STATE OF FLORIDA AGENCY FOR HEALTH CARE ADMINISTRATION AGENCY FOR HEALTH CARE ADMINISTRATION, Petitioner, vs. AHCA No: 09-01-0010 H LAWNWOOD MEDICAL CENTER, O | ~ 2) 8 q INC., d/b/a LAWNWOOD REGIONAL MEDICAL CENTER, Respondent. ADMINISTRATIVE COMPLAINT YOU ARE HEREBY NOTIFIED that after twenty one (21) days from the receipt of this complaint, the Agency for Health Care Administration (hereinafter referred to as the "Agency”) intends to impose an administrative fine in the amount of Thirty Four Thousand Nine Hundred ($34,900) dollars, upon Lawnwood Medical Center, Inc., d/b/a Lawnwood Regional Medical Center (hereinafter referred to as "Respondent"). As grounds for this administrative fine the Department alleges as follows: 1. The Agency has jurisdiction over Respondent pursuant to the provisions of Chapter 395, Part I, Florida Statutes (F.S.) and Chapter 59A-3, Florida Administrative Code (F.A.C.). 2. Respondent is licensed to operate at 1700 South 23" Street, Fort Pierce, Florida 34950-0188, as a hospital in compliance with Chapter 395, Part J, (F.S.), and Chapter 59A-3, (F.A.C.). 3. The Respondent has violated the provisions of Chapter 395, Part I, (F.S.), and the provisions of Chapter 59A-3, (F.A.C.) in that: (A) Tag H 042. During the survey conducted from 4/26-30/99 it was found that Respondent did not submit written notification of change when opened open-heart surgery program. This Rule was-not met as evidenced by: (1) The hospital applied for a service exemption on thoracic services 6/11/98. The exemption application for thoracic services listed 4 physicians who take a “minimum of 5 nights per month of ER call”. The service exemption was granted 9/25/98. At that time the hospital did not have an open-heart program. The hospital now has an active open-heart program. The hospital has not submitted written notification of this change, which would affect the conditions, which led to the granting of this exemption. 59C-1.033(5)(c), F.A.C., Open Heart Surgery Program-Service Quality states: “(c) Follow-up Care, ... There shall be at least two cardiac surgeons on the staff of . a hospital with an adult open heart surgery program, at least one of whom is board- certified and the other at least board-eligible. One of these surgeons must be on call at ail times... Backup personnel in cardiology, anesthesiology, pathology, thoracic surgery and radiology shall be on call in case of an emergency... ” This is in violation of Rule 59A-3.207(4)(f), F.A.C., carrying in this instance a $700 fine. (B) Tag H048. During the survey conducted from 4/26-30/99 it was found that the Emergency Room call listing was not available at all times. The findings are as follow: (1) The hospital had not ensured that there was a list of “on-call” critical care physicians available to the hospital at all times. Facility documentation indicated that emergency room call was not consistently covered by all required specialties. This has been an issue of no neurosurgeon available for back-up call in 10/97, thus a patient had to be transferred to another hospital. The hospital has an open- heart program and has an exemption for ER call for thoracic services. Documentation provided by the hospital indicates that these services are not covered every day of the 2 month. With the advent of the open-heart program ER call or thoracic services is required to be provided at all times by state law. This is in violation of Rule 59A-3.207(6)(c)3.4.a-c(d), F.A.C., carrying in this instance a $1,000 fine. (C) Tag H051. During the survey conducted from 4/26-30/99 it was evident that the Emergency Care did not have a method of providing for physicians on call at all times. Review of facility documents, incident reports, clinical records, the bylaws of the governing body, credentialing documentation, and interviews with staff indicate that there was not an organized and on-going hospital-wide quality assurance (QA) program. The findings include: (1) Invasive procedures resulting in mortality or morbidity were not routinely reviewed, tracked, and trended. Furthermore, the review of facility documents and interviews with facility staff confirms that serious issues that were referred to medical staff committees were not investigated timely and/or sufficiently, and lack resolution and corrective action in order to reduce risk of injury to patients. (2) . The hospital did not have a continuous and consistent process to assess data collected to determine the level and performance of existing activities and procedures; priorities for improvement, and actions to improve performance. Medical staff activities were not integrated into the hospital processes to assess data collected to determine performance improvement. (3) Medical staff activities were not routinely and systematically incorporated into the existing hospital QA processes and procedures. Lack of medical staff documentation of methods for identifying problems, monitoring activities, and clarifying results prevents a coordinated hospital-wide QA program. (4) Serious patient issues dealing with quality of care, professional technical performance, and professional standards of practice that were referred to medical staff committees were not investigated and analyzed timely and/or sufficiently and lack resolution and corrective action in order to reduce risk of injury to patients. (5) Clinical record review for patient #1 revealed the following: 82 year old patient with diagnosis of atrial fibrillation, sinoatrial node dysfunction, bradycardia syndrome with paroxysmal atrial tachycardia, and mitral valve disorder had an insertion of a “permanent pacemaker DDD” on 4/05/99. Progress note states”... with placement of the pacemaker the patient most likely had perforation of ...heart and ...developed semi-tamponade. A pericardial window was done... and a chest tube was placed in the pericardium for drainage of blood.” (6) Clinical record review for patient #2 revealed the following: 70 year old patient with diagnoses of staphylococcus aureas septicemia, multiple pressure sores with Methycillin resistant staph aureus infection and colonization, Parkinson’s disease with contractures, status post gastrostomy, probable right lower lobe pneumonia, and peripheral vascular disease involving both lower extremities had an insertion of a central venous line catheter attempted by physician on 2/02/99. The physician attempted to insert the catheter in the jugular vein and was unsuccessful, thus attempted to insert the catheter in the right subclavian vein twice and then the left subclavian vein twice. The patient began to “have a small amount of respiratory distress and I felt that more than likely what had happened is the patient had developed a pneumothorax”. The physician then “...decided to go ahead and cannulate the external jugular”. Patient had cardiopulmonary arrest. The cardiac evaluation consult done on 2/02/99 had an assessment that indicates the following: “Status post resuscitation following bilateral pneumothoraces as well as hypotension”; “Probable arteriosclerotic heart disease, with history of (?) inferior wall infarction; rule out acute myocardial infarction precipitated by hypotensive episode earlier today”; “anoxic encephalopathy complicated by seizures”. Physician progress note on 2/08/99 states that the: patient had “respiratory distress last night...” “Patient’s ET tube was also not appropriate and .. was gurgling in ..throat, so 4 respiratory therapist asked me to see patient for ET tube adjustment. When I examined the ET tube, it seems that ET tube was markedly kinked and it was markedly soft, so we decided to change tube.” Physician progress note on 2/08/99 states: “Comatose: hypoxic encephalopathy”. (7) There was no documentation of investigation analysis, or corrective action concerning these incidents by quality assurance, risk management, or any medical staff committees. (8) The medical staff had not ensured that there were written policies and procedures to ensure that there was a defined method of providing for critical care physicians to be on call at all times for the emergency room. (9). Documentation indicated that the emergency room call was not consistently covered by all required specialties. This had been an issue raised more than once, yet there had not been resolution. There was an issue of no neurosurgeon available for back-up call in 10/97, thus patient had to be transferred to another hospital. The hospital had an open-heart program and has an exemption for ER call for thoracic services. Documentation provided by the hospital indicated that these services were not covered every day of the month. With the advent of the open-heart program ER call for thoracic services was required to be provided at all times by state law. This is in violation of Rule 59A-3.207(3)(0), F.A.C., carrying in this instance a $1,000 fine. (D) Tag H107. During the survey of 4/26-30/99 it was found that the hospital did not ensure that immediately following each surgery, there was an operative report describing techniques and findings that were written or dictated and signed by the surgeon. This Rule was not met as evidenced by: During review of medical records, the “medical Records Suspension Update”, and interview with the director of the medical records department on 4/29/99 it was determined that operative reports were not being dictated and singed immediately following surgery by all surgeons. Furthermore, the 5 “Medial Staff of Lawnwood Regional Medical Center” were not in compliance with the Medical Records Department’s policies and procedures, the “Bylaws of the Medical Staff of Lawnwood Regional Medical Center, and the “Rules and Regulations of the Medical Staff 1995”. As of 4/27/99 the “Medical Records suspension Update” documents 155 operative reports as being incomplete. The findings include: (1) Review of the “Medical Records suspension Update” documented the following information: Physician #10 has a total of 76 incomplete operative reports as of 4/27/99; this physician was placed on the suspension list on 5/12/98. Physician #25 has a total of 45 incomplete operative reports as of 4/27/99; this physician was placed on the suspension list on 01/12/99. Physician #23 has a total of 14 incomplete operative reports as of 4/27/99; this physician was placed on the suspension list on 4/20/99. Physician #22 has a