The information below comes from the statement of deficiencies compiled by health inspectors and provided to AHCJ by the Centers for Medicare and Medicaid Services. It does not include the steps the hospital plans to take to fix the problem, known as a plan of correction. For that information, you should contact the hospital, your state health department or CMS. Accessing the document may require you to file a Freedom of Information Request. Information on doing so is available here.

ALTA BATES SUMMIT MEDICAL CENTER 350 HAWTHORNE AVENUE OAKLAND, CA 94609 Nov. 17, 2011
VIOLATION: NURSING SERVICES Tag No: A0385
Based on observation, interview and record review, the Condition of Participation for Nursing Services was not met as evidenced the hospital's failure to:

1. Ensure the policy and procedure for the safe administration of an intravenous medication was followed which resulted in the death of Patient 1. (See A0395)

2. Ensure that treatments were performed as ordered by the physician which resulted in an unrecognized life-threatening drop in blood sugar level for Patient 14.
(See A0395)

3. Ensure that medication orders were not accurately verified which resulted in a medication administration error for Patient 13. (See A0404)

The cumulative effects of these failures resulted in the inability of nursing services to provide patient care and services in a safe and effective manner in accordance with the Conditions of Participation for Nursing Services.
VIOLATION: RN SUPERVISION OF NURSING CARE Tag No: A0395
**NOTE- TERMS IN BRACKETS HAVE BEEN EDITED TO PROTECT CONFIDENTIALITY**

2. On 11/14/11 review of the admission face sheet showed that Patient 14 was 72 years of age and was admitted on [DATE] with a diagnosis of [DIAGNOSES REDACTED]

On 11/16/11, review of the "Pre-Printed MD Orders: Subcutaneous Insulin" for Patient `14 showed a physician's order, dated 10/12/11, for the fingerstick blood glucose testing every four hours for correctional dosing between the hours of 6:00 a.m. and 8:59 p.m. Correctional dosing is adjusting Insulin dosages to blood sugar ranges. Normal blood sugar is 80-130 milligrams /deciliter of blood; mg/dl are units of measurement. There was also an order, dated 10/12/11, for a basal bedtime dose of 5 units of Lantus insulin (long-acting insulin with a pronounced peak effect).

Review of the "Blood Glucose/Insulin Record" showed that blood glucose test performed on 10/15/11 at 9:00 p.m. showed a value of 180 mg/dl. The next scheduled blood sugar check was at 6 a.m., next morning. The Medication Administration Record showed that at 10:00 p.m., Patient 14 had 5 units of Lantus insulin, the basal dose as ordered.

On 11/17/11, review of the graphic sheet for Patient 14 showed stable vital signs and a good oxygen level at 4:00 a.m. on 10/16/11. There was no documented blood sugar check on 10/16/11 at 6:00 a.m. A nurse's note on 10/16/11 at 7:45 a.m. showed, "Patient's CBS @ 21 [fingerstick blood sugar was 21] patient unresponsive but breathing...". Also on 10/16/11, the Rapid Response Record (record of actions when there is a mobilization of staff when a patient's condition deteriorates) showed that Patient 14 received Dextrose (glucose) intravenously and the blood sugar increased to 333. Despite interventions taken, Patient 14 remained unresponsive with irregular breathing and required emergency insertion of a breathing tube.

Continued review on 11/17/11 showed a progress note, dated 10/16/11 at 9:10 a.m., in which the physician wrote that Patient 14 was in the Intensive Care Unit (ICU) and remained unresponsive due to a hypoglycemic (low blood sugar) reaction secondary to an "[DIAGNOSES REDACTED]" (tumor of the pancreas which releases insulin into the blood and can cause a precipitous drop in blood sugar). The physician also wrote that Patient 14 had an altered mental status due to "hypoglycemic [DIAGNOSES REDACTED]" ([DIAGNOSES REDACTED] means any condition which alters brain function or structure).

In an interview on 11/17/11, Director of Risk Management confirmed nursing staff did not perform a blood sugar check for Patient 14 at 6:00 a.m. as ordered by the physician.




Based on observation, interview and record review, the hospital failed ensure that the policy and procedure for the administration of a TPN solution was followed and failed to follow a physician order for fingerstick blood sugar analysis of a patient at high risk for altered blood sugar levels.

For Patient 1, RN 1 administered a commercially prepared enteral feeding formula (Glucerna) through Patient 1's intravenous PICC catheter, resulting in the death of Patient 1.

For Patient 14, a blood sugar fingerstick was not performed at the time ordered the physician and resulted in an unrecognized life-threatening drop in blood sugar level of 21 mg/dl (a normal blood sugar is 80-130 milligrams /deciliter of blood; mg/dl).

Findings:

1. Medical record review, on 9/26/11, indicated Patient 1 was a [AGE] year old woman who was admitted on [DATE]. Her multiple diagnoses included [DIAGNOSES REDACTED].

