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Based on interview and credential file review, the facility failed ensure, two (Physician 3 and 4) of five physician's credential files reviewed, contained documented evidence of current competency (experience) as a basis for privileges granted at time of reappointment to the medical staff.
This practice increased the risk of a poor health outcome for all facility patients in a universe of 22 patients.

Findings:

During a review of the credential file for Physician 3, the Clinical Privileges list, dated June 30, 2014 to May 31, 2016, indicated that Physician 3 received approval for ERCP privileges (endoscopic retrograde cholangiopancreatography -a surgical procedure to evaluate the gall bladder and pancreas) at time of reappointment. Further review of the credential file indicated no documented evidence of current competency for the ERCP.

During an interview with DMS and the MSC on October 20, 2015, at 8:40 AM, the DMS and the MSC reviewed the credential file for Physician 3 and were unable to find documentation of current competency (experience) for the ERCP procedure.

During a review of the credential file for Physician 4, the Clinical Privileges list, dated September 28, 2015 to July 31, 2017, indicated that Physician 4 received approval for Pericardiocentesis procedure privileges (a needle advanced into the area around the heart to draw off excess fluid to allow the heart to beat normally) at time of reappointment. During a review of the OPPE (Ongoing Professional Practice Evaluation) for Physician 4, dated September 21, 2015, indicated no documented evidence that Physician 4 had performed a Pericardiocentesis, or any other clinical activity, in the past two years.

During an interview with the DMS (Director of the Medical Staff) and the MSC (Medical Staff Coordinator) on October 21, 2015, at 9:15 AM, the DMS and the MSC reviewed the credential file for Physician 4 and were unable to find documentation of current competency (experience) for the Pericardiocentesis procedure.

During an interview with the DMS on October 21, 2015, at 2:10 PM, the DMS stated that Physician 4 had been in an administrative role and therefore had no clinical activity. The DMS stated that the facility planned to change Physician 4's medical staff status from Active medical staff to Associate medical staff, due to his current administrative position.

The facility Medical Staff Bylaws, dated September 29, 2014, indicated "Basis for Privileges Determination. Requests for clinical privileges shall be evaluated on the basis of the Member ' s education, training, experience."

Based on interview and credential file review, the facility did not ensure that one (1) of five physician credential files (Physician 5) contained documented evidence of competence (experience) as a basis for privileges granted at time of initial appointment to the medical staff. This practice increased the risk of a poor health outcome for all facility patients in a universe of 22 patients.

Findings:

During a review of the credential file for Physician 5, the Clinical Privileges list, dated June 29, 2015 to May 31, 2017, indicated the clinical privileges granted to Physician 5. Further review indicated no documented evidence of competency (experience) as a basis for any of the privileges granted at the time of initial appointment to the medical staff.

During an interview with DMS (Director of the Medical Staff) and the MSC (Medical Staff Coordinator) on October 20, 2015, at 8:40 AM, the DMS and the MSC reviewed the credential file for Physician 5 and were unable to find documentation of competence (experience) for the privileges granted at the time of initial appointment to the medical staff.

The facility Medical Staff Bylaws, dated September 29, 2014, indicated "Basis for Privileges Determination. Requests for clinical privileges shall be evaluated on the basis of the Member's education, training, experience, demonstrated professional competence and judgment, observed clinical performance, performance of procedures with such frequency as to maintain the practitioner's skills and knowledge, professional liability claims, adverse actions by other hospitals or professional entities, and the documented results of patient care and other quality review and monitoring that the Medical Staff and the Governing Board deem appropriate."

Based on observation, interview, and record review, the hospital failed to ensure medications were stored in accordance with manufacturer's specifications and facility policy. This failure had the potential to expose patients to medications that may not have the same potency or integrity intended by the manufacturer or prescriber. Administering a medication with less potency or has been degraded to a patient can lead to patient harm by not providing the full treatment effect in a universe of 22 patients.

