The Issue The issues in these consolidated cases are whether Respondent committed the violations charged in four Administrative Complaints and, if so, what is the appropriate discipline.
Findings Of Fact The Department has regulatory jurisdiction over licensed chiropractic physicians pursuant to section 20.43 and chapters 456 and 460, Florida Statutes. In particular, the Department is authorized to file and prosecute an administrative complaint against a chiropractic physician after a probable cause panel (PCP) of the Board determines there is probable cause to suspect a licensee has committed a disciplinable offense, and provides direction to the Department on the filing of an administrative complaint. At all times material to the allegations in the Administrative Complaints, Dr. Aderholdt has been licensed to practice chiropractic medicine in Florida, having been issued license number CH 7814. He was first licensed on January 6, 2000. He practices in an office in Bradenton, Florida. Vax-D Therapy Three of the four Administrative Complaints involve patients of Dr. Aderholdt who received Vax-D therapy. The complaints are not directed to the provision of Vax-D therapy itself, or to any other treatments provided by Dr. Aderholdt. In all four cases, the patients generally spoke well of the chiropractic care they received from Dr. Aderholdt and the manner in which they were treated by him and his office staff. Vax-D therapy is a modality using the Vax-D model for decompression of the spinal discs and spinal structure. It is used to treat a range of issues associated with low back pain, including herniated, degenerated, and bulging discs. The Vax-D model is the originator of this technology; it was the first spinal decompression device. It is a large computerized moving table. It can be programmed to provide specific axial or distractive loading. The table moves in and out, pumping nutrients at the discs. Some research shows that it can actually pull discs away from where they are causing irritation on nerves and the spinal cord. The Vax-D model is FDA-cleared for use, and the literature supports its efficacy. The Vax-D model is an expensive piece of equipment. The price range for the initial purchase is between $100,000 and $150,000, with ongoing expense thereafter for maintenance and updates. Vax-D therapy is one of the most expensive forms of therapy, if not the most expensive, in the chiropractic profession. Other models coming out after Vax-D, as well as other tools, arguably can be used for similar purposes. However, as Petitioner’s expert readily acknowledged, Vax-D is the “Rolls Royce. It’s a really nice tool.” Vax-D spinal decompression is not covered by Medicare. In fact, when it comes to chiropractic care, Medicare has never covered anything besides spinal adjustments. Coverage for Vax-D treatment by private insurance companies is rare. In 2012, Dr. Salvatore LaRusso presented a study on spinal decompression to the profession, before the Federation of Chiropractic Licensing Boards, to inform state regulators of issues associated with Vax-D therapy. The one regulatory concern he reported was that some physicians were improperly billing Vax-D as a surgical decompression procedure, when it is plainly not surgery; it is an alternative to surgery, properly billed as a non-surgical decompressive tool or traction device. Dr. LaRusso’s study also made findings on the common methods of packaging and selling the service, and the range of charges observed. He found that most practitioners providing Vax-D therapy were selling the service as a cash item in their practice, with payment up front often required. The common model was to sell a package with a certain number of visits, with or without additional services included. Dr. LaRusso found that the per-visit charges ranged from $150 to $450, depending on the ancillary services added to the decompression. Dr. Shreeve does not have any issue with the use of or charges for Vax-D therapy. Dr. Aderholdt offers Vax-D therapy pursuant to a Vax-D Therapy Payment Plan agreement (Vax-D Agreement), which is comparable to the multi-visit packages that Dr. LaRusso’s study found to be common. After initial consultation, with intake forms, patient history, x-rays, evaluation, and examination, if a patient is determined to be appropriate for Vax-D therapy, Dr. Aderholdt will give his treatment recommendations and then turn the patient over to his office staff to address the financial aspects. If the patient wants to proceed with Vax-D therapy, the Vax-D Agreement will be reviewed and signed. Patients A.M., R.O., and P.D. each received Vax-D therapy, pursuant to signed Vax-D Agreements. The terms of the Vax-D Agreements for the three patients were the same. Patient B.O. wanted Vax-D therapy, but she was determined to not be an appropriate candidate for it. The Vax-D Agreements in evidence for Patients A.M., R.O., and P.D. provided that the named patient committed to 25 to 28 Vax-D therapy sessions, for $250.00 per session. The total amount that the named patient agreed to pay Dr. Aderholdt for 25 to 28 sessions was $5,500.00, which computes to an actual per-session cost of between $196.43 (for 28 sessions) and $220.00 (for 25 sessions). For the agreed price for 25 to 28 sessions, the Vax-D Agreement provided the following treatment package: at each session, the patient would receive 30 minutes of Vax-D therapy, 30 minutes of full range interferential electrical muscle stimulation (EMS), 15 minutes of hydro-massage therapy, and manipulation (adjustments) by the doctor if needed. The first set of x-rays was also included. Dr. Aderholdt requires an up-front payment for the Vax-D therapy package. For patients who want Vax-D therapy but need help coming up with the funds, Respondent’s office staff has put the patients in touch with Care Credit, which is a medical credit program. If a patient applies and is accepted, Care Credit will finance the cost without charging interest to the patient if the loan is repaid within one year. Care Credit apparently charges a fee to Respondent when credit is extended, similar to the fees charged to merchants by credit card companies for credit card purchases. No evidence was presented regarding Care Credit’s approval criteria or how widely this method is used. All that is known about Care Credit from the record evidence is that two patients who received Vax-D therapy applied for Care Credit and were approved. The other Vax-D patient charged half of the agreed price on a Visa credit card the first day of treatment, and charged the other half after 15 treatment sessions. Patient A.M. From the end of July 2013 to early February 2014, Dr. Aderholdt treated Patient A.M., then a 66-year-old female, for lower back pain and hip pain. Patient A.M. had tried other treatments and had seen chiropractors before, but reported that her pain kept getting worse. As shown by A.M.’s medical records, A.M. was first seen by Respondent on July 29, 2013. That day, A.M.’s intake form, patient history, and x-rays were taken and evaluated, and A.M. was examined by Respondent. Respondent then formulated A.M.’s initial treatment plan. Respondent recommended Vax-D therapy, along with chiropractic adjustments, EMS, and hydrotherapy. The initial treatment plan specified a two- session per day protocol for the first two to three weeks. On July 30, 2013, A.M.’s husband, J.M., signed the Vax-D Agreement (in the space for Patient Signature). J.M. did not remember signing the Vax-D Agreement, but both he and A.M. identified his signature on the Vax-D Agreement. A.M. was named in the agreement as the patient who committed to 25 to 28 Vax-D therapy sessions and agreed to pay $5,500.00 for those sessions. Respondent did not require full payment of the agreed price prior to treatment. Instead, he accepted payment of one- half ($2,750.00) of the Vax-D therapy package price, which was charged on A.M.’s or J.M.’s Visa credit card on July 30, 2013. In accordance with the initial treatment plan, Patient A.M. received two treatment sessions per day beginning July 30, 2013, in the morning and afternoon, for nearly three weeks. After 15 treatment sessions--more than half of the 25 to 28 sessions covered for $5,500.00--the balance of $2,750.00 was charged on A.M.’s or J.M’s Visa credit card. Between July 30, 2013, and February 3, 2014, Patient A.M. had more than 60 Vax-D therapy sessions--approximately 64 total sessions. A.M. initially testified with a fair degree of confidence that she thought she had about 30 treatment sessions, until she reviewed her prior statement made to Petitioner. A.M. testified that at every session, she received Vax-D decompression therapy, hydrotherapy, adjustments “up and down” her spine, and ice packs. She left every session feeling better, with relief from her pain. The relief was temporary, however; she said the pain would come back after a few hours. After 29 sessions, having received all of the treatment sessions covered by the Vax-D Agreement, A.M. started paying additional amounts for more Vax-D therapy and the other ancillary services that she continued to receive. For approximately 35 additional treatment sessions beyond those covered by the Vax-D Agreement, A.M. made seven additional payments in the total amount of $2,226.00. In all, A.M. paid $7,726.00 for approximately 64 Vax-D therapy sessions. Rounding down to an even 60 sessions, she paid an average of $128.77 per session. A.M. was covered by Medicare at the time of her treatment. She did not have any private “Medicare supplement” health insurance. At some point, the subject of Medicare coverage came up. The details of what was said, when, and to whom were not clearly established. The only fact clearly established was that Dr. Aderholdt did not bring up the subject. Patient A.M. testified that Dr. Aderholdt did not talk to her about payment when she first visited, but that she and J.M. asked him, “Does Medicare cover this,” and he said, “Yes.” J.M. said that Dr. Aderholdt did talk to them about payment, saying “we need to do so many treatments and we should pay so much money.” J.M. said that they asked, “Will Medicare take care of it?” Dr. Aderholdt answered, “Yes, we will bill Medicare.” J.M could not say whether he asked about billing Medicare before or after he signed the Vax-D Agreement, since J.M. did not remember signing the Vax-D Agreement. When Dr. Aderholdt was asked if he told A.M. her treatments would be covered by Medicare, he answered, “No, I don’t believe I did, no.” As an interesting contrast, Patient R.O. testified that Dr. Aderholdt told him Medicare would not cover treatment under the same Vax-D Agreement; Dr. Aderholdt does not believe he made that statement, either. In the middle of the spectrum, Patient P.D. testified that Respondent never said anything to her about insurance coverage or financial arrangements. He would only talk about treatment, turning P.D. over to the office manager or billing person to address the financial issues. This version is consistent with Respondent’s testimony that he does not address “the money thing” with patients. Instead, he said he assesses x-rays, takes patient histories, performs the evaluation and examination, and ultimately formulates the recommended treatment plans, whether Vax-D or something else. Then he turns the treatment plans over to his staff to address the financial issues with the patients. A.M. and J.M. did not demonstrate a clear and certain recollection of what they asked Dr. Aderholdt or exactly what he answered. Indeed, both J.M. and A.M. could not remember most every other detail about A.M.’s treatments, often confidently stating details that were shown to be wrong by more than a little, including how many treatment sessions, and how much was paid. For example, Patient A.M. initially reported that she had paid $13,179.00 to Dr. Aderholdt, when the total was $7,726.00. The undersigned cannot find--without hesitancy--that Dr. Aderholdt made any representation to J.M. and A.M. regarding Medicare coverage before J.M. signed the Vax-D Agreement by which A.M. committed to the Vax-D therapy package. Dr. Shreeve made the point well that it is difficult to resolve this kind of he said-she said conflict, although he made the point while confusing Patient A.M. (who claimed Respondent said there would be Medicare coverage) with Patient R.O. (who claimed Respondent said there would not be Medicare coverage), in the following exchange: Q: With Patient RO, what’s your understanding of what Dr. Aderholdt told him regarding Medicare reimbursements? A: Counselor, I’m going to tell you that the investigative record shows that the patient stated that Aderholdt told him that they would be paid, is what my recollection is. And, yet, that’s not something that weighs heavily on my mind because I wasn’t there. This becomes a “he said, she said.” He said he didn’t; he said he did. I can’t get into that fight. That’s not an issue for me. (Jt. Ex. 12 at 35). (emphasis added). Respondent (or his staff) may have told A.M. and J.M., when they asked about Medicare, that the office would complete and submit the Medicare claim forms. Respondent (or his staff) may have told A.M. and J.M., when they asked, that Medicare proceeds paid on the Vax-D therapy package would be refunded. But it would be unreasonable, on this record, to find that Respondent misrepresented that Medicare would provide full coverage, or that Respondent schemed to induce A.M. and J.M. to sign up for Vax-D by guaranteeing that Medicare would pay back everything, when Respondent did not even bring up the subject.8/ The Administrative Complaint alleges that on one or more occasions, Respondent did not submit Medicare claims for Patient A.M.’s treatment. Petitioner has apparently abandoned this allegation; its PRO has no proposed finding identifying any dates of service for which claims were not submitted. The Medicare claim forms for Patient A.M. were compiled by Petitioner’s counsel for use in taking Respondent’s deposition, and are attached as deposition exhibit 2. The evidence is difficult to cull through, as there are 84 separate pages of claims and they are not in chronological order; they start out in chronological order, but then jump forward two months, then continue jumping around on dates, back and forth and back again. As best can be determined, all service dates shown in Patient A.M.’s medical records appear to be accounted for by corresponding claim forms. It appears that one claim form may have a clerical mistake, identifying the date of service as August 3, 2013, when there was no treatment session that day; the actual service date may instead be September 4, 2013, which is the date the claim form was submitted. The Medicare claim forms in evidence demonstrate that claim forms for A.M.’s treatments were regularly submitted, either on or very shortly after the dates of service. The evidence is insufficient to prove that Respondent did not submit Medicare claims for Patient A.M.’s treatment.9/ The Administrative Complaint contains no allegations regarding the disposition of the Medicare claims, although it does allege that Patient A.M. received no reimbursement from Respondent for Medicare payments. Petitioner’s expert seemed to be under the impression that Respondent received Medicare payments, because he criticized Respondent for not providing reimbursement to Patient A.M. Respondent testified that he has received no payments from Medicare for A.M.’s treatments, and Petitioner acknowledges in its PRO that Medicare has not made payments to Respondent. Acknowledging that the Administrative Complaint allegation has not been established, Petitioner instead proposed a finding (not alleged in the Administrative Complaint) that all of A.M.’s Medicare claims submitted by Respondent were rejected and payment was denied. No evidence was offered to prove the actual disposition of the 84 pages of Medicare claims submitted for A.M.’s treatments. Instead, the only record evidence of Medicare adjudications on any claims for A.M. is a group of explanation of benefits forms (EOBs) attached to a March 6, 2014, letter from Patient A.M. to Petitioner’s investigator, which is a deposition exhibit. Patient A.M. identified the small handful of EOBs attached to the March 6, 2014, letter as EOBs she had at that time, reporting on the disposition of Medicare claims submitted by other providers during the same time period as her treatments with Respondent. The EOBs reported, as to each claim, whether the claim was covered in whole or in part; and, if covered, what amount was paid, or, if not, why not. There were no EOBs for claims submitted by Respondent’s office. Patient A.M. was not asked for, and did not offer, any additional EOBs at her deposition. If, in fact, all of the Medicare claims submitted by Respondent were rejected and payment denied, then there would be a stack of EOBs explaining why each claim was denied. On this record, the evidence is insufficient to make any finding as to the outcome of the Medicare claims submitted for Patient A.M.’s treatment. There is no evidence proving whether the claims were denied, approved, or simply never acted on by Medicare. A separate allegation in the Administrative Complaint is that Patient A.M. requested copies of the Medicare claim forms submitted by Respondent’s office for her treatment. Patient A.M. said that she made verbal requests to Respondent’s office staff for the Medicare claims on more than one occasion, and the parties stipulated that Patient A.M. made these requests. Respondent’s office should have responded by giving Patient A.M. copies of the Medicare claims. Dr. Aderholdt said that he was not aware that Patient A.M. had requested copies of her Medicare claim. But it is his responsibility to ensure that his staff promptly responds to requests by patients for insurance claim forms. In the course of Petitioner’s investigation, the Medicare claim forms for Patient A.M. were provided to Petitioner (according to the investigator’s report, on May 16, 2014). It is unknown whether a set of the claim forms was provided