total of 9 incomplete operative reports as of 4/27/99, this physician was placed on the suspension list on 4/06/99. Physician #13 has a total of 4 incomplete operative reports as of 4/27/99; this physician was placed on the suspension list on 4/20/99. Physician #18 has a total of 3 incomplete operative reports as of 4/27/99; this physician was placed on the suspension list on 9/16/97. Physician #15 has a total of 2 incomplete operative reports as of 4/27/99; this physician was placed on the suspension list on 6/16/98. Physician #20 has a total of 2 incomplete operative reports as of 4/27/99; this physician was placed on the suspension list on 01/12/99. (2) Three out of eight clinical records indicated incomplete operative reports. Patient #3’2 clinical record had 2 unsigned operative reports; this patient was admitted on 3/31/99 and discharged on 4/15/99. Patient #6 had 3 admissions and discharges (3 clinical records); the clinical record from the admission of 2/28/98 with a discharge date o 3/10/99 had an unsigned operative report. The clinical record from the admission of 4/01/99 with a discharge date of 4/15/99 had an unsigned operative report. eee oe (3) = Review of the facility’s medical records policies and procedures indicates that the medical staff (the physicians) was not in compliance with the policies and procedures regarding timeliness of completion of medical records. “Policy No. HIM.REQ.101 SUBJECT: Required Contents of Medical Records” under “Procedure” documents the responsibilities of clinical staff to be to: (a) “Ensure that all required elements were entered when documenting in the medical record or when patient specific date was entered into each module”. . (b) “Documentation in the medical record should be accurate, timely and complete.” “Policy No. OPERINVA. P&P SUBJECT: Medical Records Requirements for Operative/invasive procedures” under “Responsibility: Medical Staff:4.” States that medical staff shall “Dictate all operative reports immediately after the operation or procedure,” Under “Procedure” the following was stated: “1. Surgeon or practitioner performing the procedure dictates the operative report after the procedure... 4. Operative reports are monitored for timely dictation each day. a. Any practitioner not dictating their operative report for the procedure, within the Medical Staff adopted criteria, will be subject for suspension of procedure privileges...” “Policy No. HIM.COM.400 SUBJECT: Timeliness on Completion of Medical Records” has a stated objective that states the following: “The objective of this internal policy/procedures is to ensure timely processing of the medical record to facilitate record completion by all physicians, so they may meet the timeliness set forth by their Medical Staff Rules and Regulations and to conform to JCAHO’s and Regulatory Agencies’ standards on completion of medical records,” The “policy” states that “all records are to be completed within 21 days of date of discharge. All operative reports, when applicable, are to be dictated and signed immediately after surgery.” 7 “Policy No: HIM.COM401 SUBJECT: completion of Medical Record after Discharge” purpose states: “1, All medical records will be timely, accurate and complete as per hospital’s Medical Staff Bylaws and Rules and Regulations. 2. Medical staff should complete medical records as soon as possible after discharge so that information can promptly be retrieved for clinical, legal and " performance improvement purposes.” The policy states that “a medical record is defined as delinquent when it has not been completed within 14 days after discharge of the patient.” The responsibility of the medical staff is listed as the following: a. “Complete all records within the time frame outlined in the Medical Staff Bylaws and Rules and Regulations. b. Dictate all H & P’s within 24 hours of admission. c. Dictate all Discharge Summaries within 21 days of discharge.” The procedure states the following: 1. “Medical Staff dictates all required reports in the time frames outlined in the Medical Staff Bylaws and Rules and Regulations. 2. All required documentation and authentication is completed... 4. Physician(s) are granted 21 days to complete their medical record. 5. Physician(s) not completing records within this time frame will be given a final notice of 7 days to complete their medical records. Failure to do so will result in suspension of their admitting surgical and consulting privileges.” “POLICY NO: HIM.REQ.107 SUBJECT: Documentation Elements of the Medical Record” states the following under “policy”: “F, Operative Reports document:... 3. Dictated by the surgeon immediately following the procedure”... 4) “Medical Staff of Lawnwood Regional Medical Center” were not abiding by their own bylaws and rules and regulations concerning the completion of medical records. “Article V-Part G: Medical Records Committee Section 2. Duties” states that “The committee shall review and evaluate medical records to determined that - such records: ... (b) are sufficiently complete at all times so as to facilitate continuity of care communicating among all those providing patient care services in the hospital... (€) are timely in their completion.” “Section 3. Meetings, Reports and Recommendations” states the following: ..(b) The committee shall report to the Medical Executive Committee for its consideration and appropriate action, infractions of hospital medical staff bylaws or rules with regard to the completeness, clinical pertinence and timeliness of completion of patients’ medical records. (c) The committee shall act upon recommendations from the Medical Executive Committee, the departments and any other committees responsible for patient care evaluation and other quality review evaluation and monitoring functions.” The “Rules and Regulations of the Medical Staff 1995 Section III. Medical Records” states the following: EL Operative reports shall include a detailed account of the findings at survey; tissue removed or altered, as well as the details of the surgical technique. Operative report and/or a brief operative note shall be written (or dictated) immediately following survey for outpatients as well as inpatients and the report promptly signed by the surgeon and made a part of the patient’s current medical record... H. Alt clinical entries in the patient’s medical record must be eligible, complete and must be authenticated and dated promptly by the person (identified by name and discipline) who is responsible for ordering, providing, or evaluating the service furnished. (i) The author of each entry must be identified and must authenticate his or her entry... (N) _ As per staff bylaws ALL PATIENTS AT TIME OF DISCHARGE SHOULD HAVE: Provisional Diagnosis. Final diagnosis (recorded in full without the use of symbols Nr or abbreviations) History. Physical Progress notes. Consultation (if any) Operative report (if any) and reports of all studies that have NAN Y been done. 8. Signed written and verbal orders. Charts lacking these items are delinquent within seven days from _ the time the record is available to the physician...Charts of hospital admission must be completed by 14” day following discharge...Failure to have charts completed as stated . above will result in suspension of admission privileges. A physician who is placed on the delinquent list for two consecutive MEC meetings, will lose all elective privileges until records are up to date.” (2D) On the survey conducted on 3/22/00 it was found that the physicians were not completing operative reports in a timely way and the findings were as follows: (1) Documentation in the.Medical Staff bylaws Medical Records II, “operative reports shall include a detailed account of the findings of surgery, tissue 10 removed or altered as well as details of surgical technique. Operative reports or a brief operative reports note shall be written (or dictated) immediately after surgery: (2) For the month of 12/99, four surgeons were delinquent and had not completed the operative report in 24 hours. For the month of 1/2000, 15 surgeons had not completed their operative reports in 24 hours. For the month of 3/2000, 13 surgeons had not completed their operative reports. (3D) On the survey of 8/09/00 it was determined that the hospital and the Department of Surgery did not ensure that the operative reports describing techniques and findings was written or dictated and signed by the surgeon immediately following surgery. The findings were: (1) Review of 19 medical records revealed 5 of 19 operative reports were not dictated the same day as the surgery. Clinical record #4 surgery 3/31/00 operative report dictated 4/03/00; Clinical record #5 surgery 7/25/00 operative report dictated 7/26/00; Clinical record #8 surgery 6/08/00 no operative report; Clinical record #12 surgery 4/05/00 operative report dictated 4/07/00, Clinical record #13 surgery 6/28/00 operative report dictated 6/30/00. (2) Operative reports completed in 24 hours is a monitor the hospital tracks. This tracking was reviewed by the surveyor. For the month of April 2000 there were 798 surgical procedures performed, 41 operative reports were not completed in 24 hours; For the month of May 2000 there were 792 surgical procedures performed, 60 operative reports were not completed in 24 hours. For the month of June 2000 there were 683 surgical procedures performed, 47 operative reports not completed in 24 hours; For 11 the month of July 2000 there were 578 surgical procedures and 21 operative reports were not completed in 24 hours. (3) The surveyor reviewed the hospital plan of correction/procedures for disciplinary action for physicians who did not complete medical records operative reports according to most stringent requirement, immediately after surgery. Appendix C part of hospital plan of correction documents medical staff bylaws ARTICLE VIT PART E: OTHER ACTIONS CONCERNING PERSONS HOLDING APPOINTMENTS TO MEDICAL STAFF; Section 1 Failure to Complete Medical Records. This section of the medical staff bylaws documents that physicians with delinquent medical records will be suspended. Disciplinary actions such as suspension of privileges are reportable to the Agency for Health Care Administration Division of Managed Care and Health Quality, Bureau of Consumer Protection Quality Health Care Investigative Services in accordance with Florida Statute 458.337. The hospital could provide no documentation that this was done. This is in violation of Rule 59A-3.2085(3)(0), F.A.C., carrying in this instance a $2,500 fine. (E) Tag 0188. On the survey conducted on 4/26-30/99 that medical records were not being completed by physicians in a timely and accurate manner. Furthermore, the “Medical Staff or Lawnwood Regional Medical Center” were not in compliance with the Medical Records Department’s policies and procedures, the “Bylaws of the Medical Staff of Lawnwood Regional Medical Center”, and the “Rules and Regulations of the Medical Staff 1995”. As of 4/27/99 the “Medical Records Suspension . Update” documented the following as a being incomplete: 2,234 total charts, 519 history 12 pe tees on ogee cree eRe Se EE ne a oe tee & physicals, 155 operative reports, 856 discharge summaries, 387 consultations, and 533 signatures. The findings include: (1) .