The Issue Should the Board of Medicine (the Board) discipline Respondent's license to practice medicine in Florida, based upon an alleged failure in the level of care and treatment of J.P., his patient?
Findings Of Fact STIPULATED FACTS: Petitioner is the state department charged with regulating the practice of medicine pursuant to Section 20.43, Florida Statutes; Chapter 456, Florida Statutes, and Chapter 458, Florida Statutes. The Respondent, whose address of record is 1834 SW 1st Avenue, Ocala, Florida 34474, was issued license number ME 56306. At all times material to this Complaint, the Respondent was a licensed medical physician within the State of Florida. Respondent specializes in pulmonology. Respondent was Patient J.P.'s attending physician. Respondent ordered a bronchoscopy and specimens that revealed possible Mycobacterium Avium-Intracellulare (MAI). The biopsies revealed signs of granulomalous infection as seen in MAI or tuberculosis (TB). During this (his) hospital stay, Patient J.P. was started on the drug ethambutol at 1600 mg daily. It is the manufacturer's recommendation that the dose of ethambutol, if started at 25 mg per kilogram per day, should be reduced to 15 mg per kilogram per day after 60 days. The infections (infectious disease) specialist saw Patient J.P. in his office on or about July 26, and August 8, 2000 and in his August 18, 2000 letter to Respondent, there was no mention or recommendation for a change in Patient J.P.'s dosage after two months on the ethambutol therapy. Patient J.P. was subsequently seen by the Respondent on October 23, and again on December 27, 2000, when Patient J.P. complained of eye problems. At this later visit Respondent immediately discontinued the ethambutol and referred Patient J.P. to an eye specialist. ADDITIONAL FACTS: Patient J.P.: On May 8, 2000, Patient J.P. was seen at Ocala Lung and Critical Care Associates (Ocala Lung and Critical Care) in Ocala, Florida. This practice is Respondent's Professional Association. The patient had been referred by Dr. Dave Metcalf. On that date the patient was seen by Respondent's associate, Poonan Warman, M.D. According to the note in the patient records for that date, the patient reported a complaint of "cough and cold" with no weight loss. (Petitioner's Exhibit No. 1, page 28) On May 23, 2000, the patient returned to Ocala Lung and Critical Care. Again Dr. Warman saw the patient. A note in the patient's chart describes J.P.'s condition on that date. (Petitioner's Exhibit No. 1, page 35) At that time Dr. Warman concluded that the patient had a mass in his left lung with right lung abscess. Dr. Warman scheduled a bronchoscopy and prescribed mediation. On June 13, 2000, Respondent first say Patient J.P. at Ocala Lung and Critical Care. At that time Respondent made notes in the patient's chart concerning the patient's condition. (Petitioner's Exhibit No. 1, page 49) Respondent assessed the condition as a system in the patient's right upper lobe, possible lung abscess. The note refers to the provision of an antibiotic, a CBC differential and CRP that was ordered. This was a follow- up visit for the bronchoscopy that had been performed by Dr. Warman. Cultures in association with the organism found through the bronchoscopy were pending. At that time Respondent's recommendation to the patient was to continue the antibiotic treatment of Augmentin as well as Clindamycin. The patient was to be seen back in a month's time, according to a typed note within the patient's chart bearing Respondent's signature. (Petitioner's Exhibit No. 1, page 48) In that same typed note it was noted that the bronchoscopy and the biopsy that had also been performed did not reveal malignancy but chronic inflammatory cells had developed. The type-written impression entered in the chart was right upper lobe cavitary lesion, most likely lung abscess. On this date Respondent concluded that the patient had bacterial infection in the lung and the lung abscess. Respondent wanted blood work done to monitor the side effects of the antibiotics being given. Respondent discussed the side effects of the medication with the patient as noted in the written entries in the chart. In relation to the antibiotic medications that were provided to Patient J.P., notes were made on June 14 and 20, 2000, in the patient records maintained by Ocala Lung and Critical Care, commenting on the efforts by the practice to assist Patient J.P. in obtaining those medications from that office and other doctors' offices because of his inability to pay for the medicine. (Petitioner's Exhibit No. 1, page 47) On June 27, 2000, Respondent saw Patient J.P. at the Monroe Regional Medical Center (the Medical Center) in Ocala, Florida, for a medical emergency. The Medical Center is a hospital. At that time the patient's chief complaint was a right-side chest pain. The patient was admitted to the Medical Center by Frank E. Reisner, M.D. The patient had called Respondent's office before his admission. Under the circumstances Respondent was concerned that the patient would not receive adequate treatment as an outpatient. It was recommended that the patient be admitted for inpatient hospital treatment of his lung abscess. On June 27, 2000, the emergency department note in the hospital record refers to the admission of Patient J.P. to the service of Dr. Mishra, an internist at the hospital. (Petitioner's Exhibit No. 1, page 354) Dr. Mishra had also spoken to Patient J.P. and told the patient to come to the hospital. Because the Patient J.P. had a lung abscess problem and had been seen by Respondent in the past, Respondent became responsible for the patient in the hospital upon the request of another physician. Respondent's decision to have the patient remain admitted for treatment of the lung abscess was made the same day the patient arrived at the hospital. Under this arrangement Respondent was the attending physician. On June 28, 2000, after receiving the chart for Patient J.P. from Respondent's office, to review the patient history and based upon results at the hospital that revealed the patient had possible MAI present in bronchial washings from a bronchoscopy performed in the hospital, Respondent decided to consult with Lee Prchal, M.D., who specializes in infectious disease and practices in Ocala, Florida. The reason for the consultation was that Respondent does not treat MAI. Decisions about the appropriateness of treatment for MAI, in Respondent's view, would best be made by a physician specializing in infectious diseases. Respondent did not feel comfortable treating MAI, in that he did not have sufficient knowledge about the condition and its treatment. If Dr. Prchal thought that the patient needed to be treated for MAI, Respondent expected that the other physician would be responsible for the care. With this in mind Respondent did not follow the patient as an attending physician would normally during the patient's stay in the hospital. Nonetheless, Respondent was aware that Patient J.P. had been prescribed ethambutol, also referred to as ethambutol hydrochloride or by the generic drug name Myambutol. Respondent understood that the medication had been prescribed initially in a setting in which it was uncertain whether the patient had a problem with MAI or tuberculosis. Dr. Prchal had written the order for ethambutol given to Patient J.P. in the hospital stay. Dr. Prchal intended to address any MAI with the medication. Dr. Prchal did not write orders for ethambutol upon the patient's discharge, although the patient continued to take the medication. Respondent did not order an initial visual acuity test when Patient J.P. was first prescribed ethambutol in the hospital stay. Dr. Prchal did not order visual testing to establish a baseline while the patient was hospitalized. At no point during the time Patient J.P. was treated with ethambutol did Respondent consider himself responsible in addressing MAI. Respondent did not believe that he had the duty to manage the treatment. He believed that Dr. Prchal was responsible while the patient was in the hospital and upon the patient's discharge. On July 19, 2000, following the Patient J.P.'s discharge from the hospital, Respondent saw the patient again in an office visit. Notes concerning that visit were made. (Petitioner's Exhibit No. 1, page 84) The notes reflect that the patient was doing well, and his cough had improved. Respondent's impression was that the patient had atypical TB and COPD. COPD refers to Chronic Obstructive Pulmonary Disease. At the time it was noted that the patient was advised to keep in touch with HRS for atypical TB. HRS refers to Health and Rehabilitative Services. In actuality, the Marion County Health Department was the health organization that Respondent had in mind. The comment on HRS is in association with an adult clinic in Ocala, Florida. According to a note in the patient record made by a member of Respondent's staff, someone previously had spoken to a person from the Health Department, who said that Patient J.P. did not have tuberculosis. This meant that the TB clinic with the Health Department would not follow his case for tuberculosis, but he could be followed in the adult health clinic for the condition he did have and that clinic should be able to help the patient with needed medication. (Petitioner's Exhibit No. 1, page 47) The adult health clinic is a general clinic affiliated with the Department of Health, and if seen in the general clinic Respondent