HospitalInspections.org

Based on review of a Food and Drug Administration (FDA: institution chartered by congress with oversight of the approval and quality of medications used in the United States) series of inspection reports from 2013 and 2015 (Form 483) issued to Outsourcing Facility A (an entity allowed to compound medications according to section 503 B of the Food, Drug, and Cosmetic Act as amended), review of an FDA warning letter to Outsourcing Facility A dated 7/18/14, inspection of three medications in pre-filled syringes (PFSs) compounded by Outsourcing Facility A (succinylcholine: an paralytic agent used in surgery, phenylephrine: used to support blood pressure, and ephedrine: used to support blood pressure) and available for use in the hospital (located in one out of one anesthesia carts in Operating Room 1), document review and staff interview, the hospital failed to incorporate issues, as documented in the inspection reports and in the warning letter released on 7/18/14 by the FDA to Outsourcing Facility A, into their Quality Assurance plan to ensure the sterility, potency, and identity of the medication in all batches of the products the hospital purchased from Outsourcing Facility A to the end of the prolonged beyond use dates Outsourcing Facility A assigned to their compounded products. The hospital staff was not aware of the warning letter or the adverse inspection reports issued to Outsourcing Facility A and had not pursued further investigation with Outsourcing Facility A. This had the potential to expose patients to medications that may not have been sterile or to products that did not meet United Stated Pharmacopeial Convention (USP: establishes standards for medications in the United States) Pharmacopeia compendial standards of potency.

Findings:

1. The United States Pharmacopeial Convention (USP) is a scientific nonprofit organization that sets standards for the quality, purity, identity, and strength of medicines. USP's drug standards are enforceable in the United States by the Food and Drug Administration and are published in the United States Pharmacopeia/National Formulary (USP/NF).

In 2013 congress passed the Drug Quality Act which added section 503B to the Food Drug and Cosmetic Act which allowed a compounding pharmacy to register with the FDA as an "outsourcing facility". Outsourcing facilities would be exempted from the drug approval process and the requirement to label its products with adequate instructions for use, but did not exempt them from current good manufacturing practices (CGMPs) which are rigorous regulations applied to manufacturers in the production of medications.

In February and March 2013, FDA inspectors inspected all four compounding sites of Outsourcing Facility A and issued deficient observations on their Form 483 (a preliminary report of findings) at all four sites. In addition, Site 3 was revisited in July 2015.

The 483 issued to Site 1 on 2/22/13 documented the "...failure to perform finished product potency and sterility testing on each lot of finished sterile injectable drug product processed/distributed."

The 483 issued to Site 2 on 2/27/13 documented: "Each batch of drug product required to free of objectionable microorganisms is not tested through appropriate laboratory testing" and "Testing and release of drug product for distribution do not include appropriate laboratory determination of satisfactory conformance to the identity and strength of each active ingredient prior to release."

The 483 issued to Site 3 on 2/28/13 documented: "Each batch of drug product purporting to be sterile and pyrogen-free is not laboratory tested to determine conformance to such requirements" (pyrogens can cause a fever) and "Testing and release of drug product for distribution do not include appropriate laboratory determination of satisfactory conformance to the identity and strength of each active ingredient prior to release."

The 483 issued to Site 4 on 3/22/13 documented: "Laboratory controls do not include the establishment of scientifically sound and appropriate specifications and test procedures designed to assure that drug products conform to appropriate standards of identity, strength, quality and purity" and "Each batch of drug purporting to be sterile and pyrogen-free is not laboratory tested to determine conformance to such requirements. Specifically, the firm does not conduct endotoxin testing on any finished injectable drug products."

The 483 issued to Site 4 on 7/10/15 (a repeat inspection) documented: "Testing and release of drug product for distribution do not include appropriate laboratory determination of satisfactory conformance to the identity and strength of each active ingredient prior to release. Specifically, Your firm does not perform finished product potency/sterility testing on each lot of finished injectable drug product produced prior to being distributed ... **THIS IS A REPEAT OBSERVATION**" and "Each batch of drug product purporting to be sterile and pyrogen-free is not laboratory tested to determine conformance to such requirements. Specifically, Your firm does not conduct any endotoxin testing on finished drug products purporting to be sterile ... **THIS IS A REPEAT OBSERVATION**"

These reports are available at the FDA website at:

On 7/18/14 the Food and Drug Administration issued a Warning Letter to Outsourcing Facility A documenting that "it appears you (Outsourcing Facility A) are producing drugs that violate the Federal Food, Drug and Cosmetic Act ...." The letter presented examples of such violations. On page 3 of 7 it documented that Outsourcing Facility A had registered with the FDA as a 503 B outsourcing facility and that the letter focused on unsanitary conditions and violations of CGMP (current good manufacturing practices: found in Title 21 Code of Federal Regulations, Part 210 and Part 211 and which provide regulations for manufacturing medications) requirements that continued to apply to Outsourcing Facility A even though it had registered with the FDA. On page 4 of 7 it documented "Your firm failed did not have, for each batch of drug product purporting to be sterile and/or pyrogen-free, appropriate laboratory determination of satisfactory conformance of final specifications for the drug product ..." and "Your firm did not have, for each batch of drug product, appropriate laboratory determination of satisfactory conformance to final specifications for the drug product, including the identity and strength of each active ingredient, prior to release ...." On page 4 of 7 it documented that Outsourcing Facility A' s "Attention is directed in particular to the provisions with regard to sterility testing and stability testing, and the establishment of beyond use dates." On page 5 of 7 it documented that "The violations cited in this letter are not intended to be an all-inclusive statement of violations at your facilities ... Within fifteen working days of receipt of this letter, please notify this office in writing of the specific steps you have taken to correct violations."

