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Based on observation, interview and administrative record review, the hospital did not have an effective governing body that carried out the functions required by a governing body as evidenced by:

1. The failure to ensure that an effective quality assessment and performance improvement program (QAPI) was implemented when the hospital failed to ensure monitoring of the sterile (germ free) intravenous (IV, directly into a vein) compounding (mixing) program to identify air pressure differential (air pressure difference between two room) issues in the IV compounding area. The hospital measured, and recorded, the air pressure differentials in the sterile IV compounding area. None of the recorded measurements met the minimum established by the pharmacy. The pharmacy completed quarterly quality assurance reports without verifying the recorded measurements. The quarterly quality assurance reports showed the air pressure differentials were at 100% compliance with the pharmacy established minimum. The pharmacy completed a USP (U.S. Pharmacopeia, a nationally recognized sterile compounding information source) <797> compliance study from the quarterly quality assurance reports. The compliance study showed the air pressure differentials were at 100% of USP <797> requirements. This failure resulted in the potential, from 4/1/13-7/25/13 for 3,333 patients, out of 7,729 patients admitted to Hospital A, to be exposed to 41,731 doses of contaminated IV medications (A Tag 263).

On 7/26/13 at 2:20 P.M., a group interview with the representatives of the Governing Body was conducted. The Chief Executive Officer (CEO) acknowledged that he was unaware of the sterile compounding air pressure differential issues prior to this survey.

2. The failure to ensure that Pharmacy Services developed and implemented policies and procedures to ensure that the needs of patients were met in a safe and effective manner. (A-Tag 491 #s 1-5, A-Tag 500 #s 1 and 2, A Tag 501 #s 1 and 2, A Tag 724)

3. The nursing staff at Hospital B failed to administer a medication for the treatment of a life threatening serum potassium level as ordered by the physician on two separate occasions. A patient continued to have untreated critically high serum potassium levels prior to her cardiac arrest and death. (A-Tag 405 #1)

4. The nursing staff at Hospital B failed to inform the physician of a critical lab value, a life threatening serum potassium level. (A-Tag 395 #1)

5. The nursing staff at Hospital B failed to implement the hospital's "Chain of Command" policy, when the attending physician that the RN paged, to inform him of a patient's admission to the nursing unit, did not return her call. (A-Tag 395 #1)

6. The nursing staff at Hospital A failed to ensure that sedation levels were consistently assessed for patients who were receiving narcotic pain medications via PCA pump (Patient-controlled analgesia - an electronically controlled infusion pump that delivers an amount of intravenous analgesic when the patient presses a button) as indicated in the hospital's own policy and procedure. (A-Tag 395 #2 and #3)

7. The nursing staff at Hospital A failed to ensure that independent double checks were consistently performed and documented for all patients receiving narcotic pain medication via PCA pump, in accordance with the hospital's policy and procedure. (A-Tag 395 #4)

8. The nursing staff at Hospital A were unable to consistently verbalize the correct expiration date to follow concerning the use of pre-filled antibiotic syringes. Administration of an expired medication to a patient could lead to a potential medication error relative to the stability, sterility and effectiveness of the medication. (A-Tag 505 #3)



The cumulative effect of these problems resulted in the facility's failure to deliver care in compliance with the Condition of Participation for Governing Body and failure to provide care to their patients in a safe environment.

Based on observation, interview and administrative record review, the hospital did not ensure that an effective quality assessment and performance improvement program (QAPI) was implemented as evidenced by:

1. The failure of the hospital to ensure monitoring of the sterile (germ free) intravenous (IV, directly into a vein) compounding (mixing) program to identify air pressure differential (air pressure difference between two room) issues in the IV compounding area. The hospital measured, and recorded, the air pressure differentials in the sterile IV compounding area. None of the recorded measurements met the minimum established by the pharmacy. The pharmacy completed quarterly quality assurance reports without verifying the recorded measurements. The quarterly quality assurance reports showed the air pressure differentials were at 100% compliance with the pharmacy established minimum. The pharmacy completed a USP (U.S. Pharmacopeia, a nationally recognized sterile compounding information source) <797> compliance study from the quarterly quality assurance reports. The compliance study showed the air pressure differentials were at 100% of USP <797> requirements. This failure resulted in the potential, from 4/1/13-7/25/13 for 3,333 patients, out of 7,729 patients admitted to Hospital A, to be exposed to 41,731 doses of contaminated IV medications. (A Tag 275 and A Tag 724)

2. The failure of the hospital to ensure that there was documented evidence of actions or interventions implemented to address the nursing staff's noncompliance with their own Critical Results Reporting policy. (A Tag 283)

The cumulative effect of these systemic practices and issues resulted in the failure of the hospital to deliver statutorily mandated compliance with the Condition of Participation for Quality Assessment and Performance Improvement.

Based on observation, interview, and administrative record review, the hospital failed to ensure monitoring of the sterile (germ free) intravenous (IV, directly into a vein) compounding (mixing) program to identify air pressure differential (air pressure difference between two room) issues in the IV compounding area. The hospital measured, and recorded, the air pressure differentials in the sterile IV compounding area. None of the recorded measurements met the minimum established by the pharmacy. The pharmacy completed quarterly quality assurance reports without verifying the recorded measurements. The quarterly quality assurance reports showed the air pressure differentials were at 100% compliance with the pharmacy established minimum. The pharmacy completed a USP (U.S. Pharmacopeia, a nationally recognized sterile compounding information source) <797> compliance study from the quarterly quality assurance reports. The compliance study showed the air pressure differentials were at 100% of USP <797> requirements. This failure resulted in the potential, from 4/1/13-7/25/13 for 3,333 patients, out of 7,729 patients admitted to Hospital A, to be exposed to 41,731 doses of contaminated IV medications.

Findings:

During a concurrent tour and interview, on 7/23/13 at 11:35 A.M., in the pharmacy of Hospital A, Pharmacy Manager (Pharm 1) identified the sterile IV compounding area. Inspection of the compounding area showed an ante-room (a room to prepare for compounding IVs). On the ante-room door was a certification sticker showing the room was ISO Class 8 (measurement of particles in the air). Inside the ante-room was a door leading to the buffer area (area where sterile medications are mixed). On the buffer room door was a certification sticker showing the room was ISO Class 7. Inside the buffer room were two IV compounding hoods (device to maintain a sterile area for mixing medication). Further inspection did not show instruments for monitoring air pressure in the compounding area. Pharm 1 was asked how the hospital monitored the air pressure in the compounding area. Pharm 1 stated that hospital engineering monitored the pressure.

Inspection of Hospital A's pharmacy freezer 5, on 7/23/13 at 11:50 A.M., showed it contained IV medication mixed in the compounding area. Further inspection of the medication showed it was IV ceftriaxone (antibiotic) 1 gram in 12 milliliters of sterile water. The ceftriaxone lot number was 201307722-8. It was mixed on 7/22/13 and had a frozen BUD (beyond-use date, date beyond medication cannot be stored) of 9/5/13 (45 days).

During a concurrent interview and administrative record review, on 7/23/13 at 2:15 P.M., Engineering Supervisor (Sup 1) was asked to describe the process for monitoring the air pressure in Hospital A's pharmacy sterile compounding area. Sup 1 stated a staff member measured the air pressure differences in the compounding area with a hand held device. The pressure differences were recorded on a daily form titled "Temperature, Humidity and Pressure Differential Readings." The daily form was submitted to a staff member assigned to HVC (Heating, Ventilation and Air Conditioning). The HVC staff member was responsible for determining if the recorded measurements met criteria. Sup 1 further stated that if the measurements did not meet criteria the HVC employee generated a work order to fix the problem. Sup 1 stated passing criteria for pressure difference was a positive value. Sup 1 further stated that there were no work orders created in the past 3 months.

During an interview on 7/24/13 at 1:45 P.M., Director of Pharmacy (DOP 1) was asked to describe the quality assurance monitoring and reporting process for the sterile IV compounding program. DOP 1 stated that the quality assurance measures, for the IV compounding program, were reported quarterly to the infection control committee. DOP 1 further stated that, for the past year, the IV compounding program had not received quality assurance direction from the infection control committee.

During a concurrent interview and administrative record review, on 7/25/13 at 2:05 P.M., Infection Control Manager (ICM) reviewed the Temperature, Humidity and Pressure Differential Readings form. The forms from 4/1/13 through 7/23/13 were reviewed. ICM stated that the documents did not show the pharmacy IV room pressure was positive 0.02 inches water column, or greater, from 4/1/13 through 7/23/13. ICM identified Hospital A's IV Clean Room QA Report-[Hospital A's Name], for FY12 Q4 through FY13 Q3. ICM acknowledged that each of the forms showed the specification for air pressure differential was >= (greater, or equal) 0.02 inch water column (positive). ICM further acknowledged that the IV Clean Room QA Report- [Hospital A's Name] reports showed Hospital A's compliance, with air pressure differential, for the IV clean room, was 100% for each of the four quarters reported. ICM stated that it was not the hospital's expectation for USP <797> BUD to be assigned to compounded IVs if the air pressure differential was less than specification.

During an interview, on 7/26/13 at 11:30 A.M., ICM stated that the infection control committee had not received the Clean Room QA Report-[Hospital A's Name] documents for the reporting periods of 1/13 and 4/13.

During a concurrent group interview and administrative record review, on 7/26/13 at 1:00 P.M., DOP 1 was asked to describe the IV clean room quality assurance and process improvement measures. DOP 1 stated that the hospital performed a USP <797> gap analysis (study to identify problems in sterile IV compounding) in 2013 and 2011. The hospital provided the USP <797> Compliance Study: Main Pharmacy (Start Date: 5/24/13) for Hospital A. Review of the document showed, I. Compliance: 92%, Domain, K. "Compounding Facility Management: Airflows and Pressure Differential Monitoring", score "100%." DOP 1 stated that the gap analysis was completed by reviewing the information from the IV clean room QA reports. DOP 1 was asked to describe the process for completing the air pressure differential field on the IV clean room QA report. DOP 1 stated that plant operations provided a verbal report on the pressure differential in the IV clean room. The Director of Quality and Performance Improvement stated the described process did not meet the hospital's expectation for pressure differential monitoring and reporting.

