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Based on interview and record review the facility did not ensure the presence of an effective Governing Body. The Governing Body did not make certain that:

1. The facility contracted services for Pharmacy services and Anesthesia services were monitored periodically and evaluated annually (A-083).

2. Pharmacy services provided safe, quality care (A-0490).

3. Surgical services provided safe, quality care (A-0940).

4. Anesthesia services provided safe, quality care (A-1000).

5. The Quality Assessment and Performance Improvement Program reflected the complexity of the hospital's organization and services and involved all hospital departments and services when it failed to:

Have an ongoing quality appraisal and performance improvement program that included tracking and trending of findings, and integrated interdisciplinary efforts to address deficient practices in the Operating Room and effectively implement change to improve patients' quality of care in a universe of 43 patients (A-0263).

The cumulative effect of these failures increased the risk of a poor health outcome for all facility patients.

Based on observation, interview and record review, the hospital failed to ensure that the Quality Assessment and Performance Improvement Program reflected the complexity of the hospital's organization and services and involved all hospital departments and services when it failed to:

1. Have an ongoing quality appraisal and performance improvement program that included tracking and trending of findings, and integrated interdisciplinary efforts to address deficient practices in the Operating Room (OR) and effectively implement change to improve patients' quality of care in a universe of 43 patients by failing to ensure the following:

A. That the OR staff did not use SDV (single dose vials) of medication for multiple patients.

B. That medications were not being drawn up into syringes and left unattended in the unlocked anesthesia (medication induced absence of all sensation, for example, pain) medication cart.

C. That all surgical staff followed the disinfectant (a cleaning agent applied to a surface to kill all or most bacteria on the surface) manufacturer's instructions during OR (Operating Room) cleaning.

These failures had the potential to place all surgical patients at risk for surgical site infections and could contribute to a decline in patients' health. (Refer to A-0273)

The cumulative effect of these systemic problems contributed to the hospital being unable to ensure the provision of quality health care in a safe environment.

Based on observation, interview and record review, the facility did not ensure that the Medical Staff was organized and operated under the facility Medical Staff Bylaws. The facility failed to ensure that:

1. Single Dose Vial medications were used for only one patient and then discarded.

2. All medications in syringes were labeled with the date, time, medication name and person who drew up the medication and stored in a secure manner.

3. The Allied Health Professional (CRNA: Certified Registered Nurse Anesthetist) was supervised while providing patient care. (Refer to A-0353)

The cumulative effect of these failures increased the risk of a poor health outcome for all facility patients.

Based on observations, interviews and record reviews the Condition of Participation for Infection Control was not met when the Hospital failed to:

1. Maintain a system for controlling sources of infections in a universe of 43 patients, in accordance with internal policies and procedures, nationally recognized infection control practices and guidelines, and applicable regulations, when the hospital failed to ensure the following:

A. That Surgical Tech (ST 2) followed the required four minute dwell time (must stay wet four minutes to be effective against indicated organisms) of the cleaning wipes (PDI Sani-cloth) as recommended by the manufacturer (PDI - Professional Disposables International.) (Refer to A-749)

B. That the OR staff did not use SDV (single dose vials) of medication for multiple patients. (Refer to A-951)

C. That medications were not being drawn up into syringes and left unattended in the unlocked anesthesia medication cart. (Refer to A-951)

2. That the hospital Infection Control Preventionist provided effective infection control oversight in the surgical services operating room (OR) areas when the hospital failed to ensure the following:

A. That Surgical Tech (ST 2) followed the required four minute dwell time (must stay wet four minutes to be effective against specified organisms) of the cleaning wipes (PDI Sani-cloth) as recommended by the manufacturer (PDI - Professional Disposables International). (Refer to A-0748)

B. That the OR staff did not use SDV (single dose vials) of medication for multiple patients. (Refer to A-0748)

C. That medications were not being drawn up into syringes and left unattended in the unlocked anesthesia (medication induced absence of all sensation, for example, pain) medication cart. (Refer to A-0748)

The cummulative effect of these systemic problems resulted in the hospital placing patients at risk for developing infections.

Based on observation, interview and record review, the facility failed to ensure that all
Surgical services were provided in a well-organized manner consistent with hospital policies and procedures as well as acceptable standards of practice. The facility failed to ensure that:

1. Single Dose Vial medications were used for only one patient and then discarded (Refer to A-0951).
2. All medications in syringes were labeled with the date, time, medication name and name of the provider who drew up the medication (Refer to A-0951, A-1002).
3. All medications were stored in a secure manner, away from all unauthorized personnel (Refer to A-0951, A-1002).
4. All staff followed the disinfectant (a cleaning agent applied to a surface to kill all or most bacteria on the surface) manufacturer's instructions to clean the OR table (A-0951).

An Immediate Jeopardy was called on December 4, 2013 at 12:26 PM with the administrative staff for the following:
1. Single dose medication vials were used for more than one patients.
2. Syringes of anesthesia medication inadequately labeled.
3. Surgical table was not disinfected according to disinfectant manufacturer's instructions.

The Immediate Jeopardy was abated on December 5, 2013 at 3:22 PM after receiving an acceptable plan of correction

The cumulative effect of these deficient practices increased the risk of infection and a poor surgical outcome for all surgical patients.

Based on observation, interview and record review, the facility failed to ensure that all anesthesia services were provided in a well-organized manner in order to provide safe, quality anesthesia care by failing to ensure that delivery of anesthesia services were provided according to recognized standards for anesthesia care. The facility failed to ensure that:

1. Twelve syringes of medication were completely labeled with the date, time, medication name and name of the provider who drew up the medication. (Refer to A-1002.)

2. Medications were kept locked and unavailable to all unauthorized personnel. (Refer to A-1002.)

The cummulative effect of these deficient practices increased the risk of medication use by unauthorized personnel and a poor anesthetic outcome for all surgical patients.

Based on observation, interview and record review the Governing Body (a group of physicians, adminisrators, and sometimes non-medical persons who decide how the hospital is run and approves the facility policy and procedures and develops and approves medical staff bylaws with the medical staff) did not ensure that Anesthesia and Pharmacy contracted services were evaluated annually to make certain they provided safe, high quality patient care. The facility failed to ensure that:

1. Single Dose Vial medications were used for only one patient and then discarded.
2. All medications in syringes were labeled with the date, time, medication name and person who drew up the medication.
3. All medications were stored in a secure manner, away from all unauthorized personnel.

This deficient practice increased the risk of a poor health outcome for all facility patients using hospital services.

Findings:

1. During the initial tour of the Surgery area on December 2, 2013 at 10:40 AM in OR (Operating Room) 2, the Scrub Tech (ST 1) was observed preparing six vials of medication for the physician to draw up into a syringe for the next surgical patient. ST 1 stated that they had performed five spine procedures that morning and according to the OR schedule, there were 14 more spine procedures scheduled that day in OR 2. Six vials of medication were observed, three of the vials had a protective cover on the vial, indicating that they had not been opened yet, and three with the protective cover removed and the date (December 2, 2013) written on the vial. All three opened vials appeared partially empty and the medication labels read:

1. Sensorcaine MPF (Bupivacaine Hcl) 30 ml (milliliters) 0.5% (pain medication).

2. Isovue M300 15 ml (contrast agent-a substance used to enhance the contrast of structures or fluids within the body in medical imaging).

3. Marcaine 0.25% (Bupivacaine Hcl) 30ml (pain medication).

These findings were observed and verified by the CEO (Chief Executive Officer) and the OR Manager. ST 1 stated the opened vials were multi-dose vials (which can be used multiple times, possibly for multiple patients because they contain a preservative).

However upon inspection, all of the vial labels indicated the medications were preservative-free and for single patient use only (single dose vial). ST 1 explained that spine procedures, nineteen of which were scheduled for that day, required preservative -free medications. The vials were observed to be single dose vials (SDV) without preservatives in them. The medication labels of the opened vials indicated that the remaining contents of each vial should be thrown away after use on a single patient. ST 1 confirmed that the three opened vials of medication had been used for prior patients and had not been discarded after use on a single patient. These findings were observed and verified by the CEO and the OR Manager. During a concurrent interview, the OR Manager said, "We will get you new medications."