believed that the patient could be provided needed medications. Patient J.P. had experienced difficulties obtaining needed medication in the past. As before, Respondent did not examine Patient J.P. in relation to visual acuity. The patient offered no complaints about his vision at this visit. On the July 19, 2000 visit Respondent did not consider reducing the ethambutol dosage for Patient J.P. The patient was referred to Dr. Prchal for a visit on July 26, 2000, in relation to MAI. Given the referral to Dr. Prchal, Respondent proceeded on the basis that Dr. Prchal was responsible for treating Patient J.P. for MAI. It was intended that the patient return to see the Respondent on October 23, 2000. Patient J.P. saw Dr. Prchal on July 26, 2000. Following that visit Dr. Prchal wrote the Respondent. The letter was dated August 18, 2000. (Petitioner's Exhibit No. 1, pages 87 and 88) In concluding remarks Dr. Prchal stated in the correspondence: Therefore, at this time, I would recommend continued ethambutol and biaxin for treatment of his MAI. The duration of his clindamycin will require your clinical judgment, but in view of his radiographic changes, it may require further prolonged administration. Respondent's reading of the correspondence was that Dr. Prchal would continue to monitor and be responsible for ethambutol therapy while deferring to Respondent to treat the lung abscess with Clindamycin. On October 23, 2000, Respondent saw Patient J.P. in Respondent's office. Handwritten notes were made by the Respondent during the visit, followed by typewritten notes for the patient's record. (Petitioner's Exhibit No. 1, pages 90 and 91) The patient records refer to the Respondent's perception that Dr. Prchal was treating MAI with multiple antibiotics. The note refers to COPD, lung abscess and MAI. Respondent asked the patient to discontinue Clindamycin and to continue Biaxin. Respondent also asked Patient J.P. to continue taking ethambutol. Respondent did not consider himself to be responsible for treating MAI with ethambutol. In the typed document for the patient record pertaining to the October 23, 2000 visit, it is indicated under the section dealing with Respondent's impression that the lung abscess healed resulting from treatment with clindamycin. At the same time the typed notes indicated that MAI would require long-term treatment. Although Respondent contends that Dr. Prchal would follow Patient J.P. routinely for MAI, the typewritten note describes Dr. Prchal's August 18, 2000 correspondence as a "final note." On October 23, 2000, the patient did not complain of any problems with visual acuity and no eye examination was ordered by Respondent. No specific inquiry was made concerning the patient's progress with the MAI. A follow-up appointment was scheduled for December 27, 2000. Patient J.P. kept that appointment. On December 27, 2000, Patient J.P. complained of an eye problem. He told Respondent that he was not able to see and that two weeks before he had seen an eye physician. As the patient record indicates, the patient complained to Respondent whether this problem with his vision was due to medicine. As a record on the patient care states, authored by Respondent, Respondent indicates "In response, [to complaints about the patient's vision] I have stopped his ethambutol." The impression in the patient record that was typed indicates as well "Ethambutol is being stopped today." This patient record is by way of a letter from Respondent to Dr. Prchal. (Petitioner's Exhibit No. 1, page 93) The letter goes on under the portion referred to as "Plan" to say, "I referred him back to you [Dr. Prchal] for evaluation of the disease process and then we will decide how long he will require the Biaxin." The discussion given thus far of the facts, includes the perspective of the Respondent as to his explanation of care for MAI in Patient J.P. The next part of the discussion is in relation to testimony by deposition by Dr. Prchal including his explanation of his care for MAI provided Patient J.P. Dr. Prchal has practiced in Ocala, Florida, since 1987. His primary specialty is infectious disease. His first encounter with Patient J.P. was at the Medical Center when the patient was referred to him by Respondent, the attending physician, to consult as an infectious disease specialist. When Patient J.P. was first seen, the working differential, as Dr. Prchal recalls it, was that the patient had an underlying chronic lung disease with a history of smoking and a family history of lung cancer. The patient had failed outpatient treatment and when seen could have underlying cancer and/or infections in his lung. Following the bronchoscopy performed on the patient in the hospital, Dr. Prchal wrote an order for ethambutol 1600 mg. The order was written on June 28, 2000. He wanted the patient to receive ethambutol because it was an antibiotic that is used for treating MAI. As Dr. Prchal describes, MAI is a germ in the family of tuberculosis. The patient received his first dose of ethambutol on June 29, 2000. The reason for prescribing 1600 mg of ethambutol was in recognition of the patient's weight. The dosage was presented in four tablets of 400 mg. Dr. Prchal's view of the prescription of ethambutol was that he had signed-off on the case before the patient was discharged from the hospital. At the same time, he considered the use of ethambutol to be open-ended and dependent upon the clinical response by Patient J.P. beyond his discharge. The concluding point for using ethambutol was to be decided by Respondent, in Dr. Prchal's perception, in that Respondent was the attending physician and the main person in charge of the case. Dr. Prchal's view of the choice of dosage of milligrams per kilograms of weight ranging from 15 mg to 25 mg per kilogram of weight, depends upon the person's clinical circumstance. The common starting dose is 25 mg per kg, in his view. Dr. Prchal's experience with ethambutol is that he had prescribed ethambutol to more than 50 patients. Dr. Prchal realized that optic neuritis is a potential side effect in the use of ethambutol. Dr. Prchal does not believe that baseline vision testing is necessary before providing ethambutol therapy. Dr. Prchal is familiar with the PDR concerning ethambutol, which he considers to be the manufacturers guidelines for use of that medication. In relation to the PDR reference to monthly testing for visual acuity during the use of ethambutol, particularly in dosages in the amount of 25 mg per kg, Dr. Prchal refers to the difficulty in having an ophthalmologist see patients for screening in the Ocala area and the difference of opinion among members of the medical community concerning screening. He does not believe that there is a specific standard to be followed in the community for screening. When Patient J.P. was in the hospital receiving his first dosage of ethambutol on June 29, 2000, Dr. Prchal indicated that baseline vision testing was not available in that setting and could only be done following the discharge of the patient. The frequency of testing beyond baseline testing would be on a case by case basis. According to Dr. Prchal, visual monitoring is part of the overall monitoring in the use of ethambutol. In Dr. Prchal's physician progress notes for Patient J.P. made on July 1, 2000, at the hospital, pertaining to ethambutol he referred to "appropriate monitoring." He then goes on to say that he "will sign off." He explains the latter reference to indicate that he was signing-off on the case. (Petitioner's Exhibit No. 1, page 121) Dr. Prchal saw Patient J.P. on July 26, 2000. At that time the patient was continuing with ethambutol. Dr. Prchal inquired about any visual symptoms. Patient J.P. responded that he did not have visual symptoms. The patient told Dr. Prchal that he had been referred to the Marion County Health Department. In Dr. Prchal's opinion the patient's medical condition at the time was better and the medicine seemed to be working. This is taken to mean that the ethambutol was working. Dr. Prchal saw Patient J.P. on August 8, 2000. This was their last visit. As with the visit on July 26, 2000, when Dr. Prchal saw Patient J.P. on August 8, 2000, the patient expressed no complaints about his vision. On August 8, 2000, Dr. Prchal had determined that the patient did not have tuberculosis, and medications to treat that disease were not necessary and could be discontinued. The medications for treating tuberculosis were IMH, Tyrazinamide and Rifampin. Dr. Prchal thought that ethambutol for treating MAI was still called for, together with Biaxin. Dr. Prchal did not have in mind a specific dosage of ethambutol. Being persuaded that Respondent was the attending physician overseeing the care, Dr. Prchal made known his views in the correspondence to Respondent on August 18, 2000. (Petitioner's Exhibit No. 1, pages 87 and 88) Dr. Prchal believes that the reason for Patient J.P.'s visits on July 26, 2000, and August 8, 2000, was Respondent's desire to know what medications still needed to be continued in treating the patient. EYE CARE The day before Patient J.P. saw Respondent on December 27, 2000, the patient had been at Ritz Eye Care. The reason for his visit was "check eyes-has trouble seeing." (Petitioner's Exhibit No. 1, page 192). On the visit to Ritz Eye Care he was seen by Daniel L. Ritz, O.D. Dr. Ritz consulted with Robert N. Mames, M.D., specializing in diseases and surgery of the Vitreous and Retina. Dr. Mames performed