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RAMS PHARMACY, INC., D/B/A MORENO PHARMACY vs AGENCY FOR HEALTH CARE ADMINISTRATION, 02-000480MPI (2002)
Division of Administrative Hearings, Florida Filed:Tallahassee, Florida Feb. 05, 2002 Number: 02-000480MPI Latest Update: Sep. 13, 2005

The Issue Whether Respondent Agency for Health Care Administration (AHCA) preliminary determination of alleged Medicaid overpayment to Rams Pharmacy, Inc. d/b/a Moreno Pharmacy (Rams) which arose from a Medicaid pharmacy audit, should become final agency action.

Findings Of Fact The Medicaid program is a cooperative federal-state venture designed to provide health care to the needy. States participating in the program receive federal financial assistance for compensating enrolled providers for the good and/or services they provide to Medicaid recipients. Florida is a participant in the Medicaid program, AHCA is the state agency responsible for making payments to enrolled providers in Florida. AHCA contracts with pharmacies such as Rams to provide medicine to Medicaid patients. After medicine is dispensed by a pharmacy to a Medicaid patient, the pharmacy must submit a claim to AHCA for that dispensed medication. The amount a pharmacy bills AHCA for dispensed medication generally consists of the pharmacy's wholesale costs for the medicine, plus a small dispensing fee. For each claim submitted, pharmacy Medicaid providers must disclose the information that is described in detail in Section 6 of the Prescribed Drug Handbook. Section 6 contains 11 pages of instruction for filling out of a claim form for one prescription reimbursement. A pharmacy must provide the following information for each medication dispensed: pharmacy provider number; recipient's name; recipient's Medicaid I.D. number; the prescription number; the manufacturer item; the date the prescription was filled; the quantify dispensed; the number of days the prescription covers; whether the recipient has any other insurance; the pharmacy's internal number that was assigned to the prescription; whether the prescription is being filled for the first time or is a refill; the National Drug Code from the package for the drug dispensed; the pharmacy's Florida license number; the medical certification code; whether the drug is generic or a name brand; the unit dose; the amount billed; other payer amount; and the billing date. After submission of a claim, AHCA reimburses the pharmacy for the amount billed. From time to time, after Medicaid's reimbursement and payment to a pharmacy, AHCA through its agent reviews a pharmacy's records to validate the pharmacy's claims and to assist AHCA in determining whether Medicaid may have overpaid the pharmacy. These findings are included in a proposed audit report. AHCA sends the proposed audit report to pharmacies advising them that it intends to adopt the proposed audit report and its underlying documents as the final report unless the pharmacy timely contests the proposed audit report. The AHCA analyst involved in this case opened a file in this matter on or around March 17, 2000. The file was opened after her review of a routine audit of the pharmacy performed by the fiscal agent on or about January 19, 2000, which alleged some discrepancies. The analyst chose an audit period of August 5, 1998 through December 31, 1999. She next requested from AHCA's Information Technology Department a list of Rams' "paid claims" for that period for the "top twenty" drugs, in terms of money paid to the pharmacy. She received a print-out of what purported to be those claims, which was introduced into evidence as part of the Final Agency Audit Report. The analyst then asked Rams to provide invoices to prove that during the audit period it purchased or acquired the drugs for which it had been paid by Medicaid as shown in Exhibit numbered 5. Between the dates of March 1998 and March 1999, Rams' physical location underwent substantial renovations. During the course of those renovations, boxes containing purchase invoices were either destroyed by the elements, inadvertently discarded, or misplaced. Because those invoices were not available, Rams could not produce invoices for all of its purchases of drugs during the relevant time period. However, Rams did provide some invoices and Rams' owner testified that the pharmacy acquired sufficient inventory during the audit period to cover the billings to Medicaid. Rams was credited for the invoices provided by Rams during the audit and prior to the hearing, although they were not identified or offered into evidence by AHCA or Rams. The claims that were unsupported by invoices were documented in the AHCA audit. A substantial number of invoices were not produced by Rams and are presumed lost during the renovation. From the invoices Rams provided, the analyst determined that there was three wholesalers who provided drugs to Rams during the audit period. The analyst wrote to the three wholesalers and asked them to provide lists of Rams' purchases of the "top twenty" drugs from them during the audit period. The purchase information print-outs received from Rams' three suppliers were of some assistance in reconstructing Rams' purchases. The request for invoices and purchase information and the responses received by the analyst were admitted into evidence as part of the Final Agency Audit Report. In this case, the analyst had a shelf inventory taken by the fiscal agent during a visit to the pharmacy on August 5, 1998, the date which the analyst chose as the start date of the audit period. That inventory was admitted into evidence as part of the Final Agency Audit Report. To obtain the total quantity of the twenty audited drugs purchased by Rams during the audit period by, the analyst (1) took the quantity of drugs listed in the August 5, 1998, shelf inventory; (2) added the quantity purchased on invoice from Rams' three suppliers; and (3) the total on the invoices provided by Rams. The analyst testified that she did not double count any purchase information for the audit period. She then compared the total quantity of drugs purchased by Rams, as evidenced by the invoice records, to the "reimbursed claims" for the twenty audited drugs. The quantity of drugs for which Rams was reimbursed exceeded the quantity of drugs purchases on documented invoices. The dollar value of those undocumented drugs is what AHCA seeks to recoup. Based upon that analysis, Rams was sent a Preliminary Audit Report on January 10, 2001, which alleged an overpayment of $390,327.19. A Final Agency Audit Report was issued on May 18, 2001, claiming an overpayment of $390,327.19. During the course of preparing for the hearing the amount of "overpayment" was recalculated by the analyst several times based upon: (1) additional invoices subsequently provided by Rams; and (2) additional purchase information previously provided to AHCA by one of the three suppliers, which AHCA had inadvertently overlooked during the initial review of the data. The final overpayment alleged by AHCA continued to be adjusted over the course of the hearing, and was finally set at $299,758.61. AHCA asserts that Rams was overpaid this amount for the audited drugs based on Rams' inability to establish through invoices or other purchase documentation that it actually purchased those drugs from legitimate sources.

Recommendation Based upon the foregoing Findings of Fact and Conclusions of Law set forth herein, it is RECOMMENDED: That a final order be issued to recoup $299,758.61. DONE AND ENTERED this 22nd day of June, 2005, in Tallahassee, Leon County, Florida. S __ STEPHEN F. DEAN 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 22nd day of June, 2005.

Florida Laws (3) 120.569120.57409.913
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DEPARTMENT OF HEALTH, BOARD OF PHARMACY vs WILLIAM J. FARMER, R. PH., 00-001705 (2000)
Division of Administrative Hearings, Florida Filed:Tallahassee, Florida Apr. 20, 2000 Number: 00-001705 Latest Update: Dec. 23, 2024
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BOARD OF PHARMACY vs. HISPANIA INTERAMERICA, INC.; JOSE E. VALDES; ET AL., 76-000331 (1976)
Division of Administrative Hearings, Florida Number: 76-000331 Latest Update: Jun. 03, 1977

The Issue Whether Respondent's permit to operate a pharmacy should be suspended or revoked for alleged violations of Sections 465.22(1)(c), 465.18(1)(b), 465.18(2)(b) F.S., and Rule 21S-1.14 F.A.C. At the hearing, Petitioner withdrew Count-I of the Complaint. Respondent's Motion To Dismiss Counts II and III of the Complaint at the conclusion of Petitioner's case in chief was denied.