On 8/17/15 starting at 5:26 p.m. inspection of one out of one anesthesia carts located in Operating Room 1 of the Surgery Department indicated the cart contained one 10 milliliter PFS of succinylcholine 20 milligrams/milliliter labeled to expire 10/31/15, two 10 milliliter PFSs of phenylephrine 100 milligrams/milliliter labeled to expire 10/13/15 and 10/26/15 and two 5 milliliter PFS of ephedrine 10 milligrams/milliliter labeled to expire 10/12/15 and 10/25/15. Inspection of the labels on these PFSs indicated they were compounded by Outsourcing facility A.

During a concurrent interview of the Pharmacy Operations Manager conducted at that time, she stated she was not aware of the 483 forms issued to Outsourcing Facility A in February and March 2013 or of the FDA Warning letter issued to Outsourcing Facility A on 7/18/14. She stated she was not aware that these had been incorporated into the hospital quality assurance process. During a subsequent interview of the Pharmacy Operations Manager in the Pharmacy Office on 8/19/15 starting at 12:40 p.m. she produced copies of the FDA warning letter from July 2014 as well as copies of the 483 issued to Site 3 on 2/28/13, the 483 issued to Site 4 on 3/22/13, and the 483 issued to Site 4 on 7/10/15.

In 8/19/15 at 12:48 p.m. during an interview of the Director of Pharmacy he stated he was not aware of the FDA warning letter issued to Outsourcing Facility A on 7/18/14. He stated that the hospital had not incorporated the warning letter into the hospital quality assurance process and that he had not questioned Outsourcing Facility A about the issues presented in the letter. He stated that he had received a letter from Outsourcing Facility A regarding the inspections at their compounding sites but he did not recall if he had reviewed the FDA Form 483s issued to Outsourcing Facility A or that the FDA had re-inspected some Outsourcing Facility A sites in 2015 and issued more 483 Forms. He stated that he would review the documents regarding Outsourcing Facility A that the Pharmacy Operations Manager had downloaded from the FDA website during the survey.

On 8/20/15 at 1:38 p.m. during an interview of the Director of Pharmacy and the Pharmacy Operations Manager they both stated they felt that Intravenous solution compounding was a high risk activity.

Based on interview and record review, the hospital failed to ensure Medical Staff Bylaws, rules and regulations were followed as evidenced by:

1. Medical staff failed to include a start date or time for anticoagulation medication and used an unauthorized electronic device to transmit part of the medication order to the pharmacy which resulted in the administration of the anticoagulation medication in the immediate postoperative period with subsequent hemorrhage into the operative site. (Patient 201) See A 341.

2. Medical Staff failed to authenticate 15 verbal orders within the specified time frame. (Patient 203) See A 341.

The cumulative effect of these failures resulted in the hospital's inability to assure quality health care in a safe environment.

The hospital failed to ensure medical staff bylaws and rules and regulations were followed when medical staff, 1. Wrote an initial order for anticoagulant (blood thinning) medication that did not include a start time, which resulted in the generation of a default start time by the pharmaceutical services software program and, medical staff used an electronic device to relay a order to the pharmacy to hold the anticoagulant until the following day, which the pharmacist failed to enter into the electronic health record. The anticoagulant was administered to Patient 201 on the postoperative day, which resulted in bleeding into the operative site. Patient 201 returned to surgery to have a blood clot, (hematoma) removed from the operative site, and required a blood transfusion and an extended hospital stay to treat acute blood loss anemia, and 2. Fifteen verbal orders for medications, test and treatments for Patient 203 had not been authenticated by medical staff within the required 48 hours.

Findings:


During an interview, on 7/20/15 at 9:30 a.m., Administrative Staff stated Patient 201 had a history of atrial fibrillation, (a rapid disorganized heart beat that caused blood to pool in the upper chambers of the heart increasing the risk of formation of blood clots), and transient ischemia attack (a temporary blockage of the blood supply to the brain by a clot, sometimes called a warning stroke). Patient 201's home medications included a anticoagulant medication, Lovenox, (blood thinner) to decrease the risk of blood clot formation. Patient 201 stopped taking the Lovenox 7/8/15, day before surgery, to decrease the risk of bleeding during and after surgery.

Review of a Prescribing Information document, dated 2013, issued by the manufacturer of Lovenox indicated it was a low molecular weight heparin which had antithrombotic properties, (slowed down clotting). Warnings and Precautions issued by the manufacturer included, "Increased risk of hemorrhage. Use caution with patients at risk." Different dosing regimes of Lovenox are used for prevention (prophylaxis) of blood clots or treatment of existing blood clots.

The clinical record for Patient 201 was reviewed on 7/23/15, 8/13/15, and 8/20/13.

Patient 201 underwent a simple mastectomy for breast cancer on 7/9/15.

Post operative orders entered into the hospital electronic order system (CPOE-Computerized Provider Order Entry) on 7/9/15 by Physician M included Lovenox 40 milligrams (mg-a measurement of volume) subcutaneously, (injected just under the skin), every twelve hours. The order did not include start or stop times or dates.

During an interview, on 7/20/15 at 3:13 p.m., Physician M stated she communicated with the pharmacy 1 1/2 hours after the initial order, to hold the 7/9/15 evening dose of Lovenox. Physician M stated she did not go back to the CPOE and change the order. Physician M stated she had intended the Lovenox be started 7/10/15, the day after surgery.

During an interview, on 7/20/15 at 2:13 p.m., Pharmacist N stated orders received for Patient 1 on 7/9/15 included Lovenox 40 mg twice a day.
Pharmacist B stated there was no way he could know that Patient 1 had already had surgery. Pharmacist N stated he used his personal electronic device to text Physician M to ask if the Lovenox was for prophylaxis or treatment. Pharmacist N stated Physician M responded via text that the Lovenox was for treatment and told Pharmacist N to "hold tonight's dose". Pharmacist N stated he forgot to enter the hold order into the CPOE system. Pharmacist N stated he should have paged the physician instead of texting.
Pharmacist N stated when no start time was included in the order, the computer system defaulted to the next hour after the order was entered, in this case 3 p.m. on 7/9/15.