Review of pre-printed MD orders: 'Parenteral Nutrition', dated 9/23/11, indicated Patient 1's TPN solution contained 250 cc of 20% Lipids and Regular Insulin 80 units. The TPN solution (1750 cc IV bag) was delivered by the pharmacy and placed in the unit refrigerator located in the medication room. The TPN solution was clearly labeled with Patient 1's name with a scheduled infusion time on 9/23/11 at 8:00 p.m., continuous over a 12-hour period.
According to hospital policy and procedure "Medication Use and Administration" dated 5/2011, "Prior to administration, a nurse will verify all High Alert Medications with another nurse." The policy listed insulin as a high alert medication. The policy further required verification that "...the medication selected matches the medication order and product label" and "is being administered at the proper time, in the prescribed dose, and by the correct route." Review of a policy and procedure titled "IV: Parental Nutrition (PN)-Adults", approved by the Pharmacy and Therapeutics (P&T) Committee in December 2008 and the Policy and Procedures Committee in June 200, indicated, "...the RN checks the label on the bag with the MD order before hanging the parenteral nutrition."
During a telephone interview, on 10/26/11 at 8:50 a.m., certified nursing assistant (CNA 1) stated that during his 11:00 p.m. to 7:00 a.m. shift assignment, on 9/23-24/11, on 2 North (2N), he entered Patient 1's room and "knew something was wrong". CNA 1 left the room to immediately tell the charge nurse (RN 2) about Patient 1.

During an interviews on 9/28/11 at 8:25 a.m. and 11/17/11 at 7:45 a.m., RN 2 recalled that it was "exactly 12:30 a.m." when he responded to CNA 1's request to check on Patient 1's medical condition. RN 2 stated that when he entered the room the patient was not breathing and that a "Code Blue" was called. Review of the "Code Blue" record indicated the code team responded at 12:35 a.m. on 9/24/11 and that an attempt to resuscitate Patient 1 was unsuccessful. The code blue was terminated at 12:53 a.m. and Patient 1 was pronounced dead at 1:03 a.m. on 9/24/11.
During a telephone interview, on 10/18/11 at 11:25 a.m., RN 10 confirmed that she had been assigned as a Code Blue responder on the 7:00 p.m. to 7:00 a.m. shift on 9/23-24/11. RN 10 recalled that during the code she heard the IV pump machine alarming near the Patient 1's bed and the IV pump message screen indicated there was an "occlusion" in the system. RN 10 stated that she saw an "opaque, tan/beige" enteral feeding solution running through the IV tubing/pump and into Patient 1's PICC infusion port. She immediately disconnected the tubing from the PICC infusion port. RN 10 recalled that she informed MD 1 about the enteral feeding solution being connected to the PICC and that MD 1 acknowledged it and continued with the code blue resuscitation efforts.

RN 10 recalled that she spoke with RN 1 in the patient's room after the code blue ended. She had asked RN 1 what IV fluids she administered into Patient 1's PICC prior to the Code Blue and RN 1 responded, "Just the TPN". RN 10 recalled that she was touching the bottle of enteral feeding solution that was still hanging on the IV pole when she asked RN 1, "Is this your TPN?" RN 1 replied, "Yes". RN 10 stated that RN 1 got a "deer in the headlights look" when she told RN 1 that the solution was not TPN but an enteral feeding formula (Glucerna). She stated that RN 1 "...immediately took the bottle of feeding formula [Glucerna] and the tubing off the pump and threw it in the trash."

During an interview on 11/17/11 at 7:54 a.m., RN 2 stated that Patient 1's TPN solution was discovered unused and in the medication room refrigerator on the nursing unit after the patient coded and died .

On December 5, 2011, at 12:00 PM, Officer (B) informed the Department by telephone that the coroner's autopsy finding results had determined the death of Patient 1. Patient 1's death resulted from a pulmonary embolus which was a direct result of the administration of the enteral feeding formula [Glucerna] through Patient 1's intravenous PICC line.
VIOLATION: ADMINISTRATION OF DRUGS Tag No: A0405
Based on observation, interview and record review, the hospital failed to ensure that medications were administered as ordered. Medication orders were not accurately verified which resulted in a medication administration error for Patient 13.

Findings:

During an observation on 11/14/11 at 11:30 a.m., RN 12 administered 50 mg of Seroquel (an antidepressant medication) to Patient 13 via the naso-gastric feeding tube. Review of the Medication Administration Record (MAR), dated 11/14/11, indicated the following entry: "Seroquel 50 mg = 2 Tablet Q6H Tube [every 6 hours via the feeding tube]" with a start date and time of "11/11/11 at 1502 [3:02 p.m.]." Mutual review of the physician's order with Nurse Administrator 4 indicated an order dated and timed, on "11/11/11 at 13:01," for "Seroquel 25 mg via FT q 12 hours [via feeding tube every 12 hours]" At 12:15 p.m. during an interview with Pharmacist 4 (Pharm 4), he said he checked in the pharmacy's computerized system and the physician's order on file for Patient 13 was the latter order, for Seroquel 25 mg. Pharm 4 said that Patient 13 received an incorrect dosage of Seroquel and said, "It's a medication error".