- Review of the “Medical Records Suspension Update” documented the following information: a) Physician #15 had a total of 352 incomplete charts as of 4/27/99. This included 155 history and physicals, 2 operative reports, 35 discharge summaries, 70 consultations, and 106 signatures. This physician was placed on the suspension list on 6/16/98. b) Physician #26 had a total of 267 incomplete charts as of 4/27/99. This included 15 history and physicals, 174 discharge summaries, 24 consultations, and 64 signatures. This physician was placed on the suspension list on 3/24/98. c) Physician #25 had a total of 252 incomplete charts as of 4/27/99. This included 110 history and physicals, 45 operative reports, 36 discharge summaries, and 75 consultations. This physician was placed on the suspension list on 01/12/99. d) Physician #3 had a total of 195 incomplete charts as of 4/27/99. This included 40 history and physicals, 102 discharge summaries, 7 consultations, and 72 signatures. This physician was placed on the suspension list on 5/26/98. e) Physician #5 had a total of 188 incomplete charts as of 4/27/99. This included 33 history and physicals, 72 discharge summaries, 5 consultations, 101 signatures. This physician was placed on the suspension list on 12/23/97. 13 eee a rs f) Physician #10 had a total of 162 incomplete charts as of 4/27/99. This included 25 history and physicals, 76 operative reports, 24 discharge summaries, 63 consultations, and 22 signatures. This physician was placed on the suspension list on 5/12/98. g) Physician #29 had a total of 143 incomplete charts as of 4/27/99. This included 48 history and physicals, 102 discharge summaries, and 9 consultations. This physician was placed on the suspension list on 4/07/98. h) Physician #18 had a total of 110 incomplete charts as of 4/27/99. This included 12 history and physicals, 3 operative reports, 51 discharge summaries, and 49 consultations. This physician was placed on the suspension list on 9/16/97. i) Physician #24 had a total of 62 incomplete charts as of 42/7/99. This included 1 history and physical, 20 discharge summaries, 5 consultations, and 37 signatures. This physician was placed on the suspension list on 10/13/98. j Physician #20 had a total of 56 incomplete charts as of 4/27/99. This included 4 history and physicals, 2 operative reports, 6 discharge summaries, 23 ‘consultations, and 22 signatures. This physician was placed on the suspension list on 01/12/99. k) Physician #27 had a total of 51 incomplete charts as of 4/27/99. This included 23 history and physicals, 47 discharge summaries, and 2 consultations. This physician was placed on the suspension list on 9/22/98. 14 perenne ) Physician #19 had a total of 46 incomplete charts as of 4/27/99. This included 2 history and physicals, 25 discharge summaries, 1 consultation, and 19 signatures. This physician was placed on the suspension list on 4/13/99. m) Physician #8 bad a total of 44 incomplete charts as of 4/27/99. This included 6 history and physicals, 33 discharge summaries, and 10 consultations. This physician was placed on the suspension list on 8/11/98. n) Physician #23 had a total of 42 incomplete charts as of 4/27/99. This included 4 history and physicals, 14 operative reports, 7 discharge summaries; 16 consultations, and 6 signatures. This physician was placed on the suspension list on 4/20/99. 0) Physician #6 had a total of 41 incomplete charts as of 4/27/99. This included 5 history and physicals and 40 discharge summaries. This physician was placed on the suspension list on 11/24/98. p) Physician #28 had a total of 39 incomplete charts as of 4/27/99. This included 39 signatures. This physician was placed on the suspension list on 4/13/99. oy) Physician #9 had a total of 34 incomplete charts as of 4/27/99. This included 17 ‘history ‘and physicals, 23 discharge summaries, and 6 : consultations. This physician was placed on the suspension list on 4/21/98. r) Physician #22 had a total of 27 incomplete charts as of 4/27/99. This included 9 operative reports, 15 discharge stimmaries, and 3 consultations. This physician was placed on the suspension list on 4/06/99, 15 eee gene nrer- s) Physician #2 had a total of 19 incomplete charts as of 4/27/99. This included 4 history and physicals, 4 discharge summaries, and 11 signatures. This physician was placed on the suspension list on 02/09/99. t) Physician #13 had a total of 19 incomplete charts as of 4/27/99, This included 4 operative reports, 3 discharge summaries, 4 consultations, and 8 signatures. This physician was placed on the suspension list on 4/20/99. u) Physician #1 had a total of 16 incomplete charts as of 4/27/99. This included 12 discharge summaries and 4 consultations. This physician was placed on the suspension list on 11/17/98. v) Physician #7 had a total of 16 incomplete charts as of 4/27/99. This included 2 history and physicals, 4 discharge summaries, 4 consultations, and 8 signatures. This physician was placed on the suspension list on 3/09/99. w) Physician #21 had a total of 14 incomplete charts as of 4/27/99. This included 9 history and physicals and 8 discharge summaries. x) Physician #4 had a total of 8 incomplete charts as of 4/27/99. This included 1 history and physical, 5 discharge summaries, and 3 consultations. This physician was placed on the suspension list on 02/23/99. ees y) Physician #12 had a total of 8 incomplete charts as of 4/27/99, This included 1 history and physical, 1 discharge summary, and 6 signatures. . : 2) Physician #11 had a total of 7 incomplete charts as of 4/27199. This included 2 history and physicals, 1 discharge summary, 2 consultations, and 3 signatures. This physician was placed on the suspension list on 8/11/98. 16 cecemeeeg peer 0 weeeppr oe a ee aa) Physician #17 had a total of 7 incomplete charts as of 4/27/99. This included 2 discharge summaries, 1 consultation and 4 signatures. This physician was placed on the suspension list on 7/14/98. bb) Physician #14 had a total of 5 incomplete charts as of 4/27/99. This included 3 discharge summaries and 2 signatures. This physician was placed on the suspension list on 420/99. cc) Physician #16 had a total of 4 incomplete charts as of 4/27/99. This included 1 consultation and 3 signatures. This physician was placed on the suspension list on 3/23/99. (2) Review of 8 clinical records indicated the following: a) Patient #1’s clinical ‘record had 2 unsigned verbal orders dated 01/13/ 99 (treatment) and 01/28/99 (medication), 1 unsigned telephone order (for pt. To be NPO and for a surgical consent) dated Ol 17/99, and 1 unsigned dictated consultation report from 01/20/99. bd) Patient #2’s clinical record was incomplete due to a history and physical that was not dictated; dictation of two consultations by 2 physicians had not been done; signatures needed on physician orders; signature needed on progress notes; signature validation needed; signature on the necessity order and dictation of a discharge summary needed. This patient was admitted on 3/18/98 and discharge on 4/29/98. c) Patient #3’s clinical record was incomplete due to unsigned routine MI orders that were given per telephone; multiple unsigned telephone orders for medications and treatments; multiple unsigned verbal orders for medications and treatments; 2 unsigned consulations; “2 uisigned “operative ‘reports, and ‘unsigned verification regarding patient’s s diagnoses a and procedures. This patient was admitted on 3/31/99 and discharge ¢ on 4/15/99. 17 d) Patient #4 ‘ plete due to unsigned a inpatient coding query; unsigned — ification regarding patient's s diagnoses cand ~~ procedures; unsigned telephone orders vunsigned verbal order; and unsigned progress note. : See e) Patient incomplete due to. unsigned verification regarding pati mt’s diagnoses and _ Procedures and ‘unsigned telephone orders regarding medications 2 I 01/16/99 and the discharge date was 01/25/ f) Patient He : records). The clinical record from 3/10/99 was incomplete due to needit physician orders; unsigned consultatio cardiology reports by 2 physicians; and|an n uD from the admission of 3/10/99 with a needing signature validation of L consultations needing updating and sig the admission of 4/01/99 with a disché physicians. This is in violation of rule 5 $2,000 fine. : (F) .Tag0190. Based o: Suspension Update”, interview with the direc 4/29/99, review of the Medical Reco ds Department’s po po les sand procedures, it was determined that medical records were not being completed by physicians in order that the hospital is able to maintain a current and complete medical record for every patient receiving care and services. Furthermore, the “Medical Staff of Lawnwood Regional Medical Center” were not in compliance with the Medical Records Department’s policies and procedures, the Bylaws of the Medical Staff of Lawnwood Regional Medical Center, and the “Rules and Regulations of the Medical Staff 1995”. The findings included but were not limited to the following: a) As of 4/27/99 the “Medical Records Suspension Update” documented the following as being incomplete: 2,234 total charts, 519 history & physicals, 155 operative reports, 856 discharge summaries, 387 consultations, and 533 signatures. b) Medical records were not being authenticated and dated promptly by the person who was responsible for ordering the services furnished. Telephone and verbal orders were not being signed by physicians within 24 hours as stated in the hospital’s policies and procedures. c) History and physicals were not being completed by physicians within the required 24 hours of admission or 7 days prior to admission. As of 4/27/99 per the “Medical records Suspension Update” there were 519 history and physicals, which were incomplete. d) Consultations were not being completed by physicians timely in order to facilitate continuity of care communications among all staff providing patient care services in the hospital. As of 4/27/99 per the “Medical Records Suspension Update” there were 387 consultations, which were incomplete. e) Discharge summaries were not being dictated and signed by physicians within 21 days of the date of discharge as required by the facility’s policies and procedures. As of 4/27/99 per the “Medical Records Suspension Update” there were 856 discharge summaries, which were incomplete. 