The Electronic Medication Administration Record, (e-MAR, dated 7/9/15 for Patient 1 indicated Lovenox 40 mg sq was administered to Patient 201 at 16:59 (4:59 p.m.), on 7/9/15.

Physician Progress Notes, dated 7/10/15 indicated on 7/9/15 about 7 p.m., Patient 201 developed a "right chest wall hematoma" and returned "urgently" to the operating room for evacuation of a 800 cubic centimeter hematoma. (cubic centimeter- cc, a measure of volume, 800 cc equivalent to 3.333 cups according to convert me. com)

Physician Progress Notes, dated 7/10/15 noted Patient 201's hemoglobin during the second surgery on 7/9/15 was 8.2 gm/dL and hematocrit was 26.4, (normal values vary by laboratory but generally hemoglobin 12-16 gm/dL and hematocrit 35-47% for an adult female. Hemoglobin and hematocrit, red blood cells, carry oxygen from the lungs throughout the body). Patient 201 received one unit of packed red bloods cells during surgery. On the first post operative day, 7/10/15 Patient 202's hemoglobin was 7.4 gm/dL and hematocrit was 26.5%, both lower.

Physician Progress Notes dated 7/11/15 indicated Patient 201 stayed in the hospital through postoperative day one for monitoring of acute blood loss anemia, (not enough healthy red blood cells to carry adequate oxygen to the cells). Patient 201 was given intravenous iron to help her body generate new red blood cells.

During an interview, on 8/18/15 at 9:45 a.m., Physician O, the Medical Director for Quality, stated verbal medication orders were required to be "read back" to verify the order was correct. Physician O stated the use of an electronic device to transmit medication orders did not allow the read back verification that was required.

Review on 8/17/15 and 8/18/15, of Medical Staff Rules and Regulations and Bylaws, last approved by the hospital Board of Directors 7/19/12, indicated what constituted a complete order and that medical staff would comply with hospital policy and procedure as applicable.

Review of hospital policy and procedure titled Physician Order Writing Standards, last reviewed 3/13, indicated "E-transmittal orders are orders sent by the prescriber via a password protected, HIPPA compliant, hospital approved application on an electronic device....Medication orders may not be sent via e-transmittal and are not to be accepted by staff".

2. During medical record review, on 8/18/15 at 10:30 a.m., it was noted that multiple medication orders for Patient 203 were verbal or telephone orders to nursing staff.

The verbal orders included: Digoxin 0.25 mg IV push, (used for control of the heart rate), ordered for one time each on 7/9/15, 7/10/15, and 7/13/15; Amiodarone 2 mg/min IV. Start at 2 mg/min, when HR < 80 decrease to 1 mg/min when HR <70 dc gtt" on 7/10/15, (used for control of abnormal heart rhythms); Tamsulosin 0.4 mg po bid, (used for treatment of urinary tract obstruction) ordered on 7/11/15; Albumin 5% 25 Grams intravenous once, (used as a plasma volume expander) ordered on 7/11/15 and Amiodarone 1mg/min intravenous infusion ordered on 7/13/15.

Eight additional verbal orders for diagnostic testing and nursing procedures were found in the medical record.

Dictated verbal or telephone orders are those orders given, when a provider is not physically present, to an individual authorized to receive such orders.

When asked, on 8/19/15, to provide evidence that the verbal orders had been cosigned by the physician, Administrative Staff verbally reported that Health Information Management (HIM) had determined that 15 orders for Patient 203 were physician orders that had not been co-signed by the physician.

During an interview and concurrent review of documentation, on 8/20/15 at 9:30 a.m., HIM Staff S stated that HIM reviewed the electronic health records for completeness. HIM Staff S stated HIM generated a list every week to notify physicians of orders that need to be co-signed. HIM Staff S stated orders were supposed to be co-signed within 48 hours.

Review of the hospital policy titled Verbal and Telephone Orders From Physician or Physician Extender, #1109.3.4, last reviewed 6/13, indicated, "The order(s) will be signed, dated and timed by the ordering physician within 48 hours.

Review of the hospital policy Physician Order Writing Standards, #1109.6.1, last reviewed 3/13, II Guidelines 2. Telephone/Verbal Orders/E-Transmittal Orders indicated "Orders must be co-signed by the prescriber according to medical staff by-laws.

Review on 8/18/15 at 3:15 p.m., of Medical Staff Rules and Regulations, VI Medical Records D. Authentication, "All entries...or called in verbally by responsible practitioner shall be promptly authenticated by responsible practitioner except as noted in XI B. XI Orders B. "All verbal orders shall be authenticated...within 48 hours".

Based on observation, interview, and record review, the hospital failed to ensure that each patient was provided with individualized assessment and that a plan of care was developed for each patient as evidenced by:

1. Nursing staff administered anticoagulation medication within the immediate post operative period resulting in hemorrhage into the operative site which required a return to surgery, a blood transfusion and extended hospital stay for one patient. (Patient 201) See A 395.

2. Nursing Staff did not develop a nursing plan of care for a patient assessed as high risk for development of a pressure ulcer with potential for impairment of skin integrity. (Patient 202) See A 396.

The cumulative effects of these failures resulted in the hospital's inability to provide quality health care in a safe environment.

Based on interview, and record review, the hospital failed to ensure Patient 201's needs were met within the scope of the hospital policy and procedure for medication administration when licensed staff did not evaluate the potential effects of administration of anticoagulant medication in the immediate postoperative period, and did not discuss any concerns regarding the administration of the anticoagulant with the prescriber.