Review of the MAR for Patient 13, dated 11/13/11, indicated the following entry: "Seroquel 25 mg = 1 Tablet Q 12H [every 12 hours]" with a start date and time of "11/11/11 at 1502 [3:02 p.m.]".

The MAR, dated 11/14/11, indicated the following order: "Seroquel 50 mg = 2 Tablet Q6H [every 6 hours]" with a start date and time of "11/11/11 at 1502 [3:02 p.m.]". The night shift RN initialed the "trans check" box that she verified the accuracy of the order.

During an interview on 11/14/11 at 12 p.m., the Nurse Administrator 4 (NADM 4) stated that the night shift checked the new daily medication administration record (MAR) sent up by pharmacy against the previous day's MAR. If there were changes to the new MAR then the night shift registered nurse (RN) verified the order. The initials of the night shift RN on the MAR in the "trans check" box was confirmation that the MAR was accurate.

Mutual review of the physician's order, with NADM 4, indicated one order on 11/11/11 at 13:01 p.m. for Seroquel 25 mg via feeding tube (FT) q 12 hours [via feeding tube every 12 hours.] RN 12 on the day shift, used the MAR dated 11/14/11 for the medication pass, and administered Seroquel 50 mg at 12 p.m., instead of the Seroquel 25 mg. At 12:20 p.m., Pharmacist 4 checked the physician's order in the pharmacy's computerized system and confirmed that Patient 13 received an incorrect dose of Seroquel.

On 11/15/11 at 12:40 p.m., during an interview, Pharm 2 described the process of order entry and MAR generation. Pharm 2 said that the physician wrote the order and the nurse scanned the order into the pharmacy's computerized system so that there was a mirror image of the order in the system.

The pharmacist reviewed if the order was clinically appropriate for the patient. The pharmacist then typed the order into the pharmacy's computerized system and once a day at 12:30 a.m. the system generated a MAR, for the day, to begin at 7:00 a.m. Pharm 2 said that, prior to typing new scanned orders into the computer, the pharmacist should pull up the patient's profile based on the patient's name and second identification verification; either the date of birth or medical record number. Pharm 2 said that obviously the pharmacist did not follow the practice for Patient 13. Pharm 2 said that order was incorrectly typed into Patient 13's medication profile and therefore onto the MAR resulting in the "wrong dose, wrong frequency and wrong patient" being listed on Patient 13's MAR.
VIOLATION: PHARMACEUTICAL SERVICES Tag No: A0490
Based on observation, interview and record review, the Condition of Participation for Pharmaceutical Services was not met as evidenced the hospital's failure to:

1. Ensure the implementation of a policy and procedure to evaluate viable airborne/surface microorganisms in the sterile compounding area. The hospital did not test, in 2011, the sterile compounding area for viable airborne and viable surface microorganisms. This failure resulted in the potential for 12,170 patients to be exposed to 45,579 contaminated medications, over 304 days. (See A0500)

2. Ensure the reporting of results for viable airborne/surface microorganisms testing in the sterile compounding area. The hospital did not test, in 2011, for viable airborne and surface microorganisms in the sterile compounding area. The failure of the hospital to test for microorganisms was not reported to medical staff performance improvement (MSPI) and pharmacy and therapeutics (P&T). This failure resulted in the potential for 12,170 patients to be exposed to 45,579 contaminated medications, over 304 days. (See A0500)

3. Ensure the implementation of an effective end product testing program for microorganisms in compounded intravenous medications. The hospital tested two medications out of 45,579 mixed. The sample size tested was not large enough to ensure that compounded intravenous medications were not contaminated with microorganisms. This failure resulted in the potential for 12,170 patients to be exposed to 45,579 contaminated medications, over 304 days. (See A0500)

4. Ensure that the air pressure differentials were maintained in the sterile compounding area. The hospital did not ensure that the air pressure differentials were monitored in 2011. This failure resulted in the potential for 12,170 patients to be exposed to 45,579 contaminated medications, over 304 days. (See A0500)

5. Ensure the development and implementation of a policy and procedure to evaluate gloved fingertip sampling of sterile compounding personnel. The hospital did not evaluate fingertip sampling, in 2011, of sterile compounding personnel. This failure resulted in the potential for 12,170 patients to be exposed to 45,579 contaminated medications, over 304 days. (See A0500)

6. Develop and implement a policy and procedure to ensure the sterile compounding area air changes per hour was maintained within national standards. The hospital did not monitor the air changes per hour in 2011. This failure resulted in the potential for 12,170 patients to be exposed to 45,579 contaminated medications, over 304 days. (See A0500)

7. Assign immediate use sterile compounded medications with a one hour beyond use expiration time. The hospital assigned a 12 hour beyond use time to immediate use sterile compounded medications. This failure resulted in the potential for an estimated 184 patients a day, from 11/14/11 to 11/17/11, to be exposed to contaminated medications. (See A0500)

