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Based on interview and record review, the hospital failed to provide every patient (including Patient 94) and/or patient's representative the correct phone number and address, for filing complaints with the State agency which has licensure responsibility over the hospital. This failure had the potential for unresolved complaints or grievance for a universe of 107 patients.

Findings:

During an interview with Patient 94 on December 10, 2014 at 2:25 PM, Patient 94 stated that upon admission, the hospital staff provided multiple documents to her and her daughter, including a booklet titled "Your Hospital Stay". Patient 94 provided the booklet to the surveyor.

During a review, on December 10, 2014, of the facility booklet titled, "Your Hospital Stay" (undated) under "Your rights as a Patient in California," provided patients' information where they could file a complaint about their care to different entities. Included in the booklet was the California Department of Public Health's (CDPH) address and telephone number.

During the same review, the printed address found inside the booklet was 625 Carnegie Dr. # 280 San Bernardino, CA 92408-3577 and the telephone number was (909) 388-7170, the address and telephone number were incorrect. The correct address and telephone number of San Bernardino CDPH is, 464 West 4th Street, Suite 529, San Bernardino, California 92401. The telephone number is (909) 383-4777. This descripancy was brought immediately to the attention of the Quality Coordinator (QC-A) who was accompanying the surveyor during the survey.

Quality Coordinator A was immediately observed making a call to the number printed on the booklet and confirmed that it was a different State agency district office.

During an interview with the QC-A on December 10, 2014 at 3:45 PM, the QC-A stated that this booklet, referring to "Your Hospital Stay," was given to all patients and/or patient's representative, on admission to the hospital. She also stated that the error was not caught until when it was brought to her attention by the surveyor.

During a review of the Policy and Procedure titled, "Hospital Patient Grievance" review date of September 2014, stipulated, "The patient has the right to be informed of the patient Grievance process. The process is published in the 'Patient Handbook'."

Based on interview and record review, the facility failed to ensure documented evidence (written proof) of current competence (demonstrated ability to perform the procedure) for a privilege (facility approval to perform the procedure) granted to one of eight physicians (MD 1). This practice increased the risk of a poor health outcome for all facility patients.

Findings:

During a review of the credential file (written proof of education, training and medical license) for MD1, the facility "Department of Family Medicine Request for Clinical Privileges," dated April 9, 2013, indicated the privilege to perform a "Paracentesis" (a needle procedure to remove a collection of fluid from the abdomen) was requested by MD1 and granted by the facility. However, the credential file for MD1 did not contain documented evidence of experience/competence in Paracentesis during the last reappointment (renewal of medical staff membership and privileges) period.

During an interview with Staff 1, on December 10, 2014, at 2:20 PM, she reviewed the physician credential file for MD1 and was unable to find documentation of MD1's demonstrated current competency/experience for the Paracentesis procedure. During a follow up interview with Staff 1, on December 12, 2014, at 9:05 AM, she confirmed there was no documented evidence that MD1 had performed a Paracentesis, during the recent reappointment period, and the facility withdrew the privilege.

The facility "Department of Family Medicine Request for Clinical Privileges," approved 6/ 2011, indicated "Determination of Current Competence. As indicated within the individual privileges, practitioners (such as physicians, nurse practitioners) must show evidence of current competence in the past two years when requesting the Privilege, as required by the Joint Commission (National organization that evaluates healthcare quality)... Documented Proficiency: Where indicated, the applicant must substantiate (show proof to support) the request for privileges by providing evidence of current competence."

The facility "Bylaws of the Professional Staff," dated 2011, indicated "Section B-1.c. General Qualifications (skills needed) for Membership. To qualify for and continue membership on the Professional Staff a practitioner must: 1. Document and submit evidence of his or her experience, background, training, demonstrated ability...4. Perform a sufficient number (enough to meet the needs of a situation) of procedures, manage a sufficient number of cases, and have sufficient patient care contact within...to permit the Professional Staff to assess (judge) the applicant's current competency for all privileges, whether requested or already granted." Also, "Section H-3. Renewal of Privileges. At the time of reappointment, each staff member shall submit a written request for specific privileges. Privileges are granted for a period not to exceed two (2) years."

Based on observation, document review, and staff interview, the hospital failed to
1. Ensure sevelamer (a phosphorus binder, used to prevent hypocalcemia caused by high phosphorus level in patients with chronic kidney disease on dialysis) powder was administered as ordered for Intensive Care Unit Patient 27. This failure may result in reduced effectiveness of other drugs by reduced absorption in the gastrointestinal tract.

2. Ensure warmed chlorhexidine cloths were stored in accordance with the hospital P&P.

Findings:

1. On December 10, 2014 beginning at 8:35 AM, ICU RN was observed during medication administration for Patient 27 in the presence of IPD and the Clinical Director Critical Care. Sevelamer powder, nephrovite tablet (combination of vitamin B complex and vitamin C), docusate 100 mg/10 ml liquid (stool softener), and digoxin 125 mcg tablet (used to treat congestive heart failure) were administered through the nasogastric (NG) feeding tube during this observation. Patient 27 medical record was reviewed after the medication administration observation in the presence of RN Clinical Info-specialist. Review of the electronic medication administration record (eMAR) showed to administer other medications through the NG tube one hour before or three hours after sevelamer.

During the staff interview on December 10, 2014 at 4:05 PM, the IPD acknowledged sevelamer powder was administered with the other NG medications during the observed medication administration and not according to the eMAR.

2. Review of the hospital's P&P titled "Chlorhexidine bathing to reduce drug resistant Organisms" dated 1/13 showed "...Once in warmer, cloths expire in 72 hours. Expiration date will be written on a sticker placed on cloth packages when placed in the warmer... "

On December 10, 2014 beginning at 9:30 AM, the medication storage areas of the step down unit (SDU) were inspected in the presence of IPD, the Clinical Director Critical Care and SDU RN.

Chlorhexidine gluconate 2 % cloth packages #10 were found stored in the warmer in the clean supply room. Inspection of the chlorhexidine cloth packages in the warmer showed there were no expiration date stickers on the packages. This was contrary to the hospital's P&P above.

During the concurrent interview, the Clinical Director Critical Care stated the warmed chlorhexidine cloths should have stickers with expiration dates on the packages when it was placed in the warmer.

Based on observation, interview, and document review, the hospital failed to ensure that the pharmaceutical services met the needs of all their patients as evidenced by their failure to:

1. Administer Sevelamer (a phosphate binding drug) as ordered by the patient's physician. (Refer to A-405)

2. Follow their own policies and procedures for maintaining and documenting information in the hospital's IV compounding logs and ensuring that all competency training had been completed in accordance with their education/ competency policy and procedure. (Refer to A-491)

3. Compound and store medications in accordance with the hospital's drug references and to maintain an approved Master Formula Record, as outlined in the hospital's policy and procedure. (Refer to A-500)

4. Provide written evidence of Pharmacy Technician oversight for compounded IV drugs which had been made and to ensure that cleaning and documentation (as outlined in the facility's policy and procedures had been maintained to ensure patient safety. (Refer to A-501)

5. Ensure that expired or outdated medications were not available for patient use. (Refer to A-505)

6. Ensure that hospital nursing staff used aseptic technique for preparing intravenous medications as outlined in the facility's policy and procedure and in accordance with standards of practice. (Refer to A-749)

The cumulative effect of these systemic problems resulted in the inability of the hospital's pharmaceutical services to direct staff in such a manner to meet the pharmaceutical needs of the hospital's patients in accordance with the facility's policies and procedures, drug references and acceptable standards of practice.

Based on interview, observation and document review, the hospital failed to:

A. Properly manage the pharmacy by not following hospital policy & procedure in regards to compounding medications which required documentation in the Inpatient Pharmacy Compounding Products Log.

B. Ensure that all employee's annual Chemo Competencies were completed as outlined in the hospital's policy and procedure.

These failures could have exposed patients to unnecessary medication errors or adverse drug reactions.


