PALO VERDE HEALTH CARE DISTRICT REGULAR BOARD OF DIRECTORS MEETING MINUTES July 27, 2016 City Council Chambers

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4 PVHD BOD Meeting Minutes July 27, 2016 Page 1 of 6 PALO VERDE HEALTH CARE DISTRICT REGULAR BOARD OF DIRECTORS MEETING MINUTES July 27, 2016 City Council Chambers Directors Present Administrative Staff Present Sam Burton, Director Ms. Sandra Anaya, CEO Sandy Hudson, Director Ms. Christa Rohde, Assistant CFO Carmela Garnica, Director David Brooks, MD, Director TOPIC DISCUSSION ACTION 1.a. Call To Order Director Burton calls the meeting to order at approximately 5:04 p.m. 1.b. Pledge of Allegiance The Pledge of Allegiance was led by Director Brooks. M.D. 1.c. Roll Call Ms. Dakota Doyle conducts Roll Call. All members are present with the exception of Trina Sartin and Carmela Garnica. 2. Public Comment Director Burton calls for public comment. No public comment. 3. Approval of the Agenda Director Burton presents the Agenda for board consideration and approval. 4. Consent Agenda Director Hudson motions to approve the Agenda 3; Director Brooks seconds. Motion carried unanimously. 4.a. Review and Approval of Minutes from 6/22/ Medical Executive Committee Presented by Frank Arko, MD.,Chief of Staff 5.a. Verbal Medical Executive Committee Report and Updates Director Burton presents item 4.a. for board consideration and approval. Mohammad Bakhtavar, M.D. presents the Medical Executive Committee Report on behalf of Frank Arko, M.D. Mohammad Bakhtavar, M.D. reports that there are no Medical Executive Committee updates. Director Hudson motions to approve item 4.a.; Director Brooks seconds. Motion carried unanimously. 5.b. Credentialing and Reappointments Practitioner #5020 New Application Practitioner # New Application Practitioner # Mohammad Bakhtavar, M.D. presents item 5.b. for board consideration and approval in closed session. Prepared by D. Doyle 1

5 PVHD BOD Meeting Minutes July 27, 2016 Page 2 of 6 Reappointment Practitioner # Reappointment Practitioner # Reappointment 6. Reports 6.a. Board Report Presented by Trina Sartin, President No board report. [Director Carmela Garnica enters the meeting at approximately 5:08pm] 6.b. Administrative Updates Presented by Sandra Anaya, CEO Ms. Sandra Anaya reports item 6.b. and reports the following: Congressional visit by Dr. Raul Ruiz, 36 th District to PVH. o Congressman and his team were provided insight into the current issues affecting PVH and rural facilities. o Pledge to assist the hospital in several areas. Regulatory Compliance o CDPH Corrective Action Plan for May 2,3,4,5 Safety and Medication Error Reduction Plan [MERP] Licensing Survey was submitted and accepted; focus is on ensuring quarterly reporting and evaluation of MERP. o DNV Corrective Action Plan for May 13 and 14 survey was submitted and accepted. o Monitoring activities are in place, as follow up when needed. Program Updates o Designated Rural Status Awaiting word from DNV on how they can assist us. Spoke to Octavio Gonzalez, District Policy Director for Congressman Raul Ruiz. Will help us with CDHP if needed. PRIME Program o o o o Program provides incentives to improve the way care is delivered and to transition Alternative Payment Models. Plan was approved at the end of May, Preparing progress report which is due at end of September to provide initial planning activities. All eligible dollars paid to the hospital, other than IGT funds, are paid based on Prepared by D. Doyle 2