19 f) Operative reports were not being written or dictated and signed immediately following surgery by the surgeon as required by the hospital’s policies and procedures. As of 4/27/99 per the “Medical Records Suspension Update” there were 155 incomplete operative reports. g) Medical records were not being completed by physicians within 30 days following discharge of patients. As of 4/27/99 per the “Medical Records Suspension Update” there were 2,234 incomplete patient charts. h) The facility’s medical staff was not in compliance with policies and procedures regarding: Authentication of medical records; timeliness of completion of medical records; initiation and maintenance of medical records; required contents of medical records; medical records requirements for operative/invasive procedures; completion of medical record after discharge; availability of history and physical prior to surgery; and documentation elements of the medical record. i) The “Medical Staff of Lawnwood Regional Medical Center” was not abiding by their own bylaws and rules and regulations concerning the timeliness, accuracy, completion, and clinical pertinence of medical records. jp Facility documents indicated that the medical staff committees had not given serious consideration and action in regard to the repeated problem of physicians not abiding by the hospital’s policies and procedures, and the “Medical Staff of Lawnwood Regional Medical Center” bylaws and rules and regulations relating to medical records. There had been no action taken by the involved committees or the medical staff to amend the bylaws and the rules and regulations in order to provide impetus for the medical staff to improve their practice. k) Review of the facility documents indicated that physicians had been allowed to resign from the medical staff of the hospital with incomplete medical records pending. 20 (2F) On the survey of 3/22/200 it was determined that the medical staff was not following the medical staff bylaws. The findings were as follows: a) Delinquent charts were missing physical exams, discharge summaries, consents and signatures. On 3/13/00, 158 charts were delinquent as evidenced by missing signatures, histories and physicals. (GF) On 8/09/00, after reviewing 19 clinical records for patients discharged in April, May and June 2000; the records for Patients #4, #7, #9, #10, #13, #16, #18 did not contain discharge summaries or the discharge summary was dictated later than 21 days. a) The surveyor reviewed the hospital plan of correction/procedure for disciplinary action for physicians who did not complete medical records including discharge summaries, according to most stringent requirement. This section of the medical staff bylaws dotumented that physicians with delinquent medical records will be suspended. Disciplinary actions such as suspension of privileges were reportable to the Agency for Health Care Administration Division of Managed Care and Health Quality, Bureau of Consumer Protection Quality Health Care Investigative Services in accordance with Florida Statutes 458.337. The hospital could provide no documentation that this was done. . (4F) On the survey of 11/03/00 it was determined that based on review of 12 clinical records this deficiency remained uncorrected as five of 12 patients discharged had discharge summaries that were delinquent. The findings included: ) a) Five of twelve clinical records reviewed did not contain discharge ‘summaries completed in the 21 days required by the medical bylaws. Medical records were asked to confirm there were no discharge summaries for the following patients: Record #4 patient discharged 10/04/00 no discharge summary was dictated or available. Record #5 patient discharged 9/29/00 no discharge summary available or dictated. Record #9 patient discharged 9/08/00 no discharge summary dictated or available. Record #10 patient discharged 9/27/00 no discharge summary dictated or available. 21 Record #2 patient discharged 8/15/00 the discharge summary was completed 9/23/00 not within 21 days. - (SF) On the survey of 12/18/00 and based on review of 9 clinical records, this deficiency remained uncorrected, 4 of 9 discharged records had discharge summaries that were delinquent. The findings were: a) Four of nine closed clinical records reviewed did not contain discharge summaries completed in the 21 day required by the medical staff bylaws. Discharge summaries were not completed 41 to 45 days after discharge for the four records not in compliance. This is in violation of rule 59A-3.214(3), F.A.C., carrying in this instance a $5,000 fine. (G) Tag0i%. As of 4/27/99 the “Medical Records Suspension Update” documented 155 operative reports as being incomplete. (1) Review of the “Medical Records Suspension Update” documented the following information a) Physician #10 had a total of 76 incomplete operative reports as of 4/27/99. This physician was placed on the suspension list on 5/12/98. b) Physician #13 had a total of 4 incomplete operative reports as of 4/27/99. This physician was placed on the suspension list on 4/20/99. c) Physician #15 had a total of 2 incomplete operative reports as of 4/27/99. This physician was placed on the suspension list on 6/16/98. d) Physician #18 had a total of 3 incomplete operative reports as of 4/27/99. This physician was placed on the suspension list on 9/16/97. e) Physician #20 had a total of 2 incomplete operative reports as of 4/27/99. This physician was placed on the suspension list on 01/12/99. f) Physician #22 had a total of 9 incomplete operative reports as of 4/27/99. This physician was placed on the suspension list on 4/06/99. 22 g) Physician #23 had a total of 14 incomplete operative reports as of 4/27/99. This physician was placed on the suspension list on 4/20/99. h) Physician #25 had a total of 45 incomplete operative reports as of 4/27/99. This physician was placed on the suspension list on 01/12/99. (2) 3 out of a sample of 8 clinical records indicated incomplete operative reports. a) Patient #3” clinical record had 2 unsigned operative reports. This patient was admitted on 3/31/99 and discharged on 4/15/99. b) Patient #6 had 3 admissions and discharges (3 clinical records). The clinical report from the admission of 2/28/99 with a discharge date of 3/10/99 had an unsigned operative report. The clinical record from the admission of 4/01/99 with a dischargé date of 4/15/99 had an unsigned operative report. (3) Based on the review of 5 post-operative clinical records, it was determined that 4 of the 5 records were incomplete for operative reports. 2 of the 5 records did not contain an operative report, and 2 of the 5 records did not have a signed operative report. (4) Review of the facility’s medical record’s policies and procedures indicates that the medical staff (the physicians) was not in compliance with the policies and procedures regarding timeliness of completion of medical records. This is in violation of rule 59A-3.214(4)(b), F.A.C., carrying in this instance a $700 fine. (H) Tag H0204. The governing body had not ensured that there was an effective hospital-wide quality assurance program that evaluated patient care. Review of facility documents, incident reports, clinical records, interviews with staff, the bylaws of the medical staff, the bylaws of the governing body, and recredentialing documentation indicate the following: 23 (1) Serious pathology issues involving misdiagnosis which have a direct effect on the quality of patient care were bounced between medical staff committees in excess of 2 months after the governing body requested peer review. At the time of survey conducted on 4/26-30/99 it was found to be an ongoing issue. (2) Interview with staff and documentation review indicated that adverse incidents related to patient #1 and #2, which were quality assurance issues, were not investigated, analyzed, nor was corrective action implemented by quality assurance, risk management, or any medical staff committees. (3) Mortality/morbidity review was not part of an overall assessment function that incorporated medical staff with other hospital committees into a unified quality improvement initiative. (4) Lack of medical staff documentation of methods for identifying problems, monitoring activities, and clarifying results prevents a coordinated hospital- wide QA program. (5) Invasive procedures resulting in mortality or morbidity were not routinely reviewed, tracked, and trended. Furthermore, the review of the facility documents and interviews with facility staff confirmed that serious issues that were referred to medical staff committees were not investigated timely and/or sufficiently, and lack resolution and corrective action in order to reduce risk of injury to patients. (6) Serious issues dealing with quality of care, professional technical performance, and professional standards of practice that were referred to medical staff “committees were not ‘investigated timely and/or sufficiently and lack resolution and corrective action in order to reduce risk of injury to patients. (7) The hospital did not have a continuous and consistent process to assess data collected to determine the level and performance of existing activities and procedures; priorities for improvement; and actions to improve performance. Medical 24 | | ; :: staff activities were not integrated into the hospital processes to assess data collected to determine performance improvement. (8) Medical staff activities were not routinely and systematically incorporated into the existing hospital QA processes and procedures. a) Facility documents repeatedly indicate that quality assurance and the governing body have been stymied by members of the medical staff in their attempts to address this issue of non-compliance with the hospital’s policies and procedures, the bylaws and rules and regulations of the medical staff, the bylaws of the governing body, and quality improvement initiatives. b) Review of facility documents indicate that the “Bylaws of the Medical Staff Lawnwood Regional Medical Center” were not being followed concerning recredentialihg. c) Facility documents reveal that the recredentialing committee were not reviewing medical staff by the criteria established under “Article VIl.