Findings:

A. A review of the hospital's policy & procedure for pharmacy Preparing and Dispensing, titled Pharmacy Compounding, states "For each compounded drug product, the pharmacy records shall be documented on the Inpatient Pharmacy Compounding Products Log and include the following elements:

A reference to the master formula record

The date the drug was compounded

Identity of the pharmacist who approved the use of the Master formula Record

The identity of the pharmacy personnel who compounded the drug product annotated on the label

The identity of the pharmacist reviewing the final drug product

The quantity of each component used in compounding the drug product

The manufacturer, expiration date, and lot number of each component.

The equipment used in compounding the drug product

A pharmacy assigned reference number such as a system generated prescription or order number

The expiration date of the final compounded drug product

The quantity or amount of drug product compounded"

Some or all of the elements underlined were found to be missing in the compound log reviews noted in the findings below.

During a tour of the 3rd floor NICU satellite pharmacy, the IV Compounding Log was reviewed and the following was noted in the record:

1. Patient 53: Potassium Chloride (a medication used to correct low potassium levels in the blood) in SW (sterile water) 0.1meq (milliequivalents)/ml (milliliter) Inj (injection). The compound log page and medication label were dated as March 3, 2014. No identification as to the pharmacy personnel who prepared the medication or the pharmacist who reviewed the final product was noted.

2. Patient 55:

a. Dopamine (a medication used to increase blood pressure) 400mcg (micrograms)/mL in D5W (dextrose 5% in water - a commonly used fluid used to mix with other medications to give via the vein) 20mL IV (intravenous - in the vein) Soln (solution). The compound log and label were dated March 25, 2014. No identification as to the pharmacy personnel who prepared the medication or the pharmacist who reviewed the final product was noted. No pharmacy assigned reference number (prescription/order number) was noted. No expiration date for the final product was noted.

b. Heparin Porcine (a medication used to reduce clotting of the blood) 50 units/Sodium Acetate (a medication used to correct electrolytes in the blood) 15.4 mEq/Sterile Water 100mL. The compound log and label were dated March 25, 2014. No identification as to the pharmacy personnel who prepared the medication or the pharmacist who reviewed the final product was noted.

3. Patient 54:

a. Heparin Porcine 50 Units/Sodium Acetate 7.7 mEq/Sterile Water 100mL. The compound log and label were dated March 25, 2014. No identification as to the pharmacy personnel who prepared the medication or the pharmacist who reviewed the final product was noted.

b. Caffeine Citrate (a medication used to help breathing for newborn children) 10mg in D5W 1mls. The compound log and label were dated March 26, 2014. No identification as to the pharmacy personnel who prepared the medication or the pharmacist who reviewed the final product was noted. No pharmacy assigned reference number (prescription/order number) was noted.

4. Patient 51: Gentamicin (a medication used to treat infections) 9.4 mg in 0.9% Sodium Chloride 4.7 mL IV. The compound log and label were dated as April 1, 2014. No identification as to the pharmacy personnel who prepared the medication or the pharmacist who reviewed the final product was noted. No pharmacy assigned reference number (prescription/order number) was noted. No expiration date for the final product was noted.

5. Patient 52: Dopamine 800mcg/mL in D5W mL IV Soln. The compound log and label were dated as April 1, 2014. No identification as to the pharmacy personnel who prepared the medication or the pharmacist who reviewed the final product was noted. No pharmacy assigned reference number (prescription/order number) was noted. No expiration date for the final product was noted.

6. Patient 56:

a. Caffeine Citrate 8.6mg in D5W 0.86 mL IV. The compound log and label were dated as April 22, 2014. No identification as to the pharmacy personnel who prepared the medication or the pharmacist who reviewed the final product was noted. No pharmacy assigned reference number (prescription/order number) was noted. No expiration date for the final product was noted.

b. Cefotaxime (a medication used to treat infections) 84mg in D5W 2.1 mL IV. The compound log and label were dated as April 22, 2014. No identification as to the pharmacy personnel who prepared the medication or the pharmacist who reviewed the final product was noted. No pharmacy assigned reference number (prescription/order number) was noted. No expiration date for the final product was noted.

A review of the compounding log in 3rd floor NICU satellite pharmacy indicates on each page that "NOTE PHARMACISTS AND TECHNICIANS MUST INITIAL EACH LABEL AND SPECIFY QUANTITY MADE FOR EACH PATIENT". No initials were noted on any of the patient documentation provided above.

During a tour of the 2nd floor ICU satellite pharmacy, the IV Compounding Log was reviewed and the following was noted in the record:

1. Patient 49: Vasopressin (a medication used to treat low blood pressure) 60 units/D5W 100mL. The compound log was dated "11/25-11/26" and the label was dated November 25, 2014. No expiration date for the final product was noted.

2. Patient 50: Vancomycin (a medication used to treat infections) 1,750mg/D5W 500mL. The compound log was dated "11/25-11/26" and the label was dated November 26, 2014. No pharmacy assigned reference number (prescription/order number) was noted. No expiration date for the final product was noted.

3. Patient 46: Insulin Regular Human (a medication used to treat high sugar levels in the blood) 100 Units/0.9% Sodium Chloride 100mL. The compound log was dated "11/25-11/26" and the label was dated November 25, 2014. No pharmacy assigned reference number (prescription/order number) was noted. No expiration date for the final product was noted.

4. Patient 47: Potassium Phosphate (a medication used to correct low phosphate levels in the blood) 10 mmol (millimoles)/D5W 250mL. The compound log was dated "11/25-11/26" and the label was dated November 26, 2014. No pharmacy assigned reference number (prescription/order number) was noted. No expiration date for the final product was noted.

5. Patient 48: Calcium Gluconate (a medication used to treat low levels of calcium in the blood) 1,000mg/0.9% Sodium Chloride 100mL. The compound log was dated "11/25-11/26" and the label was dated November 26, 2014. No expiration date for the final product was noted.

6. Patient 39: Phytonadione (a medication used to treat excessive bleeding) 10mg/D5W 50mL. The label was dated December 6, 2014. No pharmacy assigned reference number (prescription/order number) was noted. No expiration date for the final product was noted.

7. Patient 40: Phytonadione 10mg/D5W 50mL. The label was dated December 7, 2014. No pharmacy assigned reference number (prescription/order number) was noted. No expiration date for the final product was noted.

8. Patient 37: Vasopressin 60 Units/D5W 100mL. The compound log was dated "12/8/14 - 12/9" and the label was dated December 9, 2014. No expiration date for the final product was noted.

9. Patient 38: Epinephrine (a medication used to allergic reactions) 4,000 mcg/D5W 250mL. The compound log was dated "12/8/14 - 12/9" and the label was dated December 9, 2014. No pharmacy assigned reference number (prescription/order number) was noted. No expiration date for the final product was noted.

B. During an interview with Pharmacy Supervisor 1 on December 11, 2014 at 9:30 AM, the surveyor asked how the Pharmacy keeps track of who has completed and passed their annual competencies.

During an interview with the Regional Area Pharmacy Director on December 11, 2014 at 9:45 AM, the Regional Area Pharmacy Director indicated that all Pharmacy Staff are required to complete all competency trainings so that anyone can work in any area of the Pharmacy (the Regional Area Pharmacy Director did specify that there was an exception for some of the Pharmacy Management staff).

Pharmacy Supervisor 1 indicated that Chemotherapy competency training is completed on an annual basis for Pharmacists and Pharmacy Technicians. Pharmacy Supervisor1 proceeded to log onto the Pharmacy's: "Buzz RX record" on a Pharmacy computer terminal. The surveyors had asked about one specific Pharmacy Technician (PT 1), who we were told had been routinely assigned to prepare Chemotherapy drugs in the Pharmacy.

When PT 1's Chemotherapy competency training information was brought up on the computer screen, the screen showed that PT 1's most recent Chemotherapy competency had been completed in August 2013. Further review of the Buzz Rx record revealed that PT 1 had attempted to take the Chemotherapy Competency examination (exam) twice in (what appeared to be August 2014), and had failed on both attempts with scores of 70 and 0.