Findings Of Fact Respondent presently holds and did so hold at the time of the events alleged in the Complaint a permit to operate a pharmacy issued by Petitioner (Stipulation.) Prior to the events alleged in the Complaint, Petitioner's agent, Vernon K. Bell, an inspector, obtained an authentic prescription from another pharmacy that had not been picked up by a customer, for use in investigations of other pharmacies. The prescription was issued by Dr. George A. Fernandez, Miami, Florida, Number 012194, dated December 11, 1975, to Fela Rivias and was for twenty-one tablets of Erythrocin, 250 miligrams. Erythrocin is an antibiotic prescription drug used for various infections (Testimony of Bell, Petitioner's Exhibit 1.) On December 19, 1975, Bell visited Respondent's pharmacy and observed that the door to the prescription area was unlocked. On December 22, 1975, at approximately 3:30 P.M., Reynaldo Santiago, another agent of the Board of Pharmacy, entered Respondent's pharmacy with the prescription referred to in paragraph 2 above that had been given to him by Bell. Santiago gave it to the cashier to be filled. He observed her go to the prescription department, open a door, and place the prescription on a counter. He then observed Hildelisa Hernandez go to the prescription department and start filling the prescription. Thereafter, Ms. Hernandez, accompanied by Mr. Jose E. Valdez, came out of the prescription area and Hernandez gave a pill bottle to the cashier. The cashier in turn gave it to Santiago for the price of $3.95 or $4.00. The bottle contained 21 tablets and a label affixed thereon contained pertinent information as set forth in the prescription that Santiago had given to that cashier, including the name of the drug, doctor, prescription number and name of patient (Testimony of Santiago, Petitioner's Exhibit 2.) Santiago took the bottle of pills outside and then he and Bell re- entered the Pharmacy. Bell identified himself to Mr. Valdez and asked him who was his registered pharmacist and if he had a pharmacist on duty. Mr. Valdez stated that Hal Glass was his pharmacist, but that he had left the store at 2:00 P.M. Bell then asked Valdez if he had filled the prescription which Santiago had taken into the store and, after some hesitation, Bell asked Hernandez if she had filled it. She replied in the affirmative. She stated that she was not a licensed pharmacist in Florida, but had been a pharmacist in Cuba. Bell then wrote a violation and left the store. Neither he nor Santiago recalled seeing a sign indicating that the prescription department was closed on December 22 (Testimony of Bell, Santiago.) Jose E. Valdez testified that although he formerly had two pharmacists at his previous pharmacy, in August or September of 1975 he was forced to cut back to one part-time pharmacist because of the bad economic situation. He conceded that Ms. Hernandez was not a registered Florida pharmacist. He also stated that he was not aware of the rules requiring that the prescription department be locked when no pharmacist was present until this incident occurred and that, in fact, the door to the prescription area had not been locked although a sign indicating that the prescription department was closed had always been used. He further testified that on February 1, 1976, he hired a full-time pharmacist who is present at all times when the pharmacy is open and that the prescription department is now always locked when she is not present.

Recommendation That a civil penalty in the sum of $250.00 be imposed against Respondent in lieu of suspension or revocation of its permit, for violation of Section 465.18(1)(b), Florida Statutes, and Rule 21S-1.14, Florida Administrative Code DONE and ENTERED this 26th day of April, 1976, in Tallahassee, Florida. THOMAS C. OLDHAM Hearing Officer Division of Administrative Hearings Room 530, Carlton Building Tallahassee, Florida 32304 COPIES FURNISHED: Stanley Kaplan, Esquire 404 Biscayne Building Miami, Florida Seymour M. Litman, Esquire 10 Northwest 14 Avenue Miami, Florida 33125

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BOARD OF PHARMACY vs. HOWARD E. STAATS, 86-000287 (1986)
Division of Administrative Hearings, Florida Number: 86-000287 Latest Update: Nov. 12, 1987

Findings Of Fact Upon consideration of the oral and documentary evidence adduced at the hearing, the following relevant facts are found: At all times material to this proceeding, the Respondent, Howard E. Staats, was licensed as a pharmacist with license number PS 0007704. On July 15, 1985, Dr. Ali A. Zomorodian treated James C. Jowers for thrombose hemorrhoids at the Memorial Medical Center in Jacksonville, Florida and prescribed Proctofoam HC, allowing three (3) refills of the medication. Proctofoam HC is a "medicinal" drug which is commonly known as a "legend" or "prescription" drug which can only be dispensed by prescription. On July 15, 1985, James Jowers presented the prescription for Proctofoam HC issued by Dr. Zomorodian to the Respondent for filling at Scottie's Discount Drug Store, 41 Arlington Road South, Jacksonville, Florida. During the course of filling the prescription on July 15, 1985, the Respondent discussed genital cancer with Jowers and showed Jowers pictures of the genital area. There was insufficient evidence to show that Respondent asked Jowers to come behind the prescription counter that day on the pretense of checking Jowers' hemorrhoids, and then pulling down Jowers' shorts and touching Jowers' penis and testicles. After Respondent had filled Jowers' prescription for Proctofoam HC on July 15, 1985, Jowers decided that the price was too high and asked that Respondent return his prescription. Respondent returned the prescription to Jowers and Jowers had it filled at the Mayport Naval Station pharmacy on July 16, 1985. While Respondent had the prescription in his possession on July 15, 1985, and before returning it to Jowers, Respondent copied certain information from the prescription and gave the prescription a number (83116) on Respondent's prescription log. This information was placed on file at Scottie's. Based on information furnished by Jowers concerning Respondent's behavior on July 15, 1985, John Danson, Investigator for Petitioner and detectives from the Duval County Sheriff's Office asked Jowers to return to Scottie's and make contact with the Respondent on the pretense of needing the prescription for Proctofoam HC filled. On July 29, 1985, Jowers returned to Scottie's where Respondent was on duty and told Respondent that he had lost the prescription for Proctofoam HC but that he needed it filled. Using the information that he had copied from the original prescription on July 15, 1985, Respondent filled the prescription for Proctofoam HC and gave the medication to Jowers. Jowers upon leaving Scottie's gave the medication to Danson and the detectives from the Duval County Sheriff's Office. There was insufficient evidence to show that Respondent knew on July 29, 1985 that the prescription had been filled at the Mayport Naval Station pharmacy or that the prescription was on file at the Mayport Naval Station pharmacy. The medication given to Danson and the detectives contained the same prescription number (83116) that Respondent had given the prescription when presented to him on July 15, 1985. There was insufficient evidence to show that Respondent asked Jowers into his office and pulled down Jowers' pants and touched Jowers' penis or testicles on July 29, 1985. At all times relevant to this proceeding, the original prescription for Proctofoam HC used by Dr. Zomorodian to Jowers on July 15, 1985 was on file at the Mayport Naval Station pharmacy. The Mayport Naval Station pharmacy did not transfer the prescription for Proctofoam HC issued by Dr. Zomorodian to Jowers on July 15, 1985. Neither Dr. Zomorodian nor his staff "called-in" the prescription for Proctofoam HC given to Jowers by Dr. Zomorodian on July 15, 1985 to Scottie's or the Respondent. The Respondent did not call Dr. Zomorodian or his staff for authorization to dispense Proctofoam HC to Jowers under the prescription issued by Dr. Zomorodian to Jowers on July 15, 1985. Respondent prepared and maintains in his files a written record of the information copied from the original prescription presented to him by Jowers issued by Dr. Zomorodian for Poctofoam HC on July 15, 1985. In addition to the number (83116) being listed in the Scottie's prescription log, it is also listed on the above-referenced record. Respondent's dispensing of the Proctofoam HC to Jowers on July 29, 1985 under the circumstances of this cause was done in good faith. Although there was conflicting expert testimony, Respondent's dispensing of the Proctofoam HC to Jowers on July 29, 1985 under the circumstances of this cause was done in the course of professional practice of pharmacy.

