AUDIT TRAILS: HELPFUL OR HARMFUL? An Analysis of the Law and Impact of Hospital Metadata

Transcription

1 AUDIT TRAILS: HELPFUL OR HARMFUL? An Analysis of the Law and Impact of Hospital Metadata Eric F. Ochotorena, Esq RISSMAN, BARRETT, HURT, DONAHUE, McLAIN & MANGAN, P.A.

2 DEFINITIONS AUDIT TRAIL Business record of all transactions and activities, including access, associated with the EMR *Not meant to show proof of appropriate care or quality of care Organizational policies may define - commonly seen in health information management (i.e. security and monitoring) policies METADATA Set of data that describes and gives information about other data

3 care received BY care provided TO

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6 JOHN SMITH as Personal Representative of the ESTATE of SARA SMITH v. SOUTH FLORIDA GENERAL HOSPITAL and KELLY SHEPPARD, M.D.

7 Sara Smith _

8 Dr. Kelly Sheppard _

9 Nurse Sam Morgan _

10 Respiratory Therapist Jordan Michaels _

11 _

12 301 Room _

13 _

14 3 attempts to intubate before successful _

15 _

16 DEFENSE TIMELINE MEDICAL RECORDS DEPOSITION TESTIMONY _

17 MEDICAL RECORDS DEPOSITION TESTIMONY

18 MEDICAL RECORDS DEPOSITION TESTIMONY

19 MEDICAL RECORDS DEPOSITION TESTIMONY

20 MEDICAL RECORDS DEPOSITION TESTIMONY _

21 MEDICAL RECORDS DEPOSITION TESTIMONY

22 MEDICAL RECORDS DEPOSITION TESTIMONY

23 Which created problems. before the audit trail

24 angry

25 CONFLICTS _

26 MedSERVE South Florida General Hospital Date Range: 08/10/2014 to 08/10/2014 Emergency Department ER Events Grouped by Physician Group By: STAFF Position: PHYSICIAN Name: SHEPPARD, KELLY Events: ALL Event Event Description Event Date Workstation Visit Date Logon Logon 8/10/ :07 AM EFO1231 STAFF ASSIGNMENT Sheppard, Kelly, Patient: 8/10/ :08 AM EFO1231 8/10/ :45 AM Wayne, Bruce. Chart Entry Made Sheppard, Kelly is attending 8/10/ :08 AM EFO1231 8/10/ :45 AM physician. Patient: Wayne, Bruce Chart Entry Made Patient visited by Sheppard, 8/10/ :09 AM EFO1231 8/10/ :45 AM Kelly. Patient: Wayne, Bruce Chart Entry Made Patient presents to ER with 8/10/ :10 AM EFO1231 8/10/ :45 AM psychosis, auditory hallucinations, visual hallucinations. Patient: Wayne, Bruce Chart Entry Made Request Psych eval. Positive 8/10/ :10 AM EFO1231 8/10/ :45 AM for anxiety, auditory hallucinations, visual hallucinations. Patient: Wayne, Bruce STAFF ASSIGNMENT Sheppard, Kelly. Patient: 8/10/ :12 AM MRW7911 8/10/ :55 AM Queen, Oliver.

27 Caduceus South Florida General Hospital Date Range: 08/10/2014 to 08/10/2014 In-Patient In-Patient Events Grouped by Nurse Event Event Description Event Date Workstation Logon Logon 8/10/ :59 AM BRS3987 Chart Entry Made RN Morgan, Sam. Patient: 8/10/ :59 AM BRS3987 Smith, Sara, Room 301 Chart Entry Made Patient pushes call button for 8/10/ :03 AM BRS3987 nurse, complains of shortness of breath and severe nausea. Patient: Smith, Sara Chart Entry Made O2 SATs 93% on monitor. 8/10/ :05 AM BRS3987 Patient: Smith, Sara Chart Entry Made Pink, frothy secretions noted 8/10/ :06 AM BRS3987 at patient s mouth. Patient: Smith, Sara Chart Entry Made Patient in respiratory arrest, 8/10/ :07 AM BRS3987 O2 SATs 87% on monitor. Patient: Smith, Sara Chart Entry Made Code team call placed. Patient: 8/10/ :08 AM BRS3987 Smith, Sara Group By: STAFF Position: REGISTERED NURSE Name: MORGAN, SAM Chart Entry Made RT Jordan Michaels at bedside 8/10/ :12 AM BRS3987 in response to code. Patient: Smith, Sara