The Pharmacy's policy and procedure entitled: "Educational plan", dated November 2013, states: "...3. Buzz Rx Competency Assessment will be completed by pharmacy personnel with two chances (this P&P had a spelling error and actually read "two changes" , but the Area Regional Director of Pharmacy advised us of the mistake as we were reading through the policy), to complete with correct answer. Participants must pass with 80% or better to be considered complete." This policy and procedure also went on to state: "If a Pharmacy staff fails the assessment, pharmacy manager will need to be notified in order for the staff member to gain access to the competency assessment again in Buzz Rx."

A concurrent interview with Pharmacy Supervisor 1 revealed that this was the first time that she was aware that PT 1 had made two attempts at passing the Chemotherapy (Chemo) Assessment this year and not passed. PT-1's competency record in Buzz Rx indicated that this Pharmacy Technician had not passed this annual Chemo competency training for more than the last 15 months (August 2013 to December 2014). In the Pharmacy's policy and procedure entitled: "Educational Plan", dated November 2013, states: "All inpatient Pharmacy personnel demonstrate competency annually by completing competency assessments in Buzz Rx modules developed by Regional Pharmacy Operations ..."


Pharmacy Supervisor 1 also provided a list of current Pharmacy staff with the title: "Inpatient Chemotherapy Comp (Competency) - 2014" on December 11, 2014 at 9:55 AM. This document revealed that PT 2 and the NICU Pharmacy Technician has also taken the Chemo Competency assessment for 2014, and also had not passed their annual competency assessment.

Interview with the Regional Area Pharmacy Director on December 11, 2014 at 9:45 AM, the Regional Area Pharmacy Director stated that all Pharmacy Staff are required to complete all competency trainings so that anyone can work in any area of the Pharmacy (with the Pharmacy Management exception). Even if an employee does not pass their annual competency within the annual competency period, the employee is still allowed to continue to work in that designated area of the Pharmacy. None of the Pharmacy Technicians above were a part of the Pharmacy Management team.

Based on inspection of the hospital's Pharmacy Freezer, the 15 syringes of Activase inside the Freezer, interview with Pharmacy Supervisor 1, interview with the Pharmacy's Regional Area Pharmacy Director, and review of the hospital's policies and procedures the hospital failed to ensure that the Activase syringes were stored in accordance with the hospital's drug reference resources. The facility also failed to ensure that it had an approved Master Formula Record for the compounding of TPA syringes as outlined in their policy and procedure. This could have resulted in hospital patients receiving medications with reduced efficacy.

Findings:

Inspection of the Pharmacy's Freezer #28283 on December 8, 2014 at 11:45 am revealed 15 frozen syringes of Activase (Alteplase) 1 milligram (mg) per 2 milliliter (ml). This drug is also known as a Tissue Plasminogen Activator: "TPA". These plastic syringes had been previously compounded by the hospital's Pharmacy staff (from a bulk vial which the Pharmacy staff reconstituted by adding solution to the vial containing the active drug). Compounding is defined by Webster's Dictionary as: "putting together parts to form a whole".

Activase or TPA is used to treat patients who have had an Acute Myocardial Infarction (AMI) or an Acute Ischemic Stroke (AIS). Acute Myocardial Infarction is tissue damage to the heart as a result of an obstruction of circulation by a blood clot. Acute Ischemic Stroke occurs when there is a constriction or obstruction of a blood vessel or artery in the brain which can result in loss of consciousness, sensation and voluntary motion. The administration of TPA after an AMI drastically reduces the chances of mortality in these patients.

Review of the facility's unapproved recipe (titled: "TPA Frozen Master Formula" at the bottom of the page) for compounding and freezing the TPA plastic syringes on December 8, 2014 at 11:55 AM revealed that these syringes must be stored at -20 degrees Celsius or -4 degrees Fahrenheit. A concurrent interview with the facility's Pharmacy Supervisors on December 8, 2014 at Noon revealed that the facility did not currently have an approved compounding recipe for the TPA syringes which had been compounding for patient use. Pharmacy Supervisor 2 provided the surveyor with a 14 page printout from Lexi-comp (an online drug reference source), which confirmed that Activase when compounded in plastic syringes (like the facility had done) and frozen, must be stored at -20 degrees Celsius.

The Regional Area Pharmacy Director on December 12, 2014 at 2:35 pm, provided the surveyor with a copy of an article entitled: "Alteplase: a Safe and Cost-Effective Alternative to Urokinase", from: "The Journal of Pharmacy Practice and Research Volume 32, No. 2, 2002", which stated: "...The labeled syringes are stored at -20 degrees Celsius in a monitored freezer ....".

The freezer which these TPA syringes had been stored inside of had been set up by the Pharmacy to maintain its temperature between -10 degrees Celsius and -20 degrees Celsius. The temperature for this freezer during the survey never appeared to reach the -20 degrees Celsius during the four days (December 8, 2014 to December 11, 2014) which the surveyors were in the facility, observing this freezer. The temperature which these syringes were supposed to be stored at (-20 degrees Celsius or - 4 degrees Fahrenheit) was never maintained for these syringes, because this freezer was not set up to maintain this temperature (-20 degree Celsius). The observed temperatures of this freezer between December 8 and December 11, 2014 ranged between -15 degrees Celsius and -18 degrees Celsius. The storage of these medications outside of the -20 degrees Celsius could have reduced the potential efficacy of this medication.

Review of the hospital's policy and procedure on December 9, 2014 at 1:30 PM entitled: "Pharmacy Compounding", dated December 2014 states: "A drug product shall not be compounded until the pharmacy has first prepared a written Master Formula Record that includes at least the following elements: Active ingredients to be used, inactive ingredients to be used, process and/or procedures used to prepare the drug, types of equipment to be used, ....The Master Formula records shall serve as the primary reference for sterile and non-sterile compounding formulations, practices, storage and beyond use dating ....".

Pharmacy Supervisor 2 confirmed during an interview on December 8, 2014 at 12:05 PM that the hospital did not have an official approved Master Formula Record (recipe) for the TPA syringes which had been compounded above.

Based on observation, interview, document review, and policy and procedure review, the hospital failed to:

1. Provide evidence that, intravenous (IV) medications which had been prepared by the hospital's Neonatal Intensive Care Unit (NICU) Pharmacy Technician, for Neonatal critical care patients had been documented by the hospital's NICU Pharmacist in accordance with the facility's policy and procedure, to protect patients from medication errors and possible adverse drug reactions.

2. Provide evidence that, IV medications which had been prepared by the hospital's Chemotherapy (Chemo) Pharmacy Technician, for patients receiving Chemotherapy medications, had been documented by the hospital's Pharmacists, in accordance with the facility's policy and procedure to protect patients from medication errors and possible adverse drug reactions.

The hospital also failed to take the necessary actions to protect these patients and ensure their safety, which resulted in immediate jeopardy (called on December 9, 2014 at 5:00 PM and abated on December 11, 2014 at 3:25 PM).

Findings:

1. Inspection of the hospital's Pharmacy Intravenous (IV) compounding room on December 8, 2014 at 3:00 PM, revealed one evacuated container bottle with an unidentified solution inside the bottle was found inside hood 1. This evacuated container bottle had not been labeled. Concurrent interview with Pharmacy Supervisor 1 revealed that a Pharmacy Technician, who had been working earlier that day, had added the unknown solution to the evacuated container, but this Pharmacy Technician had already left the hospital. Pharmacy Supervisor 1 indicated that any medications (including this used evacuated container), which had been made on a different shift and not used, should have been discarded. Pharmacy Supervisor 1 was unable to definitively identify what the solution was, which had been placed into the evacuated container inside hood 1.