8. Implement a policy and procedure to ensure that medications were compounded using aseptic technique. Three pharmacy technicians, out of 20, were observed not maintaining aseptic technique while compounding medications. This failure resulted in the potential for an estimated 179 patients a day, from 11/14/11 to 11/16/11, to be exposed to contaminated medications. (See A0501)

9. Implement a pharmacy policy and procedure to label sterile compounded total parenteral nutrition bags, with storage instructions. (See A0491)

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 Conditions of Participation for Pharmaceutical Services.
VIOLATION: PHARMACY ADMINISTRATION Tag No: A0491
Based on observation, interview and record review, the pharmacy failed to label sterile compounded IV TPN solutions with storage instructions for one sampled patient (Patient 46) prior to delivering the solutions to the inpatient nursing units. This practice had the potential that nursing staff would improperly store the TPN solutions because instructions were not labeled by the pharmacy.

Findings:

During a concurrent observation and interview, on 11/15/11 at 1:40 p.m., in the non-hazardous medication compounding (mixing) room, Pharmacy Tech (Pharm Tech 2) was compounding total parenteral nutrition (TPN, intravenous nutrition) for Patient 46. Pharm Tech 2 stated that there were 11 TPNs to mix for the day.

During an observation, on 11/15/11 at 5:10 p.m., six TPN bags were delivered to the nursing units. Pharmacy Tech (Pharm Tech 4) placed the TPNs into the medication refrigerators in the medication rooms (secured storage area for medications). Inspection of the TPN labels did not show storage instructions.

During an interview, on 11/17/11 at 1:10 p.m., Pharmacist (Pharm 2) stated that the TPN labels should have included storage instructions. During an administrative record review, of the hospital's policy and procedure for 200.6a Sterile Compounding: General Requirements showed Procedure: 8. Labeling showed, "Labels are prepared in accordance with State/Federal regulations ...b. The label shall include: ...Supplemental instruction, including necessary storage conditions ..."
VIOLATION: DELIVERY OF DRUGS Tag No: A0500
Based on observation, interview, and document review, the hospital failed to deliver pharmaceutical services to meet the needs of the patients when medications were not controlled and distributed 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 evaluate viable airborne/surface microorganisms in the sterile compounding area. The hospital did not test, in 2011, the sterile compounding area for viable airborne and viable surface microorganisms. This failure resulted in the potential for 12,170 patients to be exposed to 45,579 contaminated medications, over 304 days.

2. The pharmacy failed to report the results of viable airborne/surface microorganisms testing in the sterile compounding area. The hospital did not test, in 2011, for viable airborne and surface microorganisms in the sterile compounding area. The failure of the hospital to test for microorganisms was not reported to medical staff performance improvement (MSPI) and pharmacy and therapeutics (P&T). This failure resulted in the potential for 12,170 patients to be exposed to 45,579 contaminated medications, over 304 days.

3. The pharmacy failed to ensure the implementation of an effective end product testing program for microorganisms in compounded intravenous medications. The hospital tested two medications out of 45,579 mixed. The sample size tested was not large enough to ensure that compounded intravenous medications were not contaminated with microorganisms. This failure resulted in the potential for 12,170 patients to be exposed to 45,579 contaminated medications, over 304 days.

4. The pharmacy failed to ensure that the air pressure differentials were maintained in the sterile compounding area. The hospital did not ensure that the air pressure differentials were monitored in 2011. This failure resulted in the potential for 12,170 patients to be exposed to 45,579 contaminated medications, over 304 days.

5. The pharmacy failed to ensure the development and implementation of a policy and procedure to evaluate gloved fingertip sampling of sterile compounding personnel. The hospital did not evaluate fingertip sampling, in 2011, of sterile compounding personnel. This failure resulted in the potential for 12,170 patients to be exposed to 45,579 contaminated medications, over 304 days.

6. The pharmacy failed to develop and implement a policy and procedure to ensure the sterile compounding area air changes per hour was maintained within national standards. The hospital did not monitor the air changes per hour in 2011. This failure resulted in the potential for 12,170 patients to be exposed to 45,579 contaminated medications, over 304 days.

7. The pharmacy failed to assign immediate use sterile compounded medications with a one hour beyond use expiration time. The hospital assigned a 12 hour beyond use time to immediate use sterile compounded medications. This failure resulted in the potential for an estimated 184 patients a day, from 11/14/11 to 11/17/11, to be exposed to contaminated medications (Patient 46).

Findings:

1. During a concurrent tour and interview, on 11/14/11 at 11:25 a.m., the sterile intravenous (IV, directly into a vein) compounding (mixing) area was identified. Inspection of the IV compounding area showed that it consisted of an ante-room (room used to prepare for compounding), a hazardous medication compounding room and a non-hazardous medication compounding room. Inside the compounding rooms were IV hoods (device to provide sterile (germ free) compounding area). Pharmacist (Pharm 2) stated that the pharmacy compounded sterile IV medications in the hoods.