During an administrative record review, of the USP <797>, Guidebook to Pharmaceutical Compounding-Sterile Preparations (2008, pg. 43) showed, Facility Design and Environmental Controls, "The room shall be segregated from surrounding, unclassified spaces to reduce the risk of contaminants being blown, dragged, or otherwise introduced into the filtered unidirectional airflow environment, and this segregation shall be continuously monitored. For rooms providing a physical separation through the use of walls, doors, and pass-throughs, a minimum differential positive pressure of 0.02- to 0.05-inch water column is required."

Administrative record review, of the hospital's policy and procedure for Compounding of Sterile Products (#MER-FW-MM-3239, Effective: 9-12) showed, II Policy, D. Clean Room Requirements; Laminar Airflow Hoods, 7. "A pressure gauge of velocity meter shall be installed to monitor the pressure differential or airflow between the buffer area and the ante-area and between the ante-area and the general environment outside the compounding area. The IV Room (buffer room) should have positive air pressure relative to the adjacent pharmacy, an appropriate number of air exchanges per hour, and appropriate temperature levels are required. Hospital engineering will be notified when pressure differentials go out of range ..." Further review of the policy and procedure showed L. Transport, Storage and Expiration (Beyond-Use) Dating of Sterile Products, 8. "USP<797> criteria will be used to determine appropriate Beyond Use Dating of compounded sterile products based on defined risk level ..."

An administrative record review, of a hospital document titled "[Hospital A's Name] All Compounded Products", showed from 4/1/13 through 7/25/13, Hospital A admitted 7,729 patients. Further review showed the pharmacy compounded 41,731 sterile IV medications. Additional review showed 3,333 patients received the compounded IV medications.

Based on interview, document and policy review, Hospital A and B failed to ensure that there was documented evidence of actions or interventions implemented to address the noncompliance with their Critical Results Reporting policy. The hospital's Quality Assessment and Performance Improvement Program (QAPI) data identified that there was a problem with the nursing staff documentation of physician notification of critical lab values. The failure to document actions and interventions implemented, impedes the hospital's ability to measure, monitor and track their performance to ensure that improvements were sustained and/or a revision of the action plans may be necessary due to continued noncompliance.

Findings:

On 7/26/13 beginning at 1:00 P.M., a QAPI interview was conducted. The Director of Quality and Performance Improvement (DQPI) and the Director of Patient Safety (Admin 1) were present. Admin 1 explained that quarterly audits were conducted on the nursing staff at both Hospital A and B related to the documentation of physician notification for critical lab values. She stated that based on the following data:

Quarter 1 (2013) = 48.6 % (Registered Nurse compliance rate with documenting that critical lab values were reported to the physician)
Quarter 4 (2012) = 50 %
Quarter 3 (2012) = 57.1 %.

The hospital was aware that there was a nursing staff documentation problem related to the physician notification of critical lab values, as the data collected showed compliance rates at or below 50% which did not meet the hospital's goal. There was no documented evidence to show that actions and/or interventions were implemented with regards to this identified problem.

A review of the hospital's policy and procedure entitled "Critical Results Reporting", dated 8/12, was conducted on 7/26/13. The policy's purpose indicated that "... In order to enable the provision of timely and appropriate treatment of the patient, this policy establishes requirements for communicating critical results, expected timeframes and staff responsibilities for notification of results. Per the same policy, it stipulated that "Compliance monitoring and performance improvement activities are ongoing and include the collection of data on the timeliness of reporting critical result values from tests to determine whether a need for improvement exists. When data reveals that time frames are not met, they will be reported to the Quality Assurance and Performance Improvement Committee (QAPIC) and/or Quality Council, where data trends will be tracked and analyzed. Ongoing process or performance improvements will be monitored and/or revised to ensure compliance with stated time frames."

An interview with the Director of Quality and Performance Improvement (DQPI) was conducted on 7/26/13 at 1:50 P.M. The DQPI stated that they had been auditing quarterly and collecting data related to nursing staff documentation of physician notification of critical lab values. He stated that they were aware of the noncompliance. He stated that the data was reported but the actions and interventions implemented were not documented to show the hospital's response to an identified noncompliance with their Critical Results Reporting policy.

Based on interviews, record and document reviews the hospital failed to maintain an organized nursing service that meets the needs of the patients as evidenced by:

1. The nursing staff at Hospital B failed to administer a medication for the treatment of a life threatening serum potassium level as ordered by the physician on two separate occasions. A patient continued to have untreated critically high serum potassium levels prior to her cardiac arrest and death. (A-Tag 405 #1)

2. The nursing staff at Hospital B failed to inform the physician of a critical lab value, a life threatening serum potassium level. (A-Tag 395 #1)

3. The nursing staff at Hospital B failed to implement the hospital's "Chain of Command" policy, when the attending physician that the RN paged, to inform him of a patient's admission to the nursing unit, did not return her call. (A-Tag 395 #1)

4. The nursing staff at Hospital A failed to ensure that sedation levels were consistently assessed for patients who were receiving narcotic pain medications via PCA pump (Patient-controlled analgesia - an electronically controlled infusion pump that delivers an amount of intravenous analgesic when the patient presses a button) as indicated in the hospital's own policy and procedure. (A-Tag 395 #2 and #3)

5. The nursing staff at Hospital A failed to ensure that independent double checks were consistently performed and documented for all patients receiving narcotic pain medication via PCA pump, in accordance with the hospital's policy and procedure. (A-Tag 395 #4)

6. The nursing staff at Hospital A were unable to consistently verbalize the correct expiration date to follow concerning the use of pre-filled antibiotic syringes. Administration of an expired medication to a patient could lead to a potential medication error relative to the stability, sterility and effectiveness of the medication. (A-Tag 505 #3)


The cumulative effects of these systemic problems resulted in the hospital's inability to provide nursing services and care in a safe and effective manner in accordance with the statutorily-mandated Conditions of Participation for Nursing Services.

Based on interview, document and record review the hospital failed to ensure that one staff Registered Nurse (RN 2) at Hospital B implemented the hospital's policy and procedure related to "Chain of Command" when the attending physician that she paged, to inform him of a patient's (Patient 1) admission to the hospital, did not return her call. The Charge RN and RN 2 did not implement the hospital's "Critical Results Reporting" policy and procedure when they did not inform Patient 1's attending physician of her life threatening serum potassium levels. Patient 1's attending physician never returned RN 2's call regarding Patient 1's admission to the nursing unit. No physician was ever informed of Patient 1's critically high potassium levels prior to her cardiac arrest and death on 7/1/13. In addition, Hospital A failed to ensure that 2 of 41 sampled patients' (11, 12) sedation levels were consistently assessed while receiving narcotic pain medications via PCA pump (Patient-controlled analgesia - an electronically controlled infusion pump that delivers an amount of intravenous analgesic when the patient presses a button) as indicated in the hospital's own policy and procedure. Failure to assess the patient's sedation level while receiving narcotic pain medication via PCA pump may delay the identification of the medication's adverse side effects. A delayed response to an adverse narcotic side effect could potentially cause harm to the patient. Hospital A failed to ensure that independent double checks were consistently completed for 1 of 41 sampled patients (13) while receiving narcotic pain medication via PCA pump as indicated in the hospital's own policy and procedure. Independent double checks helped to ensure that the medication being administered was the correct medication, concentration, dose and pump settings. Independent double check was an added safeguard to minimize opportunity for errors, as an error in this process can lead to serious outcome for patients.

Findings:

1. Patient 1 was admitted to Hospital B on 6/30/13 with diagnoses of acute urinary tract infection, acute renal failure (abrupt loss of kidney function) and hyperkalemia (higher than normal levels of potassium in the circulating blood) according to the Emergency Department (ED) physician's dictated Emergency Record.

On 7/23/13 at 10:30 A.M., an interview was conducted with the staff RN (RN 2) of the inpatient nursing unit that Patient 1 was admitted to on 6/30/13 at 10:00 P.M. RN 2 stated that when Patient 1 arrived on the inpatient nursing unit, within 15 minutes, she began the admission process. At 10:59 P.M., RN 2 tried to contact Patient 1's attending physician (MD 2) by calling his number that was listed at the nursing station. MD 2 never answered so RN 2 left MD 2 a voice mail message informing MD 2 of Patient 1's admission to the nursing unit. RN 2 also left a message for MD 2 to call her back. RN 2 stated that she never made any further attempts to call MD 2.

The hospital's policy and procedure, entitled "Critical Results Reporting", dated 8/12, indicated that a potassium level less than 2.7 and greater than 6.0 is considered a "critical result." The policy defined a "critical result" as "Those values/interpretations that indicate that the patient is in imminent danger of death, significant morbidity, or serious adverse consequences unless evaluated immediately. Critical results may be the value/finding of a test that was ordered routinely."

RN 2 explained that she found out about Patient 1 having a serum potassium level of 7.0 at about 11:30 P.M. when she reviewed the paper work that was faxed to the nursing unit from the ED regarding Patient 1. Handwritten on the ED report was "Admitted for UTI (Urinary Tract Infection) K (potassium) = 7 Renal Failure". RN 2 stated that a potassium of 7.0 was a critical value serum potassium and needed to be reported to Patient 1's attending physician. RN 2 stated that she never called MD 2 once she was aware that Patient 2 had a critical value potassium level. (A normal potassium level ranges between 2.7 and 5.5. Extremely high levels of potassium in the blood can lead to cardiac arrest and death). Instead of informing MD 2 of Patient 1's serum potassium level she said she chose to continue monitoring the patient. At midnight the Charge RN called RN 2 to inform her that the lab had called to report Patient 1's potassium level was 6.2 (still a critical value). RN 2 stated that she went to the Charge RN to find out if MD 2 ever called back. He had not. Neither the Charge RN nor RN 2 ever attempted to call MD 2 a second time.

Further review of the hospital's policy and procedure entitled "Critical Results Reporting", dated 8/12, indicated that "Responsibilities...Results reported to the Licensed Responsible Caregiver (RN):

1. Write down critical result, date and time.

2. If phone report, provide read back to verify reported result.

3. Notify appropriate physician or designee of critical result and document physician name, date, and time in the medical record. The licensed responsible caregiver will attempt to contact the physician at a minimum of 15 minute intervals up to 30 minutes. If the physician has not responded to notification within 30 minutes, the licensed responsible caregiver will follow the normal chain of command for critical clinical communication i.e. charge nurse, manager or Operation Supervisor.

