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Based on observation, interview, clinical record, and administrative document review, the hospital failed to have an effective governing body legally responsible for the conduct of the hospital when:

1. The hospital did not have an active and effective quality assurance and performance improvement (QAPI) program that analyzed data and used the data and analyses for the reduction of risk of medical errors. (Refer to A 273)

2. The hospital did not have a registered nurse to supervise and evaluate nursing care in accordance with accepted standards of practice. Nursing personnel performed duties outside their scope of practice, titrating medications without an order. (Refer to A 395 and A 405)

3. The hospital did not ensure that medications were administered at safe doses. (Refer to A 489 and A 500)

4. The hospital did not provide a safe environment for the preparation of sterile intravenous medications for patients. (Refer to A 749)

The cumulative effect of these systemic problems resulted in the hospital's inability to ensure the provision of quality healthcare in a safe and professional manner.

Based on interview and administrative record review, the hospital failed to implement and maintain an on-going, comprehensive, data-driven Quality Assurance and Performance Improvement (QAPI) program to improve both quality and safety when the hospital did not maintain a QAPI program which analyzed and monitored the safety of all of its services and the quality of patient care, with data collection and analysis, leading to the implementation of preventive improvement plans (Refer to A 273).

The cumulative effect of these systemic, recurrent problems resulted in the facility's inability to ensure the provision of quality patient care in a safe environment.

Based on observation, interview, clinical record, and administrative document review, the hospital failed to provide nursing supervision and oversight when:

1. The House Supervisor (HS) did not closely monitor the rate of administration of norepinephrine drip (an IV (into the vein) medication to control blood pressure) for one of 26 sampled patients (Patient 1). (Refer to A395)

2. The hospital failed to ensure doctor's orders had specific parameters for titration (the process of medication adjustments to how much medicine should be given based on doctor's order) of high risk medications (drugs that have a heightened risk of causing significant patient harm when they are used in error) and the hospital failed to administer medications per physician order for three (Patient 1, 18 and 23) of 26 sampled patients. (Refer to A 405)

3. Nursing staff failed to ensure the "control solution" (a solution that mimics blood and used to test the accuracy of a blood glucose meter and test strips) for glucometer (a device that measures blood sugar) testing was outdated for use on the hospitals' 3rd floor unit, which had a census of 15 patients. (Refer to A 409)

The cumulative effect of these systemic problems resulted in the hospital's inability to ensure the provision of quality healthcare in a safe and professional manner.

Based on observation, interview, and record review the hospital failed to ensure medications were ordered and administered based on manufacturer safety guidelines when two ( Patient 22 and Patient 23) out of the 26 sampled patients were administered doses of medications that exceeded the maximum allowed dosage for their medical condition when:

1. Patient 22 (Pt 22) was prescribed a higher than allowed dosage of blood thinner called apixaban in addition to additive effects from three other types of blood thinners for her medical conditions. (Refer to A 500)


2. Patient 23 (Pt 23) was prescribed higher than allowed dosage of an antibiotic called ciprofloxacin with a kidney diseases diagnosis. (Refer to A 500)

The cumulative effects of these systemic failures had the potential for harm due to adverse effects such as excess drug accumulation, bleeding or death.

Based on observation, interview, and record review, the hospital failed to ensure implementation of a sterile (germ free) intravenous (IV, directly into a vein) compounding (mixing) practices and environment in the clean room (clean room also called Segregated Compounding Area or SCA, where the sterile medications were prepared) when serious disease causing microbes (microbes are tiny living things that can cause disease) were identified in three out of four tastings of the hospitals clean room as evidenced by:

1. Hospital failed to prevent and mitigate the source of ongoing disease causing microbial growth (refers to an increase in disease causing microbes) in the clean room (also called Segregated Compounding Area or SCA, where the sterile intravenous medications were prepared) where IV medications were compounded (mixed). This could have resulted in contaminating the sterile intravenous medications with harmful microbes when used for hospital patients with the census of 74. (Refer to A749)

2. Staff Pharmacist 2 (RPH 2) failed to follow infection control practices during IV preparation in the hospital's clean room based on standards of practice and the hospital's policy. RPH 1 did not sanitize the products she utilized in the clean room. This had the potential of contaminating the sterile intravenous medication with microbes when used for hospital patients with the census of 74. (Refer to A749)

The cumulative effects of unsafe clean room environment and practices could have contributed to contaminated medication preparations that could cause blood infection diseases.

Based on interview and record review, the hospital failed to develop a program to analyze data to improve health outcomes when there was no process in place to review and analyze quality indicators for High Alert Medications such as norepinephrine (a medication to increase blood pressure) for one of 26 sampled patients (Patient 1).

This failure resulted in the hospital potentially not identifying and acting on critical incidents that could affect the health and well being for Patient (Pt) 1.

During an interview with the Director of Nurses (DON) on 10/20/20 at 2:30 p.m., the DON stated they do a "Live Drip Audit" to track high alert medications, but they do not go back to analyze to see if the medication was administered correctly. The DON stated he now understands that he should have looked at the monitoring and the patient charts more closely to see if medications were administered safely and correctly.

During a review of the facility documents titled "Live Drip Audit," between 9/25/20 and 9/28/20 the " Live Drip Audit" indicated once per shift the House Supervisor (HS, lead registered nurse) recorded and signed the sheet which listed items including the name of the patient, the room number, medication order, and today's current rate. The time of the audit and rate changes during the shift are not indicated on the audit sheet. The "Live Drip Audit" had no evidence to indicate that the information was analyzed by the HS to determine if the rate and patient response were appropriate.