Recommendation Having considered the foregoing Findings of Fact, Conclusions of Law, the evidence of record and the candor and demeanor of the witnesses, it is, therefore RECOMMENDED that the Amended Administrative Complaint be DISMISSED. Respectfully submitted and entered this 12th day of November, 1987, in Tallahassee, Leon County, Florida. WILLIAM R. CAVE 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 12th day of November, 1987. APPENDIX TO RECOMMENDED ORDER, CASE NO. 86-0287 The following constitutes my specific rulings pursuant to Section 120.59(2), Florida Statutes, on all of the Proposed Findings of Fact submitted by the Petitioner in this case. Rulings on Proposed Findings of Fact Submitted by the Petitioner Adopted in Finding of Fact 1. Adopted in Finding of Fact 2. Adopted in Finding of Fact 3. Adopted in Findings of Fact 4 and 6. Adopted in Finding of Fact 6. Adopted in Finding of Fact 8. Adopted in Findings of Fact 8 and 15 but clarified. Adopted in Finding of Fact 8. Adopted in Findings of Fact 6 and 12 but clarified. Rejected as not supported by substantial competent evidence, as being hearsay and as not being material or relevant. 11-13. Adopted in Findings of Fact 13 and 14 but clarified. 14.-15. Although Dr. Zaenger's background and the fact that she testified as an expert witness on the standards of practice in pharmacy are important to determine the weight given her testimony, these findings are not necessary and add nothing to the finding of fact in this order. Rejected as being a conclusions of law rather than a Finding of Fact. Rejected as not being material or relevant since it is not a finding of fact but only a statement of a hypothetical situation. Rejected as not supported by substantial competent evidence. 19.-23. Rejected as not being material or relevant. Rulings on Proposed Findings of Fact Submitted by the Respondent 1. Adopted in Finding of Fact 1. 2-3. Adopted in Finding of Fact 4. 4. Adopted in Finding of Fact 13 but clarified. 5.-6. Adopted in Findings of Fact 13 and 14 but clarified. 7.-8. Paragraph 7 and the first sentence of paragraph 8 rejected as a restatement of the testimony and not a finding of fact. The balance of paragraph 8 is adopted in Findings of Fact 6, 7 and 8 but clarified. Adopted in Finding of Fact 6. Adopted in Finding of Fact 7. Adopted in Finding of Fact 5 but clarified. 12.-14. Adopted in Finding of Fact 8. Adopted in Finding of Fact 6. Rejected as not being material or relevant. 17.-19. Adopted in Finding of Fact 8. Adopted in Finding of Fact 12. Adopted in Finding of Fact 14 but clarified. Adopted in Finding of Fact 3. Adopted in Finding of Fact 8. 24.-27. The first two (2) sentences of paragraph 25 are adopted in Findings of Fact 3 and 10. The balance of paragraphs 24-27 are rejected as being a restatement of the testimony and not a finding of fact. COPIES FURNISHED: Robert D. Newell, Jr., Esquire Newell & Stahl, P.A. 102 S. Monroe St. Tallahassee, Florida 32301 Robert Palmer, Esquire Michael Ed wards, Esquire Suite 305, 24 N. Market St. Jacksonville, Florida 32202 Tom Gallagher, Secretary Department of Professional Regulation 130 North Monroe Street Tallahassee, Florida 32399-0750 Rod Presnell, Executive Director Board of Pharmacy Department of Professional Regulation 130 N. Monroe St. Tallahassee, Florida 32399-0750

Florida Laws (7) 120.57455.227465.003465.004465.015465.016465.026
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DEPARTMENT OF HEALTH vs CAPITAL HEALTH, INC., AND BRUCE L. STORRS, 02-003883 (2002)
Division of Administrative Hearings, Florida Filed:Fort Lauderdale, Florida Oct. 03, 2002 Number: 02-003883 Latest Update: Dec. 23, 2024
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BOARD OF PHARMACY vs. AMERICAN APOTHECARIES, INC., D/B/A SCOTTIE DRUGS, 82-001628 (1982)
Division of Administrative Hearings, Florida Number: 82-001628 Latest Update: Feb. 22, 1983

The Issue The issues to be determined here concern disciplinary action to be taken against Respondent for those administrative offenses pertaining to the controlled substances Talwin, Dilaudid and Paregoric dispensed by Scottie Drug Store in Duval County, Florida, during the period April 2, 1981, to March 23, 1982, in violation of various provisions of Chapter 465, Florida Statutes. These contentions made by the State of Florida, Department of Professional Regulation, are more particularly described in the Administrative Complaint, DPR Case No. 0022147.

Findings Of Fact Howard E. Staats is a pharmacist who has been issued a license by the State of Florida, Department of Professional Regulation, Board of Pharmacy. The license number is 0007704. At times relevant to this proceeding, Staats practiced pharmacy in Jacksonville, Florida. At all times pertinent to the Administrative Complaint, which is the focus of this action, Staats was the managing pharmacist at American Apothecaries, Inc., which does business as Scottie Drug Store at 41 Arlington Road South, Jacksonville, Florida. A copy of Respondent's most recent license may be found as Petitioner's Exhibit No. 1, admitted into evidence. Petitioner's Exhibit No. 2, admitted into evidence, is a copy of the permit for American Apothecaries. Sometime within the period March 23, 1982, through March 29, 1982, an audit was conducted at the Scottie Drug Store. The audit revealed that in the period April 2, 1981, through March 23, 1982, the drug store had purchased 66,900 tablets of Talwin, 50 mg., had sold 29,373 tablets of that drug, had lost by robbery or theft, 1,000 tablets of the drug, leaving 36,527 tablets of Talwin unaccounted for. During that same audit period, the pharmacy purchased 4,000 tablets of Dilaudid, 4 mg., selling 3,025 tablets of that drug, losing by robbery or theft, 200 tablets of the drug and failing to account for 775 tablets of the drug. Finally, during the audit period, 2,064 ounces of Paregoric had been purchased and 699 ounces sold, with the remaining amount of 1,285 ounces being unaccounted for. See Petitioner's Exhibit No. 4. Talwin is a Schedule IV controlled substance within the meaning of Chapter 893, Florida Statutes. Dilaudid is a Schedule II controlled substance within the meaning of Chapter 893, Florida Statutes. Paregoric is a Schedule III controlled substance within the meaning of Chapter 893, Florida Statutes. The audit which was conducted at the Scottie Drug Store revealed numerous prescriptions for the controlled substance Talwin, 50 mg., written on prescription blanks of Drs. W. W. Shell, Jr., and L. T. McCarthy, Jr., which had allegedly been signed by those physicians, when in fact the patients for whom the prescriptions were written were unknown to the physicians and the signatures of the physicians were forgeries. Those prescriptions are depicted in Petitioner's Exhibit No. 5, admitted into evidence. During the period covered by the audit, it was shown that Staats filled a number of prescriptions for various patients for the controlled substance Talwin, which had been written on prescription pads of Methodist Hospital and Baptist Medical Center in Jacksonville, Florida, and signed by individuals who are not physicians having hospital privileges at those medical centers nor practicing as physicians in the Duval County area. Copies of those prescriptions may be found as Petitioner's Exhibit No. 6, admitted into evidence. In the course of the time sequence related to the audit review process, it was discovered that Staats had refilled numerous prescriptions for controlled substances on more occasions than had been authorized by physicians, namely prescription No. 51632 was refilled twice although the physician indicated there were to be no refills; prescription No. 51579 was refilled once although the prescription indicated there should be no refills; prescription No. 51639 was refilled twice although the prescription indicated there should be no refills; prescription No. 51217 was refilled once although the prescription indicated there should be no refills; prescription No. 51238 was refilled once although the prescription indicated that there should be no refills; prescription No. 53010 was refilled once although the prescription indicated that there should be no refills; prescription No. 53597 was refilled four (4) times although the prescription indicated that it should only be refilled once; prescription No. 53537 was refilled once although the prescription indicated that it should not be refilled; and prescription No. 53592 was refilled twice although the prescription indicated that there should be no refills. Petitioner's Exhibit No. 7, admitted into evidence, is copies of prescriptions spoken to in this paragraph. Respondent Staats had operated the Scottie store under a lease arrangement during 1979 and 1980, and in January of 1981, took a position as an active pharmacist in that store. After becoming the principal operating pharmacist in the Scottie store, Staats began to receive prescriptions from doctors Shell and McCarthy for the substance Talwin and when a prescription purportedly written by those physicians was in question, Staats would call the office of the physicians for confirmation, which at times would be given over the phone and at other times an indication was made that a call back from the physician's office to Staats would be necessary. Some of the indications of physicians' prescription authority of the substances in question would be placed on a separate log and not on the back of the prescription and on other occasions, the note of the prescription information would be placed on the back of the prescription form and not in the log. Normally, this information would be reflected both in the log and on the back of the prescription. There were occasional circumstances in which the authority was not stated in either place. At approximately the same time as was covered by the audit, Staats began to ask for identification from customers who were seeking prescriptions for Talwin and noted that the demand for that substance declined with the advent of the request for identification. Staats posted a notice in the window of the pharmacy to the effect that state law imposed a fine of $5,000.00 or might cause incarceration for five (5) years for presenting forged prescriptions or conspiring or agreeing with another to have a forged prescription filled. On two (2) occasions Staats called law enforcement officials on a circumstance involving suspect prescriptions and those persons were apprehended. (Poor record keeping and mistakes in estimating the amount of losses due to a robbery and a larceny which occurred in the period covered by the audit contributed to the unaccounted for controlled substances, but those matters of record keeping and theft reports would cause only a slight differential in the disparity, as opposed to explaining the whereabouts of a substantial portion of the missing controlled substances.) Beginning on March 25, 1982, Staats began to keep a daily inventory log on the substance Talwin and a number of other controlled substances. A copy of that log may be found as Respondent's Exhibit No. 9, admitted into evidence. In addition, certain out-of-date and otherwise undesirable controlled substances, Schedules II, III and IV, have been removed from inventory and turned over to appropriate authorities for destruction.