6 PVHD BOD Meeting Minutes July 27, 2016 Page 3 of 6 the hospital meeting the required performance measures. TCPI Program o Three [3] clinical health coaches were trained to help establish, coordinate and implement program activities. o Focus is on wellness and prevention for Medicare population. o Includes health screening and comprehensive care management. Diabetic Grant Program o On target with established milestones and reporting. o Will incorporate depression screening with use of evidence based tools. o Will continue to have monthly calls with program representative through HRSA. o Conference room will be utilized to start the health and wellness programs. o Diabetic Self-Management program will be implemented; Diabetic Educator will attend the Consortium Meeting on August 18 th to provide an overview of program activities. This will be a community program. Human Resource/Staff Development o Beta-rm ED Program Risk assessment will be conducted by Beta on August 30 and 31. Assessment is the foundation of their Quest for Zero program which focuses on improving outcomes in the ED to drive risk reduction. CE programs are associated with the program. Rural Trauma Class; presented by Abrazo o Course provided overview of immediate care for actual and potential trauma victims. o Staff knowledge will help with disaster planning as well. Radiology Contract Renewal o Terms of contract include Dr. Bowen being responsible for additional radiologic services and his own billing. o Hospital will pay a flat monthly rate. o Quality metrics are built-on for monitoring turnaround time. Policy o Updating Clinic policies o Starting to review Swing Bed standards Prepared by D. Doyle 3

7 PVHD BOD Meeting Minutes July 27, 2016 Page 4 of 6 and policy development. Human Resources o Having difficulty with recruitment of professional personnel: RN s, Lab Technologists. o Travelers also do not want to battle the heat. Plant Operations/Housekeeping o Final plans for CT have been submitted to OSHPD. If approved, bidding and advertising will be initiated. Want to get CT installed by first of year or shortly after. Directors Hudson and Garnica commented in regards to the article in the Palo Verde Times and that the hospital wasn t mentioned in Congressman Dr. Raul Ruiz s visit to Blythe. Ms. Anaya acknowledges and comments that she will write an article 6.c. Financial Updates Presented by Christa Rohde, Assistant CFO Ms. Christa Rohde reports item 6.c. and reports the following: IGT Funds were received this week approximately $430,000. Cash balance of approximately $2.1 million. Nearly done with the May charges in the new system. Goal is to have May, June and July financials completed by September 1 st. In regards to billing, wrapping up HMS this week with the expectation that HMS will not be accessible after August 1 st. All-Scripts billing is moving forward. Continuing to work with All-Scripts in building the patient module. Anticipate completing the payroll implementation in the next three weeks. o Including training for managers and employees on how to use the new system. 7. Action Items 7.a.Chief Executive Officer Agreement 7.b. Radiology Services Amendment Director Burton requests a motion to approve items 7.a., 7.b. and 7.c.. Director Hudson motions to approve item 7.a., 7.b., 7.c; Director Garnica seconds. Motion carried unanimously. Prepared by D. Doyle 4

8 PVHD BOD Meeting Minutes July 27, 2016 Page 5 of 6 7.c.Laboratory Director Agreement 7.d.Biennial Adoption of Conflict of Interest Code 8. Closed Session 8.a. Hospital Quality Assurance Report pursuant to Health & Safety Code b. Conference with Legal Counsel Existing Litigation Government Code (d) one case (1) Rutherford et al., v. PVHD, et al, USDC Case No.:EDCV JAK (OPx) 8.c. Conference with Legal Counsel concerning Potential Litigiation per Govt Code (d)(2) one case. 8.d. Report involving Trade Secret Discussion will concern proposed new services and facility. Estimated date of public disclosure: August Director Burton presents item 7.d. for board consideration and approval. Director Hudson makes a motion to table item 7.d. until further discussions with Ms. Sandra Anaya can take place. [The board steps out for closed session at approximately 5:30 p.m.] Director Hudson motions to table item 7.d.; Director Brooks seconds. Motion carried unanimously. 8.e.Credentialing for review and approval: Practitioner #5020 New Application Practitioner #5021 New Application Practitioner # Reappointment Practitioner # Reappointment Practitioner # Prepared by D. Doyle 5

9 PVHD BOD Meeting Minutes July 27, 2016 Page 6 of 6 Reappointment 9. Report After Closed Session Director Burton calls the meeting back to order at approximately 5:48 p.m. 10. Adjournment Director Burton adjourns the meeting at 5:49 p.m. Director Burton reports that the board voted and approved credentialing for practitioner #5020, practitioner #5021, practitioner #315152, practitioner #315229, and practitioner # The board took no further action in closed session. Sam Burton, Secretary Prepared by D. Doyle 6

