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E. Use-by Dating. Each dosage preparations are prepared, stored and dispensed.” . buffer area. . If Hyaluronidase is not mixed with the Lidocaine then there is the risk of an Beyond Use Dating: Varies, Based on Final Formulation -viscous lidocaine-exa 12/15, diphenhydramine elixir (exp 10/17), mallow (eep 3/ 18) . -beyond use date (BUD) a date after which a compounded preparation All components, non-freestanding equipment, and containers shall be stored off of . --buffer area (an ISO class 7 area)(less than 10, particles/cubic foot of air ). Oct 18, Use: This preparation has been used in the treatment of oral pain. Stability: A beyond-use date of up to 14 days when stored in a refrigerator may be used for Xylocaine Viscous 2% contains lidocaine hydrochloride 20 mg/mL, gum, carrageenan, sodium phosphate, and citric acid as buffering agents.
It is available as extended-release oral capsules and tablets, solution, tablets, suppositories, and injection. Water has a specific gravity of 0. It is miscible with most polar solvents and is chemically stable in all physical states ice, liquid, and steam. It has a low surface tension, which provides for an even film over the mucous membrane. It is packaged in mL plastic bottles. It is an amide-type local anesthetic with a rapid onset and an intermediate duration of action.
Lidocaine HCl is highly soluble in water 1: It is available in both anhydrous and monohydrate forms. Lidocaine HCl is reported to be incompatible in solution with amphotericin, sulfadiazine sodium, methohexitone sodium, cefazolin, and phenytoin sodium.
In polyvinyl chloride IV solution bags, the agent has been reported to exhibit pH-dependent sorption of the plastic. It has a pH of approximately 4. It contains purified water, microcrystalline cellulose, sodium carboxymethylcellulose, xanthan gum, carrageenan, sodium phosphate, and citric acid as buffering agents, simethicone as an antifoaming agent, and potassium sorbate and methylparaben as preservatives.
Ora-Sweet is buffered to a pH of approximately 4. Pharmacopeial Convention, Inc; Standard operating procedure for performing physical quality assessment of oral and topical liquids. Dubash D, Shah U. Handbook of Pharmaceutical Excipients. American Pharmaceutical Association; 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.
A 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 admittedthat 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.
RN 1 became aware of the elevated potassium level closer to 8: 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: 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. 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: Patient 1 was transferred to the inpatient nursing unit at 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. 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. 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 hrs. However, Patient 1 could not take anything orally. RN 2 stated that she informed the Charge RN that she did not administer the Kayexalate but she never informed the attending physician. Possible UGI upper gastro-intestinal Bleed.
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 heartintravenous 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, datedindicated that "All patient medical records must be legible, complete, dated, timed and authenticated in written or electronic form by the person responsible The EDRNM acknowledged that the way that MD 1 had written his physician's orders was not in accordance with hospital policy and procedure.
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.
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.
Morphine Sulfate Swish and Swallow
Patient 4 was admitted on 20.11.2018 to the Intensive Care Unit ICU of Hospital B with diagnoses that included change in mental status, hyponatremia low blood sodiumhistory of opiate a drug derived from opium dependence according to the admission History and Physical.
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 bowelsand the administration of two medications.
Per the same record, a time of "9P" with no date was documented. 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. A 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: 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 pharmacy completed a USP U. The Chief Executive Officer CEO acknowledged that he was unaware of the sterile compounding air pressure differential issues prior to this survey. 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 1 5. A-Tag 1 6. A-Tag 2 and 3 7. A-Tag 4 8. A-Tag 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.
Stablity and Compatability Articles from the International Journal of Pharmaceutical Compounding
A 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: 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. 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. The pharmacy mixed IV antibiotics, labeled the drug with a frozen BUD beyond-use date, date beyond which medication cannot be storedand 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. 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 1.
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.
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. 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. 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.
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. Further inspection of the medication showed it was IV ceftriaxone antibiotic 1 gram in 12 milliliters of sterile water. The ceftriaxone lot number was 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 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. 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 For rooms providing a physical separation through the use of walls, doors, and pass-throughs, a minimum differential positive pressure of 0. Further review showed the pharmacy compounded 41, sterile IV medications. Additional review showed 3, patients received the compounded IV medications.
Inside the ante-room was a door leading to the buffer area area where sterile medications were mixed. 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. 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 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.
Additional review showed 3, patients received compounded IV medications. 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. Clean room requirements; Laminar Airflow Hoods, 8. If turned off, allow at least 30 minutes for complete purging of room air from the IV Room. 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 milliliters. 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. Environmental Services Housekeeping ; 1. Floors are mopped daily when no aseptic operations are in progress During a tour of the satellite pharmacy located by the surgery department of Hospital A at approximately 1: Exposing phenylephrine to light can cause chemical reactions and loss of potency of the drug.
During an interview at approximately 1: A 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: 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.
Further inspection of the medication showed it was IV ceftriaxone antibiotic 1 gram gm in 12 milliliters ml of sterile water.
Stablity and Compatability Articles from the International Journal of Pharmaceutical Compounding
DOP 2 described the process for ceftriaxone. After the ceftriaxone was thawed it was labeled with a refrigerated BUD of a maximum of 9 days. The group identified ceftriaxone, ceftazidime and cefuroxime. 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 requested information was not provided before the end of the survey. End Product Testing, 1. Further review showed the pharmacy compounded 3, doses of the three antibiotics listed above.
Additional review showed 1, patients received the antibiotics. During a tour of the pharmacy located in Hospital B at approximately 9: 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.
A 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: 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.
The record showed the following: