REPORT ON COVID-19 TEST REPORTING INVOLVING THE IOWA DEPARTMENT OF PUBLIC HEALTH AND STATE HYGIENIC LABORATORY FOR THE PERIOD APRIL 21, 2020 THROUGH JULY 10, 2020 2060-5880-B0P1 Table of Contents Page Auditor of State’s Report 3 Background Information Detailed Findings Recommended Control Procedures 4 5-6 7-8 Staff 9 Appendices: Copy of IDPH Order dated April 18, 2020 Copy of Letter to State Hygienic Lab Copy of Response from the Iowa Department of Public Health Issued through the Office of the Attorney General Copy of Response from the State Hygienic Lab 2 Appendix 1 2 3 4 11 12 13-16 17 OFFICE OF AUDITOR OF STATE STATE O F I OWA Rob Sand Auditor of State State Capitol Building Des Moines, Iowa 50319-0006 Telephone (515) 281-5834 Facsimile (515) 281-6518 Auditor of State’s Report To the Department of Public Health, State Hygienic Lab, and Office of the Chief Information Officer: This report was initiated due to state and county level employees reaching out to the Auditor of State’s Office to discuss reporting delays related to Test Iowa. The reporting delays mentioned could have a negative impact on the pandemic response by hindering contact tracing and decisionmaking at both governmental and individual levels.. The Auditor of State’s Office performed the following procedures: (1) Interviewed employees of county public health departments. (2) Collected information from the Iowa Department of Public Health (IDPH) and SHL through respective employees and attorneys. (3) Reviewed the $26,000,000 Test Iowa contract between Nomi Health, Inc. and the State of Iowa. (4) Reviewed Chapter 139A of the Code of Iowa, as well as Court decisions related to the word “immediately.” The above procedures identified illegal and unbusinesslike practices, inefficiencies, and apparently pointless risks. The procedures described above do not constitute an audit of financial statements conducted in accordance with U.S. generally accepted auditing standards. We anticipate performing a broader examination with additional procedures on related issues. Copies of this report have been filed with the Johnson and Polk County Sheriff’s Offices, the Iowa Division of Criminal Investigation, the Johnson and Polk County Attorneys’ Offices, and the Iowa Attorney General’s Office. ROB SAND Auditor of State July 13, 2020 3 Report on COVID-19 Test Reporting Background Information Public health is the branch of medicine dealing with the health of the public as a single unit. One aspect of public health focuses on limiting the impact of infectious diseases, including but not limited to epidemics and pandemics. The Iowa Department of Public Health (IDPH) is the state department focused on putting the knowledge of the public health field into practice in Iowa. Iowa Code 139A, titled “Communicable and Infectious Diseases and Poisonings,” lays out the framework within which IDPH and other relevant parties must perform their work related to infectious diseases. It provides requirements of what diseases health care providers must report to the IDPH and how they must report them, and provides authority for isolation and quarantine of individuals by public health authorities at the state and local government levels. When an individual is diagnosed with a reportable disease, public health authorities aim to trace that person’s contacts. “Contact tracing” is an effort to determine and alert any individuals that may have had contact with that diagnosed person, so that, as necessary, those persons may be isolated, quarantined, or advised of that contact. Such actions can prevent those exposed individuals from exposing others to the same disease prior to personally realizing they may be ill. Contact tracing is a primary method for limiting the spread of diseases. It relies upon accurate, reliable, and quick identification of individuals with the disease, and then accurate, reliable, and quick sharing of that information with the individuals who will conduct contact tracing. Contact tracing is most effective when it is conducted as soon as possible after an individual is diagnosed. In addition, accurate, reliable, and quick sharing of aggregate data about a disease’s spread, such as the number and location of positive cases, facilitates decisions made by public health authorities about how to best address the disease. The disease relevant to this report at all times, COVID-19, is so named because it was first identified in 2019. The United States had its first confirmed cases of COVID-19 on January 21, 2020. Iowa had its first 3 cases identified on March 8, 2020. On Tuesday, April 21, Iowa Governor Kim Reynolds launched Test Iowa, an initiative to increase COVID-19 testing in Iowa. The initiative was finalized through a no-bid contract valued at $26,000,000 that the State entered into with Nomi Health, Inc. An earlier Emergency Proclamation Governor Reynolds had signed generally allowed for no-bid contracts in relation to COVID-19 related procurement. Nomi Health planned