Managing Error in Ambulatory Care

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1 Ann L. Puopolo, BSN, RN Current Clinical Issues in Primary Care

2 Managing Error in Ambulatory Care Ann Louise Puopolo, BSN,RN Director, Loss Prevention & Patient Safety Risk Management Foundation of the Harvard Medical Institutions November 14, 2009 Objectives: Recognize the role of malpractice data, when coupled with other data sources, in identifying models to mitigate ambulatory risk and improve patient safety Understand the major allegations and contributing factors that exemplify ambulatory patient safety Examine a series of ambulatory case studies that Examine a series of ambulatory case studies that illustrate both cognitive and system-based themes that contribute to error 1

3 CRICO/Risk Management Foundation Controlled Risk Insurance Company (CRICO) captive created in 1976 Operating structure: CRICO Cayman, CRICO Vermont Insure: 11,400+ physicians (3,700 residents/fellows), 25 hospitals, 100,000 employees, AL, PL, GL Premium: approximately $133 million for $5 million coverage Risk Management Foundation of the Harvard Medical Institutions (RMF) a membership organization created in 1979 CRICO/RMF Members Cambridge Health Alliance CareGroup, Inc. Beth Israel Deaconess Hospital Needham Campus Beth Israel Deaconess Medical Center, Inc. Mount Auburn Hospital New England Baptist Hospital Children s Hospital Boston Dana-Farber Cancer Institute, Inc. Harvard Vanguard Medical Associates, Inc. Harvard Pilgrim Health Care, Inc. Presidents and Fellows of Harvard College Harvard Medical School Harvard School of Dental Medicine Harvard School of Public Health Harvard University Health Services Joslin Diabetes Center, Inc. Judge Baker Children s Center, Inc. Massachusetts Eye and Ear Infirmary Massachusetts Institute of Technology Partners HealthCare System, Inc. Brigham and Women s Hospital Faulkner Hospital The Massachusetts General Hospital McLean Hospital North Shore Medical Center Newton-Wellesley Hospital Spaulding Rehabilitation Hospital *shareholders 2

4 CRICO/RMF Coding Methodology Coding scheme established in 1990 Clinical coding gperformed by nurses ~650 proprietary codes Multi-level hierarchies to enhance reporting 17 clinical dimensions captured such as: Allegations Risk Management Issues Injury Severity (NAIC) Responsible Service Diagnosis & procedure codes (ICD-9) Medications Location Caveats Malpractice claims are a small n have age to them represent a unique convergence no statistical significance 3

5 Strengths of the Malpractice Claims Yield relatively large numbers of rare events (e.g. retained foreign bodies, wrong site surgery) Emphasis on errors that cause the most severe injuries Rich information set on events that led to harm Alignment of risk management and quality improvement perspectives The Model Methodology: Data into Action Capture vulnerabilities as they occur Contemporaneous analysis of asserted malpractice cases Put them into context Integration of relevant denominator data and peer comparative data Are you still vulnerable? Assessment of present-tense risk through risk assessments, focus groups Determine potential solutions Continuous identification of relevant models, processes, education, and training programs that address key risk areas Implement, educate, train Championship by high-level leadership to effect real change and to sustain it Measure/Metrics Measure the impact in the near term (with a predictive eye for the long term) 4

6 CRICO Cases Asserted by top major allegations 350 $300,000,000 Claim Count T otal Inc urred number of cases $250,000,000 $200,000,000 $150,000,000 $100,000,000 $50,000,000 total incurred 0 Anesthesia-Related Medication-Related OB-Related Treatment Safety & Security Medical Treatment Surgical Treatment Diagnosis-Related $0 Pt Monitoring N=1,157 CRICO PL cases asserted 1/1/04-03/31/09. Total Incurred-aggregate of expenses, reserves, and payments on open and closed cases. CRICO Cases Asserted by claimant type N=1,143 CRICO PL cases asserted 1/1/04-3/31/09 with a claimant type of inpatient or outpatient. 5