an ophthalmic examination and diagnosed the Patient J.P.'s condition as (1) decreased visual acuity in both eyes; (2) minimal nuclear sclerosis; and (3) history of lung abscess, Mycobacterium Avium. In his impression Dr. Mames said "etiologies include optic neuropathy secondary to ethambutol versus CAR syndrome (Canon-associated retinopathy), which is unlikely with no history of cancer." These findings were made in the report from Dr. Mames to Dr. Ritz dated January 16, 2001. (Petitioner's Exhibit No. 1, page 199) Patient J.P. was seen at the University of Florida, College of Medicine, Department of Ophthalmology, on March 23, 2001, by M. Tariq Bhatti, M.D., an assistant professor of the Department of Ophthalmology and Neurology. He indicates in correspondence to Mandouh H. Zeini, M.D., practicing in Ocala, Florida, "It appears that Mr. P. has bilateral optic atrophy. As you are aware, ethambutol is a well-known toxin to the optic nerves. However, I think it would be important to rule out other treatable causes of his optic atrophy. Therefore, I have recommended B-12, folate level, sedimentation rate, syphilis serology, ANA and an MRI of the brain and orbits." (Petitioner's Exhibit No. 1, page 224) On April 25, 2001, Dr. Bhatti saw Patient J.P. again. In turn, he corresponded with Dr. Zeini on that date. (Petitioner's Exhibit No. 1, page 227) With the negative work-up on the prior tests given Patient J.P., Dr. Bhatti wrote, "I suspect Mr. P.'s bilateral optic neuropathies are ethambutol- related. He has discontinued the use of ethambutol, therefore this should remain a static process with no visual loss." PHYSICIAN DESK REFERENCE: MYAMBUTOL The PDR in referring to MYAMBUTOL under the heading DESCRIPTION states: MYAMBUTOL ethambutol hydrochloride is an oral chemo-therapeutic agent which is specifically effective against actively growing micro- organisms of the genus mycobacterium, including M. tuberculosis. In the PDR under the heading INDICATIONS it is stated: MYAMBUTOL is indicated for the treatment of pulmonary tuberculosis. The PDR refers to CONTRAINDICATIONS where it states: MYAMBUTOL is contraindicated in patients who are known to be hypersensitive to this drug. It is also contraindicated in patients with known optic neuritis unless clinical judgment determines that it may be used. Under PRECAUTIONS the PDR states: . . . Because the drug may have adverse effects on vision, physical examination should include ophthalmoscopy, finger perimetry and testing of color discrimination. . . . In relation to ADVERSE REACTIONS the PDR states: MYAMBUTOL may produce decreases in visual acuity which appear to be due to optic neuritis and to be related to dose and duration of treatment. . . . Patients should be advised to report promptly to their physician any change of visual acuity. . . . Testing of visual acuity should be performed before beginning MYAMBUTOL therapy and periodically during drug administration, except that it should be done monthly when a patient is on a dosage of more than 15 mg. per kilogram per day. . . . In relation to INITIAL TREATMENT the PDR states: In patients who have not received previous antituberculosis therapy, administer MYAMBUTOL 15 mg. per kilogram. (7 mg. per pound) of body weight, as a single oral dose once every 24 hours. On the related subject of RETREATMENT the PDR states: In patients that have received previous anti- tuberculosis therapy, administer MYAMBUTOL 25 mgs. Per kilogram (11 mg. per pound) of body weight, as a single oral dose every 24 hours. . . . After 60 days of MYAMBUTOL administration, decrease the dose to 15 mg. per kilogram (7 mg. per pound) of body weight, and administer as a single oral dose every 24 hours. During the period when a patient is on a daily dose of 25 mg/kg monthly eye examinations are advised. EXPERT OPINION TESTIMONY: George Andrews Schoonover, M.D. has been licensed to practice in Florida since 1978. He practices pulmonary medicine in Jacksonville, Florida. He is certified in pulmonary medicine as well as internal medicine and has a sub-specialty in critical care medicine. For proposes of this hearing Dr. Schoonover was recognized as an expert in pulmonary diseases. To prepare himself for testimony at hearing he looked at the materials in Petitioner's Exhibit No. 1, which describes the care and treatment received by Patient J.P. during the relevant period. He also looked at the PDR in relation to MYAMBUTOL (ethambutol hydro-chloride). (Petitioner's Exhibit No. 3) His testimony was offered as a consultant for Petitioner. It supports Petitioner's attempt to impose discipline against Respondent's license. In interpreting the physician's progress note entered by Dr. Prchal on July 1, 2000, while Patient J.P. was in the hospital, which states "would sign off," Dr. Schoonover takes this to mean that Dr. Prchal will not be seeing the patient again, either in the hospital or as an outpatient, unless asked to formally consult at a future date. (Petitioner's Exhibit No. 1, page 121) Patient J.P. was discharged from the hospital on July 5, 2000, by Nagesh Kohli, M.D. Dr. Schoonover points out that the discharge summary explained to the patient in the discharge instructions that the patient, if experiencing any recurrence of symptoms, dyspnea, fever or questions or concerns, may call the Respondent. As well, the discharge instructions note that the patient was to follow up with Dr. Mitra in three to four weeks. (Petitioner's Exhibit No. 1, page 77) This instruction tends to coincide with the patient's visit to Respondent on July 19, 2000. Dr. Schoonover commented on the medications that Patient J.P. would continue upon discharge, in particular ethambutol 1600 mg q.d., part of the discharge summary by Dr. Kohli. This is as distinguished from the ethambutol Dr. Prchal had prescribed earlier in the hospital stay. In a patient medication record for Patient J.P. maintained by Respondent's practice, information is contained concerning ethambutol use over time. (Petitioner's Exhibit No. 1, page 9) Dr. Schoonover refers to the dosage of 400 mg four times per day, on July 19, 2000, October 23, 2000, and December 27, 2000, reflected in the patient record. Based upon the record, Dr. Schoonover assumes that Respondent was aware of the dosage of ethambutol for Patient J.P. upon these dates when the patient was seen, indicating a lack of change in the dosage over time. Dr. Schoonover commented upon the correspondence from Dr. Prchal to Dr. Mitra dated August 18, 2000. In his reading, Dr. Schoonover believes that the correspondence points out that Respondent was the physician of record from the standpoint of monitoring Patient J.P., and in treating the patient from the hospital discharge until the patient was seen by Dr. Prchal on July 26, 2000. In this connection notes made by Dr. Prchal concerning Patient J.P. in August 2000 were interpreted by Dr. Schoonover to indicate that the patient was receiving his prescriptions for medication from Respondent. (Petitioner's Exhibit No. 1, page 270) Dr. Schoonover also mentions the August 30, 2000 note in Patient J.P.'s records maintained by Respondent's practice, which describes a call by Dr. Prchal and his office note, taken to mean the correspondence directed to Respondent on August 18, 2000, in which Dr. Prchal requests Respondent to make sure that the patient has plenty of meds (medication) while Dr. Prchal was out of town through September 18, 2000. (Petitioner's Exhibit No. 1, page 89) That note maintained by Respondent in his practice indicates that the request was honored where it states, "Done." Dr. Schoonover assumes that the reference to meds would include ethambutol. Dr. Schoonover commented on the October 23, 2000 visit with Respondent as reflected in the note made on that date by Respondent (Petitioner's Exhibit No. 1, page 90), wherein it indicates that that patient is being continued on ethambutol. Dr. Schoonover believes that Respondent was responsible for monitoring that therapy and potential side effects and drug interactions associated with ethambutol. Dr. Schoonover commented on the December 27, 2000 correspondence from Respondent to Dr. Prchal, in which Respondent describes the complaint by Patient J.P. made December 26, 2000, about some eye problem, and whether the problem was due to medication. As Dr. Schoonover was aware, Respondent responded to those remarks by stopping the ethambutol. Dr. Schoonover was asked about his ability to form an opinion with a reasonable degree of medical certainty, whether the Respondent by his treatment of Patient J.P. practiced medicine with that level of care, skill, and treatment which is recognized by a reasonably prudent similar physician as being acceptable under similar conditions and circumstances. He had an opinion. That opinion was that Respondent deviated from the standard of care, that the Respondent fell below the standard of care. Dr. Schoonover feels that deviation was in two areas. The first was the failure to order eye examinations for Patient J.P. The second reason was that the Respondent did not reduce the dosage of ethambutol after two months of therapy. Dr. Schoonover offered his opinion with the belief that Respondent was the attending physician in the hospital and continued to treat the patient beyond the patient's release from the hospital. Dr. Schoonover indicated that had the Respondent not ordered an initial eye examination be done, then at some subsequent point in the care the examination should