During an interview with Surgical Tech 2 (ST 2) on December 2, 2013, at 1:55 PM he stated that he was not certain how long he had been using SDV for multiple patients, but he had been doing it as long as he's been there. He had been working at the facility for ten months. He said he was just doing what he had been told to do. At the same time ST 1 was questioned further, she stated that she had "always done it this way, it was how I was trained. She estimated that the practice had been going on for a year. The CEO and the OR Manager were present during the interviews.

During an interview with MD (Medical Doctor) 1 in the physicians lounge, on December 2, 2013 at 2:00 PM, MD 1 stated that he was unaware that the scrub techs were using SDV medications on multiple patients, except for the use of Isovue. He stated that he had knowledge that the Isovue was being used for more than one patient. He stated that at another facility he was told it was not cost-effective to use the Isovue on only one patient and then throw it away. He said he drew up the medications himself with a new needle and a new syringe each time, but confirmed that he did not look at the medication label to verify the identity of the medication. He confirmed that he does not want to use medication with preservative in it for spinal injection procedures. The CEO and the OR Manager were present during the interview.

During an interview with the Pharmacist in charge (PIC) on December 2, 2013 at 3:45 PM, he stated he was unaware that the OR staff were using SDV of medication for multiple patients. He also was unaware of how many vials of medication were used for the 19 procedures in the OR 2 surgery schedule for December 2, 2013. When asked if he noticed that there were 19 procedures on the schedule and thus 19 vials of medications would be used or required, he said "No." The CEO and the pharmacy representative for the contracted service were present during the interview. The PIC was asked to provide records of how many vials of medication were used for the 19 procedures that day and he was unable to produce any medication records. Therefore, the pharmacy was unaware of the amount of each medication (Buprivocaine & Isovue) required or used by the OR staff. The Director of Pharmacy was asked if he monitored the medications used in the OR and he replied "No." The CEO was also present during the interview.


During an interview on December 4, 2013 at 10:00 AM, with the medical director of Anesthesia (MD 2), he stated that he oversees all anesthesia services provided in the facility. He was surprised to hear that on December 2, 2013 in OR 2, MD 1 and his staff re-used SDV's on more than one patient.

During an interview on December 4, 2013 at 2:15 PM, with the Director of Pharmacy and the pharmacy representative, it was confirmed that in the case of a drug recall, the pharmacy would not be able to provide the lot numbers of the medications used for past patient care, including medications used on December 2, 2013. The CEO was also present during the interview.


During an interview on December 4, 2013, at 4:00 PM, with the Circulating Registered Nurse (Nurse R) who was present in OR 2 on December 2, 2013, she stated that her duties included preparing the next patient for surgery, transportation of the patient to the OR and positioning of the patient. She stated that for each patient she checked the preoperative check list to make sure everything had been done, checked the History and Physical, made certain the operative site had been marked and the consent form was signed by the patient before transporting the patient into the OR. She did not mention supervision of the scrub technician and use of medications in the OR. She confirmed that she did not see the survey team enter OR 2 on two occasions between surgical patients on December 2, 2013, while she was the circulating RN (registered nurse) for OR 2. Thus, she was not present in the OR when the scrub technician was preparing the medications for the next patient. She stated that MD 1 requests preservative free medications due to the proximity (closeness) of the injection site to the brain. She admitted that she was aware that the Isovue was preservative-free and was used for multiple patients by MD 1, and possibly other physicians. Nurse R stated that MD 1 draws up his own medications while the scrub tech holds the vial. She is unsure if other physicians draw up their own medications.

During an interview on December 5, 2013, with the Chief of Staff (MD 3), at 9:05 AM, he confirmed that he is a member of the Governing Board (GB) and he was unaware that the Pharmacy and director of Anesthesia services were not monitoring the medications used in the OR. He also was unaware that the OR staff were using Single dose vials (SDV) for multiple patients.

During a group interview on December 6, 2013, at 10:00 AM, with the Quality Assurance MD (MD 4) and Quality Assurance Coordinator (QAC), they stated that they relied on the OR RN's and the OR Manager to report to the QA committee regarding medication use in the OR area. MD 4 also stated, "the GB does not ask the QA committee to do anything. "MD 4" assumes that the GB is satisfied, because the GB does not tell the QA staff what we're not doing."

During a group interview on December 6, 2013, at 3:25 PM, with three members of the Governing Body (GB 1, GB 2 & GB 3), they were asked about their priorities for the facility. GB 1 stated the Governing Body was concerned about Quality of Care provided to the patients and they were disappointed in the survey observations regarding medications in the OR area. They admitted they were unaware of the lack of pharmacy oversight of the medications used in the facility. They were unaware that the pharmacy was not accounting for the medications used in the facility and that medication inventory was not monitored. They were unaware that safe injection practices were not being practiced by the OR staff. They said they expected the OR manager and nurses to observe and report these findings and they would be sent up the chain of command to the Governing Body. When asked if the Governing Body evaluated the contracted services, including the pharmacy contracted service, they said yes, once per year. However, they were unable to produce any documented evidence that contracted services were evaluated by the Governing Body over the last year.

Review of the facility policy titled "Single Use Sterile (free of living microorganisms) Drugs and Devices", reviewed January, 2011, indicated, "Single-use sterile drugs and devices shall be used and disposed of in accordance with this policy." "Single-use sterile drugs and devices shall not be reused. Unused portions of single-use sterile drugs shall not be saved for later use." "The Director of Pharmacy shall ensure the disposal of all contaminated and potentially contaminated single-use sterile drugs and devices in accordance with the facility's policies."

2 & 3. During an observation in OR 2, on December 2, 201,3 at 2:20 PM, upon checking the OR 2 Anesthesia cart, it was noted to be unlocked and unattended. CRNA 1 (Certified Registered Nurse Anesthetist 1) was not present in the OR. Inside the cart, in drawer three, nine unlabeled syringes of a white substance were observed (Propofol-an anesthetic agent). Also, three incompletely labeled syringes of Fentanyl (a pain medication) were observed in the same unlocked, unattended drawer. These findings were observed and verified by the CEO and the OR Manager.

During an interview with the CRNA 1 on December 2, 2013 at 2:30 PM, outside of the OR Managers office, he confirmed that he had left the Anesthesia Medication Cart unlocked and unattended after he left OR 2. He stated that he didn't have a key to lock the anesthesia medication cart. He also confirmed that he had drawn up Propofol (an anesthetic agent) into syringes, and left them in the third drawer unlabeled, because he needed some medication on hand. He was reminded that nine unlabeled, unsecured pre-drawn syringes of white substance were found sitting in the anesthesia cart drawer along with three incompletely labeled syringes of Fentanyl. He confirmed that the syringes of Fentanyl and Propofol were not labeled with the date, time, and the name of the person who drew up the medications. The CEO was also present during the interview.

During an interview with the Pharmacist in charge (PIC) on December 2, 2013, at 3:45 PM, the (PIC) confirmed that he did not monitor the medications used in the OR. He was unaware that medications were being drawn up into syringes and left unattended in the unlocked anesthesia medication cart. The CEO was also present during the interview.

During an interview on December 4, 2013, at 10:00 AM, with the medical director of Anesthesia (MD 2), he stated that he oversees all anesthesia services provided in the facility. He was surprised to hear that on December 2, 2013, in OR2, multiple syringes of Propofol were found in an unlocked, unattended anesthesia medication cart in OR 2. He stated that he does not supervise the CRNA because he is under the supervision of the Anesthesiologist/Pain Specialist (MD 1) during the procedure. He was surprised that MD 1 did not supervise the CRNA. The CEO was also present during the interview.

During an interview on December 5, 2013, with the Chief of Staff (MD 3), at 9:05 AM, he confirmed that he is a member of the Governing Board (GB) and has become aware that CRNA 1 left nine pre-drawn, unlabeled syringes of Propofol unattended in the unlocked anesthesia medication cart in OR2. He stated that he interviewed CRNA 1 about the syringes of Propofol drawn up and left unattended in the anesthesia medication cart and CRNA 1 told MD 3 "I do that all the time." MD 3 stated, "That should never happen." MD 3 stated that he expected the medical director of anesthesia to supervise the anesthesiologist/pain specialist performing the procedure and the CRNA providing the patient anesthesia while they are providing anesthesia services in the facility. He further stated that he was unaware that the Pharmacy and director of Anesthesia services were not monitoring the medications used in the OR. MD 3 expected the Chief of Anesthesia to provide monitoring and surveillance of all anesthesia services provided in the facility and he expects the anesthesia director to share any concerns with him.

During a group interview on December 6, 2013, at 3:25 PM, with three members of the Governing Body (GB 1, GB 2 & GB 3), they were asked about their priorities for the facility. GB 1 stated the Governing Body was concerned about Quality of Care provided to the patients and they were disappointed in the survey observations regarding medications in the OR area. They admitted they were unaware of the lack of pharmacy oversight of the medications used in the facility. They were unaware that the pharmacy was not accounting for the medications used in the facility and that medication inventory were not monitored. They were unaware that safe injection practices were not being practiced by the OR staff. They said they expected the OR manager and nurses to observe and report these findings and they would be sent up the chain of command to the Governing Body. When the Governing Body members were asked if the Governing Body evaluated the Pharmacy contracted service, they said yes, once per year. However, they were unable to produce any documented evidence that contracted services were evaluated by the Governing Body over the last year.

Review of the facility policy titled "Medication Labeling", revised June, 2011, indicated, 1. "Medications will be labeled in a standardized manner in accordance with the state and federal laws and regulations. 2. Medication containers are labeled whenever medications are prepared but not immediately administered. 5. Staff will label all medications and medication containers, even if only one medication is used in the procedure. Medication containers include syringes..."

Review of the facility policy titled "Storage of Medications", revised February 2013, indicated, "1. Approved medications are properly and safely stored throughout the hospital between receipt by an individual health care provider and administration of the medication, including safe storage, handling, security, disposition, and return to storage."

Based on observation, interview and document review, the hospital failed to have an ongoing quality appraisal and performance improvement program that included tracking and trending of findings, and integrated interdisciplinary efforts to address deficient practices in the Operating Room (OR) and effectively implement change to improve patients' quality of care in a universe of 43 patients by failing to ensure the following:

1. That the OR staff did not use SDV (single dose vials) of medication for multiple patients.

2. That medications were not being drawn up into syringes and left unattended in the unlocked anesthesia (medication induced absence of all sensation, for example, pain) medication cart.

3. That all surgical staff followed the disinfectant (a cleaning agent applied to a surface to kill all or most bacteria on the surface) manufacturer's instructions during OR cleaning.

These failures had the potential to place all surgical patients at risk for surgical site infections and could contribute to a decline in patients' health.

Findings:

1. During the initial tour of the Surgery area on December 2, 2013 at 10:40 AM in OR (Operating Room) 2, the Scrub Tech (ST 1) was observed preparing six vials of medication for the next surgical patient. ST 1 stated that they had performed five spine (the backbone) procedures that morning and according to the OR schedule, there were 14 more spine procedures scheduled that day for OR 2. Six vials of medication were observed, three of the vials had a protective cover on the vial, indicating that they had not been opened as yet, and three with the protective cover removed and the date (December 2, 2013) written on the vial. All three opened vials appeared partially empty and the medication labels read:

1. Sensorcaine MPF (Bupivacaine Hcl) 30 ml (milliliters) 0.5% (pain medication).

2. Isovue M300 15ml (contrast agent-a substance used to enhance the contrast of structures or fluids within the body in medical imaging).

3. Marcaine 0.25% (Bupivacaine Hcl) 30ml (pain medication).

These findings were observed and verified by the CEO (Chief Executive Officer) and the OR Manager. ST 1 stated the opened vials were multi-dose vials (which can be used multiple times, possibly for multiple patients because they contain a preservative). However upon inspection, all of the vial labels indicated the medications were preservative-free and for single patient use only (single dose vial). ST 1 explained that spine procedures, 19 of which were scheduled for that day, required preservative-free medications. The vials were observed to be single dose vials (SDV) without preservative in them. The medication labels of the opened vials indicated that the remaining contents of each vial should be thrown away after use on a single patient. ST 1 confirmed that the three opened vials of medication had been used for prior patients, were going to be used for the next patient and had not been discarded after use on a single patient. These findings were observed and verified by the CEO and the OR Manager. During a concurrent interview, the OR Manager said, "We will get you new medications."

During an interview with the Pharmacist in charge (PIC) on December 2, 2013, at 3:45 PM, he stated he was unaware that the OR staff were using SDV of medication for multiple patients. He also was unaware of how many vials of medication were used for the 19 procedures on the OR 2 surgery schedule for December 2, 2013. When asked if he noticed that there were 19 procedures on the schedule and thus 19 vials of medications would be used or required, he said "No." The CEO and the pharmacy representative for the contracted service were present during the interview. The PIC was asked to provide records of how many vials of medication were used for the 19 procedures that day and he was unable to produce any medication records. Therefore, the pharmacy was unaware of the amount of each medication (Buprivocaine & Isovue) required or used by the OR staff. The PIC was asked if he monitored the medications used in the OR and he replied "No."

During an interview on December 6, 2013, at 11:20 AM, with the CEO and the Pharmacy Representative (PR), the CEO and PR admitted that the medications used in OR 2 on Monday during the 19 procedures could not be tracked. The CEO and PR stated that their records indicated that the pharmacy had 80 vials of Isovue on Monday and 69 vials on Wednesday 12/4/13. Thus, it was estimated that 11 vials of Isovue was used for 19 patients. The CEO and PR said that it could not be estimated how much Bupivocaine was used.

2. During an observation in OR 2, on December 2, 2013, at 2:20 PM, upon checking the OR 2 Anesthesia cart, it was noted to be unlocked and unattended. CRNA 1 (Certified Registered Nurse 1), the anesthesia provider, was not present in the OR. Inside the cart, in drawer three, nine unlabeled syringes of a white substance (Propofol-an anesthetic agent) were observed. Also, three incompletely labeled syringes of Fentanyl (a pain medication) were observed in the same unlocked, unattended drawer. These findings were observed and verified by the CEO and OR Manager.

During an interview with the Pharmacist in charge (PIC) on December 2, 2013, at 3:45 PM, the PIC was asked if he monitored the medications used in the OR and he replied "No." He was unaware that medications were being drawn up into syringes and left unattended in the unlocked anesthesia medication cart.

3. During an observation in OR 2, on December 2, 2013 at 2:20 PM, ST 2 was observed to be cleaning the top portion of the OR table mattress pad, in preparation for the next patient, with a PDI (PDI-Professional Disposables International) Sani-cloth which required a four minute dwell time (must stay wet four minutes to be effective to kill specified organisms). The OR table appeared to be almost completely dry after two to three minutes. During the observation, ST 2 did not clean the bottom of the OR table mattress pad. During a concurrent interview, ST 2 was asked if the OR table mattress pad had been disinfected properly, since it was almost completely dry after two to three minutes. ST 2 pointed to a two inch by two inch area of the OR table mattress pad, that was still wet, and said "yes, the table is still wet." It was mentioned to ST 2 that the entire surface of the OR table mattress pad must remain wet for four minutes, and may need additional wiping with the Sani-cloth to remain wet for the entire four minutes. The dwell time is the exposure time to the disinfectant required to kill all specified organisms on the OR table mattress pad between patients. These findings were observed and confirmed by the CEO and the OR Manager.

During a group interview on December 5, 2013, at 1:15 PM, with the Infection Control Preventionist (ICP) and two corporate area directors (IC-AD 1 & 2) who supervised the ICP, the ICP confirmed and stated that there was "no routine monitoring or surveillance of the OR area" to identify any infection control concerns. When asked if the cleaning of the OR table was observed or monitored for appropriate disinfection, the answer was "no." The ICP and IC-AD 1 confirmed that there was no monitoring or surveillance of the OR by the infection control staff but that they rely on the OR Manager or the Pharmacist or other OR staff to report infection control issues. When asked if they ever rounded in the OR's at the beginning or in the middle of the day, they stated "no."