28 Caduceus South Florida General Hospital Date Range: 08/10/2014 to 08/10/2014 In-Patient Group By: STAFF Position: PHYSICIAN Name: SHEPPARD, KELLY In-Patient Events Grouped by Physician Event Event Description Event Date Workstation Logon Logon 8/10/ :24 AM BRS3987 Chart Entry Made Sheppard, Kelly. Patient: 8/10/ :25 AM BRS3987 Smith, Sara Chart Entry Made Patient in respiratory distress, 8/10/ :25 AM BRS3987 Code called by RN Sam Morgan, Code team at bedside including myself and RT Jordan Michael Chart Entry Made Patient Evaluation: C-section 8/10/ :25 AM BRS3987 delivery of baby boy yesterday by Dr. Douglas Ross, no complications during surgery according to bedside RN Morgan, Patient now complains SOB and nausea, RN Morgan reports patient had pink frothy secretions at mouth immediately prior to Code call Chart Entry Made Patient place on 2 Ipm Nasal 8/10/ :26 AM BRS3987 Cannula, pain 0/10 Chart Entry Made Order: Phenergan 25 ccs IV, 8/10/ :27 AM BRS3987 reason: Patient nausea

29 ROOM 301 ROOM 325 BRS3987 DJB3979

30 Conflict Conflict Conflict _

31 MedSERVE South Florida General Hospital Date Range: 08/10/2014 to 08/10/2014 Emergency Department ER Events Grouped by Physician Group By: STAFF Position: PHYSICIAN Name: SHEPPARD, KELLY Events: ALL Event Event Description Event Date Workstation Visit Date Chart Entry Made Sheppard, Kelly is attending 8/10/ :13 AM MRW7911 8/10/ :55 AM physician. Patient: Queen, Oliver Chart Entry Made Patient visited by Sheppard, 8/10/ :14 AM MRW7911 8/10/ :55 AM Kelly. Patient: Queen, Oliver Chart Entry Made Patient present to ER with 8/10/ :14 AM MRW7911 8/10/ :55 AM puncture wound, shot with arrow. Patient: Queen, Oliver Chart Entry Made Order: Tetanus shot, bandage. 8/10/ :15 AM MRW7911 8/10/ :55 AM Patient: Queen, Oliver STAFF ASSIGNMENT Sheppard, Kelly. Patient: 8/10/ :16 AM CAW0424 8/10/ :58 AM Monroe, Ororo Chart Entry Made Sheppard, Kelly is attending 8/10/ :17 AM CAW0424 8/10/ :58 AM physician. Patient: Monroe, Ororo Chart Entry Made Patient visited by Sheppard, 8/10/ :18 AM CAW0424 8/10/ :58 AM Kelly. Patient: Monroe, Ororo

32 Conflict Conflict _

33 ROOM 301 5:20 AM: Dr. Sheppard makes decision that patient should be sent to ICU 5:18 AM 5:22 AM: Dr. Sheppard treating another patient (Monroe, Ororo) in the ER and is entering orders at workstations located only in the ER [Dr. Sheppard MedSERVE Audit Trail]