to partner with Qualtrics and Domo to perform their obligations under the contract. All three entities are private companies based in Utah. Test Iowa provided an online assessment tool for individuals to fill out, which would tell them whether they were qualified to receive a test. If the assessment determined they were qualified to receive a test, it would show them available testing locations and times near them, or if there were none available, instruct the individual to check for locations and times at a later date. In accordance with Chapter 263 of the Code of Iowa, Iowa’s State Hygienic Lab (SHL) serves all of Iowa’s 99 counties through disease detection, environmental monitoring, and newborn and maternal screening. It analyzes COVID-19 samples taken from individuals in Iowa to determine whether the individual has COVID-19, and analyzes every Test Iowa sample. It is a part of the University of Iowa. Iowa’s Office of the Chief Information Officer (OCIO) was “created for the purpose of leading, directing, managing, coordinating, and providing accountability for the information technology resources of state government.” These duties currently include receiving test specimen results from a private contractor for Test Iowa and delivering them to IDPH, although there is no specific statutory or contractual authority for it to be doing so. 4 Detailed Findings This report was initiated due to state and county level employees reaching out to the Auditor of State’s Office to discuss concerns with reporting delays related to Test Iowa. The reporting delays mentioned could have a negative impact on the pandemic response by hindering contact tracing and decision-making at both governmental and individual levels. Following those contacts, this Office conducted additional interviews and reviewed relevant portions of the Code of Iowa. Section 139A.3 of the Code of Iowa says “the health care provider or public, private, or hospital clinical laboratory attending a person infected with a reportable disease shall immediately report the case to the department.” It further states “the department shall publish and distribute instructions concerning the method of reporting.” Section 139A.25 makes violations of Chapter 139A a simple misdemeanor and a fineable offense for the entity failing to immediately report to IDPH. On April 18, 2020, IDPH ordered as follows: “all Iowa health care providers and public, private, and hospital laboratories are required to immediately report all positive and negative SARS-CoV-2 testing results to the department. Reports must be made electronically through the Iowa Disease Surveillance System (IDSS) when a facility has electronic transmission capabilities, otherwise reports can be faxed to [fax number].” (SARS-CoV-2 is the virus that causes COVID-19.) A copy of this order is included in Appendix 1. Local health departments, as well as contact tracers who collect information about what individuals and locations may have been exposed to an infected person, use IDSS to guide their work in responding to the pandemic. IDSS informs them of testing in their jurisdiction. The Iowa State Hygienic Lab (SHL) is analyzing every potential COVID-19 specimen collected through Test Iowa. However, SHL employees relayed that the reporting system for Test Iowa tests was provided to SHL in a manner that sent results exclusively to the private entities running Test Iowa, rather than reporting them immediately to IDPH. SHL was not involved in that decision. In addition, according to SHL employees, some of the testing equipment related to that reporting system was so inefficient it was replaced. However, even after necessary changes for those efficiency purposes, IDPH asked SHL to maintain the reporting system that sent Test Iowa results to private entities prior to sending them to IDPH. In contrast, the SHL also analyzes COVID-19 tests that are not tied to Test Iowa, but reports those results immediately to IDPH. This Office informed SHL that the reporting system being used for Test Iowa did not comply with Chapter 139A.3 of the Code of Iowa and requested that SHL comply with the law. That communication is included as Appendix 2. The IDPH and their attorney at the Iowa Attorney General’s Office received copies of that communication as well. The SHL did not initially respond. IDPH replied through their attorney. That response is included as Appendix 3. The IDPH, through their attorney, stated that “Test Iowa specimen samples are processed at SHL and upon processing are released to Qualtrics within an hour of the test result. Qualtrics then makes the data available to Domo within two hours of its receipt of the test result, which makes the data available to the OCIO. The OCIO extracts the test data on an hourly basis into an STFP folder, which is then made available to an IDPH network...” The IDPH through their attorney also laid out reporting mechanisms for non-Test Iowa specimens. The letter stated that all reporting entities send their results to IDPH through some combination of Rhapsody, AIMS, and SmartLab. These are all one form or another of data integration engines, or simply shared software platforms for sharing data. They are not distinct entities under separate control, and do not add to the reporting chain. 