Further observation in hood 2 revealed that the NICU Pharmacy Technician who had been assigned to compound the Neonatal Intensive Care Unit's (NICU) IV medications was currently working inside this hood. She was observed drawing up Fluconazole (Diflucan), an antifungal drug, from a 100 ml bag in order to make 2 milligrams (mg) per milliliter (ml) syringes. The NICU Pharmacy Technician had just started to draw up the first syringe of Fluconazole as the surveyor walked up to hood 2. After observing the NICU Pharmacy Technician, and speaking with her, the surveyor observed 3 labels which had been generated for placement on the final plastic syringes of Fluconazole for Patients 30, 31, and 32.

The NICU Pharmacy Technician also had a label on the surface of a portable stand behind her for an Insulin Stock Solution bag which she was going to compound. The insulin stock solution is used to help control the blood sugar for the neonatal patients in NICU. This label was observed as being pre-signed off by the NICU Pharmacist, indicating that the drug had already been checked and verified by the NICU pharmacist as being correct, and ready to send to the patient care area (NICU).

The IV bag which the NICU Pharmacy Technician was using to make the Insulin Stock Solution was still inside its plastic overwrap container from the manufacturer. This overwrap is a plastic sealed pouch which covers the Normal Saline 100 ml piggyback bag to prevent moisture loss from the IV bag until it is ready for use. The labels for these Fluconazole syringes had also been signed off as being checked and verified by the NICU Pharmacist.

During an interview with the NICU Pharmacist on December 9, 2014 at 8:30 AM, the NICU Pharmacist indicated that she had indeed been pre-signing the IV labels for the medications above. The NICU Pharmacist also indicated that it was part of her normal routine to pre-sign the NICU IV labels before the NICU Pharmacy Technician had compounded any of her IV medications. ....". Pharmacist oversight when compounding Neonatal IV medications is extremely critical, to ensure patient safety as these medications are considered "High Alert/High Risk".

Review of the hospital's policy and procedure entitled: "Intravenous Admixture Process and Sterile Compounding Preparations", on December 9, 2014 at 12:40 PM, the policy stated the following: "I. Compounding manipulations and procedures are checked by a Pharmacist prior to the medication being dispensed. The technician/Intern Pharmacist must present the syringe, with the additives present, in the volume of the component added to the final product for the Pharmacist to check for all ...NICU, PICU and High-Alert Medications." The verification of this check above is documented by the Pharmacist applying his or her signature on the label of these medications.

Review of the hospital's policy and procedure entitled: "Pharmacy Compounding" on December 9, 2014 at 1:30 PM, the policy stated: "The Pharmacist performing or supervising compounding is responsible for the proper preparation, labeling, storage, delivery instructions, quality, review of the compounded drug product and completion of the appropriate documentation." The hospital was unable to provide any documented evidence that the NICU Pharmacist, who was supervising the NICU Pharmacy Technician, had checked these medications prior to these medications being sent out to the NICU patient care area.

Review of the National Association of Neonatal Nurses (a nationally recognized association) position statement # 3055 (dated July 2011), states: "Although establishing the frequency of medication errors in the NICU is difficult, published studies indicate that medication errors in NICU are common, ranging from 13 to 91 medication errors per 100 NICU admissions ... In addition, NICU patients are more likely to experience a medication error than other hospital patients and to experience more harm when a medication error occurs ...These data demonstrate that NICU patients require additional system wide safeguards against medication errors and that healthcare providers must be especially vigilant when working with medications in the NICU. Because of the vulnerable nature of NICU patients, the complexity of the medications used, and the challenges of the NICU environment, preparing and administering medications for neonatal patients are inherently risky ...The medications dispensed are often adult strength, requiring complex, multistep dilutions prior to dispensing or administering them, which increases the opportunity for errors ....".

2. During the inspection of the Pharmacy's Sterile Compounding IV room on December 8, 2014 at 3:45 PM, the surveyor entered into the Pharmacy's IV Chemotherapy compounding room. Further inspection of the hospital's IV Chemotherapy room revealed one vial of Mitomycin (Mutamycin), which is used with other drugs to treat stomach and pancreatic cancers. The vial of Mitomycin was found in a yellow plastic bin outside of the Chemotherapy (Chemo) IV hood. Mitomycin has also been shown to be effective in fighting cancer tumors, by blocking the growth of cancer cells. The vial of Mitomycin had been stored inside of a non-chemo bag (Ziploc), which was observed partially open (unzipped).

During a concurrent interview with Pharmacy Supervisor 1 (during the inspection), she indicated that the Mitomycin should have been stored inside of one of the Pharmacy's special Chemotherapy bags. The storage of this Mitomycin outside of the facility's special Chemotherapy bags potentially exposed any Pharmacy staff which entered into the room to this hazardous medication.

As stated in the hospital's Pharmacy policy and procedures, a Pharmacist must be responsible for the oversight of all medications which are prepared in all areas of the hospital Pharmacy. The Chemotherapy room is used for the compounding and packaging of drugs which are used to treat cancer patients. The National Institute for Occupational Safety and Health (which is an extension of the Center for Disease Control), published an alert in 2004 which discussed the hazards of healthcare workers working with "drugs to treat cancer and other hazardous drugs". The Alert goes on to state: "Health care workers who work with or near hazardous drugs may suffer from skin rashes, infertility, miscarriage, birth defects, and possibly leukemia or other cancers." In short, drugs used to treat cancer can be dangerous for any unprotected staff which may be exposed to them.

Further inspection of the IV Chemotherapy room hood on December 8, 2014 at 3:50 PM, revealed that the following Chemotherapeutic drugs had been compounded and left inside the hood from the previous weekend (December 6 and 7 of 2014): Two vials of Mesna 1gram per 10 ml, four vials of Cytaribine 100mg per 5 ml, Cyclophosphamide 500mg per 25 ml, and one vial of Camphosar 40mg per 2 ml. Pharmacy Supervisor 1 indicated that the facility's policy was for Pharmacy staff to remove all chemotherapy agents from the hood at the end of the day.

Inspection of the Pharmacy's daily cleaning log for the IV Chemo hood on December 8, 2014 at 3:50 PM, revealed that this chemo hood had not been cleaned since November 16, 2014. During a concurrent interview with Pharmacy Supervisor 1, she indicated that Chemo medications had been made inside this hood on November 27, 2014, November 30, 2014, December 6, 2014 and December 7, 2014, without any documentation of the hood being clean on these dates.

Inspection of the hospital's IV room Chemotherapy manufacturing log at 4:05 PM on December 8, 2014, revealed that no Chemotherapy compounding had been recorded in this official log book since November 30, 2014.

Concurrent interview with Pharmacy Supervisor 1 revealed that it was the facility's policy and procedure was to ensure that all IV Chemo medications which had been compounded must be documented inside this official Chemo compounding log book.

The surveyor further observed, inside one of the facility's yellow bins next to the wall inside the Chemo room, that there was a stack of seven Chemo labels. None of the seven labels (for Patients 28 and 29), had been signed by the Chemo Pharmacy Technician, who had compounded these IV Chemo medications (on December 6 and 7th, 2014), and there was no documentation to show that these Chemo medications had been verified and checked by a Pharmacist prior to these drugs going out to the patient care unit for use, as outlined in the facility's policies and procedures.

The Chemotherapy room is used for the compounding and packaging of drugs which are used to treat cancer patients. The National Institute for Occupational Safety and Health (which is an extension of the Center for Disease Control), published an alert in 2004 which discussed the hazards of healthcare workers working with "drugs to treat cancer and other hazardous drugs". The Alert goes on to state: "Health care workers who work with or near hazardous drugs may suffer from skin rashes, infertility, miscarriage, birth defects, and possibly leukemia or other cancers." In short, drugs used to treat cancer can be dangerous for any unprotected staff which may be exposed to them.

Review of the hospital's policy and procedure entitled: "Pharmacy Compounding" on December 9, 2014 at 1:30 PM, the policy stated: "The Pharmacist performing or supervising compounding is responsible for the proper preparation, labeling, storage, delivery instructions, quality, review of the compounded drug product and completion of the appropriate documentation."