Florida Laws (5) 120.57465.015465.023893.04893.07
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BOARD OF MEDICINE vs SAM NAJJAR, 97-003363 (1997)
Division of Administrative Hearings, Florida Filed:Jacksonville, Florida Jul. 21, 1997 Number: 97-003363 Latest Update: Dec. 14, 1998

The Issue Whether disciplinary action should be taken against Respondent's license to practice medicine based on: The allegations of the Administrative Complaint in DOAH Case No. 97-3363, pertaining to patient R.W., of violations of Sections 458.331(1)(q), Florida Statutes, [failure to appropriately prescribe in the best interest of the patient]; 458.331(1)(t), Florida Statutes, [failure to practice 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]; and Section 458.331(1)(m), Florida Statutes, [failure to keep medical records justifying the course of treatment of the patient during his care of the patient]; and The allegations of the Administrative Complaint in DOAH Case No. 97-3442, pertaining to patient N.W., of violating Section 458.331(1)(t), Florida Statutes, [failure to practice medicine with that level of care, skill, and treatment recognized by a reasonably prudent similar physician as being acceptable under similar conditions and circumstances].

Findings Of Fact Respondent is a licensed medical physician in the State of Florida and has been licensed in Florida at all times material under license number ME0041782. Respondent is Board-certified in internal medicine, and his area of specialty is pulmonary medicine. AHCA Case No. 95-5043; DOAH Case No. 97-3442; Patient R.W. On or about November 5, 1990, Patient Mr. R.W. suffered a work-related accident resulting in a very significant injury to his back, including a complete disc herniation. On November 10, 1990, orthopedic surgeon Georges El Bahri, M.D., performed major spinal surgery, including a complete laminectomy of L4, L5, disc excision of L5, S1, and exploratory surgery in the region of S1 on R.W. at Memorial Medical Center in Jacksonville, Florida. This surgery was of an emergency nature to prevent paraplegia. Prior to this surgery, R.W. was referred by Dr. El Bahri to Respondent on a pulmonary consult for surgical clearance because R.W. was suffering from chronic pulmonary disease, (CPD). R.W. experienced genitourinary dysfunction (a dysfunction of the genitalia or urinary organs) as a result of his accident, and he saw a urologist, Mohammed N. Mona, M.D., for treatment. On November 22, 1990, a second surgery was required for removal of a previously unidentified disc fragment. Dr. El Bahri recommended a spinal fusion. Evaluation by a second orthopedic surgeon indicated that R.W. had suffered a 30 percent disability of the body as a whole related to his orthopedic injuries. The second orthopedic surgeon also suggested a bone fusion. A spinal fusion operation would have exposed R.W. to a risk of loss of lower body function, and he declined the operation. Dr. El Bahri referred R.W. to Respondent to provide continuing care for R.W.'s pulmonary problem. Without surgery, R.W.'s back pain would continue to be severe and intractable. Dr. El Bahri had tried multiple alternative modalities of pain management with R.W. during the period of time that he participated in R.W.'s care, including use of a cane, weight reduction, corset, body brace, physical therapy, and a transcutaneous epidural nerve stimulator unit (TENS). Dr. El Bahri also had prescribed pain mediation for R.W. An implanted nerve stimulation device had been recommended, but R.W. declined it. Dr. El Bahri and Respondent consulted concerning efforts to control R.W.'s pain. Dr. El Bahri made Respondent aware of the various alternative pain modalities that he had tried. At some point, it was agreed between Dr. El Bahri and Respondent that where there is intractable pain requiring prescription drugs, one physician should assume primary care. Dr. El Bahri, as the orthopedic surgeon who could not get R.W. to agree to further surgery, deferred to Respondent who was treating R.W.'s chronic pulmonary problems. Dr. El Bahri and Respondent agreed that Respondent would prescribe analgesic and other medications for management of R.W.'s intractable pain. R.W.'s first office visit with Respondent was on May 3, 1991, and his last office visit was on June 16, 1993. Petitioner alleged violations by Respondent both as to level of care and the keeping of medical records because he did not perform and record a full physical for R.W. at or about the time of R.W.'s first office visit. However, Dr. Harvey, testifying on behalf of Petitioner, as well as Dr. Corral, testifying on behalf of Respondent, agreed that it would not be necessary for Respondent to repeat a complete history and physical on R.W. between the November 1990 hospital consultation and physical and the May 3, 1991, office visit. Dr. Harvey would have allowed a ten-month delay, and Dr. Corral felt no further complete physical was necessary for treatment of a chronic condition so long as there was evidence of frequent office visit evaluations. All the medical expert witnesses faulted Respondent's office records if they did not physically contain the hospital consultation sheets, and there is reason to believe that Respondent's office records did not include the consultation sheets until after R.W.'s death. Likewise, I do not find the other, later brief notes in Respondent's office records of partial examinations by Respondent or by his Physician's Assistant to constitute sufficient alternative documentation under the circumstances. See, infra. Therefore, to this degree, Respondent's records did not justify his course of treatment of R.W. R.W. presented to Respondent with multiple problems: intractable back pain secondary to his injuries, chronic obstructive pulmonary disease (CPD-COPD), a history of smoking a pack and a half of cigarettes every day for 25 years, impotency, back surgery, hyperlipidemia, and labile hypertension. "Hyperlipidemia" means high cholesterol and trigylcerides. "Labile hypertension" refers to erratic high blood pressure. At 205 pounds, R.W. also was overweight, but not "morbidly obese" for his height and age. While under Respondent's care, R.W. continued to suffer from intractable back pain secondary to his injury, anxiety, and situational depression. On April 10, 1992, while under Respondent's care, R.W. underwent a psychiatric evaluation at the University of Florida Health Sciences Center in Jacksonville, Florida. The psychiatrist, Ernest C. Miller, M.D., prepared a report dated June 9, 1992, in which he indicated that R.W. suffered adult situational disorder with chronic depression. He recommended "psychiatric contact." Respondent facilitated the workers' compensation insurance carrier's referral of R.W. to the psychiatrist for evaluation. Respondent's office records are deficient on this matter, but it appears most likely from the evidence as a whole that R.W. did not follow up on the psychiatrist's recommendation for psychiatric counseling because his workers' compensation employer-carrier declined to pay for any further psychiatric care. Although Dr. Harvey testified that Respondent should have tried to talk R.W. into psychiatric counseling, the evidence as a whole falls short of demonstrating that Respondent bore any professional responsibility to force R.W. into psychiatric care or counseling against R.W.'s will and at R.W.'s own expense. The psychiatrist recommended tricyclic anti- depressants. Respondent prescribed tricyclic anti-depressants as well as other drugs described infra. Respondent obtained consultations of specialists, including two orthopedic physicians and a neurosurgeon. Respondent also tried additional alternative modalities of pain management, including Marcaine (analgesic) trigger point injections, and topical anesthetics. Despite Petitioner's charge that Respondent's care of R.W. was substandard due to his failure to refer R.W. to a pain management specialist, I find that between Dr. El Bahri and Respondent, most acceptable pain management modalities were attempted with R.W, and Respondent's failure to refer R.W. to a pain management specialist did not fall below the professional standard of care. In making this finding of fact, I have given weighted consideration to Dr. Harvey's testimony that there was no other pain management besides drugs unless Respondent could talk R.W. into psychiatric counseling or surgery, or retrying a TENS unit, and to Dr. Corral's testimony that it was not necessary for Respondent to consult with a pain specialist because the patient had refused all invasive and some non- invasive pain management and that anything other than invasive pain management could be done for R.W. by the Respondent. During the period of time R.W. was under Respondent's care, Respondent prescribed to him analgesic medications for pain. He also prescribed anti-depressant, anti-anxiety, and muscle relaxant medications. It is with the quantity of these prescriptions, the inter-action of the drugs prescribed, and the failure to record these prescriptions in Respondent's office records for R.W. that the Petitioner finds fault. Between April 21, 1992, and July 6, 1993, Respondent wrote R.W. in excess of 30 prescriptions for pain management and depression. Dispensation of these prescriptions, including approved refills, exceeded 4,000 tablets. However, during this period of time, Respondent also recorded 11 office visits: 4/21/92, 5/15/92, 5/18/92, 5/20/92, 6/18/92, 8/21/92, 11/9/92, 2/1/93, 4/5/93, 5/4/93, and 6/16/93. Based on a "Pharmacy Profile," R.W. received the following medications prescribed by Respondent between April 21, 1992, and July 6, 1993. Drug Prescribed Dosage/Quantity Dates Filled Diazepam 10mg 50 06/16/93 