During and interview on 10/20/20, at 3:40 p.m. with the HS, the HS stated she was the HS working the night when Pt 1 was receiving norepinephrine and was aware of the order to administer "2-30 mcg/minute [unit of measurement range of medication]" to keep blood pressure > 90 [blood pressure parameter]." The HS stated she met with Registered Nurse (RN) 2 before the medication was started. The HS reviewed the instructions with RN 2 and RN 2 still continued with the wrong medication dosage. The HS stated, "I should have stayed with her or checked on her more often." The HS stated she thought RN 2 understood the instructions, but now realized RN 2 did not understand because RN 2 deviated from the "Just in Time [an educational tool used to verify the accuracy of the medication being administered]" soon after the medication started. The HS stated she signed the "Live Drip Audit" but did not analyze the medication administration to determine if there were any errors that needed to be addressed immediately.

During a concurrent interview on 10/21/20, at 3:40 p.m. with the Quality Assurance/Performance Improvement (QAPI) Committee and the Director of Quality Assurance and Performance Improvement (DQAPI), the QAPI Committee and the DQAPI stated their quality indicators for this fiscal year include "Medication Errors." The Chief Executive Officer/Chief Nursing Officer (CEO/CNO) stated the facility has not done an in-depth analysis of any patients receiving high-risk medications since prior to July 1, 2020, which concluded 4 months with no analysis of high risk medications. The CEO/CNO stated "the last one we did was the heparin case when you were here last time [June 2020]", which concluded 4 months with no analysis of high risk medications.

During a review of the facility document titled, "PDSA [Plan Do Study Act] Cycle Template," the document indicated, "...1. What are we trying to accomplish (aim)?... "by auditing the IV drips in house, we will be able to quickly identify any errors or barriers to patients on drips....A daily audit will be conducted and any fall outs will be addressed immediately."

Based on observation, interview, and record review, nursing staff failed to ensure the "control solution" (a solution that mimics blood and used to test the accuracy of a blood glucose meter and test strips) for glucometer (a device that measures blood sugar) testing was outdated for use on the hospitals' 3rd floor unit, which had a census of 15 patients.

This failure had the potential to result in inaccurate blood sugar measurements for all patients that needed blood sugar measurement on the hospital's third floor unit.

Findings:

During an concurrent observation and interview, on 10/19/20, at 10:20 a.m.,with the Director of Pharmacy (DOP) and Director of Nursing (DON), blood glucose kit (a container that stored all supplies needed to maintain the glucometer accuracy) was noted to have three bottles of a "control solution" with a "date open" marked as 2/7/20.

In an interview on 10/19/20 at 10:30 a.m., the DON stated he was not sure about how long the control solution should have been used after opening. He stated that the hospital's central supply department re stocked the blood glucose kits and it was the nursing staff's responsibility to date the product upon opening. DON acknowledged the "control solution" should have been discarded on 5/20 (3 months after opening) and was still being used, five months after the control solution should have been discarded.

A review of the control solution package insert (package insert included a detailed information that health care staff needed to know on how to use a product) titled, "MediSense Glucose and Ketone Control Solution" ..."Storage and Handling", dated, 10/19/20 indicated to mark the date when a new bottle opened and "Discard control solution 3 months after opening."

A review of the hospital policy number POCT 08, titled "Glucose Monitoring Quality Control", last reviewed on 4/2019, indicated "Quality control should be performed: 1. Daily with each meter 2. Each time a new lot of test stripes started 3. When test results contradict clinical symptoms 4. When a blood glucose result is questionable" ... The policy also indicated the test is "performed by RN, LVN in Control Test procedure."

Based on interview and record review, the hospital failed to provide nursing supervision and oversight for patients receiving high risk medications for one of 26 sampled patients (Patient 1) when the House Supervisor (HS) did not closely monitor the rate of administration of norepinephrine drip (an IV (intravenous, into the vein) medication to control blood pressure.)

This failure had the potential to contribute to unsafe medication administration and monitoring for 26 sampled patients.

Findings:

During a review of Pt 1's clinical record dated 9/18/20, Medical Doctor (MD) 1's orders indicated, Pt 1 was started on a medication called norepinephrine on 9/25/20 to keep the blood pressure within the specific goal ordered by the physician. The order was written in the medical record as follows:
"Medication: Levophed [norepinephrine] IV (into vein) 4 mg/250 mL (milligram or "mg" and milliliter or "mL" are units of measurement)
Comments: 2-30 mcg/minute (microgram or "mcg" is a unit of measure)
Goal: SBP greater than 90 (or Systolic Blood Pressure- a number that showed how well the heart beats and pushes blood through arteries to the rest of body)
High Alert Central Line (an indication that this drug had higher risk of harm and required special handling with use of large arteries for infusing it into the body)."

During a concurrent interview and record review, on 10/20/20, with the Director of Pharmacy (DOP) and the Chief Executive Officer/Chief Nursing Officer (CEO/CNO) validated the electronic drug administration records titled " Critical Medication Flowchart" (a computerized data entry for drug dosages and monitoring parameters) dated 9/25/20 to 9/27/20, indicated the norepinephrine was started at 4 mcg/minute (rate of infusion into the veins per minute) at 19:55 [7:55pm] on 9/25/20, the rate of infusion was 2 points higher than the initial rate ordered by MD 1. The same rate was continued until 9:15 p.m. on 9/25/20, and then with a 45 minutes delay in dose adjustment, the rate was increased to 6 mcg/minutes when the SBP was at 63 (a very low rate). Further review of the "Critical Medication Flowchart", indicated a rate increase to 24 mcg/min on 9/25/20 at 10 p.m. when SBP was 96. The same rate of 24 mcg/min was continued for another day with SBP at 63 on 9/26/20 at 01:25 [1:25 a.m.] and 68 on 9/26/20 at 10:55 p.m. From 9/25/20- 9/26/20 the rate was not administered per the MD order and the SBP did not stay in parameters described in the MD order to maintain a safe SBP greater than 90.