Licensed Staff administered the anticoagulant to Patient 201 on the postoperative day, which resulted in bleeding into the operative site. Patient 201 returned to surgery to have a blood clot, (hematoma) removed from the operative site, and required a blood transfusion and an extended hospital stay to treat acute blood loss anemia.

Findings:

During an interview, on 7/20/15 at 9:30 a.m., Administrative Staff stated
Patient 201 had a history of atrial fibrillation, (a rapid disorganized heart beat that caused blood to pool in the upper chambers of the heart increasing the risk of formation of blood clots), and transient ischemia attack, (TIA-a temporary blockage of the blood supply to the brain by a clot, sometimes called a warning stroke). Patient 201's home medications included a anticoagulant medication, Lovenox, (blood thinner) to decrease the risk of blood clot formation. Patient 201 stopped taking the Lovenox 7/8/15, day before surgery, to decrease the risk of bleeding during and after surgery.

Review of a Prescribing Information document, dated 2013, issued by the manufacturer of Lovenox indicated it was a low molecular weight heparin which had antithrombotic properties, (slowed down clotting). Warnings and Precautions issued by the manufacturer included, "Increased risk of hemorrhage. Use caution with patients at risk." Different dosing regimes of Lovenox are used for prevention (prophylaxis) of blood clots or treatment of existing blood clots.

The clinical record for Patient 201 was reviewed on 7/23/15, 8/13/15, and 8/20/13.

Patient 201 underwent a simple mastectomy for breast cancer on 7/9/15.

Post operative orders entered into the hospital electronic order system (CPOE-Computerized Provider Order Entry) on 7/9/15 at 13:46 (1:46 p.m.)by Physician M included Lovenox 40 milligrams (mg-a measurement of volume) subcutaneously, (injected just under the skin), every twelve hours.

The Electronic Medication Administration Record, (e-MAR), for Patient 1, dated 7/9/15 indicated Lovenox 40 mg sq was administered to Patient 201 at 16:59 (4:59 p.m.), on 7/9/15 by Licensed Staff Q.

During interview, on 7/20/15 at 2:43 p.m., asked if it was common to give an anticoagulant the day of surgery, Licensed Staff Q replied, "No". Licensed Staff Q stated she was aware of Patient 201's history of atrial fib and TIA. Licensed Staff Q stated she did not call the physician to clarify the order. Licensed Staff Q stated she re-checked the order and talked to Patient 201's family who said "Oh good" when told Patient 201 would receive the anticoagulant. Licensed Staff Q stated "I had an order to give it so I gave it". Licensed Staff Q stated about 2-4 hours after giving the medication, she noted Patient 201's operative site was swollen and puffy. Licensed Staff Q notified the physician and Patient 201 was sent to the operating room.

Physician Progress Notes, dated 7/10/15 indicated on 7/9/15 about 7 p.m., Patient 201 developed a "right chest wall hematoma" and returned "urgently" to the operating room for evacuation of a 800 cubic centimeter hematoma. (cc-cubic centimeter-a measure of volume, 800 cc is equivalent to 3.33 cups according to convert me. com)

Physician Progress Notes, dated 7/10/15 noted Patient 201's hemoglobin during the second surgery on 7/9/15 was 8.2 gm/dL and hematocrit was 26.4, (normal values vary by laboratory but generally hemoglobin 12-16 gm/dL and hematocrit 35-47% for an adult female. Hemoglobin and hematocrit, red blood cells, carry oxygen from the lungs throughout the body). Patient 201 received one unit of packed red bloods cells during surgery. On the first post operative day, 7/10/15 Patient 202's hemoglobin was 7.4 gm/dL and hematocrit was 26.5%, both lower.

Physician Progress Notes dated 7/11/15 indicated Patient 201 stayed in the hospital through postoperative day one for monitoring of acute blood loss anemia, (not enough healthy red blood cells to carry adequate oxygen to the cells). Patient 201 was given intravenous iron to help her body generate new red blood cells.

Hospital policy titled Medication Administration, #424.1.3, last reviewed 3/12 indicated under III General Information, B. The Nurse will: 2. Administer medication ordered by a physician according to the nurse's respective...job description..." 3. Evaluate the effects of medication for therapeutic outcomes and intervene as needed".

The Clinical RN (Registered Nurse) I, II, III (Generic) Job Description, last review date 7/03, indicated, " The Clinical RN will provide assessment,...and collaborating with physicians...to optimally manage patient care in the interest of the patient, acting as a patient advocate as necessary".

Based on observation, interview, and review of clinical records and hospital policy and procedures, the hospital failed to ensure nursing staff developed and kept current a nursing care plan for potential alteration of skin integrity for Patient 202, who was assessed at high risk for alteration of skin integrity with potential for skin breakdown.

Findings:

The most recent History and Physical dated 7/30/15 for Patient 202, indicated Patient 202 was admitted on 7/30/15 with diagnoses that included sepsis, (systemic infection), diarrhea, and quadriplegia, (inability to move arms or legs). Patient 202 received all nutrition via a percutaneous endospopic gastrostomy tube (PEG-a flexible tubing inserted through the abdominal wall into the stomach).

During an observation, on 8/19/15 at 9:30 a.m., Patient 202 rested in bed with the head elevated 45 degrees. Patient 202 nodded to questions, but was unable to speak due to the tracheotomy tube that aided his breathing. Licensed Staff R administered medications to Patient 202 via a PEG tube.

Braden Scale, scoring for Patient 202 indicated his score on 8/19/15 was 11 out of 23. A red text message appeared on the screen that indicated a score of 10-12 represented high risk for pressure ulcer development.