Amitriptyline 50mg 30 07/24/92 50mg 30 08/11/92 50mg 30 09/23/92 50mg 30 10/20/92 50mg 30 11/20/92 50mg 30 12/16/92 100mg 30 02/01/93 100mg 30 03/03/93 100mg 30 04/02/93 100mg 30 05/03/93 150mg 30 05/07/93 100mg 30 06/02/93 100mg 30 06/25/93 Drug Prescribed Dosage/Quantity Dates Filled Lorcet Plus 100 06/18/92 100 07/15/92 100 08/11/92 90 09/11/92 90 10/07/92 90 11/09/92 90 12/07/92 90 12/31/92 90 01/29/93 100 03/01/93 100 04/02/93 100 05/03/93 100 05/07/93 100 06/07/93 100 07/06/93 Roxicet 5/325 40 04/05/93 Clorazepate 100 04/05/93 Xanax 1mg 100 04/22/92 100 05/26/92 100 07/09/92 100 08/11/92 100 10/07/92 100 11/09/92 100 12/07/92 100 12/31/92 100 01/29/93 100 03/01/93 100 04/02/93 100 05/03/93 100 06/07/93 100 07/06/93 Acetaminophen 500mg 100 09/11/92 100 10/20/92 100 11/20/92 100 12/05/92 100 02/10/93 Notriptyline 50mg 120 09/11/92 120 10/20/92 120 01/18/93 Carisoprodol 350mg 100 05/07/93 100 07/06/93 Xanax, Lorcet Plus, Amitriptyline, Clorazepate, Roxicet, Diazepam, and Carisoprodol are Central Nervous System (CNS) depressants and several, including Xanax and Diazepam (Valium), are benzodiazepines. When taken together, CNS depressants can produce additive CNS effects. Benzodiazepines are drugs which are in a class of structurally related compounds. They have sedative, anti- convulsant, and skeletal muscle relaxant properties and are used for the treatment of anxiety and other purposes. Using several benzodiazepines together can also be fatal, because the patient may develop a tolerance to the drug and ultimately consume toxic dosages. Xanax is a Schedule IV legend drug used to treat anxiety disorders. It produces additive CNS depressant effects when administered with other CNS depressants. Lorcet Plus is a Schedule III legend drug which contains Hydrocodone. It is used for treating moderate to moderately severe pain. If used with other CNS depressants, it can produce additive CNS depression. Amitriptyline is a legend drug and a trycyclic anti- depressant. It can enhance the effects of alcohol, barbiturates, and CNS depressants. It can aggravate heart conditions. Clorazepate is a Schedule IV benzodiazepine legend drug indicated for the treatment of anxiety disorders. It has a CNS effect. Clorazepate should not be administered to patients with indications of drug dependencies. Roxicet is a Schedule II legend drug which has a high potential for abuse and has a currently accepted, but severely restricted, medical use. It can produce dependency of the morphine type. Diazepam is a Schedule IV drug indicated for the treatment of anxiety disorder. It is a form of Valium and is a CNS depressant. Nortriptyline is a legend drug that is a tricyclic anti-depressant. Carisoprodol is a legend drug that is indicated as an adjunct to rest, physical therapy, and other measures for the relief of discomfort associated with acute, painful musculoskeletal conditions. It is a CNS depressant. R.W. died unexpectedly at his home on July 9, 1993. Petitioner contends that because the prescribed medications were not listed in R.W.'s chart at the material times, the prescriptions and renewals were given by Respondent without any reference to a medical record which would allow Respondent or any physician to provide R.W. with sufficient warnings or information regarding the combined use of these drugs and/or to appropriately monitor or limit R.W.'s simultaneous intake of the CNS depressants, and that, whether one concludes that R.W. died due to multiple drug toxicity or as a result of a myocardial infarction is not critical, but that Respondent's care and treatment was so careless as to create an environment in which R.W. was an "accident waiting to happen." All the testifying medical experts agreed that Respondent should have given R.W. medication overdose and interaction warnings. Respondent claims to have orally warned R.W. and R.W.'s wife concerning R.W.'s prescriptions, but it is not disputed that prior to R.W.'s death, R.W.'s chart/medical records in Respondent's office did not contain adequate notations of oral medication overdose and interaction warnings. Dr. Corral testified that not all such warnings must be recorded. It is also undisputed that prior to R.W.'s death, his chart/records in Respondent's office did not contain adequate notes on the drugs prescribed by Respondent. In his office practice, Respondent had established a system whereby requests for refills of medications previously prescribed to patients would be documented on a separate IO9 drug tally sheet or "day sheet" by Respondent's staff. Sometime during each work day, Respondent would review the list of requested refills, and approve or deny each by making a written notation on the "day sheet." Respondent's staff would then telephonically authorize the pharmacy to refill only those prescriptions that Respondent had authorized in writing. By making a written notation approving requested refills, Respondent was creating a record of drugs he prescribed. Under Respondent's system, his staff members were then supposed to transpose the refill information from the "day sheet" onto each patient's individual medical record chart. The aforementioned system for approval of requested refills and documentation thereof is an acceptable means of documenting refill information on medications for individual patient charts, but it was not followed in this instance. Vickie Browning, as receptionist and "front office" staff member, was primarily responsible for the transfer of the medication information from the day sheets to individual patient charts. Periodically, when she got backed up with telephone calls or otherwise behind in her work, Ms. Browning simply threw away piled-up day sheets without transferring the prescription information to individual patient charts. In making this finding of fact, I have noted the clear testimony of another staff member, Angie McKenzie, who saw Ms. Browning throw away a pile of prescription day sheets, but who admittedly did not advise Respondent of what was going on. I also have considered Linda Eady Turner's testimony that Ms. Turner saw a pile of day sheets in the trash can on a single occasion. I also have carefully scrutinized Ms. Browning's testimony, which by candor and demeanor, internal inconsistencies, and motivation to fabricate, I find to be unreliable and incredible. Despite R.W.'s 11 office visits during the material period of time, during each of which Respondent presumably reviewed R.W.'s chart, Respondent did not become aware that prescription refill information was not being recorded in R.W.'s chart. Likewise, Respondent did not become aware that prescription refill information was not being recorded in any patient charts until he reviewed R.W.'s medical chart after R.W.'s death. As the medical professional ultimately responsible for accuracy of medical records and treatment of his patients, Respondent should have noted the gaps on R.W.'s and other patients' charts before he did. For the same reasons, he should have known, prior to R.W.'s death, that his system was not being followed. After R.W.'s death, the Duval County Medical Examiner confiscated drugs from R.W.'s home and created a Medication Log containing the following drugs: Xanax 1 mg, 1-1/2 pills remaining; Amitriptyline 150 mg, 1 remaining; Amitriptyline 100 mg, 8 remaining; Ketoproten 75 mg, 61 remaining, Zantac 150 mg, 1 remaining; Amoxicillin 500 mg, 1 remaining; Helotestin 10 mg, 9 remaining; Lorcet Plus tablets, 88 remaining; Carisoprodol 350 mg, 54 remaining; Xanax 1 mg, 88-1/2 remaining; Carisoprodol 350 mg, 97 remaining; and Hydrocodone, 27 remaining. All of these drugs were prescribed by Respondent. Laboratory tests performed on R.W. revealed the presence of Amitriptyline, Hydrocodone, Nordiazepam (which is from Diazepam), Carisoprodol, and Xanax. Respondent was quickly embroiled in legal actions arising out of R.W.'s death. Upon discovering that prescription refill information relating to R.W. had not been recorded by his staff on R.W.'s chart, Respondent instructed members of his staff to obtain prescription information from the pharmacy, and recreate a medication list for R.W.'s chart. He further advised his staff to record any recollections they had which related to interactions of any staff members and R.W. or R.W.'s wife. Once his staff had completed the prescription information recreation, Respondent placed a note on the recreated records, identifying them as recreations and not contemporaneous notes. He also advised his attorney and the attorney representing the estate of R.W. of the recreated records. This would logically show no intent to, or conspiracy by, Respondent to fabricate or falsify patient records, but merely an intent and effort to recreate prescription information for his defense at trial. In making this finding of fact, I have again discounted Ms. Browning's testimony for the reasons previously cited. All testifying medical experts agreed that it is professionally acceptable for a medical physician to add notes as an addendum, provided the physician indicates the date of additional notes and clearly shows that they are not contemporaneous. At the request of one of R.W.'s relatives employed in the Sheriff's Office, the Assistant Medical Examiner for Duval County, Dr. Bonafacio Floro, performed an autopsy on R.W.'s corpse. He opined that the immediate cause of R.W.'s death was "multiple drug toxicity," although he noted "arteriosclerotic disease" as a secondary, or contributing, cause of death. He also speculated that one or more prescription drugs could have caused a myocardial infarction. In formulating his opinion on the proximate cause of R.W.'s death, Dr. Floro relied almost exclusively on laboratory tests performed by the Duval County Medical