have been ordered. Concerning reducing the dosage of ethambutol, Dr. Schoonover further explains his opinion that the dosage should have been reduced by Respondent after 60 days or at least determined why the specialist (Dr. Prchal) had not reduced it after 60 days. Dr. Schoonover concludes that Respondent could have taken steps to prevent the permanent visual impairment of Patient J.P. through an initial eye examination or subsequent follow-up eye examination, finding the problem early enough that this discontinuation of the medication would resolve the problem and promote improvement before permanent damage was done. Dr. Schoonover holds the opinion that Dr. Prchal also deviated from the recognized standard of care in his treatment of Patient J.P. in relation to ethambutol. He believes that both Respondent and Dr. Prchal were in a situation wherein they shared the care and they were both equally responsible and failed to meet the standard of care for the same reasons. In essence Respondent was treating the Patient J.P. for MAI as well as Dr. Prchal. In his testimony Dr. Schoonover is less precise in his opinion concerning the responsibility for a physician to order an initial eye examination for Patient J.P., testifying that it was someone's responsibility. He then goes on to say that it was several persons' responsibility and that Respondent and Dr. Prchal were among those persons. They are the persons discussed as well as Dr. Kohli. Finally, in order to find a deviation from the standard of care by Respondent, Dr. Schoonover believes that it is necessary to show that the patient had diminished visual acuity more probably than not connected to ethambutol. His reading of the April 25, 2001 correspondence from Dr. Bhatti in particular, leads him to believe that there was a connection between the use of ethambutol and bilateral optic neuropathies as described by Dr. Bhatti. (Petitioner's Exhibit No. 1, page 227) Raymond L. Parker, Jr., M.D., has been practicing in Florida since 1976. His current practice is with Pulmonary Physicians of South Florida in South Miami, Florida. He specializes in internal medicine, pulmonary disease and critical care. He is board certified in all specialties. He testified by deposition in behalf of Respondent as an expert, in particular, in relation to his specialty in pulmonary diseases. (Petitioner's Exhibit No. 2) In the deposition the parties stipulated that the witness was an expert in pulmonary diseases. That stipulation is accepted. In preparing to offer his opinion concerning the care provided by Respondent to Patient J.P., Dr. Parker had exposure to the deposition of Respondent, the deposition of Dr. Prchal, the deposition of Dr. Kohli, medical records of Dr. Prchal, Frank's Pharmacy records, medical records of Dr. Leslie Husband, medical records of Beatriz X-Ray and Imaging Center, medical records of Dr. Zeini, medical records of Dr. DiLorenzo, medical records of the Marion County Department of Health, medical records of Express Care of Belleview, and medical records of the Monroe Regional Medical Center. Dr. Parker also had exposure to records related to Patient J.P., part of Respondent's office practice. Dr. Parker comments on the bronchoscopy performed by Respondent on June 29, 2000, while Patient J.P. was in the hospital, in which the bronchoscopic specimen showed no endoscopic evidence of malignancy. Based upon the results of the bronchoscopy in the hospital and an earlier bronchoscopy performed a Dr. Warman on June 7, 2000, Dr. Parker was persuaded that the patient was going to be treated for MAI based upon cultures that grew out from the procedures. Further, Dr. Parker refers to the discharge diagnosis when Patient J.P. left the hospital, where it is stated that the patient had atypical tuberculosis, MAI, in addition to a right-upper lobe abscess and COPD. Dr. Parker's refers to the progress note dated July 1, 2000, when Patient J.P. was in the hospital, made by Dr. Prchal, in which Dr. Prchal recommends 400 mg tablets, four times daily of ethambutol, totaling 1600 mg, as being part of a treatment for TB and MAI pending AFB culture results. Dr. Parker's reading of the note by Dr. Prchal calling for "Appropriate monitoring. Will sign off," in the context of other materials reviewed by Dr. Parker, meant that Patient J.P. was being referred to the tuberculosis health center and those persons in that facility would manage the tuberculosis and MAI issue in the future. Dr. Parker refers to information in the patient records where the wife of Patient J.P. contacted a social worker leading to the patient being informed that the tuberculosis unit did not treat MAI but that an attempt was being made to make an appointment for Patient J.P. to be seen at the adult clinic. Ultimately, Dr. Parker interprets the information he reviewed as indicating that Patient J.P.'s wife decided that an appointment needed to be made with Respondent resulting in the appointment on July 19, 2000, between the patient and Respondent. Between July 1, 2000, when Dr. Prchal wrote his "sign off" note and July 19, 2000, when the patient was seen by Respondent, Dr. Parker expressed the opinion that Respondent and Dr. Kohli were the attending physicians for Patient J.P. The prescription recommendations upon discharge would have been the responsibility of Dr. Kohli because he discharged the patient. According to Dr. Parker this included ethambutol. Dr. Parker is familiar with the PDR. He does not consider it to be an authoritative source for information among doctors. He considers that the information contained in the PDR was written years before. Consequently, it is not authoritative or up to date. Dr. Parker prescribes ethambutol for his patients but rarely. He has a special interest in MAI. He is aware of the recommendations within the PDR pertaining to visual testing and dosage for ethambutol. He considers some of the recommendations for using ethambutol to be controversial. For example, he does not recommend his patients get monthly monitoring for their vision. Instead, he recommends that they watch out for problems. He considers that this approach is the general consensus in the community where he treats patients. Specifically, Dr. Parker does not question the prescription of 25 mg per kg of patient weight for the Patient J.P. when ethambutol was first prescribed. The dosage points to the patient loosing weight, fevers and sweats, not doing well and the need to "jump on him or he would just wither away." Dr. Parker does believe that there should have been an eye test when starting the patient on ethambutol. Dr. Parker in his understanding perceives that when Dr. Kohli discharged the patient from the hospital, Dr. Kohli believed that the patient would be attending the TB Clinic for treatment and monitoring, to include baseline studies for visual acuity. Dr. Parker in his opinion looks upon the suggestion in the PDR that the dosage of ethambutol be changed over time as being a guideline and that the proper treatment is in view of the clinical needs of the patient. If the patient is improving the dosage can be reduced. If he remains very sick, he would not necessarily reduce the dose. Concerning the maintenance of 25 mg per kg over periods of three, four, five, or six months Dr. Parker says that under appropriate circumstances the maintenance of 25 mg per kg of patient weight is acceptable. He does not offer his opinion concerning this case. Concerning the prospect for reducing the dosage, Dr. Parker's review of the records does not lead him to a conclusion one way or the other. When patients are maintained on 25 mg. per kg. of patient weight, Dr. Parker expresses the opinion that more frequent eye testing is in order. If the dosage is less than that amount he would not recommend that a patient have repeat eye testing but that the patient be cautioned to quickly advise the doctor about changes in vision and or visual fields or color vision. From his review of the records Dr. Parker was aware that the patient was maintained on ethambutol 25 mg per kg of weight for approximately six months and no eye tests were provided during that period. Dr. Parker interprets the correspondence from Dr. Prchal to Respondent dated August 18, 2000, as a guiding letter for addressing Patient J.P.'s MAI, leading to the belief by Dr. Parker that Respondent deferred to Dr. Prchal in the treatment of MAI with ethambutol following that correspondence. Overall Dr. Parker does not believe that Respondent was treating Patient J.P. for MAI and had no experience with the drug ethambutol as part of that care. This meant that Dr. Parker does not believe that Respondent was addressing the MAI issue or ethambutol. Dr. Parker interprets the note in Respondent's office practice where on August 30, 2000, the call was received from Dr. Prchal referring to the office note of August 18, 2000, from Dr. Prchal. That request asks that the patient have plenty of meds while Dr. Prchal was out of town until September 18, 2000. This indicates that Dr. Prchal could not write the prescriptions and that he was requesting Respondent's office to handle the writing of prescriptions. This is not seen by Dr. Parker as turning over the management of the patient in reference to the prescriptions. In Dr. Parker's view, when consultants prescribe medication, the attending physician does not have a standard of care obligation to hold the knowledge about these drugs prescribed by the consultant for the