Patricia Salvato: Failed to maintain adequate medical records

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Patricia Salvato is a doctor in Houston, Texas who has strange beliefs about Lyme disease. She has been investigated and charged by the Texas Medical Board (TMB) but still managed to keep her license to practice medicine.

Dr. David Gorski has documented the TMB’s  failure to stop incompetent doctors like a notorious cancer quack and others from preying on patients.

Real Lyme disease is rare in Texas, but there is a large community of chronic Lyme believers.

Remedial Plan

In 2016, the TMB found that Patricia Salvato “failed to adequately document physical examination findings for several patients.” However, this Finding did not result in a formal disciplinary action.

Instead of prosecuting the Finding, the TMB and Salvato reached a settlement which established a non-disciplinary Remedial Plan.

The Remedial Plan required, among other things, Salvato to complete Continuing Medical Education (CME) and pay a fee to cover the cost of the Remedial Plan.

Board Complaint

In 2017, the TMB issued more allegations about Patricia Salvato (“Respondent”), which it summarized as follows:

It is alleged that that Respondent failed to meet the standard of care for one patient seeking treatment for neuralgia and fatigue symptoms. Specifically, it is alleged that Respondent prescribed a medication to the patient without adequate medical justification and that Respondent failed to maintain an adequate medical record. It is also alleged that Respondent ordered unnecessary, duplicative lab testing which had recently been performed.

Detailed Complaint Allegations

The following allegations are excerpted from the 2017 Complaint:

1. On July 18, 2016, Patient 1 visited her gynecologist and reported she had developed fatigue and diffuse body pains after a vacation to Montana two months earlier. The physician ordered blood work, including a test for the Epstein Ban virus. On July 22, 2016, the test results came back indicative of an infection with Epstein Barr virus in the past, which ruled out a current infection of the virus. The physician prescribed doxycycline, an antibiotic, to treat Patient 1 for potential exposure to Lyme disease. Patient 1 was then referred to an infectious diseases physician for further evaluation.

2. On August 12, 2016, Patient 1 visited a physician who is board certified in in internal medicine and infectious diseases. Patient 1 continued to have complaints of fatigue and pain. The physician ordered additional blood work, including testing for blood parasites, Rocky Mountain spotted fever, and Lyme disease (Western blot, serum; Lyme Ag IgM by WB). On August 16, 2017, the blood work results were negative for each test.

3. Patient 1 continued to experience musculoskeletal pain and fatigue which Patient 1 believed could be related be related to chronic Lyme disease, which in medical literature is known as “post-treatment Lyme disease syndrome.” According to the Centers of Disease Prevention and Control (CDC), it is not uncommon for patients to have continued symptoms of pain and fatigue for a number of years after having been treated for Lyme disease.

4. Patient 1 then sought out Respondent for a second opinion as to whether she had been infected with Lyme disease.

5. Respondent initially treated Patient 1 on October 6, 2016. Respondent noted that Patient 1’s chief complaint was neuralgia of the left extremity and face. Respondent noted that the pain began in 2011. Respondent reviewed Patient 1’s previous lab results from July and August and then provided Patient 1 with a prescription for cefuroxime (Ceftin), an antibiotic. Respondent also ordered repeat testing for blood parasites, Rocky Mountain spotted fever, and Lyme disease (Western blot, serum; Lyme Ag IgM by WB).

6. Respondent’s medical records for this appointment were inadequate for the following reasons:

1) failure to document a diagnosis before prescribing Ceftin;

2) failure to document a written plan for care to include treatments and medications (prescriptions and samples) and specifying amount, frequency, number of refills, and dosage;

3) failure to obtain written consent to treatment;

4) failure to document that Patient 1 was provided patient education for the Ceftin.

7. Respondent’s failure to create and maintain an adequate medical record is a violation of the Act and Board Rules, specifically:

Section 164.051 (a)(3) of the Act authorizes the Board to take disciplinary action against Respondent based on Respondent’s violation of a Board rule, specifically Board Rule 165.1, which requires the maintenance of adequate medical records.