During a concurrent interview and record review, on 10/20/20 at 1:30 p.m., Nurse Educator (RN-EDU) described the document titled "Just-In-Time-Information" (a quick drug information) sheet, dated 9/3/20. The "Just -In- Time- Information" was developed for monitoring and dose adjustments of the high-risk critical medications such as norepinephrine by nursing staff.

During and interview on 10/20/20 at 3:40 p.m. with the House Supervisor (HS), the HS stated she was the HS working the night of 9/25/20 when Pt 1 was started on norepinephrine and was aware of the order to administer "2-30 mcg/minute" to keep blood pressure > 90." The HS stated she met with Registered Nurse (RN) 2 before the medication was started and reviewed the instructions with RN 2. The HS stated, "I should have stayed with her or checked on her more often." The HS stated she thought RN 2 understood the instructions, but now realizes RN 2 did not understand because RN 2 deviated from physician orders.

During a record review of the hospital policy number 050, titled "Medication Management/Ordering and Transcribing", last reviewed on 4/2019, indicated the "Required elements of a complete medication order: each drug order shall include: ...Drug name, Dosage form (If necessary) ...frequency of administration, direction for use ..." The policy further indicated, "Each practitioner who prescribes drugs must clearly state the administration time or the time interval between doses."

Based on interview, and record review, the hospital failed to ensure doctor's orders had specific parameters for titration (the process of medication adjustments to how much medicine should be given based on doctor's order) of high risk medications (drugs that have a heightened risk of causing significant patient harm when they are used in error) and the hospital failed to administer medications per physician order for three (Patient 1, 18 and 23) of 26 sampled patients when:

1. When insulin detemir (medication used to provide blood sugar control) was not administered per physician order for one of 26 sampled patients (Patient, Pt) 18.

2. The Medical Doctor 1's (MD 1) order for norepinephrine, an IV (into the vein) medication to control Patient 1's (Pt 1) Blood Pressure (BP- the pressure of the blood in the circulatory system to keep blood flowing all over the body), was not specific to guide the nursing staff to monitor and adjust the medication accurately.

3. The Medical Doctor 1's (MD 1) order for IV (into the vein) fentanyl and midazolam, medications used to control Patient 23's (Pt 23) pain and sedation level (sedation level is when a drug can cause a state of calm or sleep), was not specific to guide the nursing staff to monitor and adjust the medication accurately.

These failures had the potential for patients to receive the wrong dose of medication and ineffective drug therapy resulting in negative health outcomes for three of 26 sampled patients.

Findings:

1. During a concurrent interview and record review, on 10/19/20, at 3 p.m., with the Registered Nurse Educator (RN-EDU), a review of Pt 18's clinical record, dated 9/4/20, the "Order Detail" indicated, Patient 18 was ordered to receive five units (measurement used to administer insulin) of insulin detemir, every evening at 10 p.m. The medication administration record dated 10/13/20 at 9:37 p.m. indicated, the insulin detemir was not administered to Pt 18. The nurse's note dated 10/13/20 at 11:23 p.m. indicated, Pt 18 had a blood sugar of 93 and no insulin was needed to be administered to Pt 18. The medication administrations dated 10/14/20 at 9:18 p.m. indicated, the insulin detemir was not administered to Pt 18. The nurse's note dated 10/14/20 at 9:19 p.m. indicated, Pt 18 had a blood sugar of 105 mg/dl (blood sugar measurement) and no insulin was needed to be administered to Pt 18. RN-EDU stated the nurse's notes on 10/13 and 10/14 indicated the nurse held the insulin because the blood sugar was "too low." RN-EDU stated insulin detemir had no parameter for when to hold the insulin for Pt 18. RN-EDU stated the nurse held the insulin with no direction from the physician nor order set of when to hold the insulin.

During an interview on 10/20/20, at 9 a.m., with RN-EDU, RN-EDU stated nurses needed to be educated on administering all medications and when to hold medication administration. RN-EDU stated insulin should be held if the blood sugar is 65 or less. RN 1 stated nurses should be educated on long acting insulin (medication used to control blood sugars for 12-24 hours) and the importance of maintaining blood sugar level goals. RN-EDU stated nurses should be educated on when to administer insulin and when to hold.

During a review of the facility policy and procedure titled, "Diabetes Mellitus, Routine Care and Hypoglycemia Protocol" dated 4/19, indicated, " ...A. Hypoglycemia is defined as blood glucose less than 65 mg/dl ...Hypoglycemia is the most frequently encountered acute complication of insulin-taking diabetic patients ..."

During a review of the facility policy and procedure titled, "Medication Administration" dated 4/19, indicated, " ...C. When a medication dose in NOT administered due to the patient's condition or other unavoidable factor, the individual responsible for administering the medication will circle doses NOT given and note reason on the paper MAR [medication administration record]. On the eMAR [electronic medication administration record] the dose will be marked as a missed dose with the appropriate reason for holding/missing the dose ..."