A review of the hospital's policy and procedure entitled "Chain of Command",dated 7/13, indicated that "In the event a patient care staff member has experienced a clinical issue involving the appropriateness of a physician's management of patient care and are not successful in resolving the issue directly with the physician(s) of record, the following steps will be followed:

1. Staff member to inform the Charger Nurse, Manager/Supervisor of the unit, or if after hours or weekends, call the Operations Supervisor.

2. The Manager or Supervisor will assess the patient issue and call the physician to discuss.

3. If the issue cannot be resolved between the Manager/Supervisor and physician, the Manager/Supervisor is responsible for following both the medical chain of command (see below) and the nursing chain of command (Manager > Director > Assistant Administrator [Hospital B] > CNOE (Chief Nursing Operating Executive).

Chain of Command Flow Chart - Medical Management

Patient Issue > Call Physician > Notify Manager or Operations Supervisor > Contact Physician If unresolved or if MD is unavailable, call Chief of Department

In the event the Supervisor is unable to reach the Chief of the Department, the Chief of Staff, Chair of the Physician Leadership Cabinet (Hospital B only) or Senior Director of Medical Affairs should be contacted. The Operations Supervisor will maintain a current list of contact information for these individuals."

During the interview with RN 2, RN 2 stated that she should have made multiple attempts to call MD 2 regarding Patient 1's critical value serum potassium level. In addition, RN 2 acknowledged that she should have advocated for the patient by calling the Operations Supervisor regarding Patient 1's critical potassium level and to inform the Operations Supervisor that MD 2 had not responded to her call.

RN 2 explained that at 7:00 A.M. on 7/1/13, she received a call from the Telemetry Technician (A technician who was continuously monitoring Patient 1's heart rhythm). The technician informed RN 2 that Patient 1's heart rate was in the 40's with long pauses in between each beat. RN 2 went to Patient 1's room. Patient 1 was unresponsive and breathing very slowly. Patient 1's heart rate then went down to the 30's and 20's (a normal heart rate was 60 to 100 beats per minute). At first RN 2 called for the Rapid Response Team (rapid intervention for patients that are quickly deteriorating) but then quickly called a Code Blue (a team of medical personnel work to revive a patient in cardiac arrest) because the patient's condition had deteriorated. The Code Blue was unsuccessful. Patient 1 was pronounced dead on 7/1/13 at 7:30 A.M.

A review of Patient 1's Autopsy Report, dated 7/9/13, listed the following clinical diagnoses at the time of Patient 1's death:

1. Cardiac Arrest Secondary to Severe Hyperkalemia
2. Acute Renal Failure
3. Urosepsis (an infection of the blood caused by a urinary tract infection)
4. Diabetes Mellitus
5. Possible UGI (upper gastro-intestinal) Bleed

An interview was conducted with the Chief Nursing and Operations Executive (CNOE) on 7/23/13 at 11:15 A.M. The CNOE stated that the expectation regarding the nurses responsibility for critical lab values was to contact the MD immediately. If the MD did not respond the nurse should use the chain of command up to the Chief of Staff to address the patient's critical lab value. The CNOE further explained that the RN was the patient's representative. Patient 1 was vulnerable and had a very high potassium level. RN 2 should have advocated for Patient 1 to get medication orders from an MD to lower her potassium level. That, however, did not occur.









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2. A tour of Hospital A's 10th floor Trauma Unit was conducted on 7/23/13 at 11:25 A.M. The patient was observed awake in bed.

Patient 11's medical record was reviewed on 7/23/13 at 1:20 P.M. The patient was admitted to Hospital A on 7/21/13 with diagnoses that included fracture of the left leg per the History and Physical, dated 7/22/13.

A review of the PCA preformatted order (PFO - preprinted physician's order) sheet indicated that Hydromorphone (a potent narcotic pain medication) PCA was ordered on 7/21/13 at 10:00 P.M. Per the PFO under the category of "Monitoring", the instruction indicated that, "RN (registered nurse) monitor: Vital Signs (BP - blood pressure and HR - heart rate), respiratory rate and quality, pain level, sedation level....at the following minimum intervals: Baseline: every 1 hour x 2 hours, then every 4 hours until PCA discontinued."

A review of Patient 11's PCA Flowsheet indicated that Hydromorphone 0.2 mg (milligrams) was started on 7/21/13 at 11:00 P.M. However, there was no documented evidence that the patient's sedation level was assessed until 7/23/13 at 8:00 A.M., 33 hours after the medication was started.

An interview with registered nurse (RN) 11 was conducted on 7/23/13 at 1:30 P.M. RN 1 stated that sedation level assessments were completed every 4 hours for patients on PCA narcotic medications to ensure that the patients were not getting too much medication. RN 11 also stated that too much narcotic pain medication may cause respiratory arrest.

A review of the hospital's policy and procedure titled "Pain Management: Patient Controlled Analgesia" was conducted on 7/23/13 at 3:30 P.M. The policy indicated that, "RN will monitor patient per requirements as defined in the PCA PFO." This policy and procedure was not followed as written when there was no documented evidence that Patient 11's sedation level was assessed every hour for 2 hours and every 4 hours until the PCA was discontinued.

3. A tour of Hospital A's 7th floor Surgical Unit was conducted on 7/24/13 at 8:50 A.M. Patient 12 was observed awake in bed.

A review of Patient 12's medical record was conducted on 7/24/13 at 9:10 A.M. The patient was admitted to Hospital A on 7/17/13 with diagnoses that included left knee postoperative cellulitis (skin infection) per the History and Physical, dated 7/17/13.

A review of the PCA preformatted order (PFO - preprinted physician's order) sheet indicated that Hydromorphone (a potent narcotic pain medication) was ordered on 7/18/13 at 9:30 P.M. Per the PFO under the category of "Monitoring", the instruction indicated that, "RN (registered nurse) monitor: Vital Signs (BP - blood pressure and HR - heart rate), respiratory rate and quality, pain level, sedation level.....at the following minimum intervals: Baseline: every 1 hour x 2 hours, then every 4 hours until PCA discontinued."

A review of Patient 12's PCA flowsheet indicated that the patient received PCA Hydromorphone the whole day of 7/19/13. Per the flowsheet, on 7/19/13 at 4:00 A.M., the patient sedation level was marked as "S" (sleeping). However, there was no documented evidence that the patient's sedation level was assessed until 8:56 A.M., 4 hours and 56 minutes later.

A review of the hospital's policy and procedure titled "Pain Management: Patient Controlled Analgesia" was conducted on 7/23/13 at 3:30 P.M. The policy indicated that, "RN will monitor patient per requirements as defined in the PCA PFO." This policy was not followed when Patient 12's sedation level was not consistently assessed every 4 hours as indicated in the PCA PFO.

A joint record review and interview with the Director of Surgical Unit (DSU) was conducted on 7/24/13 at 9:40 A.M. The DSU acknowledged that Patient 12's sedation level was not consistently assessed every 4 hours as indicated in the PCA PFO and per the hospital's policy and procedure.

4. A tour of Hospital A's 8th floor Medical/Oncology Unit was conducted on 7/23/13 at 1:55 P.M.

A review of Patient 13's medical record was conducted on 7/23/13 at 2:20 P.M. Patient 13 was admitted to Hospital A on 6/20/13 with diagnoses that included cellulitis (skin infection) per the History and Physical, dated 6/20/13.

A review of the PCA preformatted order (PFO - preprinted physician's order) sheet indicated that Morphine (a narcotic pain medication) PCA was ordered for Patient 13 on 7/7/13 at 10:00 A.M.

A review of the hospital's policy and procedure titled "Pain Management: Patient Controlled Analgesia" was conducted on 7/23/13 at 3:30 P.M. The policy indicated to, "Perform and document an independent double check with another RN (registered nurse)/ pharmacist/ physician at these intervals: a. PCA initiation b. Changes in syringe c. Any change in the pump program d. During hand off communication (Change of shift and/or department hand off; Receiving the patient from another unit/department)."

However, a review of Patient 13's PCA Flowsheet indicated that independent double check were not consistently done during hand off communication. Per the flowsheet, the night nurse on 7/7/13 conducted her independent check on 7/8/13 at 7:00 A.M. but the morning nurse did not conduct her own independent check. There was also no record on the flowsheet that the morning and evening nurse for 7/8/13 conducted their independent double checks during their hand off communication.

A joint record review and interview with the Unit Manager (UM) was conducted on 7/23/13 at 4:30 P.M. The UM acknowledged that the nurses were not consistently conducting independent double checks during their hand off communication. The UM acknowledged that the hospital's policy and procedure was not followed as written.

Based on interview and record review, the hospital failed to ensure that one Emergency Department (ED) Registered Nurse (RN 1) at Hospital B administered a medication, ordered by the ED physician for the treatment of a life threatening serum potassium level, for 1 of 41 sampled patients (Patient 1). In addition, one staff RN (RN 2) at Hospital B failed to notify the same patient's (Patient 1) attending physician, after Patient 1 was admitted, that RN 2 was unable to administer a second dose of the same medication to continue to lower Patient 1's critically high serum potassium level. Untreated critically high levels of potassium in the blood can lead to cardiac arrest and death. Patient 1 continued to have untreated critically high serum potassium levels prior to her cardiac arrest and death on 7/1/13.

Findings:

1. Patient 1 was admitted to Hospital B on 6/30/13 with diagnoses of acute urinary tract infection, acute renal failure (abrupt loss of kidney function) and hyperkalemia (higher than normal levels of potassium in the circulating blood) according to the Emergency Department (ED) physician's dictated Emergency Record.

The hospital's policy and procedure, entitled "Critical Results Reporting", dated 8/12, indicated that a potassium level less than 2.7 and greater than 6.0 is considered a "critical result." The policy defined a "critical result" as "Those values/interpretations that indicate that the patient is in imminent danger of death, significant morbidity, or serious adverse consequences unless evaluated immediately. Critical results may be the value/finding of a test that was ordered routinely."

On 7/23/13 at 3:45 P.M., an interview was conducted with the ED Registered Nurse (RN 1) assigned to care for Patient 1. RN 1 stated that on 6/30/13 at about 7:30 P.M., the ED physician (MD 1) received a call informing him that Patient 1's serum potassium level was 7.0. (A normal potassium level ranges between 2.7 and 5.5. Extremely high levels of potassium in the blood can lead to cardiac arrest and death). RN 1 became aware of the elevated potassium level closer to 8:00 P.M. on 6/30/13 when MD 1 ordered Kayexalate (a medication used to treat high levels of potassium in the blood) 30 Grams (gm) to be given to Patient 1 orally. RN 1 scanned the physician's order for Kayexalate to the pharmacy expecting that the pharmacy would deliver the medication to the ED. Patient 1 was being admitted to the hospital and RN 1 found out between 9:00 P.M. and 9:30 P.M. that Patient 1's inpatient bed was available. At 10:00 P.M. on 6/30/13, RN 1 took Patient 1 on a gurney to the inpatient nursing unit. RN 1 stated that she never called the pharmacy to follow up on the release of the Kayexalate. RN 1 never administered the Kayexalate to Patient 1.

An interview was conducted with the RN Manager of the ED (EDRNM) on 7/25/13 at 8:45 P.M. The EDRNM stated that the Kayexalate should have been available within twenty minutes of when it was scanned to the pharmacy. However, the pharmacy never received the scan of the physician's medication order for Patient 1. And, RN 1 never called the pharmacy, in follow-up, to check on the availability of the Kayexalate. The EDRNM further explained that it is the expectation that the medication should have been administered by RN 1 within 1 hour of the ED physician writing the medication order. The ED physician wrote the order for the Kayexalate at about 8:00 P.M. on 6/30/13. Patient 1 was transferred to the inpatient nursing unit at 10:00 P.M., two hours later.

During the interview with RN 1, she explained that she faxed a report regarding Patient 1 to the inpatient nursing unit prior to Patient 1's transfer. However, there was no documentation in the faxed report that the Kayexalate had not been administered. When RN 1 arrived on the inpatient nursing unit with Patient 1, RN 1 told the Charge RN that the Kayexalate had not been administered to the patient in the ED. During the interview, RN 1 stated that looking back she thought that the pharmacy would deliver the Kayexalate. RN 1 said that she should have been more aggressive by scanning the medication order and then calling the pharmacy. RN 1 stated that a patient should not leave the ED until every physician's order has been completed. RN 1 acknowledged that did not occur.

When Patient 1 arrived on the inpatient nursing unit, RN 1 gave a hand-off report to RN 2, the nurse assigned to care for Patient 1. RN 1 informed RN 2 that the Kayexalate was never administered to Patient 1 in the ED. A review of the Admission Orders, written by MD 1, revealed that there was a second physician's order for "Kayexalate 30 gm po (orally) @ 2200 hrs. (10:00 P.M.)"

An interview was conducted with RN 2 on 7/23/13 at 10:30 A.M. At 11:40 P.M. on 6/30/13, RN 2 attempted to administer the Kayexalate to Patient 1. However, Patient 1 could not take anything orally. The second dose of Kayexalate, written by MD 1 in Patient 1's Admission Orders was never administered. RN 2 stated that she informed the Charge RN that she did not administer the Kayexalate but she never informed the attending physician. The Charge RN never informed the attending physician nor did she encourage RN 2 to do so.

On 7/1/13 at 6:56 A.M. the lab called and informed RN 2 that patient 1's serum potassium was 7.6. At 7:00 A.M. on 7/1/13, RN 2 received a call from the Telemetry Technician (A technician who was continuously monitoring Patient 1's heart rhythm). The technician informed RN 2 that Patient 1's heart rate was in the 40's with long pauses in between each beat. RN 2 went to Patient 1's room. Patient 1 was unresponsive and breathing very slowly. Patient 1's heart rate then went down to the 30's and 20's ( a normal heart rate was 60 to 100 beats per minute). At first RN 2 called for the Rapid Response Team (rapid intervention for patients that are quickly deteriorating) but then quickly called a Code Blue (a team of medical personnel work to revive a patient in cardiac arrest) because the patient's condition had deteriorated. The Code Blue was unsuccessful. Patient 1 was pronounced dead on 7/1/13 at 7:30 A.M.

A review of the Patient 1's Autopsy Report, dated 7/9/13, listed the following clinical diagnoses at the time of Patient 1's death:

1. Cardiac Arrest Secondary to Severe Hyperkalemia
2. Acute Renal Failure
3. Urosepsis ( an infection of the blood caused by a urinary tract infection)
4. Diabetes Mellitus
5. Possible UGI (upper gastro-intestinal) Bleed.

Based on interview, document and record review the hospital failed to ensure that all physicians at Hospital A and Hospital B implemented the hospital's Medical Staff Rules and Regulations related to medical record entries. One physician (MD 31) at Hospital A and three physicians at Hospital B (MD 1, MD 3, MD 4) failed to document a date and/or time that they wrote physician's orders in 4 of 41 sampled patient's (Patient 1, 2, 4, 31) medical records. The failure to document a date and/or time that the physician wrote an order made it impossible to verify that the physician's order was carried out in a timely manner.

Findings:

1. Patient 1 was admitted to Hospital B on 6/30/13 with diagnoses that included urinary tract infection, renal failure (loss of normal kidney function), hyperkalemia (elevated potassium level in the blood) according to the Emergency Department (ED) Physician Record. A review of Patient 1's medical record was conducted on 7/23/13 at 3:45 P.M. On the physician's order section of the Emergency Department Physician Record, the ED physician (MD 1) had ordered ten laboratory tests, a Chest X-ray, a Computerized Tomography (CT - a radiological technique that produces images of cross sections through a patient's body using low levels of radiation) scan of the abdomen and pelvis, an electrocardiogram (EKG - a test that checks for problems with the electrical activity of the heart), intravenous fluids and orders for the administration of four medications. However, there was no documentation of the time that the physician wrote these orders.

A review of the hospital's Medical Staff Rules and Regulations, dated 2012, indicated that "All patient medical records must be legible, complete, dated, timed and authenticated in written or electronic form by the person responsible..."

An interview was conducted with the Registered Nursed Manager of the ED (EDRNM) on 7/23/13 at 10:20 A.M. The EDRNM acknowledged that the way that MD 1 had written his physician's orders was not in accordance with hospital policy and procedure. The EDRNM acknowledged that all physician's orders must be signed, dated and timed.

2. Patient 2 was treated in the Emergency Department (ED) of Hospital B on 7/22/13 for cholelithiasis (gallstones) and biliary colic (pain secondary to gallstones) according to the ED physician's Emergency Record. A review of Patient 2's ED Record was conducted on 7/23/13 at 10:05 A.M. According to the Emergency Department Physician Record, the ED physician (MD 3) ordered five laboratory tests, a Computerized Tomography (CT - a radiological technique that produces images of cross sections through a patient's body using low levels of radiation) scan, Ultrasound (US - use of ultrasonic waves for diagnostic or therapeutic purposes) of the abdomen and pelvis, intravenous fluids and orders for the administration of four medications. The orders were dated 7/22/13. However, there was no time documented anywhere on the ED Physician Record to indicate when MD 3 examined Patient 2 or when he had written each of the orders described above.

A review of the hospital's Medical Staff Rules and Regulations, dated 2012, indicated that "All patient medical records must be legible, complete, dated, timed and authenticated in written or electronic form by the person responsible..."

An interview was conducted with the Registered Nursed Manager of the ED (EDRNM) on 7/23/13 at 10:20 A.M. The EDRNM acknowledged that the way that MD 1 had written his physician's orders was not in accordance with hospital policy and procedure. The EDRNM acknowledged that all physician's orders must be signed, dated and timed.

3. Patient 4 was admitted to the hospital on 7/23/13 to the Intensive Care Unit (ICU) of Hospital B with diagnoses that included change in mental status, hyponatremia (low blood sodium), history of opiate (a drug derived from opium) dependence according to the admission History and Physical. A review of Patient 4's medical record was conducted on 7/24/13 at 9:30 A.M. According to the physician's orders, a physician (MD 4) wrote orders on 7/23/13 for the administration of a medication, four laboratory tests, a Chest X-ray and intravenous fluids. However, there was no documented evidence on the physician's order sheet of what time on 7/23/13 MD 4 had written the orders.

A review of the hospital's Medical Staff Rules and Regulations, dated 2012, indicated that "All patient medical records must be legible, complete, dated, timed and authenticated in written or electronic form by the person responsible..."

An interview was conducted with the ICU Registered Nurse Manager (ICURNM) on 7/24/13 at 9:45 A.M. The ICURNM acknowledged that it was a requirement for the physicians at Hospital B to sign, date and time all physician orders.



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4. A review of Patient 31's medical record was conducted on 7/23/13 at 4:16 P.M. Patient 31 was admitted to the Emergency Department at Hospital A for abdominal pain on 7/23/13 at 8:30 A.M., per the Facesheet. On the physician's order section of the Emergency Department Physician Record, the ED physician (MD 31) had ordered five laboratory tests, a Computerized Tomography (CT - a radiological technique that produces images of cross sections through a patient's body using low levels of radiation) scan of the abdomen and pelvis, fleet enemas (a procedure of introducing liquids into the rectum and colon via the anus for cleansing and stimulating evacuation of the bowels), and the administration of two medications. Per the same record, a time of "9P" with no date was documented. The documentation was unclear making it difficult to determine on what date and time the physician's orders were written, since Patient 31 was admitted in the morning of 7/23/13.

A review of the hospital's Medical Staff Rules and Regulations, dated 2012, indicated that "All patient medical records must be legible, complete, dated, timed and authenticated in written or electronic form by the person responsible..."

An interview with the Director of Patient Safety (Admin 1) was conducted on 7/24/13 at 10:17 A.M. Admin 1 agreed that MD 31 did not complete Patient 31's ED Physician Record when the time was unclear and there was no date documented on the record. She acknowledged that all physician's orders must be signed, dated and timed.

Based on observation, interview, and administrative record review, the hospital failed to ensure the provision of pharmaceutical services and care that meets the needs of the patients as evidenced by:

1. The pharmacy failed to ensure the development and implementation of a policy and procedure to monitor, and evaluate, the air pressure differential (difference in air pressure between two rooms) in the sterile (germ free) intravenous (IV, directly into a vein) compounding (mixing) room. The pharmacy did not monitor, and evaluate, the recorded air pressure differential in the sterile IV compounding room. This failure resulted in the potential, from 4/1/13-7/25/13 for 3,333 patients, out of 7,729 patients admitted to Hospital A, to be exposed to 41,731 doses of contaminated IV medications (A-Tag 491 #1 and A-Tag 724).