Findings:

1. During a tour of the Pharmacy Department on October 19, 2015, at 10:30 AM, the following medications were observed to be stored on pharmacy shelves in storage bins and exposed to light:

a. Two (2) ampules of Digoxin (a medication used to treat abnormal heart rhythm) 0.5 mg (milligram)/ml (milliliter) solution for injection

b. Five (5) vials of Cefazolin (a antibiotic used to treat infections) 10 gm powder for reconstitution

c. Five (5) vials of Cefuroxime (a antibiotic used to treat infections) 750 mg powder for reconstitution

d. Seven (7) vials of Ceftriaxone (a antibiotic used to treat infections) 2 gm powder for reconstitution

During a concurrent interview with the Director of Pharmacy, he confirmed that the medications were exposed to light and stated that he would have his staff remove the exposed medications and store the remaining supply in light protective containers.

A review of the manufacturer package insert information (a document provided by medication manufacturers that provide detailed information about the medication, including recommended storage conditions) for each medication indicated the following:

a. Digoxin package insert states, under the section How Supplied/Storage and Handling, "Protect from light".

b. Cefazolin package insert states, under the section How Supplied, "Before reconstitution PROTECT FROM LIGHT".

c. Cefuroxime package insert states, under the section How Supplied, "Cefuroxime should be.....protected from light".

d. Ceftriaxone package insert states, under the section How Supplied, "Storage Prior to Reconstitution: Protect from light."

A review of the hospital policy and procedure titled Medication Procurement, Storage, Security and Inventory Control", dated "01/15" (January 2015), states, "Medications are to be stored in a sanitary manner, under proper environmental conditions (lighting, temperature, moisture, and ventilation)....". It further states under a section titled Storage, "Medications are stored under proper conditions to assure stability of that medication".

2. During a tour of the PACU (post anesthesia care unit) on October 19, 2015, at 3:45 PM, the medication refrigerator was inspected. Observed to be stored in the freezer portion/section of the refrigerator were 3 bags of 0.9% Sodium Chloride (normal saline - a fluid medication used to hydrate patients) 1 Liter for IV (intravenous - in the vein) injection. In one of the bags, it was observed that the liquid was not clear, but was opaque (cloudy) and slushy (thick). The fluid was more solid than liquid and appeared to be reaching a frozen state.

During a concurrent interview with the Operating Room Charge Nurse, she confirmed that the bag contained an opaque, slushy looking fluid that was not fully liquid or solid. When asked, "Does this look frozen to you?", she responded, "Definitely".

During an interview with Pharmacy Technician 1 on October 19, 2015, at 4:15 PM, he was asked if he knew that the bags were being stored in the freezer section of the PACU refrigerator. He stated, "We were cleaning out the fridges last week, I accidentally put them in there".

A review of the medication bag and the storage recommendations printed on the bag by the manufacturer indicated, "Recommended storage: Protect from freezing".

A review of the hospital policy and procedure titled Medication Procurement, Storage, Security and Inventory Control", dated "01/15" (January 2015), stated, "Medications are to be stored in a sanitary manner, under proper environmental conditions (lighting, temperature, moisture, and ventilation)....". It also states under a section titled Storage, "Medications are stored under proper conditions to assure stability of that medication". The policy, under the section "Storage of medications in patient care areas", it states, "The proper environmental control (i.e. proper temperature, light, humidity) will be maintained wherever medications are stored in patient care areas.

Based on observation, interview, and record review, the hospital failed to ensure that all medication orders were accurately reviewed for appropriate dosing by a pharmacist prior to dispensing and administering to the patient. This failure had the potential to dose the patient with an amount of medication different than what the prescriber intended which could lead to patient harm in a universe of 22 patients.

Findings:

During a patient medication regimen review on October 20, 2015, at 11:00 AM, it was observed that Patient 33 had a insulin aspart (a medication used to control high sugar in the blood) order with the following parameters:

a. BS (blood sugar result) 0-60 Give 1 AMP (ampule) D50 (Dextrose 50% - a highly concentrated intravenous (in the vein) medication given to increase blood sugar) IVP (intravenous push - a procedure where the medication is given quickly into the vein)
b. BS below 200 = no insulin coverage (do not give insulin)
c. BS 201-250 Give 2 units
d. BS 251-300 Give 4 units
e. BS 301-350 Give 6 units
f. BS 301-350 Give 8 units
g. BS 351-400 Give 8 units
h. BS 351-400 Give 10 units
i. BS Greater than 401 call MD (medical doctor)

During an interview with the Director of Pharmacy on October 20, 2015, at 4:00 PM, he was asked why the parameters were duplicate for BS 301-350 and BS 351-400. He stated, "I talked with my pharmacist about that. My pharmacist just missed it." When asked if it was possible that the patient could receive different amounts of insulin for the same blood sugar result, he stated, "Yes".