During a group interview on December 6, 2013, at 10:00 AM, with the Quality Assurance MD (MD 4) and Quality Assurance Coordinator (QAC), they stated that they relied on the OR RN's and the OR Manager to report to the QA committee regarding medication use in the OR area. MD 4 also stated, "the GB (Governing Body-a group of physicians, adminisrators, and sometimes non-medical persons who decide how the hospital is run and approves the facility policy and procedures and develops and approves medical staff bylaws with the medical staff) does not ask the QA committee to do anything." MD 4 "assumes that the GB is satisfied, because the GB does not tell the QA staff what we're not doing."

During a review of the Governing Body minutes it was noted that there was no documentation that QAPI reported medication or disinfection problems in the OR.

Based on observation, interview and record review, the facility did not ensure that all Medical Staff Bylaws were enforced, including the requirement that all Hospital policies and procedure be followed, as evidenced by the failure to ensure that:

1. Single Dose Vial medications were used for only one patient and then discarded.

2. All medications in syringes were labeled with the date, time, medication name and person who drew up the medication and stored in a secure manner.

3. The medical staff supervised the CRNA (Certified Registered Nurse Anesthetist) while providing patient care.

This practice increased the risk of a poor health outcome for all facility patients undergoing surgical procedures.

Findings:

1. During the initial tour of the Surgery area on December 2, 2013 at 10:40 AM in OR (Operating Room) 2, the Scrub Tech (ST 1) was observed preparing six vials of medication for the physician to draw up in syringes for the next surgical patient. ST 1 stated that they had performed five spine (the backbone) procedures that morning and according to the OR schedule, there were 14 more spine procedures scheduled that day for OR 2. Six vials of medication were observed, three of the vials had a protective cover on the vial, indicating that they had not been opened as yet, and three with the protective cover removed and the date (December 2, 2013) written on the vial. All three opened vials appeared partially empty and the medication labels read:

1. Sensorcaine MPF (Bupivacaine Hcl) 30 ml (milliliters) 0.5% (pain medication).

2. Isovue M300 15ml (contrast agent-a substance used to enhance the contrast of structures or fluids within the body in medical imaging).

3. Marcaine 0.25% (Bupivacaine Hcl) 30ml (pain medication). These findings were observed and verified by the CEO (Chief Executive Officer) and the OR Manager. ST 1 stated the opened vials were multi-dose vials (which can be used multiple times, possibly for multiple patients because they contain a preservative).

However upon inspection, all of the vial labels indicated the medications were preservative-free and for single patient use only (single dose vial). ST 1 explained that spine procedures, nineteen of which were scheduled for that day, required preservative-free medications. The vials were observed to be single dose vials (SDV) without preservative in them. The medication labels of the opened vials indicated that the remaining contents of each vial should be thrown away after use on a single patient. ST 1 confirmed that the three opened vials of medication had been used for prior patients, were going to be used on the next patient and had not been discarded after use on a single patient. These findings were observed and verified by the CEO and the OR Manager. During a concurrent interview, the OR Manager said, "We will get you new medications."

During an interview with Surgical Tech 2 (ST 2) on December 2, 2013, at 1:55 PM he stated that he was not certain how long he had been using SDV for multiple patients, but he has been doing it as long as he's been here. He has been working at the facility for ten months. He said he was just doing what he had been told to do. At the same time ST 1 was questioned further, she stated that she had "always done it this way, it was how I was trained." She estimated that the practice had been going on for a year. The CEO and the OR Manager were present during the interviews.

During an interview with MD (Medical Doctor) 1 in the physicians lounge, on December 2, 2013, at 2:00 PM, MD 1 stated that he was unaware that the scrub techs were using SDV medications on multiple patients, except for the use of Isovue. He stated that he had knowledge that the Isovue was being used for more than one patient. He stated that at another facility he was told it was not cost-effective to use the Isovue on only one patient and then throw it away. He said he drew up the medications himself with a new needle and a new syringe each time, but confirmed that he did not look at the medication label to verify the identity of the medication. He confirmed that he does not want to use medication with preservative in it for spinal injection procedures. The CEO and the OR Manager were present during the interview.

During an interview on December 4, 2013 at 10:00 AM, with the medical director of Anesthesia (MD 2), he stated that he oversees all anesthesia (medication induced absence of all sensation, for example, pain) services provided in the facility. He was surprised to hear that on December 2, 2013 in OR 2, MD 1 and his staff re-used SDV's on more than one patient. The CEO was also present during the interview.

During an interview on December 4, 201,3 at 4:00 PM, with the Circulating Registered Nurse (Nurse R) who was present in OR 2 on December 2, 2013, she stated that she was not present in the OR when the scrub technician was preparing the medications for the next patient. She stated that MD 1 requests preservative-free medications due to the proximity (closeness) of the injection site to the brain. She admitted that she was aware that the Isovue was preservative-free and was used for multiple patients by MD 1, and possibly other physicians. Nurse R stated that MD 1 draws up his own medications while the scrub tech holds the vial. She was unsure if other physicians draw up their own medications.

During an interview on December 5, 2013, with the Chief of Staff (MD 3), at 9:05 AM, he confirmed that he is a member of the Governing Board (GB-a group of physicians, adminisrators, and sometimes non-medical persons who decide how the hospital is run and approves the facility policy and procedures and develops and approves medical staff bylaws with the medical staff) and he was unaware that the Pharmacist and director of Anesthesia services were not monitoring the medications used in the OR. He also was unaware that the OR staff were using SDV's for multiple patients.

A review of the facility policy titled "Single Use Sterile (free of living microorganisms) Drugs and Devices", reviewed January 2011, indicated "Single-use sterile drugs and devices shall be used and disposed of in accordance with this policy." "Single-use sterile drugs and devices shall not be reused. Unused portions of single-use sterile drugs shall not be saved for later use." "The Director of Pharmacy shall ensure the disposal of all contaminated (a condition of being soiled, stained, touched or otherwise exposed to harmful agents, making an object potentially unsafe for use) and potentially contaminated single-use sterile drugs and devices in accordance with the facility's policies."

Review of the Medical Staff Bylaws, dated March 28, 2013, indicated under "Article II. The purpose of this organization shall be: a. To see that all patients admitted to or treated in any of the facilities, departments, or services of the Hospital shall receive high quality care consistent with the capability of the Hospital and to provide a mechanism to ensure a uniform standard of quality patient care, treatment and services."... 3.7 "Each member of the Medical Staff shall pledge to: a. provide patients with care at the generally recognized professional level of quality and efficiency established by the Medical Staff ....d. Abide by the Medical Staff Bylaws, Rules and Regulations, policies and rules of the Hospital".

2 &3. During a second observation in OR 2 on December 2, 2013 at 2:20 PM, upon checking the OR 2 Anesthesia cart, it was noted to be unlocked and unattended. Inside the cart, in drawer three, nine unlabeled syringes of a white substance (Propofol-an anesthetic agent) were observed. Also, three incompletely labeled syringes of Fentanyl (a pain medication) were observed in the same unlocked, unattended drawer. These findings were observed and verified by the CEO and the OR Manager.

During an interview with CRNA 1 (Certified Registered Nurse Anesthetist) on December 2, 2013 at 2:30 PM outside of the OR Managers office, he confirmed that he left the Anesthesia Medication Cart unlocked and unattended after he left OR 2. He stated that he did so because he didn't have a key to lock the anesthesia medication cart. He also confirmed that he had drawn up Propofol into syringes, and left them in the third drawer, because he needed some medication on hand. He was reminded that nine unlabeled, unsecured pre-drawn syringes of Propofol were found sitting in the anesthesia cart drawer along with three incompletely labeled syringes of Fentanyl. He confirmed that the syringes of Fentanyl were not labeled with the date, time, and the name of the person who drew up the medications. The CEO was also present during the interview.