The Braden Scale is a scoring tool used to assess the risk of pressure ulcer development, an extreme example of alteration in skin integrity. The scale consists of six categories for assessment; sensory perception, moisture, activity, mobility, nutrition, and friction/shear. The total score can range from 6-23, the lower the score the higher the risk. The score serves as a guide to the intensity of interventions that should be used.

During interview, on 8/19/15 at 1:10 p.m., Licensed Staff R, stated the admission nurse started a plan of care for the patient(s), additions to the care plan were made by staff as patient care problems or potential problems were subsequently identified. During concurrent review, of the nursing plan of care for Patient 202, a plan of care could not be found for prevention of pressure ulcer or prevention of alteration in skin integrity. Licensed Staff R stated that the potential for altered skin integrity was addressed by the problem identified in Patient 202's care plan as Physical Mobility Impairment (Actual). Review of the care plan for Physical Mobility Impairment indicated one goal was "Remains Free From Complications of Impaired Mobility ". "Reposition and Inspect Skin PRN" (as needed), was the only intervention applicable to Patient 202's skin.

During an interview, on 8/20/15 at 8:50 a.m., the Wound Care Nurse stated that she would expect to see a nursing care plan for potential alteration in skin integrity for a patient with a Braden Scale score of 11.

Hospital policy titled Maintaining Skin Integrity, #406.2.3, last reviewed 8/11, indicated, "III. Procedure: D. Document in the EMR (Electronic Medical Record) care planning for patients with identified risks and problems to ensure appropriate nutritional intake,...assess, treat, and protect skin daily. E. Implement preventative interventions according the Protocol". The policy's Prevention Protocol identified a patient with a Braden Scale Score of 14 or less as "Extremely High Risk" and listed multiple patient care interventions to protect the patient from alteration in skin integrity, including reposition/move every 2 hours, keep bed at 30 degrees or less to reduce friction and sheer and examine skin each shift.

Based on observation, interview, and record review, the hospital failed to assure safe and effective Pharmaceutical Services as evidenced by:

1. Pharmacy staff communicated with medical staff on an unauthorized electronic device regarding an order for anticoagulation and failed to enter a physician order to hold anticoagulation into the Electronic Health Record which resulted in administration of the anticoagulation medication the post operative day, with subsequent hemorrhage into the operative site which required return of the patient to the operating room for evacuation of a hematoma and an extended hospital stay for treatment of acute blood loss anemia. (Patient 201) See A 500.

2. A pressure gauge was not installed in a satellite pharmacy to allow monitoring of the negative pressure differential between the corridor and the satellite pharmacy. See A 500.

3. The volume of heparin container was not listed on the contents list of the Malignant Hyperthermia (MH) Cart in the Surgery Department. See A 500.

4. Malignant Hyperthermia Cart (MH) contents list did not specify location of refrigerated normal saline for immediate use in a MH crises. See A 500.

5. Syringes filled with normal saline were stored in a unlocked drawer. See A 502.

6. Outdated medications and intravenous solutions were available on the Malignant Hyperthermia Cart in Surgery, one adult emergency cart, one pediatric emergency cart and one anesthesiology cart. See A 505.

7. The amount of medication was incorrect on the label one intravenous medication compounded by the hospital pharmacy. See A 505.

8. The hospital policy for Automated Medication Stop Dates was implemented for only two medications in the computerized patient medication profile system.
See A 507.

The cumulative effects of these failures resulted in the hospital's inability to provide pharmaceutical services and care in a safe and effective manner.

Based on observation, interview, and record review the hospital failed to assure safe and effective Pharmaceutical Services as evidenced by:

1.The hospital failed to assure patient safety in the dispensing of medications when pharmacy staff communicated with medical staff on an unauthorized electronic device regarding an order for a medication for anticoagulation and failed to enter a physician order to hold an anticoagulation medication into the Electronic Health Record (EHR). The anticoagulant was administered to Patient 201 on the postoperative day, which resulted in bleeding into the operative site. Patient 201 returned to surgery to have a blood clot, (hematoma) removed from the operative site, and required a blood transfusion and an extended hospital stay to treat acute blood loss anemia.

2. The hospital failed to ensure that a pressure gauge was installed in the Fifth Floor Pharmacy Satellite wall so staff could monitor the negative pressure differential between the satellite and the hospital corridor or that the pressure differential between the satellite and the hospital corridor was continuously monitored as required by United States Pharmacopeial Convention chapter 797 (provides guidelines for compounding sterile products safely) which the Director of Pharmacy identified as the standard the hospital followed to ensure the quality of compounded sterile products in the hospital and to ensure safety of staff. As a result, staff would not know if the Fifth Floor Pharmacy lost negative pressure which could result in release of hazardous substances into the general hospital environment.

3. The hospital failed to specify the volume of the heparin container (at a concentration of 1,000 units/milliliter) listed on the external content list of the MH Cart. This product comes in 1 milliliter, 10 milliliter, and 30 milliliter vials (as documented in FDA approved product labeling). Consequently, it was not clear which size the medical staff had intended staff place in this emergency medication supply and

The hospital failed to ensure that all the refrigerated normal saline (NS: physiologic saline or 0.9% sodium chloride solution) listed on the external MH Cart content list and which would be used to cool a patient undergoing an MH Crisis, was in fact available for immediate use to treat an MH crisis. The hospital also failed to make clear which of the three refrigerators was the " Medication Refrigerator " listed on the content list as available refrigerated supplies were dispersed among two out of three refrigerators located in the Surgery Department. As a result, not enough saline was available as determined by the medical staff, to cool a patient undergoing an MH crisis and there might be a delay in treatment as staff checked three different refrigerators to locate the refrigerated supplies.