During an interview, on 11/17/11 at 8:15 a.m., Pharmacist (Pharm 1) and Pharm 2 were asked did the hospital test for viable (living microorganism) airborne (in the air) and viable surface (on the surface) testing, as part of the sterile compounding quality assurance (monitoring and evaluation of a process) program. Pharm 1 and Pharm 2 stated that the hospital, in 2011, did not test the sterile compounding area for viable airborne microorganisms and viable surface microorganisms.

During an interview, on 11/17/11 at 1:10 p.m., Pharm 1 and Pharm 2 stated that the IV compounding program made 45,579 medications from 1/1/11 to 10/31/11.

During an administrative record review, of the SMC Inpatient Admits, from 1/1/11 to 10/31/11, showed the hospital serviced 12,170 patients.

During an administrative record review, of the hospital's policy and procedure for 200.6b Sterile IV Compounding: IVs Prepared in Pharmacy IV Preparation Areas (Review Date(s): 8/11) showed Procedure: C Buffer Area (compounding room) and Ante Area, 12. "Evaluation of viable airborne/surface microorganisms in the controlled air environments of the compounding area will be performed periodically as required by USP/NF 797."

Review of the United States Pharmacopeia 797 (USP <797>), a nationally recognized compounding information source, Guidebook to Pharmaceutical Compounding-Sterile Preparation (2008, pg. 46) showed Environmental Viable Airborne Particle Testing Program "Review of the data generated during a sampling event may detect elevated amounts of airborne microbial bioburden (levels); such changes may be indicative of adverse changes within the environment."

Review of USP<797> Guidebook to Pharmaceutical Compounding-Sterile Preparation (2008, pg. 52) showed Surface Cleaning and Disinfection Sampling and Assessment "Surface sampling is an important component of the maintenance of a suitable microbially controlled environment for compounding CSPs (compounded sterile preparation), especially since transfer of microbial contamination from improperly disinfected work surfaces via inadvertent touch contact by compounding personnel can be a potential source of contamination into CSPs."

2. During a concurrent tour and interview, on 11/14/11 at 11:25 a.m., the sterile intravenous (IV, directly into a vein) compounding (mixing) area was identified. Inspection of the IV compounding area showed that it consisted of an ante-room (room used to prepare for compounding), a hazardous medication compounding room and a non-hazardous medication compounding room. Inside the compounding rooms were IV hoods (device to provide sterile (germ free) compounding area). Pharmacist (Pharm 2) stated that the pharmacy compounded sterile IV medications in the hoods.

During an interview, on 11/17/11 at 8:15 a.m., Pharmacist (Pharm 1) and Pharm 2 were asked did the hospital test for viable (living) microorganism airborne (in the air) and viable surface (on the surface) testing, as part of the sterile compounding quality assurance (monitoring and evaluation of a process) program. Pharm 1 and Pharm 2 stated that the hospital, in 2011, did not test the sterile compounding area for viable airborne microorganisms and viable surface microorganisms.

During an interview, on 11/17/11 at 1:10 p.m., Pharm 1 and Pharm 2 stated that the IV compounding program made 45, 579 medications from 1/1/11 to 10/31/11. Continuing the interview, Pharm 1 and Pharm 2 stated that quality assurance data was reported to MSPI and P&T. Additionally, Pharm 1 and Pharm 2 stated that the data for viable airborne/surface testing was not reported to MSPI and P & T in 2011.

During an administrative record review, of the SMC Inpatient Admits, from 1/1/11 to 10/31/11, showed the hospital serviced 12,170 patients.

During an administrative record review, of the hospital's policy and procedure for 200.6b Sterile IV Compounding: IVs Prepared in Pharmacy IV Preparation Areas (Review Date(s): 8/11) showed Procedure: C Buffer Area (compounding room) and Ante Area, 12. "Evaluation of viable airborne/surface microorganisms in the controlled air environments of the compounding area will be performed periodically as required by USP/NF 797."

Review of the United States Pharmacopeia 797 (USP <797>), a nationally recognized compounding information source, Guidebook to Pharmaceutical Compounding-Sterile Preparation (2008, pg. 46) showed Environmental Viable Airborne Particle Testing Program "Review of the data generated during a sampling event may detect elevated amounts of airborne microbial bioburden (levels); such changes may be indicative of adverse changes within the environment."

Review of USP<797> Guidebook to Pharmaceutical Compounding-Sterile Preparation (2008, pg. 52) showed Surface Cleaning and Disinfection Sampling and Assessment "Surface sampling is an important component of the maintenance of a suitable microbially controlled environment for compounding CSPs (compounded sterile preparation), especially since transfer of microbial contamination from improperly disinfected work surfaces via inadvertent touch contact by compounding personnel can be a potential source of contamination into CSPs."

3. During a tour, on 11/14/11 at 2:30 p.m., the fourth floor pharmacy was inspected. Inside the pharmacy was a sterile intravenous (IV, directly into a vein) compounding (mixing) area. The surveyor observed Pharmacy Tech (Pharm Tech 1) compounding an IV medication.