During an interview on December 4, 2013, at 10:00 AM, with the medical director of Anesthesia (MD 2), he stated that he oversees all anesthesia services provided in the facility. He was surprised to hear that nine syringes of unlabeled white substance (Propofol) were found in an unlocked, unattended anesthesia medication cart in OR 2. He stated that he does not supervise the CRNA because he is under the supervision of the Anesthesiologist/Pain Specialist (MD 1) during the procedure. He was surprised that MD 1 did not supervise the CRNA. The CEO was also present during the interview.

During an interview on December 5, 2013, with the Chief of Staff (MD 3), at 9:05 AM, he confirmed that he is a member of the Governing Board (GB) and has become aware, through the survey findings, that CRNA 1 left nine pre-drawn, unlabeled syringes of Propofol unattended in the unlocked anesthesia medication cart in OR 2. He stated that he interviewed CRNA 1 about the syringes of Propofol drawn up and left unattended in the anesthesia medication cart and CRNA 1 told MD 3 "I do that all the time." MD 3 stated, "That should never happen." MD 3 stated that he expected the medical director of anesthesia to supervise the anesthesiologist/pain specialist performing the procedure and the CRNA providing the patient anesthesia while they are providing anesthesia services in the facility. He further stated that he was unaware that the Pharmacist and director of Anesthesia services were not monitoring the medications used in the OR. MD 3 expected the Chief of Anesthesia to provide monitoring and surveillance of all anesthesia services provided in the facility and he expected the anesthesia director to share any concerns with him.

Review of the facility policy titled "Medication Labeling", revised June 2011, "1. Medications will be labeled in a standardized manner in accordance with the state and federal laws and regulations. 2. Medication containers are labeled whenever medications are prepared but not immediately administered... 5. Staff will label all medications and medication containers, even if only one medication is used in the procedure. Medication containers include syringes..."

Review of the facility policy titled "Storage of Medications", revised February, 2013, "1. Approved medications are properly and safely stored throughout the hospital between receipt by an individual health care provider and administration of the medication, including safe storage, handling, security, disposition, and return to storage."

Review of the Medical Staff Bylaws, dated March 28, 2013, indicated under "Article VII: Allied Health Professionals (AHP's) 7.3. Procedure for Granting Practice Privileges. An AHP (CRNA 1) must apply and qualify for practice privileges; and practitioners who desire to supervise or direct AHP's who provide dependent services must apply and qualify for privileges to supervise approved AHP's... Each AHP shall be assigned to the clinical Department appropriate to their occupational or professional training and, unless otherwise specified in the Rules and Regulations, shall be subject to terms and... ...appropriately tailored to the particular AHP's profession." Also, 11.2 Organization of Departments. "The Department Chair shall have general supervision over the work within the department and shall be responsible to the Medical Executive Committee..." 11.3. Functions of Department Chairs (g) "Conduct ongoing review and continuing surveillance of the professional performance of practitioners with clinical privileges in the department." Also, "10.7-1 Chief of Staff: "The Chief of Staff shall serve as the Chief Administrative Officer of the Medical Staff to: be responsible for the enforcement of Medical Staff Bylaws, Rules and Regulations."

Based on interview and record review, the hospital failed to ensure that a physician order for a change in medication route was carried out for 1 of 47 sampled patients (Patient 74) in a universe of 43 patients. This failure had the potential to result in an adverse drug reaction.

Findings:

During a review of the medical record for Patient 74 the record showed that the patient was admitted to the facility on November 5, 2013, with diagnoses that included status post septic shock (after having an overwhelming infection of the blood that could lead to death).

During a review of the Physician Orders dated November 21, 2013, it was noted that the following telephone orders were received by the nurse:

Change Divalproex {Depakote-a medication to prevent seizures(seizures-a sudden, violent involuntary contraction of a group of muscles)}to liquid form 500 mg (milligrams) NGT (naso-gastric tube-a tube inserted through the nose into the stomach) daily.
Depakote level in AM.

Change Protonix (a medication to reduce stomach acid) to IV (intravenous) 40 mg daily.
Albumin 25% (protein) 100 ml (milliliters) IV X1 (one time) dose.

During a review of the computer medication administration record (CMAR), it showed that Protonix was given by NGT from November 21, 2013 until November 28, 2013.

The order to change Protonix NGT to IV was not carried out by the nursing staff.

In an interview on December 3, 2013 at 4:20 PM, was conducted with the Clinical Analyst. The Clinical Analyst stated that the Protonix order for a change of route given was not carried out by the nursing staff and should have been.

Based on interview and record review, the hospital failed to ensure that 4 of 47 sampled patients (Patients 63, 72, 73 and 74), in a universe of 43 patients, had all of their physician orders authenticated (with the name, date and time) of the ordering practitioner, within 48 hours. This failure had the potential for errors in transcription and the potential to affect the patients' treatment and safety.

Findings:

1. During a record review for Patient 63, it was noted that the daily assessments for the necessity of a Foley catheter (a flexible tube placed through the patient's urethra and into the urinary bladder used for passing urine), had not been authenticated by the ordering physician for the following dates: November 15, 16, 17, 18, 19, 20, 21, 29 and 30, 2013. The daily assessment for the need of the Foley catheter on these dates, did not include the physician's signature, or the time and date the physician had reviewed and approved the continuing use of the Foley catheter, for Patient 63.

On December 2, 2013, at 10:30 AM, during the time of record review for Patient 63, the Supervisor Nurse (RN 2) and the Clinical Analyst assisting with the computer record review, both stated, that the daily assessments for the use of the Foley catheter should be signed and authenticated, by the ordering physician, within 48 hours of when the order was written.



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2. During a record review on December 2, 2013, for Patient 72, it was noted that the daily assessments for the necessity of a Foley catheter and a Central Line (tube inserted into a large vein by the physician to use for intravenous medication, fluid and nutrition and/or for blood draws for lab tests) had not been authenticated by the ordering physician for the following dates: November 28, 29 and 30, 2013. The daily assessment for the need of the Foley catheter and Central Line on these dates did not include the physician's signature or the time and date the physician had reviewed and approved the continuing use of the Foley catheter and Central Line for Patient 72.

On December 2, 2013, at 10:30 AM, during the time of record review for Patient 72, the Chief Clinical Officer (CCO), stated that the daily assessments for the use of the Foley catheter and Central Line should be signed and authenticated, by the ordering physician daily.

3. During a record review for Patient 73, it was noted that the daily assessments for the necessity of a Foley catheter and a Central Line had not been authenticated by the ordering physician for the following dates: November 23, 28, 29 and 30 and December 1, 2013. The daily assessment for the need of the Foley catheter and Central Line on these dates did not include the physician's signature or the time and date the physician had reviewed and approved the continuing use of the Foley catheter and Central Line for Patient 73.

On December 3, 2013, at 10:50 AM, during the time of record review for Patient 73, RN (Registered Nurse) 3 acknowledged that the Foley catheter and Central Line assessment forms should be signed and authenticated, by the ordering physician.

4. During a review of the medical record for Patient 74 on December 3, 2013, the record showed that the patient was admitted to the facility on November 5, 2013 with diagnoses that included status post septic shock (after having an overwhelming infection of the blood that could lead to death).

During a review of the Physician Orders dated November 14, 2013 for morphine 4 mg (milligrams) IVP (intravenous push-giving the medication through the vein) it was noted that the order was not signed, dated or timed by the physician.

During a review of the Physician Orders dated November 21, 2013, it was noted that the following telephone orders were received by the nurse:

1. Change Divalproex (Depakote-medication to prevent seizures) to liquid form 500 mg NGT (naso-gastric tube-a tube inserted through the nose into the stomach) daily.
2. Depakote level in AM.
3. Change Protonix (a medication to reduce stomach acid) to IV (intravenous) 40 mg daily.
4. Albumin 25% (protein) 100 ml (milliliters) IV X1 (one time) dose.

The telephone orders were not authenticated, dated or timed by the physician.

During an interview on December 3, 2013 at 4:20 PM with the Clinical Analyst, the Clinical Analyst stated that the physician orders were not signed and acknowledged that they should have been.