7 CRICO Cases Asserted by claimant type N=1,143 CRICO PL cases asserted 1/1/04-3/31/09 with a claimant type of inpatient or outpatient. CRICO Outpatient Cases by top major allegations N=621 CRICO PL cases asserted 1/1/04-03/31/09 with a claimant type of outpatient. Total Incurred-aggregate of expenses, reserves, and payments on open and closed cases. 6

8 CRICO Outpatient Diagnostic Cases by top responsible services N=259 CRICO PL cases asserted 1/1/04-3/31/09 with a claimant type of outpatient and a diagnosis-related major allegation. Total Incurred=aggregate of expenses, reserves, and payments on open and closed cases. CRICO Outpatient Diagnostic Cases by top final diagnoses Final Diagnoses # cases Cancer 106 Heart disease 21 Diseases of arteries; arterioles; and capillaries 10 Fractures 8 Cerebrovascular disease 7 Complications 6 Benign tumor 6 Diseases of the urinary system 6 Bacterial infection 5 Top Cancers # cases Prostate cancer 21 Colorectal cancer 18 Lung cancer 16 Breast cancer 13 Cancer of lymphatic and hematopoietic 8 tissue Cancer of uterus and cervix 7 N=259 CRICO PL cases asserted 1/1/04-3/31/09 with a claimant type of outpatient and a diagnosis-related major allegation. 7

9 CRICO Outpatient Diagnostic Cases process of care Step # cases % of cases Total incurred 1. Patient notes problem and seeks care 15 6% $13,157, History/physical and evaluation of symptoms % $95,966, Order of diagnostic/lab tests % $137,781, Performance of tests 20 8% $14,389, Interpretation of tests 95 37% $92,283, Receipt/transmittal of test results 38 15% $26,982, Physician follow up with patient 54 21% $54,659, Referral management 52 20% $40,551, Patient compliance with follow-up plan 10 4% $5,627,751 N=259 CRICO PL cases asserted 1/1/04-3/31/09 with a claimant type of outpatient and a diagnosis-related major allegation. History/physical- Evaluation of Symptoms Elicit pertinent family history to identify those at increased risk using templates with built-in i prompts Patient electronic portals to report family history prior to visit Centralized health screening programs staffed by non-physicians 8

10 Ordering of Diagnostic and Lab Tests Embed decision-support tools (guidelines/algorithms) into practice workflow (i.e. EMR etc.) Population management strategies A differential diagnosis should be generated regardless of the situation If the diagnostic plan fails to resolve the patient s symptoms, alter the clinical i l approach Consider peer consultation with persistent complaints and repeat visits Closed Loop Communication Test Result and Referral Management Establish office-based process to ensure tracking & reconciliation of critical test results & critical referrals Patient access to test results (patient portals) Confirm physician review & receipt of critical test results prior to filing reports Issue patient notification of normal & abnormal test results (i.e. patient access to test results including electronic portals) Provide specialists with the rationale for the referral & relevant clinical information Establish responsibility for coordination of care with patient & specialty physicians Implement a process to identify & follow-up with patients who fail to complete referrals as ordered 9

11 Office Practice Evaluation Program Site Interviews Medical Director Practice Manager Office Staff Medical Record Review Assesses documentation of compliance with health screening and disease management guidelines Evaluates whether practice-based processes are supporting and enhancing provider documentation Analysis and recommendations Follow-up educational programs 6 Characteristics of a Model Practice 1. Assessment and Diagnosis History and physical examination Evidence of diagnosis and proposed treatment plan 2. Disease Management Care is rendered in compliance with nationally recognized standards (HEDIS, ADA requirements) 3. Health Screening Assessment for health screening based upon age, gender and relevant personal and family history Evidence of appropriate recommendations for health screening Execution of health screens Evidence of provider review, including an appropriate follow-up plan Evidence that a diagnosis has been established 10