Review of another hospital's policy and procedure entitled: "Intravenous Admixture Process and Sterile Compounding Preparations", on December 9, 2014 at 12:40 PM, the policy stated the following: "I. Compounding manipulations and procedures are checked by a Pharmacist prior to the medication being dispensed. The technician/Intern Pharmacist must present the syringe, with the additives present, in the volume of the component added to the final product for the Pharmacist to check for all ...NICU, PICU and High-Alert Medications." The hospital had failed to follow both of it policies and procedures above.

The Institute for Safe Medication Practices (ISMP), a nationally known organization and a leader in establishing health care standards in their 2014 "ISMP List of High-Alert Medications in the Acute Care Settings", states: "High alert medications are drugs that bear a heightened risk of causing significant patient harm when they are used in error. Although mistakes may or may not be more common with these drugs, the consequences of an error are clearly more devastating to patients. We hope that you will use this list to determine which medications require special safeguards to reduce the risk of errors. This may include strategies such as standardizing the ordering, storage, preparation, and administration of these products; ...limiting access to high-alert medications; using auxiliary labels and automated alerts; and employing redundancies such as automated or independent double checks when necessary." This article goes on to list classes/categories of Medications which they include in their High-Alert List. These include: "Chemotherapeutic agents both parenteral and oral, along with insulin both subcutaneous and IV".

Interview with Pharmacy Supervisor 2 on December 8, 2014 at 4:44 PM revealed that she had gone into the Medication Administration Record of patient 28 and 29 to verify that these patients had received the IV Chemo medications which had been made by the Chemo Pharmacy Technician on December 6, 2014 and December 7, 2014. The hospital was unable to provide written evidence that these IV Chemo medications had been checked by a Pharmacist prior to the administration of these medications to the Patients 28 and 29 above.

Based on observation, the hospital failed to ensure outdated drugs were not available for patient use.

Findings:

On December 8, 2014 at 3:45PM, a tour of the inpatient main pharmacy chemotherapy hood room was conducted. A reconstituted bottle of Mitomycin (a drug used for cancer) 5mg (milligram)/10mL (milliliter) was found in a yellow storage bin outside of the hood. It was labeled as "reconstituted 11/30/14 with 10mL SWFI (sterile water for injection) = 0.5mg/mL". The label also indicated an expiration date of December 6, 2014.

On December 9, 2014 at 10:36AM, a tour of the 2nd floor ICU satellite pharmacy was conducted. One bag of 3% Sodium Chloride (a medication used to replenish fluid in the body) 500mL was found in the storage shelves. This bag had a labeled expiration date of June 30, 2014. Three bags of Magnesium Sulfate (a medication used for low magnesium levels in the body) 2gm (gram) in 50mL D5W (dextrose 5% in water - a commonly used fluid for mixing medications to give via the vein) were found in the storage shelves. These bags had a labeled expiration date of December 8, 2014.

Based on observation and staff interviews, the hospital failed to ensure, for a universe of 363 patients, that emergency food supply was stored safely to prevent the contamination of food with water waste (sewage). Failure would result in contamination of the food supply which was stored below a pipe labeled as "Sanitary Waste". This failure had the potential to affect all patients, staff and visitors that were included in the hospital's emergency plan.

Finding:

During observation of the emergency food and water storage areas on December 10, 2014 at 10:00 AM, there were several overhead pipes observed in the room. One of the pipes was labeled "Sanitary Waste". The Director (FSD) and the Assistant Director of food and nutrition (AFD), were present during the observation and were asked what the sanitary waste was. They stated that the hospital Engineering Department staff would be in a better position to answer the question.

At 10:05 am, the Engineering Director (ED 1) was interviewed on the content of the pipe. He explained it was hospital waste (sewage). He also stated the hospital had several options to limit the risks of contamination which included moving the items from the room.

The 2013 Food Code described sewage as "liquid waste containing animal or vegetable matter in suspension and may include liquids containing chemicals in solution. 2013 Food Code Section 3-305 (F) stated "Food may not be stored under sewer lines that are not shielded to intercept potential drips". However, state regulations are more stringent and it prohibits the storage of food in a room "subject to sewage or waste water ..."

The hospital failed to store its emergency water and food supplies in a manner to prevent potential contamination by sewage.

Based on observation, document review, and staff interview, the Hospital failed to maintain a system for controlling sources of infections in accordance with internal policies and procedures, nationally recognized infection control practices and guidelines, and applicable regulations, when:

1. Operating Room (OR's) were not appropriately cleaned in accordance with national recognized infection control guidelines when sticky residue was observed on horizontal surfaces in the OR (Operating Room).

2. STERIS automated enzymatic dosing machine was not calibrated to dispense the required dose of enzymatic in accordance with manufacturer's IFU.

3. The hospital failed to ensure the nursing staff used proper aseptic techniques during the medication administration process. This failure could result in contamination of the injectable medications.


Findings:
1. During an observation on December 11, 2014 at 2:15 PM, the mattress pads on the surgical table was observed to have substance buildup with sticky residue.

Operating Room 1: (observation of empty operating room)

i. The body of the mattress was observed to have four(4) approximately 1" to 2" long by ½" wide strips of sticky residue running horizontal with 2" similar strips running vertical on the mattress in the first ¼ of the mattress. The last one-fourth of the mattress was to have one similar strip of residue approximately 2" wide.

ii. The arm rest in the first one-third of the arm rest with approximately (one) 1 inch wide by 1 to 3 inches long in strips of residue running into and over each other. The middle one-third of the arm rest was observed with three similar strips of residue.

iii. During a concurrent interview, the OPRC: confirmed that terminal cleaning was completed the night before on Operating Room 1. EVS stated the operating room to be ready to be occupied for surgery. indicated, "No, the residue should not be there."

Operating room 4: (observation of active cleaning and completion of between patients "turnover" cleaning.)

i. The body of the mattress was observed to have two (2) approximately 1" to 2" long by 1/2" wide strip of sticky residue running horizontal across the top of the pad.

In a Subsequent interview at 2:40 PM, EVS1 stated, "No it should not still be there. It (residue) should be removed or replaced. We notify the supervisor right-a-way for a replacement mattress." EVS indicated she had not notified the supervisor for a replacement. In an interview at 2:45 PM, with the Operating Room Coordinator he stated, "No it (residue) should not be there. They are all very good (EVS) and clean the mattress for the entire dwell time." At time of exit policy and procedures were not supplied as requested.

2. On December 9, 2014 at 11:30 AM, during a tour of the decontamination room. The Sterile Processing technician was observed to be completing the manual decontamination of the Surgical Instruments in a sink using tap water with no and/or insufficient amount of enzymatic solution.

The Technician was observed utilizing a Steris automatic dosing machine in which, when manually checked by measuring the contents revealed little product (approximately 4 drops of enzymatic solution and an insufficient amount to be measured in ounces) being released. The facilities policy is one ounce to one gallon of water. The technician was observed to fill the sink to the stated, 6 gallon mark on the sink with water, and also was observed to dispense 4 drops of the enzymatic solution.

In a concurrent interview the technician, she stated that she expected 3 ounces of enzymatic solution to be dispensed into the sink. The technician was observed to push tubing down into container of enzymatic and then adjust tubing running from the dispenser to the sink to dispense in a 2 oz measuring container. The technician ran the automatic dispenser and manually measured the dispensed enzymatic stating, "this will over flow." However, the dispenser only dispensed 1 3/4 oz. The expected 3oz. was not dispensed from the machine.

A review of facility policy titled, "Decontamination, dated 2013", indicated that the enzymatic manual cleaning process is the first step in the sterilization process. The technician was observed to continue with the sterilization process even though the first step was not accurately followed.

The manufacture recommendations for Steris Prolystica 2x Concentrate was for 1/8 to ½ ounce of solution for each gallon of water. According to the manufacture ½ ounce per (1) gallon in manual decontamination, is the recommended amount of enzymatic to effectively ensure decontamination of surgical instruments. The facility's automatic dispenser, did not dispense the manufacture recommended dose.