2. The pharmacy failed to ensure the development and implementation of a policy and procedure to monitor, evaluate, and report, the air changes per hour in the sterile (germ free) intravenous (IV, directly into a vein) compounding (mixing) room. The pharmacy did not monitor, evaluate, and report the air changes per hour in the sterile IV compounding area. This failure resulted in the potential, from 4/1/13-7/25/13 for 3,333 patients, out of 7,729 patients admitted to Hospital A, to be exposed to 41,731 doses of contaminated IV medications (A-Tag 491 #2).

3. The pharmacy failed to ensure the implementation of a policy and procedure to monitor, and evaluate, the potency (active ingredient strength within +/- 10% of the labeled amount) for intravenous (IV, directly into a vein) antibiotics produced in the sterile (germ free) IV compounding (mixing) room. The pharmacy mixed IV antibiotics, labeled the drug with a frozen BUD (beyond-use date, date beyond which medication cannot be stored), and once thawed relabeled them with a refrigerated BUD. The pharmacy did not have documentation supporting the potency of the antibiotics at the end of the frozen, thawed, and refrigerated BUD range. This failure resulted in the potential, from 4/1/13-7/25/13 for 1,397 patients, out of 7,729 patients admitted to Hospital A, to be exposed to 3,303 doses of IV antibiotics at other than labeled potency (A-Tag 500 #1).

4. The pharmacy failed to ensure that compounded sterile preparations were prepared in accordance with hospital sterile compounding policy & procedure and master formulas for batch compounding. Beyond use date assignment on batch compounded products was not consistent with the hospital developed master formulas. In addition, the quantities of each component used in batch compounding documented in the compounding log were inconsistent with the final volume or quantity of product prepared (A-Tag 501 #1).

5. The pharmacy failed to ensure that sterile compounding of medication for intravenous use were prepared accurately to the labeled strength/potency (A-Tag 501 #2).

The cumulative effects of these systemic problems resulted in the pharmacy's inability to provide pharmaceutical services and care in a safe and effective manner in accordance with the statutorily-mandated Conditions of Participation for Pharmaceutical Services.

Based on observation, interview, and document review, the hospital failed to administer pharmaceutical services to meet the needs of the patients in accordance with standards of practice, federal and state laws as evidenced by:

1. The pharmacy failed to ensure the development and implementation of a policy and procedure to monitor, and evaluate, the air pressure differential (difference in air pressure between two rooms) in the sterile (germ free) intravenous (IV, directly into a vein) compounding (mixing) room. The pharmacy did not monitor, and evaluate, the recorded air pressure differential in the sterile IV compounding room. This failure resulted in the potential, from 4/1/13-7/25/13 for 3,333 patients, out of 7,729 patients admitted to Hospital A, to be exposed to 41,731 doses of contaminated IV medications.

2. The pharmacy failed to ensure the development and implementation of a policy and procedure to monitor, evaluate, and report, the air changes per hour in the sterile (germ free) intravenous (IV, directly into a vein) compounding (mixing) room. The pharmacy did not monitor, evaluate, and report the air changes per hour in the sterile IV compounding area. This failure resulted in the potential, from 4/1/13-7/25/13 for 3,333 patients, out of 7,729 patients admitted to Hospital A, to be exposed to 41,731 doses of contaminated IV medications.

3. The pharmacy failed to ensure the implementation of a policy and procedure for the continuous operation of a laminar airflow hood [device to maintain a germ free area for mixing intravenous (IV, directly into a vein) medication]. Hospital A's second floor pharmacy did not continuously operate the mixing hood. This failure resulted in the potential for patients to be exposed to a delay in receiving stat (as soon as possible) pharmacy compounded (mixed) IV medications.

4. The pharmacy failed to ensure the development and implementation of a policy and procedure to monitor, and evaluate, the condition of walls, and cleaning of floors, of the sterile (germ free) intravenous (IV, directly into a vein) compounding (mixing) ante-room. The pharmacy did not monitor the condition of the walls in the ante-room. The pharmacy did not monitor the cleanliness of the ante-room floor. These failures resulted in the potential for patients to be exposed to contaminated IV medications.

5. The pharmacy failed to ensure that drugs and biologicals were stored in accordance with manufacturers' direction. Phenylephrine (a vasoconstrictor that constricts blood vessels) injectable were not protected from light as indicated by the manufacturer's storage condition.

Findings:

1. During a concurrent tour and interview, on 7/23/13 at 11:35 A.M., in the pharmacy of Hospital A, Pharmacy Manager (Pharm 1) identified the sterile IV compounding area. Inspection of the compounding area showed an ante-room (a room to prepare for compounding IVs). On the ante-room door was a certification sticker showing the room was ISO Class 8 (measurement of particles in the air). Inside the ante-room was a door leading to the buffer area (area where sterile medications are mixed). On the buffer room door was a certification sticker showing the room was ISO Class 7. Inside the buffer room were two IV compounding hoods (device to maintain a sterile area for mixing medication). Further inspection did not show instruments for monitoring air pressure in the compounding area. Pharm 1 was asked how the hospital monitored the air pressure in the compounding area. Pharm 1 stated that hospital engineering monitored the pressure.

Inspection of Hospital A's pharmacy freezer 5, on 7/23/13 at 11:50 A.M., showed it contained IV medication mixed in the compounding area. Further inspection of the medication showed it was IV ceftriaxone (antibiotic) 1 gram in 12 milliliters of sterile water. The ceftriaxone lot number was 201307722-8. It was mixed on 7/22/13 and had a frozen BUD (beyond-use date, date beyond medication cannot be stored) of 9/5/13 (45 days).

During a concurrent interview and administrative record review, on 7/23/13 at 2:15 P.M., Engineering Supervisor (Sup 1) was asked to describe the process for monitoring the air pressure in Hospital A's pharmacy sterile compounding area. Sup 1 stated an employee measured the air pressure differences in the compounding area with a hand held device. The pressure differences were recorded on a daily form titled "Temperature, Humidity and Pressure Differential Readings." The daily form was submitted to a staff member assigned to HVC (Heating, Ventilation and Air Conditioning). The HVC staff member was responsible for determining if the recorded measurements met criteria. Sup 1 further stated that if the measurement did not meet criteria the HVC staff member generated a work order to fix the problem. Sup 1 stated passing criteria for pressure difference was a positive value. Sup 1 further stated that there were no work orders created in the past three months.

During a concurrent interview and administrative record review, on 7/25/13 at 2:05 P.M., Infection Control Manager (ICM) reviewed the Temperature, Humidity and Pressure Differential Readings form. The forms from 4/1/13 through 7/23/13 were reviewed. ICM acknowledged the documents did not show the Pharmacy IV room pressure was positive 0.02 inches water column, or greater, from 4/1/13 through 7/23/13.

Administrative record review, of the hospital's policy and procedure for Compounding of Sterile Products (#MER-FW-MM-3239, Effective: 9-12) showed, II Policy, D. Clean Room Requirements; Laminar Airflow Hoods, 7. "A pressure gauge of velocity meter shall be installed to monitor the pressure differential or airflow between the buffer area and the ante-area and between the ante-area and the general environment outside the compounding area. The IV Room (buffer room) should have positive air pressure relative to the adjacent pharmacy, an appropriate number of air exchanges per hour, and appropriate temperature levels are required. Hospital engineering will be notified when pressure differentials go out of range ..." Further review of the policy and procedure showed L. Transport, Storage and Expiration (Beyond-Use) Dating of Sterile Products, 8. " USP<797> criteria will be used to determine appropriate Beyond Use Dating of compounded sterile products based on defined risk level ..."

During an administrative record review, of the USP (U.S. Pharmacopeia) <797>, a nationally recognized sterile compounding information source, Guidebook to Pharmaceutical Compounding-Sterile Preparations (2008, pg. 43) showed, Facility Design and Environmental Controls, "The room shall be segregated from surrounding, unclassified spaces to reduce the risk of contaminants being blown, dragged, or otherwise introduced into the filtered unidirectional airflow environment, and this segregation shall be continuously monitored. For rooms providing a physical separation through the use of walls, doors, and pass-throughs, a minimum differential positive pressure of 0.02- to 0.05-inch water column is required."

An administrative record review, of a hospital document titled "[Hospital A's Name] All Compounded Products", showed, from 4/1/13 through 7/25/13, Hospital A admitted 7,729 patients. Further review showed the pharmacy compounded 41,731 sterile IV medications. Additional review showed 3,333 patients received the compounded IV medications.

2. During a concurrent tour and interview, on 7/23/13 at 11:35 A.M., in the pharmacy of Hospital A, Pharmacy Manager (Pharm 1) identified the sterile IV compounding area. Inspection of the compounding area showed an ante-room (a room to prepare for compounding IVs). On the ante-room door was a certification sticker showing the room was ISO Class 8 (measurement of particles in the air). Inside the ante-room was a door leading to the buffer area (area where sterile medications were mixed). On the buffer room door was a certification sticker showing the room was ISO Class 7. Inside the buffer room were two IV compounding hoods (device to maintain a sterile area for mixing medication).

Inspection of Hospital A's pharmacy freezer 5, on 7/23/13 at 11:50 A.M., showed it contained IV medication mixed in the compounding area. Further inspection of the medication showed it was IV ceftriaxone (antibiotic) 1 gram in 12 milliliters of sterile water. The ceftriaxone lot number was 201307722-8. It was mixed on 7/22/13 and had a frozen BUD (beyond-use date, date beyond medication cannot be stored) of 9/5/13 (45 days).

During a concurrent interview and administrative record review, on 7/25/13 at 2:05 P.M., Infection Control Manager (ICM) and Director Patient Safety (DPS) were asked to describe the process for how air changes per hour were monitored in the IV compounding area. ICM and DPS stated that they were aware the hospital was monitoring the air changes per hour (ACH). ICM and DPS stated that it was their expectation to be informed when there was a problem with the air changes per hour in the IV compounding area.

An administrative record review, of [Hospital A's Name] Annual 2013 Validation of Decon, Main Pharmacy IV, Pharmacy Ante, Pharmacy 8th floor, OR Clean Workroom & OR Dirty Workroom (Project Number 135453, Date April 4, 2013) showed, Crucial Area Validation, Pharmacies, Main Phar IV, Actual ACH, "13.81." Further review showed, Phar Ante, Actual ACH, "20.26."