10 Aminoglycoside Dosing Protocol Department: Pharmacy Function: Medication Management P & P Number: Pharmacy & Therapeutics 07/2016 Policy Protocol Procedure MEC Approval Date 07/2016 GB Approval Date 08/2016 Review Date 07/16 Initials AB I. Purpose: To provide a uniform and evidence based approach to aminoglycoside dosing. II. Affected Areas/Departments: All Departments that prescribe and dispense drugs. III. Policy The protocol is to standardize aminoglycoside therapy in order to maximize both safety and efficacy. IV. Procedure: A. The physician will assess the need for aminoglycoside therapy. Clinical factors such as results of the CBC and differential, C&S, gram stain, x-rays and the past and current status of the patient will be considered. B. When the physician wishes the pharmacy staff to regulate the aminoglycoside dosing, he/she should decide on the appropriate aminoglycoside to use (gentamicin, tobramycin, or amikacin) C. The physician should enter an order for Gentamicin Pharmacy to Dose, or Tobramycin Pharmacy to Dose or Amikacin Pharmacy to Dose in the EMR. After the pharmacist verifies the ordered request, he/she will obtain the following information from the patient s chart prior to initiation of therapy. 1. Height/weight 2. Age/sex 3. Serum creatinine/bun 4. CBC with differentials 5. Site of infection 6. Suspected/confirmed organisms (C&S) 7. Concurrent problems 8. Concurrent medications

11 9. Highest temperature for the past 24 hours D. If a recent serum creatinine is not available, appropriate lab tests may be ordered by the pharmacist as a part of the necessary baseline information. E. Based on the information obtained, an appropriate dose and interval will be calculated. The pharmacist will enter the order for the aminoglycoside in the EMR. A summary of the pharmacist assessment and recommendations shall be entered in the Progress Notes section of the EMR. F. If the pharmacist or physician determines that a change in dosage is necessary, the pharmacist will calculate a new regimen from the data available and discuss the results with the physician. G. Serum creatinine determination will be made every 3 days after the baseline level is known. The physician or pharmacist may order serum creatinine as often as necessary when the renal function changes or becomes unstable. H. The pharmacist will leave regular notes in the Progress Notes section of the EMR. These notes will inform the physician of the patient s progress. The physician does not have to be contacted verbally unless a significant change has occurred. V. EXTENDED-INTERVAL AG (also called once-daily ) THERAPY 1. The pharmacist will determine if the patient is a candidate for High-Dose aminoglycoside dosing. The following patient populations will be excluded from High-Dose therapy: 2. Pediatric (less than 18 years old) 3. Age greater than 60 years 4. Creatinine clearance less than 40ml/min 5. Pregnant 6. Burn patients 7. Patients with ascites 8. Dialysis patients 9. Enterococcal endocarditis 10. Febrile neutropenia B. Patient s estimated aminoglycoside elimination half-life is 5 hours or greater C. If the patient is a candidate for High_Dose aminoglcoside therapy the dose will be based on the patient s estimated Ideal Body Weight (IBW), rounded to the nearest 20mg for gentamicin/tobramycin, and 50mg for amikacin. 1. Standard gentamicin or tobramycin = 7mg/kg 2. Standard amikacin = 25mg/kg

12 3. The above doses are based on an assumed distribution volume = 0.3mg/kg. D. The goal of therapy is to achieve an aminoglycoside peak/mic ratio of at least 10:1. Larger or smaller doses may be desired depending on the volume of distribution of the patient and/or the MIC of the organism being treated. E. Order a single serum aminoglycoside concentration (SDS) 6 to 14 hours after the time the dose is administered. Refer to the nomogram (see below) to determine the dosing interval for gentamicin or tobramycin. Nomogram for assessment and adjustment of AG serum level following a 7mg/kg dose (Tobramycin and Gentamicin). Nicolau, et al. VI. CONVENTIONAL THERAPY VII. A. For conventional aminoglycoside dosing, determinations will be based on pharmacokinetic formulas listed in Appendix 2. B. Once therapy has been initiated, peak and trough levels obtained after the third dose to confirm the safety and the existence of the therapeutic concentrations. C. Trough levels: 30 minutes prior to the scheduled dose D. Peak levels: 1 hours after the IM dose or 30 minutes after completion of a 30 minute infusion E. Goals for peaks and troughs are found in the chart below. GOAL RANGES FOR AMINOGLYCOSIDE THERAPY (Conventional Dosing) Indication for therapy Gentamicin/Tobramycin Amikacin Peak (mcg/ml) Trough (mcg/ml) Peak (mcg/ml) Trough (mcg/ml)

