Memo

DATE: TO: September 26, 2011 Pam Dickfoss, Acting Director, Center for Health Care Quality, Licensing and Certification Howard Backer, MD, MPH

FROM: SUBJECT:

Complainant written appeal pursuant to Health and Safety Code (HSC) 1280.5 Chino Valley Medical Center; Desert Valley Hospital; San Dimas Community Hospital; West Anaheim Medical Center (Complaint Number CA00258305) This is in response to the written appeals of the complaints investigated by the California Department of Public Health (CDPH), Licensing and Certification Program. Background The original complaint was submitted by Senator Elaine Alquist and Assemblymember William Monning, in response to allegations in a report submitted by the Service Employees International Union-United Healthcare Workers (SEIU-UHW) that Prime Healthcare Services, Inc. (Prime Healthcare) operated hospitals had much higher than average rates of sepsis when compared nationally or within California. Prime operated five of the six hospitals with the highest septicemia rates in the United States according to Medicare claims data. This discrepancy persisted when analyzed with Medi-Cal claims within California; Prime Healthcare operated four of the California facilities with the highest rates of septicemia as compared to statewide benchmarks. The report recognized that the source of the higher rates could be one or a combination of higher rates of infection in the communities, infection control practices leading to healthcare associated infections, or coding practices. CDPH cited violations for infection control practices and issued a deficiency for failure to document and monitor central venous catheters at Desert Valley Hospital, and issued a deficiency related to collaboration of infection control professionals with senior health care facility leadership. The written appeals did not contest the deficiencies cited for Health and Safety Code, Section 1288.6 and the hospitals responded with corrective actions. Therefore, the appeal will not address these violations . Surveyors also evaluated specific patient records with diagnosis of sepsis, selected from the hospitals with the highest rates of septicemia according to Medi-Cal claims data. This review led to deficiencies delineated on Form 2567 citing 22 CCR, Division 5, Chapter 1, Article 70701(a)(1)(G): Preparation and maintenance of a complete and accurate medical record for each patient.

Prime Healthcare Hospital appeal

September 26, 2011

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Basis for Appeal Pursuant to Health and Safety Code Section 1280.5, the CDPH may accept, consider, and resolve written appeals by a licensee or health facility administrator of findings made upon the inspection of a health facility. All four hospitals appealed these deficiencies using the same arguments: 1. CDPH is basing the deficiencies on an evaluation of clinical judgment of the treating physicians, over which CDPH has no authority. Moreover, hospital medical staff are independent and autonomous from the Hospital Corporation. 2. CDPH based the deficiencies on improper coding of diagnoses, over which CDPH has no expertise or authority. 3. CDPH did not accurately identify documentation of sepsis by treating physicians, so is erroneous in designating the records as inaccurate. The criteria that CDPH surveyors used was not consistent with guidelines in the medical literature. 4. Finally, the hospitals representative argued that this written appeal must be considered and resolved by a physician that was not involved in the original reviews or surveys. Reviewer This review was completed by Dr. Howard Backer, MD, MPH, FACEP. Dr. Backer is Board certified in both Emergency Medicine and Preventive Medicine Public Health. He practiced medicine full-time for 25 years, primarily emergency medicine, but also family and sports medicine in various settings, including urban, suburban, and rural hospitals. For the past 10 years, Dr. Backer has worked for the California Department of Public Health as Chief of the Immunization Branch and for the California Health and Human Services Agency as Associate Secretary for Emergency Preparedness. Twice, he has served as Interim Director of the Department of Public Health and the California State Health Officer. Dr. Backer was recently appointed Director of the Emergency Medical Services Authority. During this assessment, Dr. Backer reviewed the following documents: Initial report and analysis of Septicemia at Prime Hospitals from SEIU-UHW Letter of complaint from Senator Alquist dated August 17, 2010 Deficiencies issued via a Statement of Deficiencies and Plan of Correction, State Form 2567 which is issued to providers for violations Four Hospitals State 2567s with Corrective Actions in response to deficiencies Letters of Appeal from all four of the Prime Healthcare Service hospitals Patient records noted in the deficiencies and response, supplied by hospitals to CDPH Pertinent literature on the definition and clinical criteria for sepsis Coding guidelines provided by Prime Healthcare and available on-line1