to A.M. at that time. She is entitled to a copy of the claim forms if she has not already been given a set. Respondent should have verified that Patient A.M. has received the claim forms she requested, or, if not, provided them to her. Finally, the Administrative Complaint alleges that on the Medicare claim forms for A.M.’s treatments on August 6, 2013, and December 11, 2013, Respondent utilized Current Procedural Terminology (CPT) code 98941, which is the code for adjustments to three or four regions of the spine. However, Respondent’s Subjective, Objective, Assessment and Plan notes (referred to as SOAP notes) for those dates identify spinal adjustments to L3, L4, and L5, which are in a single region--the lumbar region. Beyond the SOAP notes, however, Dr. Aderholdt’s notes for Patient A.M.’s morning session on August 6, 2013 (there were two sessions that day), show multiple adjustments, not only to the lumbar region, but also, to the sacrum and ilium. Dr. Aderholdt’s notes for December 11, 2013, show multiple adjustments to the thoracic, lumbar, and sacrum regions. At hearing, Dr. Shreeve identified the five spinal regions as follows: “a region would be considered cervical, thoracic, lumbar, sacrum, ilium.” (Tr. 106, lines 21-22). Based on his testimony, and considering all of Patient A.M.’s medical records, there were multiple adjustments to three spinal regions on both days identified in the Administrative Complaint.10/ The Administrative Complaint has no other factual allegations regarding CPT code issues in connection with Patient A.M.’s treatment. The complaint pointedly identified one specific CPT code that was used on two specific dates, but was allegedly not supported by SOAP notes for either date. At hearing, Dr. Shreeve attempted to expand the factual allegations regarding CPT coding issues by questioning other CPT codes shown on A.M.’s patient ledger. Dr. Shreeve’s criticism was improper, not only because he strayed beyond the allegations in the Administrative Complaint, but also, because the criticism was based on his misunderstanding of what Dr. Aderholdt’s patient ledgers portray. In particular, Dr. Shreeve was critical of CPT code 99212 entries (for focused patient examinations) on A.M.’s patient ledger, without use of modifier code -25. He said that these repeated entries of CPT code 99212 were inappropriate without use of modifier code –25, to indicate they should not be considered for payment, because they are redundant with other CPT treatment codes that include examination. Dr. Shreeve should have reviewed the actual Medicare claim forms to look for the modifier codes, because the CPT code 99212 entries do, in fact, add a modifier of -25. The modifier code conveys information to the third-party payor, as Dr. Shreeve acknowledged, regarding whether or how payment should be made. The modifier codes need to be used, when appropriate, on the Medicare claim forms, and they were used just as Dr. Shreeve said was appropriate. The modifier codes do not appear on Dr. Aderholdt’s patient ledgers because they are not claim forms sent to third- party payors, nor are they bills sent to patients. Instead, a patient ledger, as used in Respondent’s practice, is an internal practice management tool to account for and track everything associated with treating patients: how many examinations, how many adjustments, how many Vax-D treatments, how many ice packs, and so on. Dr. LaRusso explained that this is a perfectly reasonable use of patient ledgers, and is a common practice among physicians. The usage statistics are analyzed for practice management, for such purposes as making changes in the services or treatments and stocking supplies. Dr. Shreeve admitted that he assumed Respondent’s patient ledgers reflected the exact CPT coding used on insurance claims and bills sent to patients. The evidence refuted that assumption. Modifier codes were used on the Medicare claims. And Dr. Shreeve admitted he saw no evidence that Respondent’s patient ledger for A.M. was ever sent to her as a bill, or that any patient ledgers were ever sent to any patients as bills. Dr. Shreeve also admitted that there is no standard for patient ledgers, much less a regulation mandating the contents and use of patient ledgers. As he put it, he could go to 1,000 chiropractic offices and find 1,000 different variations in what is called a patient ledger. Dr. Shreeve would like to see a standard adopted for “patient ledgers,” but his aspiration simply underscores that there is no standard now; Respondent’s practices cannot be judged against or held to conform to a non-standard, non-regulation.11/ In somewhat stream-of-consciousness fashion, untethered from the Administrative Complaint, Dr. Shreeve interjected a number of other comments about Dr. Aderholdt’s practices related to Patient A.M., such as the adequacy and legibility of his medical records and the quality of x-rays. He raised questions about Dr. Aderholdt’s compliance with trust accounting requirements in connection with payments for A.M.’s Vax-D therapy, and Dr. Aderholdt’s compliance with obligations in connection with Petitioner’s investigation. None of these factual matters were alleged in the Administrative Complaint, and none of the corresponding statutory or rule provisions implicated by Dr. Shreeve’s open-ended commentary were charged in the Administrative Complaint. No findings can be made on matters not alleged, and violations not charged, in the Administrative Complaint. Moreover, there is no competent evidence fleshing out any of these matters, because they were not alleged, charged, or identified in the Joint Pre-hearing Stipulation as issues of fact or law to be litigated. Patient B.O. Between April and June 2013, Respondent treated B.O., then a 78-year-old female, for back and neck pain. B.O. is married to R.O. They both went to Respondent’s office on the same day for their initial consultation. B.O. completed intake forms, had x-rays and patient history taken, and was examined by Respondent, similar to R.O. Whereas R.O. was determined to be a candidate for Vax-D therapy, B.O. was not. Unlike for the Vax-D therapy plan, there was no protocol calling for a certain range of sessions needed and no set payment correlated to a planned number of sessions for B.O.’s recommended treatment plan that called for adjustments, hydrotherapy, and ice packs. At the time of her treatment, B.O. had Medicare coverage and a “Medicare supplement” insurance policy through Horizon Blue Cross and Blue Shield of New Jersey (Horizon). As was his practice, Respondent had B.O. address the financial aspects of the treatment he recommended with his office staff. Upon review of B.O.’s insurance coverage, B.O. was informed by Respondent’s staff that Horizon would probably cover the cost of her treatment that exceeded her copay. The staff determined that, although it was possible Horizon would apply its lower in-network copay of $15.00 per visit, there was no guarantee that Horizon would not consider Respondent out-of- network, with a copay of $25.00 per visit. Therefore, B.O. was charged $25.00 per visit. She paid that amount per visit, although sometimes she did not pay at all on one or more visits, and would catch up at a subsequent visit. B.O. received treatments on 23 occasions. B.O. experienced some relief from her pain as a result of those treatments.12/ For those 23 visits, B.O. paid a total of $575.00 in copays. After B.O. had stopped going to Dr. Aderholdt for treatment, Horizon determined that its lower in-network copay of $15.00 per visit applied. The total copay amount should have been $345.00 for 23 visits. The difference is $230.00. The Administrative Complaint alleges that Respondent “overcharged” B.O., misrepresenting that her copay was the out- of-network charge, to exploit her for financial gain. This allegation was not proven. Respondent made no representation. The representations of his staff, as described by B.O., were not shown to be the product of anything other than a good faith attempt to determine the undeterminable details of insurance coverage. There is no evidence to support the allegation that B.O. was intentionally charged more than she should have been charged, based on the information available at the time. On this point, the expert testimony was in lockstep: figuring out insurance coverage details is a “nightmare.” It is virtually impossible, according to both experts, to obtain sufficient information to make a correct determination for a new patient on such issues as in-network versus out-of-network, because, as they agreed, the insurance coverage details keep changing. “Now, you can be in network today and they can decide you’re out of network tomorrow. And then you can be out of network and then they decide you’re in network, and they don’t tell you.” That’s--that makes no sense.” (Dr. Shreeve, Tr. 131). In fact, when asked how he determines if a patient is out-of-network, Dr. Shreeve responded: “Counselor, I don’t. I leave that to the patient. I run a cash practice. I give them a bill. We’ll help them fill out a health insurance claim form, if they need it. But they pay us when they receive the service.” (Tr. 130). The Administrative Complaint also alleges that Respondent billed Horizon for medical visits by Patient B.O. that did not occur. There is no credible evidence of this allegation; the evidence is to the contrary. Petitioner contends in its PRO that Respondent billed B.O. for treatments received on June 3, 7, 11, and 14, 2013, when B.O.’s appointments were cancelled on those days. The record citations offered by Petitioner fail to support this proposed finding. Instead, B.O.’s bank records directly refute the proposed finding, and corroborate Dr. Aderholdt’s treatment notes and the SOAP notes that detail B.O.’s treatment on those four days.13/ In addition to B.O.’s bank records, B.O.’s patient records include the “merchant copy” receipt for a debit card payment on June 14, 2013. The receipt shows that a $50.00 payment was made at Dr. Aderholdt’s office on June 14, 2013, and it bears the clear signature of B.O. B.O.’s accusation that she did not go to Respondent’s office for treatment on these four days is belied by the documentation that she personally went there and paid the copay charges for her treatments on those four days ($50.00 check on June 7 for two copays; $50.00 debit card payment on June 14 for two copays). Petitioner’s own expert, Dr. Shreeve, conceded that this evidence refutes B.O.’s accusation that her insurer was billed for treatment on four days when she did not go to Respondent’s office for treatment. A separate problem proving this allegation (besides B.O.’s false accusation) is that there is no evidence to prove what was billed to Horizon for B.O.’s treatments. There is no evidence in the record of claims submitted by Respondent’s office to bill Horizon for B.O.’s treatment. In pre-hearing discovery proceedings, shortly before hearing, Petitioner sought to compel production of Medicare claim forms or Horizon claim forms submitted by Respondent’s office. However, Petitioner declined an Order compelling production that was offered along with additional time to pursue this evidence. Instead, Petitioner chose to go forward with the hearing on the basis that there were no such records (as Respondent represented). Another allegation in the Administrative Complaint is that B.O. was not given a copy of her medical records upon request. B.O. testified that she made several verbal requests to two staff persons at Respondent’s office, Lisa14/ and Amanda, for her medical records. She said she was given a copy of her patient ledger, but nothing more. B.O. and R.O. then mailed a letter addressed to Respondent that they jointly wrote on December 31, 2013, requesting their medical records and updated patient ledgers. Respondent said that he was never informed of any verbal requests for records, nor did he believe he ever saw the letter that was mailed to him. Indeed, B.O. handwrote on her file copy of the letter, provided to Petitioner’s investigator: “Letter to Dr. who probably didn’t see – no response to date.” The evidence is clear and convincing that Respondent has failed in his obligation to promptly respond to B.O.’s requests for medical records. However, there is no evidence that Respondent was aware of the requests before the investigation and intentionally refused to comply, or that he ever instructed his office staff to ignore such requests. But even though the evidence only establishes that Dr. Aderholdt’s staff failed to promptly respond to requests for medical records, the obligation to ensure these patient requests are promptly addressed remains Dr. Aderholt’s responsibility. It is clear that his office procedures require serious overhauling, as both Dr. Aderholdt and his expert acknowledged. It is unknown if B.O.’s medical records were provided to her when they were produced by Respondent’s counsel during the investigation.15/ In her deposition, when B.O. was asked if she had gotten the records from Respondent’s office yet, she said “not from them.” Among other remedial steps in the aftermath of this proceeding, if B.O. and R.O. do not already have copies of their medical records and updated patient ledgers as they requested long ago, Respondent must provide them. It is concerning that he did not come to this hearing with proof that he had provided B.O. and R.O. with the records they had requested or confirmed that they already had a copy. Lastly, the Administrative Complaint alleges that Respondent received payment from Horizon for B.O.’s treatment, but has not provided a refund. There is insufficient evidence to determine whether B.O. is entitled to a refund. The only information regarding the extent to which Horizon covered B.O.’s treatment is the information in the EOBs issued by Horizon after B.O.’s treatment ended, identifying amounts that would be covered and reporting payments to Respondent. For B.O.’s treatments, Horizon paid $1,770.00 to Respondent. What is unknown is whether B.O. owed more for her treatments than what Horizon paid. Dr. LaRusso reasonably opined that the receipt of an insurance payment would not generate an obligation for a patient refund if the payment is applied to a balance due by the patient. No evidence, methodology, or calculation was offered to prove that after Horizon’s payment was applied, a refund was owed to B.O. As noted previously, Respondent’s “patient ledger” is an internal practice management tool that does not function as an accounting of what a patient or insurance company owes. However, the patient ledger for B.O. reflects a total amount of $5,575.00 in services provided to B.O. Application of the Horizon payments of $1,770.00 and B.O.’s payments of $575.00 would reduce the patient ledger amount by less than half. Again, this is not to say that Patient B.O. owes the remaining patient ledger amount, but it is at least a point of reference suggesting the possibility that the Horizon payment did not cover all of B.O.’s treatment costs. Viewed another way, all B.O. paid for 23 treatment sessions was $25.00 per visit. B.O. was informed at the outset that she would not be charged for the full treatments she would be getting, because Horizon would “probably” cover her treatment except for the copay. Although she paid $230.00 more than the amount Horizon ultimately applied as copays, if B.O. owed $230.00 or more for treatment provided that was not covered by Horizon’s payment, then no refund would be due. Patient R.O. As noted previously, Patient R.O. is Patient B.O.’s husband. Like B.O., R.O. was treated by Respondent from April through June 2013. R.O., then a 64-year-old male, sought treatment for severe back pain. R.O. completed the intake form, had x-rays and patient history taken, provided detailed records of recent treatments and surgeries (including back surgery), and was evaluated and examined by Dr. Aderholdt. Dr. Aderholdt determined that R.O. was a candidate for Vax-D therapy. Respondent’s then-office manager, Lisa, took over to address the financial aspects of the recommended treatment. R.O. informed Respondent’s staff that he could not afford to pay $5,500.00 up front. R.O. was given contact information for Care Credit. He called Care Credit, then submitted an application. R.O.’s application was approved, and Care Credit agreed to finance the cost of Vax-D therapy without charging interest if the amount was paid off within one year. R.O. accepted the loan, and the result was that Care Credit paid Respondent $5,500.00 minus a fee absorbed by Respondent, similar to fees by credit card companies charged to merchants for sales using their credit cards. R.O. testified that he has paid off the Care Credit loan. R.O. signed the Vax-D Agreement, by which he committed to 25 to 28 Vax-D therapy sessions at $250.00 per session, for a total payment amount of $5,500.00. His Vax-D Agreement included the treatment package detailed in paragraph 13 above. R.O. testified that during the time of his treatment by Respondent, he had health insurance coverage with Medicare and Horizon (the private Medicare supplement insurance coverage that B.O. also had). He also had Tricare for Life, but said that that coverage would not have been applicable. R.O. recalled that Respondent told him that none of his insurance plans would cover the Vax-D therapy. As previously noted, Respondent does not believe he discussed insurance coverage with R.O., as that is not his standard practice. Regardless, R.O. had no expectation of insurance coverage. R.O. found the Vax-D therapy helpful in relieving his pain. He felt better after every treatment and wanted to continue. Rather than stopping after the 25 to 28 sessions included in the Vax-D Agreement, R.O. had a total of 40 treatment sessions. However, at some point, Respondent’s office manager informed R.O. that he needed to pay for additional sessions. R.O. said he could not afford to pay more, and discontinued treatment. After R.O. discontinued his treatments, he received an EOB from Horizon, stating that Horizon had paid a total of $5,465.84 in claims for both R.O. and B.O. According to the EOB summary, as noted above, $1,770.00 was paid to Respondent for treatments to B.O. The rest--$3,335.84--was paid to two providers for services to R.O. (A minor discrepancy is noted, in that Petitioner’s PRO stated that $3,335.00 was paid to Respondent for treatments to R.O.; however, the EOB reports that $10.84 was paid to a different provider (“Ga Emergency Phys”) for services provided to R.O. Thus, the actual total payment to Respondent for R.O.’s treatment was $3,325.00). The total amount paid to Dr. Aderholdt for R.O.’s 40 Vax-D therapy sessions, including Horizon’s payments, was $8,825.00, an average of $220.63 per session. R.O. believes the insurance payment should be paid to him as reimbursement for part of the $5,500.00 he paid. But that payment was for 25 to 28 sessions. The insurance payment was reasonably applied to the additional amounts due for R.O.’s sessions that were not covered by the $5,500.00 payment. No reason was offered as to why Dr. Aderholdt should not have applied the insurance payment to charges owed for the 12 sessions that were not covered by the Vax-D Agreement. Chiropractic physicians are not required to provide free care. Dr. Shreeve admitted that he does not provide chiropractic care to patients for free. As found above with respect to Patient B.O., R.O. joined B.O. in submitting a written request to Respondent for their medical records and updated patient ledgers by letter dated December 31, 2013, although Respondent said that he did not see the letter that was mailed to him. The findings above with respect to B.O., as one party to the joint written request, apply with equal force to R.O. as the other party to the joint written request. The Administrative Complaint also included an allegation that Respondent failed to practice chiropractic medicine at an acceptable level of skill, care, and treatment, charged as a violation under section 460.413(1)(r). This was the only charge in any of the Administrative Complaints that was based on the care provided by Dr. Aderholdt. The allegation was that adjustments indicated as having been performed on R.O. were physically impossible. However, at hearing, Petitioner’s expert retreated from the allegation, agreeing that the procedure in question was plausible. As a result of his concession, Petitioner’s PRO abandoned the charge, stating, “Petitioner is no longer pursuing discipline for the alleged violation of section 460.413(1)(r).” Pet. PRO at 4. Patient P.D. In March and April 2013, Respondent treated Patient P.D., then a 62-year-old female, for back pain. After completing intake forms and patient history, Patient P.D. was x-rayed, then examined and evaluated by Dr. Aderholdt, who determined that P.D. was a candidate for Vax-D therapy. Dr. Aderholdt turned P.D. over to his then-office manager, Lisa, to address the financial aspects of his recommended treatment plan. P.D. confirmed that Dr. Aderholdt never discussed financial issues or insurance with her. P.D. signed the Vax-D Agreement on March 8, 2013, the same day that she completed a Care Credit application that was approved for $5,500.00. P.D. paid off the Care Credit loan in 11 months, at $500.00 per month, so the loan was interest-free. At the time of the treatments, P.D. was not yet eligible for Medicare. She had insurance coverage through Blue Cross Blue Shield of Michigan (Blue Cross). P.D. said that Lisa, the office manager, told her that she would file claims with Blue Cross. Thereafter, P.D. had 33 Vax-D therapy sessions. P.D. was pleased with the Vax-D therapy. She found it effective in relieving her pain. P.D. learned at some point from Blue Cross that several months after her treatment ended, Blue Cross paid Respondent for a portion of P.D.’s treatment. No evidence was offered to prove the details of the Blue Cross coverage, such as EOBs explaining what was covered and what was not. P.D. said that she contacted Respondent’s office and spoke with staff multiple times before Respondent provided her reimbursement in the full amount of the Blue Cross payment. Respondent refunded $946.45 on April 8, 2015, and $1,046.45 on April 10, 2015, for a total of $1,992.90. P.D. acknowledged that she has been fully reimbursed and is owed nothing further. The Administrative Complaint includes an allegation that Respondent improperly utilized CPT “billing codes” 99204 and 99212 for P.D.’s first session on March 6, 2013. Dr. Aderholdt admitted that for March 6, 2013, P.D.’s patient ledger incorrectly lists both CPT code 99204 (for a comprehensive examination for a new patient), and CPT code 99212 (for a focused examination for an established patient). The first CPT code should have been the only one entered on this day. The second code was entered by mistake. Although Dr. Aderholdt admitted the error made in the patient ledger, there is no evidence that the erroneous CPT code was “utilized” for billing purposes. No evidence was presented that both CPT codes were submitted by Respondent in a claim for payment to Blue Cross (and Petitioner did not charge Respondent with having submitted a claim to P.D.’s insurer for a service or treatment not provided). No evidence was presented of the actual claims submitted to Blue Cross. No evidence was presented to show that P.D. was ever sent a bill utilizing the referenced CPT codes. The error recording an extra CPT code on P.D.’s patient ledger might throw off Respondent’s internal practice management statistics, but there is no evidence that the admitted CPT coding mistake on the patient ledger was repeated in any claim or bill submitted to anyone. Expert Opinions Considering All Four Cases Both Dr. Shreeve and Dr. LaRusso offered their overall opinions, taking the four cases as a whole. Dr. Shreeve’s Oinions Dr. Shreeve testified that, while he might be more understanding of issues he saw in each individual case, “I’ve got four cases that I reviewed together. I received them all at once. So my view on each individual case might be seen as a little more tolerant of something I saw. But when it becomes repeated, it becomes less understanding [sic].” (Tr. 109). In forming his opinions, Dr. Shreeve relied on allegations that have not been proven, his own extension of the Administrative Complaint allegations to add other concerns about use of CPT codes (which were also shown not to be valid concerns), and his observations about a litany of matters nowhere mentioned or charged in the Administrative Complaints. Dr. Shreeve made clear that he elevated his opinion from concerns about sloppy office practices to fraud, misrepresentation, and patient exploitation, because of matters that were either unproven, not alleged or charged, or both. For example, he injected the concern, shown to be based solely on patient ledgers, that CPT code 99212 appeared many times without the -25 modifier when used in conjunction with an adjustment CPT code. Starting with A.M.’s case, he complained of the repeated use of CPT code 99212 without a -25 modifier, when CPT code 98941 (adjustments) was used for the same office visit. He said, “If we were going to bill 99212, an E/M code with that, we would use a modifier of -25.” (Tr. 110). As previously found, however, Dr. Aderholdt did use the -25 modifier with every entry of CPT code 99212 in the Medicare claim forms. In explaining how his opinion was affected by his misimpression from the patient ledgers that CPT code 99212 was not used with the -25 modifier, he said: This is repeated over and over during the record. If it were one off, it occurred in one place in the ledger or on a form, you know, everybody is human. They can make a mistake. If it is the trend, that becomes not a mistake. That becomes, I’m doing the wrong thing. And if I’m doing it over and over again, and I’m then billing for one service two times, two different ways, and I’m – I hope to get paid for it. Then that’s where I start to see the trend of exploiting the patient for financial gain. (Tr. 111). Dr. Shreeve further elevated the significance of not seeing modifiers with the evaluation codes in the patient ledgers, when he spoke about R.O.’s case: If [Dr. Aderholdt] did both codes [for evaluation and adjustments] every visit, if he did, which is not normal, we would have to have a modifier, the -25, to tell us it’s a reduced service because it’s duplicative. A modifier was never present in any record I saw on this patient or any other patient of the records of Dr. Aderholdt. So misusing the codes. This is not standard of care that we expect, and this appears to me exercising influence on the patient to exploit them for financial gain. That’s what it looks like to me. By the time we’re through with the third case that’s what I see. (Tr. 148). Not only was this CPT coding issue not alleged in any of the four Administrative Complaints, but it is a false accusation. If Dr. Shreeve did not see a single use of CPT code 99212 with the -25 modifier in any record he saw, then he did not look at the records very carefully. As found above, the only evidence of actual claims submitted to any third-party payor--the Medicare claim forms for Patient A.M.--shows that CPT code 99212 was never used without the -25 modifier. But Dr. Shreeve only looked at the patient ledgers for modifiers. As also found above, the only two CPT coding issues that were alleged (improper use on two specified dates of CPT code 98941 for adjusting three or four spinal regions for Patient A.M.; and improper use on Patient P.D.’s first day of service of two patient examination CPT codes for billing purposes) were not proven. Dr. Shreeve also relied on the allegation that Patient B.O.’s insurance carrier was billed for treatment that was not provided. He pointed to “notes” written (by B.O.) on the patient ledger stating that the patient cancelled, but CPT codes were entered for treatments that day. He concluded: That’s blatant. I don’t have a way to explain that away. To me that absolutely says, I billed for something that I didn’t do. That’s fraud. Because that’s with intent. That’s not an accident. (Tr. 137). When Dr. Shreeve was shown the $50.00 debit card receipt signed by Patient B.O. on June 14, 2014, he quickly retreated: “That would indicate that they were there, even though they said they were not. So my apologies for that. It’s good to clear that up.” (Tr. 183). Later, he added that the June 14, 2013, payment of $50.00 was for that visit and the prior visit on June 11, 2013. He explained that this was consistent with Respondent’s daily notes, which identified treatments for each visit and also logged the copay charges by visit and B.O.’s periodic payments. Dr. Shreeve did not explain how he would alter his overall opinion after conceding that what he characterized as blatant fraud by Dr. Aderholdt was actually a false accusation by the patient. In formulating his overall opinion that what otherwise might be viewed as mistakes or sloppy office practice were elevated in his mind to fraud and exploitation, Dr. Shreeve also relied heavily on matters that were neither alleged nor charged in the Administrative Complaints, and, as a result, were not fleshed out with competent evidence in the record. Dr. Shreeve repeatedly alluded to issues regarding trust accounting requirements in statute and rule. The four Administrative Complaints that were issued as directed by the PCP on June 19, 2018 (as noted on the Administrative Complaints), contain no allegations related to trust accounting practices. The PCP-authorized Administrative Complaints do not charge Dr. Aderholdt under the trust accounting statute, section 460.413(1)(y), or the trust accounting rule, Board rule 64B2- 14.001. To the extent Dr. Shreeve’s perception of trust accounting issues contributed to his opinion that these four cases rise to the level of fraud and patient exploitation, that was error, and his opinion must be discounted accordingly. Likewise, Dr. Shreeve gratuitously offered critiques of Dr. Aderholdt’s medical records, including complaints about the handwriting, complaints about x-ray quality, questions about the adequacy of justifications for the course of treatment, and suggestions regarding how he would rewrite SOAP notes. Again, the Administrative Complaints are devoid of allegations directed to the quality or adequacy of Respondent’s medical records, and they are devoid of charges under the medical records provision in section 460.413(1)(m) and the corresponding medical records rule, Board rule 64B2-17.0065. To the extent these critiques contributed to Dr. Shreeve’s opinion that these four cases rise to the level of fraud and patient exploitation, that, too, was error, and his opinion must be discounted accordingly. Dr. Shreeve also relied on what he characterized as Respondent’s failure to respond, or failure to respond quickly enough, to investigative subpoenas. He made it clear that his opinion was greatly influenced by his perception that Respondent intentionally failed to meet his obligations in responding to the investigations: I think this is absolute fraud. The doctor is not wanting to do the right thing, has flagrant disregard for the law, and the statutes and the rules for the profession, for the Department of Health by not responding. (Tr. 153). Despite Dr. Shreeve’s view that he thinks it is “very clear” that Dr. Aderholdt did not respond timely during the investigation, the timeline and details of the investigation were not established by competent evidence; there is only hearsay evidence addressing bits and pieces of that history, with huge gaps and many questions about the reasons for those gaps (if the reasons why investigations were so protracted was relevant). But the details of the investigations are not laid out in the evidentiary record because the Administrative Complaints do not contain factual allegations related to Dr. Aderholdt’s actions or inactions during the investigation process, nor are there any charges predicated on what was or was not done during the investigation process. Either these matters were not presented to the PCP in June 2018 for inclusion in the Administrative Complaints, or they were presented and not included. Either way, Dr. Shreeve’s perception regarding whether Dr. Aderholdt met his legal obligations in responding to the investigations cannot be injected now. It was improper for Dr. Shreeve to consider, and give great weight to, circumstances that were neither alleged nor charged in the PCP-authorized Administrative Complaints. As found above, the proven allegations are that Respondent failed to provide Patient A.M. copies of the claims submitted to Medicare for her treatment (although she may have them now); and Respondent failed to provide copies of the medical records of Patients R.O. and B.O. upon their joint written request (although they may have them now). Only by considering allegations that were not proven and by injecting matters not alleged or charged was Dr. Shreeve able to characterize these four cases as involving the same problems again and again. In terms of the proven allegations, however, the only duplicative finding is with respect to the husband and wife team, in that Respondent did not meet his obligation to promptly respond to their joint request for medical records and updated patient ledgers. The matters considered by Dr. Shreeve beyond the allegations and charges in the Administrative Complaints were also improperly used by Dr. Shreeve to buttress his view that two disciplinary actions against Dr. Aderholdt based on facts arising in 2005 and 2006, raised “the same or similar” issues. Dr. Shreeve’s attempt to draw parallels between the prior actions and these four cases was unpersuasive. Dr. LaRusso disagreed with the characterization of the two prior actions as similar to the issues presented here. Dr. LaRusso’s opinion is credited. A comparison of the allegations, ultimately resolved by stipulated agreement in two 2008 Final Orders, confirms Dr. LaRusso’s view in this regard. The first disciplinary action was based on Respondent’s treatment of one patient in February 2005. An administrative complaint alleged that Respondent failed to complete intake forms, take the patient’s history, and conduct a sufficient examination to support the diagnosis. Respondent was charged with violating section 460.413(1)(m) by not having adequate medical records. The same facts gave rise to a second count of violating section 460.413(1)(ff) (violating any provision of chapters 456 or 460, or any rules adopted pursuant to those chapters), through a violation of rule 64B2-17.0065, which elaborates on the requirements for adequate medical records. There is no repetition of these statutory and rule violations charged in any of the four Administrative Complaints at issue here. The prior administrative complaint also alleged that Respondent billed the patient he saw in 2005 for neuromuscular reeducation and therapeutic exercises, when neither Respondent’s notes nor the SOAP notes reflected those services. In these cases, the only allegation regarding discrepancies between billing records and physician/SOAP notes is the allegation as to Patient A.M. that on two dates, Respondent used the CPT code for adjustments to three or four spinal regions, whereas the SOAP notes reflected adjustments to only one region. The prior disciplinary action supports the findings above that Respondent’s notes must also be considered, in addition to the SOAP notes, to determine what services A.M. received on those two days. A different kind of billing discrepancy allegation in Case No. 18-4485 is the claim that Respondent billed B.O.’s insurer for treatment on days on which services were allegedly never provided. This allegation was not proven, as found above. B.O.’s accusation that Respondent falsely charged for treatment on several days when no treatment was provided was itself proven to be a false charge. Perhaps Dr. Shreeve was thinking of this allegation, based on B.O.’s false charge, when he characterized the 2005 incident as involving the same or similar problems that he saw here. The allegation