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3. Review of the hospital P&P titled "Sterile Product - Guidelines for Nursing in the preparation of Intravenous Admixture Solutions" dated 9/14, showed under policy statements: "Aseptic techniques will be employed in the preparation and administration of intravenous solutions at all times." This hospital P&P also showed under "Provisions/Procedure: When preparing intravenous solutions, the nurse shall: ... Remove outer cap from vial and rub rubber diaphragm of vial or neck of ampule with a 70 % alcohol swab. Use aseptic technique to maintain the sterility of reconstituted additives drawn through a needle and syringe ..."

Review of the Lippincott Procedures (standard of nursing practice provided by the hospital) online version titled "IV (intravenous) solution preparation, adding medications to the container" dated 7/14 (printed 12/10/2014), showed "...For medication from a vial: Remove the medication vial's lid. Disinfect the vial stopper thoroughly with an alcohol pad using friction, and then allow it to dry. If the medication must be diluted, disinfect the port of the diluent container thoroughly with an alcohol pad using friction, allow it to dry, and then withdraw the needed volume of diluent ..."

On December 10, 2014 beginning at 9:50 AM, SDU RN was observed administering medications to Patient 26. Heparin (used to treat and prevent bold clots) 5000 units injection was one of the medications administered to patient 26. SDU RN removed the heparin 5000 units injection vial cap, withdrew the content of the vial through the rubber stopper and injected it subcutaneously.

During concurrent staff interview, SDU RN acknowledged not disinfecting the rubber stopper and did not know the rubber stopper should be disinfected prior to piercing. The Clinical Director Critical Care expected her staff to follow the standard of nursing practice, to disinfect the medication vial rubber stopper prior to piercing.

On December 10, 2014 beginning at 10:15 AM, Neonatal Intensive Care Unit (NICU) RN was observed administering ampicillin (antibiotic) injection to Patient 84 in the presence of IPD and the Director Maternal Child unit. NICU RN reconstituted ampicillin injection powder with sterile water for injection. NICU RN took off the cap of ampicillin 250 mg injection vial and the cap of sterile water for injection (SWFI) 10 ml plastic bottle. NICU RN used one side of the alcohol swabs to rub the rubber septum on the ampicillin vial, flipped the alcohol swabs over and used the other side (where her finger was) to rub the rubber septum on the SWFI 10 ml and flipped the alcohol swabs over again to rub the ampicillin vial.

During concurrent interview, NICU RN stated two alcohol swabs were used; alcohol swab on side one was used to wipe the ampicillin vial and flipped over to the other side, alcohol swab on side two was used to wipe the SWFI 10 ml.

During the interview on December 10, 2014 beginning at 1:20 PM, the Infection Control Preventionist stated the standard of practice is to disinfect the rubber septum of a medication vial with an alcohol swap and discard, take a new alcohol swab to disinfect the second medication vial.

During the interview on December 12, 2014 beginning at 9:20 AM, the Department Administrator, Infection Control stated "the standard of practice is to use one alcohol swab to disinfect a vial then discard, and use another alcohol swab to disinfect the second vial".

Based on interview, observation and document review, the hospital failed to:

A. Properly manage the pharmacy by not following hospital policy & procedure in regards to compounding medications which required documentation in the Inpatient Pharmacy Compounding Products Log.

B. Ensure that all employee's annual Chemo Competencies were completed as outlined in the hospital's policy and procedure.

These failures could have exposed patients to unnecessary medication errors or adverse drug reactions.


Findings:

A. A review of the hospital's policy & procedure for pharmacy Preparing and Dispensing, titled Pharmacy Compounding, states "For each compounded drug product, the pharmacy records shall be documented on the Inpatient Pharmacy Compounding Products Log and include the following elements:

A reference to the master formula record

The date the drug was compounded

Identity of the pharmacist who approved the use of the Master formula Record

The identity of the pharmacy personnel who compounded the drug product annotated on the label

The identity of the pharmacist reviewing the final drug product

The quantity of each component used in compounding the drug product

The manufacturer, expiration date, and lot number of each component.

The equipment used in compounding the drug product

A pharmacy assigned reference number such as a system generated prescription or order number

The expiration date of the final compounded drug product

The quantity or amount of drug product compounded"

Some or all of the elements underlined were found to be missing in the compound log reviews noted in the findings below.

During a tour of the 3rd floor NICU satellite pharmacy, the IV Compounding Log was reviewed and the following was noted in the record:

1. Patient 53: Potassium Chloride (a medication used to correct low potassium levels in the blood) in SW (sterile water) 0.1meq (milliequivalents)/ml (milliliter) Inj (injection). The compound log page and medication label were dated as March 3, 2014. No identification as to the pharmacy personnel who prepared the medication or the pharmacist who reviewed the final product was noted.

2. Patient 55:

a. Dopamine (a medication used to increase blood pressure) 400mcg (micrograms)/mL in D5W (dextrose 5% in water - a commonly used fluid used to mix with other medications to give via the vein) 20mL IV (intravenous - in the vein) Soln (solution). The compound log and label were dated March 25, 2014. No identification as to the pharmacy personnel who prepared the medication or the pharmacist who reviewed the final product was noted. No pharmacy assigned reference number (prescription/order number) was noted. No expiration date for the final product was noted.

b. Heparin Porcine (a medication used to reduce clotting of the blood) 50 units/Sodium Acetate (a medication used to correct electrolytes in the blood) 15.4 mEq/Sterile Water 100mL. The compound log and label were dated March 25, 2014. No identification as to the pharmacy personnel who prepared the medication or the pharmacist who reviewed the final product was noted.

3. Patient 54:

a. Heparin Porcine 50 Units/Sodium Acetate 7.7 mEq/Sterile Water 100mL. The compound log and label were dated March 25, 2014. No identification as to the pharmacy personnel who prepared the medication or the pharmacist who reviewed the final product was noted.

b. Caffeine Citrate (a medication used to help breathing for newborn children) 10mg in D5W 1mls. The compound log and label were dated March 26, 2014. No identification as to the pharmacy personnel who prepared the medication or the pharmacist who reviewed the final product was noted. No pharmacy assigned reference number (prescription/order number) was noted.

4. Patient 51: Gentamicin (a medication used to treat infections) 9.4 mg in 0.9% Sodium Chloride 4.7 mL IV. The compound log and label were dated as April 1, 2014. No identification as to the pharmacy personnel who prepared the medication or the pharmacist who reviewed the final product was noted. No pharmacy assigned reference number (prescription/order number) was noted. No expiration date for the final product was noted.

5. Patient 52: Dopamine 800mcg/mL in D5W mL IV Soln. The compound log and label were dated as April 1, 2014. No identification as to the pharmacy personnel who prepared the medication or the pharmacist who reviewed the final product was noted. No pharmacy assigned reference number (prescription/order number) was noted. No expiration date for the final product was noted.

6. Patient 56:

a. Caffeine Citrate 8.6mg in D5W 0.86 mL IV. The compound log and label were dated as April 22, 2014. No identification as to the pharmacy personnel who prepared the medication or the pharmacist who reviewed the final product was noted. No pharmacy assigned reference number (prescription/order number) was noted. No expiration date for the final product was noted.

b. Cefotaxime (a medication used to treat infections) 84mg in D5W 2.1 mL IV. The compound log and label were dated as April 22, 2014. No identification as to the pharmacy personnel who prepared the medication or the pharmacist who reviewed the final product was noted. No pharmacy assigned reference number (prescription/order number) was noted. No expiration date for the final product was noted.

A review of the compounding log in 3rd floor NICU satellite pharmacy indicates on each page that "NOTE PHARMACISTS AND TECHNICIANS MUST INITIAL EACH LABEL AND SPECIFY QUANTITY MADE FOR EACH PATIENT". No initials were noted on any of the patient documentation provided above.