5 The IDPH through their attorney asserted that all COVID-19 reporting entities and methods were roughly similar in the amount of time that it took to get the information to IDPH. This position conflicts with publicly reported information and with information provided to this Office. This Office has not at this point reviewed that assertion, but the conclusions and recommendations contained in this report stand regardless of this information’s veracity. However, every system but Test Iowa had the health care provider reporting immediately to IDPH. Only the Test Iowa reporting system instead has a chain of both private and public entities that receive the information prior to IDPH. The attorney reported that the IDPH’s position is that Test Iowa results are meeting the legal requirement of being reported “immediately...to the department” even though the SHL, who holds the statutory obligation to report “immediately...to the department,” reports them only to Qualtrics, a private company in Utah. Qualtrics then reports the data to Domo, another private company in Utah, which then reports the data to OCIO, which then reports the data to IDPH. The State of Iowa contracted with Nomi Health Inc. to run Test Iowa. The contract both parties signed contains no language that obligates the State to provide Test Iowa data first to private entities before providing it to the IDPH. It if did, that language could justify some of the confusion that created the current reporting structure. The language itself, however, would be void, because it would contradict Chapter 139A and thus be invalid. Moreover, the contract does not mention OCIO at all. Similarly, an order from IDPH that contradicted the statutory obligation SHL has to immediately report to the department would also be illegal and invalid. No documentation of such an order exists, but its occurrence, whether written or verbal, is consistent with the positions of both SHL and IDPH. IDPH’s discretion is limited to instructing about the method of reporting, as it does in its April 18 order when it states results must be sent through IDSS if a facility has the ability, otherwise through fax, and lists the fax number. This Office responded with additional questions and concerns. IDPH was asked twice for any reason that Test Iowa results could not be sent to IDPH directly from SHL, while then also being sent to Qualtrics and/or other contracted entities. Rather than providing a reason, the IDPH through its attorney repeated its position that “as a legal matter, there is no reason for SHL to alter their current manner of reporting.” On July 10, 2020 the SHL provided a written response which is included as Appendix 4. As illustrated by the Appendix, SHL officials reported “…SHL is currently reporting all COVID-19 test results, including those associated with the Test Iowa program, to the Iowa Department of Public Health in accordance with IDPH’s Statewide Standing Order for COVID-19 Testing.” However, the Statewide Standing Order for COVID-19 Testing refers to Iowa Code section 139A.3, Chapter 641 of the Iowa Administrative Code and the Mandatory Reporting Order, dated April 18, 2020 and signed by the IDPH Director and the IDPH Medical Director, all require immediate reporting to IDPH. As previously stated, a copy is included in Appendix 1. This office requested clarification after receiving the letter and the SHL confirmed that the reporting chain for Test Iowa results remained SHL to Qualtrics to Domo to OCIO to IDPH. Despite requests, no written documentation has been provided of any order that directs the SHL to report Test Iowa results in that manner. Statute requires IDPH to publish orders. As a result, a verbal order would not comply with Code requirements. 6 Recommended Control Procedures There is no dispute that SHL was directed to report Test Iowa results to Qualtrics only. Such orders, if given, should be in writing and published in compliance with the Code. The practice of documenting orders helps ensure accountability for such orders and ensures compliance with Code. Moreover, the documenting of orders helps assure that those issuing those orders are doing so under the belief that the order complies with the law. Orders that apparently conflict with statutes are especially important to document, as an order that conflicts with a statute is invalid and any analysis for how it might not conflict would be important. To date, no such analysis has been provided. The reporting chain for Test Iowa results is contrary to law, takes apparently pointless risks, and exposes taxpayers to potential legal liabilities. The Test Iowa reporting system is illegal because the results are not