Findings:

1. During an interview, on 7/20/15 at 9:30 a.m., Administrative Staff stated Patient 201 had a history of atrial fibrillation, (a rapid disorganized heart beat that caused blood to pool in the upper chambers of the heart increasing the risk of formation of blood clots), and transient ischemia attack, TIA, (a temporary blockage of the blood supply to the brain by a clot, sometimes called a warning stroke). Patient 201's home medications included a anticoagulant medication, Lovenox, (blood thinner) to decrease the risk of blood clot formation. Patient 201 stopped taking the Lovenox 7/8/15, day before surgery, to decrease the risk of bleeding during and after surgery.

Review of a Prescribing Information document, dated 2013, issued by the manufacturer of Lovenox indicated it was a low molecular weight heparin which had antithrombotic properties, (slowed down clotting). Warnings and Precautions issued by the manufacturer included, "Increased risk of hemorrhage. Use caution with patients at risk." Different dosing regimes of Lovenox are used for prevention (prophylaxis) of blood clots or treatment of existing blood clots.

The clinical record for Patient 201 was reviewed on 7/23/15, 8/13/15, and 8/20/13.

Patient 201 underwent a simple mastectomy for breast cancer on 7/9/15.

Post operative orders entered into the hospital electronic order system (CPOE-Computerized Provider Order Entry) on 7/9/15 at 13:46 (1:46 p.m.) by Physician M included Lovenox 40 milligrams (mg-a measurement of volume) subcutaneously, (injected just under the skin), every twelve hours. The order did not include start or stop times or dates.

During an interview, on 7/20/15 at 3:13 p.m., Physician M stated she communicated with the pharmacy 1 1/2 hours after the initial order, to hold the 7/9/15 evening dose of Lovenox, Physician M stated she did not go back to the CPOE and change the order. Physician M stated she had intended the Lovenox be started 7/10/15, the day after surgery.

During an interview, on 7/20/15 at 2:13 p.m., Pharmacist N stated orders received for Patient 1 on 7/9/15 included Lovenox 40 mg twice a day.
Pharmacist B stated there was no way he could know that Patient 1 had already had surgery. Pharmacist N stated he used his personal electronic device to text Physician M to ask if the Lovenox was for prophylaxis or treatment. Pharmacist N stated Physician M responded via text that the Lovenox was for treatment and told Pharmacist N to "hold tonight's dose". Pharmacist N stated he forgot to enter the hold order into the system.
Pharmacist N stated he should have paged the physician instead of texting.
Pharmacist N stated when no start time was included in the order, the computer system defaulted to the next hour after the order was entered, in this case 3 p.m. on 7/9/15.

The Electronic Medication Administration Record, (e-MAR), for Patient 1for 7/9/15 indicated Lovenox 40 mg sq was administered to Patient 201 at 16:59 (4:59 p.m.), on 7/9/15.

Physician Progress Notes, dated 7/10/15 indicated on 7/9/15 about 7 p.m., Patient 201 developed a "right chest wall hematoma" and returned "urgently" to the operating room for evacuation of a 800 cubic centimeter hematoma. (cc-cubic centimeter-a measure of volume, 800 cc equivalent to 3.33 cups according to convert me. com)

Physician Progress Notes, dated 7/10/15 noted Patient 201's hemoglobin during the second surgery on 7/9/15 was 8.2 gm/dL and hematocrit was 26.4, (normal values vary by laboratory but generally hemoglobin 12-16 gm/dL and hematocrit 35-47%). Hemoglobin and hematocrit carry oxygen from the lungs throughout the body. Patient 201 received one unit of packed red bloods cells during surgery. On the first post operative day, 7/10/15 Patient 202's hemoglobin was 7.4 gm/dL and hematocrit was 26.5%, both lower.

Physician Progress Notes dated 7/11/15 indicated Patient 201 stayed in the hospital through postoperative day one for monitoring of acute blood loss anemia, (not enough healthy red blood cells to carry adequate oxygen to the cells). Patient 201 was given intravenous iron to help her body generate new red blood cells.

During an interview, on 8/18/15 at 9:45 a.m., Physician O, the Medical Director for Quality, stated verbal medication orders were required to be "read back" to verify the order was correct. Physician O stated the use of an electronic device to transmit medication orders did not allow the read back verification that was required. Physician O stated nurses were trained to refuse medication orders sent via electronic devices.

During an interview, on 8/18/15 at 9:55 a.m., a.m., the Pharmacy Operations Manager stated pharmacy staff had also been trained not to take medication orders via electronic devices but to encourage physicians to enter orders into CPOE.

Hospital policy and procedure titled Physician Order Writing Standards, last reviewed 3/13, indicated "E-transmittal orders are orders sent by the prescriber via a password protected, HIPPA compliant, hospital approved application on an electronic device....Medication orders may not be sent via e-transmittal and are not to be accepted by staff".





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2. The United States Pharmacopeial Convention (USP) is a scientific nonprofit organization that sets standards for the quality, purity, identity, and strength of medicines ...USP's drug standards are enforceable in the United States by the Food and Drug Administration and are published in the United States Pharmacopeia/National Formulary (USP/NF). The USPs revised general chapter <797> (USP 797) entitled PHARMACEUTICAL COMPOUNDING-STERILE PREPARATIONS documents that: "The objective of this chapter is to describe conditions and practices to prevent harm, including death that could result from (1) microbial contamination (nonsterility) ...." Under the section entitled "Hazardous Drugs as CSPs" (CSPs means compounded sterile products) USP 797 documents that if a compounding aseptic containment isolator (CACI: a sealed glove box maintained at negative pressure to the room in which it is located so as to contain hazardous drugs, prevent the release of harmful aerosols into the work area, and is used by staff to compound hazardous drugs) is located outside of a clean room "... the compounding area shall maintain a minimum negative pressure o 0.01-inch water column ...." Under "Pressure Differential Monitoring" USP 797 documents that "A pressure gauge ... shall be installed to monitor the pressure differential ..." and "The results will be reviewed and documented on a log ... at least daily or by a continuous recording device."