During a concurrent observation and interview, on 11/15/11 at 1:40 p.m., in the non-hazardous medication compounding room, Pharmacy Tech (Pharm Tech 2) was compounding total parenteral nutrition (TPN, IV nutrition) for Patient 46. Pharm Tech 2 stated that there were 11 TPNs to mix for the day.

During an interview, on 11/17/11 at 7 a.m., Pharmacist (Pharm 1) and Pharmacist (Pharm 2) described the 2011 end product testing (testing compounded medications for microorganisms) process. End product testing was done on large volume solutions that had two or more additives. They further stated that a 10 milliliter sample was taken from the compounded medication. The sample was then sent to the laboratory for analysis. Continuing the interview, they stated that end product testing was done on two samples, one on 10/31/11 and one on 11/9/11.

During an interview, on 11/17/11 at 1:10 p.m., Pharm 1 and Pharm 2 stated that the IV compounding program made 45,579 medications from 1/1/11 to 10/31/11. Pharm 2 further stated that two items sampled out of 45,579 was not statically significant (results did not assure that microbial contamination did not occur in the 45,577 other compounds).

During an administrative record review, of the hospital's policy and procedure for 200.6a Sterile Compounding: General Requirements showed Procedure: 15 Quality Assurance (QA): b) "End-product Testing: Testing of CSP s will be examined on sampling basis to assure that no microbial contamination has occurred."

During an administrative record review, of the SMC Inpatient Admits, from 1/1/11 to 10/31/11, showed the hospital serviced 12,170 patients.

4. During a concurrent tour and interview, on 11/14/11 at 11:25 a.m., the sterile intravenous (IV, directly into a vein) compounding (mixing) area was identified. Inspection of the IV compounding area showed that it consisted of an ante-room (room used to prepare for compounding), a hazardous medication compounding room and a non-hazardous medication compounding room. Inside the compounding rooms were IV hoods (device to provide sterile (germ free) compounding area). Pharmacist (Pharm 2) stated that the pharmacy compounded sterile IV medications in the hoods.

During an interview, on 11/17/11 at 1:10 p.m., Pharm 2 described that the Pressura system (an electronic monitoring system) monitored the IV compounding area air pressure differentials (difference in air pressure between two rooms). She described that there was an electronic monitoring station installed by the door of the hazardous, the door of the non-hazardous and the door of the ante-room. The monitoring stations were programed to compare the air pressure between two rooms. She further stated that the stations were programmed to alarm when the pressure differential reached zero. She stated that the monitoring stations were not programmed to alarm at any other air pressure differential. She also stated that the monitoring stations did not keep a record, of the pressure differentials, from 1/1/11 to 11/17/11.

During an interview, on 11/17/11 at 1:10 p.m., Pharmacist (Pharm 1) and Pharm 2 stated that the IV compounding program made 45,579 medications from 1/1/11 to 10/31/11.

During an administrative record review, of the United States Pharmacopeia 797 (USP <797>), a nationally recognized compounding information source, Guidebook to Pharmaceutical Compounding-Sterile Preparations (2008, pgs. 42 - 43) Facility Design and Environmental Controls "Compounding facilities are physically designed and environmentally controlled to minimize airborne contamination from contacting critical sites...For rooms providing a physical separation through the use of walls, doors, and pass-through, a minimum differential positive pressure of 0.02- to 0.05-inch water column is required."

During an administrative record review, of USP <797> Guidebook to Pharmaceutical Compounding-Sterile Preparations (2008, pg37) showed Hazardous Drugs as CSPs "The ISO Class 5 BSC or CACI shall be placed in an ISO Class 7 area that is physically separated...and optimally has not less than 0.01 inch water column negative pressure to adjacent positive pressure ISO Class 7 or better ante-areas, thus providing inward airflow to contain any airborne drug. A pressure indicator shall be installed that can be readily monitored for correct room pressurization."

During an administrative record review, of the SMC Inpatient Admits, from 1/1/11 to 10/31/11, showed the hospital serviced 12,170 patients.

5. During a concurrent tour and interview, on 11/14/11 at 11:25 a.m., the sterile intravenous (IV, directly into a vein) compounding (mixing) area was identified. Inspection of the IV compounding area showed that it consisted of an ante-room (room used to prepare for compounding), a hazardous medication compounding room and a non-hazardous medication compounding room. Inside the compounding rooms were IV hoods (device to provide sterile (germ free) compounding area). Pharmacist (Pharm 2) stated that the pharmacy compounded sterile IV medications in the hoods.

During an interview, on 11/17/11 at 8:15 a.m., Pharmacist (Pharm 1) and Pharm 2 were asked did the hospital evaluate the sterile compounding personnel for gloved fingertip sampling (test for viable (living microorganism) on gloves) as part of the sterile compounding quality assurance (monitoring and evaluation of a process) program. Pharm 1 and Pharm 2 stated that the hospital, in 2011, did not include gloved fingertip sampling in the quality assurance program.