13 Pneumonia 7 10 Less than Less than 10 Sepsis of 7 10 Less than Less than 10 unknown origin UTI sepsis 5 7 Less than Less than 10 Neutropenic 5 7 Less than Less than 10 fever Intraabdominal 5 7 Less than Less than 10 infection Complicated 5 7 Less than Less than 10 skin/soft tissue infection UTI/cystitis 4 6 Less than Less than 7 Synergy for gram positive endocarditis (gentamicin) 2 4 ~1

14 Vancomycin Dosing Protocol Department: Pharmacy Function: Medication Management P & P Number: Pharmacy & Therapeutics 07/2016 Policy Protocol Procedure MEC Approval Date 07/2016 GB Approval Date 08/2016 Review Date 07/16 Initials AB I. Purpose: To provide a safe and efficacious vancomycin therapy using evidence based practices. II. Affected Areas/Departments: All Departments that prescribe and dispense drugs. III. Policy Vancomycin orders will be assessed, dosed, and monitored by the Pharmacy department. IV. Procedure: A. When a physician places the order, Vancomycin per Pharmacy Dosing 1. A Pharmacist will assess the appropriateness of therapy and order initial laboratory values that aid in pharmacokinetic dosing 2. A nurse will a. Dosing guidelines found in APPENDIX A a. re-verify the patient s height in centimeters and weight in kilograms and call the Pharmacy with the values b. provide the dose to the patient as scheduled on the MAR B. Intravenous vancomycin will be given to adult patients, 18 years old C. Monitoring 1. Physicians will reassess the appropriateness of therapy daily a. Suspected adverse reactions will be reported to the physician for re-evaluation of drug therapy 2. Pharmacists will order laboratory values that monitor for safety and efficacy.

15 3. Laboratory personnel will obtain levels on schedule and verify the when the last dose of vancomycin before drawing blood Appendix A: Vancomycin Dosing Guidelines Background Vancomycin is a glycopeptide antibiotic used to treat penicillinase-producing strains of Staphyloccocus aureus and works by inhibiting bacterial cell wall synthesis. It has a timedependent bacteriocidal activity and is notorious for ototoxicity and nephrotoxicity. Before the advent of the Center for Drug Evaluation and Research (CDER), an organization responsible for approving proprietary drug names, vancomycin was known as brand name Vancocin - to take after the word vanquish. Vancomycin was also initially dubbed as Mississippi mud due to the impurities that gave it a brown color. Patient-specific Pharmacokinetic Parameters The patient-specific information that needs to be gathered for appropriate vancomycin dosing parameters are: 1) Height in centimeters 2) Weight in kilograms 3) Age in years 4) Sex 5) BUN 6) Serum creatinine 7) Complete blood count with differentials 8) Site of infection 9) Concurrent problems Before calculating any pharmacokinetics, it is important to identify if the patient falls into one of the following special populations: 1) obesity, actual body weight (ABW) 120% of ideal body weight (IBW); 2) hemodialysis; 3) pregnancy; 4) amputation. These populations have special considerations that must be weighed into their pharmacokinetic calculations. See APPENDIX B for the aforementioned special considerations. An equation list, located on APPENDIX C, will help estimate patient-specific pharmacokinetic parameters such as vancomycin clearance (CL vanco ), half-life (t 1/2 ), volume of distribution (V d ), elimination constant (k el ). These parameters will determine the patient s loading dose (LD), maintenance dose (MD), frequency of dosing (T), and rate of infusion (t in ). Loading Dose (LD): Do not delay a vancomycin loading dose because of pharmacokinetic calculations. Provide the patient with a single gram of vancomycin over one hour before estimating a loading dose. An additional dose, to appropriately load the patient, may be provided after the end of the first infusion. If one gram of vancomycin is more than the estimated loading dose, then it is still