Available records referenced in the deficiencies issued and the hospitals response were reviewed, not to make clinical judgments of the care, but to evaluate the
1

http://www.cdc.gov/nchs/data/icd9/icdguide09.pdf

Prime Healthcare Hospital appeal

September 26, 2011

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patient-specific justification provided; the complex interplay of primary and secondary diagnoses; the potential for subjectivity of the clinical picture when reviewing records; and the role of coders in creating the medical record and justifying a diagnosis that may not be prominent or even present in the physicians list of diagnoses. Response to appeal 1. Prime alleges that CDPH does not have the authority to evaluate the clinical judgment of the treating physicians. Although it is clearly within the purview of CDPH to perform detailed evaluation of the medical records in order to discern health care practices within the hospital, peer review is outside the scope of this survey. The standard of medical practice is determined by actions of peer providers within the community. The optimal process for evaluating clinical judgment is through peer-review by medical staff with similar training and experience. CDPH makes no assertion of clinical incompetence or substandard patient care in this survey or review. 2. Prime alleges that CDPH has no expertise or authority to evaluate coding. While surveyors were trained in coding practice, the reviewer has determined that there is not sufficient basis for determining that the medical records were incomplete or inaccurate. Coding guidelines are not determined by Title 22, rather are set by an industry association in collaboration with government agencies. The coding guidelines for sepsis utilize accepted standards from the medical literature; allow coding for possible, suspected, or probably diagnoses as well as any condition that was evaluated clinically, treated, or increases nursing care of length of stay; and allow the coder some leeway to determine the condition that should be designated as the principal diagnosis. This suggests that hospitals can include sepsis in the final list of coded diagnoses when it may not have been listed as the principal admitting or discharge diagnosis. Not surprisingly, the coders were sometimes inaccurate in their application of sepsis criteria, such as documenting high percent of neutrophils when the criteria actually is elevated immature neutrophils (bands), or failing to distinguish new organ dysfunction from pre-existing disease. Not all SIRS findings are related to sepsis.2

(ii) Systemic inflammatory response syndrome (SIRS) generally refers to the systemic response to infection, trauma/burns, or other insult (such as cancer) with symptoms including fever, tachycardia, tachypnea, and leukocytosis. (iii)Sepsis generally refers to SIRS due to infection. The Coding of SIRS, sepsis and severe sepsis The coding of SIRS, sepsis and severe sepsis requires a minimum of 2 codes: a code for the underlying cause (such as infection or trauma) and a code from subcategory 995.9 Systemic inflammatory response syndrome (SIRS). http://www.cdc.gov/nchs/data/icd9/icdguide09.pdf

Prime Healthcare Hospital appeal

September 26, 2011

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Concerns over coding and billing irregularities that may constitute fraud are referred to Department of Health Care Services, Audits and Investigation Unit for Medi-Cal billing or the Health and Human Services Office of the Inspector General for Medicare billing. CDPH has not excluded this as an underlying reason for the markedly elevated rates of sepsis found among patients in Prime Healthcare operated hospitals and has referred the issue to appropriate agencies for possible investigation. 3. Prime alleges that CDPH did not accurately identify documentation of sepsis by treating physicians, so is erroneous in designating the records as inaccurate. The accepted published criteria for diagnosis of sepsis is very broad. It does not require blood stream infection documented by a blood culture. The Systemic Inflammatory Response Syndrome (SIRS) criteria are very sensitive and not at all specific for response to infection. The cut-off for many of the parameters is set very low. This was presumably done by professional societies to initiate aggressive treatment, without consideration for coding. Subsequently, a large percent of patients sick enough to be hospitalized will meet the SIRS criteria and with any source of infection will technically qualify as sepsis. Most ICU patients and many general ward patients meet the SIRS criteria. In the Sepsis Occurrence in Acutely ill Patients study, 93% of ICU admission had at least two SIRS criteria at some point during their ICU stay. Moreover, each of the SIRS criteria can be present in many different conditions, so that a label of SIRS provides little or no information about the underlying disease process; the SIRS criteria cannot separate septic from other types of shock. 3 Establishing that the patient has an ongoing infection and, therefore, has sepsis rather than a noninfective cause of the systemic inflammatory response syndrome can be extremely difficult.4 Some criteria are highly questionable since they are less objective; for example, a respiratory rate of 20 may be recorded without adequate monitoring. It is acknowledged that subsequent surveyors need to follow acknowledged criteria consistently. Making this even more difficult, criteria for sepsis varies between references, even among those provided in the hospital written appeal. An example is the number of variables to be considered, the number required (2 or more, some, at least one) and the criteria (change in creatinine of more than 0.5 or creatinine greater than 2.0 mg/dL). Criteria for accurate and complete medical record 22 CCR 70701 requires a complete and accurate medical record for each patient. Further definition of this is limited to a list of items that should be included in the record (22CCR 70749). No deficiency was issued related to the completeness of the medical records considering the presence of these required elements.