During a tour of the 2nd floor ICU satellite pharmacy, the IV Compounding Log was reviewed and the following was noted in the record:

1. Patient 49: Vasopressin (a medication used to treat low blood pressure) 60 units/D5W 100mL. The compound log was dated "11/25-11/26" and the label was dated November 25, 2014. No expiration date for the final product was noted.

2. Patient 50: Vancomycin (a medication used to treat infections) 1,750mg/D5W 500mL. The compound log was dated "11/25-11/26" and the label was dated November 26, 2014. No pharmacy assigned reference number (prescription/order number) was noted. No expiration date for the final product was noted.

3. Patient 46: Insulin Regular Human (a medication used to treat high sugar levels in the blood) 100 Units/0.9% Sodium Chloride 100mL. The compound log was dated "11/25-11/26" and the label was dated November 25, 2014. No pharmacy assigned reference number (prescription/order number) was noted. No expiration date for the final product was noted.

4. Patient 47: Potassium Phosphate (a medication used to correct low phosphate levels in the blood) 10 mmol (millimoles)/D5W 250mL. The compound log was dated "11/25-11/26" and the label was dated November 26, 2014. No pharmacy assigned reference number (prescription/order number) was noted. No expiration date for the final product was noted.

5. Patient 48: Calcium Gluconate (a medication used to treat low levels of calcium in the blood) 1,000mg/0.9% Sodium Chloride 100mL. The compound log was dated "11/25-11/26" and the label was dated November 26, 2014. No expiration date for the final product was noted.

6. Patient 39: Phytonadione (a medication used to treat excessive bleeding) 10mg/D5W 50mL. The label was dated December 6, 2014. No pharmacy assigned reference number (prescription/order number) was noted. No expiration date for the final product was noted.

7. Patient 40: Phytonadione 10mg/D5W 50mL. The label was dated December 7, 2014. No pharmacy assigned reference number (prescription/order number) was noted. No expiration date for the final product was noted.

8. Patient 37: Vasopressin 60 Units/D5W 100mL. The compound log was dated "12/8/14 - 12/9" and the label was dated December 9, 2014. No expiration date for the final product was noted.

9. Patient 38: Epinephrine (a medication used to allergic reactions) 4,000 mcg/D5W 250mL. The compound log was dated "12/8/14 - 12/9" and the label was dated December 9, 2014. No pharmacy assigned reference number (p

Based on observation, interview, document review, and policy and procedure review, the hospital failed to:

1. Provide evidence that, intravenous (IV) medications which had been prepared by the hospital's Neonatal Intensive Care Unit (NICU) Pharmacy Technician, for Neonatal critical care patients had been documented by the hospital's NICU Pharmacist in accordance with the facility's policy and procedure, to protect patients from medication errors and possible adverse drug reactions.

2. Provide evidence that, IV medications which had been prepared by the hospital's Chemotherapy (Chemo) Pharmacy Technician, for patients receiving Chemotherapy medications, had been documented by the hospital's Pharmacists, in accordance with the facility's policy and procedure to protect patients from medication errors and possible adverse drug reactions.

The hospital also failed to take the necessary actions to protect these patients and ensure their safety, which resulted in immediate jeopardy (called on December 9, 2014 at 5:00 PM and abated on December 11, 2014 at 3:25 PM).

Findings:

1. Inspection of the hospital's Pharmacy Intravenous (IV) compounding room on December 8, 2014 at 3:00 PM, revealed one evacuated container bottle with an unidentified solution inside the bottle was found inside hood 1. This evacuated container bottle had not been labeled. Concurrent interview with Pharmacy Supervisor 1 revealed that a Pharmacy Technician, who had been working earlier that day, had added the unknown solution to the evacuated container, but this Pharmacy Technician had already left the hospital. Pharmacy Supervisor 1 indicated that any medications (including this used evacuated container), which had been made on a different shift and not used, should have been discarded. Pharmacy Supervisor 1 was unable to definitively identify what the solution was, which had been placed into the evacuated container inside hood 1.

Further observation in hood 2 revealed that the NICU Pharmacy Technician who had been assigned to compound the Neonatal Intensive Care Unit's (NICU) IV medications was currently working inside this hood. She was observed drawing up Fluconazole (Diflucan), an antifungal drug, from a 100 ml bag in order to make 2 milligrams (mg) per milliliter (ml) syringes. The NICU Pharmacy Technician had just started to draw up the first syringe of Fluconazole as the surveyor walked up to hood 2. After observing the NICU Pharmacy Technician, and speaking with her, the surveyor observed 3 labels which had been generated for placement on the final plastic syringes of Fluconazole for Patients 30, 31, and 32.

The NICU Pharmacy Technician also had a label on the surface of a portable stand behind her for an Insulin Stock Solution bag which she was going to compound. The insulin stock solution is used to help control the blood sugar for the neonatal patients in NICU. This label was observed as being pre-signed off by the NICU Pharmacist, indicating that the drug had already been checked and verified by the NICU pharmacist as being correct, and ready to send to the patient care area (NICU).

The IV bag which the NICU Pharmacy Technician was using to make the Insulin Stock Solution was still inside its plastic overwrap container from the manufacturer. This overwrap is a plastic sealed pouch which covers the Normal Saline 100 ml piggyback bag to prevent moisture loss from the IV bag until it is ready for use. The labels for these Fluconazole syringes had also been signed off as being checked and verified by the NICU Pharmacist.

During an interview with the NICU Pharmacist on December 9, 2014 at 8:30 AM, the NICU Pharmacist indicated that she had indeed been pre-signing the IV labels for the medications above. The NICU Pharmacist also indicated that it was part of her normal routine to pre-sign the NICU IV labels before the NICU Pharmacy Technician had compounded any of her IV medications. ....". Pharmacist oversight when compounding Neonatal IV medications is extremely critical, to ensure patient safety as these medications are considered "High Alert/High Risk".

Review of the hospital's policy and procedure entitled: "Intravenous Admixture Process and Sterile Compounding Preparations", on December 9, 2014 at 12:40 PM, the policy stated the following: "I. Compounding manipulations and procedures are checked by a Pharmacist prior to the medication being dispensed. The technician/Intern Pharmacist must present the syringe, with the additives present, in the volume of the component added to the final product for the Pharmacist to check for all ...NICU, PICU and High-Alert Medications." The verification of this check above is documented by the Pharmacist applying his or her signature on the label of these medications.

Review of the hospital's policy and procedure entitled: "Pharmacy Compounding" on December 9, 2014 at 1:30 PM, the policy stated: "The Pharmacist performing or supervising compounding is responsible for the proper preparation, labeling, storage, delivery instructions, quality, review of the compounded drug product and completion of the appropriate documentation." The hospital was unable to provide any documented evidence that the NICU Pharmacist, who was supervising the NICU Pharmacy Technician, had checked these medications prior to these medications being sent out to the NICU patient care area.

Review of the National Association of Neonatal Nurses (a nationally recognized association) position statement # 3055 (dated July 2011), states: "Although establishing the frequency of medication errors in the NICU is difficult, published studies indicate that medication errors in NICU are common, ranging from 13 to 91 medication errors per 100 NICU admissions ... In addition, NICU patients are more likely to experience a medication error than other hospital patients and to experience more harm when a medication error occurs ...These data demonstrate that NICU patients require additional system wide safeguards against medication errors and that healthcare providers must be especially vigilant when working with medications in the NICU. Because of the vulnerable nature of NICU patients, the complexity of the medications used, and the challenges of the NICU environment, preparing and administering medications for neonatal patients are inherently risky ...The medications dispensed are often adult strength, requiring complex, multistep dilutions prior to dispensing or administering them, which increases the opportunity for errors ....".