34 Conflict Conflict _

35 MedSERVE South Florida General Hospital Date Range: 08/10/2014 to 08/10/2014 Emergency Department ER Events Grouped by Physician Group By: STAFF Position: PHYSICIAN Name: SHEPPARD, KELLY Events: ALL Event Event Description Event Date Workstation Visit Date Chart Entry Made Patient presents to ER after 8/10/ :19 AM CAW0424 8/10/ :58 AM being struck by lightning. Patient: Monroe, Ororo Chart Entry Made Order: Cardiology consult, EKG, 8/10/ :22 AM CAW0424 8/10/ :58 AM Echocardiogram. Patient: Monroe, Ororo STAFF ASSIGNMENT Sheppard, Kelly. Patient: Kent, 8/10/ :35 AM EFO1231 8/10/ :25 AM Clark Chart Entry Made Patient visited by Sheppard, 8/10/ :38 AM EFO1231 8/10/ :25 AM Kelly. Patient: Kent, Clark

36 Caduceus South Florida General Hospital Date Range: 08/10/2014 to 08/10/2014 In-Patient In-Patient Events Grouped by Nurse Group By: STAFF Position: REGISTERED NURSE Name: MORGAN, SAM Event Event Description Event Date Workstation Chart Entry Made Dr. Sheppard at bedside in 8/10/ :24 AM BRS3987 response to code. Patient: Smith, Sara Chart Entry Made Dr. Sheppard placed orders for 8/10/ :26 AM BRS3987 patient to be put on nasal cannula and IV Phenergan for nausea. Dr. Sheppard requests transfer of patient from the floor to ICU. Patient: Smith, Sara Logon Logon 8/10/ :28 AM DJB3979 Chart Entry Made RN Morgan, Sam. Patient: 8/10/ :32 AM DJB3979 Snyder, Erika, Room: 325 Chart Entry Made Patient Requests pain meds 8/10/ :34 AM DJB3979 and chocolate cake. Patient: Snyder, Erika Chart Entry Made Patient give ibuprofen for 8/10/ :35 AM DJB3979 headache. Patient: Snyder, Erika Chart Entry Made Patient demanding to speak 8/10/ :37 AM DJB3979 to doctor about when can be discharged home. Call placed to Dr. Ross re: patient discharge. Patient: Snyder, Erika

37 ROOM 301 ROOM 325 BRS3987 DJB3979

38 ROOM 301 ROOM 325 Nurse Morgan testified that after the first code he stayed with the patient Sara Smith in her room (301) through the second code until the patient was officially transferred off the floor 5:28 AM 5:37 AM: Nurse Morgan logged onto a different workstation (DJB3979) on 3 West and treating a different patient (Snyder, Erika) in a different room (325) [Nurse Morgan Caduceus Audit Trail]

39 LEGAL IMPLICATIONS Preservation Adverse inference Presumption of negligence Discoverability Objections to production Case law Admissibility Authentication Recommendations _

40 DUTY TO PRESERVE? Federal Law 45 C.F.R (a)(1) - covered entities must [e]nsure the confidentiality, integrity, and availability of all electronic protected health information the covered entity... creates, receives, maintains, or transmits C.F.R (a)(1)(D) covered entities must [i]mplement procedures to regularly review records of information system activity, such as audit logs, access reports, and security incident tracking reports. _

41 45 C.F.R covered entities must [i]mplement technical policies and procedures for electronic information systems that maintain electronic protected health information to allow access only to those persons or software programs that have been granted access rights C.F.R conditions for hospital participation in Medicare and Medicaid services including maintenance of medical records for 5 years, system to ensure integrity of records, and procedures to ensure confidentiality and appropriate access of records. _

42 Florida Law (1), Florida Statutes (2016) [a]ny licensed facility shall, upon written request... furnish, in a timely manner... a true and correct copy of all patient records, including X rays, and insurance information concerning such person, which records are in the possession of the licensed facility...

43 2016 JURY INSTRUCTIONS Florida Jury Instruction 402.4d(1) If you find that DEFENDANT lost, destroyed, mutilated, altered, concealed or otherwise caused the (evidence) to be unavailable, while it was within his/her/its possession, custody, or control; and the (evidence) would have been material in deciding the disputed issues in this case; then you may, but are not required to, infer that this evidence would have been unfavorable to DEFENDANT.