patient. The attending physician relies upon the consultant for guidance on the drugs and any questions need to be followed up with the consultant, according to Dr. Parker. In this case he goes on to describe the expectation, upon the discharge from the hospital, that the patient would be seen by a clinic where the attending physician felt there would be necessary expertise. Dr. Parker reached an opinion on standard for care issues concerning Respondent's treatment and care of Patient J.P. His opinion is that Respondent met the standard of care because he was the treating physician limited to the lung abscess and COPD. Dr. Parker interprets the results of the July 19, 2000 visit to Respondent to be one in which Respondent realized that the patient was not going to be seen at a tuberculosis health clinic, resulting in Respondent referring the patient back to Dr. Prchal for management of MAI. Dr. Parker attaches importance to the August 18, 2000 letter from Dr. Prchal to Respondent, in which Dr. Prchal indicates a treatment plan for MAI and Respondent defers to that judgment. At the inception Dr. Parker believes Respondent was acting appropriately to refer Patient J.P. to Dr. Prchal, an infectious disease expert. Concerning the need for a baseline eye examination to be performed when ethambutol is being started, Dr. Parker thinks that is necessary. However, the physician managing the care with respect to the MAI and who ordered the medication is responsible for ordering the initial eye examination. In this case that would have been Dr. Prchal. Any follow-up eye examinations on a periodic basis would be the responsibility of the physician with a special interest in management of atypical mycobacterial disease, with some understanding of the various drugs involved, to include ethambutol. Dr. Parker believes that additional eye examinations are needed when continuing the dosage of 25 mg per kg of patient weight. Given the continuing dosage over time, Dr. Parker believes that Dr. Prchal was responsible for ordering subsequent eye examinations. In relation to the suggestion in the PDR that around 60 days the dosage of ethambutol be reduced, Dr. Parker believes that it is dependent upon the clinical response of the patient. Sometimes the dosage would be reduced earlier, sometimes later. The judgments concerning dosage would be that of the expert familiar with the MAI and drugs used to address it. SUMMARIZING FACTS: Respondent's explanation of the availability of the adult clinic in Ocala, Florida, to address Patient J.P.'s need for medications and other services only establishes that availability. It does not establish what was done at the clinic, if anything, in terms of treatment for MAI through the use of ethambutol and related vision tests. There is no proof that anything transpired at the adult clinic to treat MAI, or test for visual acuity. Whatever may have been offered to the patient in treatment and care by the adult clinic, it does not change the fact that Respondent and Dr. Prchal were involved with the treatment for MAI, to include the need to properly use ethambutol. Having considered the facts found concerning the care provided Patient J.P. by Respondent and Dr. Prchal and the opinions by the parties' experts Dr. Schoonover and Dr. Parker, Respondent has failed to practice medicine with the level of care, skill, and treatment which is recognized by a reasonably prudent similar physician as being acceptable under similar conditions and circumstances. Dr. Prchal was responsible for prescribing ethambutol while Patient J.P. was in the hospital. Consequently Dr. Prchal was responsible for testing initial visual acuity for the patient. The initial treatment provided was upon a request to consult made by Respondent. Dr. Prchal was also responsible for establishing the initial dosage for the patient. When the patient was discharged from the hospital, Dr. Prchal was no longer responsible for the treatment from July 5, 2000, the discharge date until July 26, 2000, when called upon again by Respondent to consult. When Dr. Prchal saw Patient J.P. on July 26, 2000, and August 8, 2000, it reestablished his responsibility but only temporarily. The treatment was turned back to Respondent as established in the correspondence following the second consult. That correspondence was dated August 18, 2000, from Dr. Prchal to Respondent involving ethambutol and its use in treating Patient J.P. Respondent had responsibility for Patient J.P. in relation to ethambutol following the patient hospital discharge and upon the visit by Patient J.P. to Respondent's office on July 19, 2000. Respondent briefly deferred to Dr. Prchal as a consultant on July 26, 2000, until he received the correspondence from Dr. Prchal dated August 18, 2000. Beyond that point in time, Respondent was responsible for Patient J.P.'s use of the medication ethambutol. This responsibility was evidenced in the Respondent's transcribed office note dated October 23, 2000, when the Patient J.P. was seen on a follow-up visit. It refers to the final note from Dr. Prchal dated August 18, 2000 and the continuation of ethambutol for the patient. It describes the need for the patient to continue on ethambutol for a year or so. On December 27, 2000, when Patient J.P. was next seen by Respondent in the office, the patient complained of an eye problem. In response Respondent "stopped his ethambutol" as of that day. During the time that Respondent was responsible for Patient J.P., related to the use of ethambutol by that patient, he was expected to make a clinical judgment about the proper dosage, but not necessarily at a two-month interval. There is no indication that he made any judgment. More significantly, given allegations in the Administrative Complaint, Respondent should have arranged periodic testing of visual acuity, while he was responsible for the use of ethambutol in treating Patient J.P., having failed to reduce the dosage from 25 mg per kg of body weight. Respondent's failure to meet the standard of care is not excused by Dr. Prchal's conduct when treating Patient J.P. with ethambutol. Respondent's belief that Dr. Prchal was all together responsible for treating Patient J.P.'s MAI with ethambutol and other medications is not accepted, realizing that to some degree Respondent undertook the treatment whether capable or not. Finally, there was no proof in this record concerning the local Department of Health, adult clinic providing treatment to Patient J.P. for MAI, to include judgment about the dosage of ethambutol and test for visual acuity. Absent such proof the responsibility fell entirely to Respondent and Dr. Prchal at various times. Their stated assumptions concerning the role, if any, played by the Department of Health, adult clinic in treating Patient J.P. without proof are unavailing and create no defense for their conduct. DISCIPLINARY HISTORY In the case of Department of Health, Petitioner vs. Purushottam Mitra, M.D., Respondent, DOH Case No. 1999-58979, a Final Order was entered. This Final Order was based upon a Recommended Order in Department of Health, Board of Medicine, Petitioner vs. Purushottam Mitra, M.D., Respondent, DOAH Case No. 01-2069PL. The Final Order concluded that Respondent had violated Section 458.331(1)(m), Florida Statutes, pertaining to maintenance of patient records justifying a course of treatment for a patient. It imposed an administrative fine amounting to $5,000.00. Respondent was also reprimanded by the Board. (Petitioner's Exhibit No. 4)
Recommendation Upon consideration of the facts found and conclusions of law reached, it is RECOMMENDED: That a final order be entered finding Respondent in violation of Section 458.331(1)(t), Florida Statutes (2000), imposing an administrative fine of $10,000.00, and issuing a written reprimand. DONE AND ENTERED this 25th day of February, 2005, 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 25th day of February, 2005. COPIES FURNISHED: Irving Levine, Esquire Judith Law, Esquire Department of Health 4052 Bald Cypress Way, Bin C-65 Tallahassee, Florida 32399-3265 Michael R. D'Lugo, Esquire Wicker, Smith, O'Hara, McCoy, Graham & Ford, P.A. Bank of America Center, Suite 1000 Post Office Box 2753 Orlando, Florida 32802-2753 Larry McPherson, Executive Director Board of Medicine Department of Health 4052 Bald Cypress Way Tallahassee, Florida 32399-1701 R. S. Power, Agency Clerk Department of Health 4052 Bald Cypress Way Tallahassee, Florida 32399-1701
The Issue Whether Respondent committed the violations alleged in the Amended Administrative Complaint and, if so, what penalty should be imposed.