On 8/18/15 starting at 11:09 a.m. an inspection of the Fifth Floor Satellite Pharmacy indicated it contained a CACI used to compound hazardous chemotherapeutic medications used to treat cancer patients. This observation was verified at that time during a concurrent interview of the Pharmacy Operations Manager. The Pharmacy Operations Manager stated that the pharmacy satellite was maintained at negative pressure relative to the hospital corridor into which it opened but there was no gauge mounted in the wall of the satellite that staff could use to measure the pressure differential between the satellite and the corridor.

On 8/19/15 at 12:48 p.m. during an interview of the Director of Pharmacy, he stated the hospital followed the USP 797 standards to assure the quality of compounded sterile products made by pharmacy staff and to establish beyond-use dates for these CSPs.

3. Malignant hyperthermia (MH) is a rare but potentially lethal adverse effect of certain medications, the anesthetic gases and succinylcholine (a muscle relaxant used during surgery), used in anesthesia and surgery. It is characterized by a rapid rise in a patient's temperature up to 110 degrees Fahrenheit or more. If not treated immediately it can result in injury to or death of a patient.

On 8/17/15 starting at 3:37 p.m. an inspection of the MH Cart indicated it contained one 10 ml vial of heparin at a concentration of 1,000 units/milliliter. A review of the content list posted on the exterior of this supply indicated it documented the cart contained one vial of heparin at a concentration of 1,000 units/milliliter but it did not document the volume of the vial. This observation was verified at that time during a concurrent interview of the Pharmacy Operations Manager. The FDA approved product labeling for heparin sodium indicates that it is available in 1 milliliter, 10 milliliter, and 30 milliliter vials.

On 8/17/15 at 3:37 p.m. a review of the content list posted on the exterior of the MH Cart indicated that four 1000 milliliter intravenous solution (IV) bags of NS (used to lower the temperature of patients undergoing an MH crisis), four 1000 milliliter plastic pour bottles of NS for irrigation (used to lavage body cavities and thus cool patients undergoing an MH crisis) and one vial of regular insulin (used with IV dextrose, a sugar, to lower the high potassium levels that might occur during an MH crisis) were stored under refrigeration in the "Medication Refrigerator" . A subsequent inspection of three refrigerators in the Surgery Department indicated that the refrigerator in the Cardiac Storage Room contained two 1000 milliliter plastic pour bottles of NS for irrigation, the Anesthesia Work Room refrigerator contained no refrigerated NS, and the refrigerator attached to the Surgery Department Pyxis MedStation (a computer controlled robotic dispensing device) contained no NS but it did contain three vials of regular insulin. This observation was verified at that time during a concurrent interview of the Pharmacy Operations Manager.

Based on inspection of one out of one Nurse Server Carts on the Cardiac Care Unit and staff interview, the hospital failed to ensure that staff placed pre-filled syringes of normal saline (NS: 0.9% sodium chloride used to flush intravenous [IV] lines) in a locked drawer. The drawer to the cart was ajar and not locked. As the cart was located in an open corridor in the unit, the syringes of NS would have been accessible by non-licensed staff and hospital visitors.

Findings:

1. On 8/19/15 at 4:39 p.m. an inspection of the Cardiac Unit the surveyor saw an open drawer in a cart identified by the Cardiac Unit Nurse Manager as a Nurse Server Cart. It contained several 10 milliliter pre-filled syringes of normal saline (0.9% sodium chloride used to flush IV lines). During a concurrent interview of the Cardiac Unit Nurse Manager, she verified this observation and stated the drawer should have been locked.

Based on inspection of one out of one Malignant Hyperthermia (MH: a rare but potentially lethal side effect of certain medications used in the practice of anesthesiology) Cart located in the Surgery Department, one out of one Adult Crash Cart (contains equipment and medications used to manage medical emergencies) and one out of one Pediatric Crash Cart located on the Pediatric Unit, one out of one warmers used to warm solutions in the Surgery Department, one intravenous solution (IV) bag of vancomycin (an antibiotic) in the Pharmacy IV Room, and one out of one anesthesia carts located in Operating Room (OR) 1, document review, and staff interview:

1. The hospital failed ensure that an expired bag of IV mannitol (used to increase urine flow during acute kidney failure that can be seen in an MH Crisis) had been replaced in the MH Cart in the Surgery Department and failed to ensure that an expired packet of petroleum jelly (a lubricant) had been removed from the Adult Crash Cart located in Pediatric Department. The mannitol had expired 3/1/15 (5.5 months prior to the survey) and the petroleum jelly had expired 12/14 (8.5 months prior to the survey) with the potential to have deteriorated medications/chemicals available for patient use. Furthermore, the internal content list that listed the petroleum jelly documented the earliest expiration date would be 6/16 (10.5 months in the future at the time of the survey). The content list served as a label for these packets and therefore mislabeled the expiration date of these packets (see 1 and 2).

2. The hospital failed to ensure that staff placed the correct "Out" date (date medication would be considered expired and must be removed from active supply) on five out of five 3000 milliliter flexible irrigation bags produced by Manufacturer B and stored in the Surgery Department Warmer. The expiration dates were 15 days out from the "In" date not 14 days as stipulated by Manufacturer B for warmed solutions with the potential that expired solutions could be available for patient use (see 3).

