DHHS, state, and federal data security standards, ensuring confidentiality, integrity, and protection against unauthorized access or disclosure;

(4) Billing. All billing and invoicing activities are accurate, timely, and fully compliant with contractual and DHHS requirements, ensuring financial accountability, and minimal administrative correction; and

(5) Legal and Court Support Readiness. All legal documentation, expert testimony, and court-related support services are delivered accurately, and in full compliance with judicial and DHHS requirements, ensuring legal defensibility of all genetic results.

5.2 Outcome Measures. Each outcome will be measured by the following:

(1) Sample Collection and Chain of Custody. This outcome is achieved by:

(A) maintaining 100% compliance with chain-of-custody documentation;

(B) ensuring zero instances of confirmed Sample contamination or misidentification; and

(C) reaching a first-time Sample collection success rate of >98%;

(2) Test Processing Services and Reporting. This outcome is achieved by:

(A) delivering over 90% of results within 24 hours of completion;

(B) maintaining an on-time delivery rate of >95% for all contractual deadlines;

(C) limiting the resubmission rate due to transmission errors to <5%; and

(D) resubmitting 100% of corrupted files within 24 hours of notification;

(3) Secure and Compliant Data Handling. This outcome is achieved by:

(A) maintaining 100% compliance with all DHHS data security, confidentiality, and transmission requirements (including SFTP and applicable federal and state standards);

(B) achieving zero confirmed data breaches or unauthorized disclosures;

(C) ensuring 100% encryption of data; and

(D) resolving and reporting any data security incident within 24 hours, with full corrective action documentation.

(4) Billing. This outcome is achieved by:

(A) maintaining an invoice accuracy rate of >98% upon first submission;

(B) limiting invoice rejection or corrections to <5% of total invoices submitted;

(C) ensuring 100% inclusion of required invoice elements;

(D) submitting 100% of invoices within contractually required timelines; and

(E) resolving billing discrepancies within <5 business days of notification; and

(5) Legal and Court Support Readiness. This outcome is achieved by:

(A) maintaining 100% compliance with court and DHHS requests;

(B) providing requested documentation within <5 business days, unless otherwise specified;

(C) ensuring 100% of expert testimony is delivered by qualified personnel meeting contractual and credentialing requirements; and

(D) maintaining zero instances of rejected or invalid legal documentation due to Contractor error.