Findings Of Fact AHCA is the agency responsible for the licensing and regulation of assisted living facilities in Florida pursuant to chapters 429 and 408, Part II, Florida Statutes. At all times material hereto, Kipling Manor was licensed by AHCA as an assisted living facility. Kipling Manor is located in Pensacola, Florida, and operates a 65-bed facility, license number 7285, and holds a specialty limited health license. Norma Endress is a registered nurse employed by AHCA. She conducts surveys of nursing homes and assisted living facilities for compliance. Ms. Endress is supervised by Patricia McIntire, a nurse consultant supervisor for AHCA. Ms. McIntyre has been with AHCA for 13 years. Belie Williams is the administrator of Kipling Manor. He has been involved with health care services for approximately 35 years, and has been an administrator of ALFs for approximately 15 years. He has been involved with the Florida Assisted Living Association (FALA) and served on its board. Mr. Williams helped implement training sessions for ALFs in conjunction with FALA for the past eight years. Kipling Manor has two nurses who visit the facility to provide care to the residents. Elizabeth McCormick is an advanced nurse practitioner (ARNP) in family, psychiatric and mental health. She has been a nurse since 1983 and has extensive experience dealing with inpatient and outpatient psychiatric residents in long-term facilities. Nurse McCormick works with a VA facility providing inpatient and outpatient care on a high intensity psychiatric unit. She was also an assistant professor at the University of West Florida in the Mental Health Nursing Program. Nurse McCormick provides medical and mental healthcare for residents at several ALFs in Pensacola, including Kipling Manor. She sees patients at Kipling Manor several times a month. She manages the healthcare of residents, diagnoses illnesses, and writes prescriptions as needed. She describes Kipling Manor as not being a typical setting because her patients there are seriously mentally ill, which presents huge challenges. Angela Lavigne is a registered nurse certified by Medicare to provide psychiatric care to patients. She is employed by a company called Senior Care. Among other things, she works with assisted living facilities providing therapeutic counseling, assisting doctors with adjusting medication, and providing in-service training to staff of these facilities in regard to psychiatric care. Nurse Lavigne has been seeing patients at Kipling Manor for almost three years. She visits Kipling Manor approximately four times a week. At the time of the survey, she visited the facility once or twice a week. She provides patient care as well as in-service training to the staff regarding psychiatric issues. She also runs group sessions with the residents to make them feel more independent and feel more like they are in their homes. On July 12 through 14, 2011, Nurse Endress conducted an unannounced complaint survey of Kipling Manor that gave rise to the Amended Administrative Complaint and to this proceeding. Count I--Resident 8 Count I alleges that Kipling Manor failed to provide incontinent care for Resident 8 and failed to provide nail and facial care for Resident 6. Ms. Endress observed Resident 8 walking with a "med tech" to the "med room" to receive her medications. Ms. Endress observed wetness on Resident 8's clothes, and noticed the smell of urine. The med tech gave Resident 8 her medications, then assisted her to an open area where Resident 8 sat down. Ms. Endress observed Resident 8 for about two hours. Ms. Endress approached a personal care assistant (PCA), who was a new employee, and inquired of the PCA as to whether the resident was incontinent. As a result of this inquiry, Ms. Endress believed that this resident was incontinent. After approximately two hours had passed, Ms. Endress called this to the attention of the PCA, who then changed Resident 8 immediately. Ms. Endress determined that Respondent was "not providing care for this lady, incontinent care. They were not monitoring her." This determination was based in large part on her belief that Resident 8 was incontinent. However, Resident 8's health assessment indicates that Resident 8 needed supervision while toileting, but did not carry a diagnosis of incontinence. Ms. Endress acknowledged at hearing that supervision with toileting is not the same thing as being diagnosed with incontinence. Resident 8's health assessment also reflects diagnoses of personality disorder, dementia, and Alzheimer's among other conditions. Ms. McCormick provided health care services to Resident 8. She quite frequently is involved with residents who have toileting issues. Had Resident 8 developed skin problems because of toileting issues, she would have been aware of it. Ms. McCormick noted that the records indicated that Resident 8 received a skin cream three times a day to prevent such skin problems. Both Ms. Endress and Ms. McCormick are of the opinion that, while it is better to change a resident as soon as possible, a two-hour check is appropriate for someone with toileting issues. According to Ms. McCormick, if she were looking to determine whether there existed a direct physical threat to Resident 8, there would be monitoring for skin breakdown, redness or irritation, or a possible urinary tract infection (UTI). Neither Ms. McCormick nor Ms. Lavigne were notified or saw any signs of a skin infection, other skin problems, or a UTI regarding Resident 8. There was no evidence presented that Resident had any skin problems or UTI as a result of this incident or her toileting issues. Erica Crenshaw is a "med tech" and a supervisor employed by Kipling Manor. She provided care for Resident 8 and was on duty the days of the survey in question. Ms. Crenshaw verified that Resident 8 was on a two-hour check at the time of the survey. This involved checking to see if Resident 8 was wet or dry. If she were found to be wet, staff would take off the resident's brief, change and wipe the resident, put on a new brief noting the date and time, as well as recording the staff person's initials. When changing Resident 8, staff would apply a barrier cream, and check to see if any bed sores developed. Ms. Endress determined that this was a Class II violation because of the potential for skin breakdown and infection as well as potential for emotional harm, in that she perceived this as a dignity issue for Resident 8. Ms. Endress based this opinion in large part on her mistaken belief that Resident 8 was incontinent. Her supervisor, Ms. McIntyre, reviewed the classification recommended by Ms. Endress and concurred that Class II was appropriate because "[r]esidents, in particular elderly residents, left sitting in urine, there is a great potential for them to experience skin breakdowns, which would certainly have a severe negative impact on their physical health." Mr. Williams saw Resident 8 while Ms. Endress was conducting her inspection. He saw that she was wet from urine on the back of her clothes. He did not detect any strong odor of urine although he was close to her. Count I--Resident 6 Count I also includes allegations regarding Resident Ms. Endress observed Resident 6 with long facial hair (Resident 6 is female) and long, dirty fingernails. Ms. Endress interviewed Resident 6 regarding these observations. Based upon this interview, Ms. Endress believed that staff did not cut her facial hair or trim her nails, despite Resident 6 wanting them to do so. Ms. Endress estimated Resident 6's nails to be approximately one-quarter inch long but could not recall the length of her facial hair. Resident 6's health assessment reflects a diagnosis of dementia with poor short term memory, and that she needs assistance bathing, dressing, and grooming. Erica Crenshaw described Resident 6 as "a little difficult to work with." Staff works on nails, hands and feet, two days a week. If at first Resident 6 was resistant to having her nails trimmed, they would "give her space" then approach her again later. She described Resident 6's nails as "pretty decent." Resident 6 received health care from both Ms. Lavigne and Ms. McCormick. Both nurses are of the opinion that staff worked with Resident 6 to keep her nails in good shape. As a resident of an ALF, Ms. McCormick noted that Resident 6 had the right to refuse nail care and decide whether her nails needed to be trimmed. Ms. Lavigne informed staff that they needed to work with Resident 6 at her own pace, and to be careful not to make her combative. Ms. Lavigne treated Resident 6 for a wrist problem in mid-summer of 2011, when Resident 6 was in a splint for approximately six weeks, and received physical therapy. She described Resident 6's nails as "nice, round, nothing broken, nothing chipped. Every once in a while she's actually let staff put nail polish on them but as far as cutting them down, it's like an act of Congress to get her to sit down enough to trim them." There is no evidence as to what could have been under Resident 6's nails when Ms. Endress saw her. However, the evidence establishes that Resident 6's nails were tended to by staff on a regular basis, and that her treating nurse was not aware of any problem with them. Regarding facial hair, Ms. Lavigne never noticed any facial hair on Resident 6 other than having "a couple little whiskers here and there." Ms. Lavigne was Resident 6's treating nurse in the general time-period around the survey in question, and was never informed about any problems with Resident 6 regarding nails or facial hair, nor noticed any. Ms. Endress classified the findings she made regarding Resident 6's nails and hair as a Class II violation because she perceived it as a "dignity issue because women do not like facial hair on them." Ms. McIntyre confirmed the class determined by Ms. Endress, although the record is not clear why. Count II--cleanliness and maintenance Count II of the Amended Administrative Complaint alleges that Kipling Manor failed to honor the rights of residents by not providing a safe and decent living environment to prevent the spread of disease for all residents. The Amended Administrative Complaint alleges in pertinent part as follows: In an interview resident #3 on 7/12/11 at 9:00 am stated this place was not clean. He stated the cook will have gloves on his