Examiner's Office and by an outside laboratory revealing the presence of several drugs in R.W.'s blood. The results of the drug tests performed by the Duval County Medical Examiner's Office and the outside laboratory are inconsistent, but this is largely a difference without a distinction. By either test, R.W.'s blood level of Hydrocodone would be "lethal" as established by a generally accepted medical text, and his blood level of Xanax would be "toxic" as established by the same generally accepted medical text. This medical text, however, is basically only a catalogue of drug toxicity levels in persons already dead. According to Dr. Venard Adams, however, all of the drugs in R.W.'s blood at the time of his death were at therapeutic levels, except for Hydrocodone, which was at the low end of the generally accepted lethal range, and this level might not be lethal for one who had developed a tolerance for several drugs. Dr. Adams's opinion on this score was shared by Dr. Thomas F. Hegert. Each of these physicians are also Florida Medical Examiners. Dr. Floro's conclusion that multiple drug toxicity was the proximate cause of R.W.'s death also was not shared by the other medical experts, and Dr. Floro conceded that he had no opinion on where the line is crossed between achieving therapeutic levels and toxic or lethal levels in living patients with increased medicinal tolerance. Except for Dr. Floro, all of the other medical experts testified that the Respondent's prescriptions for R.W. continued to be mostly the same types and amount of each drug from R.W.'s first visit to his last; that Respondent's prescriptions did not exceed reasonable amounts of each individual medication; that in some cases the amounts Respondent prescribed were less than the maximum amounts permissible for individual medications; and that the prescriptions, if taken as prescribed, should not have exceeded reasonable amounts for their purpose. Dr. Corral considered Respondent's use of all the drugs together to be common practice. Dr. Hegert considered the combination of drugs selected by Respondent to be appropriate within current chronic pain management therapy and effective, in that because of the combination and amounts Respondent used, Respondent would not have had to prescribe even stronger pain medications which have a greater potential for addiction than those Respondent actually used. Dr. Hegert also found no indication that the drug levels in R.W.'s blood at death, as indicated by the laboratory reports, were any different than the probable levels R.W. had experienced over a considerable period of time. Although Dr. Floro reviewed some cut sections of the deceased's heart, Dr. Floro did not clearly acknowledge evidence of an acute myocardial infarction. Cut sections of R.W.'s heart were prepared with a special stain by Dr. Hegert and microscopically viewed. These sections revealed myocardial injury, "clear evidence" of an acute myocardial infarction. Dr. Hegert concluded that R.W. died of acute myocardial infarction secondary to severe coronary artery disease. There are a few pills from R.W.'s last prescriptions which are unaccounted for, but this is insufficient under the facts of this case to assume that R.W. consumed more pills than the labels prescribed or that excessive use of a single prescription drug or several prescription drugs triggered his myocardial infarction. In light of the testimony of a borderline nature for R.W. of the Hydrocodone level and the probable therapeutic level of the other drugs, there is no clear and convincing evidence that R.W. exceeded the labeled dosage. There is certainly no clear evidence that if R.W. exceeded the labeled dosage, he did so because of Respondent's failure to warn him. Finally, there is no clear and convincing evidence that Respondent's prescription practice rendered R.W. chemically dependent on prescription drugs. AHCA Case No. 95-01594; DOAH Case No. 97-3363; Patient N.W. Mrs. N.W. had been a patient of Respondent since April 17, 1992. Approximately a year before April 6, 1994, N.W. had required hospitalization due to severe gastroenteritis. At that time, she was hospitalized for re-hydration and attendant care. Thereafter, until April 6, 1994, N.W. enjoyed reasonably good health, except that she suffered from systemic lupus and erythema. On Wednesday, April 6, 1994, N.W. presented to Respondent's office with complaints of having eaten bad ham at a picnic, nausea, vomiting, and diarrhea for several days. These were similar symptoms to those at her hospitalization the year before. Long-term nausea, vomiting, and diarrhea can cause severe dehydration. Respondent recommended that N.W. be hospitalized for re-hydration. N.W. and her husband refused, accepting instead a prescription for antibiotics. On Friday, April 8, 1994, N.W. was not improved and either she or her husband contacted Respondent's office. Respondent's office was advised that N.W. had continued to suffer from nausea, vomiting, and diarrhea since her Wednesday office visit. N.W. then accepted Respondent's recommendation, and directions were given for her to be directly admitted to Memorial Medical Center (hospital) in Jacksonville, Florida, without first being seen at Respondent's office. N.W. was admitted to the hospital at approximately 4:30 p.m. Patients suffering from dehydration can develop hypovolemia (low blood volume) and can appear very ill and develop low blood pressure (hypotension); high or low heart rate (tachycardia or bradycardia); and become cold and clammy. These symptoms are also consistent with a myocardial infarction, although high heart rate is more common than bradycardia with a myocardial infarction. Appropriate treatment of hypovolemia is re-hydration through the administration of intravenous (IV) fluids. N.W. ultimately died four days later on April 12, 1994, from congestive heart failure initiated by a myocardial infarction which had most probably occurred sometime around noon on April 8, 1994, prior to her admission to the hospital. All witnesses concur that the only period of time that is material to the charges against Respondent is approximately 4:00 p.m. April 8, 1994 to 8:00 a.m. April 9, 1994. The thrust of the Administrative Complaint is that the information of an abnormal EKG and abnormal cardiac enzymes were repeatedly relayed to Respondent by telephone and that he failed to timely take aggressive action. Sometime subsequent to April 9, 1994, the nursing progress notes covering the period of time from approximately 8:00 p.m. April 8, 1994, until approximately 7:00 a.m. April 9, 1994, were found to be missing. Subsequently, the hospital's Risk Management staff directed that the nursing notes be recreated. The recreated notes were reviewed by the Risk Management staff and the hospital attorney. They were dissatisfied with them as being too subjective. At their instruction, a second set of nursing notes was recreated. However, Risk Management and the hospital attorney ultimately included the first set of recreated notes in N.W.'s hospital chart, believing that the first set of recreated notes would be more accurate because they were closer in time to the events charted. The copy of a 7:32 p.m. April 8, 1994, electrocardiogram (EKG) report currently in the hospital chart, which indicates an acute myocardial infarction, was not the copy of the EKG interpretation that was originally placed in N.W.'s hospital chart during the period of time that N.W. was hospitalized on April 8, 1994. The EKG copy in the hospital chart is a copy that has been interpreted by a cardiologist, Benjamin C. Olive, M.D. The undersigned has had the benefit of considering both sets of recreated notes, the witnesses' testimony, and all other exhibits admitted in evidence. In making the following Findings of Fact, the undersigned has compared, considered credibility, and weighed all elements of the record. After initial evaluation by hospital nursing staff, N.W. was evaluated at approximately 7:30 p.m., by Earl Manion, Respondent's Physician's Assistant. Mr. Manion noted, among other things, that because N.W.'s abdominal pain was very high up into the sternum, cardiac involvement should be investigated. Mr. Manion gave appropriate orders for initial laboratory and radiological evaluation of N.W. A CPK test is part of a standard chemistry panel done for all admittees, but the initial tests ordered by Mr. Manion included the performance of an EKG and blood chemical studies including cardiac enzyme testing (CPK-MB). At Memorial Medical Center, as in many facilities, EKGs are initially interpreted by a computer program, which provides a printed verbal interpretation of the EKG. Hospital nurses are not expected to interpret the line configurations on EKGs. Standard procedure is for them to notify the admitting physician of the computer's printed verbal interpretation. Mr. Manion did not remain on the cardiopulmonary floor to which N.W. was initially assigned (Three South Tower) to read the results of the tests he had ordered. He anticipated that Respondent would shortly be making rounds and would see the test results for himself. He did not relay his cardiac concerns to Respondent or tell Respondent that he had ordered a CPK-MB instead of a CPK test. In fact, Respondent did not make rounds that evening, and there was no requirement that he should do so. Lay persons normally refer to a myocardial infarction as a "heart attack." Persons can suffer from a myocardial infarction and, dependent upon its severity, they may not even be aware it has occurred. A myocardial infarction may be classified as "acute," meaning "recent" or "on-going," or it may be classified as "chronic," meaning "old" or "in the past." If it is an old infarction, no