44 Florida Jury Instruction 402.4d(1) Court has discretion to impose additional or other sanctions or remedies against a party for inadvertent or intentional conduct in the loss or destruction of material evidence Basis for punitive damage claim? Inference Presumption Pub. Health Tr. Of Dade Cty. v. Valcin, 507 So. 2d 596 (Fla. 1987)

45 Florida Jury Instruction 402.4d(2) The court has determined that DEFENDANT had a duty to maintain (evidence)/keep a record of (subject matter). DEFENDANT did not do so. Because DEFENDANT did not maintain (evidence) or keep a record of (subject matter), you should find that PLAINTIFF established his/her claim of medical negligence unless DEFENDANT proves otherwise by the greater weight of the evidence.

46 Florida Jury Instruction 402.4d(2) The party invoking the presumption must establish to the satisfaction of the court that the absence of the missing evidence hinders the party s ability to establish its claim or defense. Pub. Health Tr. Of Dade Cty. v. Valcin, 507 So. 2d 596 (Fla. 1987)

47 DISCOVERABILITY How will Plaintiff lawyers try to get to this information? Is it discoverable?

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49 DISCOVERABILITY Florida Rules of Civil Procedure and 1.380(e)

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53 DISCOVERABILITY Florida Rules of Civil Procedure and 1.380(e) No Florida appellate decisions Proffitt v. Adventist Health System, Pasco County Circuit Court (January 2015 memorandum of law in support of motion to compel production of audit trail)

54 State Court Decisions Vargas v. Lee - Kings County, NY Medical malpractice lawsuit arising out of alleged delay in diagnosis and treatment of post-operative complications resulting in gangrene and amputation of leg Audit trail of entire admission requested to elicit details of timing and substance of care Hospital objected on grounds that request was overreaching, overbroad, unduly burdensome and not relevant MTC Denied

55 Trial court findings: Metadata is electronically stored data (ESI) EMR audit trail = system metadata System metadata is not routinely produced unless the requesting party shows good cause Plaintiff failed to distinguish utility of audit trail from the EMR; can presumably obtain treatment details from the EMR System metadata relevant when (1) the process by which a document is created is at issue or (2) there are questions concerning authenticity

56 Kipoliongo v. Tchabo Fairfax County, VA Medical malpractice lawsuit related to labor and delivery events MTC granted hospital required to produce OB audit trail for all entries made by specific nurse on L&D patients in 6.5 hour window Rauchfuss v. Shultz - Newport News, VA Medical malpractice lawsuit; dispute as to whether nurse timely sent regarding medical finding MTC by co-defendant MD granted onsite metadata and printing (for a fee) allowed access to

57 Federal Court Decisions Hall v. Flannery, U.S. District Court of Illinois Medical malpractice lawsuit with allegation that hospital illegally edited or modified EMR Plaintiff sought manuals, instructional materials and data dictionary regarding metadata and audit trail Hospital did not object to pre-incident audit trail entries (on grounds of burdensomeness or relevance) Objection only to entries related to peer review process and risk management after MR request issued to hospital

58 Trial court findings: Info initiated, created, prepared or generated by peer review committee is privileged; however, the audit trail/metadata sought was not protected by the peer review privilege because only showed what person viewed the EMR and when Audit trail is one aspect of the EMR generated in the ordinary course of business and not for the specific use of a peer review committee Audit trail is not created in anticipation of litigation or for trial and does not include attorney work product or mental impressions or theories concerning anticipated litigation

59 ADMISSIBILITY Florida Rule of Evidence

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61 ADMISSIBILITY Florida Rule of Evidence Authentication Records custodian IT/vendor representative

62 RECOMMENDATIONS Request AUDIT TRAIL early and share with defense counsel (pursuant to joint defense agreement) Identify process necessary to retrieve and commit process to writing Evaluate internal policies defining EMR

63 RECOMMENDATIONS Object to discovery requests and require a court order Prepare witnesses (before deposition) to use qualifiers and approximations for time, location, etc.

64 BOTTOM LINE

65 QUESTIONS?