hands when he leaves the kitchen. The cook continues rolling the food down the hallway to the dining room while simultaneously rolling the open garbage container which is soiled. Without changing his gloves he will serve the food to the residents.1/ An observation of lunch on 7/12/11 at 12:00 pm revealed the cook serving turkey with gloved hands not using a utensil. Without changing his gloves he handled silver ware, moved a gallon of milk and was touching the dining room table. He was using the same gloved hand to serve corn bread. While serving food he never changed his gloves between clean and dirty. Other staff wearing gloves were serving lunch to residents and cleaning tables and pouring beverages without changing gloves. They were serving beverages touching the rims of glasses without changing clothes [sic]. During the survey, the following was seen: Bathroom floor for room 9 on wing 1 was dirty with build-up of dirt in the corners. Lounge area at the end of wing 1 had a broken recliner that was being used by a resident. The floor and furniture were soiled. Room and bathroom #3 on wing 1 had dirty floors with build-up of dirt along baseboards and the toilet lid was too small for the tank. Vents were clogged with dust. The door was too short for the opening; wood was missing on door frame and the threshold had broken tile. Dining room bathroom at the end of wing 2 had dirty floors with build-up of dirt along baseboards; around bottom of the toilet was black and the seal was cracked. Dining room floors were dirty and walls had dried food on them. Room 27 had filthy floors with build up along baseboards; dried spills were noted and the drywall had a hole in it. Wing 2 had drywall that was pulling away from ceiling and the ceiling had brown water spots: soiled dirty walls; dirty baseboards with build up of dust; spills on walls and vents dusty. Wing 2 had no baseboard near the shower; the cabinet had mildew on the outside surface; the wood was warped and peeling. The sink was soiled with dried brown substance. The door to the cabinet would not close. The baseboard wood near sink was split and the drywall had an indentation of the door knob. Room 21 floors were filthy and smelled of urine. Soiled clothes laid on the floor with soiled underwear which were observed while medication technician was assisting resident. No action was taken by the medication technician. Laundry room floors were filthy. There was no division between clean clothes and dirty clothes. Clothes were lying on the floor.2/ Based upon this complaint, Ms. Endress observed the dining room during a meal and toured the building. At hearing, Ms. Endress acknowledged that she did not see the cook touch the garbage pail or garbage and then touch food. She maintained, however, that she observed the cook while wearing gloves, touch food then touch "dirty surfaces," then go back and touch food on plates and touch the rims on glasses. Ms. Endress did not specify at hearing what she meant by "dirty surfaces," but in her report which was the basis for the Amended Administrative Complaint, she noted that the cook would touch food and then touch surfaces such as moving a gallon of milk, touching the dining room table, and handling silver ware. She also testified that she saw other staff wearing gloves who were serving residents, cleaning tables, and serving beverages without changing their gloves. Deborah Jackson is a personal care assistant (PCA), food server, and laundry worker at Kipling Manor. Ms. Jackson and one other PCA serve meals for about 60 residents. She received training in food service. She was working at Kipling Manor the days Ms. Endress was there for the survey. Ms. Jackson always wears gloves when serving the residents. If she touches anything besides food she changes gloves. For example, if she moves chairs, she changes gloves before resuming food service. She has never seen the other PCA touch other items then serve food. She was trained never to touch the rims of the glasses but to pick up glasses and cups from the side. She goes through "probably a whole box" of gloves in a day. According to Ms. Jackson, the cook stands behind the area and puts the food on the plates, preparing two plates at a time. She watches him prepare the plates of food. She and the other PCA then serve the food to the residents. The garbage can is kept in the back, not where food is being served. She has never seen the cook touch the garbage can then prepare plates of food. When he has finished, he takes all "his stuff" out on a cart, while the PCAs clean up. If a resident spilled food, the PCAs, not the cook, would clean it up. L.N. was the cook at the time of the survey inspection. L.N. was hired in April 2011 and received training in infectious control and food service sanitation. L.N. no longer works for Kipling Manor.3/ Billie Williams, as administrator of Kipling Manor, confirmed Ms. Jackson's description of the cook's role in serving dinner. That is, that the cook prepared plates of food and the PCAs then served the residents. At hearing, Ms. Endress essentially reiterated her findings regarding the other allegations in count II dealing with the cleanliness and condition of the facility. No further proof was offered regarding these or any other allegations in the Amended Administrative Complaint. Mr. Williams' testimony contradicted much of what Ms. Endress described regarding the cleanliness and condition of the facility. Specifically, Mr. Williams noted that on the day of the survey inspection, maintenance men were repairing a ceiling leak. The ceiling leak was the cause of the "drywall pulling away from the ceiling" and the "brown water spots" on the ceiling cited in the Amended Administrative Complaint. These conditions were the result of the water leak and were in the process of being repaired at the time of the survey. The workers arrived early in the morning and cut drywall from the ceiling where the water dripped down on it. They necessarily used a ladder to do the ceiling repair work. A maintenance man stood at the bottom of the ladder and, if a resident approached, would escort the resident around the ladder. Regarding the issues of cleanliness, Mr. Williams has two housekeepers, a person who does the laundry, and two maintenance men. Mr. Williams acknowledged that there may be a small wax buildup along baseboards or on the inside corner of a door. However, the two maintenance men wax, strip, and buff the floors throughout the building. The floors are swept and buffed every day. The baseboards (wall to floor) are dust mopped twice a day. Regarding the allegation that there was black around the bottom of the toilet and the seal was cracked in the bathroom off the dining room area, Mr. Williams went to that room with the maintenance men to personally inspect it. He observed some discoloration on the floor where the toilet may have overflowed at some time and got underneath the tile. The maintenance men cleaned this immediately and replaced the tile. Regarding the allegation that there was mildew on a bathroom cabinet, Mr. Williams inspected the black mark and found it to be a tire mark from a wheelchair. He found no mold or mildew. The black mark was removed. There is a separate laundry room where washers and dryers are located. Any clothes on the floor are for sorting or separating by color or other reason prior to washing. Once clothes are washed, they are taken back to the residents' rooms immediately. Clean sheets, towels, and wash cloths are placed on wooden shelves that were built for that purpose. There is no evidence that establishes that clean and dirty clothes were mixed on the floor. Mr. Williams also inspected the recliner. The recliner has snap-on armrests and one had been snapped off. The maintenance men snapped the armrest back on the chair, and it was easily repaired. Regarding the allegation that the drywall in a bathroom had an indentation of the door knob, Mr. Williams inspected that and found that the doorstop on the bottom had broken off. There was an indentation in the wall the size of a doorknob where the door had been opened hard. This was repaired by the maintenance men. Regarding the allegation of vents being clogged with dust in a room and bathroom, Mr. Williams found "a little" dust on a vent which was cleaned immediately by staff. He then instructed staff to check the vents daily for dust build-up. Mr. Williams could not find a door that was too short for the opening, and noted that this would be a fire code violation. Kipling Manor is current on fire and health safety inspections. In general response to the allegations regarding cleanliness and maintenance and to a question asking whether he keeps a well-maintained building, Mr. Williams stated: We try our best. I mean, I have--you know, when you have incontinent residents who are demented, who are bipolar or suffering from depression, they will do things. And, yes, they do. And like, I think in one of the reports she wrote up, there was wet clothes on the floor. Well, if a resident, some of them are semi-independent, too. I mean, they take care of their own needs. If they had an incontinent issue that morning, and they took their clothes off and left it there on the floor, you know, they expect the staff to pick it up and take it to a laundry room when they come through. You know, we do, I think, we do a darn good job given the -- a lot of my residents have been homeless, have never had any structured living. Nobody