40903

2. During a review of the Medical Doctor (MD) 1's History and Physical (or H&P that shows history of present illness, relevant past medical history, review of systems and physical examination), dated 9/18/20, indicated Patient 1 (Pt 1) was a 92 year old being cared for pneumonia (infection in lungs) related to COVID 19 (a virus that causes respiratory disease) disease. Further review of MD 1's orders indicated, Pt 1 was started on a medication called norepinephrine (also known as Levophed, drug used to control low blood pressure) on 9/25/20 to keep the blood pressure in a safe range and prevent further medical issues. The order was written in medical records as follow:

"Medication: Levophed IV (into vein) 4mg/250mL (milligram or "mg" and milliliter or "mL" are units of measurement)
Comments: 2 30 mcg/minute (microgram or "mcg" is a unit of measure)
Goal: SBP greater than 90 mmHg (mmHg is a unit of measurement called millimeters of mercury and Systolic Blood Pressure a number that showed how well the heart beats and pushes blood through arteries to the rest of body)
High Alert Central Line (an indication that this drug had higher risk of harm and required special handling with use of large arteries for infusing it into the body)"

During a 10/20/20 review of the electronic drug administration records titled 'Critical Medication Flowchart" (a computerized data entry for drug dosages and monitoring parameters) dated 9/25/20 to 9/27/20, accompanied by Director of Pharmacy (DOP) and the Chief Executive Officer/Chief Nursing Officer (CEO/CNO), the CEO/CNO indicated the norepinephrine (or levophed) was started at 4 mcg/minute (rate of infusion into the veins per minute) at 19:55 p.m. on 9/25/20. This rate of infusion was 2 points higher than the initial rate ordered by MD 1. The same rate was continued until 21:15 p.m. on 9/25/20, and then with a 45 minutes delay in dose adjustment, the rate was increased to 6 mcg/minutes when the SBP was at 63. Further review of the Critical Medication Flowchart, indicated a rate increase to 24 mcg/min on 9/25/20 at 22:00 p.m. when SBP was 96. The same rate of 24 mcg/min was continued for another day despite low recordings of SBP at 63 on 6/26/20 at 00:25 a.m. and 68 on 9/26 at 22:55 p.m.

During a concurrent interview and record review on 10/20/20 at 1:30 p.m., Nurse Educator (RN EDU) described a document titled "Just In Time Information" (a quick drug information sheet), dated 9/3/20, which was used by nursing staff to monitor and make dosage adjustments of the high risk critical medications such as norepinephrine (or Levophed) when the doctor's order did not provide "specific drug adjustment order (specific drug adjustment means how much to increase or decrease drug dosage based on blood pressure changes.) The RN EDU acknowledged that the documents did not have any clinical reference to validate the accuracy of the information, as it was not part of electronic medical record and not signed by a doctor. Additionally, MD 1 order did not give any reference to use this document as a dosing or monitoring guideline for the nursing staff. RN EDU, furthermore, stated the medical doctor needed to write specific orders ( specific order means how to increase or decrease drug dosages based on blood pressure fluctuation) and the information sheet was not a "protocol order" (means an agreed upon framework outlining the specific care provided to patients.) Further review of the "Just In Time Information" sheet for norepinephrine, indicated a statement on the first page, "Note: These titration scales, parameters, max/min values, are general guides. ALWAYS follow the Provider order for medication."


During an interview on 10/21/20 at 1:57 p.m., when asked about the non-specific orders written without clear guideline for dug adjustment and monitoring, MD 1 stated, "I assumed most nurses were aware and clear on how to administer high risk titration drugs". MD 1 additionally acknowledged that the medication orders for critical care IV drugs (drugs given via veins that has high risk for harm if not used properly) should be more specific with dosage adjustment based on blood pressure levels to prevent error or confusion on interpretations.

During a review of hospital policy number 050, titled "Medication Management/Ordering and Transcribing", last reviewed on 4/2019, indicated the "Required elements of a complete medication order: each drug order shall include: ...Drug name, Dosage form (If necessary) ...frequency of administration, direction for use ..." The policy further indicated, "Each practitioner who prescribes drugs must clearly state the administration time or the time interval between doses."

3. During a 10/20/20 review of the Medical Doctor 1's (MD 1) discharge summary (a clinical report prepared at the conclusion of a hospital stay) dated 9/19/20, indicated Patient 23 (Pt 23) was transferred to the hospital for further care with a tracheostomy tube (a breathing tube, placed through the hole and directly into the trachea or windpipe to help breathing) for COVID 19 (a viral respiratory disease) complications. Further review of MD 1's medication orders indicated, Pt 23 was started on intravenous (or IV, means into vein) sedative pain medication called fentanyl (a drug used to control pain and sedation) on 9/13/20. The doctor's order was documented in the medical records (a record that stores medical information in hospital) as follows:

"Drug: Fentanyl/D5W (D5W is sugar based fluid) IV Drip 400mcg/100mL ("mcg" or microgram and "mL" or milliliter are measure of units; D5W is a fluid mixed with the drug).
Comments: RASS 2 (Richmond Agitation and Sedation Scale (RASS), a validated and reliable method to assess patients' level of sedation or state of drowsiness).
Goal: 25 mcg/hour 100 mcg/hour (microgram or "mcg" is a unit of measure)"

A 10/20/20 review of the electronic drug administration records titled 'Critical Medication Flowchart" (a computerized data entry for drug dosages and monitoring parameters) dated from 9/08/20 to 9/13/20, accompanied by Director of Pharmacy (DOP) and the Chief Nurse Executive and Chief Operating Office (CNE/CEO), indicated fentanyl was started on 9/8/20 at the rate of 25 mcg/hour and continued with the same rate throughout the 4 days period (from 9/8/20 to 9/13/20.) There was no data entry from 9/9/20 at 1900 until 09/11/20 for monitoring of the sedation score or RASS score as ordered by MD 1. Further review of the medication flowchart dated 9/9/20 at 0900 a.m., indicated addition of a second sedative drug (sedative caused drowsiness) called midazolam by MD 1. The flowchart, additionally indicated, Pt 23's sedation scale on 9/9/20 at 0900 a.m. was within the normal limits as ordered by MD 1. The RASS score documented was listed as "minus 2" (target RASS range was minus 2 or 2 to keep a light sedation or semi awake) in the electronic medical record. The order for midazolam was written as follows:

"Drug: Midazolam/NS IV Drip 100mg/100mL (milligram or "mg" and milliliter or "mL" are measure of units; NS refers to Normal Saline fluid mixed with midazolam)
Comments: 1 10 mg/hr (means a range of dose from 1mg to 10mg per hour)
Goal: RASS 2 (Richmond Agitation and Sedation Scale (RASS), a validated and reliable method to assess patients' level of sedation or state of drowsiness)"

During a concurrent interview and record review on 10/20/20 at 1:30 p.m., Nurse Educator (RN EDU) described a document titled "Just In Time Information" (a quick drug information sheet), dated 9/3/20, which was used by nursing staff to monitor and make dosage adjustments of the high risk critical medications such as fentanyl and midazolam, when the doctor's order did not provide "specific drug adjustment order (specific drug adjustment means how much to increase or decrease drug dosage based on blood pressure changes.) The RN EDU acknowledged that the documents did not have any clinical reference to validate the accuracy of the information, as it was not part of electronic medical record and not signed by a doctor. Additionally, MD 1 order did not give any reference to use this document as a dosing or monitoring guideline for the nursing staff. RN EDU, furthermore, stated the medical doctor needed to write specific orders ( specific order means how to increase or decrease drug dosages based on blood pressure fluctuation) and the information sheet was not a "protocol order" (means an agreed upon framework outlining the specific care provided to patients.) Further review of the "Just In Time Information" sheet for both fentanyl and midazolam indicated a statement on the first page, "Note: These titration scales, parameters, max/min values, are general guides. ALWAYS follow the Provider order for medication."


During an interview on 10/21/20 at 1:57 p.m., when asked about the non-specific orders written without clear guideline for dug adjustment and monitoring, MD 1 stated, "I assumed most nurses were aware and clear on how to administer high risk titration drugs". MD 1 additionally acknowledged that the medication orders for critical care IV drugs (drugs given via veins that has high risk for harm if not used properly) should be more specific with dosage adjustment based on blood pressure levels to prevent error or confusion on interpretations.



During a record review of the hospital policy number 050, titled "Medication Management/Ordering and Transcribing", last reviewed on 4/2019, indicated the "Required elements of a complete medication order: each drug order shall include: ...Drug name, Dosage form (If necessary) ...frequency of administration, direction for use ..." The policy further indicated, "Each practitioner who prescribes drugs must clearly state the administration time or the time interval between doses."

Review of a statement by Institute for Safe Medication Practices (ISMP), a leading medication and patient safety organization, accessed on 10/25/20 via https://forms.ismp.org/Tools/institutionalhighAlert.asp titled "ISMP List of High Alert Medications in Acute Care Setting", indicated "High alert medications are drugs that bear a heightened risk of causing significant patient harm when they are used in error ... The consequences of an error are clearly more devastating to patients." The list included norepinephrine, fentanyl and midazolam IV infusions.

Based on observation, interview, and record review, nursing staff failed to ensure the "control solution" (a solution that mimics blood and used to test the accuracy of a blood glucose meter and test strips) for glucometer (a device that measures blood sugar) testing were not expired and available for use on the hospitals' 3rd floor unit, which had a census of 15 patients.

This failure had the potential to result in inaccurate blood sugar measurements for all patients that needed blood sugar measurement on the hospital's third floor unit.

Findings:

During a concurrent observation and interview, on 10/19/20, at 10:20 a.m.,with the Director of Pharmacy (DOP) and Director of Nursing (DON), blood glucose kit (a container that stored all supplies needed to maintain the glucometer accuracy) was noted to have multiple bottles of a "control solution" with a "date open" marked as 2/7/20. The DOP validated the "control solution" should have been discarded 5/20 (3 months after opening) and was still being used, five months after the control solution should have been discarded.

In an interview on 10/19/20 at 10:30 a.m., the DON stated he was not sure about how long the control solution should have been used after opening. The DON stated it was the nursing staff's responsibility to date the product upon opening.

During a review of the control solution package insert (package insert included a detailed information that health care staff needed to know on how to use a product) titled, "MediSense Glucose and Ketone Control Solution" ..."Storage and Handling", dated, 10/19/20 indicated to mark the date when a new bottle opened and "Discard control solution 3 months after opening."

During a review of the hospital policy number POCT-08, titled "Glucose Monitoring Quality Control", last reviewed on 4/2019, indicated "Quality control should be performed: 1. Daily with each meter 2. Each time a new lot of test stripes started 3. When test results contradict clinical symptoms 4. When a blood glucose result is questionable" ... The policy also indicated the test is "performed by RN[registered nurse], LVN [licensed vocational nurse] in Control Test procedure."

Based on interview and record review the hospital failed to ensure medications were ordered and administered based on manufacturer safety guidelines when two ( Patient 22 and Patient 23) out of the 26 sampled patients were administered doses of medications that exceeded the maximum allowed dosage for their medical condition when:

1. Patient 22 (Pt 22) was prescribed a higher than allowed dosage of blood thinner called apixaban in addition to additive effects from three other types of blood thinners for her medical conditions.


2. Patient 23 (Pt 23) was prescribed higher than allowed dosage of an antibiotic called ciprofloxacin with a kidney diseases diagnosis.

Findings:

1. During a 10/19/22 review of Patient 22 (Pt 22) medical records dated 9/24/20, titled "History and Physical" (or H&P that shows history of present illness and relevant past medical history), written by Medical Doctor 1 (MD 1), indicated she had a history of fall with injury, wound on her skin, heart surgery, and dialysis (dialysis is a treatment for kidney failure that helped remove unwanted body wastes and excess fluids by filtering the blood) for kidney disease. The H&P further indicated Pt 22 was bed bound due to knee injury and was placed on a drug called apixaban (also known as Eliquis, a blood thinner) to help prevent blood clot in her system.

During a 10/19/20 review of MD 1 medication orders as listed in the Medication Administration Record (known as MAR used to document medications taken by each patient) indicated that Pt 22 was prescribed the following medications on 9/24/2020 as follow:
"Apixaban (Eliquis) 5 mg (milligram or mg, a unit of measure) twice daily;
Clopidogrel (or Plavix, a blood thinner) 75 mg once daily;
Aspirin EC 81 mg (aspirin coated tablet is a blood thinner and pain reliever) once daily; and
Heparin (heparin is a blood thinner) 1000 units/mL ("units" is a measure of potency and "mL" is a measure of volume) injectable, 2000 units every Monday, Wednesday and Friday for dialysis catheter care (catheter used for exchanging blood to and from dialysis machine and a patient.)"

During a 10/19/20 review of Pt 22's daily progress report written by MD 1, dated 10/19/20 at 09:59 a.m., indicated to "Continue ... deep vein thrombosis prophylaxis with Eliquis" (which means continue to use Eliquis or apixaban for prevention of blood clots.)

During an interview on 10/19/20 at 2:36 p.m., accompanied by the Chief Executive Officer/Chief Nursing Officer(CEO/CNO), the Director of Pharmacy (DOP) acknowledged that the dosage for apixaban was above the documented indication in the medical record. The DOP stated he was not sure why the pharmacists did not question the ordering doctor, considering the patient was on three other blood thinners at the same time.

During an interview on 10/21/20 at 2:02 p.m., MD 1 stated she thought apixban dosage was 2.5mg twice daily because it was used for prevention of blood clot.

During an interview on 10/22/20 at 8:45 a.m., Staff Pharmacist (RPH 1) could not find any intervention document that indicated active monitoring of the apixaban by a pharmacist. He added that a documentation dated 10/21/20 at 3:31 p.m. in medical record showed that MD1 had called the pharmacy to discontinue the apixaban since it was used for blood clot prevention.

During an interview with DOP on 10/22/20 at 9:56 a.m., he stated that the newer generation of blood thinners like apixaban were not part of hospital policy to guide the pharmacists' monitoring of this medication.

A 10/22/20 review of Pt 22's medical record titled "Problem List", dated 10/21/20, did not show any nursing "care plan" (a care plan was a detailed approach to care customized to patient's needs and helped manage a multiple health condition) to monitor the blood thinner (apixaban) and what should have been monitored by nursing staff.

A 10/22/2020 review of the hospital policy number 031, titled "High Risk/High Alert Medications", last revised on 7/2020, indicated "Central Valley Specialty Hospital (CVSH) is committed to provide safe environment for our patients through identification of high risk medications ... to mitigate the risk when administering medications ..." Hospital's list of high risk/ high alert medications (medications known to pose highest risk of harm) included the following: "Heparin ...; Other Anticoagulants: Enoxaparin (Lovenox); Warfarin (Coumadin)..." The list did not include apixaban, which was a newer generation of blood thinners with similar risk factors.

A 10/22/2020 review of the hospital policy number 002 titled "Anticoagulant Management", last revised on 6/2020, indicated "Patients receiving anticoagulants (medication that thin the blood and prevent or treat blood clot in the body) will receive individualized care to provide effective, safe treatment." "A defined anticoagulation management program individualizes care in a uniform and consistent manner to provide safe and effective treatment with these high risk medications." The policy did not address safe monitoring of the newer generation of blood thinner like apixaban, which was used at the hospital.

A review of DailyMed ( DailyMed is the official provider of drug information for United States Food and Drug Administration or FDA which is a government agency responsible for protecting the public for safety of drugs.), last accessed on 10/25/2020 via https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=e9481622 7cc6 418a acb6 c5450daae9b0, stipulated the recommended dose of ELIQUIS (or apixaban) is 2.5 mg taken orally twice daily for prevention of blood clot. The document additionally indicated "ELIQUIS increases the risk of bleeding and can cause serious, potentially fatal bleeding ...Concomitant use of drugs affecting hemostasis increases the risk of bleeding. These include aspirin and other antiplatelet (blood thinner) agents, other anticoagulants (blood thinner), heparin ... "


2. A 10/20/20 review of the Patient 23's(Pt 23) Medication Administration Record (known as MAR used to document medications taken by each individual) dated 9/13/20 to 9/14/20, indicated Pt 23 received higher than usual dosage of an antibiotic called ciprofloxacin for treating an infection. The antibiotic ordered by Medical Doctor 1 (MD 1) on 9/8/20 was written as follow:

"Ciprofloxacin (Cipro an antibiotic) 500 mg ("mg" is a unit of measure) every 12 hours from 9/8/20 to 9/22/20; Give 2 4 hours before or 4 6 hours after multivitamin, dairy products; Okay with meals; Black Box Warning [or BBW, the most stringent warning for drugs on the market by Food and Drug Administration (FDA is a government agency responsible for protecting the public for safety of drugs.)]"

A 10/20/20 review of medical record and Medical Doctor 1's (MD 1) discharge summary (discharge summary is a clinical report prepared by the doctor at the conclusion of a hospital stay) dated 9/19/20, indicated Patient 23 (Pt 23) had a diagnosis of pneumonia (infection of the lungs) and kidney disease that required dialysis (dialysis is a treatment for kidney failure that helped remove unwanted body wastes and excess fluids by filtering the blood.) The order for ciprofloxacin (an antibiotic) was continued with the same dosage throughout the hospital stay.

During an interview on 10/21/20 at 2:02 p.m., MD 1 stated that she relied on pharmacists to help her in medication adjustments that required renal dosing (renal dosing means reducing the amount or dosage of medication to prevent accumulation when kidney was not working well.)