16 clinically justified as the benefits of treating a serious gram-positive infection out-weigh the risk for nephrotoxicity. Provide the patient with vancomycin 1 gram IVPB over 1 hour initially, and then provide the patient with an additional dose immediately following the first gram to adequately load the patient (if necessary). The loading dose is calculated as where C p is the desired peak, 35 mg/l. Maintenance Dose (MD), Dosing Interval ( ), and Rate of Infusion (t in ): A maintenance dose is derived from the steady-state equation and assumes a desired vancomycin trough at steady-state, C ss,min, of 10 mg/l. A goal trough for deep seeded infections (pneumonia, osteomyelitis, endocarditis, and meningitis) is 15 to 20 mg/l. You will need the patient-specific pharmacokinetic parameters as well as the dosing interval and infusion time. The dosing interval is based on the patient-specific t 1/2 and is expressed as. T is 2 times the t 1/2. Choosing the nearest 8 hour interval may ease dosing administration. Selecting a rate of infusion, t in, is important in avoiding an infusion-related reaction known as Red Man Syndrome. This is likely to happen when 500 mg of vancomycin is infused in 30 minutes. For quantities 1 gram, infuse over 1 hour For quantities > 1 gram, infuse over 2 hours When determining the MD, we can use either the IV bolus model or short-infusion model. The short-infusion model applies to all situations of first-order kinetics. The IV bolus model is an abbreviated method that is valid when 6t in <t 1/2. IV bolus method: Short-infusion method: Revision of Initial Regimen Sudden changes in renal function and a subtherapeutic or supratherapeutic vancomycin trough warrants a revision of the dose.

17 Serum creatinine increases of >0.5 mg/dl (or 50%) suggests vancomycin-induced nephrotoxicity. When nephrotoxicity occurs, it is important to reassess the patient s antibiotic regimen with the physician staff and weigh the benefits of continuing therapy with the risks of severe adverse reactions. If vancomycin use is still appropriate, then draw a trough level just before the next due dose and hold the dose until the results return. Revise k el and determine a new regimen. Vancomycin troughs <10 mg/l encourages antibiotic resistance, while supratherapeutic vancomycin troughs between 30 to 65 mg/l has been associated with nephrotoxicity. If the vancomycin trough concentration is supratherapeutic or subtherapeutic, then the following questions must be answered 1. Was the value drawn appropriately? 2. Was this patient s renal function estimated appropriately? 3. Was this patient s vancomycin V d estimated incorrectly? Was the value drawn appropriately? An appropriately drawn vancomycin trough occurs 0.5 hours or less prior to the next administered dose, has prior administrations of vancomycin doses done as scheduled, and was drawn after the line was flushed. Investigate if these criteria have been met by contacting the corresponding responsible hospital staff. Failure to comply with appropriate draws warrants a medication error report (form PHPR3910), corrective feedback to staff, and a redraw of the vancomycin trough. Was this patient s renal function estimated appropriately? Patient s creatinine clearance is estimated using the Cockcroft-Gault equation and remembering to decrease it by 15 ml/min when the albumin is less than 3.0 mg/dl is easily missed when obtaining baseline pharmacokinetic parameters. If the patient s renal function has not changed, then re-estimate the creatinine clearance for the patient and see if it accounts for the out-of-range trough. The Cockcroft-Gault equation is not a perfect estimate of a patient s vancomycin clearance; errors in estimation occur mostly in obese and elderly patients. If the Cockcroft-Gault estimation does not clinically correlate with your patient, then revise k el and determine a new regimen. Was this patient s vancomycin V d estimated incorrectly? The volume of distribution is the most ignored pharmacokinetic parameter in vancomycin dosing and needs two post-distributive levels in order to evaluate. When predicted values are much greater or much less than the calculated value, it is warranted to use two post-distributive levels to calculate a new k el and V d. How to Revise a Regimen Method 1: Revising Cl vanco If the renal function has changed or if the trough was slightly under or over-estimated, then this method is recommended. First provide a best estimate for steady-state peak and trough (C ss,max and C ss,min respectively).