Administrative record review, of the hospital's policy and procedure for Compounding of Sterile Products (#MER-FW-MM-3239, Effective: 9-12) showed, II Policy, D. Clean Room Requirements; Laminar Airflow Hoods, 7. "A pressure gauge of velocity meter shall be installed to monitor the pressure differential or airflow between the buffer area and the ante-area and between the ante-area and the general environment outside the compounding area. The IV Room (buffer room) should have positive air pressure relative to the adjacent pharmacy, an appropriate number of air exchanges per hour, and appropriate temperature levels are required." Further review of the policy and procedure showed L. Transport, Storage and Expiration (Beyond-Use) Dating of Sterile Products, 8. "USP (U.S. Pharmacopeia) <797> criteria will be used to determine appropriate Beyond Use Dating of compounded sterile products based on defined risk level ..."

During an administrative record review, of the USP <797>, a nationally recognized sterile compounding information source, Guidebook to Pharmaceutical Compounding-Sterile Preparations (2008, pg. 43) showed, Facility Design and Environmental Controls, "Room air exchanges are typically expressed as ACPHs (air changes per hour). Adequate HEPA-filtered airflow supplied to the buffer area and ante-area is required to maintain cleanliness classification during operational activity through the number of ACPHs ...An ISO Class buffer area and ante-area supplied with HEPA-filtered air shall receive an ACPHs of not less than 30. The PEC (hood) is a good augmentation to generating air changes in the air supply of an area but cannot be the sole source of HEPA-filtered air. If the area has an ISO Class 5 recirculating device, a minimum of 15 ACPHs through the area supply HEPA filters is adequate, providing the combined ACPH is not less than 30."

An administrative record review, of a hospital document titled "[Hospital A's Name] All Compounded Products", showed, from 4/1/13 through 7/25/13, Hospital A admitted 7,729 patients. Further review showed the pharmacy compounded 41,731 sterile IV medications. Additional review showed 3,333 patients received compounded IV medications.

3. During a concurrent tour and interview, on 7/23/13 at 1:05 P.M., in the second floor pharmacy of Hospital A, a sterile IV compounding hood was identified. The second floor pharmacy contained one IV hood. Inspection of the hood showed that it was not in operation. Pharmacy Technician (RPT 3) was asked to describe how the hood was used. RPT 3's description included turning off the hood, during the hours the pharmacy was open, to reduce noise in the pharmacy. RPT 3's description included turning on the hood and letting it run for 30 minutes. IVs were then mixed after the 30 minutes of operation. RPT 3 stated the pharmacy mixed stat (needed as soon as possible) IV medications. The hospital was requested to provide the policy and procedure for IV hoods.

Administrative record review, of the hospital's policy and procedure for Compounding of Sterile Products (#MER-FW-MM-3239, Effective: 9-12) showed, II. Policy, D. Clean room requirements; Laminar Airflow Hoods, 8. "The laminar-airflow hood will be operated continuously. If turned off, allow at least 30 minutes for complete purging of room air from the IV Room."

4. During a concurrent tour and record review, on 7/24/13 at 9:10 A.M., in Hospital B's pharmacy, a medication storage refrigerator was identified. Inspection of the refrigerator showed it contained a sterile compounded IV medication. Further inspection showed the medication was KCl (electrolyte) 10 mEq (milliequivalent) in normal saline (salt water) 1000 milliliters. The medication was prepared on 7/19/13 and expired on 8/2/13.

During a concurrent tour and interview, on 7/24/13 at 9:35 A.M., in Hospital B's pharmacy, Director of Pharmacy (DOP 2) identified the sterile IV compounding area. Inspection of the compounding area showed a door leading to the ante-room (a room to prepare for compounding IVs). Inside the ante-room was a door leading to the buffer area (area where sterile IV medications were mixed). Inspection of the ante-room walls showed an area where the paint had peeled off and the bare wall was exposed. Further inspection showed there were multiple pin holes in the wall. DOP 2 acknowledged the damaged wall. Continued inspection of the ante-room showed dark grey powdery materials in two corners of the floor. DOP 2 acknowledged the materials in the two corners of the room.

Administrative record review, of the hospital's policy and procedure for Compounding of Sterile Products (#MER-FW-MM-3239, Effective: 9-12) showed, II. Policy, C. Environment Design, 7. "Walls, floors, fixtures, and ceilings should be non-permeable, smooth and free of cracks, crevices and be of non-shedding materials." Further review showed, E. Environmental Services (Housekeeping); 1. "Daily: Floors are mopped daily when no aseptic operations are in progress ..."



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5. During a tour of the satellite pharmacy located by the surgery department of Hospital A at approximately 1:20 P.M. on 7/23/13, twelve vials of 1-ml (milliliter) phenylephrine 10mg(milligrams)/ml and 8 syringes of phenylephrine 100mg/10ml were found on the shelf exposed to light. The product labeling on each vial/syringe indicated that medication should be protected from light.
Exposing phenylephrine to light can cause chemical reactions and loss of potency of the drug.
During an interview at approximately 1:25 P.M. on 7/23/13, the Director of Pharmacy of Hospital A (DOP 1) stated that the identified products should be protected from light for proper storage to ensure the integrity and potency of the drug.

Based on observation, interview, and administrative record review, the hospital failed to implement policies and procedures to ensure the safe use of medications in accordance with standards of practice, federal and state laws as evidenced by:

1. The pharmacy failed to ensure the implementation of a policy and procedure to monitor, and evaluate, the potency (active ingredient strength within +/- 10% of the labeled amount) for intravenous (IV, directly into a vein) antibiotics produced in the sterile (germ free) IV compounding (mixing) room. The pharmacy mixed IV antibiotics, labeled the drug with a frozen BUD (beyond-use date, date beyond which medication cannot be stored), and once thawed relabeled them with a refrigerated BUD. The pharmacy did not have documentation supporting the potency of the antibiotics at the end of the frozen, thawed, and refrigerated BUD range. This failure resulted in the potential, from 4/1/13-7/25/13 for 1,397 patients, out of 7,729 patients admitted to Hospital A, to be exposed to 3,303 doses of IV antibiotics at other than labeled potency.

2. The pharmacy failed to ensure that compounded sterile preparations for intravenous (into the vein) use were labeled with expiration dates in accordance with hospital policy and procedures.

Findings:

1. During a concurrent tour and interview, on 7/23/13 at 11:35 A.M., in the pharmacy of Hospital A, Pharmacy Manager (Pharm 1) identified the sterile IV compounding area. Inspection of the compounding area showed an ante-room (a room to prepare for compounding IVs). On the ante-room door was a certification sticker showing the room was ISO Class 8 (measurement of particles in the air). Inside the ante-room was a door leading to the buffer area (area where sterile medications are mixed). On the buffer room door was a certification sticker showing the room was ISO Class 7. Inside the buffer room were two IV compounding hoods (device to maintain a sterile area for mixing medication).

Inspection of Hospital A's pharmacy freezer 5, on 7/23/13 at 11:50 A.M., showed it contained IV medication mixed in the compounding area. Further inspection of the medication showed it was IV ceftriaxone (antibiotic) 1 gram (gm) in 12 milliliters (ml) of sterile water. The ceftriaxone lot number was 201307722-8. It was mixed on 7/22/13 and had a frozen BUD of 9/5/13 (45 days).

During an interview, on 7/24/13 at 1:10 P.M., Director of Pharmacy (DOP 2) was ask to describe the process for assigning a BUD to a sterile compounded IV antibiotic, that was frozen, and then was thawed. DOP 2 described the process for ceftriaxone. The ceftriaxone was compounded in the IV room and labeled with a frozen BUD of 45 days. After the ceftriaxone was thawed it was labeled with a refrigerated BUD of a maximum of 9 days. DOP 2 stated that the refrigerated BUD was not greater than the original frozen BUD.

During an interview, on 7/25/13 at 12:45 P.M., Director of Pharmacy (DOP 1), DOP 2 and Pharm 1 were asked to identify the antibiotics compounded in the IV room and then frozen. The group identified ceftriaxone, ceftazidime and cefuroxime.

During a concurrent group interview and administrative record review, on 7/26/13 at 8:30 A.M., DOP 1, DOP 2, and Pharm 1 identified three written master formulas (compounding formula). The three formulas were for ceftriaxone 1 Gm/SW (sterile water) 12 mL, ceftazidime (antibiotic) 1 Gm/SW 12 mL, and cefuroxime (antibiotic) 750 mg/ SW 10 mL. The group acknowledged the master formulas showed ceftriaxone can be frozen for 45 days and remains stable for 9 days post thaw, ceftazidime can be frozen for 45 days and remains stable for 3 days post thaw, and cefuroxime can be frozen for 45 days and remains stable for 7 days post thaw. The hospital was requested to provide documentation showing the potency of the three antibiotics was within +/- 10% of the labeled amount at the end of the maximum refrigerated plus frozen BUD. The requested information was not provided before the end of the survey.

Administrative record review, of the hospital's policy and procedure for Compounding of Sterile Products (#MER-FW-MM-3239, Effective: 9-12) showed, II. Policy, N. End Product Testing, 1. "Samples will be retained from selected batches for periodic testing for end product evaluation and testing to assess:, a. "Integrity" (retention of potency until the expiration date noted on the label), b. "Potency" (active ingredient strength within +/- 10% of the labeled amount), c. "Quality" (the absence of harmful levels of contaminants, including filth, putrid or decomposed substances, and absence of active ingredients other than those noted on the label, d. "Strength" (amount of active ingredient per unit of a compounded drug product)."

An administrative record review, of a hospital document titled "[Hospital A's Name]", showed, from 4/1/13 through 7/25/13, Hospital A admitted 7,729 patients. Further review showed the pharmacy compounded 3,030 doses of the three antibiotics listed above. Additional review showed 1,397 patients received the antibiotics.



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2. During a tour of the pharmacy located in Hospital B at approximately 9:18 A.M. on 7/24/13, the following compounded sterile preparations were observed in the medication storage refrigerator:

3 bags of intravenous fluid labeled as Vancomycin (an antibiotic) 1250 mg (milligrams)/250 ml (milliliters) with preparation date of 7/22/13 and expiration date of 7/29/14 (1 year and 7 days)

3 bags of intravenous fluid labeled as Vancomycin 1250 mg/250 ml with preparation date of 7/23/13 and expiration date of 7/30/14 (1 year and 7 days)

During an interview at approximately 9:20 A.M. on 7/24/13, the Director of Pharmacy at Hospital B (DOP 2) stated that the expiration dates on the identified products were incorrect. DOP 2 further stated that the products were compounded by the pharmacy and should be labeled with an expiration date of 7 days according to hospital policy.