immediate physician response is necessary. The first EKG performed on N.W. printed out the verbal interpretation of "consider inferior infarct, age undetermined." This result is not an acute myocardial infarction alert. This result was reported telephonically to Respondent by Donna Hughes, R.N. Nurse Hughes was the first nurse significantly involved in N.W.'s care, and was the responsible nurse between admission and midnight on April 8, 1994. The CPK-MB test results came in subsequent to Ms. Hughes' first telephone call to Respondent, so she made a second telephone call to Respondent about 10:30 p.m. on April 8, 1994. She subsequently recreated notes to the effect that she related to Respondent that N.W. showed "elevated cardiac enzymes," but in her testimony, Ms. Hughes confirmed that she recalled telling Respondent only that the "CPK" was elevated. Despite reports by N.W.'s husband that his wife's face "was turning colors," neither nurse Hughes nor Physician's Assistant Manion observed such a phenomenon. In fact, to them, N.W. denied any chest pain or chest tightness. Nurse Hughes did not believe that N.W. was having a myocardial infarction during her shift. Chemical tests can be performed on a patient's blood for various enzymes that are released into the bloodstream as a result of stress on muscle systems. Various enzymes and "bands" of enzymes reflect stress or damage to different muscle systems. A CPK is an enzyme test that may indicate damage to muscles in the body generally, or more specifically, damage to skeletal muscles. It may also reflect systems' reactions to injected anti-vomiting medications, which N.W. had received. A CPK-MB (or CK-MB) band is a more specific enzyme test that is indicative of stress or damage to the heart muscle. The CPK-MB (or CK-MB) band is appropriately referred to as a "cardiac enzyme test." The CPK is not appropriately referred to as a "cardiac enzyme test." There is no clear and convincing evidence that Nurse Hughes advised Respondent that the CPK-MB or CK-MB was elevated. It is more likely that she only correctly identified that the test was a "cardiac enzyme test" in her recreated notes. Because Respondent was aware of N.W.'s past history of gastroenteritis and that N.W. had been suffering from vomiting, including retching, and had received intra-muscular injections of anti-nausea medication, and because retching and intra-muscular injections can result in an elevated CPK, it would be reasonable for him to discount the results of a CPK, which he did during the second phone call from Nurse Hughes. He ordered an increase in the potassium IV. Jennifer Stephenson, R.N., was a graduate nurse (G.N.) performing nursing care for N.W. on Three South Tower after midnight on April 8, 1994. She involved the charge nurse and the nurse coordinator due to her G.N. status and due to her concern for N.W.'s condition. She placed a telephone call to Respondent's "service" but did not speak to him. When Respondent returned the telephone call, his call was received by Tess Bunal, R.N. He denied that any clear information about the CPK-MB or about a new EKG was given to him in this phone call. During this phone call, Respondent authorized the transfer of N.W. to the Telemetry Unit (Three Central) for closer monitoring. The Telemetry Unit is a monitored unit with heart pattern displayed at each bedside and at a monitor bank. It provides one staff nurse for every three to four patients. It is only one step down from an intensive care floor. Upon N.W.'s arrival at the Telemetry Unit, Kevin Murphy, R.N. became the nurse involved in her care. Mr. Murphy spoke with Respondent at or about 1:40 a.m. on April 9, 1994, regarding N.W.'s EKG, low blood pressure, and increased heart rate. At that time, Nurse Murphy relied on another nurse's oral report that Respondent had already been informed of the elevated heart enzymes and also had been informed of the results of an abnormal EKG. Nurse Murphy recommended that N.W. be transferred to an intensive care unit, also known as a "cardiac care unit" (CCU). However, Mr. Murphy testified that he did not advise Respondent of the result of the EKG or any specific enzyme results, because he believed Respondent already had that information. The Respondent rejected Nurse Murphy's recommendation to transfer N.W. to CCU. Instead, he gave orders to increase the IV. Nurse Murphy was uncomfortable with Respondent's response to his recommendation. He closely monitored N.W. N.W.'s vital signs did not change markedly, but she continued to complain of nausea and even some chest tightness. Nurse Murphy ordered another EKG, which showed an "acute myocardial infarction." He again spoke with Respondent by telephone at approximately 3:40 a.m. on April 9, 1994, and again requested that N.W. be transferred to the intensive care unit. He did not inform Respondent of an EKG showing "acute myocardial infarction" or that the MB band was elevated. His testimony does not clarify whether he did or did not relay to Respondent any complaint of chest tightness. However, at Nurse Murphy's insistence, Respondent ordered N.W. transferred to CCU. At no time on any of the three units (cardiopulmonary, telemetry, or cardiac care) did any nurse become sufficiently concerned about N.W.'s condition or about Respondent's responses so as to call on the hospital's "fail safe" procedures which included the opportunity to involve an on-call "intensivist." At approximately 7:00 a.m. on April 9, 1994, a new nurse, Nurse Waples, began her shift on CCU. She contacted Respondent by telephone at 7:20 a.m. and advised Respondent clearly that N.W. was complaining of chest tightness, and of the results of the latest EKG. She also clearly stated that N.W. had an elevated CK-MB. Respondent immediately gave appropriate orders for evaluation and treatment of a possible cardiac problem, including EKG, cardiac medication, oxygen, arterial blood gases, pulse oxymeter, and a cardiac consultation, and he proceeded directly to the hospital. The Respondent saw N.W. in the hospital for the first time at 7:55 a.m. on April 9, 1994. At that time, he and a cardiologist correctly diagnosed her as having had an acute myocardial infarction and going into cardiogenic shock. Respondent timely requested the participation of a cardiologist and provided appropriate orders for N.W.'s cardiac condition. He also appropriately monitored her status. Nonetheless, N.W. ultimately went into congestive heart failure. After several unsuccessful treatment attempts, she died on April 12, 1994, at 5:33 p.m. Petitioner's medical physician expert, Dr. Patel, testified that Respondent, in response to the several nurses' telephone calls concerning "elevated cardiac enzymes" and an abnormal EKG, should have either been in immediate personal attendance at N.W.'s bedside, or should have obtained a proper consultation with a cardiologist, and/or should have called on the intensivist provided by the hospital, and that Respondent's failure to take at least one of these courses of action constituted his failure to practice medicine with that level of care, skill, and treatment recognized by reasonably prudent physicians as being acceptable under similar conditions and circumstances. Respondent's experts agreed that if Respondent had received clear notification of an "acute" condition by EKG, of an elevated CPK-MB or CK-MB, or of clear symptomatology such as chest pain, these were "red flags" telling Respondent that he should aggressively address a cardiac problem. However, all experts, even Dr. Patel, concurred that if the EKG had showed only "consider inferior infarct, age undetermined," that, alone, would not be sufficient to trigger an immediate response from Respondent. Based on all he reviewed, which was not all of the evidence in this case, Dr. Patel acknowledged that if the information relayed by Nurse Waples had been given Respondent earlier he could have met the standard of care by merely requesting that the nurse call a cardiologist for a consultation or call the hospital's intensivist to see N.W. Under these circumstances, Respondent would not even have had to come into the hospital, and therefore his failure to respond could not be attributed to "laziness." Because Respondent acted knowledgeably and appropriately when clearly informed of N.W.'s condition by Nurse Waples, Dr. Patel would not attribute Respondent's lack of response to lack of knowledge or ability. Dr. Patel ultimately opined that because the first set of recreated notes showed repeated notifications to Respondent that N.W.'s blood pressure was falling while her heart rate was rising; this, with all the other information, including notification of chest tightness, should have resulted in a more aggressive response from Respondent, but he conceded that these symptoms occasionally are consistent with hypovolemia, and the undersigned notes that in testimony, only Nurse Murphy clearly testified that he notified Respondent of the disparity in blood pressure and heart rate, and did not specifically state that he mentioned chest tightness. No witness clearly suggested that Respondent had an affirmative duty to inquire whether a CPK or CPK-MB had been administered to N.W., or to inquire if a second EKG had been performed after the first one, or to personally order a subsequent EKG based on the several phone calls as related by the testifying nurses. No one testified that repeated phone calls from nursing staff by itself should have alerted Respondent to a myocardial infarction. Respondent's experts concurred that absent clear notification of an elevated CPK-MB, the information that N.W.'s EKG showed an old myocardial infarction did not require any response beyond the responses Respondent made.