Based on observation, interviews and record review, the hospital's Pharmaceutical Services were not provided to meet the needs of the patients. The facility failed to ensure the following:

(1) That medication use and supply was under the supervision of the Pharmacist in charge (PIC) by failing to do the following:

A. Single Dose Vial medications were used for only one patient and then discarded.
B. All medications in syringes were labeled with the date, time, medication name and person who drew up the medication.
C. All medications were stored in a secure manner, away from all unauthorized personnel. (Refer to (A-0501)

(2) That directions for the management of Insulin (a medication used to decrease blood sugar levels) dependent patients requiring Sliding Scale Regular Insulin to the nursing staff were based on measured blood sugar levels and failed to ensure that the level or intensity of pain (mild, moderate, severe) being treated matched the therapeutic potency of the drug selected for pain. (Refer to A-0500)

The cumulative effect of these systemic problems resulted in the hospital's inability to ensure the provision of pharmaceutical services in a safe environment.

Based on interview and document review, the facility failed to ensure that (1) directions for the management of Insulin (a medication used to decrease blood sugar levels) dependent patients requiring Sliding Scale Regular Insulin to the nursing staff were based on measured blood sugar levels, (2) the level or intensity of pain (mild, moderate, severe) being treated matched the therapeutic potency of the drug selected for pain. This failure had the potential to adversely impact patient care in a universe of 43 patients.

Findings:

1. A review of the facility's preprinted form titled, "Spinal (the backbone) Surgery Post-Operative Orders" indicated the following:

Sliding Scale Regular Insulin
Blood Glucose 121-150 mg/dl (milligrams per deciliter) = 2 units of Insulin
Blood Glucose 151-200 mg/dl = 2 units of Insulin
Blood Glucose 201-250 mg/dl = 2 units of Insulin
Blood Glucose 251-300 mg/dl = 2 units of Insulin
Blood Glucose 301-350 mg/dl = 2 units of Insulin
Blood Glucose Over 350 mg/dl = 2 units of Insulin (Notify On-Call Physician)

The hospital failed to proactively provide safe and effective insulin dosing guidelines to administer doses of insulin to meet the blood sugar goals ordered by the physician by not changing the insulin dose with changes in a patient's blood glucose level.

During an interview with the Director of Pharmacy on December 5, 2013 at 3:15 PM, and an interview with the CEO (Chief Executive Officer) on December 6, 2013 at approximately 3:30 PM, they acknowledged that the preprinted form titled, "Spinal Surgery Post-Operative Orders" approved by the medical staff committees lacked proper guidance to the nurses for medication administration.

2. A review on December 5, 2013 at 3:15 PM of the facility's preprinted form titled, "Spinal Surgery Post-Operative Orders" indicated the following:

Acetaminophen (a pain medication for mild to moderate pain) 1{Gr (gram)} IV (intravenous) Over 15 min (minutes) Q (every) 6 hours X(times) 48 hours
Dilaudid (strong narcotic pain medication) ____(blanks for the physician to fill in the dose ) mg (milligram) IV every ____ (blank for the physician to fill in how often the medication is to be given)hours as needed for pain
Morphine (narcotic pain medicatiion) ___mg IV every ____ hours as needed for pain
Demerol (narcotic pain medication) ___ mg IV every ___ hours as needed for pain __15 mg __ 30 mg
Toradol (non-narcotic pain medicatiion) ___ mg IM (intramuscular)/IV every 6 hours prn (as needed) for pain (not to exceed 5 days) IM/IV loading dose pump
The level or intensity of pain (mild, moderate, severe) being treated did not match the therapeutic potency of the drug selected for pain.
During an interview with the Pharmacist in charge (PIC) on December 5, 2013 at 3:15 PM, and an interview with the CEO (Chief Executive Officer) on December 6, 2013 at approximately 3:30 PM, they acknowledged that the preprinted form approved by the medical staff committees lacked proper guidance to the nurses for medication administration.

Based on observation, interview and record review the hospital failed to ensure that medication use and supply was under the supervision of the Pharmacist in charge (PIC) by failing to do the following:

1. Single Dose Vial medications were used for only one patient and then discarded.
2. All medications in syringes were labeled with the date, time, medication name and person who drew up the medication.
3. All medications were stored in a secure manner, away from all unauthorized personnel.

These failures had the potential to affect the health and safety of all patients receiving medications in the operating room.

Findings:

1. During the initial tour of the Surgery area on December 2, 2013, at 10:40 AM, in OR Operating Room) 2, the Scrub Tech (ST 1) was observed preparing six vials of medication for the next surgical patient. ST 1 stated that they had performed five spine (the backbone) procedures that morning and according to the OR schedule, there were 14 more spine procedures scheduled that day for OR 2. Six vials of medication were observed, three of the vials had a protective cover on the vial, indicating that they had not been opened as yet, and three with the protective cover removed and the date (December 2, 2013) written on the vial. All three opened vials appeared partially empty and the medication labels read: 1. Sensorcaine MPF (Bupivacaine Hcl) 30 ml (milliliters) 0.5% (pain medication). 2. Isovue M300 15ml (contrast agent-a substance used to enhance the contrast of structures or fluids within the body in medical imaging). 3. Marcaine 0.25% (Bupivacaine Hcl) 30ml (pain medication). These findings were observed and verified by the CEO (Chief Executive Officer) and the OR Manager. ST1 stated the opened vials were multi-dose vials (which can be used multiple times, possibly for multiple patients because they contain a preservative). However upon inspection, all of the vial labels indicated the medications were preservative-free and for single patient use only (single dose vial). ST 1 explained that spine procedures, 19 of which were scheduled for that day, required preservative-free medications. The vials were observed to be single dose vials (SDV) without preservative in them. The medication labels of the opened vials indicated that the remaining contents of each vial should be thrown away after use on a single patient. ST 1 confirmed that the three opened vials of medication had been used for prior patients, were going to be used on the next patient and had not been discarded after use on a single patient. These findings were observed and verified by the CEO and the OR Manager. During a concurrent interview, the OR Manager said, "We will get you new medications."

During an interview with Surgical Tech 2 (ST 2) on December 2, 2013, at 1:55 PM he stated that he was not certain how long he had been using SDV for multiple patients, but he has been doing it as long as he's been here. He has been working at the facility for ten months. He said he was just doing what he had been told to do. At the same time ST 1 was questioned further, she stated that she had "always done it this way, it was how I was trained. She estimated that the practice had been going on for a year. The CEO and the OR Manager were present during the interviews.

During an interview with MD (Medical Doctor) 1 in the physicians lounge, on December 2, 2013, at 2:00 PM, MD1 stated that he was unaware that the scrub techs were using SDV medications on multiple patients, except for the use of Isovue. He stated that he had knowledge that the Isovue was being used for more than one patient. He stated that at another facility he was told it was not cost-effective to use the Isovue on only one patient and then throw it away. He said he drew up the medications himself with a new needle and a new syringe each time, but confirmed that he did not look at the medication label to verify the identity of the medication. He confirmed that he does not want to use medication with preservative in it for spinal injection procedures. The CEO and the OR Manager were present during the interview.

During an interview with the Pharmacist in charge (PIC) on December 2, 2013 at 3:45 PM, he stated he was unaware that the OR staff were using SDV of medication for multiple patients. He also was unaware of how many vials of medication were used for the 19 procedures in the OR 2 surgery schedule for December 2, 2013. When asked if he noticed that there were 19 procedures on the schedule and thus 19 vials of medications would be used or required, he said "No." The CEO and the pharmacy representative for the contracted service were present during the interview. The PIC was asked to provide records of how many vials of medication were used for the 19 procedures that day and he was unable to produce any medication records. Therefore, the pharmacy was unaware of the amount of each medication (Buprivocaine & Isovue) required or used by the OR staff. The PIC was asked if he monitored the medications used in the OR and he replied "No."

During an interview on December 5, 2013, with the Chief of Staff (MD3), at 9:05 AM,
he confirmed that he is a member of the Governing Board (GB-a group of physicians, adminisrators, and sometimes non-medical persons who decide how the hospital is run and approves the facility policy and procedures and develops and approves medical staff bylaws with the medical staff) and he was unaware that the Pharmacist and director of Anesthesia (medication induced absence of all sensation, for example, pain) services were not monitoring the medications used in the OR. He also was unaware that the OR staff were using Single dose vials (SDV) for multiple patients.

Review of the facility policy titled "Single Use Sterile (free of living microorganisms) Drugs and Devices", reviewed January 2011, indicated, "Single-use sterile drugs and devices shall be used and disposed of in accordance with this policy." "Single-use sterile drugs and devices shall not be reused. Unused portions of single-use sterile drugs shall not be saved for later use." "The Director of Pharmacy shall ensure the disposal of all contaminated (a condition of being soiled, stained, touched or otherwise exposed to harmful agents, making an object potentially unsafe for use) and potentially contaminated single-use sterile drugs and devices in accordance with the facility's policies."

2 & 3. During an observation in OR 2, on December 2, 201,3 at 2:20 PM, upon checking the OR 2 Anesthesia cart, it was noted to be unlocked and unattended. CRNA 1 (Certified Registered Nurse Anesthetist 1) was not present in the OR. Inside the cart, in drawer three, nine unlabeled syringes of a white substance were observed (Propofol-an anesthetic). Also, three incompletely labeled syringes of Fentanyl (a pain medication) were observed in the same unlocked, unattended drawer. These findings were observed and verified by the CEO and the OR Manager.

During an interview with the CRNA 1 on December 2, 2013 at 2:30 PM, outside of the OR Managers office, he confirmed that he had left the Anesthesia Medication Cart unlocked and unattended after he left OR 2. He stated that he didn't have a key to lock the anesthesia medication cart. He also confirmed that he had drawn up Propofol (an anesthetic agent) into syringes, and left them in the third drawer unlabeled, because he needed some medication on hand. He was reminded that nine unlabeled, unsecured pre-drawn syringes of white substance were found sitting in the anesthesia cart drawer along with three incompletely labeled syringes of Fentanyl. He confirmed that the syringes of Fentanyl and Propofol were not labeled with the date, time, and the name of the person who drew up the medications. The CEO was also present during the interview.

During an interview with the Pharmacist in charge (PIC) on December 2, 2013, at 3:45 PM, the (PIC) confirmed that he did not monitor the medications used in the O.R. He was unaware that medications were being drawn up into syringes and left unattended in the unlocked anesthesia medication cart. The CEO was also present during the interview.

During an interview on December 5, 2013, with the Chief of Staff (MD 3), at 9:05 AM, he confirmed that he is a member of the Governing Board (GB) and has become aware that CRNA 1 left nine pre-drawn, unlabeled syringes of Propofol unattended in the unlocked anesthesia medication cart in OR2. He stated that he interviewed CRNA 1 about the syringes of Propofol drawn up and left unattended in the anesthesia medication cart and CRNA 1 told MD 3 "I do that all the time." MD 3 stated, "That should never happen."

Review of the facility policy titled "Medication Labeling", revised June, 2011, indicated, 1. "Medications will be labeled in a standardized manner in accordance with the state and federal laws and regulations. 2. Medication containers are labeled whenever medications are prepared but not immediately administered. 5. Staff will label all medications and medication containers, even if only one medication is used in the procedure. Medication containers include syringes..."

Review of the facility policy titled "Storage of Medications", revised February 2013, indicated, "1. Approved medications are properly and safely stored throughout the hospital between receipt by an individual health care provider and administration of the medication, including safe storage, handling, security, disposition, and return to storage."

Based on observation and interview, the facility failed to maintain a crash cart with the required resuscitative, monitoring equipment, and medications within the Radiology Department to meet the needs of the patients.

This failue had the potential to affect the health and safety of patients by not having essential emergency supplies readily available.

Findings:

During a tour of the Radiology Department on December 6, 2013 at approximately 2:45 PM, it was observed that a crash cart (a specialized cart that contains emergency supplies and equipment to resusitate a patient) was not available.

In an interview with the CEO and Board Members on December 6, 2013 at approximately 3: 30PM, they acknowledged that a crash cart was not available in the Radiology Department.

Based on observations, interviews and record reviews, the hospital failed to ensure that the director of dietary services developed procedures, monitored staff practices and knowledge according to standards of practice for the dietary operational practices at the hospital. The hospital also failed to ensure the director of dietary services satisfied all the requirements of the California Health and Safety Code 1265.4 before assuming the position. This deficiency had the potential to affect the health and safety of patients.

Findings:

1. During a tour of the kitchen on December 3, 2013, at 9:05 AM, reach-in freezers #1 and 2 were observed. The freezers contained multiple items that had been removed from their original boxes. The items included: approximately 20 individual pizzas, 12 large pans of Healthy Choice entrees, a bag containing scallops, a bag containing lobster ravioli, a bag containing chicken breasts, a bag containing stuffed mushrooms, 3 bags of French fries, and a ziplock bag containing potato cubes. None of the items were dated to indicate an expiration or manufacture date.

During a concurrent interview with the Dietary Manager (DM), he stated, "We rarely date things in the freezer." He was unable to explain how they monitor the shelf life of the frozen items without dating them.

Also observed the same day, at 9:45 AM, in refrigerator #3, were 9 large beef roasts, raw and individually sealed, labeled with a received date of November 26, 2013, 7 days prior. Also observed in refrigerator #4 were 3 sealed bags of peeled, hard cooked eggs labeled with a received date of November 29, 2013. There were no expiration or use by dates on these products.

During a concurrent interview with the DM, he stated that the roasts and eggs were delivered in boxes and had been removed from their boxes. He was unable to state how long the foods could be safely stored in the refrigerator. He reviewed the hospital's policy and procedures for storage guidelines and was unable to find staff guidance on the shelf life of the beef. He verified that the expiration or use by date for the eggs was on the box that it came in which had been discarded.

A review of the hospital's policy titled "Food and Supply Storage", dated August 2012, indicated that, "For food products that are opened and not completely used or prepared at facility and stored, the product should be labeled as to its contents and use by dates." It also directed staff to, "Rotate food products (dry, refrigerated, or frozen) to ensure the oldest inventory is used first...a product's use date or delivery date is marked on the product."

2. During a tour of the cafeteria on December 3, 2013, at 11:45 AM, several quarts of a liquid egg product labeled "keep frozen" were observed in a reach-in refrigerator in the cafeteria. Most of the quarts were still frozen, but eight were not. There were no dates on the cartons to indicate when they had been placed in the refrigerator to thaw. The label on the cartons indicated that the product should be kept frozen and was best if used within 3 days of opening. None of the cartons were opened. There was no guidance on the label regarding how long the product was safe once it was thawed but unopened.

During a concurrent interview with the DM and the Registered Dietitian (RD), they were unable to state how long the egg product could be safely stored once thawed. The DM stated that the 8 thawed quarts had been in the refrigerator since the last delivery, one week prior. The remaining frozen quarts had been delivered that day. The DM did not have guidance as to how long the refrigerated shelf life for the product was.

3. During a tour of the kitchen on December 3, 2013, at 9:30 AM, patient coffee cups were noted stacked adjacent to the trayline (where patient meal trays were assembled). The cups were inspected. Six cups were noted to have significant brown stains on the inside.

During a concurrent interview with the DM, he stated that the stacks of cups were clean. He verified that many of the inspected cups were stained. He stated that these cups should have been discarded and not served to patients.

A review of the hospital's policy titled "Dishwashing: Dish Machine", dated August 2013, indicated directions to staff, "Clean Dishes, remove rack from the (dish) machine when cycle is finished. Inspect the rack as it comes out of the machine for soiled items. Items that are not thoroughly clean are sent through the dish machine again."

4. During an interview and concurrent observation with Dietary Staff (DS) on December 3, 2013, at 10:10 AM, DS demonstrated how the patient dishes were washed. DS was observed loading dirty patient dishes on a rack which was then placed in the dish machine to be cleaned. When the dishes were clean, DS removed the rack of dishes from the dish machine and allowed them to dry for a couple of minutes. DS was then observed removing and stacking the clean dishes. DS was observed twice handling the dirty and then clean dishes without washing her hands in between. During a second observation the same day at 11:17 AM, DS was again observed handling dirty dishes then clean dishes without washing her hands.