During an interview on 10/21/20 at 11:24 a.m., Director of Pharmacy (DOP) acknowledged the order for ciprofloxacin should have been lowered to prevent drug accumulation with kidney disease. He stated that pharmacists could have adjusted the dosage based on hospital approved policy.

During a 10/22/20 review of hospital policy number 065, titled "Renal Dosing Guidelines", last reviewed on 4/2019, indicated " The Pharmacy and Therapeutic Committee ( a hospital committee with oversight of safe medication use) approves a list of medications which requires dose adjustment for patients with renal insufficiency." The policy, further indicated the dosage for ciprofloxacin in the setting of dialysis should be reduced to half of regular dose such as " 250mg every 12 hours or 250 500mg once daily after dialysis"

During a review of DailyMed (the official provider of FDA drug information) last accessed on 10/25/2020 via https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=888dc7f9 ad9c 4c00 8d50 8ddfd9bd27c0, under the "Dosage Modifications in Patients with Renal (kidney) Impairment", indicated "Ciprofloxacin is eliminated primarily by renal (kidney) excretion; ... modification of dosage is recommended, particularly for patients with severe renal dysfunction ..." It further recommended reducing the dosage of ciprofloxacin to "250 500 mg every 24 hours (after dialysis)" in patients on dialysis."


The cumulative effects of these systemic failures had the potential for an avoidable harm due to excess drug accumulation, bleeding or death.

Based on observation, interview, and record review, the hospital failed to ensure implementation of a sterile (germ free) intravenous (IV, directly into a vein) compounding (mixing) practices and environment in the clean room (clean room also called Segregated Compounding Area or SCA, where the sterile medications were prepared) when serious disease causing microbes (microbes are tiny living things that can cause disease) were identified in three out of four tastings of the hospitals clean room as evidenced by:

1. Hospital failed to prevent and mitigate the source of ongoing disease causing microbial growth (refers to an increase in disease causing microbes) in the clean room (also called Segregated Compounding Area or SCA, where the sterile intravenous medications were prepared) where IV medications were compounded (mixed). This could have resulted in contaminating the sterile intravenous medications with harmful microbes when used for hospital patients with the census of 74.

2. Staff Pharmacist 2 (RPH 2) failed to follow infection control practices during IV preparation in the hospital's clean room based on standards of practice and the hospital's policy. RPH 1 did not sanitize the products she utilized in the clean room. This had the potential of contaminating the sterile intravenous medication with microbes when used for hospital patients with the census of 74.

Findings:

1. In a concurrent interview and record review of hospitals clean room (also called Segregated Compounding Area or SCA, where the sterile intravenous medications are prepared) on 10/28/2020 at 11:31 a.m., the Director of Pharmacy (DOP) stated that the clean room was tested and certified twice a year for ruling out contaminations to assure cleanliness. The second biannual (twice a year)test and certification was conducted on 8/19/20, showed growth of yeast (yeasts are microscopic organisms that can cause infection in the body) on the surface of the Compounding Aseptic Isolator (or CAI a closed system apparatus or hood located in a clean room where sterile medications were prepared.) The DOP added, when he received results of the positive yeast growth on 8/31/20, he immediately stopped preparing IV medications in the hospital's clean room. DOP stated they repeated testing of CAI surfaces on 8/31/20 and results reported on 9/8/20 did not show any growth of yeast or other microbes on the surfaces. Additionally, the air sample tests ( a type of test that takes air from the room and test it to see if there is any microbe floating in the air) in the clean room (or SCA) on 8/19/20 and 9/28/20, showed presence of disease causing yeast like microbial growths.

In an interview on 10/28/20 at 12:30 p.m., the Chief Executive Officer/Chief Nursing Officer (CEO/CNO) stated that hospital's Infection Preventionist (or IP leader, a role within a hospital to help prevent and control the spread of infections) was not available for an interview. The CEO/CNO, however, provided a written document described the actions taken to mitigate the recurring yeast or mold (similar to yeast, can cause disease) growth in the pharmacy's clean room. The CNE/CEO additionally stated that she was considering use of an outside expert organization to help them mitigate the ongoing infection control issue in the pharmacy's clean room.

During review of an undated document titled "IP Report on Pharmacy department mold Problem" signed by Medical Doctor 2 (MD 2) as the hospital's IP leader, indicated after industrial level cleaning (type of cleaning services with specialized cleaning instruments and chemicals) of pharmacy and the clean room, the air samples in the SCA still showed high level (a level that required an action to fix the harmful microbes) of mold or yeast like growth. The document further noted, "From the patterns of results we observed, the possible next steps would be to make the pharmacy department a positive pressure room (positive pressure rooms is a protective environment that maintain a higher pressure air inside the clean room than that of the surrounding and prevent infections and germs entering the room.)" The report did not provide further timeline or immediate plan of action from infection control standpoint to help in mitigating the ongoing disease causing microbes in the clean room.

During review of a document, titled "Pharmacy Cleaning Log", dated October of 2020 indicated a total of 14 days when the "hood" (hospital's Compounding Aseptic Isolator device or CAI) temperature was above the normal range of 68 75 degree Fahrenheit. The log, additionally documented a total of 16 days between 10/1/20 to 10/28/20, with room temperature exceeding 75 degree Fahrenheit and as high as 83 degree Fahrenheit. On 4 occasions dated 10/6/20, 10/14/20, 10/24/20 and 10/25/20 a note indicated "notified maintenance", "opened ticket" or "notified pharmacist" when pharmacy staff reported the abnormal temperature excursions to the hospital's maintence staff.

In an interview on 10/28/20 at 4:49 p.m., the DOP stated that he had worked with facility maintenance staff to help address the airflow system and temperature excursions above the normal range in the pharmacy and the clean room. DOP contributed the small space and heat-producing instruments could have contributed to changes in temperature recordings above the normal range. DOP acknowledged the room temperature above the normal range could contribute to the growth of microbes.