reported immediately to IDPH, which Iowa Code 139A.3(1) requires. Iowa Courts have already reviewed the definition of the word “immediately.” In State v. White, 545 N.W.2d 552, 556 (Iowa 1996) the Iowa Supreme Court said 'immediately” meant “without delay” and does not include “within a reasonable time.” Additionally, in 1981, the Iowa Supreme Court defined “immediately” according to the Webster’s Dictionary definition of “without intermediary: in direct connection or relation...” Farm Bureau Mut. Ins. Co. v. Sandbulte, 302 N.W.2d 104, 108 (Iowa 1981). A reporting system with three intermediaries is not “without intermediary,” and is thus not immediate. In addition, assuming it is reported in about the same amount of time as non-Test Iowa results, as claimed, that would not make it immediately if it could be done faster. According to the Iowa Supreme Court, “within a reasonable time” is not immediate. The Iowa Supreme Court has noted that a party contesting a word’s meaning does not necessarily make the meaning unclear. In addition, a reporting chain with three intermediaries is wasteful and risky when compared to immediate reporting. Each link in the chain is another area where the integrity, reliability, and timely transmission of information is put at unnecessary risk of error, equipment failure, maladministration, outright falsification, or any other cause. The same companies also have contracts with Utah, Nebraska, and may be pursuing additional contracts. Adding them to the reporting chain makes timely reporting of results, and therefore public health in Iowa, dependent upon their processing schedules and capacity, which may be impacted by additional contracts that do not benefit Iowa. There appears to be no legitimate reason the results could not be reported immediately to IDPH while at the same time reported to Qualtrics, Domo, and then OCIO. In addition to being compliant with the Code and less risky, reporting directly to IDPH would provide a control population to ensure the results they receive back from OCIO after receiving it from the private companies match what the SHL reported. Finally, making IDPH the fourth entity receiving the data despite the requirement of immediate reporting to IDPH increases taxpayers’ exposure to potentially paying damages in a negligence lawsuit. Preventing illness and death depends in part upon prompt disclosure of outbreak information, in part for decision-making at governmental and individual levels but also for effective contact tracing to limit spreading. Making the IDPH fourth in line appears to be a prima facie breach of the state’s duty, making proving that element of such a case substantially easier. 7 The State Hygienic Lab should begin immediately reporting Test Iowa results to the Department of Public Health, as the law requires. There is no prohibition apparent on reporting them simultaneously to Qualtrics, Domo, and/or OCIO if IDPH desires to continue doing so. Due to the ongoing and high-risk nature of the COVID-19 pandemic, this change should be made immediately in order to eliminate apparently pointless risks, potential legal liability, and improve the state’s response to the pandemic. 8 Report on Covid-19 Test Reporting Involving the Iowa Department of Public Health and State Hygienic Laboratory Staff This performance audit was conducted by: James S. Cunningham, CPA, Director Lesley R. Geary, CPA, Manager Anthony M. Heibult, Senior Auditor II Annette K. Campbell, CPA Deputy Auditor of State Marlys K. Gaston, CPA Deputy Auditor of State 9 Appendices 10 Appendix 1 Report on Covid-19 Test Reporting Involving the Iowa Department of Public Health and State Hygienic Laboratory Copy of IDPH Order dated April 18, 2020 11 Appendix 2 Report on Covid-19 Test Reporting Involving the Iowa Department of Public Health and State Hygienic Laboratory Copy of Letter to State Hygienic Lab 12 Appendix 3 Report on Covid-19 Test Reporting Involving the Iowa Department of Public Health and State Hygienic Laboratory Copy of Response from the Iowa Department of Public Health Issued through the Office of the Attorney General 13 Appendix 3 Report on Covid-19 Test Reporting Involving the Iowa Department of Public Health and State Hygienic Laboratory Copy of Response from the Iowa Department of Public Health Issued through the Office of the Attorney General 14 Appendix 3 Report on Covid-19 Test Reporting Involving the Iowa Department of Public Health and State Hygienic Laboratory Copy of Response from the Iowa Department of Public Health Issued through the Office of the Attorney General 15 Appendix 3 Report on Covid-19 Test Reporting Involving the Iowa Department of Public Health and State Hygienic Laboratory Copy of Response from the Iowa Department of Public Health Issued through the Office of the Attorney General 16 Appendix 4 Report on Covid-19 Test Reporting Involving the Iowa Department of Public Health and State Hygienic Laboratory Copy of Response from the State Hygienic Lab 17