During a concurrent review of the patient's medication administration record, the record indicated that a dose of insulin was given on October 15, 2015, at 5:38 PM. The blood sugar result was 324, which, according to the parameters of the order, 6 or 8 units of insulin should be given. The amount of insulin documented by nursing was only 3 units.

A review of the facility policy & procedure titled "High Risk / High Alert Medications", dated "9/13", indicates that "Insulin Products" are listed as a High Risk/High Alert medication. Under the policy section, it states, "High Risk/High Alert medications are drugs with higher potential for significant patient harm when error is committed in use. Because the consequences of an error associated with use of one of these medications can result in significant patient injury, special precautions will be employed with their overall management throughout the institution."

A review of the Institute for Safe Medication Practices (ISMP -an organization regarded as an authority on the safe use of medication) List of High Alert Medications in the Acute Care Settings, states that, "High alert medications are drugs that bear a heightened risk of causing significant patient harm when they are used in error." Insulins are included on the ISMP list.

Based on observation, interview, and record review, the hospital failed to ensure outdated medications were not available for immediate patient use. This failure had the potential for medications to be used past their expiration date and for the patient to receive a medication that may not provide the full treatment benefit as intended by the manufacturer and prescriber which could lead to patient harm in a universe of 22 patients.

Findings:

During a tour of the pharmacy department on October 19, 2015, at 10:30 AM, it was observed that 6 boxes of medication containing Gentamicin (a antibiotic used to treat infections) 80 mg (milligram) / 50 mL (milliliter) of NS (normal saline - a fluid used to mix with other medications for injection into the body) were stored on the pharmacy storage room shelves. Each box contained 24 units of the medication. The boxes were labeled with a manufacturer stamped expiration date of "12/07" (December 2007). In addition, there were small yellow sticky notes labeled by pharmacy personnel with "Exp. 12/07" (Expires December 2007). On one of the boxes, a wholesaler invoice was attached and dated with a delivery date of "1/23/06" (January 23, 2006). One of the boxes was opened and several units of the Gentamicin medication units were removed. It was observed and confirmed that the Gentamicin medication units were stamped by the manufacturer with an expiration date of December 2007.

During a concurrent interview with the Director of Pharmacy, he confirmed that the medication was expired and available for immediate patient use.

A review of facility policy & procedure titled "Medication Procurement, Storage, Security and Inventory Control", dated "01/15" (January 2015), states, "Expired, damaged and/or contaminated medications will be stored in an isolated area in the Pharmacy Department that has been designated for the storage of such unusable drugs. The drugs shall remain there until proper disposal or pick up can be made.

Based on observations, interviews and record reviews, the hospital failed to develop a system for identifying, investigating, controlling infections, and ensuring sanitary conditions to maintain a safe environment free from the possibility of spreading infection, and communicable diseases. The facility failed to ensure the following:

1. Failed to ensure nursing staff from the emergency room demonstrated proper disinfection of the glucometer (a testing device that measures blood sugar levels) according to manufacturer's recommendations.

This deficient practice had the potential to jeopardize the health and safety of the patient population and could cause transmission of hospital acquired infection among patients receiving emergency care in the Emergency Room.

2. Failed to ensure all surgical instrument tape was intact and in good condition before surgical instruments were cleaned and prepared for use in surgery.

This practice increased the risk of infection for all patients receiving surgical services in a universe of 22 patients.

3. Failed to ensure the " ice machine" was kept clean and sanitary at all times to prevent transmission of food- borne illness among patients in a universe of 22 patients.

Findings:

During a tour of the emergency room, (ER) on October 19, 2015, at 10:15 AM, with the Registered Nurse 1/ Charge Nurse, a glucometer was observed in medication room. RN 1 was asked to demonstrate how he disinfects ( process of killing harmful bacteria) their glucometer after each patient's use.