-Part A: procedure for Continued Appointment, Section 3. ” Members of the bylaws and other enumerated criteria were approved with barely a cursory review. d) Review of facility documents indicate that the Credential Comminute, the Recredentialing Committee, and the Medical Executive Committee had been in violation of the “Bylaws of the Medical Staff of Lawnwood Regional Medical Center” and the “Rules and Regulations of the Medical Staff 1995” regarding recredentialing and initial credentialing. There was no uniformity in the initial credentialing process. There was no documented evidence that steps haven taken to review, revise and prevent recurrence of deficient credentialing practice. e) Facility docurnented that administration has cited the committees with inconsistencies in credentialing. 25 (9) Facility documents indicated that the Recrendentialing Committee and the Medical Executive Committee had recredentialed physicians who have been on the “Medical Records Suspension Update” repeatedly. Examples include the following. a) Physician #5 was re-credentialed on 01/21/99 and this physician had been on the suspension list since at least 12/23/97. Documentation indicates that this physician had been out of compliance with medical records issues for approximately 2 years. This physician was re-credentialed in spite of this evidence on 01/28/99. b) Physician #25 was reappointed to active staff on 01/21/99. This physician was on the “Medical Records Suspension Update” dated 01/26/99. This physician had 229 incomplete medical records as of that date, which consisted of the following delinquent itéms: 53 history and physicals, 38 operative reports, 22 discharge summaries, 45 consultations, and 82 signatures. On 2/18/99 this physician was granted additional privileges in Interventional Cardiology. (10) Incident reports were not consistently completed with all of the required information, which enables tracking, and trending of information for quality improvement activities. (2H) On the revisit of 3/22/00 and based on interview with administration and staff, and review (of the facility do documentation, the governing body did not ensure that the quality ¢ assurance program was enforced ‘and. risk management received “adequate oversight by a licensed Risk Manager. There also were existing and ongoing issues in the department of: surgery concerning pathology. The findings include: men) _ The pathology department is part of the department of surgery. The hospital has an internal quality assurance program in place to address serious issues involving misdiagnosis in pathology. This plan was reviewed by the state agency during the January revisit. The pathology director has existing and ongoing problem of only half 26 of the professional staff cooperating with the quality assurance plan for pathology. This was a continuous problem that had not been resolved. (2) Records of patient #8 were reviewed. The patient had a lung biopsy 3/99, which was diagnosed as benign. The same biopsy was reviewed in October 1999 and diagnosed as malignant. The hospital administration, through an external review at the Mayo clinic, had the biopsy confirmed as malignant 11/99. The patient had treatment delayed from March 1999 to October 1999. The patient lived only 4 months _ after the cancer diagnosis. This patient was referred to risk management via incident report for review on 01/27/00. The risk management department secretary signed the incident report 2/14/00; the risk manager had not signed the report. This case was first referred to the Cancer Tumor Board 11/99, then to the Tissue Committee for review. This case was referred tb surgical audit on 3/06/00 when the committee met; this was not reviewed as of date of survey, 3/22/00, and this case had never been reviewed. (3) Quality assurance and risk management were not tracking and trending pathology discrepancies as indicators of quality of care for the Performance Improvement tracking for department of surgery. (4) _ The risk management reviews of incidents were being done by an RN designee. Record 9, reviewed by surveyors, was a death that occurred in the cardiac path laboratory in March. The RN designee had not reported this on a 24 hour report or filed a Code 15 report. This was reported after surveyor review. This is in violation of rule 59A-3.216(1)(a), carrying in this instance a $2,000 fine. re) Tag H205. No effective hospital wide QA program to identify and establish issues for improvement. Review of facility documents, incidents reports, clinical records, the bylaws of the medical staff, the bylaws of the governing body, credentialing documentation, and interviews with staff indicated that there was not an organized and on-going hospital-side quality assurance (QA) program that consistently identifies and establishes issues for improvement. The findings include: 27 (1) Invasive procedures resulting in mortality or morbidity were not routinely reviewed, tracked, and trended. Furthermore, the review of facility documents and interviews with facility staff confirms that serious issues that were referred to medical staff committees were not investigated timely and/or sufficiently, and lack resolution and corrective action in order to reduce risk of injury to patients. (2) The hospital did not have a continuous and consistent process to assess data collected to determine the level and performance of existing activities and procedures; priorities for improvement; and actions to improve performance. Medical staff activities were not integrated into hospital processes to assess date collected to determined performance improvement. (3) Medical staff activities were not routinely and systematically incorporated into the existing hospital QA processes and procedures. Lack of medical staff documentation of methods for identifying problems, monitoring activities and clarifying problems, monitoring activities and clarifying results prevents a coordinated hospital-wide QA program. (4) — Serious issues dealing with quality of care, professional technical performance, and professional technical performance, and professional standards of practice that were referred to medical staff committees were not investigated and analyzed timely and/or sufficiently and lack resolution and corrective action in order to reduce risk of injury to patients. (5) Clinical record review for patient #1 revealed the following: a) 82 year old patient with diagnosis of atrial fibrillation, sinoatrial dysfunction, bradycardia syndrome with paroxysmal atrial tachycardia, and mitral valve disorder had an insertion of a “permanent pacemaker DDD” on 4/05/99. Progress note states ...” with placement of the pacemaker, the patient most likely had perforation of ...heart and ...developed semi-taponade. A pericardial window was done...and a chest tube was placed in the pericardium for drainage of blood.” 28 7 SeEre “Ter (6) Clinical record review for patient #2 revealed the following: a) 70 year old patient with diagnosis of staphylococcus aureas, septicemia, multiple pressure sores with methicillin resistant staph aureas infection and colonization, Parkinson’s disease with contractures, status post gastrostomy, probable right lower lobe pneumonia, and peripheral vascular disease involving both lower extremities had an insertion of a central venous line catheter attempted by physician on 2/02/99. The physician attempted to insert the catheter in the jugular vein and was unsuccessful, thus attempted to insert the catheter in the right subclavian vein twice and then the left subclavian vein twice. The patient began to “have a small amount of respiratory distress and | felt that more than likely what had happened was the patient had developed a pneumothorax.” The physician then “...decided to go ahead and cannulate the external cardiac evafuation consult done on 2/02/99 has an assessment that indicated the following: “Status post resuscitation following pneumothoraces as well as hypotension”; “Probably arteriosclerosis heart disease, with history of (?) inferior wall infarction; rule out acute myocardial infarction precipitated by hypotensive episode earlier today”; “anoxic encephalophathy complicated by seizures.” b) Physician progress note on 2/08/99 stated that the patient had “Respiratory distress last night...”.Patient’s ET tube was also not appropriate and... was gurgling in...throat, so respiratory therapist asked me to see patient for ET tube adjustment. When I examined the ET tube, it seems that ET tube was markedly kinked and it was markedly soft, so we decided to change tube.” Physician progress note on 2/08/99 stated: “Comatose: hypoxic encephalopathy.” c) There was no documentation of investigation, analysis or corrective action concerning these incidents by quality assurance, risk management or any medical staff committees. (7) Review of facility documentation and interview of medical staff indicated that there was no evidence of regular and consistent contact with the Medical 29 Examiner’s office consider if autopsies were warranted in unexpected and unusual deaths, deaths with implications of medical-legal consequence, and death reviews that would yield educational benefits. (21) _ During the survey of 3/22/00 it was determined that the Department of Surgery did not have an effective quality assurance system in place for pathology. The findings include: (a) There were existing and ongoing problems in the Department of Surgery concerning Pathology. ‘Lack of cooperation of half the professional staff. Professional issues of competency involving misdiagnosis. This is in violation of Rule 59A-3.216(2)(a-h), F.A.C., carrying in this instance a $2,000 fine. cet av (J) Tag H0206. Based on review of facility documents and interview with staff it was determined that the hospital did not have a continuous and consistent process F t i i to assess data collected to determine the level and performance of existing activities and procedures; priorities for improvement; and actions to improve performance. Findings include: (1) Medical staff activities were not integrated into hospital process to assess data collected to determine performance improvement. (2) adverse incidents related to patient #1 and #2, ‘which were quality 2 assurance issues, were Interview with Staff and documentation Teview, indicated that ~ not ‘investigated, analyzed, nor was corrective action implemented by quality ; assurance, risk management, or any medical staff committees. ; “@) Mortality/morbidity review was not part of an overall assessment function that incorporated medical staff with other hospital committees into a unified quality i improvement initiative. 