During an interview, on 11/17/11 at 1:10 p.m., Pharm 1 and Pharm 2 stated that the IV compounding program made 45,579 medications from 1/1/11 to 10/31/11.

During an administrative record review, of the SMC Inpatient Admits, from 1/1/11 to 10/31/11, showed the hospital serviced 12,170 patients.

During an administrative record review, of the United States Pharmacopeia 797 (USP <797>), a nationally recognized compounding information source, Guidebook to Pharmaceutical Compounding-Sterile Preparations (2008, pg. 51) showed "Aseptic Work Practice Assessment and Evaluation via Personnel Glove Fingertip Sampling-Sampling of compounding personnel glove fingertips shall be performed for all CSP (compounded sterile preparation) risk level compounding because direct touch contamination is the most likely source of introducing microorganisms into CSPs prepared by humans. Glove fingertip sampling shall be used to evaluate the competency of personnel in performing hand hygiene and garbing procedures in addition to educating compounding personnel on proper work practices, which include frequent and repeated glove disinfection using sterile 70% IPA during actual compounding of CSPs. All personnel shall demonstrate competency in proper hand hygiene and garbing procedures and in aseptic work practices ..."

6. During a concurrent tour and interview, on 11/14/11 at 11:25 a.m., the sterile intravenous (IV, directly into a vein) compounding (mixing) area was identified. Inspection of the IV compounding area showed that it consisted of an ante-room (room used to prepare for compounding), a hazardous medication compounding room and a non-hazardous medication compounding room. Inside the compounding rooms were IV hoods (device to provide sterile (germ free) compounding area). Pharmacist (Pharm 2) stated that the pharmacy compounded sterile IV medications in the hoods.

During a concurrent interview and administrative record review, on 11/17/11 at 8 a.m., Pharm 1 and Pharmacist (Pharm 2) stated that the IV compounding area, air changes per hour (ACPH, number of times air is changed in a room), was verified as meeting engineering design on 10/2/09. Review of the hospital's test and balance report, by Engineering company (OE), showed that the compounding area met the design specifications on 10/2/09. Continuing the interview, Pharm 1 and Pharm 2 stated that the hospital had not verified, since 10/2/09, that the air changes per hour had remained within the design specifications.

During an administrative record review, of the United States Pharmacopeia 797 (USP <797>), a nationally recognized compounding information source, Guidebook to Pharmaceutical Compounding-Sterile Preparations (2008, pgs. 42-23) showed "Facility Design and Environmental Controls...Room air exchanges are typically expressed as ACPHs. Adequate HEPA-filtered (filter to remove particles) airflow supplied to the buffer area (compounding room) and ante-area is required to maintain cleanliness classification during operational activity through the number of ACPHs. An ISO Class 7 (measurement of air particles)...buffer area and ante-area supplied with HEPA-filtered air shall receive an ACPH of not less than 30."

7. During an interview, on 11/16/11 at 10:45 a.m., Pharmacist (Pharm 2) stated that the fourth floor pharmacy compounded (mixed) intravenous (IV, directly into a vein) medications for first and stat doses. Pharm 2 further stated that the pharmacy compounded these medications as immediate use and that the start of administration must be within 60 minutes of the time of mixing. Continuing the interview, Pharm 2 stated that the pharmacy assigned a beyond use (expiration) time of 12 hours to these immediate use medications.

During an observation, on 11/16/11 at 5 p.m., in the fourth floor pharmacy, Pharmacy Tech (Pharm Tech 3) mixed an immediate use IV medication for Patient 47. Inspection of the label showed a 12 hour beyond use time.

During an interview, on 11/17/11 at 8:40 a.m., Pharmacist (Pharm 3) stated that the pharmacy had an ISO 5 (measurement of air quality) IV hood (device used to provide a sterile (germ free) compounding environment), which was located in a worse than ISO 7 (measurement of air quality) environment. She further stated that the IV medications mixed in these conditions were defined as immediate use and assigned a beyond use time of 12 hours.

During an administrative record review, of USP <797> Guidebook to Pharmaceutical Compounding-Sterile Preparations (2008, pg. 36) showed Immediate-Use CSPs "The immediate-use provision is intended only for those situations where there is a need for emergency or immediate patient administration of a CSP (compounded sterile preparation) ...4. Administration begins not later than 1 hour following the start of the preparation of the CSP...5. Unless immediately and completely administered by the person who prepared it ...the CSP shall bear a label listing...the exact 1-hour BUD (expiration date) and time."
VIOLATION: PHARMACIST SUPERVISION OF SERVICES Tag No: A0501
Based on observation, interview, and administrative record review, the hospital failed to compound and dispense medications in accordance with policy and procedure as evidence by:

1. The pharmacy failed to ensure the implementation of a policy and procedure for the use of aseptic technique. Three pharmacy technicians, out of 20, were observed not maintaining aseptic technique while compounding medications. This failure resulted in the potential for an estimated 179 patients a day, from 11/14/11 to 11/16/11, to be exposed to contaminated medications (Patient 46).