During a review of hospital policy number 035, titled "Intravenous Admixture Sterile Preparation", last revised on 08/2020, indicated "All compounded sterile preparations ... are sterile to sterile, non hazardous, low to medium risk and mixed in the (germfree) ... compounding aseptic isolator (CAI) located in the pharmacy, in a sterile compounding area in accordance with standards for sterility and infection control guidelines."


2. On a concurrent interview and observation of hospitals clean room (also called Segregated Compounding Area or SCA, where the sterile intravenous medications are prepared) on 10/28/2020 at 11:31 a.m., the Director of Pharmacy (DOP) stated due to recurrent growth of yeast, the hospital had been using pre made IV medications whenever available commercially. When an IV product was not available, they compounded (mix) the drug in the clean room's CAI (or Compounding Aseptic Isolator, a closed system apparatus or hood located in a clean room where sterile medications were prepared.) DOP added, medications prepared in the CAI had been given a Beyond Use Date (or BUD, a date and time which the product could not be used due to risk of contamination) of one hour.

During an observation of a Compounded Sterile Product (or CSP when a pharmacy staff prepares an IV medication using a CAI) inside hospital's clean room, on 10/28/20 around 4:03 p.m., Staff Pharmacist 2 (RPH 2) did not follow infection control practices to prevent contamination of sterile medication preparation. RPH 2 did not sanitize items transferred inside the CAI chamber. The items taken into CAI chamber included the following: bag of IV fluid, a vial of antibiotic, syringes, needles and alcohol wipes. RPH 2 additionally did not sanitized the Direct Compounding Area (or DCA area inside CAI hood where actual sterile preparation conducted) prior to starting the compounding. Once the product was prepared, RPH 2 did not sanitize the DCA surfaces.

In an interview on 10/28/20 around 4:49 p.m., RPH 2 acknowledged she missed pre cleaning the products taken inside the CAI chamber and failed to clean DCA surfaces prior and after IV compounding. She contributed this to the difficulty in using the gloves.

During a review of hospital policy number 035, titled "Intravenous Admixture Sterile Preparation", last revised on 08/2020, indicated on page 5 of the policy "All items to be used in the LFGI (stand for Laminar Flow Glove BOX Isolator also called CAI, a closed space to prepare IV medication) must be wiped down with a microkill sporicidal (a microbe killing product) agent prior to being placed in the LFGI (LFGI stands for Laminar Flow Glove box Isolator, also called CAI, a germ free closed hood system where IV medications were prepared), and wiped down with ...sterile ...alcohol." The LFGI cleaning procedure on the policy's attachment A indicated, "subsequent disinfecting shall be done after a spill or surface contamination and after 30 minutes of continued use ..."

During a review of the United States Pharmacopeial Convention (or USP, a scientific nonprofit organization that sets standards for the quality, purity, and strength of medicines), accessed on 11/02/20 via https://www.usp.org/compounding/general chapter 797, last revised in 2008, under the general chapter <797> (USP 797) entitled PHARMACEUTICAL COMPOUNDING STERILE PREPARATIONS, enforceable in the United States by the Food and Drug Administration (the institution chartered by Congress with the responsibility for regulating and ensuring the safety, quality, and efficacy of medications sold in the United States), documented in the introduction that "The objective of this chapter is to describe conditions and practices to prevent harm, including death to patients that could result from ... microbial contamination ... (and) excessive bacterial endotoxins ..." among other things. The USP 797 stipulated "Regardless of the number of CFU (means the number of microbes) identified in the pharmacy, further corrective actions will be dictated by the identification of microorganisms recovered (at least the genus level) by an appropriate credentialed laboratory of any microbial bioburden captured as a CFU using an impaction air sampler. Highly pathogenic (disease causing) microorganisms (e.g. Gram negative rods, coagulase positive staphylococcus, molds and yeast) can be potentially fatal to patients receiving CSPs and must be immediately remedied, regardless of CFU count, with the assistance of a competent microbiologist, infection control professional, or industrial hygienist." (Genus is a name given to a group of organisms sharing common characteristics. Pathogenic means giving origin to disease. Coagulase is an enzyme that if found, by laboratory methods, in the genus of staphylococcus indicates that organism has a heightened capacity to cause disease. Molds and yeast are collectively known as fungi.) Additionally, the USP guidelines on "Cleaning and Disinfecting the Compounding Area" indicated, "Environmental contact is a major source of microbial contamination of CSPs. Consequently, scrupulous attention to cleaning and disinfecting the sterile compounding areas is required to minimize this as a source of CSP contamination." The USP 797 guidelines, furthermore, on "Responsibility of Compounding Personnel", indicated "Compounding personnel are responsible for ensuring that CSPs are accurately identified, measured, diluted, and mixed and are correctly purified, sterilized, packaged, sealed, labeled, stored, dispensed, and distributed. These performance responsibilities include maintaining appropriate cleanliness conditions ..."

A review of the American Society of Health System Pharmacy (ASHP an organization that sets minimum standards for hospitals in the United States) Guidelines on Compounding Sterile Preparations last access on 11/2/20 via https://www.ashp.org/ /media/assets/policy guidelines/docs/guidelines/compounding sterile preparations.ashx, and https://www.ashp.org/ /media/store files/p1794 sample chapter 21 indicated, "Any microbial growth that results from viable environment sampling must be identified... If any highly pathogenic organisms (... means disease causing microbes or yeasts) are identified, infection control specialists should immediately be consulted to assist in formulating a response to the situation."



The cumulative effects of unsafe clean room environment and practices could have resulted in contaminated medication preparations that could cause blood infection diseases.