12 6 Characteristics (continued) 4. Test Result Management Ordered tests are executed Incoming test results are received Test results reviewed by the provider Patients are notified of test results (even those within normal limits) Evidence of a follow-up plan Evidence that a diagnosis has been established 5. Referral Management Systems in place to promote communication between the PCP (referral information) and the specialist (findings and recommendations) 6. Practice Infrastructure Practice and organizational processes identifying and addressing obstacles in the delivery of consistent high quality care Top CRICO Cancer-related Cases with a diagnosis-related allegation N = 149 CRICO PL cases asserted 1/1/99 3/31/09 with a final diagnosis code of breast, colorectal, lung or prostate cancer and diagnosis-related allegation. Total incurred losses=$101 million 11

13 Public Perception of Cancer Litigation Early diagnosis of cancer equals cure Physicians are responsible for the patient s medical outcome CRICO Breast Cancer Outpatient Cases process of care breakdown Step # cases % of cases Total incurred 1. Patient notes problem and seeks care 0 0% $0 2. Hit History/physical i and evaluation of symptoms 4 31% $4,740, Order of diagnostic/lab tests 7 54% $6,285, Performance of tests 1 8% $$930, Interpretation of tests 10 77% $9,446, Receipt/transmittal of test results 0 0% $0 7. Physician follow up with patient 1 8% $1,040, Referral management 1 8% $1,040, Patient compliance with follow-up plan 1 8% $790,000 N=13 CRICO PL outpatient cases asserted 1/1/04-3/31/09 with a final diagnosis of breast cancer and diagnosis-related major allegation. Total Incurred-aggregate of expenses, reserves, and payments on open and closed cases. 12

14 CRICO/RMF Breast Care Algorithm Compliance with Breast Care Management Algorithm breast complaint OPE Element Personal history of predisposing breast conditions % Compliant 88% Family history of breast cancer 69% Clinical breast exam at time of discovery 98% Review of diagnostic tests at the time of the breast complaint 93% Recommendations for women less than 30 43% Recommendations for women age 30 or over 87% OPE results from , 407 medical records reviewed with a complaint of a breast lump, mass or thickening 13

15 Effect of the Intervention by loss year Breast Care Guidelines published Breast Care Algorithm published* 7 Number of claims Loss Year N=93 CRICO PL cases occurred 1/1/76 3/31/09 with a final diagnosis of breast cancer and diagnosis-related allegation. *An updated edition was issued in 2004; a new edition is planned for early Projected Losses without Intervention 12 BCA Algo Number of claims Projection : N=108 cases, $108M indemnity incurred 6 6 Actual : N=27 cases, $14M indemnity incurred Assert Year N=93 CRICO PL cases asserted 1/1/79 3/31/09 with a final diagnosis of breast cancer and diagnosis-related allegation.. 14

16 CRICO Colorectal Cancer Outpatient Cases process of care breakdown Step # cases % of cases Total incurred 1. Patient notes problem and seeks care 1 6% $2,215, Hit History/physical i and evaluation of symptoms 8 44% $9,106, Order of diagnostic/lab tests 11 61% $13,621, Performance of tests 1 6% $871, Interpretation of tests 9 50% $9,557, Receipt/transmittal of test results 0 0% $0 7. Physician follow up with patient 6 33% $9,240, Referral management 2 11% $3,620, Patient compliance with follow-up plan 1 6% $170,944 N=18 CRICO PL outpatient cases asserted 1/1/04-3/31/09 with a final diagnosis of colorectal cancer and diagnosis-related major allegation. Total Incurred-aggregate of expenses, reserves, and payments on open and closed cases. Colon Cancer Screening Screening has now been proven to be effective Offering screening to appropriate p patients is the standard of medical care Do something rather than nothing for each and every patient over 50 years of age who walks through the door Byers T. et al, CA Cancer J Clin, 1997; 47:

17 Compliance with Colorectal Algorithm Rectal Bleeding OPE Element % Compliant Personal history of predisposing colorectal cancer 90% Family history of colorectal cancer 58% Recommendations for patients less than 40 85% Recommendations for patients age % Recommendations for patients age 50 and above 92% OPE results from , 439 medical records reviewed with a complaint of rectal bleeding CRICO/RMF CRC Algorithm 16