3. The hospital failed to ensure the correct expiration date for the one intravenous solution (IV) bag of 5% dextrose in water stored in a sealed tray labeled "Tray Pedi Intubation (Broselow Cart)" was posted on the internal content list. Furthermore, the expiration date for this IV bag written on the content list was 7/16 while the manufacturer's expiration date printed on the IV bag was 4/16 with the potential that staff would not be alerted to exchange this bag before it expired thus having an expired medication available for patient use (see 4).

4. The hospital failed to ensure that pharmacy staff had properly labeled an IV bag of vancomycin. It was labeled to contain 1000 grams of vancomycin (usual dose is 1 to 2 grams) when it should have read 1 gram or 1000 milligrams. Two staff had checked this bag and signed off on it and it was sitting on a cart in the IV room ready to be sent out to the nursing unit. This had to potential to delay therapy if a nurse questioned the labeling (see 5).

5. The hospital failed to ensure that the anesthesia cart in OR 1 did not contain expired medications. It contained one vial of furosemide for injection (used to increase urine flow) on which the manufacturer documented the vial had expired 8/1/15 (16 days prior to the survey: see 6).

Findings:

1. Malignant hyperthermia (MH) is a rare but potentially lethal adverse effect of certain medications, the anesthetic gases and succinylcholine (a muscle relaxant used during surgery), used in anesthesia and surgery. It is characterized by a rapid rise in a patient's temperature up to 110 degrees Fahrenheit or more. If not treated immediately it can result in injury to or death of a patient.

On 8/17/15 starting at 3:37 p.m. an inspection of the MH Cart indicated it contained one 500 milliliter IV bag of mannitol with a manufacturer's expiration date of 3/1/15 (5.5 months prior to the survey). This observation was verified at that time during a concurrent interview of the Pharmacy Operations Manager.

2. On 8/18/15 starting at 4:09 p.m. an inspection of the Adult Crash Cart located on the Pediatric Unit indicated staff had placed two 5 gram packets of petroleum jelly into the fourth drawer. One of the two packets had expired 12/14 (8.5 months prior to the survey). Inspection of the internal content list which listed these packets indicted the first date to expire for these two packets was 6/16 (10.5 months in the future). This observation was verified at that time during a concurrent interview of the Pharmacy Operations Manager.

3. On 8/17/15 starting at 5 p.m. inspection of one out of one warmers used to warm solutions in the Surgery Department indicated the digital dial for the bottom compartment indicated it was maintained at 99 degrees Fahrenheit. Inspection of the bottom compartment indicated it contained two 3000 milliliter flexible containers of Sterile Water for Irrigation (used for sterile irrigation, washing, and rinsing), two 3000 milliliter flexible containers of 0.9% sodium chloride for irrigation (used for sterile irrigation, washing and rinsing), and one 3000 milliliter flexible container of 3% sorbitol urologic irrigation solution (used to irrigate the bladder during certain procedures) all made by Manufacturer B. Staff had applied a label to each bag on which was printed "In" followed by a written date and "Out" followed by a written date. Staff had placed one of the following "In" and "Out" dates on these labels on each of these bags:

In: 8/1315 Out: 8/28/15 (15 days) or

In: 8/14/15 Out: 8/29/15 (15 days)

During a concurrent interview of the Surgery Dept. Evening Charge Nurse at that time she verified these observations and stated that the "In" date was the date the bag was placed in the warmer and the "Out" date was the date the bag would be considered expired and was to be removed from the warmer (at the end of the day).

On 8/17/15 at 5:19 p.m. a review of a letter from Manufacturer B indicated provided by the Surgery Department Staff indicated that it documented that the flexible bags of irrigation solution could be warmed for up to 14 days (not 15 days) at a temperature not to exceed 113 degrees Fahrenheit.

4. On 8/18/15 starting at 3:14 p.m. an inspection of the Pediatric Crash Cart indicated it contained a tray sealed in plastic through which a content list, entitled "Tray Pedi Intubation (Broselow Cart)" was visible. It documented that it contained a 250 milliliter IV bag of 5% dextrose in water that would expire 7/16. Inspection of the tray contents indicated this bag was labeled by the manufacturer to expire 4/16. This observation was verified at that time during a concurrent interview of the Pharmacy Operations Manager.

5. On 8/18/15 starting at 1:24 p.m. an inspection of the IV Room in the Pharmacy indicated that staff had labeled an 250 milliliter IV bag of 5% dextrose in water as containing 1000 grams of vancomycin (a usual dose is one gram) intended for use on Patient 101. During a concurrent interview of the Pharmacy Operations Manager at that time she stated that was an issue as the label should have read 1000 milligrams (or 1 gram). She verified that a pharmacy technician and a pharmacist had signed off on this label.

6. On 8/17/15 an inspection of the anesthesia cart indicated it contained one expired vial of furosemide 40 milligrams/4 milliliters for injection. It had expired 8/1/15. The Pharmacy Operations Manager verified this observation during a concurrent interview conducted at that time.

Based on review of the automatic stop order policy and staff interview the hospital failed to establish a process to discontinue medications after a 30 day period for all medications (except the pain reliever ketorolac) as required by hospital policy. Only ketorolac had a stop date in the computerized patient medication profile system: 48 hours.

Findings:

1. On 8/20/15 at 11: 40 a.m. a review of Policy and Procedure 424.08 entitled AUTOMATIC MEDICATION STOP ORDERS (Approved 1/08, Revised 1/08) indicated it stipulated ketorolac was to stop after 48 hours and all other medications were to stop after 30 days. During a concurrent interview of Pharmacist 1 he stated that ketorolac and IV acetaminophen (active ingredient of Tylenol) had 48 hour stop dates in the computer but the other medications had no activated stop dates and there was no warning to staff that these medications were to stop after the time determined by the policy. During a concurrent interview of the Director of Pharmacy and the Pharmacy Operations Manager at that time, they verified the above observations and agreed that the policy was not being implemented as written.