in the prior complaint was that the patient was actually billed for services not provided, and a refunded was ordered. At first, Dr. Shreeve believed the same was true in B.O.’s case. However, he later retreated and acknowledged that B.O. had not been truthful in her accusation. The only other allegation of a billing discrepancy in any of the four cases at issue was not a billing discrepancy at all, but rather, a CPT coding error on P.D.’s patient ledger that was not billed to anyone. As Dr. Shreeve noted, in the prior disciplinary action, Respondent agreed to be put on probation with a requirement that he practice with a monitor. Dr. Shreeve explained that the monitor would have worked with Respondent “to help this doctor not do the same behaviors that got them into trouble.” In his view, these four cases show that Dr. Aderholdt did not learn his lesson from the monitor “not to do the same problems again.” As he put it, “That really flips me rather quickly to think there’s a question of fraud.” (Tr. 152-153). To the contrary, whereas Respondent was faulted for not having intake records, patient histories, and appropriate examinations to support his diagnosis and recommended treatment plan in February 2005, no such issues were raised in these Administrative Complaints. Dr. Aderholdt did learn his lesson. The medical records for the four patients at issue include patient intake forms, patient histories, evaluations, and examinations that were not alleged to be inadequate. Nor was there any repetition of the problem with billing a patient for treatment or services that were not documented in the medical records taken as a whole, including Dr. Aderholt’s notes. The other disciplinary action resolved by settlement in a 2008 Final Order involved an advertising issue. The Department alleged that Respondent improperly advertised as a specialist in Vax-D disc therapy when the Board does not recognize any such specialty. The Department also found fault in the failure of the advertising to disclose the usual fee. The Department also critiqued an advertisement for identifying a different practice location than Respondent’s practice address of record. The charges were under section 460.413(1)(d), (cc), and (ff); rule 64B2-15.001(2)(e) and (i); and rule 64B2-10.0055. Quite plainly, this prior action bears no similarity to the four Administrative Complaints at issue here. No such allegations or charges were raised here. Dr. Shreeve did not contend that this prior action bears any similarity to the four cases here. Dr. Shreeve was never asked for his opinion as to the type or level of discipline he believes is warranted in these cases. However, his “flip” to “fraud,” due to the perceived repetitive nature of the issues in the four cases (whether charged or not)--which he characterized as the “same problems” in 2005 that resulted in discipline--was the basis for Petitioner proposing the most severe penalty available: license revocation, plus substantial fines and assessments of fees and costs. Dr. LaRusso’s Opinions Dr. LaRusso served as a Board member for multiple terms, and is a past-chair. After leaving the Board, he continued to serve on probable cause panels as recently as 2017. Having reviewed and been involved in thousands of disciplinary matters, he was of the strong opinion that nothing in the four Administrative Complaints warrant discipline at the level being sought here. Imposing a severe penalty in these four cases would be out of line with the Board’s prior practice in disciplinary matters. Dr. LaRusso’s studied review of all of the depositions and records in this case led him to opine that there is no evidence that Dr. Aderholdt deceived his patients, committed fraud, or engaged in double-billing or overbilling. Instead, Dr. LaRusso saw evidence of sloppy office practices, which he attributed to Dr. Aderholdt’s poor management skills. He has seen many doctors like Dr. Aderholdt over the years who just want to deal with taking care of patients. They do not want to have anything to do with administrative and clerical responsibilities. Instead, they leave everything besides patient care to their office manager and staff. In Dr. LaRusso’s view, Dr. Aderholdt’s office protocols and procedures require serious fine-tuning. He believes that Dr. Aderholdt would benefit from re-education in billing and collection practices, as well as laws and rules. He needs to ensure that procedures are in place, and followed, for prompt responses to patient requests for medical records or for claims sent to third-party payors. At the same time, however, Dr. LaRusso reasonably characterized the four cases as involving billing, clerical, communication, and correspondence issues. It bears emphasis that Dr. Aderholdt’s patient care is not in question. There are no issues of endangering the public, where a doctor is doing things that will hurt people, doing something dangerous or sexually inappropriate. Those are the cases where it is appropriate to go after someone’s livelihood, when the person does not belong in the profession. Dr. LaRusso observed that, rather than endangering the public, Dr. Aderholdt was helping his patients by relieving their pain, according to their own testimony. Dr. LaRusso agreed to become involved in this case because he found it so incongruous that the Department would be pursuing this action apparently to try to take Dr. Aderholdt’s license. Dr. LaRusso noted that the four investigations against Dr. Aderholdt were originally being spearheaded by a prior prosecutor for the Department (to whom Respondent’s counsel mailed CDs of patient records in 2014), and that the cases were assigned to Dr. Willis, who was a favored expert witness for the Department. Dr. LaRusso alluded to “inappropriate issues” with the prosecutor and expert that led to the Board having to pay a large award of attorneys’ fees and costs for pursuing discipline against Dr. Christian. According to Dr. LaRusso, those issues ultimately led to the prosecutor and expert being discharged from these cases. There is no evidence as to when or why Dr. Willis was replaced with Dr. Shreeve. Dr. Willis apparently was involved long enough to prepare an expert report. But then, according to Dr. LaRusso, the cases went dormant for a long period of time. The bits and pieces of hearsay evidence in the file comport with this understanding: there were four investigations that began upon complaints in 2014 by the four patients about billing and records issues; documents were collected from Respondent and from the patients; and Investigative Reports were issued, all before 2014 was over. It is unknown when Dr. Willis was involved, when he prepared his expert report, or when he was discharged from the cases. It is unknown when Dr. Shreeve was retained, but there was plainly some duplication of work, in that Dr. Shreeve prepared his own expert report. Neither expert report is in evidence. There is no evidence of any additional investigation or follow-up documentation from the patients or otherwise. There is no evidence of what was presented to the PCP--just that the panel met on June 19, 2018, and authorized the four Administrative Complaints issued on June 20, 2018. While this background is a bit of a curiosity, without impermissible speculation, the most that can be said about this history is that the protracted period of time from investigation to the PCP submission that resulted in issuance of the Administrative Complaints is apparently due, at least in large part, to the turnover in the prosecution-expert witness team assignments. Dr. LaRusso did not persuasively demonstrate grounds to cast nefarious aspersions on the Department for continuing forward with its investigation. One might reasonably question whether the Department dropped the ball, so to speak, in not updating its investigation, given the extended period of dormancy. For example, the Administrative Complaint in Case No. 18-4487 incorrectly alleged that P.D. was not reimbursed, when any cursory check with P.D. would have revealed the “news” that she had been repaid in April 2015, more than three years before the Administrative Complaint was authorized by the PCP. Dr. LaRusso may reasonably debate, as he did, whether the charges lodged against Respondent are inappropriate. And Dr. LaRusso may certainly question, as he did in convincing fashion, whether the discipline apparently being sought is unduly harsh, uncalled for, and way out of line with Board practice. But there is no basis in this record for attributing bad motives to the Department for prosecuting the Administrative Complaints. Dr. LaRusso’s opinions regarding the nature of the violations proven and the appropriate discipline in scale with those violations were more persuasive that Dr. Shreeve’s opinions. Dr. LaRusso’s opinions are credited.
Recommendation Based on the foregoing Findings of Fact and Conclusions of Law, it is RECOMMENDED that a final order be entered by the Board of Chiropractic Medicine: In Case No. 18-4484PL: Dismissing Counts I, II, and IV; and Finding that Respondent violated section 460.413(1)(aa), as charged in Count III; In Case No. 18-4485PL: Dismissing Counts I, III, and IV; and Finding that Respondent violated section 460.413(1)(i), through a violation of rule 64B2-17.0055(1), as charged in Count II; In Case No. 18-4486PL: Dismissing Counts II, III, and IV; and Finding that Respondent violated section 460.413(1)(i), through a violation of rule 64B2-17.0055(1), as charged in Count II; In Case No. 18-4487PL, dismissing Counts I and II; Placing Respondent on probation for a period of three years, with conditions deemed appropriate by the Board; Imposing a fine of $3,000.00; Requiring continuing education deemed appropriate by the Board; and Requiring payment of the costs of investigation and prosecution of the charges on which violations were found. DONE AND ENTERED this 15th day of February, 2018, in Tallahassee, Leon County, Florida. S ELIZABETH W. MCARTHUR Administrative Law Judge Division of Administrative Hearings The DeSoto Building 1230 Apalachee Parkway Tallahassee, Florida 32399-3060 (850) 488-9675 Fax Filing (850) 921-6847 www.doah.state.fl.us Filed with the Clerk of the Division of Administrative Hearings this 15th day of February, 2018.
Findings Of Fact Upon consideration of the oral and documentary evidence adduced at the hearing, the following relevant facts are found: At all times pertinent to this proceeding, respondent Robb E. Ross was a licensed physician engaged in the practice of family medicine as a sole practitioner. He was licensed to practice medicine in the State of Florida in 1966 and holds license number 12433. He was board certified in family practice in 1970. Respondent also holds a license as a pharmacist. Respondent treated patient N.B. from September of 1970 through October of 1986. She initially presented as a new patient moving into the area, aged 61, for maintenance of her general physical medical care, primarily relating to her mild depression that she had for years following a mastectomy. While believing that patient N.B. had previously been under the care of a psychiatrist or psychologist, respondent never requested her prior medical records. Patient N.B. informed the respondent that she had been taking Biphetamine, a steroid amphetamine that is no longer produced, for the past ten years. Respondent continued patient N.B. in that treatment modality for over ten years, as well as treating her for other complaints. At some point, he did attempt to titrate her from Biphetamine, but she did not function as well with a substitute drug. When the drug Biphetamine was phased out of the market in either 1980 or 1982, respondent prescribed Dexedrine to patient N.B. and continued to do so approximately every six months. Respondent maintained her on Dexedrine due to her mild depression and the fact that she had been on amphetamines for many, many years. He was reluctant to take her off Dexedrine for fear that she could become overtly depressed. Since she did well with Dexedrine, respondent maintained her on that regiment due to the adverse side effects of other compounds utilized to control depression. The respondent's medical records for patient N.B. contain virtually no patient history or background information. For each patient visit, there is a brief notation which includes N.B.'s temperature, blood pressure and weight and also a reason for the visit. The reason noted on the records are either "check- up" or a brief statement of the patient's complaint on that particular day. The medication prescribed is noted, though very difficult to read. While the symptom or patient complaint is often noted, the patient records contain no statements of medical diagnosis, assessment or treatment plan. It is not possible to determine from N.B.'s medical records the reason that Dexedrine was prescribed for this patient. While N.B. complained of tiredness, she did not suffer from narcolepsy. Patient G.B. was under respondent's care from August of 1979 through May of 1985. He initially presented, at age 56, with problems relating to emphysema, lung collapse, exhaustion, impotency and aches and pains. Respondent prescribed various medications for him, including Nitroglycerin for chest pains. Respondent felt that due to his age and his complaints, patient G.B. had some type of arteriosclerosis. Patient G.B. frequently complained of being weak, exhausted and having no endurance or energy. For this reason, respondent prescribed Dexedrine for him on March 30, 1984. Other medications to increase his energy were tried before this and after this time. Nothing appeared to give him any relief. After determining that patient G.B. "liked his medicine too much," respondent terminated his treatment of him. The respondent's medical records for patient G.B. are brief and difficult to decipher. Again, the patient's temperature, blood pressure and weight are recorded for each visit, and there is a brief statement of the patient's complaint. There is no statement indicating a medical diagnosis or a treatment plan. The medications prescribed at each visit are written on the records, but are difficult to read. D.M. was a patient under respondent's care from December of 1976 until his death, at age 84, in March of 1986. He initially presented with stomach problems and subsequently had a host of other medical problems, surgeries and hospitalizations throughout the years. This patient was given so many different medications for his various physical problems that respondent did not always write each of them down on his records after each office visit. It appears from respondent's medical records that he first started patient D.M. on Dexedrine in January of 1984. At that time, D.M.'s chief complaint was "dizziness, falling, no pep." Respondent maintained D.M. on Dexedrine or an amphetamine type of compound from that period until his death, primarily because of his weakness, dizziness, falling down and low blood pressure. Other specialists were consulted regarding D.M.'s fainting and falling episodes, caused by postural hypotension, and were unable to remedy the problem. Respondent was of the opinion that the administration of Dexedrine enabled patient D.M. to function more properly and that it worked better than anything else. Patient D.M. expired in March of 1986. Respondent listed the cause of death as "cardiac arrest." The respondent's medical records on patient D.M. are typical of those previously described for patients N.B. and G.B. The office visit notes list patient complaints or symptoms and no medical diagnosis or comprehensive assessments. There are indications in the record that D.M. complained of chest pains in 1983, 1984 and 1985. The medications prescribed indicate the presence of cardiac disease. Respondent's record-keeping with regard to patients N.B., G.B. and D.M. are below an acceptable standard of care. They fail to include an adequate patient history and initial assessment of the patients. It is impossible to determine from these records what medicines the patients had taken in the past, what reactions they had to such medications, what medical procedures they had in the past or other important information regarding the patient's background. The respondent's only notation of treatment is a listing, and a partial listing in the case of D.M., of medications prescribed. His remaining notations are not acceptable to explain or justify the treatment program undertaken. Dextroamphedimine sulfate, also known as Dexedrine, is a sympathomimetic amine drug and is designated as a Schedule II controlled substance pursuant to Chapter 893, Florida Statutes. Commonly, it is referred to as "speed" or an "upper." It is addictive and highly abusive. While individual patients react differently to Dexedrine, its consumption can cause psychosis, marked elevations of blood pressure and marked rhythmic disturbances. As such, its use is contraindicated in patients with coronary disease. In addition, because Dexedrine is an "upper" and makes a patient "feel good," it can mask a true physical condition and prevent the patient from being treated for the physical ailment he is experiencing. A patient should not be relieved of pain without first knowing what is causing the pain. In Florida, Dexedrine may only be prescribed, administered or dispensed to treat specifically enumerated diseases, conditions or symptoms. Section 458.331(1)(cc), Florida Statutes. Neither respondent's medical records nor his testimony indicate that patients N.B., G.B. and/or D.M. suffered from the conditions, symptoms or diseases which warranted the statutorily approved and limited use of Dexedrine. Respondent was not aware that there were statutory limitations for the use of Dexedrine. He is aware of the possible dangers of amphetamines and he prescribes Dexedrine as a treatment of last resort when he believes it will help the patient. Respondent further testified that his medical record-keeping is adequate to enable him, as a sole practitioner, to treat his patients, though he admits that his medical records could be improved.