In a concurrent interview with RN 1, he stated, the emergency room used the device called " Nova Stat Strip Glucose Meter, to check patients' blood sugar level. He stated, he used the glucometer on multiple patients. He will take the glucometer at the patient's bedside and test their blood sugar. After using the glucometer, he wiped the outside of the glucometer and the area where blood is tested with alcohol pads and he dries the outside of the glucometer, immediately with dry wipes to protect the screen. He stated, "we do not use bleach, because it will ruin the screen."

During interview with the nurse manager, on October 19, 2015 at 10:20 AM, he stated, staff should clean and disinfect the glucometer with fresh germicidal wipes after each patient's use. He acknowledged the use of alcohol pads would not properly disinfect the glucometer and could cause transmission of blood borne pathogens (a microscopic organism such as the hepatitis B virus, a virus which can cause a serious liver disease) and other infections to patients and personnel.

A review of "manufacturer's recommendation, for glucometer, " Nova Stat Strip Glucose Meter," under, " Validated Cleaning and Disinfection Procedure," indicated, " All meter external surfaces should be cleaned and disinfected with a fresh Clorox Germicidal Wipe,....To clean the meter, remove a fresh germicidal wipe from the canister and wipe the external surface of the meter thoroughly. To disinfect the meter... using a new, fresh germicidal wipe, thoroughly wipe the surface of the meter ( top, bottom, left, and right sides) a minimum of three times horizontally and three times vertically avoiding the meter's bar code scanner ...Ensure the meter surface stays wet for one minute and then allowed to air dry for additional one minute.....Clorox germicidal wipes are the only product validated for use with the StatStrip and StatSensor systems."

A review of APIC ( Association for Practitioner in Infection Control ) publication dated, July 30, 2009, titled, "Position Paper: Safe Injection, Infusion and Medication Vial Practices in Healthcare, indicated, to "Clean and disinfect glucometer, if they must be reused between patients.... Disinfect the exterior surfaces of the glucometer after each use following the manufacturer's directions. Use an EPA-registered disinfectant effective against HBV ( Hepatitis B Virus ), HCV( Hepatitis C Virus ) and HIV ( Human Immunodeficiency Virus ), or a 1:10 bleach solution (one part bleach to 9 parts water). "


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2. During an observation on October 19, 2015, at 9:30 AM, in the sterile processing department, there was chipped surgical tape noted on a surgical clamp in the minor tray. Another surveyor confirmed the observation of chipped surgical tape on the surgical clamp. During a concurrent interview with Sterile Processing Department Technician (SPD tech. 1), he confirmed that surgical tape was present on the surgical clamp in the minor tray, and present on other surgical instruments in the sterile processing area.

The facility policy and procedure titled " Identification Tape Application Instructions " , dated April 2014, indicated, " Replace tape when it starts to chip, flake or lift off the instrument. "



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3. During an observation on the initial tour accompanied by the Director of Food and Nutrition (DFN), on October 20, 2015, at 9:50 AM, it was observed that the ice machine was located in the "Cold prep room". The top surface along the edge where the hinge of the ice bin's door was, it was observed that it was covered with visible dusty white fragments adhering to the sticky top surface. The DFN wiped the surface with a dry and clean paper towel and the surface produced a grayish and greenish colored smear on the towel.

Further observation of the ice machine's top compartment, a vent outlet (for heat exhaustion to keep the machine cool) on the front panel of the compartment was covered with visible dirt.

During a concurrent interview with DFN, she acknowledged the surface was not cleaned. When asked how often the ice machine's outside surface was clean, she stated it was cleaned daily. She did not know why the surface was sticky.

During an observation of the same ice machine with the DFN and the Supervisor for Engineering (SE), on October 20, 2015, at 10:00 AM, after the SE had opened the top compartment on top of the ice bin, the inside surface compartment was covered with heavy white buildup and rusty colored spots on the bottom surface. A metallic tray located directly under the ice-making container contained water dripped from the ice-making compartment. Within the metallic tray, there was white and pinkish colored fiber-like substance floating and scattered about.

During a concurrent interview with SE, he acknowledged the inside surface of the ice machine's top compartment were covered with buildup. He stated the ice machine was checked and sanitized two weeks ago. He did not know if the surface was cleaned as part of the sanitizing process of the machine.

A review of the ice machine's "Service manual" provided by the facility, under section "Maintenance" for the "stainless steel exterior, indicated "to prevent corrosion, wipe the exterior occasionally with a clean and soft cloth."