Working with CDPH: Avoiding and Managing “Immediate Jeopardy” and “Citation and Fine”

Situations

TWO CASE STUDIES ON CHALLENGING CDPH CITATIONS AND FINES

Cyrus A. Tabari, Esq.SHEUERMAN, MARTINI, TABARI, ZENERE & GARVIN,

A Professional Corporation

CASE ONE FACTS• PATIENT M.B UNDERWENT A LUMBAR LAMINECTOMY ON OCTOBER 10,

2012 AT HOSPITAL A. THE SURGERY WAS UNEVENTFUL. ON JANUARY 3, 2011 A ROUTINE POST-OP X-RAY REVEALED A RETAINED SPONGE. SURGERY WAS PERFORMED ON JANUARY 5, 2011 TO REMOVE THE SPONGE.

• THE CIRCULATOR NURSE AND THE SCRUB TECH WERE BOTH TRAVELLERS. BOTH HAD EXTENSIVE OR EXPERIENCE. ONE HAD BEEN AT THE FACILITY FOR APPROXIMATLEY NINE MONTHS; THE OTHER ABOUT TWO MONTHS

• CULTURES WERE OBTAINED AND ALL CAME BACK NEGATIVE, EXCEPT MRSA WAS GROWN IN THE “BROTH ONLY.” TO BE SAFE M.B. UNDERWENT 4 WEEKS OF DAILY VANCOMYCIN INFUSIONS AT AN OUTPATIENT INFUSTION CENTER. HE HAD NO FURTHER COMPLICATIONS

• THE HOSPITAL HAD A VERY DETAILED AND COMPREHENSIVE SPONGE COUNT POLICY AND PROCEDURE.

CASE TWO FACTS• PATIENT S.T. WAS ADMITTED TO THE SUBACUTE UNIT OF HOSPITAL B ON MAY 11,

2012. THE SUBACUTE UNIT HAS A DISTINCT PART SNF LICENSE. S.T. WAS A 59 YEAR OLD ALS PATIENT WHO HAD A TRACHEOTOSTMY AND WAS VENTILATOR DEPENDENT. HOWEVER, SHE COULD BREATHE INDEPENDENTLY WITHOUT THE VENTILATOR FOR UP TO FIVE MINUTES AT A TIME.

• ON THE MORNING OF DECEMBER 26, 2012 RESPIRATORY THERAPIST R.W. SAW T.S. AND PROVIDED ROUTINE TRACH CARE. DURING THIS PROCESS HE PUT THE VENTILATOR ON STANDBY MODE. AFTER COMPLETEING THE TRACH CARE HE LEFT THE ROOM, AND INADVERTENLY LEFT THE VENTILATOR ON STANDBY. IN ADDITION TO NOT PROVIDING BREATHS TO THE PATIENT, STANDBY MODE ALSO SUSPENDED ALL ALARMS.

• THE PATIENT’S NURSE WENT TO HER ROOM ABOUT TEN MINUTES AFTER THE R.T. HAD LEFT AND FOUND THE PATIENT TO BE NONRESPONSIVE. A CODE BLUE WAS CALLED AND IT WAS AT THIS TIME THE VENTILATOR WAS FOUND TO BE IN STANDBY MODE.

• S.T. WAS SUCCESSFULLY RESUSCITATED AND TRANSFERRED TO THE ICU. HOWEVER, SHE REMAINED NONRESPONSIVE, AND IT WAS FELT SHE HAD DEVELOPED IRREVERSIBLE ANOXIC BRAIN DAMAGE. THE FAMILY REQUESTED SHE BE CONVERTED TO COMFORT CARE ON DECEMBER 29, 2012 AND SHE DIED A SHORT TIME LATER THAT SAME DAY.

REGULATORY VIOLATIONS• CASE ONE:• CDPH DETERMINED HOSPITAL A

VIOLATED TITLE 22, SECTION 70223 (b) (2), WHICH STATES:

(b) A committee of the medical staff shall be assigned responsibility for:(2) Development, maintenance and implementation of written policies and procedures in consultation with other appropriate health professionals and administration. Policies shall be approved by the governing body. Procedures shall be approved by the administration and medical staff where such is appropriate.

• CASE TWO:• CDPH DETERMINED HOSPITAL

B VIOLATED FEDERAL REGULATION 42 CFR SECTION 483.25 (h) (1) WHICH STATES:

(h) The facility must ensure that–

(1) The resident environment remains as free from accident hazards as is possible;

CITATIONS AND FINES

• CASE ONE: CDPH FOUND IMMEDIATE JEOPARY EXISTED AT HOSPITAL A AND ISSUED A FINE OF $50,000.

• CASE TWO:CDPH FOUND THAT THE REGULATORY VIOLATION DIRECTLY LED TO THE DEATH OF T.S. AND ISSUED AN AA CITATION AND FINE OF $65,000

PROCEDURAL MECHANISM TO APPEAL THE CITATIONS AND FINES

CASE ONE:

HEALTH AND SAFETY CODE SEC. 100171 PROVIDES THAT APPEALS FROM IMMEDIATE JEOPARY FINDINGS, AND ASSOCIATED FINES, ARE HEARD IN AN ADMINISTRATIVE COURT HEARING. THESE HEARINGS ARE HELD AS A MATTER OF COURSE IN SACRAMENTO

CASE TWO:

HEALTH AND SAFETY CODE SEC. 1424 PROVIDES THAT ANY APPEAL OF A CLASS AA CITATION IS IN THE FORM OF A CIVIL ACTION FILED IN THE SUPERIOR COURT FOR THE COUNTY WHERE THE FACILITY IS LOCATED

ALLEGED BASIS OF THE CLAIMED REGULATORY VIOLATIONS

CASE 1:

CDPH CONTENDED THAT WHILE HOSPITAL A HAD A SPONGE COUNT POLICY AND PROCEDURE, IT OBVIOUSLY HAD NOT PROPERLY IMPLEMENTED IT, OTHERWISE PATIENT M.B. WOULD NOT HAVE SUFFERED A RETAINED SPONGE

CDPH ALSO ALLEGED HOSPITAL A SHOULD HAVE HAD A POLICY IN PLACE WHICH PREVENTED THE CIRCULATING NURSE AND SCRUB TECH FOR A GIVEN SURGERY BOTH BEING TRAVELERS OR REGISTRY.