Recommendation Based upon the findings of fact and conclusions of law recited herein, it is RECOMMENDED that respondent be found guilty of violating Section 458.331(I), subparagraphs (cc),(q),(t) and (n), Florida Statutes, and that the following penalties be imposed: an administrative fine in the total amount of $2,000.00, and probation for a period of twelve (12) months, with the following conditions: (a) that respondent complete continuing medical education courses or seminars in the areas of medical record-keeping and the dangers and authorized use of compounds designated as Schedule II controlled substances, and (b) that respondent submit to the Board on a monthly basis the medical records of those patients for whom a Schedule II controlled substance is prescribed or administered during the probationary period. Respectfully submitted and entered this 2nd day of September, 1987, in Tallahassee, Florida. DIANE D. TREMOR, Hearing Officer Division of Administrative Hearings The Oakland Building 2009 Apalachee Parkway Tallahassee, Florida 32399-1550 (904) 488-9675 Filed with the Clerk of the Division of Administrative Hearings this 2nd day of September, 1987. APPENDIX TO RECOMMENDED ORDER, CASE NO. 86-3483 The proposed findings of fact submitted by counsel for the parties have been carefully considered. To the extent that the proposed factual findings are not included in this Recommended Order, they are rejected for the following reasons: Petitioner: The 48 proposed findings of fact submitted by the petitioner consist of summaries or recitations of the testimony of the witnesses presented by the petitioner in this proceeding. While the summaries and/or recitations constitute an accurate representation of the testimony received by those witnesses at the hearing, and are thus accepted, they do not constitute proper factual findings by themselves. Instead, they (along with the testimony presented by the respondent) form the basis for the findings of fact in this Recommended Order. Respondent: Page 4, Paragraph 1 The reference to 30 years is rejected as contrary to the evidence. COPIES FURNISHED: David E Bryant, Esquire Alpert, Josey, Grilli, Paris and Bryant 100 South Ashley Drive Suite 2000 Tampa, Florida 33602 David J. Wollinka, Esquire P. O. Box 3649 Holiday, Florida 33590 Van Poole, Secretary Department of Professional Regulation 130 North Monroe Street Tallahassee, Florida 32399-0750 Joseph A. Sole, General Counsel Department of Professional Regulation 130 North Monroe Street Tallahassee, Florida 32399-0750 Dorothy Faircloth, Executive Director Board of Medical Examiners 130 North Monroe Street Tallahassee, Florida 32399-0750 =================================================================
The Issue The issues presented for consideration on this occasion concern an administrative complaint brought by the State of Florida, Department of Professional Regulation, against the Respondent. In particular, it is alleged that on the named dates, January 7 and 8, 1983, Respondent failed to check vital signs for patients in the intensive care unit who were receiving her care. Additionally, it is alleged that Respondent abandoned patients in her care by leaving her assigned floor for long periods of time without notifying her supervisor. These actions purportedly are acts of unprofessional conduct which depart from or fail to conform to minimal standards of acceptable nursing practice per Section 464.018(1)(f), Florida Statutes, and violate Section 464.018(1)(j) , Florida Statutes, by violating Board of Nursing Rule 210- 10.05(2)(d) and (2)(e) 1., Florida Administrative Code, through inaccuracies in record keeping or falsification of patient records or charts.
Findings Of Fact Respondent is a licensed practical nurse, having been issued license No. 0524551 by the Board of Nursing in the State of Florida. At all times relevant to these proceedings, Respondent was employed as a nurse at Ormond Beach Hospital, Ormond Beach, Florida. Beginning at 11:00 p.m. on January 7, 1983, and continuing until January 8, 1983, at 7:00 a.m., Respondent was working in the intensive care unit of Ormond Beach Hospital. During that time, she was primarily responsible for the care of the Patients Eleanor Prentzel and Evelyn Burkman. On that duty shift, at 12:00 midnight and 6:00 a.m., Respondent checked the vital signs of the two patients. In addition, other assessments were made during that duty cycle related to the patients. The recordation of the vital signs and statement of assessments may be found in the 24 hour nurse's notes pertaining to the two patients. These entries are part of Petitioner's exhibits 2 and 3 admitted into evidence which are patient records related to the patients in question for Burkman and Prentzel respectively. During the duty shift, between 1:30 a.m. and 5:00 a.m., Respondent was gone from her duty station for an unacceptable amount of time. While absent, Ms. Burkman, who was a cardiac patient, complained of chest pains and had to be attended by Margaret S. Vogini, R.N., who was working in the ICU on this shift. Vogini had the patient do deep breathing and listened to her lungs and heart, checked her blood pressure and watched the cardiac monitor. The patient was experiencing pain on deep inspiration, which led Vogini to believe that the problem was with the patient's lungs and not related to cardiac difficulty. Respondent worked the duty shift beginning 11:00 p.m., January 8, 1983, and concluding 7:00 a.m., January 9, 1983. Again, she attended patients in the intensive care unit. One of those patients was Prentzel. The patient Burkman was assigned to Vogini on this duty shift. Again there were unacceptably longer periods of time when Respondent was out of the intensive care unit. During that duty shift, an unnamed patient became comatose and suffered cardiac arrest; requiring cardiopulmonary resuscitation. At that time, Respondent was not in the intensive care unit and had to be summoned back to the unit to assist other nurses that were working that shift. On this same shift, at 12:00 midnight, Respondent failed to take the temperature of the patient Prentzel. This should have been done in keeping with physician's orders either 30 minutes before or 30 minutes after midnight. Respondent indicated that the reason for not taking the temperature was because she did not want to wake the patient up. This was an inappropriate decision about a patient in the intensive care unit. Respondent also failed to record the blood pressure reading which she took related to the patient Prentzel at 12:00 midnight on this shift. Again, this was an inappropriate judgement about a patient in the intensive care unit. During the two evenings in question, Respondent was suffering from a bladder infection and reported this problem to Virginia Hilbert, R.N., nurse supervisor of the Respondent. This medical problem required frequent trips to the bathroom on the part of Respondent. On occasion, it was necessary for the Respondent to leave the intensive care unit to accomplish her purposes. At most, those trips would have taken four minutes and did not satisfactorily account for the length of time in which the Respondent was not caring for her patients on the two duty shifts at issue. Because of her conduct on the evenings in question, Respondent was called before the hospital administration for counseling. In the course of this session, Respondent admitted that she did not always take respiration of patients in her charge. She made this comment during the course of a discussion of the events of the two duty shifts in question. Nonetheless, the record does not establish with reasonable certainty that her comments pertained to those patients Burkman and Prentzel who were in her care on January 7-8 and 8-9, 1983. The circumstances described in discussing the absence of Respondent on the two duty shifts in question, leads to the conclusion that the Respondent was absent from her duty station without properly notifying another nurse or supervisor working in the unit. That absence without proper notification, as established through testimony of Nurse Vogini, was a departure from acceptable nursing practice in that it was below the minimal standards of acceptable and prevailing nursing practice in Florida. Charlotte Brooks, R.N., Assistant Administrator at Ormond Beach Hospital and Director of Nursing, set forth the importance of taking vital signs as next described. By taking vital signs, the nurse discovers the patient's reaction to illness, stress, and drugs. In the intensive care unit, the results of these checks demonstrate the need to either start or stop medication and measure the patient's response to the disease process. The taking of vital signs can detect shock and various other kinds of problems that the patient may experience. Generally, temperature and respiration checks help to track the patient's progress. Finally, these notations of vital signs made by the nurses assist subsequent shift nurses in treating the patients, to include initiation or institution of doctor's orders based upon reported vital signs.
The Issue This is a license discipline case in which the Petitioner seeks to take disciplinary action against a licensed medical doctor. By means of a two-count Administrative Complaint, the Respondent is charged with violations of Sections 458.331(1)(m) and 458.331(1)(t), Florida Statutes, by allegedly failing to keep written medical records justifying the course of treatment of a patient, and by failing to practice medicine with the required level of care, skill, and treatment. The Respondent denies the violations charged in the Administrative Complaint, and also asserts that the Administrative Complaint should be dismissed by reason of the Petitioner's failure to timely investigate and prosecute the subject charges.
Findings Of Fact Findings stipulated by the parties4 The Respondent is, and has been at all times material hereto, a licensed physician in the State of Florida. The patient R. C. presented with a history of diabetes and hypertension. The Respondent did not attempt or make any contact with the primary care physician of patient R. C. Brevital was administered intravenously to the patient R. C. without the use of an IV pump. Resuscitative drugs and equipment should always be immediately available. There is no documentation of respiratory monitoring during the administration of anesthetics and the surgical procedure performed on patient R. C. It is well below the standard of care to both administer a general anesthesia and perform the surgical procedure. Findings based on evidence At all times material, the Respondent has specialized in urology. The Respondent is not board certified in urology. At all times material to this case, the Respondent was associated with a clinic named Instituto Latino Americano de Impotencia y Diagnostico (ILAID). One or two days each week, the Respondent would see patients at ILAID that were potential candidates for penile implant surgery. At all times material to this case there were at least two other licensed physicians associated with ILAID who often were the first physicians to see patients who came to ILAID with complaints of impotency. The subject patient (Patient R. C.) went to ILAID for the first time on May 24, 1993. On that day the patient signed a form titled "Patient Information," which contains little more than patient identification information, and a form titled "Patient's Declaration and Agreement."5 The patient probably saw a physician at ILAID on May 24, 1993, because a blood sample was taken from the patient that day and the results of the blood tests were reported back to ILAID on May 25, 1993. However, there is no documentation that the patient was seen by a physician at ILAID on May 24, 1993. Specifically, there is no medical chart documenting that on that day a physician took a history from the patient, examined the patient, evaluated the patient, ordered any tests of the patient, or otherwise treated or cared for the patient. At all times material to this case, the routine practice and procedure of ILAID regarding patients who went to ILAID with complaints of impotency was to have the patients seen by a physician associated with ILAID. It was also the routine practice and procedure at ILAID for the physician who first saw the patient to prepare a-medical record documenting the patient's visit. Such a medical record would routinely document a patient history, an examination of the patient, the physician's evaluation of the patient, and any treatments given or tests ordered by the physician. The impotency patients at ILAID were also routinely put through an evaluation procedure to determine the extent of and the nature of their impotency before implant surgery was recommended or performed. The results of the evaluation procedure were also routinely documented in the patient's medical chart. The Respondent first saw the subject patient on July 13, 1993, at the ILAID facility. On that date there were no patient records regarding the subject patient prepared by any other physician associated with ILAID for the Respondent to review. In the absence of any medical documentation, the Respondent apparently assumed that the patient had been through the normal routine at ILAID and proceeded to go forward on that assumption. On July 13, 1993, the Respondent took a brief, limited history from the patient and conducted a limited physical examination of the patient. The physical examination was limited to the patient's abdomen and urogenital area. Based on that limited history and examination, the Respondent concluded that penile implant surgery was an appropriate course of treatment, subject to the patient receiving medical clearance for the surgery. The Respondent did not perform any objective tests for impotence on the patient. The Respondent did not obtain a detailed medical history from the patient. The Respondent did not obtain a detailed history regarding the nature, extent, or duration of the patient's impotence. The Respondent did not conduct a complete physical examination of the patient. Prior to performing penile implant surgery, a physician should perform objective tests to determine if the surgery is indicated. Two objective tests that should always be performed are blood tests to determine the patient's testosterone level and prolactin level.6 Depending on the details elicited during the patient history, other objective tests may also be indicated. The Respondent failed to have tests done to determine the testosterone level and the prolactin level of the patient. The failure to perform these two objective tests is a departure from acceptable standards of medical care recognized by a reasonably prudent similar physician. Prior to performing penile implant surgery, a patient's condition must be assessed by a physician to determine whether surgery is indicated. The surgeon does not have to personally perform all aspects of the assessment of the patient's condition, but the surgeon must at least verify that an adequate assessment has been performed by another physician, and that the assessment has been documented in the patient's medical records. Adequate assessment of a patient's condition requires, at a minimum, a detailed medical history, a complete physical examination, and the performance of any objective tests indicated by the history and physical examination. The performance of surgery without either performing an adequate assessment of the patient's condition or verifying that such an assessment has been documented by another physician is a departure from acceptable standards of care recognized by a reasonably prudent similar physician. The Respondent did not obtain a detailed medical history from the patient, did not perform a complete physical examination of the patient, and failed to order at least two objective tests that were indicated by the patient's complaints. The Respondent also failed to verify that documentation existed which showed that any other physician had obtained a detailed medical history from the patient, had performed a complete physical examination of the patient, and had ordered the objective tests indicated by the patient's complaints. If the Respondent had attempted to verify the existence of such documentation, he would have discovered that the documentation did not exist. The Respondent's performance of surgery on the patient without performing an adequate assessment of the patient's condition, or without verifying that such an assessment had been documented by another physician, was a departure from acceptable standards of medical practice. The Respondent made arrangements for additional blood tests and for an EKG to be administered to the patient. The Respondent also believed that he had made arrangements for one of the other physicians at ILAID to medically clear the patient for surgery. Anticipating no problems regarding the medical clearance, the Respondent also contacted the director of ILAID, Rogelio Medel, and asked him to arrange a location for the implant surgery. In view of the patient's financial circumstances and his lack of medical insurance, it was decided that the surgery would be done in an operating room at a physician's clinic, which would be somewhat less expensive than performing the surgery in a hospital operating room. Rogelio Medel contacted Dr. Francisco A. Prado and arranged for the use of one of the operating rooms at Dr. Prado's clinic. Rogelio Medel had made similar arrangements with Dr. Prado twice before. The arrangement with Dr. Prado was that Dr. Prado would provide not only the use of the operating room, but would also provide all necessary supplies (including the anesthesia medications), as well as the services of a nurse anesthetist, Eduardo Perez, who worked for Dr. Prado on a regular basis. The surgery was scheduled for early in the afternoon on July 16, 1993. Unbeknownst to Rogelio Medel and to the Respondent, Eduardo Perez was not a licensed nurse anesthetist. The Respondent did not inquire of Eduardo Perez regarding the latter's qualifications or licensure status. Rather, relying on the representations of Dr. Prado, the Respondent assumed that Eduardo Perez possessed the necessary qualifications and licensure to function as a nurse anesthetist. While it is clear that Eduardo Perez was not licensed as a nurse anesthetist, there is no clear and convincing evidence in the record as to whether Eduardo Perez was or was not trained in the use of anesthetics, was or was not trained in the use of respiratory and cardiac monitoring equipment, or was or was not trained in the use of resuscitative drugs and equipment.7 The Respondent assumed that Eduardo Perez was trained in these matters, based on the assumption that Eduardo was a licensed nurse anesthetist. In view of the representations of Dr. Prado, it was reasonable for the Respondent to make that assumption.8 The Respondent was not trained in the techniques and procedures of advanced cardiac life support. The Respondent was not trained in the use of a defibrillator. The Respondent was not trained in the use of anesthetics. Prior to performing surgery on the subject patient, the Respondent had received a copy of the laboratory results dated July 16, 1993. He had also received a copy of the EKG report prepared by Dr. Freddie Rodriguez. Prior to performing the surgery, the Respondent had not received any written medical clearance for the patient to undergo the planned implant surgery. The Respondent never received any written medical clearance for the patient to undergo surgery, because the patient was never medically cleared. The Respondent did not receive any telephonic verification that the subject patient had been medically cleared for surgery, because no other physician had cleared the patient for surgery.9 Prior to performing surgery, it is the responsibility of the surgeon to verify that the patient has been medically cleared for the proposed surgery. Under similar conditions and circumstances, a reasonably prudent similar physician would not perform surgery without verification that the patient had been medically cleared for the proposed surgery. It is a departure from minimum standards of medical practice for a surgeon to perform surgery without such verification. Early in the afternoon on July 16, 1993, the Respondent performed penile implant surgery on the subject patient. The surgery was conducted in one of the operating rooms at Dr. Prado's clinic, as previously arranged with Dr. Prado. During the surgery the patient was anesthetized with the anesthetic agents Versed and Brevital. These anesthetic agents were administered by Eduardo Perez, who was functioning as a nurse anesthetist. Eduardo Perez was present during the entire surgical procedure, during which time he monitored the administration of the anesthetic agents, monitored the patient's vital signs, and otherwise performed the functions that would be performed by a nurse anesthetist. At all times material, the Respondent believed, based on the representations of Dr. Prado, that Eduardo Perez was a licensed and qualified nurse anesthetist who regularly worked in that capacity for Dr. Prado. When the surgical procedure had been completed, the Respondent left the patient in the care of Eduardo Perez while the Respondent left the operating room to change clothes. When the Respondent left the operating room the patient appeared to be normal. When the Respondent returned to the operating room a few minutes later, he noticed that the patient had become pale and sweaty. The Respondent also noticed that the patient had very little pulse or blood pressure. The Respondent and Eduardo Perez initiated cardiopulmonary resuscitation and also called fire rescue for assistance. The Respondent and Eduardo Perez continued their cardiopulmonary resuscitation efforts until the fire rescue personnel arrived a few minutes later. The fire rescue personnel initiated advanced cardiac life support measures and subsequently transported the patient to a hospital emergency room, where further efforts were made to resuscitate the patient. Shortly thereafter the patient was pronounced dead in the emergency room. Following an autopsy and investigation into the cause of death, the Dade County Medical Examiner was of the opinion that it could not be stated with any degree of medical certainty that the death of the subject patient was caused by the surgery. In order to have medical records sufficient to justify penile implant surgery, a physician must have written medical records that document at least the following matters: (a) a detailed patient history; (b) a complete physical examination of the patient; (c) a consideration of alternative therapy options; and (d) a pre-operative medical clearance. With regard to the subject patient, the Respondent does not have, and never did have, written medical records documenting any of the four matters itemized immediately above. By failing to keep written medical records documenting such matters with regard to the subject patient, the Respondent failed to keep records justifying the course of treatment of the patient.10
Recommendation On the basis of all of the foregoing it is RECOMMENDED that a Final Order be issued in this case concluding that the Respondent has violated Sections 458.331(1)(t) and 458.331(1)(m), Florida Statutes, imposing a penalty consisting of the imposition of administrative fines totaling $6,000. 00, and the suspension of the Respondent's license to practice medicine for a period of 90 days. DONE AND ENTERED this 23rd Day of September, 1998, in Tallahassee, Leon County, Florid __________________________________ MICHAEL M. PARRISH Administrative Law Judge Division of Administrative Hearings The DeSoto Building 1230 Apalachee Parkway Tallahassee, Florida 32399-3060 (850) 488-9675 SUNCOM 278-9675 Fax Filing (850) 921-6847 Filed with the Clerk of the Division of Administrative Hearings this 23rd day of September, 1998.