2. During the inspection of the Pharmacy's Sterile Compounding IV room on December 8, 2014 at 3:45 PM, the surveyor entered into the Pharmacy's IV Chemotherapy compounding room. Further inspection of the hospital's IV Chemotherapy room revealed one vial of Mitomycin (Mutamycin), which is used with other drugs to treat stomach and pancreatic cancers. The vial of Mitomycin was found in a yellow plastic bin outside of the Chemotherapy (Chemo) IV hood. Mitomycin has also been shown to be effective in fighting cancer tumors, by blocking the growth of cancer cells. The vial of Mitomycin had been stored inside of a non-chemo bag (Ziploc), which was observed partially open (unzipped).

During a concurrent interview with Pharmacy Supervisor 1 (during the inspection), she indicated that the Mitomycin should have been stored inside of one of the Pharmacy's special Chemotherapy bags. The storage of this Mitomycin outside of the facility's special Chemotherapy bags potentially exposed any Pharmacy staff which entered into the room to this hazardous medication.

As stated in the hospital's Pharmacy policy and procedures, a Pharmacist must be responsible for the oversight of all medications which are prepared in all areas of the hospital Pharmacy. The Chemotherapy room is used for the compounding and packaging of drugs which are used to treat cancer patients. The National Institute for Occupational Safety and Health (which is an extension of the Center for Disease Control), published an alert in 2004 which discussed the hazards of healthcare workers working with "drugs to treat cancer and other hazardous drugs". The Alert goes on to st

Based on observation, document review, and staff interview, the Hospital failed to maintain a system for controlling sources of infections in accordance with internal policies and procedures, nationally recognized infection control practices and guidelines, and applicable regulations, when:

1. Operating Room (OR's) were not appropriately cleaned in accordance with national recognized infection control guidelines when sticky residue was observed on horizontal surfaces in the OR (Operating Room).

2. STERIS automated enzymatic dosing machine was not calibrated to dispense the required dose of enzymatic in accordance with manufacturer's IFU.

3. The hospital failed to ensure the nursing staff used proper aseptic techniques during the medication administration process. This failure could result in contamination of the injectable medications.


Findings:
1. During an observation on December 11, 2014 at 2:15 PM, the mattress pads on the surgical table was observed to have substance buildup with sticky residue.

Operating Room 1: (observation of empty operating room)

i. The body of the mattress was observed to have four(4) approximately 1" to 2" long by ½" wide strips of sticky residue running horizontal with 2" similar strips running vertical on the mattress in the first ¼ of the mattress. The last one-fourth of the mattress was to have one similar strip of residue approximately 2" wide.

ii. The arm rest in the first one-third of the arm rest with approximately (one) 1 inch wide by 1 to 3 inches long in strips of residue running into and over each other. The middle one-third of the arm rest was observed with three similar strips of residue.

iii. During a concurrent interview, the OPRC: confirmed that terminal cleaning was completed the night before on Operating Room 1. EVS stated the operating room to be ready to be occupied for surgery. indicated, "No, the residue should not be there."

Operating room 4: (observation of active cleaning and completion of between patients "turnover" cleaning.)

i. The body of the mattress was observed to have two (2) approximately 1" to 2" long by 1/2" wide strip of sticky residue running horizontal across the top of the pad.

In a Subsequent interview at 2:40 PM, EVS1 stated, "No it should not still be there. It (residue) should be removed or replaced. We notify the supervisor right-a-way for a replacement mattress." EVS indicated she had not notified the supervisor for a replacement. In an interview at 2:45 PM, with the Operating Room Coordinator he stated, "No it (residue) should not be there. They are all very good (EVS) and clean the mattress for the entire dwell time." At time of exit policy and procedures were not supplied as requested.

2. On December 9, 2014 at 11:30 AM, during a tour of the decontamination room. The Sterile Processing technician was observed to be completing the manual decontamination of the Surgical Instruments in a sink using tap water with no and/or insufficient amount of enzymatic solution.

The Technician was observed utilizing a Steris automatic dosing machine in which, when manually checked by measuring the contents revealed little product (approximately 4 drops of enzymatic solution and an insufficient amount to be measured in ounces) being released. The facilities policy is one ounce to one gallon of water. The technician was observed to fill the sink to the stated, 6 gallon mark on the sink with water, and also was observed to dispense 4 drops of the enzymatic solution.

In a concurrent interview the technician, she stated that she expected 3 ounces of enzymatic solution to be dispensed into the sink. The technician was observed to push tubing down into container of enzymatic and then adjust tubing running from the dispenser to the sink to dispense in a 2 oz measuring container. The technician ran the automatic dispenser and manually measured the dispensed enzymatic stating, "this will over flow." However, the dispenser only dispensed 1 3/4 oz. The expected 3oz. was not dispensed from the machine.

A review of facility policy titled, "Decontamination, dated 2013", indicated that the enzymatic manual cleaning process is the first step in the sterilization process. The technician was observed to continue with the sterilization process even though the first step was not accurately followed.

The manufacture recommendations for Steris Prolystica 2x Concentrate was for 1/8 to ½ ounce of solution for each gallon of water. According to the manufacture ½ ounce per (1) gallon in manual decontamination, is the recommended amount of enzymatic to effectively ensure decontamination of surgical instruments. The facility's automatic dispenser, did not dispense the manufacture recommended dose.




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3. Review of the hospital P&P titled "Sterile Product - Guidelines for Nursing in the preparation of Intravenous Admixture Solutions" dated 9/14, showed under policy statements: "Aseptic techniques will be employed in the preparation and administration of intravenous solutions at all times." This hospital P&P also showed under "Provisions/Procedure: When preparing intravenous solutions, the nurse shall: ... Remove outer cap from vial and rub rubber diaphragm of vial or neck of ampule with a 70 % alcohol swab. Use aseptic technique to maintain the sterility of reconstituted additives drawn through a needle and syringe ..."

Review of the Lippincott Procedures (standard of nursing practice provided by the hospital) online version titled "IV (intravenous) solution preparation, adding medications to the container" dated 7/14 (printed 12/10/2014), showed "...For medication from a vial: Remove the medication vial's lid. Disinfect the vial stopper thoroughly with an alcohol pad using friction, and then allow it to dry. If the medication must be diluted, disinfect the port of the diluent container thoroughly with an alcohol pad using friction, allow it to dry, and then withdraw the needed volume of diluent ..."

On December 10, 2014 beginning at 9:50 AM, SDU RN was observed administering medications to Patient 26. Heparin (used to treat and prevent bold clots) 5000 units injection was one of the medications administered to patient 26. SDU RN removed the heparin 5000 units injection vial cap, withdrew the content of the vial through the rubber stopper and injected it subcutaneously.

During concurrent staff interview, SDU RN acknowledged not disinfecting the rubber stopper and did not know the rubber stopper should be disinfected prior to piercing. The Clinical Director Critical Care expected her staff to follow the standard of nursing practice, to disinfect the medication vial rubber stopper prior to piercing.

On December 10, 2014 beginning at 10:15 AM, Neonatal Intensive Care Unit (NICU) RN was observed administering ampicillin (antibiotic) injection to Patient 84 in the presence of IPD and the Director Maternal Child unit. NICU RN reconstituted ampicillin injection powder with sterile water for injection. NICU RN took off the cap of ampicillin 250 mg injection vial and the cap of sterile water for injection (SWFI) 10 ml plastic bottle. NICU RN used one side of the alcohol swabs to rub the rubber septum on the ampicillin vial, flipped the alcohol swabs over and used the other side (where her finger was) to rub the rubber septum on the SWFI 10 ml and flipped the alcohol swabs over again to rub the ampicillin vial.

During concurrent interview, NICU RN stated two alcohol swabs were used; alcohol swab on side one was used to wipe the ampicillin vial and flipped over to the other side, alcohol swab on side two was used to wipe the SWFI 10 ml.

During the interview on December 10, 2014 beginning at 1:20 PM, the Infection Control Preventionist stated the standard of practice is to disinfect the rubber septum of a medication vial with an alcohol swap and discard, take a new alcohol swab to disinfect the second medication vial.

During the interview on December 12, 2014 beginning at 9:20 AM, the Department Administrator, Infection Control stated "the standard of practice is to use one alcohol swab to disinfect a vial then discard, and use another