CASE 2:

CDPH CONTENDED HOSPITAL B SHOULD HAVE HAD POLICIES AND PROCEDURES IN PLACE TELLING RESPIRATORY THERAPISTS NOT TO LEAVE VENTILATORS ON STANDBY AFTER PROVIDING CARE TO PATIENTS.

CDPH ALSO ALLEGED THE DEVICE MANUAL REQUIRED THAT THE STANDBY SETTING NOT BE USED AT ANY TIME.

BURDEN OF PROOF IN ACTIONS TO CHALLENGE CITATIONS AND FINES

IN BOTH FORUMS, ADMINISTRATIVE COURT AND SUPERIOR COURT, CDPH HAS THE BURDEN OF PROVING EVERY ELEMENT NECESSARY TO JUSTIFY THE CITATION AND FINE. THE BURDEN IN BOTH FORUMS IS PREPONDERANCE OF THE EVIDENCE.

THE BURDEN OF PROOF FOR THE LICENSEE IS TO SHOW IT ACTED REASONABLY, IF THIS AFFIRMATIVE DEFENSE IS TO BE USED. THIS BURDEN IS ONLY TRIGGERED IF CDPH FIRST MEETS ITS BURDEN OF PROOF.

TRIAL PROCEEDINGS IN CASE ONE• CDPH WAS REPRESENTED BY AN IN-HOUSE CDPH LAWYER.

WHILE SHE IS TECHNICALLY A DEPUTY A.G., SHE WORKS EXCLUSIVELY FOR CDPH OUT OF CDPH OFFICES.

• CDPH WITNESSES INCLUDED THE SURVERYOR, THE DISTRICT MANAGER, THE BRANCH CHIEF, THE PATIENT, AND AN EXPERT IN OR NURSING FROM THE EAST COAST.

• FOR HOSPITAL A WE PRESENTED THE OR MANAGER AND A LOCAL OR NURSING EXPERT

• THE TRIAL LASTED TWO FULL DAYS. THE PARTIES THEN SUBMITTED WRITTEN CLOSING ARGUMENTS, FIRST BY CDPH, THEN BY HOSPITAL A, THEN A REBUTTAL BY CDPH. THIS BRIEFING WAS COMPLETED IN DECEMBER 2014. NO FINAL DECISION HAS BEEN RENDERED

TRIAL PROCEEDING IN CASE TWO• THE SUPERIOR COURT ACTION COMMENCED IN EARLY

DECEMBER 2014. CDPH WAS REPRESENTED BY TWO DEPUTY A.G.’S FROM THE SAN FRANCISCO OFFICE OF THE A.G. WITNESSES FOR CDPH WERE THE TWO SURVEYORS INVOLVED IN THE INVESTIGATION, THE BRANCH MANAGER, AN IN-HOUSE MEDICAL CONSULTANT WITH CDPH FROM SACRAMENTO, AND TWO EXPERT WITNESSES, A PHYSICIAN AND A RESPIRATORY THERAPIST.

• HOSPITAL B WITNESSES WERE THE V.P. OF QUALITY AND RISK, AND A RESPIRATORY THERAPY EXPERT WITNESS.

• AT THE CONCLUSION OF THE TRAIL THE JUDGE ISSUED A TENTATIVE RULING IN FAVOR OF THE HOSPITAL. ADDITIONAL CLOSING ARGUMENTS WERE HEARD ON FEBRUARY 26, 2015. A FINAL DECISION IS STILL PENDING.

WHY CHALLENGE CITATIONS AND FINES?• EFFECT ON CIVIL CASES: IN BOTH CASES THERE WERE

ACCOMPANYING CIVIL CASES. BOTH SETTLED BEFORE THE HEARINGS CHALLENGEING THE CITATIONS. HAVING APPEALS PENDING WAS A FACTOR IN NEGOTIATING THE SETTLEMENTS

• SENDING A MESSAGE TO CDPH: CDPH HAS BEEN MORE AGGRESSIVE RECENTLY IN ISSUING CITATIONS AND FINES FOR INCIDENTS THAT PREVIOUSLY WOULD NOT HAVE RESULTED IN SUCH. IN BOTH CASES, ONE OF THE MOTIVATING FACTORS FOR THE CLIENTS WAS CONCERN ABOUT FUTURE CITATIONS AND FINES, AND SENDING A MESSAGE TO CDPH THAT THEY WOULD FIGHT THEM.

• REDUCING THE FINE: IN BOTH CASES THERE WERE SETTLEMENT DISCUSSIONS PRIOR TO THE HEARINGS ON THE MERITS. IN BOTH CASES CDPH OFFERED SUBSTANTIAL DISCOUNTS OF THE FINE ONCE THE APPEAL PROCESS WAS UNDERWAY.