The Issue Should discipline be imposed against Respondent's license to practice medicine for violation of Section 458.331(1)(m) and (t), Florida Statutes (2005)?
Findings Of Fact Stipulated Facts: Petitioner is the state department charged with the regulation of the practice of medicine pursuant to Chapter 20.43, Florida Statutes; Chapter 456, Florida Statutes; and Chapter 458, Florida Statutes. Respondent is John B. Milton, M.D. Respondent is a licensed medical doctor in the State of Florida having been issued license ME 53961. Respondent's mailing address of record is 4702 Van Kleeck Drive, New Smyrna Beach, Florida 32169. Additional Facts: Hospital Records (Petitioner's Exhibit numbered 1) On December 31, 2005, Patient W.C. came to the Bert Fish Medical Center (Bert Fish) in New Smyrna Beach, Florida, at 1:40 a.m. He was 40 years old at the time. He was seen in the Emergency Department at Bert Fish. Triage of the patient took place at 1:43 a.m. The triage record reports that he walked in to the hospital complaining of his throat swelling and difficulty breathing. The record reflects that the patient was experiencing pain of an intensity level seven (7) in his throat. At the time his blood pressure was 153/83. His pulse rate was 88. His respirations were 20. His temperature was 98.2. His 02 sat. was 99. In the heading within the Emergency Department Triage Record, statement of "Previous Surgery/Other Medical Hx (referring to history)" it states "allergic reaction to birds with throat swelling, " According to the Emergency Department triage nursing notes Patient W.C. was first seen by Respondent at 1:55 a.m. on the aforementioned date. Respondent was serving in the capacity of emergency room physician at Bert Fish at the time. Among the nursing note entries in the Emergency Department triage record for Patient W.C. are handwritten nursing notes that state: At 2:05 Rocephin was given; at 2:20 a.m. pt. (patient) states throat closing saO2 98%; at 2:25 a.m. pt. (patient) tubed by Dr. Milton- placement checked tube pulled-(pt.) patient vent 100% O2 via ambu; at 2:31 a.m. crick. (cricothyroidotomy) by Dr. Milton tube inserted 100% 02; at 2:35 a.m. H/R 40's - atropine; at 2:37 a.m. b/p 213/90 P-87 Dr. Milton attempting crick 0249 epi 1 mg IV; at 2:41 a.m. Dr. Schreiber here; at 2:43 pt. (patient) tubed by Dr. Schreiber s/r 0 pulses and at 2:54 a.m. code called by Dr. Milton. The Bert Fish Emergency Physician Record refers to Patient W.C.'s chief complaint as "shortness of breath." It states "pt (patient) seems to have acute severe pharyngitis and difficulty breathing and mild stridor at rest." The degree of the condition is further described in the record as "moderate." An associated symptom is listed under "Pulmonary," as "cough." It is noted in this record that the patient is experiencing a "sore throat." The Emergency Physician Record under the "Social Hx (history)," notes that the Patient W.C. was a "smoker" and occasionally used "alcohol." No reference is made to the use of any other form of drugs. On the patient chart describing a physical exam performed on the patient, the categories of "alert" and "anxious" are checked. The level of distress is described as "NAD." There is a reference to "pharyngeal erythema," associated with that entry a handwritten note states "mild stridor at rest." A reference is made to "lymphadenopathy" both right and left "mild." There was no "respiratory distress" and "breath sounds nml (normal);" Again the condition "stridor" is noted while the patient is "at rest." "CVS" is noted as regular rate rhythm with "no JVD." On the same page as discussed in the preceding paragraph, within the patient record maintained by Bert Fish, under "clinical impression," Respondent notes several things in the overall experience in treating the patient. They are in turn: acute severe pharyngitis/epiglottitis; emergency cricothroidotomy cardio pulmonary arrest and ER death. These entries reflect events at the end of the case. The medication administration record at Bert Fish in relation to Patient W.C. notes administration of Decadron (a steroid) at 2 a.m.; Solu-cortef (a steroid) at 2:02 a.m.; Rocephin (an antibiotic) at 2:05 a.m.; Versed (a sedative) at 2:20 a.m. and Anectine (a paralytic agent) at 2:25 a.m. A separate set of entries is made in the Code Blue Record at Bert Fish, noting the administration of Epinephrine, and Atropine during the Code Blue response prior to Patient W.C.'s death due to his cyanotic condition (lack of oxygen). Nurse's notes on the Code Blue Record for Patient W.C. maintained by Bert Fish state: Upon me entering the room Dr. Milton was doing CPR on pt. Dr. Schreiber, Dr. Milton and the ER staff attending to pt. ER staff busy. I started scribing for them. Note pt. was in PRA throughout the code. Pt. was given 3 ep. & 3 atoprine total = (-)response. Respondent signed the Code Blue Record as physician. The ER Physician's Order Sheet, as signed by Respondent concerning Patient W.C., in a shorthand reference, describes orders for nebulized racemic Epinephrine, which is an aerosol adrenaline agent, together with the Solu-cortef, Decadron and Rocephin. In the records maintained by Bert Fish concerning Patient W.C., there is a handwritten note made by Respondent at 3:35 a.m., on December 31, 2005, following Patient W.C.'s death, which says: S/P IV steroids, Racemic epinephrine PT continued to c/o "getting worse" "can't breath." At times his respirations were gasping. .. I discussed with him fact the he may require intubation & he understood. PT placed in TRI and preparation made for intubation. PT had secure IV site, Respiratory TX in Room to assist. S/P preoxygenation 1HR> 80 PT had IV Versed and Anectine to facilitate intubation. The laryngoscope revealed a massive "beefy" appearance of the epiglottis. Attempted X 2 E 8.0 & 7.5 ET to secure an airway but Ø success. PT had attempts to ventilate E BVM? Ø air movement. PT cyanotic @ this point so a scalpel was used to attempt a crichothyroidotomy. When a ETT was passed thru the incision however attempts to ventilate were again unsuccessful. Dr. Schreiber (gen surgery) had been paged and he responded. He was able to place a ETT in the airway but by now PT had arrested. Monitor-bradycardia at this time ACLS measures were undertaken and PT given repeated doses of atropine/epinephrine/CPR-> ventilated E BVM. PT continued to have Ø response to proper ALS measurers and Resus efforts stopped @ 0254. Patient Care Explained Nurse Haas William Haas, R.N., was working at Bert Fish on the early morning that Patient W.C. was seen. Nurse Haas first saw the patient around 1:55 a.m. He hooked the patient up to a monitor and took his vital signs. None of the readings were considered by the nurse to be abnormal. Those readings were blood pressure 153/83, heart rate 88, respirations 20, temperature 98.2. and O2 sat. 99%. Patient W.C. was taken into treatment room 16 and was seen by Respondent and nurse Haas. Nurse Haas asked Respondent what Respondent thought was wrong with the patient. Orders were given by the Respondent for 8 mg. of Decadron and 100 mg. of Solu-cortef IV. The purpose of these medicines was to reduce inflammation. Both medications were steroids designed for that purpose. At that time Respondent gave an order for the antibiotic Rocephin. Respondent also wanted a racemic Epinephrine treatment. That treatment was to be provided by the respiratory therapist. When nurse Haas first saw the patient, the patient was complaining about difficulty breathing. Nurse Haas did not observe any manifestation of those difficulties. At one point the patient told nurse Haas that he, the patient, was experiencing an allergic reaction to feathers or birds. The patient told nurse Haas by way of history that it happened to him in the past. (None of this was true. He had no allergy to birds. The patient's deception was never discovered by the hospital treatment team, and they all proceeded on the basis that the patient had a bird allergy.) On the evening before arriving at the hospital, the patient explained to nurse Haas that he went to bed about 9:00 or 10:00 p.m. and woke up around 1:00 a.m. with a raspy feeling in his throat and he felt like his throat was closing up. So he came to the emergency room for care. After attending to the patient in treatment room 16, nurse Haas left the presence of the patient. He next saw the patient standing in treatment room 17 talking on the phone. This was around 2:20 a.m. The patient was again placed on a monitor to track his vital signs. Nothing about those vital signs appeared abnormal. At that time Mary Boothe, R.N., told nurse Haas that the patient was going to be intubated. Nurse Haas inquired of Respondent on the subject, and Respondent told nurse Haas that the patient wanted to be intubated and to get ready to perform the intubation. The procedure for intubation that was being utilized by Respondent is referred to as rapid sequence intubation or RSI. Nurse Haas retrieved Anectine and Versed to be administered in the intubation. The patient was told about the procedure for intubation. The patient was laid down. Nurse Haas gave the patient Versed and Anectine. The Versed was designed to, as nurse Haas describes it, "muddle the mind." The Anectine was an agent that would promote paralysis in the area where the intubation would occur. When in treatment room 17, at around 2:20 a.m., the patient said to nurse Haas that the patient felt that his throat was closing. Those remarks were made when the patient was being hooked up to the monitor to measure his vital signs. This was the second time that the patient had mentioned his throat closing. He had made similar remarks when nurse Haas first saw him in treatment room 16. Steve Igrec, R.T., participated in the intubation procedure in addition to nurse Haas, nurse Boothe and Respondent. Prior to the laryngoscope being introduced in the intubation procedure, nurse Haas did not notice any sharp decline in Patient W.C.'s vital signs. When Respondent accessed the airway for Patient W.C., nurse Haas heard Respondent say, "Oh, he's got epiglottitis," while proceeding further with the intubation. Respondent was unable to intubate and removed the ET tube. Another tube was used to try and intubate, again without success. Nurse Boothe Nurse Boothe first encountered Patient W.C. after he had undergone his racemic Epinephrine treatment. He came out of the treatment room and told her that he did not feel that the treatment had worked. Respondent came by and the nurse repeated what the patient had told her. Nurse Boothe did not notice anything about the patient that made her believe that he was having difficulty breathing. He coughed and told her, "Can you hear it?" but he was not gasping for air, nor making gestures about his chest or throat. Respondent then offered the patient the option of being admitted to the hospital and continuing treatments by steroids to address his condition or putting him on a ventilator and letting him have the treatments through the ventilator. The patient elected the latter option. The ventilator option would allow the patient to be released the next day. The patient was told by Respondent that he would "knock him out" and put the tube in and give the patient the medication that way and that the patient's release would come the next day. Nurse Boothe did not hear the Respondent make any mention to the effect of what might happen if there were difficulties in intubating the patient. The attempted intubation was made in the treatment room 17, which is also referred to as CC-1. The patient walked into the room. Once in the room nurse Boothe did not notice anything about the patient that indicated any difficulty breathing. The patient did mention that he was not feeling any better. Nurse Boothe overheard the patient talking on the telephone. On his end of the conversation he told his wife that he did not feel any better and that they were going to "knock him out" and put him on a breathing machine overnight and that he would see her the following day. Nurse Boothe noticed that as the attempted intubation proceeded, the patient began to have trouble with the intubation. The equipment that was in the room for those purposes included the laryngoscope, the intubation tube, and a stylet. Before the tube was introduced the patient was being ventilated with a bag and mask. When difficulties arose concerning the intubation, nurse Boothe left the treatment room to get a scalpel and to get what is referred to as a "cric" kit. That kit is a set-up that has been assembled to aid in providing emergency access to the trachea. The kit is not kept in treatment room 17. It was kept in another room on a respiratory cart. Nurse Boothe observed Respondent utilize the scalpel and the "cric." After the Respondent experienced difficulties in this effort, the on-call surgeon was contacted by a secretary at the hospital. The Surgeon Arrives On December 31, 2005, Dr. Schreiber was the on-call surgeon at Bert Fish. When he was paged by the hospital, he called and was told that he needed to go immediately to the emergency room because of an airway problem. He received the call at approximately 2:30 a.m. He arrived at the hospital at 2:41 a.m. Once at the hospital Dr. Schreiber, took over and performed surgery, insertion of the endotracheal tube, thereby ventilating the patient. That procedure by Dr. Schreiber was quickly performed. Mr. Igrec Mr. Igrec administered the racemic Epinephrine treatment to Patient W.C. Prior to providing the treatment Mr. Igrec visibly examined the patient to see if the patient was using assessory muscles to breathe or if he had any stridor, any wheezing or anything of that nature. He did not observe the patient using any assessory muscles to breathe. He did not notice the patient evidencing stridor, that is to say a high- pitched sound that is made when a person experiences upper airway obstruction. Mr. Igrec provided two of the treatments to Patient W.C. Before the second treatment, he visibly examined Patient W.C. and did not notice the patient having difficulty breathing. Sometime during the course of the treatment, near the end, the patient asked the question, "How long is this going to take to work?" Mr. Igrec told the patient to give it time. The patient appeared anxious. He did not appear short of breath. Mr. Igrec reported to Respondent that he had provided Patient W.C. the second treatment. Following the second treatment, Mr. Igrec suggested to Respondent the use of Decadron to aerosolize Patient W.C. The racemic Epinephrine is a short- acting drug, and Decadron is a steroid that takes longer to work. In response, the Respondent told Mr. Igrec "We may have to intubate." Mr. Igrec was called to treatment room 17 where Respondent told him that they were going to intubate Patient W.C. In preparation, an ambu-bag, mask, intubation tube, pressure cuff, stylet and strap were retrieved. The cuff was used to keep the intubation tube in place during the procedure. The stylet keeps the tube rigid. Once the patient was sedated, Mr. Igrec began to use the ambu-bag with the patient. At that time, there was no difficulty using the bag, squeezing the bag to provide air into the patient's lungs. Mr. Igrec had one hand on the mask over the patient's face and one hand on the ambu-bag. Respondent used the laryngoscope in placing the tube, trying to look while placing the tube. The tube went into the stomach and not the trachea, such that ventilation did not occur. After that, when Mr. Igrec was bagging the patient he had a lot more resistance, to the point where Respondent had to hold the mask while Mr. Igrec bagged the Patient W.C. After a second attempt to intubate the patient, Respondent attempted to establish a surgical airway. Respondent was using a scalpel and palpating the patient to try and find the crichothyroid cartilage to create the necessary incision. An incision was created. There was no success in placing an airway because the tube did not pass through the crichothyroid cartilage. Mr. Igrec understood this because the tube that he had cut down to place and to ventilate the patient could not be used because there was no hole in the