Based on observation, interview, and document review, the hospital failed to ensure that intravenous compounding and intravenous medication labeling was performed consistent with standards of practice, federal and state laws as evidenced by:

1. The pharmacy failed to ensure that compounded sterile preparations were prepared in accordance with hospital sterile compounding policy & procedure and master formulas for batch compounding. Beyond use date assignment on batch compounded products was not consistent with the hospital developed master formulas. In addition, the quantities of each component used in batch compounding documented in the compounding log were inconsistent with the final volume or quantity of product prepared.

2. The pharmacy failed to ensure that sterile compounding of medication for intravenous use were prepared accurately to the labeled strength/potency.

Findings:

1. A review of Hospital B's pharmacy compounding record was conducted with the Director of Pharmacy (DOP 2) on 7/24/13 at approximately 4:00 P.M. The record showed the following:

a. The master formula for the batch compounding of 15 vials of buffered lidocaine 2% (a local anesthetic) 20 ml (milliliters) showed that the compounded products were to be assigned an expiration date of 7 days at room temperature.

The compounding record of a batch of 20 buffered lidocaine 2% 5 ml vials prepared on 5/21/13 showed that the products were assigned an expiration date of 5/28/13 with no specification of storage condition.

According to USP <797>, such batch compounding, when performed in an environment in accordance with the USP <797> standards, may be assigned beyond-use date of up to 48 hours at room temperature if no sterility testing is performed.

DOP 2 acknowledged that the expiration date of 7 days at room temperature on the master formula was a mistake.

b. The compounding record of a batch of 5 bags of Magnesium sulfate (an electrolyte supplement) 25 grams/200 ml (milliliters) prepared on 7/3/13 showed an expiration date of 7/17/13 (14 days).

The compounding record of a batch of 4 bags of Magnesium sulfate 25 grams/200 ml prepared on 7/6/13 showed an expiration date of 7/20/13 (14 days).

The compounding record of a batch of 2 bags of Magnesium sulfate 25 grams/200 ml prepared on 7/10/13 showed an expiration date of 7/19/13 for storage at room temperature (9 days).

The compounding record of a batch of 5 bags of Magnesium sulfate 25 grams/200 ml prepared on 7/22/13 showed an expiration date of 8/5/13 (14 days).

DOP 2 stated that the identified products should have been assigned expiration dates of 48 hours for room temperature storage or 9 days for storage under refrigeration according to hospital policies and procedures. DOP 2 acknowledged that the identified products were assigned expiration dates incorrectly.

c. The compounding record of a batch of 8 bags of Vancomycin 1250 mg (milligrams)/250 ml (milliliters) prepared on 6/26/13 were assigned an expiration date of 7/7/13 (11 days).

The compounding record of a batch of 13 bags of Vancomycin 750 mg/250 ml prepared on 7/20/13 were assigned an expiration date of 7/17/14 (372 days).

The compounding record of a batch of 8 bags of Vancomycin 1250 mg/250 ml prepared on 7/22/13 were assigned an expiration date of 7/29/14 (372 days).

The compounding record of a batch of 8 bags of Vancomycin 1250 mg/250 ml prepared on 7/23/13 were assigned an expiration date of 7/30/13 (372 days).

DOP 2 stated that the identified products were assigned expiration dates incorrectly and the products should have only been assigned an expiration of 7 days from compounding date for storage under refrigeration.

d. The compounding record of a batch of 8 bags of Vancomycin 1250 mg (milligrams)/250 ml (milliliters) prepared on 6/26/13 showed that the quantity of each ingredient used was inconsistent with the amount of the final product prepared suggestive of compounding error or recording error.

The compounding record of a batch of 8 bags of Vancomycin 1250 mg/250 ml prepared on 6/29/13 showed that the quantity of each ingredient used was inconsistent with the amount of the final product prepared suggestive of compounding error or recording error.

The compounding record of a batch of 8 bags of Vancomycin 1250 mg/250 ml prepared on 7/1/13 showed that the quantity of each ingredient used was inconsistent with the amount of the final product prepared suggestive of compounding error or recording error.

The compounding record of a batch of 8 bags of Vancomycin 1250 mg/250 ml prepared on 7/7/13 showed that the quantity of each ingredient used was inconsistent with the amount of the final product prepared suggestive of compounding error or recording error.

The compounding record of a batch of 8 bags of Vancomycin 1250 mg/250 ml prepared on 7/10/13 showed that the quantity of each ingredient used was inconsistent with the amount of the final product prepared suggestive of compounding error or recording error.

The compounding record of a batch of 24 bags of Vancomycin 1250 mg/250 ml prepared on 7/11/13 showed that the quantity of each ingredient used was inconsistent with the amount of the final product prepared suggestive of compounding error or recording error.

The compounding record of a batch of 8 bags of Vancomycin 1250 mg/250 ml prepared on 7/18/13 showed that the quantity of each ingredient used was inconsistent with the amount of the final product prepared suggestive of compounding error or recording error.

A review of the hospital policy and procedure on compounding of sterile products showed that the quantity of each component used in compounding the drug products should be documented in the compounding record.

During an interview at approximately 4:15 P.M. on 7/24/13, DOP stated that pharmacy management did not review or audit compounding records to ensure that compounding of sterile products were prepared accurately.

2. A review of the compounding record for a batch of 30 syringes Ceftazidime (an antibiotic) 1 gram/12 ml (milliliters) prepared on 7/22/13 by Technician 2 (RPT 2) showed that 5 vials of Ceftazidime 6 grams and a total of 360 ml (260 ml + 100 ml) of sterile water for injection were used for the compounding.

A review of the manufacturer's prescribing information showed that each vial of Ceftazidime 6 grams was to be reconstituted with 26 ml of sterile water to yield a final total volume of 30 ml (5 ml increase in volume per vial from the dissolving of the powder in sterile water).

Based on the reconstitution direction and the amount of sterile water used in the compounding, the final concentration of the compounded product was 30 grams per 380 ml (360 ml + 20 ml). By calculation, each 12-ml syringe would contain 947 mg of Ceftazidime instead of labeled strength of 1000 mg.

During an interview at approximately 2:20 P.M. on 7/25/13, RPT 2 stated that she always followed the master formula when compounding batch products. RPT 2 also stated that she always calculated the amount of diluent needed and documented the amount of drug and diluent she used for the compounding.

A review of the compounding record for 2 batches of 100 syringes each of Ceftriaxone 1 gram/12 ml prepared on 5/31/13 and 7/22/13 by Pharmacy Technician 1 (RPT 1) showed that for each batch, 100 grams of Ceftriaxone and 1100 ml of sterile water was used.

Based on the manufacturer's reconstitution direction and the amount of each component used in the compounding, the final concentration of the product would be 100 grams/1150 ml. Each 12-ml syringe contained 1043 mg of Ceftazidime instead of the stated strength of 1000 mg/12 ml.

During an interview at approximately 5:40 P.M. on 7/25/13, RPT 1 stated that she had always been making the Ceftazidime batch compounding by using a 1 liter bag of sterile water for injection and she would draw out water from the liter bag of sterile water to reconstitute the vials and then inject the reconstituted solution back into the 1-l bag of sterile water. RPT 1 then stated that she would add an extra 100 ml of sterile water to bring the solution to its labeled concentration. When asked by the surveyor how the 100 ml was calculated, RPT 1 stated that adding the 100-ml was how she was taught and she had been doing it the same way every time.

During an interview at approximately 5:45 P.M. on 7/25/13, Pharmacy Manager 1 (Pharm 1) stated that the overfill volume in each 1 liter bag of sterile water for injection would likely bring the final concentration of final product to the label strength.

During an interview at approximately 10:30 A.M. on 7/26/13, Pharmacist 2 (Pharm 2) was asked if he knew the total filled volume of a 1-liter bag of sterile water for injection. Pharm 2 stated that he did not know. Pharm 2 further stated that the pharmacy did not have reference on the overfill volume of each of the large volume parenteral product. Pharm 1 who was also present at the interview, stated that RPT 1 should not have estimated the overfill volume of the 1-liter bag of sterile water to assume the final concentration and volume of the compounded product.

Based on observation, interview and record review, Hospital A failed to ensure that syringes containing antibiotics were labeled with the correct "beyond use date" (BUD - the date or time after which a compounded sterile preparation shall not be stored or transported; the date was determined from the date or time the preparation was compounded) in accordance with the hospital policy and procedure, for 3 of 15 medication refrigerators audited. Multiple medication refrigerators on different units at Hospital A were inspected and several syringes were found with incorrect BUDs in the ED. In addition, syringes containing antibiotics labeled with two dates, one was the expiration date from the manufacturer and the other was a "use by date" from the hospital pharmacy, were found in a medication refrigerator in one of the nursing units. The two dates labeled on the syringes made it confusing for the nursing staff to determine which date to follow. Medications labeled with incorrect BUDs and/or confusion amongst the nursing staff on what "expiration" date to use, could potentially lead to medication errors related to questionable stability, sterility and effectiveness of a medication.

Findings:

1. On 7/23/13 beginning at 9:45 A.M., a tour of Hospital A's Emergency Department (ED) was conducted with the Director of ED (DED) and the Senior Director of ED (SDED). The ED was comprised of 6 Suites: Suite A, B, C, D, E, and F.

A medication refrigerator located between Suite B and C of the ED was inspected on 7/23/13 at 10:20 A.M. Six syringes of Cefazolin (antibiotic) 1 gm (gram) per 10 ml (milliliters) were found, ready for patient use. On each syringe, the following information was noted: "made on 7/2/13", expiration on 8/16/13, and the use by date was 7/28/14.

An interview was conducted with a pharmacy technician (RPT 31) on 7/23/13 at 10:24 A.M. The medication refrigerator inspection regarding the Cefazolin syringes were shared with RPT 31. RPT 31 stated that she was not sure but per her recollection, the use by date for Cefazolin should not exceed 14 days after the medication had been thawed. She also stated that regardless, the beyond use date should never exceed the manufacturer's expiration date. She stated that a mistake had been made and the use by date should not have been 7/28/14, it should have read "7/28/13".