30 SE Ee Pap aeegrne ompener reper (4) Lack of medical staff documentation of methods for identifying problems, monitoring activities, and clarifying results prevents a coordinated hospital- wide QA program. (5) ‘Invasive procedures resulting in mortality or morbidity were not routinely reviewed, tracked, and trended. Furthermore, the review of facility documents and interviews with facility staff confirmed that serious issues that were referred to medical staff committees were not investigated timely and/or sufficiently, and lacked resolution and corrective action in order to reduce risk of injury to patients. (6) Serious patient issues dealing with quality of care, professional technical performance, and professional standards of practice that were referred to medical staff committees were not investigated timely and/or sufficiently and lacked resolution and correctivé action in order to reduce risk of injury to patients. (7) The “Bylaws of the Medical Staff of Lawnwood Regional Medical Center”, the “Rules and Regulations of the Medical Staff 1995” and policies and procedures regarding medical records were not being followed as evidenced by the “Medical Records Suspension Update” dated 4/27/99, which documented the following as being incomplete: 2,234 total charts, 519 history & physicals, 155 operative reports, : 856 discharge summaries, 387 consultations, and 533 signatures. (8) "Facility documents repeatedly indicate that quality a assurance and - the governing body ade been stymied by members of the medical staff in their attempts to address this issue of non-compliance with the hospital’s policies and procedures, the bylaws and rules and regulations of the medical staff, the bylaws of the governing body, and quality improvement initiatives. (9) Review of the facility documents indicate that the “Bylaws of the Medical Staff of Lawnwood Regional Medical Center” were not being followed concerning recredentialing. Facility documents revealed that the recredentialing committee were not reviewing medical staff by criteria established under “Article VII- , 31 Part A: Procedure for Continued Appointment, Section 3.” ” Members of the medical staff who were been in violation of the bylaws and other enumerated criteria were approved with barely a cursory review. (10) Review of the facility documents indicate that the Credentials Committee, the Recredentialing Committee, and the Medical Executive Committee had been in violation of the “Bylaws of the Medical Staff of Lawnwood Regional Medical Center” and the “Rules and Regulations of the Medical Staff 1995” regarding re- credentialing and initial credentialing process. There was no documented evidence that step had been taken to review, revise and prevent recurrence of deficient credentialing practices. The findings include: (1) ‘Facility documents indicated that the Recredentialing Committee and the Medical Executive Committee had re-credentialing physicians who had been on the “Medical Records Suspension Update” repeatedly. Examples included the following (a) Physician #5 was re-credentialed on 01/21/99 and this physician had been on the suspension list since at least 12/23/97. Documentation indicated that this physician had been out of compliance with medical records issues for approximately 2 years. This physician was re-credentialed in spite of this evidence on 01/28/99. . vee (>) _ Physician #25 was reappointed to active staff on 01/21/99. a. This physician was on the “Medical Records Suspension Update” dated 0126/99. This physician had 229 incomplete medical records as of that date, which consisted of the following delinquent items: 53 history and physicals, 38 operative reports, 22 discharge summaries, 45 consultations, and 82 signatures. On 02/18/99 this physician was granted additional privileges in Interventional Cardiology. . (2) : Incident reports were not consistently completed with all of the required information, which enables tracking, and trending of information for quality improvement activities. 32 og. yp eerie see (2J) On the survey of 3/22/00 and based on interview and review of performance improvement and Risk Management tracking and trending, and also review of the Quality Assurance and the Department of Surgery tracking and trending, the level __ of performance in the pathology department could not be determined. (1) Risk Management designee did not have adequate oversight by the licensed Risk Management on site who was also the chief Nursing Officer at the time of the survey. There was also a consultant This is in violation of Rule 59A-3.216(3), F.A.C., carrying in this instance a $2,000 fine. (K) Tag 0207. The medical staff activities were not incorporated into existing hospital Quality Assurance. This was determined on the survey of 4/30/99 and based on the review of the facility documents and interviews with staff. The findings include: (1) — Mortality/morbidity review was not part of an overall assessment function that incorporated medical staff with other hospital committees into a unified ' quality improvement initiative. (2) Lack of medical staff documentation of methods for identifying problems, monitoring activities, and clarifying results prevented a coordinated hospital- wide QA program. (3) Invasive procedures resulting in mortality or morbidity were not routinely reviewed, tracked, and trended. Furthermore, the review of facility documents and interview with facility staff confirms that serious issues that were referred to medical staff committees: were not investigated timely and/or sufficiently, and lack resolution and corrective action in order to reduce risk of injury to patients. (4) Serious i issues dealing with quality of care, professional technical performance, and professional standards of practice that were referred to medical staff committees were not investigated timely and/or sufficiently and lack resolution and corrective action in order to reduce risk of injury to patients. 33 (5) Medical and surgical issues dealing with patient diagnosis and treatment involving professional technical performance and acceptable professional standards of practice were not consistently evaluated by medical staff committees for quality improvement. (2K) During the survey of 3/22/00 it was determined that based on ongoing issues in Pathology tat there was not being trended and tracked. The findings were as follows: (1) - No trending and tracking was being done by Risk Management and Quality Assurance regarding accuracy of pathology department reports. The pathology department did not have an effective quality assurance plan based on the non-cooperation of half the professional staff. This is in violation of Rule 59A-3.216(4), F.A.C., carrying in this instance a $2,000 fine. . (L) Tag 0208. The hospital did not have an effective governing body, which was legally responsible for hospital operation. This was evidenced by the following on the survey conducted on 4/20/99: (1) Serious pathology issues involving misdiagnosis, which had a direct effect on the quality of patient care, were bounced between the Medical Executive Committee and the Surgical Review Committee in excess of 12 months after the governing body requested peer review. At the time of survey this was found to be an ongoing issued (2) Review of facility documents showed that the governing body had been made impotent by the medical staff. The medical staff prevented (blocked) the governing body from taking appropriate action when necessary on issues affecting: the quality of patient care and the health, safety, and welfare of patients; the coordination of patient care; the financial viability of the hospital; standards of professional practice; 34 patient safety and risk management activities; hospital quality assurance; and professional ethics. (3) Review of facility documents dated 1998 indicated that the governing body had addressed the problem of medical records not being completed. The governing body directed physicians to resolve the problem of physicians being able to schedule procedures even though they were suspended. Review of 1999 facility documents indicated. that incomplete medical records continues to be an ongoing problem and that physicians continued to be able to schedule procedures even though they were suspended. Physicians were also recredentialed in spite of documented evidence that they were not in compliance with the bylaws regarding medical records. The governing body and the medical staff had not abided by their respective bylaws concerning these issues. (4) The governing body was charged with responsibility to act in the best interest of the hospital and the community if the decision had not negative impact on the quality of patient care. The governing body recommended changing the residency requirement for medical staff from the Saint Lucie County boundary to a 20 mile radius. The governing body determined that with the advent of the open-heart unit that it was wise to be able to ensure regional coverage and this issue also had economic implications for the hospital. The Medical Executive Committee (MEC) refused to abide by the governing body’s decision to change the medical staff residency requirements. The MEC failed to abide to document any reason that this change would be detrimental to patient (5) Documentation indicated that the emergency room call was not consistently covered by all required specialties. This has been an issued raised more than once, yet there had not been resolution. There was an issue of no neurosurgeon available for back-up call in 10/97, thus the patient had to be transferred to another hospital. The hospital had an open-heart program and had an exemption for ER call for thoracic services. Documentation provided by the hospital indicated that these services were not 35 covered every day of the month. With the advent of the open heart program ER call for thoracic services is required to be provided at all times by state law. (6) Review of facility documents indicated that the Credentialing Committee approved appointment of a Registered Nurse as an Allied Health Professional. The candidate filed out an application from for an Advanced Registered Nurse Practitioner, however is a R.N. The definition of an Allied Health Professional in the bylaws of the medical staff is “any individual who is permitted by law and who is also permitted by the hospital to provide patient care and serves without direction or supervision, within the scope of his license...”