trachea. Blood was pooling around the patient. Dr. Schreiber arrived and established the surgical airway. During this time, CPR was provided the patient under Code Blue conditions where the patient's heart had stopped beating. Attempts at reviving the patient were not successful. Respondent and Patient W.C. Prior to the occasion when he intubated Patient W.C., Respondent had vast experience in performing intubations. As he describes it, this is a necessary skill for an emergency room doctor, recognizing that having an unobstructed airway is vital to a patient's survival. When intubating a patient, Respondent believes that you would want to do this before they "crash," before they lose their vital signs and become unconscious. Before his attempt to intubate Patient W.C., Respondent had never had an instance in which he could not intubate the patient, a function that he had performed numerous times without the assistance of a surgeon or an anesthesiologist. By contrast, before the circumstance that was confronted in Patient W.C., Respondent had never performed a crichothyroidotomy. He had been trained to perform that procedure. On December 31, 2005, nurse Haas approached Respondent and told Respondent that he placed Patient W.C. in a treatment room, described as the ortho room, and that the patient was having trouble breathing and that he needed to be seen by Respondent. Respondent inquired of the patient about the duration of his problem. He asked the patient if he had asthma. Had this happened before? The patient told Respondent that he was having an allergic reaction to his wife's bird and that this problem that he was experiencing had occurred once years before. Respondent asked the patient if he was telling Respondent that an hour ago he was fine and that now he was not. Patient W.C. said "absolutely." When listening to the patient's lungs Respondent did not notice any wheezing. There was no fever in the patient and the patient had not been sick. Unlike the other health care providers attending the patient, Respondent observed that Patient W.C. was having trouble getting air in, the patient was having inspriatory stridor. Respondent believed that the presentation by Patient W.C. was that of someone having an allergic reaction, with some airway compromise, he refers to as laryngospasm. Respondent told nurse Haas to start an IV on the patient and get respiratory therapy to provide a racemic Epinephrine treatment. The reasons for this decision was Respondent thought the patient was having an allergic reaction. In particular, Respondent's impression at that moment was that the patient was someone having an allergic reaction to birds. Patient W.C.'s case was comparable to another case that Respondent had with a woman who had experienced an allergic reaction. In the case of the woman, the patient worsened and quickly had to be intubated. The differential diagnosis that Respondent was proceeding with was that of a patient having an allergic reaction. The orders Respondent gave concerning administration of medications were designed to alleviate an airway problem associated with an allergic reaction. Consistent with Respondent's orders, the nurse started the IV and provided medications, and the respiratory therapist came to provide the aerosol treatment. Respondent observed that Patient W.C. was sitting up in bed and did not appear to be doing anything unusual. Respondent received the report on the patient's status. Respondent went to see Patient W.C., who at that time was anxious and restless. He was having trouble getting air in and telling Respondent that he could not breathe and that his airway was closing off. Patient W.C. told Respondent that "you guys ain't helping me at all." Respondent told the patient that the treatment already provided was the normal thing that was done. Respondent got more history from the patient by asking the patient, "You were perfectly fine until an hour ago?" The response was "yes." Respondent asked the patient if he had not been sick at all. Again the response was "no." The Respondent asked the patient if he had a sore throat. The patient said a little bit. Respondent took a tongue depressor and looked in the patient's throat. It looked pretty normal. (The Emergency Physician Record indicated the patient had a sore throat.) The patient had very mild prominent lymph nodes but nothing out of the ordinary. There was still no wheezing. At that juncture, the decision was made to give Patient W.C. another aerosol treatment. In addition, the decision was made to provide antibiotics in case there was some tracheitis, pharyngitis. It was anticipated that the antibiotics would take 24 hours to have any effect. Epiglottitis was a condition at the bottom of the list on the differential diagnosis. Respondent's experience with that condition was that a patient would be sick for a period of time before the condition worsened. Nothing in Patient W.C.'s presentation led Respondent to believe that he had epiglottitis at that point. By way of history, there was no indication from the patient that he had used cocaine within 24 hours of the time of his visit to the emergency room. (Indeed subsequent toxicology studies revealed recent use of cocaine.) Had such use been reported Respondent would have acted differently in treating Patient W.C. In his second encounter with the patient on the night in question, the patient told him several times that his airway was closing off and that he believed that any second he was not going to be able to breathe. In reply, Respondent told Patient W.C. that the normal things to address his condition had been done, but there was one other thing that could be done and that would be to intubate Patient W.C. Respondent explained that it meant that they would lay the patient in a critical care room and render him unconscious and take a breathing tube and put it into his lungs and admit Patient W.C. to the hospital. This would then be followed by 24 to 48 hours of ventilatory support with use of steroids to address swelling. Patient W.C. told Respondent "let's do it quick." Respondent told a nurse to gather the standard rapid sequence medication, which in this instance involved the use of Versed and Anecitine. In the procedure room where the intubation was attempted, the procedure commenced with the patient having a good heart rate. There was a crash cart available in case there were problems. At the moment, Respondent continued to believe that the patient was experiencing an allergic reaction. Although the patient could have been experiencing epiglottitis secondary to infection, the patient did not show any signs or symptoms of that condition, indications of an on-going infection such as a fever. He was not sweating, his heart rate was not rapid. Once in the treatment room where the intubation was attempted, the patient worsened. Patient W.C. was gasping. He closed his eyes a second. The respiratory therapist Mr. Igrec experienced problems bagging the patient. Efforts by Respondent and the respiratory therapist were not succeeding in getting air into the patient. When Respondent looked in, using the laryngoscope, he noticed something that he had not encountered before. Patient W.C.'s epiglottis had the appearance of a "mushroom." It did not appear as normal anatomy. Respondent described it as a "moonscape." When Respondent looked into the patient using the laryngoscope, he describes the "picture" as looking like a scorched airway when viewing the larynx and the epiglottis. Now that he had observed the epiglottitis, Respondent decided to try and "get under it" using the ET tube. He encountered a complete blockage. Respondent then asked for a smaller tube. The smaller tube did not work. Efforts at bagging the patient were not successful. Respondent concluded that he could not intubate the patient and could not ventilate the patient in that manner, leaving him the only choice, in his perception, to deal with the obstruction by establishing a surgical airway. Respondent asked for a scalpel to perform a "cric." Respondent also told someone to call and get the surgeon and indicate that there was an airway emergency and to come immediately, as Dr. Schreiber did. Respondent took the scalpel and located the crichothyroid membrane below the crichothyroid cartilage and made an incision and air bubbled out. Respondent widened the incision, as he had been trained to do in a course dealing with trauma associated with the airway. Respondent took the ET tube that he had been using and inserted it. It went in smoothly and the treatment team was able to bag the patient. Respondent then noticed that the heart rate was dropping and that the "stats" were not coming up. Respondent then observed that the patient's neck was bigger. What had happened was that the tube had slipped out of the incision, tracking anteriorly over the trachea and the air was being introduced into the neck. Once the subcutaneous emphysema was seen in the neck, it occurred to Respondent that the tube was in the wrong place. The patient was bleeding profusely. There was an effort at reintroducing the tube but the neck had become more swollen, and the tube could not be replaced. A nursing supervisor, Tom Frith, went to the next trauma room and took one of the crichothyroidotomy kits and brought it back. Respondent was not trained to use that kit. He had seen the kits used at a demonstration. The kit was opened. Respondent took a needle from the kit and tried to find an airway but was unable to locate the airway that had been created because efforts at aspiration produced more blood. Other equipment in the kit was utilized to try to replace the endotracheal tube back in the patient, but the field would quickly fill with blood and the tube could not be placed into the membrane. When Dr. Schreiber arrived, using the skill of a surgeon, not that of an emergency room doctor, he performed an emergency tracheotomy on Patient W.C. Respondent acknowledges that persons suffering from an allergic reaction have a common presentation where they experience hives and itching. Some people have wheezing. Patient W.C. had none of these symptoms. Nonetheless, the patient appeared to Respondent to be having an allergic reaction involving the airway Respondent describes as laryngospasm. Respondent understood the patient's condition to be one in which he was able to move about and speak but he was unable to get air in. While able to compensate for that condition for awhile, that ability did not last. Respondent had never seen a patient with epiglottitis. Hypothetically, if a patient were perceived as having that condition, Respondent would consult with a surgeon or an anesthesiologist, if he had time. If confronted with classic signs of epiglottitis, Respondent would start an IV, give the patient supplemental oxygen and not attempt intubation unless the case was emergent. Given sufficient time, the patient would be taken to an operating room and an anesthesiologist could attempt intubation, failing which a surgeon would be available to address the obstruction by placing a surgical airway. This case became one of an emergency, and Respondent took the measures he deemed appropriate. Concerning notes made pertaining to treatment provided Patient W.C., that record was provided after Patient W.C. died. Given the volume of patients that were being seen in the emergency room, other patients as well as Patient W.C., five sets of records and tests were being established aside from Patient W.C. As a consequence, Respondent was doing paperwork on those patients and telling nurses what to do for Patient W.C. Only after the attempts at trying to save Patient W.C. were unsuccessful and after talking to Patient W.C.'s family did Respondent turn his attention to the medical records for Patient W.C. Expert Opinion Dr. John Murray is an emergency physician at Central Florida Regional Hospital in Sanford, Florida. He is licensed to practice in Florida and has been since 1983. He is also licensed to practice in Alabama. Dr. Murray attended medical school at the University of South Florida in Tampa, Florida. He did his residency at the University of Alabama in Tuscaloosa, Alabama. His residency was in family practice. Dr. Murray practiced in Tuscaloosa, Alabama, in emergency medicine, until four or five years ago. He then entered family practice for about three years. Following that time, he returned to practice in emergency medicine. Dr. Murray is board-certified in family practice and emergency medicine. Dr. Murray was received as an expert in emergency medicine to allow him to offer his opinion as an expert. Dr. Murray served as Petitioner's consultant in the case and was presented as its witness at hearing. To prepare himself to testify, Dr. Murray reviewed the Bert Fish hospital records relating to Patient W.C., the autopsy report, the Administrative Complaint, correspondence from Respondent's attorney, Respondent's deposition, the deposition of the nurses who treated Patient W.C. at Bert Fish, the deposition of the respiratory therapist involved with Patient W.C.'s patient care, and the toxicology report pertaining to Patient W.C. Having prepared himself Dr. Murray testified concerning Respondent's performance when measured against the expected "standard of care." In offering his opinion, Dr. Murray conformed to the expectation that Respondent's performance meet what was minimally acceptable in the standard of care. Dr. Murray does not believe that Respondent met the standard of care incumbent upon Respondent. In Dr. Murray's opinion, when a patient is seen in an emergency room the development of the differential diagnosis begins with the worse case scenario. In Patient W.C.'s case, the first consideration in the differential diagnosis should have been epiglottitis, recognizing that the main problem in the condition is inspiratory stridor, the closing of the airway or the upper airway which may cause the patient to die. Therefore, the physician should do everything possible to assure that this does not happen. Dr. Murray believes that the patient was presenting with signs and symptoms of epiglottitis when he arrived at the emergency room at Bert Fish. Dr. Murray believes that when Respondent decided to intubate Patient W.C., it should have been anticipated that there was going to be a very difficult procedure if the patient had acute epiglottitis. Sometimes the intubation fails and there is the need to provide a surgical airway. Because Respondent did not anticipate that difficulty, the intubation procedure was not properly "setup," according to Dr. Murray. That setup would envision dealing with intubation to potentially be followed by the need to provide a surgical airway. Given the possibility that the patient had epiglottitis, it was important to have the most experienced person available to perform the intubation. Dr. Murray believes that would be an anesthesiologist. Beyond that point, if the surgical airway is needed, a surgeon should be available to provide a surgical airway. Dr. Murray believes there was time to have a successful intubation, or if not, the provision of a successful airway by surgery and these arrangements were not made. Notwithstanding the patient's reported history, recognizing the symptoms present, Dr. Murray did not believe that the patient was suffering from an allergic reaction. Nothing in the medical records suggested to Dr. Murray that Patient W.C. was under the influence of cocaine when he was seen at Bert Fish. Commenting on the medical record where the term "pharyngeal erythema" was circled, Dr. Murray explained that pharyngitis is a form of infection either viral or bacterial in relation to the red or sore throat seen in the back of the throat of Patient W.C. when examined by Respondent. Respondent also made reference to lymphadenopathy both right and left, swollen lymph nodes. Patient W.C. was experiencing inspiratory stridor, difficulty in getting air in to his lungs. With inspiratory stridor, swollen lymph nodes and a red and painful throat, Dr. Murray said he would be concerned about Patient W.C.'s having an infection. Dr. Murray was concerned that if Patient W.C. had a lot of inspiratory stridor