2. The pharmacy failed to ensure the implementation of a procedure for dispensing medications as ordered by the physician. The pharmacist inaccurately entered an order into the computer for one of twenty seven patients, Patient 13. This failure resulted in Patient 13 receiving an incorrect dosage of an antidepressant.

Findings:

1. During a concurrent observation and interview, on 11/14/11 at 2:30 p.m., the fourth floor pharmacy was inspected. Inside the pharmacy was a sterile intravenous (IV, directly into a vein) compounding (mixing) area. The surveyor observed Pharmacy Tech (Pharm Tech 1) mixing an IV medication in the IV hood (device used to provide a sterile compounding environment). Pharm Tech 1 was not wearing gloves while he was mixing. Pharmacist (Pharm 2) stated that Pharm Tech 1 should have worn gloves while mixing the medication.

During a concurrent observation and interview, on 11/15/11 at 1:40 p.m., in the non-hazardous medication compounding (mixing) room, Pharmacy Tech (Pharm Tech 2) was mixing total parenteral nutrition (IV nutrition) for Patient 46. The surveyor observed that Pharm Tech 2 did not maintain aseptic (germ free) technique by: not using alcohol to sanitize his gloves when reentering the IV hood, touching the open ends of tubing (sterile plastic tube) sets, blocking airflow from the HEPA (removes small particles from the air) filter to the critical site (sterile area of medication vials, syringes, tubing and bags), not changing gloves after he picked up a wrapper from the floor. Pharm Tech 2 stated that there were 11 TPNs to mix for the day.

During a concurrent observation and interview, on 11/16/11 at 5 p.m., in the fourth floor pharmacy, Pharmacy Tech (Pharm Tech 3) was mixing an IV medication. The surveyor observed that Pharm Tech 3 changed her sterile gloves twice during the mixing process. Both times she contaminated the outside of the gloves, by placing them on the work surface of the IV hood, before she put them on.

During an administrative record review, of the hospital's policy and procedure for 200.6a Sterile Compounding: General Requirements (Review Date 8/11) showed Procedure: 6. CSP (compounded sterile preparation) Preparation, a. "CSP's shall be prepared with aseptic technique (see P&P 200.6b) ...Sterile gloves are required in all cases (immediate use and products stored for later use."

During an administrative record review, of the hospital's policy and procedure for 200.6b Sterile IV Compounding: IVs Prepared in Pharmacy IV Preparation Areas (Review Date: 8/11) showed Procedure: B. Laminar (type of air pattern) Flow Hood, 10. "Hands never pass between the filter and the work area or over any open vials or ampoules. Further review showed Procedure: B. Laminar Flow Hood, 13. "Critical sites of needles, vials, ampoules, containers and transfer sets should have an uninterrupted flow of air from the HEPA filter."

During an administrative record review, of the Summit Medical Center census, for 11/14/11 to 11/16/11, showed the hospital serviced an estimated 179 patients a day.

2. During an observation on 11/14/11 at 11:30 a.m., Registered Nurse 12 (RN 12) administered 50 mg of Seroquel, an antidepressant, to Patient 13 via the naso-gastric feeding tube. Review of the Medication Administration Record (MAR) dated 11/14/11, showed the following entry: "Seroquel 50 mg = 2 Tablet Q6H Tube [every 6 hours via the feeding tube]" with a start date and time of "11/11/11 at 1502." Mutual review of the physician's order with the Nurse Administrator 4 showed an order dated and timed, on "11/11/11 at 13:01," for "seroquel 25 mg via FT q 12 hours [via feeding tube every 12 hours]" At 12:15 p.m. during an interview, Pharmacist 4 (Pharm 4) said he checked in the pharmacy's computerized system and the physician's order on file for Patient 13 was the latter order, for Seroquel 25 mg. Pharm 4 said that Patient 13 received an incorrect dosage of Seroquel, "it's a medication error."

On 11/15/11 at 12:40 p.m., during an interview, Pharm 2 described the process of order entry and MAR generation. Pharm 2 said that the physician wrote the order and the nurse scanned the order into the pharmacy's computerized system so that there was a mirror image of the order in the system. The pharmacist reviewed if the order was clinically appropriate for the patient. The pharmacist then typed the order into the pharmacy's computerized system and once a day at 12:30 a.m. the system generated a MAR, for the day, to begin at 7 a.m. Pharm 2 said that, prior to typing new scanned orders into the computer, the pharmacist should pull up the patient's profile based on the patient's name and second identification verification; either the date of birth or medical record number. Pharm 2 said that obviously the pharmacist did not follow the procedure for Patient 13. Pharm 2 said there was another patient with a different name than Patient 13, who had a new order for Seroquel 50 mg every six hours. Pharm 2 said that order was incorrectly typed into Patient 13's medication profile and therefore onto the MAR resulting in the "wrong dose, wrong frequency and wrong patient."