Recommendation Upon the foregoing findings of fact and conclusions of law, it is RECOMMENDED that the Board of Medicine enter a Final Order that Finds Respondent not guilty of violating Section 458.331(1)(t) in DOAH Case No. 97-3363 with regard to Patient N.W. Finds Respondent not guilty of violating Sections 458.331(1)(q) and (t), in DOAH Case No. 97-3442 with regard to Patient R.W. Finds Respondent guilty of violating Section 458.331(1)(m) Florida Statutes, in DOAH Case No. 97-3442 with regard to Patient R.W., and imposes a penalty of two months suspension of license followed by probation of Respondent's license for six months upon such terms and conditions as the Board may impose to correct his record-keeping, and imposes a $1,000.00 fine. See Rule 21M-20.001(2)(m), Florida Administrative Code. DONE AND ENTERED this 18th day of August, 1998, in Tallahassee, Leon County, Florida. ELLA JANE P. DAVIS 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 18th day of August, 1998. COPIES FURNISHED: Bruce Lamb, Esquire Shear, Newman, Hahn & Rosenkranz, P.A. Post Office Box 2378 Tampa, Florida 33601 Albert Peacock, Senior Attorney Agency for Health Care Administration 2727 Mahan Drive Post Office Box 14229 Tallahassee, Florida 32317 Dr. Marm Harris, Executive Director Department of Health Board of Medicine 1940 North Monroe Street Tallahassee, Florida 32399-0792 Angela T. Hall, Agency Clerk Department of Health 1317 Winewood Boulevard Building 6 Tallahassee, Florida 32399-0700

Florida Laws (3) 120.57455.225458.331
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