18 Case Study #1 69-year-old female Pt began treatment with insured 11/87 (age 57). 11/95: office record denotes pt s younger sister died from lung/colon CA (pt then age 66). No documentation of stool guaiac or discussions about routine screening in record. Pt has PMH for PUD, arthritis, obesity, microcytosis, & CAD. There was no social history found in chart. 3/96: c/o abdominal pain, stool guaiac (-). 6/96 (office visit): for abdominal pain, wt 187.5#, treated with H 2 blocker 8/96 (office visit): f/u abdominal pain, wt 187#, pt stated stomach pain better. H/H 41/13.4, CEA?. Case Study #1 (cont d) 5/97 (office visit): f/u visit for H. pylori, wt 183#, no blood in stool for a long time. When were stools tested? Was this ever done? 1998 multiple appointments scheduled & rescheduled by pt. Last recorded wt in 11/98=191#. 5/99 (office visit rescheduled): wt 181.5# ( 9# in 6mo) H/H = 37/12.1. Note made to do iron levels/ stool guaiac x 3 next visit. PAP performed: results (+) for dysplasia suggesting precancerous stage. Pt declined further investigation. 17

19 Case Study #1 (cont d) 9/9/99: episodic visit for tooth problem. Wt 161#; wt (20# in 4 months) not addressed. F/u iron levels & stool guaiacs not addressed. 11/14/99: patient to ED with wt loss CXR showed multiple pulmonary nodules CT c/w cecal mass with metastasis to liver & lung H/H = 36.1/10.9 Pt to f/u w PCP 11/18/99: appointment rescheduled 11/30.? if patient kept appointment. Case Study #1 (cont d) 12/1/99: office note says: patient to palliative care. 12/19/99: patient expired. Of Note: in the course of 4 years with IM the patient had 17 no shows for scheduled appointments. 18

20 Case #1 (cont d) Allegation Estate of the patient alleges failure to screen for and diagnose colon cancer resulting in the patient's wrongful death. Defendant Internal Medicine Case #1 (cont d) Contributing Factors Pt non-compliant with f/u call/appointments Narrow dx focus chronic/previous dx assumed Lack/inadequate assessment noting noting clinical information Failure to r/o abnormal finding Failure/delay ordering dx test Failure/delay scheduling/performing test Failure in system patient care other Insufficient/lack of documentation f/u efforts Insufficient lack of documented history Disposition Case settled for > $750,000 19

21 CRICO Prostate Cancer Outpatient Cases process of care breakdown Step # cases % of cases Total incurred 1. Patient notes problem and seeks care 1 5% $2,540, History/physical and evaluation of symptoms 9 43% $6,648, Order of diagnostic/lab tests 14 67% $8,108, Performance of tests 1 5% $1,040, Interpretation of tests 4 19% $3,240, Receipt/transmittal of test results 11 52% $8,986, Physician follow up with patient 11 52% $9,808, Referral management 4 19% $2,371, Patient compliance with follow-up pp plan 2 10% $2,060,000, N=21 CRICO PL outpatient cases asserted 1/1/04-3/31/09 with a final diagnosis of prostate cancer and diagnosis-related major allegation. Total Incurred-aggregate of expenses, reserves, and payments on open and closed cases. General and Prostate-specific Cancer Testing Risk Management Discuss the risks and benefits of testing options (including no testing) and document the discussion in the medical record Track and document tests ordered and performed, and their results Follow- up on all test results Transmit test results to the patient with an explanation appropriate for the patient s level of understanding When referring a patient to a specialist, track the referral and coordinate future care and follow-up with the specialist Document recommendations to the patient for further testing and evaluation Add reminders to your tickler system 20