8. Respondent failure to arrive at a diagnosis before prescribing Ceftin was also a violation of the standard of care. In addition, Respondent failed to disclose reasonable alternative treatments with Patient 1 at the initial visit. Respondent’s failure to diagnose and failure to disclose alternative treatments constitute violations of the Act and Board Rules, specifically:

Section 164.05l(a)(6) of the Act authorizes the Board to take disciplinary action against Respondent based on Respondent’s failure to practice medicine in an acceptable professional manner consistent with public health and welfare, as further defined by Board Rules 190.8(1)(A), failure to treat a patient according to the generally accepted standard of care; 190.8(1)(B), negligence in performing medical services; 190.8(1)(C), failure to use proper diligence in one’s professional practice; 190.8(1)(D), failure to safeguard against potential complications; and 190.8(1)(H), failure to disclose reasonable alternative treatments to a proposed procedure or treatment.

9. Respondent’s order for the same lab testing as had been performed only two months prior was unnecessary. The lab results in question were not likely to change in a significant manner in that span of time. It is a violation of the Act and Board Rules to order unnecessary medical testing, specifically:

Section 164.052(a)(5) of the Act authorizes the Board to take disciplinary action against Respondent based on unprofessional or dishonorable conduct that is likely to deceive or defraud the public, as provided by Section 164.053, or injure the public, and as further defined by Board Rule 190.8(2)(1), providing medically unnecessary services to a patient.

10. Patient 1 reports that she did not take the Ceftin because she was concerned Respondent had prescribed it to her without having the results of the new blood work first and without a definitive diagnosis of Lyme disease.

11. On October 28, 2016, Patient 1 had a follow-up visit with Respondent. Respondent noted that Patient 1’s chief complaint was “diffuse pain.” Respondent reviewed lab results of the blood work taken on October 6, 2016, which was negative for Rocky Mountain spotted fever, blood parasites, and Lyme.

12. It was Respondent’s medical opinion that Patient 1’s symptoms could be caused by “chronic Lyme disease” despite the negative test results because of Patient 1’s history of tick bites as a child, symptoms, and other testing results which Respondent states is linked to symptoms of post-treatment Lyme disease syndrome (elevated transforming growth factor-beta 1, TGF-B I; and low CD57-NK).

13. Respondent states that she informed Patient 1 that there is “considerable uncertainty” regarding the diagnosis and treatment of Lyme disease.

14. Respondent provided reasonable treatment options to Patient 1 and documented a discussion of the two standards of care for the treatment of chronic Lyme disease. Specifically, Respondent documented that she discussed the risks of antibiotic treatment versus holistic treatment.

15. Respondent’s treatment plan was to start Tindamax, an antibiotic, for two weeks and then follow up with Ceftin, which had been prescribed at the initial visit. Respondent did not document why the prescription for Ceftin had been prescribed at the initial visit when it was intended to be used after the Tindamax provided at the follow-up visit.

16. The standard of care required that Respondent document both antibiotic prescriptions in the chart. The medication list only contains the prescription for Tindamax at this visit. In addition, Respondent was negligent and/or failed to act with due diligence by failing to ask Patient 1 about whether the Ceftin prescription was filled and what effect the Ceftin had on Patient 1’s symptoms. Respondent’s actions constitute violations of the Act and Board Rules, specifically:

Section 164.051 (a)(6) of the Act authorizes the Board to take disciplinary action against Respondent based on Respondent’s failure to practice medicine in an acceptable professional manner consistent with public health and welfare, as further defined by Board Rules 190.8(1)(A), failure to treat a patient according to the generally accepted standard of care; 190.8(1)(B), negligence in performing medical services; 190.8(1)(C), failure to use proper diligence in one’s professional practice; and 190.8(1)(D), failure to safeguard against potential complications.

17. Before leaving Respondent’s medical office on October 28, 2016, Patient 1 requested a copy of her lab results.

18. After the passage of about 10 minutes, Respondent’s office staff stated that Respondent had reviewed incorrect lab results due to a sample labeling error committed by the lab. The office staff then provided Patient 1 with a set of lab results which were different from those reviewed by Respondent.