that the condition might be epiglottitis. With infection and stridor, the airway can close quickly. These circumstances could make intubation of the patient difficult, if not impossible. Dr. Murray acknowledges that epiglottitis was on Respondent's differential diagnosis for Patient W.C. Respondent's orders for use of racemic Epinephrine through nebulization and the provision of steroids, Decadron and Solu-cortef were appropriate in Dr. Murray's view. Repeating the nebulization would have been appropriate in dealing with an allergic reaction which was the number one condition treated by Respondent. Dr. Murray speaks of the use of antihistamines as well. Dr. Murray opined that as long as Patient W.C. was perceived as having an allergic airway problem, the patient would be treated with updraft treatments and antihistamines, if the patient remained stable and did not appear to be "going down hill and crashing." If the patient is "crashing," stops breathing, then a response to the condition would be necessary before the patient had respiratory arrest. However, with epiglottitis most patients would have to be intubated to protect the airway. The condition would be treated as an infection with use of an antibiotics and steroids over time while being cautious about the patient having his or her airway close off. Criticism that Dr. Murray has of Respondent's care was not the basic idea that the patient was intubated to address epiglottitis. It was the expectation that intubation need not be done unless it was absolutely an emergent circumstance, i.e., the patient had stopped breathing. If there is suspected epiglottitis, the physician should not use a tongue blade that may cause spasms or a laryngoscope. The physician should not paralyze the patient. The doctor is going to be confronted potentially with the fact that there is "no hole" to put the tube, in an attempt at intubation and it becomes necessary to "do something and get an airway in." Again the arrangement that needs to be made, in Dr. Murray's opinion, is the double setup to address the intubation and possible surgical airway. Dr. Murray does not believe that Respondent had the needed equipment to address the patient's condition when he began the intubation. In particular, the necessary equipment for the second step in the double setup, that of providing a surgical airway had not been sufficiently arranged by Respondent. Only in the instances where the patient had stopped breathing and Respondent had no time to call in other physicians would it be appropriate to paralyze the patient and attempt the intubation. Dr. Murray does not believe that the patient was dying, and there was the opportunity to call in the surgeon who was available in eight minutes, to provide assistance if one anticipates difficulty. Dr. Murray described three methods of addressing the surgical airway. One is crichothyroidotomy, which was attempted here. The second method is jet insufflation used in pediatrics but also taught for use in adults. The third method is the use of a needle with a catheter. Dr. Murray explained that if using the crichothyroidotomy is a procedure that is comfortable to the physician, then there is no necessity for redundancy beyond the use of that method for providing a surgical airway. Redundancy would be the use of the kit known as Seldinger that causes a small puncture wound. This method is a new technique, an alternative to needle crichothyroidotomy and regular crichothyroidotomy. The Seldinger method is the jet insufflation. Jet insufflation is not a common procedure in adults and is used more in pediatric care. In Dr. Murray's opinion, a reasonably prudent emergency room doctor would know of the availability of that option for ventilating a patient whether the patient is an adult or a child. Dr. Murray criticizes Respondent's medical records for Patient W.C. In his review, Dr. Murray did not find an explanation why it was necessary to intubate Patient W.C. at that moment and by the method employed. The record does not justify attempting a paralytic intubation under the existing circumstances, according to Dr. Murray. Dr. Marlon Priest, witness for Respondent, graduated from the University of Alabama with a degree in chemistry. He attended the University of Alabama School of Medicine from 1974 until 1977. He completed an internal medicine residency. From 1981 through November of 2006, Dr. Priest was on the faculty of the University of Alabama, Birmingham, Alabama, and served as a professor of emergency medicine and director of critical care transport. Over the years, Dr. Priest has had extensive experience in emergency medicine in a hospital setting. He is licensed to practice medicine in Alabama. Dr. Priest was accepted as an expert and allowed to testify concerning his opinion of Respondent's care provided Patient W.C., whether Respondent met the standard of care. Dr. Priest reviewed the Administrative Complaint, the medical records from Bert Fish concerning Patient W.C., Respondent's deposition, the deposition of Thomas Beaver, M.D., and the deposition of Michael A. Evans, Ph.D. to prepare himself to testify. He found the information sufficient to prepare to offer his opinion concerning the care provided Patient W.C. When asked whether Respondent violated the standard of care for failing to consult with or gain the assistance from an anesthesiologist or the on-call surgeon prior to inducing paralysis and attempting RSI, referring to rapid sequence intubation on Patient W.C., fell below the standard of care for an emergency room physician, Dr. Priest indicated that he felt that Respondent met the applicable standards. Dr. Priest believes emergency medicine has evolved to the point where emergency room physicians are able to assess and carryout that form of intubation. In Dr. Priest's experience, on numerous occasions, he has intubated patients without consulting a surgeon or an anesthesiologist. Based upon those insights Dr. Priest does not believe that Respondent was obligated to consult a surgeon or an anesthesiologist before attempting the intubation on Patient W.C. Specific to Patient W.C.'s case, the patient presented with shortness of breath and stridor and having failed to improve following treatment to address a possible allergic reaction, the decision was made to oxygenate the patient prior to some event where the patient could not breathe. Based upon the symptoms of the patient and gravity of the situation, Dr. Priest is persuaded that it was appropriate to attempt intubation. Concerning the allegation that Respondent failed to meet the standard of care by inducing paralysis in Patient W.C., Dr. Priest indicated that RSI is the preferred method of gaining access to a patient's airway where the patient is awake and alert and who might struggle if that method was not employed in an effort to intubate the patient. In his opinion, Dr. Priest makes mention of the progression in the case from having stridor, complaining of not being able to breathe and Dr. Priest's expectation that the airway was becoming smaller over time. Dr. Priest believes that the principal diagnosis in the differential pertaining to Patient W.C., possible allergic reaction was a reasonable diagnosis based upon information in the patient records. Concerning the allegation about Respondent's medical records related to alleged failure to document symptoms in Patient W.C. that would justify paralysis and RSI, as opposed to other less risky forms of securing the airway, Dr. Priest believes that there is sufficient evidence in the medical record to justify the intubation. Related to the second allegation dealing with record keeping by Respondent alleging that Respondent failed to document Patient W.C.'s O2 sat. and cardiac activity during the RSI attempt and subsequent procedures, Dr. Priest believes that this information would have been written down by someone else on the treatment team during the course of the treatment, the attempt to intubate. Even beyond that point, Dr. Priest believes that standard protocol would call upon the respiratory therapist or the nurse to create the record or potentially someone else on the hospital staff, not the Respondent. The inaccurate report by Patient W.C. concerning his past history with bird allergies changes the priorities in the differential diagnosis, in Dr. Priest's opinion. That history meant that allergic reaction was placed at the top of the differential diagnosis, in particular with a physical examination that was consistent with the history. Dr. Priest holds this belief even in the absence of fever, sweating, or questionable vital signs in the patient. When Dr. Schreiber entered the treatment room, he noticed a group including a physician and nurses who were attending Patient W.C. They were trying to resuscitate the patient. The patient did not have an airway. The patient was cyanotic. The patient was bloated and did not have a pulse. An attempt was being made to revive the patient from arrest. A valve bag mask was being used and drugs administered that would support the patient's blood pressure. An effort at gaining a surgical airway had not succeeded. There was a surgical incision on the patient's neck. Blood was on the patient and on the floor. At the moment no attempt was being made to establish a surgical airway. Dr. Schreiber observed that the patient had a protruding tongue that was obstructing this mouth and airway. Dr. Schreiber observed that the Petitioner's upper check and abdomen were bloated. Dr. Schreiber noted that the patient evidenced crepitancy, indicating subcutaneous air in the patient's neck and chest. This would be consistent with the placement of an airway tube into the subcutaneous tissue outside the trachea and air blown into the area. Dr. Schreiber made a nick in the trachea and placed a number 8 ET tube into the trachea. Following the placement of the ET tube in the trachea, Dr. Schreiber observed air movement in the lungs. However, the patient did not regain a pulse or adequate saturation of oxygen. On January 3, 2006, Dr. Thomas Beaver, Chief Medical Examiner and pathologist, performed an autopsy on Patient W.C. As part of his Medical Examiner's report on Patient W.C., special studies had been done, and a comprehensive toxicology analysis performed by AIT Laboratories. Dr. Beaver determined the cause of death as complications of acute epiglottitis and that the manner of death was of natural causes. The complications of acute epiglottitis were explained as a status post crichothyroidotomy. Dr. Beaver also noted atherosclerotic cardiovascular disease involving coronary arteries, mild. In particular, Dr. Beaver found that the epiglottis was swollen to an extent that it obstructed the deceased's airway. The condition observed was not the result of an attempted intubation of the patient, in Dr. Beaver's opinion. The condition observed was a disease process that Dr. Beaver felt was on-going for a matter of hours or perhaps a number of days before the attempted intubation. This type of mechanical obstruction in the epiglottitis would obstruct the airway and disable the patient from breathing, according to Dr. Beaver. The condition of the epiglottitis was not perceived by Dr. Beaver to be in association with some form of allergic reaction. The exact cause was not clear. Dr. Beaver does not believe that the ingestion of cocaine, whose metabolites were in the body caused the death. Marie Herrmann, M.D., is the present Medical Examiner and pathologist in the jurisdiction where Dr. Beaver served. Dr. Herrmann had the opportunity to review Dr. Beaver's autopsy report on Patient W.C. and to examine some evidence available to Dr. Beaver in performing his examination. She too was not persuaded that cocaine was a contributing factor to Patient W.C.'s death. In offering this opinion Dr. Herrmann was aware of the toxicology report from AIT Laboratories. Dr. Herrmann agrees with Dr. Beaver's opinion concerning Patient W.C.'s cause of death. Dr. Herrmann was unable to determine within a reasonable degree of medical certainty that the efforts by Respondent to intubate Patient W.C. caused the blockage in the airway. Michael Evans, Ph.D., is the founder, president and CEO of AIT Laboratories. He is an expert in toxicology. He testified concerning the findings in his laboratory related to Patient W.C. using established protocols for examination of the samples provided his facility. Based upon his analysis, Dr. Evans believes that Patient W.C. had ingested cocaine as recent as three hours and no longer than 24 hours before his death based upon values found in the blood and urine samples provided. Bruce Goldberger, Ph.D., is an expert in forensic toxicology. He is a professor and director of toxicology at the University of Florida College of Medicine, Departments of Pathology and Psychiatry. He is familiar with the medical examiner's report prepared by Dr. Weaver and the AIT Laboratories' report on Patient W.C. Dr. Goldberger offered the opinion that Patient W.C. could have been using cocaine a day or two before his death. He defers to the medical examiner as to the cause of the patient's death. It is accepted from the findings made in the autopsy report by Dr. Beaver that Patient W.C. died from complications of acute epiglottitis, from natural causes, not as a result of Respondent's attempt to intubate the patient. Having considered the facts and the opinions of experts, clear and convincing evidence was not presented to establish the violations alleged in Count One (Section 458.331(1)(t), Florida Statutes) paragraph 27. a). and b). related to consultation with or assistance from an anesthesiologist or the on-call surgeon prior to inducing paralysis in the patient as part of RSI. Likewise, the violation alleged in Count Two (Section 458.331(1)(m), Florida Statutes) paragraph 30. a). relating to failure to document symptoms justifying paralysis and RSI was not proven by clear and convincing evidence. Concerning the alleged violation in Count Two (Section 458.331(1)(m), Florida Statutes) paragraph 30. b). involving the documentation of Patient W.C.'s O2 sat. and cardiac activity during the RSI attempt and subsequent procedures, the opinion of Dr. Priest is compelling. Based upon that opinion Respondent would not be expected to provide that documentation and maintain the record beyond that point in time. Respondent's Background Respondent received his undergraduate education from the University of Tennessee, earning a B.S. in biology. He attended medical school in Nashville, Tennessee, at Harry Medical College and worked as an emergency physician in Tennessee. He undertook a flexible internship at the University of Tennessee in Knoxville, Tennessee. In 1987 Respondent went to Jacksonville, Florida, to do a three-year residency in pediatrics, graduating from that program in 1990. During that time he worked in local emergency rooms in St. Augustine, Palatka, and Tallahassee, Florida. He took courses in Advanced Trauma Life Support and Advanced Cardiac Life Support. Since 1990 Respondent has been a full-time emergency room physician living in New Smyrna Beach, Florida. At present, Respondent works for M. Care Emergency Services in Jacksonville, Florida. Mitigation and Aggravation Respondent has no prior violations related to his license to practice medicine in Florida. Patient W.C.'s Family Patient W.C. was married to F.C. and had two young children. At his death his daughter was approximately two-and- a-half years old and his son was 14 months old. Following Patient W.C.'s death, the family has had a difficult time coping with their loss.
Recommendation Based upon the findings of facts found and the conclusions, RECOMMENDED: That a final order be entered, which dismisses the Administrative Complaint, as amended. DONE AND ENTERED this 14th day of April, 2008, in Tallahassee, Leon County, Florida. S CHARLES C. ADAMS Administrative Law Judge Division of Administrative Hearings The DeSoto Building 1230 Apalachee Parkway Tallahassee, Florida 32399-3060 (850) 488-9675 SUNCOM 278-9675 Fax Filing (850) 921-6847 www.doah.state.fl.us Filed with the Clerk of the Division of Administrative Hearings this 14th day of April, 2008.