A review of the hospital's policy and procedure entitled "Medication Management - Beyond Use Dating", effective date of 1/13, was conducted. The policy defined beyond use dating as "Date established where a product is expected to perform as anticipated when kept under the prescribed conditions. Beyond use dates are shorter than manufacturer expiration dates to account for the fact that the manufacturer's original container has been opened, altered or the product stored in an environment different than recommendations." Per the same policy, the definition of an expiration date was "... determined by the manufacture for the chemical and physical stability of the manufactured product when left in original packaging and stored under manufacturer guidelines."

An interview with the Director of Pharmacy (DOP 1) was conducted on 7/26/13 at 8:15 A.M. DOP 1 explained the pharmacy department's process for the labeling and dispensing of Cefazolin syringes. He stated that Cefazolin syringes were initially frozen and then thawed. Once thawed, the medication had a 9 day stability period. A pink sticker was applied to the syringe (medication) that read "use by" and a date. He stated that the "use by date", also known as the "beyond use date" (BUD) sticker was ultimately the medications' expiration date. He stated that the accuracy of this date and correct labeling of Cefazolin syringes was important to ensure the stability and sterility of the medication. He acknowledged that the Cefazolin syringes were labeled with incorrect BUD stickers.

2. On 7/23/13 beginning at 9:45 A.M., a tour of Hospital A's Emergency Department (ED) was conducted with the Director of ED (DED) and the Senior Director of ED (SDED). The ED was comprised of 6 Suites: Suite A, B, C, D, E, and F.

A medication refrigerator located in Suite E of the ED was inspected on 7/23/13 at 10:46 A.M. Eight syringes containing Cefazolin (antibiotic) 1 gm (gram) per 10 ml (milliliters) were found, ready for patient use. On each syringe, the following information was noted: "made on 7/2/13", expiration on 8/16/13, and the use by date was 7/28/14.

A joint observation and interview with Hospital A's pharmacy manager (Pharm 1) was conducted on 7/23/13 at 1:32 P.M. The same Cefazolin syringes from the morning inspection were still found in the same medication refrigerator, ready and accessible for patient use. Pharm 1 acknowledged that the "use by date" stickers were incorrect, as the expiration of the medication would not have been 1 year and 26 days after it was made. She stated that when the Cefazolin syringes were identified to have an incorrect "use by date", they should have been removed immediately from the the medication refrigerator, which she did.

A review of the hospital's policy and procedure entitled "Medication Management - Beyond Use Dating", effective date of 1/13, was conducted. The policy defined beyond use dating as "Date established where a product is expected to perform as anticipated when kept under the prescribed conditions. Beyond use dates are shorter than manufacturer expiration dates to account for the fact that the manufacturer's original container has been opened, altered or the product stored in an environment different than recommendations." Per the same policy, the definition of an expiration date was "... determined by the manufacture for the chemical and physical stability of the manufactured product when left in original packaging and stored under manufacturer guidelines."

An interview with the Director of Pharmacy (DOP 1) was conducted on 7/26/13 at 8:15 A.M. DOP 1 explained the pharmacy department's process for the labeling and dispensing of Cefazolin syringes. He stated that Cefazolin syringes were initially frozen and then thawed. Once thawed, the medication had a 9 day stability period. A pink sticker was applied to the syringe (medication) that read "use by" and a date. He stated that the "use by date", also known as the "beyond use date" (BUD) sticker was ultimately the medications' expiration date. He stated that the accuracy of this date and correct labeling of Cefazolin syringes was important to ensure the stability and sterility of the medication. He acknowledged that the Cefazolin syringes were labeled with incorrect BUD stickers.



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3. A medication storage inspection of the 11th floor Direct Observation Unit (DOU) in Hospital A was conducted on 7/23/13 at 1:05 P.M. Inside the refrigerator were 9 syringes of Ancef (antibiotic) with labeled expiration dates of 8/30/13 and "use by date" of 8/3/13.

Registered Nurse (RN) 12 was asked which date she would use to determine whether or not the medication was still safe to use. RN 12 stated that she would use the expiration date which was 8/30/13.

A review of the hospital's policy and procedure entitled "Medication Management - Beyond Use Dating", effective date of 1/13, was conducted. The policy defined beyond use dating as "Date established where a product is expected to perform as anticipated when kept under the prescribed conditions. Beyond use dates are shorter than manufacturer expiration dates to account for the fact that the manufacturer's original container has been opened, altered or the product stored in an environment different than recommendations." Per the same policy, the definition of an expiration date was "... determined by the manufacture for the chemical and physical stability of the manufactured product when left in original packaging and stored under manufacturer guidelines."

An interview with the Director of Pharmacy (DOP) 1 was conducted on 7/26/13 at 8:10 A.M. The DOP 1 stated that the expiration date on the syringes were expiration date from the antibiotic's manufacturer. The DOP 1 explained that the "use by date" were the dates placed by the hospital's pharmacy based on when the syringes were thawed and how long the antibiotic would be good for. The DOP 1 explained that if a Registered Nurse administered a medication to a patient beyond the "use by date", the stability and sterility of the medication could not be guaranteed. The DOP 1 acknowledged that having the two dates on the syringes made it confusing for the nurses to determine which date to use.

Based on observation, interview, and administrative record review, the hospital failed to ensure that the pharmacy and infection control officer obtained accurate monitoring data and had complete oversight on the hospital's sterile (germ free) intravenous (IV, directly into a vein) compounding (mixing) program, to ensure an acceptable level of safety and quality. The hospital did not monitor, and evaluate, the air pressure differences in the sterile IV compounding room. This failure resulted in the potential, from 4/1/13-7/25/13 for 3,333 patients, out of 7,729 patients admitted to Hospital A, to be exposed to 41,731 doses of contaminated IV medications.

Findings:

During a concurrent tour and interview, on 7/23/13 at 11:35 A.M., in the pharmacy of Hospital A, Pharmacy Manager (Pharm 1) identified the sterile IV compounding area. Inspection of the compounding area showed an ante-room (a room to prepare for compounding IVs). On the ante-room door was a certification sticker showing the room was ISO Class 8 (measurement of particles in the air). Inside the ante-room was a door leading to the buffer area (area where sterile medications are mixed). On the buffer room door was a certification sticker showing the room was ISO Class 7. Inside the buffer room were two IV compounding hoods (device to maintain a sterile area for mixing medication). Further inspection did not show instruments for monitoring air pressure in the compounding area. Pharm 1 was asked how the hospital monitored the air pressure in the compounding area. Pharm 1 stated hospital engineering monitored the pressure.

Inspection of Hospital A's pharmacy freezer 5, on 7/23/13 at 11:50 A.M., showed it contained IV medication mixed in the compounding area. Further inspection of the medication showed it was IV ceftriaxone (antibiotic) 1 gram in 12 milliliters of sterile water. The ceftriaxone lot number was 201307722-8. It was mixed on 7/22/13 and had a frozen BUD (beyond-use date, date beyond medication cannot be stored) of 9/5/13 (45 days).

During a concurrent interview and administrative record review, on 7/23/13 at 2:15 P.M., Engineering Supervisor (Sup 1) was asked to describe the process for monitoring the air pressure in Hospital A's pharmacy sterile compounding area. Sup 1 stated a staff member measured the air pressure differences in the compounding area with a hand held device. The pressure differences were recorded on a daily form titled "Temperature, Humidity and Pressure Differential Readings." The daily form was submitted to a staff member assigned to HVC (Heating, Ventilation and Air Conditioning). The HVC employee was responsible for determining if the recorded measurements meet criteria. Sup 1 further stated that if the measurements did not meet criteria the HVC staff member generated a work order to fix the problem. Sup 1 stated passing criteria for pressure difference was a positive value. Sup 1 further stated that there were no work orders created in the past 3 months.

During an interview, on 7/24/13 at 1:45 P.M., Director of Pharmacy (DOP 1) and Director of Pharmacy (DOP 2) described the reporting process for the sterile IV compounding program. DOP 1 and DOP 2 stated monitoring information was provided to the infection control committee. DOP 1 and DOP 2 further stated that for the past year the infection control committee had not provided direction to the sterile IV compounding program that was based upon the reported monitoring information.

During a concurrent interview and administrative record review, on 7/25/13 at 2:05 P.M., Infection Control Manager (ICM) reviewed the Temperature, Humidity and Pressure Differential Readings form. The forms from 4/1/13 through 7/23/13 were reviewed. ICM stated that the documents did not show the pharmacy IV room pressure was positive 0.02 inches water column, or greater, from 4/1/13 through 7/23/13.

During an administrative record review, of the USP (U.S. Pharmacopeia) <797>, a nationally recognized compounding information source, Guidebook to Pharmaceutical Compounding-Sterile Preparations (2008, pg. 43) showed, Facility Design and Environmental Controls, "The room shall be segregated from surrounding, unclassified spaces to reduce the risk of contaminants being blown, dragged, or otherwise introduced into the filtered unidirectional airflow environment, and this segregation shall be continuously monitored,. For rooms providing a physical separation through the use of walls, doors, and pass-throughs, a minimum differential positive pressure of 0.02- to 0.05-inch water column is required."

Administrative record review, of the hospital's policy and procedure for Compounding of Sterile Products (#MER-FW-MM-3239, Effective: 9-12) showed, II Policy, D. Clean Room Requirements; Laminar Airflow Hoods, 7. "A pressure gauge of velocity meter shall be installed to monitor the pressure differential or airflow between the buffer area and the ante-area and between the ante-area and the general environment outside the compounding area. The IV Room (buffer room) should have positive air pressure relative to the adjacent pharmacy, an appropriate number of air exchanges per hour, and appropriate temperature levels are required. Hospital engineering will be notified when pressure differentials go out of range ..." Further review of the policy and procedure showed L. Transport, Storage and Expiration (Beyond-Use) Dating of Sterile Products, 8. "USP<797> criteria will be used to determine appropriate Beyond Use Dating of compounded sterile products based on defined risk level ..."

An administrative record review, of a hospital document titled "[Hospital A's Name] All Compounded Products", showed, from 4/1/13 through 7/25/13, Hospital A admitted 7,729 patients. Further review showed the pharmacy compounded 41,731 sterile IV medications. Additional review showed 3,333 patients received the compounded IV medications.