3 4

Vincent JL et al. Crit Care Clin 25 (2009) 665 675 Cohen J, et al, Crit Care Med 2004

Prime Healthcare Hospital appeal

September 26, 2011

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The deficiencies were based on the requirement for accuracy and determined by the concurrence of the clinical records and summaries provided by the health care providers compared to the list of ICD9 diagnoses from the coders. The discrepancies noted often resulted when the coder listed a diagnosis of sepsis but this diagnosis was not present in the preliminary admitting diagnoses and/or in the discharge list of diagnoses; this was especially a concern when the coder listed the diagnosis of sepsis as the principal diagnosis. The issue of whether appropriate criteria for the diagnosis of sepsis were present in the record was addressed above. The reviewer could not identify any widely accepted standards or guidelines for medical record accuracy, or whether the coding document should be considered an accurate problem list for the medical record. From the records provided by the hospitals, it appeared that this was an integral part of the medical record and placed as the cover or face sheet for the hospital record. Yet, in materials included with its written appeal, West Anaheim hospital argued that the coding abstract on which the principal diagnosis is recorded and which the surveyors apparently relied on is not typically considered part of the medical record. Coding guidelines state that the coder determination of which diagnosis to list as principal diagnosis should be the one that was chiefly responsible for admission of the patient to the hospital; however, this would require physician input in many if not most cases.5 This is supported by Palmetto GBA, the administrator for Medicare health insurance for the Centers for Medicare & Medicaid Services (CMS), which states that hospitals are responsible for reporting codes that accurately reflect the patients conditions and procedures and should review the entire medical record to determine the appropriate codes and the selection of the principal and secondary diagnoses. When coding claims, if there is conflicting or contradictory information in the medical record, a coder should query the attending physician to clarify the correct principal and secondary diagnoses. This conflict was recognized by several of the hospitals that developed corrective actions to the deficiencies while contesting them that included increased medical staff involvement and communication with coding staff. Resolution of Appeal In order to sustain these deficiencies, the CDPH must prove the presence of substantial evidence that the facility did violate one or more regulatory requirements. The findings of the written appeal conclude that there is not sufficient basis for determining that the medical records were incomplete or inaccurate and therefore, deficiencies cited for
5

(a) Sepsis and severe sepsis as principal diagnosis

If sepsis or severe sepsis is present on admission, and meets the definition of principal diagnosis, the systemic infection code (e.g., 038.xx, 112.5, etc) should be assigned as the principal diagnosis, followed by code 995.91, Sepsis, or 995.92, Severe sepsis, as required by the sequencing rules in the Tabular List. (b) Sepsis and severe sepsis as secondary diagnoses When sepsis or severe sepsis develops during the encounter (it was not present on admission), the systemic infection code and code 995.91 or 995.92 should be assigned as secondary diagnoses.

Prime Healthcare Hospital appeal

September 26, 2011

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incomplete or inaccurate medical records will be removed from the final survey documents. Coding practices are a potential cause of the elevated rates of sepsis at Prime Health Care operated hospitals, but should be evaluated by other agencies concerned with billing practices. Sincerely,

Howard Backer, MD, MPH Enclosure

Prime Healthcare Hospital appeal

September 26, 2011

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