22 CRICO Lung Cancer Outpatient Cases process of care Step # cases % of cases Total incurred 1. Patient notes problem and seeks care 0 0% $0 2. History/physical and evaluation of symptoms 7 44% $5,850, Order of diagnostic/lab tests 13 81% $14,075, Performance of tests 1 6% $1,115, Interpretation of tests 9 56% $10,047, Receipt/transmittal of test results 5 31% $4,665, Physician follow up with patient 4 25% $5,765, Referral management 0 0% $0 9. Patient compliance with follow-up pp plan 0 0% $0 N=16 CRICO PL outpatient cases asserted 1/1/04-3/31/09 with a final diagnosis of lung cancer and diagnosis-related major allegation. Total Incurred-aggregate of expenses, reserves, and payments on open and closed cases. Case #2 Plaintiff: 53 y/o female, 2-pack-per-day smoking history Defendants: Internist & Neurosurgeon Internist performed preop Hx and PE & referred pt to surgeon for back surgery Pre-op chest X-ray ordered by neurosurgeon prior to diskectomy (herniated disc) 21

23 Case #2 (cont d) 2.5cm mass identified in rt lung (not seen on previous films) Follow-up film was recommended by radiologist in his report Surgeon stated he never saw the report Case #2 (cont d) Day surgery center nursing assessment noted the patient s PCP. The record reflected chest X-ray report called to MD PCP and surgeon denied receiving a call about the report Surgeon stated that he never saw the report, yet he documented (6 months later) in the discharge summary patient s preoperative and laboratory studies were unremarkable 22

24 Case #2 (cont d) One year later, a chest X-ray was ordered for rt side chest pain 5 cm mass identified Adenocarcinoma of lung was diagnosed Plaintiff died one year later of lung cancer Settled in the high range against surgeon Case #2 (cont d) No tracking system in place by surgeon s office to ensure results were received Surgeon states that he did not see chest X-ray report, although the report was in the medical record PCP not included in communication loop 23

25 Case #2 (cont d) Anesthesia failed to review chest X-ray in pre-op evaluation No documentation that radiology called the surgeon to alert him about the significant chest X-ray finding The report was not sent to the PCP Surgeon does not recall any phone call Incidental Findings Significant unexpected findings should be directly communicated to the ordering or responsible physician* All telephone conversations re results need to be documented identify caller in the record discrepancy between TC and final report Ordering physician has a duty to review and follow-up on the results of the chest X-ray prior to surgery *ACR Standard for Communication,

26 CRICO Outpatient Medication-related Cases by top responsible services N=41 CRICO PL cases asserted 1/1/04-3/31/09 with a claimant type of outpatient and medication-related allegation. Total Incurred=aggregate of expenses, reserves, and payments on open and closed cases. CRICO Outpatient Medication-related Cases process of care Step Cases % of Cases Total Incurred Ordering 17 41% $8,739,577 Pharmacy dispensing 5 12% $563,138 Provider administration 4 10% $820,289 Monitoring and management 12 29% $5,140,104 Other medication related (includes unknown allergy) 3 7% $80,123 N=41 CRICO PL cases asserted 1/1/04-3/31/09 with a claimant type of outpatient and medication-related allegation. Total Incurred=aggregate of expenses, reserves, and payments on open and closed cases. 25

27 Medication Claims: Case Types Clinical Case Type Anti-coagulants Wrong medication Dosage errors of right medication Process/Skills Case Type Poor management of high-risk medications Failure to see the whole picture (drug interactions, side effects, etc.) Lack of safety nets to catch errors Safeguards to prevent administration of wrong medication Reliable systems to prevent dosage errors Medication-related Interventions Medication Reconciliation (at all transition points) Improve Ordering Process (e.g.) CPOE: computerized physician order entry E-Prescribing Bar Coding Improve Documentation EMAR: electronic medication administration record 26

28 Summary Malpractice information reflects trends only Partner malpractice data with other data sources to compel action Ambulatory providers are responsible for ensuring that screening tests are ordered at the correct intervals and followed up Tracking systems for test results and referrals to specialists are critical prevent falling through the cracks Variation in practice leads to increased risk Standardization is a patient safety intervention CRICO/RMF Resources What Works A collection of effective practices for office based care Describes electronic and manual processes observed within the CRICO community designed to ensure high reliability and encourage appropriate documentation CRICO/RMF Website Online CMEs FORUM/Resource publications 27

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