19. Patient 1 states that she asked whether Respondent wanted to go over the correct lab results with her and whether she should take the antibiotics. Patient 1 reports that the office staff told her that Respondent did not need to go over the correct results with her and that she should take the antibiotics. A follow-up appointment was not made.

20. Patient 1 reports that she understood that she was to take the Tindamax for two weeks and then take the Ceftin for four to six weeks.

21. Patient 1 reports that she chose not to take the Tindamax and Ceftin based on her concerns about Respondent’s choice to prescribe the Ceftin before the Tindamax and Respondent’s failure to go over the other set of lab results with her. Patient 1 reports that she decided to treat her symptoms with self-care (diet, exercise, etc.) and that her symptoms improved over time.

22. Respondent denies that her office staff instructed Patient 1 to take the antibiotic after having discovered a lab error. Respondent states that her nurse practitioner instructed Patient 1 to hold off on the antibiotics. However, Respondent did not document that Patient 1 was informed on October 28, 2016, that she was to hold off on the antibiotics. A phone note from the nurse practitioner states only that a message was left to request that Patient 1 return for repeat testing due to a “possible lab error.”

23. The next phone messages are dated November 7-8, 2016, and state that messages were left with Patient 1 informing her that the lab was “sorting through the results” and that Patient 1 should hold off on the antibiotics.

24. Respondent mailed a certified letter informing Patient 1 of the lab error and that Patient 1 should hold off on taking the antibiotics because “it is not an emergency to treat Lyme disease immediately.” Although the letter is dated October 31, 2016, records from the United States Postal Service reflect that the certified letter was mailed on November 7, 2016, which is three days after the Board mailed a letter to Respondent which notified her of Patient 1’s complaint.

25. Although it is possible that Respondent’s nurse practitioner verbally informed Patient 1 on October 28, 2017, not to take the antibiotics prescribed by Respondent, the medical documentation is inadequate to establish that Patient 1 was informed of this. In addition, the medical records themselves do not contain an order for repeat testing.

26. After the discovery of the lab error, Respondent’s records should have contained specific instructions for Patient 1’s follow-up care, including contemporaneous documentation that Patient 1 was instructed to hold off on the antibiotics and that repeat testing was required. The records also should have reflected which set of lab results were provided to Patient 1 after the appointment. The failure to include new instructions to Patient 1 and to identify which lab results were provided constitutes a violation of the Act and Board Rules, specifically:

Section 164.05l(a)(3) of the Act authorizes the Board to take disciplinary action against Respondent based on Respondent’s violation of a Board rule, specifically Board Rule 165.I, which requires the maintenance of adequate medical records.

27. The records should also have contained contemporaneous documentation explaining how the Jab results differed and what the labeling error was. Specifically, Respondent’s certified letter dated October 31, 2016, states that the lab results reviewed during the appointment reflected Patient 1’s CD-57 was 14, which Respondent stated is consistent with Lyme disease and that the lab results discovered after the appointment reflected Patient 1’s CD-57 as 157. This error was not identified in the medical record for the October 28, 2016, nor was the clinical significance documented.

28. The failure to contemporaneously document a lab error and the clinical significance of that error constitutes a violation of the Act and Board Rules, specifically:

Section 164.051(a)(3) of the Act authorizes the Board to take disciplinary action against Respondent based on Respondent’s violation of a Board rule, specifically Board Rule 165.1, which requires the maintenance of adequate medical records.

Charges Settled

In 2018, the TMB and Salvato agreed to settle the charges in the 2017 Complaint by issuing an Agreed Order. The Agreed Order found that Salvato:

failed to maintain adequate medical records for one patient during the evaluation and treatment of Lyme disease.

Salvato was only required to complete CME. Therefore, she can continue treating patients in a questionable manner. For example, CD57 is not a valid test for diagnosing or ruling out Lyme disease.

Resources

Texas Medical Board: Remedial Plan for Patricia Salvato, 2016

Texas Medical Board: Complaint about Patricia Salvato, 2017

Texas Medical Board: Agreed Order for Patricia Salvato, 2018

East Texas Matters: 3 East Texas doctors disciplined by Medical Board