. The hospital had no existent R.N. privilege list. The application process was improper and it was unclear as to why a R.N. needed to be credentialed to perform the same duties as staff R.N.’s. (7) Review of facility documents and interview with key personnel indicated that the Credentialing Committee approved the appointment of a morgue assistant who had had no position description for a morgue assistant and had been working at the hospital examining placentas since the 1980’s (8) Review of facility documents indicated that there was no formal medical staff mortality and morbidity review process. (9) Interview with physicians during the days of the survey and review of facility documents disclosed that there was impermissible handling of absentee ballots for the election of officers of the medical staff and for election of membership for the various medical staff committees. (10) Review of facility documents indicated that the Medical Executive Committee had no formal ongoing peer review process. (2L) On the survey of 3/22/00 it was found the same deficiency. The governing body was not ensuring quality of care for patients in the hospital. Based on the foregoing issues of Quality Assurance and Risk Management not trending and tracking issues of accuracy of pathology reports. The findings were as follows: 36 i fl 1 i ' i 1 Ri etek (1) There continued to be no effective quality assurance program in the department of surgery for pathology (2) Risk Management designee did not have adequate oversight and supervision. This is in violation of Rule 59A-3.217(1), F.A.C., carrying in this instance a $2,000 fine. (M) Tag 0211. On the survey conducted on 4/30/99 it was determined that governing body had not ensured that standards and procedures were consistently applied during the credentialing and re-credentialing processes. Review of facility documents indicated that the Recredentialing Committee and the Medical Executive Committee had been in violation of the “Bylaws of the Medical Staff of Lawnwood Regional Medical Center” and the “Rules and Regulations of the Medical Staff 1995” regarding recredentialing and initial credentialing. There was no documented evidence that steps have been taken to review, revise and prevent recurrence of deficient credentialing practice. The findings include: ; (1) Facility documents indicated that administration had cited the committee with inconsistencies in credentialing. (2) Facility documents indicated that the Recredentialing Committee had recredentialed physicians who have been on the “Medical records Suspension Update” repeatedly. Examples included the following: (a) Physician #5 was recredentialed on 01/21/99 and this physician had been on the suspension list since at least 12/23/97. Documentation indicated that this physician had been out of compliance with medical records policies and procedures for approximately 2 years, 108 medical records were incomplete as of 01/26/99. This physician was recredentialed in spite of this evidence on 01/28/99. (b) Physician #25 was reappointed to active staff on 01/21/99. This physician was on the “Medical Records Suspension Update” dated 01/26/99. This 37 ee eee ewe pe oor physician had 229 incomplete medical records as of that date, which consisted of the following delinquent items; 53 history and physical, 38 operative reports, 22 discharge summaries, 45 consultations, and 82 signatures. On 2/18/99 this physician was granted additional privileges in Interventional Cardiology. (2M) On the survey of 3/22/00 it was found this was a repeated deficiency based on review of credential files of physicians for re-appointments and initial appointments, the governing body and committee were not ensuring that standards were being consistently applied. The findings included: (a) The re-credentialing committee credentialed a radiologist for mammography privileges in March who did not meet the Federal Mammography Quality Standards credential standard. In February, the re-credentialing committee had denied this privilege based on lack of documentation. (b) There were four new physicians with locum tenets privileges awaiting initial privileges. The medical staff bylaws had no provision for a charge or locum tenets privileges but these new physicians were charged a fee. These new physicians were not reviewed for initial credentialing in February or March. (c) Three physicians were waiting for their -re-credentialing whish was not completed in February or March. This is in violation of Rule 59A-3.217(4), F.A.C., carrying in this instance a $2,000 fine. . () | . ‘Tag 0 0214. On the survey of 4/30/99 it was determined that the Board of Trustees had been in violation of the “: Lawnwood Regional Medical Center Bylaws of Board of Trustees”, and the Credentials Committee, the Recredentialing Committee had been in violation of the “Bylaws of the Medical Staff of Lawnwood Regional Medical Center” and the “Rules and Regulations of the Medical Staff 1995” regarding recredentialing and initial credentialing. There was no documented evidence that steps 38 SG of patient care, standards of ocessional ractic had been taken to review, revise and prevent recurrence of deficient credentialing practices. The findings included: (1) Facility documents indicate that administration had cited the committees with inconsistencies in credentialing. (2) Facility documents indicated that the Recredentialing Committee and the Medical Executive Committee had recredentialed physicians who had been on the “Medical Records Suspension Update” repeatedly. Examples included: (a) Physician #5 was recredentialed on 01/21/99 and this physician had been on the suspension list since at least 12/23/97. Documentation indicated that this physician had been out of compliance with medical records policies and procedures for approximately 2 years, 108 medical records were incomplete as of 01/26/99. This physician ¥ was recredentialed i in spite ‘of this evidence on 01/28/99. (b) "Physician #25 was reappointed to active staff on 01/21/99. This physician was on the “Medical Records Suspension Update” dated 01/26/99. This physician had 229 incomplete medical records as of that date, which consisted of the following delinquent items; 53 history and physical, 38 operative reports, 22 discharge summaries, 45 consultations, and 82 signatures. On 2/l 8/99 this physician was granted additional privileges in Interventional Cardiology. (3) Review of facility documents, clinical records, policies and procedures identified issues in the following areas: completion of medical records, quality the medical staff functioning as an “integral Part of the hospital, and the ‘Bylaws of the Medical Staff of Lawnwood Regional Medical. center” > and t the “Rules and Regulations o of the Medical Staff 1995” >” provided no of the medical staff on »probiem issues. (4) Required CME’s had n not t been part of the recredentialing process. This is in violation of Rule 59A-3.217(4)(e-h), F.A.C., carrying in this instance a $1,000 fine. (O) Tag 0220. Clear lines of responsibility and accountability were not delineated as evidenced by facility documents, non-compliance with policies and procedures and bylaws, incomplete medical records, lack of timely completion of medical records, deficient credentialing practices (both, initial credentialing and re-credentialing), and an internal risk management that did not meet the requirements of the Management and Administration Department. The Chief Executive Officer (CEO) of the hospital had not ‘developed effective lines of communication between the governing body, administration, the medical staff, and various departments of the hospital. This had lead to ineffective intemal controls and coordination of services to the inpatient hospital population. The finding’s included: (1) | Facility documents and interviews with medical staff and administration indicated that there had been serious inconsistencies in credentialing. (2) Facility documents indicated that the Recredentialing Committee and the Medical Executive Committee had recredentialed physicians who had been on the “Medical Records Suspension Update” repeatedly. Examples included the following: te ee @ Physician #5 was tecredentialed on 01/21/99 and this physician had been on the suspension list since at least 12/23/97. Documentation indicated that this physician had been out of compliance with medical records policies and procedures for approximately 2 years, 108 medical records were incomplete as of 01/26/99. This physician was recredentialed in spite of this evidence on 01/28/99. 