else in town takes them, but I have. Ms. Endress classified the alleged violations in Count II as Class II "because of the potential for harm to residents which could occur from an unsafe environment and potential spread of infection." Ms. McIntyre agreed with Ms. Endress that "the totality of all the findings are what drove the deficiency to be considered a Class II." Count III--Resident 4 medications Count III alleges that Kipling Manor failed to administer medications according to the medication observation record (MOR) for 1 out of 9 sampled residents (Resident 4). During lunch, Ms. Endress observed Resident 4 become agitated, rub his face, and complain loudly in the dining room. Following an observation of this resident and a conversation with him, Ms. Endress reviewed Resident 4's medication observation record (MOR) and health assessment. Ms. Endress determined that Resident 4 had not been given one of his medications, Interferon, when scheduled. The MOR shows a time for administration as 8 a.m. According to Ms. Endress, on the date this took place, July 12, 2011, the MOR was blank in the box that should be initialed when the medication was administered. The MOR in evidence, however, reflects initials in that box (i.e., it is not blank). When a drug is self-administered, the staff member initials the box for that day. Erica Crenshaw recognized and identified the initials in the box for that day as those of former unit manager Tekara Levine, who trained Ms. Crenshaw. According to Mr. Williams, Ms. Levine, was certified in the self- administration of medications and was a trustworthy employee. Ms. Endress observed Resident 4 wheel himself from the dining room to the medication room and self-administer his medication. This occurred around noon that day. Ms. Endress determined this to be a Class II violation as she believed it directly threatened the resident emotionally. She based this in part on the resident's demeanor before the medication and afterwards, and the comments the resident made to her. Resident 4 is one of Nurse Lavigne's patients. Resident 4 has a diagnosis of MS, major depression, post traumatic stress disorder, a paranoid psychosis, and anxiety and affective disorder. He receives Interferon for his MS. It is injectable and he self-administers it every other day. According to Nurse Lavigne, there is no doctor's order stating that the Interferon must be given at 8 a.m. or any other particular time. The injection can be administered at any time during the day. Resident 4 sometimes gets confused about his medications. He gets extremely upset if he thinks he has not gotten his medications. He will sometimes tell her (Nurse Lavigne) that he did not receive a particular medication when he, in fact, did receive it. Once he is shown the MOR indicating that he has received his medication, he visibly calms down. He does not like to leave his room because he thinks somebody is changing stations on his TV. Regarding his once-a- day medications, staff will wait until he is ready to come out of his room because he can get agitated. He sometimes gets upset if there are a lot of people around him, such as in the dining room. Nurse Lavigne does a full assessment when she sees Resident 4. She was not aware of any problems with Resident 4 during that time period regarding his medications. While the record is unclear as to why Resident 4's MOR shows an administration time of 8 a.m., the evidence established, through Nurse Levine, his treating nurse, that there is no doctor's order requiring that the drug be administered at that particular time. The evidence also established that Resident 4 self-administered his medication at noon on July 14, and that this was initialed by a staff member on his MOR. Count IV--Resident 1 medications As a result of a complaint received, Ms. Endress interviewed residents about their medications and spoke to a new staff member. Based upon these interviews, Ms. Endress determined that one of Resident 1's medications (Flexeril) had not been available for one dose on July 13, 2011, and another of this resident's medications (Visteril) had not been available from June 23 until July 12, 2011). Ms. Endress classified this alleged violation as a Class II because she determined that that it directly affected the resident psychologically and physically. Resident 1 had a diagnosis of COPD and has an anxiety disorder. She is alert and oriented. Resident 1 was prescribed Flexeril to be administered every evening, and Vistaril and Ativan for anxiety. She is to receive Ativan twice a day and PRN (as needed) and Visteril before bed and PRN. Each day a medication is administered, the residents' MORs are initialed by staff in a box indicating each day of the month. However, if the resident runs out of a drug, the staff member will put a circle in the box representing that day and makes a note on the back of the MOR. No circles or notes appear on Resident 1's MOR indicating that either drug was not available. Resident 1 is a patient of Nurse McCormick. Resident 1 becomes anxious or agitated if she does not receive her medication for her anxiety disorder. Nurse McCormick considered Resident 1's anxiety disorder well controlled by the medications. Resident 1's MOR reflects that she received Visteral from June 1 through 30 at night as ordered and received it PRN several times prior to June 23, 2011, but did not receive it PRN the rest of the month of June or July 1 through 14. She also received Ativan twice a day routinely in June and July and five times PRN during the period June 23 through 30, 2011, and four times during the period July 1 through 14. According to Nurse McCormick, either medication was appropriate for controlling Resident 1's anxiety disorder. Resident 1's MOR reflects that she received Flexeril on June 30, 2011. Nurse McCormick was not made aware at any time that Resident 1 was not receiving any of her medications. As the treating and prescribing nurse, missed or unavailable medications would have come to Nurse McCormick's attention. Resident 1 was not anxious, nervous or agitated when interviewed by Ms. Endress on July 12, 2011. There is no competent evidence that Resident 1 displayed any signs of anxiety, nervousness or agitation during the survey or during the times that the Amended Administrative Complaint alleges that she did not receive her medication. Nurse McCormick found the staff of Kipling Manor to be careful with all residents. She has been to the facility at various times of the day from early in the morning to late into the evening. Nurse McCormick is of the opinion that the staff takes care of all its residents and provides them with dignity. Despite Kipling Manor's resident population of seriously mentally ill residents, Nurse McCormick is of the opinion that the facility manages its residents with dignity and care. Count V--Background Check The Amended Administrative Complaint alleges that one staff member of Kipling Manor, the cook, had not been background screened. Based upon record review and staff interview, Ms. Endress determined that the facility did not complete a level 2 background check for 1 out of 8 sampled staff members. A record review revealed that this employee had been hired in April 2011. On April 26, 2011, the employee in question signed an Affidavit of Compliance with Background Screening Requirements, using AHCA form #3100-0008. By signing this form, the employee attested to never having been arrested for, pled nolo contendere to, or convicted of certain disqualifying offenses. Mr. Williams did not complete a background check on the cook because he did not think the cook was covered under the law. That is, he did not think the law applied to the cook because of the lack of personal contact with the residents. The cook is present during meal times serving plates of food to the dining workers who then directly serve the residents. The living areas are accessible to the cook. This employee no longer works at Kipling Manor. The record is not clear as to when he stopped working there. Ms. Endress determined that this constituted a Class II deficiency as she believed that it could potentially lead to harm to residents of the facility. According to Ms. McIntyre, AHCA always imposes a Level II deficiency for failure to have a level 2 background screening for employees. Both Ms. Endress and Ms. McIntyre testified at hearing regarding what constitutes Class II and Class III deficiencies. In several instances, Ms. Endress classified a violation or deficiency that could potentially result in harm to a resident as a Class II. Ms. McIntyre testified that "a potential harm to a resident could be a class II deficiency." She described a Class III as one that "indirectly threatens the physical, emotional health or safety of a resident. . . . indirectly or potentially." The Agency provided a mandatory correction date of August 1, 2011, for all five counts in the Administrative Complaint.
Recommendation Based upon the foregoing Findings of Fact and Conclusions of Law set forth herein, it is RECOMMENDED: That the Agency for Health Care Administration enter a final order imposing a fine of $2,000, imposing a survey fee of $500, and dismissing the remaining allegations of the Amended Administrative Complaint against Respondent, Kipling Manor. DONE AND ENTERED this 1st day of May, 2012, in Tallahassee, Leon County, Florida. S BARBARA J. STAROS 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 1st day of May, 2012.