18 1., where C meas is the value obtained ½ hour prior to the next dose It is easier for the laboratory technicians and nurses to time the trough a half-hour prior to the next dose, hence the 0.5hr value in the equation above. Adjust the elapsed time based on how close the trough was drawn with respect to the next dose. 2. Revise the k el and assume that the IV bolus model is valid. 3. Recalculate the patient specific pharmacokinetic parameters using the new k el and original V d, and adjust the regimen. Method 2: Revising V d If the patient s renal function has not changed and the trough was grossly under or overestimated, then this method is recommended. Use the best steady-state peak and trough (C ss,max and C ss,min respectively) using the steady-state equation. Then calculate the new volume of distribution using the new elimination constant and the best peak and trough estimates. Recalculate the patient specific pharmacokinetic parameters using the new V d and original Cl vanco, and adjust the regimen. Monitoring Toxicity Common toxicities with vancomycin include red man syndrome, nephrotoxicity, and ototoxicity. Red man syndrome is associated with a histamine release and manifests as tingling and flushing of the face, neck, and upper torso during rapid infusions of >500 mg of vancomycin over 30 minutes. Vancomycin as a monotherapy antibiotic has an incidence of nephrotoxicity between 5 to 7%. Reported incidence has increased with concomitant use of aminoglycosides or other nephrotoxic agents. There is no established evidence that maintaining vancomycin serum concentrations within a given range can prevent nephrotoxicity. In addition nephrotoxicity with

19 this drug has been associated with older age, longer treatment courses, and higher serum trough concentrations (30 to 65 mg/l). Vancomycin destruction of glomeruli and necrosis of the proximal tubule are thought to be due to oxidative stress that is usually reversibly. The reported incidence of vancomycin-induced ototoxicity is between 1 to 9% and has been associated with serum concentrations above 40 mg/l. It is characterized as damage to the auditory nerve that initially affects high-frequency sensory and then middle and low frequency sensory. High-tone deafness occurs before low-tone deafness at all frequencies and is permanent. Nevertheless, severe ototoxicity from this drug is rare, and monitoring of serum vancomycin levels to prevent ototoxicity is not recommended. The following parameters will be used to monitor for vancomycin toxicity: 1. Daily serum creatinine hour urine output 3. BUN 4. Renal specific electrolytes: potassium, magnesium, and phosphorous Efficacy In 2006, the Clinical and Laboratory Standards Institution (CLSI), lowered the susceptibility of vancomycin to minimum inhibitory concentrations (MIC) 2 mg/l. There is little data showing that appropriate vancomycin dosing reduces mortality in patients infected with MRSA, however vancomycin serum troughs of <10 mg/l may predict therapeutic failure and the potential for vancomycin resistance. It is advised to continue vancomycin therapy if the sensitivities show an MIC 1 mg/l and an achievable area under the curve (AUC) to MIC ratio can be sustained at Cultures and sensitivities a. Minimum inhibitor concentration (MIC) >1 is a strong predictor of vancomycin failure 2. Area under the curve by adding Lin trap and Log trap together and account for a 24 hour dose. The AUC 0-24hr to MIC ratio must be greater than Vancomycin trough a. Should be drawn no sooner than at steady-state b. With prolonged use (>5 days), it is reasonable to monitor a vancomycin trough once weekly Appendix B: Vancomycin Special Considerations

20 Obesity In patients with a total body weight (TBW) 120% of ideal body weight (IBW), but not 300% of IBW, it is best to use the Leonard and Boro model and adjusted body weight (ABW) to calculate vancomycin clearance. Providing obese patients with 15 mg/kg every 8-12 hours may lead to supratherapeutic levels. It is recommended to stay within either: 1) 10 mg/kg every 12 hours using TBW 2) 15 mg/kg every 24 hours using TBW Hemodialysis PHLB contracts with Davita Dialysis that provides hemodialysis with the 2008K 2 Hemodialysis by Fresenius Medical Care. It is anticipated that one-third of vancomycin is pulled per hemodialysis session. Amputees These populations have special considerations that must be weighed into their pharmacokinetic calculations. When calculating their clearance, it is best to use their IBW based on how tall they were originally. Pharmacokinetic Parameter Ideal Body Weight, IBW Adjusted Body Weight, ABW Estimated Creatinine Clearance, CrCl Equation Variables Comments x h TBW SF wt Resulting units expressed in kilograms height in inches Total Body Weight resulting units expressed as ml/min

21 Pharmacokinetic Parameter Vancomycin Clearance, Cl vanco Volume of distribution, V d Elimination constant, k el Half-life, t 1/2 Equation Variables Comments use ABW if obese, otherwise use IBW Leonard and Boro model If CrCl 60ml/min If CrCl <60ml/min

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