6) ; “Physician #25 was reappointed to active staff on 01/21/99. . pension Update” dated 01/2698. This physician had 229 incomplete medical records as of that date, which consisted of the following delinquent items: 53 history and physical, 38 operative reports, 22 discharge 40 as T summaries, 45 consultations, and 82 signatures. On 2/18/99 this physician was granted: additional privileges in Interventional Cardiology. This is in violation of Rule 59A-3.218(2)a-b, F.A.C., carrying in this instance a $2,000 fine. (P) Tag 0229. Organized Medical Staff. On the survey of 4/30/99 it was determined, during review of facility documents indicated that the medical staff had not been accountable to the governing body regarding the quality of care provided to patients. _ Facility documents demonstrated that the medical staff repeatedly refused to deal with issues related to the quality of patient care, compliance with state and federal laws, and medical professional practice issues. Facility documents indicated that the governing body had repeatedly brought up issues related to patient quality of care to the medical staff and that nothing effective, productive, and/or constructive was accomplished by the medical staff regarding the quality of care provided to patients. The medical staff was not operating as an integral part of the hospital in order to affect positive change in order to improve quality of patient care and to provide for the health, safety, and welfare of the patients provided at this facility. Members of the medical staff were not complying with the followings bylaws, rules and regulations. (2P) During the survey of 3/22/00 and based on review of minutes of meetings of the organized ‘medical staff, and interviews with hospital staff was not demonstrating accountability to the bylaws to the patients of the hospital. The findings include: cok (1) credentialing | and e-credentialing process was not consistent. New physicians were recharged for Jocum tenets privileges when there was no Provision in the bylaws for this. The surgical department continues to have ongoing issues with nonparticipation of some professional staff. There was still delinquency in completing medical records documentation according. to the bylaws, Appropriate committees did not review serious pathology i issues brought to the attention of risk management in January, 4b cal which involved patient care, at the time of the survey. The medical staff continues to demonstrate lack of participation in quality/performance improvement process. This is in violation of Rule 59A-3. 2200), F.A.C. carrying in this instance a $3,000 fine. (Q) Tag 0230. On the survey of 4/30/99 it was determined that the medical at staff had not ensured that current bylaws were being followed and/or enforced. The medical staff had not adopted new bylaws when necessary to ensure that provisions of the bylaws would be followed and could be effectively enforced in order that the medical staff accomplishes its responsibilities. The findings include: . . (1). The “Bylaws of the Medical Staff of Lawnwood Regional Medical Center” and the “Rules and Regulations of the Medical Staff 1995” Tegarding medical records were not being followed as evidenced by the “Medical Records Suspension 7 Update” dated 4/2719 which documented the following as being incomplete” 2,234 total ae a charts, 519 history & Physicals, 155 operative reports, 856 discharge summaries, 387 consultations, and 533 signatures. (2) Review of facility ¢ documents indicated that the “Bylaws of the Medical Staff of Lawnwood Regional “Medical Center” were not being ‘followed / concerning recredentialing.. Facility documents revealed that. the recredentialing goes ee oan mt ¢ was not reviewing medical staff iby t the criteria established d under Atticle Vile with barely a cursory review. G6) Committee, the Recredentialing Cor been i ; Center” and the “Rules and Regulations of ‘the Medical Staff 1995” ‘Fegarding Te- Review. of ‘eclty documents ‘indicated that ‘the “Credentials Bylaws f the Medical staff of Lawnwood Regional Medical _ ittee, and the Medical Executive Committee had . There was not uniformity in the initial _ credentialing process. There was no documented evidence that steps have been taken to review, revise and prevent recurrence of deficient credentialing practices. Facility documents indicated that the Recredentialing Committee and the Medical executive Committee had-recredentialed physicians who had been on the “Medical Records Suspension Update” repeatedly. Examples included the following: (a) Physician #5 was recredentialed on 01/21/99 and this physician had been on the suspension list since at least 12/23/97. Documentation indicated that this physician had been out of compliance with medical records policies and procedures for approximately 2 years, 108 medical records were incomplete as of 01/26/99. This physician was recredentialed in spite of this evidence on 01/28/99. (b) Physician #25 was reappointed to active staff on 01/21/99. This physician was on the “Medical Records Suspension Update” dated 01/26/99. This physician had 229 incomplete medical records as of that date, which consisted of the “following delinquent items; 53 “history and ‘physical, 38 operative reports, 22 discharge summaries, 45 consultations, and 82 signatures. On 2/18/99 this physician was granted additional privileges in Interventional Cardiology. my (4) Review. of facility documents, clinical records, policies and procedures identified issues in the following areas: completion of medical records, quality of patient care, standards of professional practice, the medical staff functioning as an integral part of the hospital, and quality assurance. Timeframes for initial credentialing varied widely and Tequirements for ‘materials submitted varied from individual to individual. * ». (5) Interview with Physicians during the days of the survey and review of facility documents disclosed that there was impermissible handling of absentee for ballots for the election of officers of the medical staff and for election of >F membership for the various medical staff committees. eg (6) Review of facility documents indicated that there was non- compliance with the by-laws requirement requiring of all invasive procedures resulting in mortality or serious morbidity. (7) Review of facility documents revealed that the Medical Executive Committee minutes were approved without the presence of a quorum. (8) Review of facility documents indicated that the Medical executive Committee had no formal ongoing peer review process. (9) Review of facility documents indicated that the Credentialing Committee approved appointment of a Registered Nurse as an Allied Health Professional, The candidate filled out an application form for an Advanced Registered Nurse practitioner, however, is a R.N. The definition of an Allied health Professional in the bylaws of the medical Staff is “any individual who is permitted by law and who is also Bo permitted by the hospital to provide patient care and serves without direction or supervision, within the scope of this license...” The hospital has no existent R.N. privilege list. _The application process was improper to be credentialed to perform the same duties as staff R.N.’s. 7 (10) — Review of facility documents and interview with key personnel indicated that the Credentialing Committee approved the appointment of a morgue en no position description for a morgue assistant since the 1980’s assistant. There had b n of Rule 59A-3.220(2), F.A.C., carrying in this instance a $2,000 fine. . @Q - Tag 0283. Peer Review. Documentation reviewed demonstrated that no- meaningful peer review was taking g place at the facility. Findings were as follows: Om “Review ‘of facility documents indicated that ‘trends: had been identified « concerning procedures and practitioners yet there was no indication of investigation, analysis, and corrective action i in a order to promote reduction ‘inpatient morbidity a and mortality, and to improve patient care. (2) There was no documented evidence that peer review procedures had been reviewed annually by the governing board. The “Lawnwood Regional Medical Center Bylaws of Board of Trustees” did not address the governing board reviewing peer review procedures annually. This is in violation of Section 395.0193(2), F.S., carrying in this instance a $2,000 fine. 4. The Respondent has violated the provisions 395.018(2)(a), (FS), in that the Respondent has violated the minimum standards, rules and regulations promulgated by the Department under Chapter 395, Part I, (F.S.) 5. The above referenced violations constitute grounds to levy this administrative fine pursuant to Section 395.1041(5), (F.S.), in that the above-referenced conduct of _ Respondent constitutes 4 a violation of the minimum standards rules and regulations for the - operation of a hospital. 6. Respondent i is s notified that it has a right to request an administrative hearing 7 pursuant-to Section 120.569, (F.S.); to be represented by counsel (at its expense); to take testimony, to call and cross-examine witnesses, to have subpoenas and/or subpoenas duces tecum issued, and to present written evidence or argument if it requests a hearing. In order to obtain a for 1 proceedii 1g, your request for an administrative hearing must conform to ‘the requirements in Rule 28-106.201, , AC.), and must state which issues of "material fact you dispute. Failure’to dispute material issues of fact in your request for a hearing may be treated by the Agency as an election by you of an informal proceeding under Section 120.57(2), (F.S.) ELECTION AND EXPLANATION OF RIGHTS FORMS ATTACHED 7. RESPONDENT Is FURTHER NOTIFIED THAT FAILURE TO REQUEST A HEARING WITHIN TWENTY ONE (21) DAYS FROM THE RECEIPT OF THIS 45 COMPLAINT WILL RESULT IN AN ADMISSION OF THE FACTS ALLEGED IN THE COMPLAINT AND THE ENTRY OF A FINAL ORDER BY THE AGENCY. I HEREBY CERTIFY that a true and correct copy of the foregoing has been furnished by U.S. Certified Mail, Return Receipt Requested to Mr. Thomas Pentz, Administrator, Lawnwood Regional Medical Center, 1700 S. 23 Street, Fort Pierce, Florida 34950-0188 (#7000 0520 0016 7234 4674), Lawnwood Medical Center, Inc., One Park Plaza, Nashville, TN 37203 (#7000 0520 0016 7234 4667), and to The Prentice-Hall Corporation System, Inc., 1201 Hays Street, Suite 105, Tallahassee, Florida 32301 (#7000 0520 0016 7234 4650) on 14. {4 » 2001. , PATRICIA FEENEY, Field Office Manger _ Agency for Health Care Administration 1710 East Tiffany Drive, Suite 100 West Palm Beach, Florida 33407 Copy sent to: Alba M. Rodriguez, Assistant General Counsel Agency for Health Care Administration 8355 N.W. 53rd Street Miami, Florida 33166 Hospital Program Office - Agency for Health Care Administration 2727 Mahan Drive _ Tallahassee, Florida 32308 Gloria Collins Finance and Accounting Agency for Health Care Administration 2727 Mahan Drive Tallahassee, Florida 32308 46

Docket for Case No: 01-002784