During an interview with Corporate Registered Dietitian the same day, at 11:17 AM, she stated that she had noticed that DS did not wash her hands between handling dirty and clean dishes.

A review of the hospital policy titled "Dishwashing: Dish Machine", dated August 2013, indicated that for clean dishes, "Remove rack (of clean dishes) from the machine when the cycle is finished. Hands must be washed according to standard hand washing procedures prior to handling clean dishes."

A hospital Education/Training Attendance Roster, dated May 30, 2013, showed that DS had attended a program titled "Personal Hygiene" in which hand hygiene was discussed. There was no documentation that DS was competent or evaluated to ensure she understood the training.

5. During a concurrent observation and interview with Dietary Staff (DS), on December 3, 2013, at 10:10 AM, DS demonstrated how she tested the concentration of the sanitizing solution used in emergency dish washing. DS immersed the test strip in the sanitizer solution for 2 seconds. The strip was then compared to the color chart which indicated that the solution was less than 200 parts per million (ppm). DS stated that the sanitizer needs to be 200 ppm.

A concurrent review of the directions on the test strip dispenser indicated that the strip must be immersed in the solution for 10 seconds before comparing it to the color chart to determine the concentration.

The DM and RD were unable to provide evidence that DS had been trained on how to properly test the concentration of the sanitizer.

6. During an observation and concurrent review of the hospital's disaster food plan, on December 3, 2013, at 10:15 AM, the plan indicated that 3 ounces of canned tuna would be served to patients requiring a pureed texture diet at lunch and dinner for all four days of the plan.

During a concurrent interview with the Corporate Registered Dietitian, she confirmed that the plan lacked instructions on how tuna could be pureed if there were no utilities available during a disaster.

During a concurrent interview with the DM, he verified that the plan relied on many canned items. He stated that there were hand held manual can openers stored in his office that could be used in the disaster. He also stated that the kitchen had a table mounted commercial type can opener that could also be used. He verified that the plan did not indicate where the can openers were located. He also verified that staff who did not normally work in the kitchen may not know where the commercial type can opener was located or how to use it.

A review of the hospital's policy titled "Disaster Feeding/Menu Plan", dated June 2011, did not reveal details on how the canned tuna would be pureed. It also did not provide direction to staff on the location of the can openers or how to use them. It further stated that "pureed or mechanically altered food will be available for patients requiring them."

7. According to the State of California Health and Safety Code, 1265.4, a licensed health facility shall employ a full-time, part-time, or consulting dietitian. A health facility that employs a registered dietitian less than full time (to run the daily operations of the dietary services), shall also employ a full-time dietetic services supervisor who meets the requirements of subdivision (b) to supervise dietetic service operations. The dietetic services supervisor shall receive frequently scheduled consultation from a qualified dietitian.
(b) The dietetic services supervisor shall have completed at least one of the following educational requirements:
(1) A baccalaureate degree with major studies in food and nutrition, dietetics, or food management and has one year of experience in the dietetic service of a licensed health facility.
(2) A graduate of a dietetic technician training program approved by the American Dietetic Association, accredited by the Commission on Accreditation for Dietetics Education, or currently registered by the Commission on Dietetic Registration.
(3) A graduate of a dietetic assistant training program approved by the American Dietetic Association.
(4) Is a graduate of a dietetic services training program approved by the Dietary Managers Association and is a certified dietary manager credentialed by the Certifying Board of the Dietary Managers Association, maintains this certification, and has received at least six hours of in-service training on the specific California dietary service requirements contained in Title 22 of the California Code of Regulations prior to assuming full-time duties as a dietetic services supervisor at the health facility.
(5) Is a graduate of a college degree program with major studies in food and nutrition, dietetics, food management, culinary arts, or hotel and restaurant management and is a certified dietary manager credentialed by the Certifying Board of the Dietary Managers
Association, maintains this certification, and has received at least six hours of in-service training on the specific California dietary service requirements contained in Title 22 of the California Code of Regulations prior to assuming full-time duties as a dietetic services supervisor at the health facility.
(6) A graduate of a state approved program that provides 90 or more hours of classroom instruction in dietetic service supervision, or 90 hours or more of combined classroom instruction and instructor led interactive Web-based instruction in dietetic service
supervision.
(7) Received training experience in food service supervision and management in the military equivalent in content to paragraph (2), (3), or (6).

A review of the job description for the Dietary Manager (DM) indicated that it was the duties of the position to plan, direct and coordinate the activities of the Food Services Department to provide dietetic services to patients as well as employees and guests. The duties also included establishing policies and procedures to provide administrative direction for cafeteria menu formation, food preparation, distribution and service, budgeting, purchasing, sanitation standards, safety practices, staffing and staff development.

During a review of the employee file for the DM, on December 5, 2013, it was noted that his credentials included a Certified Dietary Manager through the period ending August 31, 2014. It further indicated that the credentials included an associates of arts degree in culinary arts. There was no documented evidence that he completed the required minimum of six hours of in-service training on the specific California dietary service requirements contained in Title 22 of the California Code of Regulations prior to assuming full-time duties as a dietetic services supervisor at the hospital.

During an interview with the Registered Dietitian (RD), she stated that her duties included providing clinical nutrition services for the patients in the hospital. She did not run the daily operations of the dietary services. The DM ran the daily operations of the dietary services with consultation from the RD.

During an interview with the DM, on December 5, 2013, at 4:00 PM, he verified that he had not completed the Title 22 continuing education requirements. He had other training that he had completed that did not specifically cover Title 22 dietetic services requirements.

Based on observations, interviews and record reviews, the hospital failed to:
1. Follow the physician ordered fluid restriction for one of 47 sampled patients (Patient 41). This failure had the potential to negatively impact the medical condition for Patient 41.
2. Ensure that the patient menus met the nutrition needs of the patients. This failure had the potential to result in constipation and under nutrition in a medically vulnerable patient population.


Findings:

1. A review of the medical record for Patient 41 indicated that the patient was admitted to the hospital on November 23, 2013. The patient was admitted with diagnoses that included hyponatremia (low blood sodium level often treated with restricted fluids). A review of the physician orders showed an order, dated December 2, 2013, for "Fluid Restriction, Restrict to 1000 ml (milliliters)/(per)24 hours."

A review of the laboratory reports for Patient 41, dated December 2, 2013, showed her sodium was 130 milliequivalents per liter (mEq/L). Normal sodium level was 136-145 mEq/L.

During an observation of trayline (patient meal tray assembly), on December 3, 2013, at 12:15 PM, the lunch tray for Patient 41 was reviewed. The liquids on the meal tray included a 125 milliliters (ml) of juice, 237 ml of milk and 237 ml of ice tea, for a total of 599 ml of fluids. At 12:30 PM, the meal tray was given to the patient. Also at her bedside was a cup with approximately 180 ml of water a pitcher that contained approximately 750 ml of ice water. There was no notice in the patient room indicating that there was an order for fluid restriction.

A review of the Intake and Output ( a record kept of the amount of fluid a patient drinks or takes in intrvenously and the fluid the patient puts out such as urine or wound drainage) for Patient 41 for December 3, 2013, indicated that the patient drank 360 ml of fluid at 12:30 AM, 120 ml of fluid at 5:21 AM, 240 ml of juice and 180 ml of milk at 11:44 AM. This was a total of 900 ml before the patient was served 599 ml at lunch.

During an interview with Registered Nurse 1 (RN 1), the same day at 12:30 PM, she stated that she was the nurse for Patient 41. She was not aware that the patient was on a fluid restriction. RN 1 looked at the medical record for the patient and verified that there was a physician order for 1000 ml fluid restriction in 24 hours.

During a concurrent interview with the Registered Dietitian (RD), she confirmed that the patient had a physician order for a 1000 ml fluid restriction. She also verified that the patient was served 599 ml of fluid on her lunch tray and had about 180 ml of water in the cup with a straw. She stated that the procedure for ensuring that physician ordered fluid restrictions were followed was that dietary provided half of the fluid restriction for the day on the patient's meal trays. She stated that with a 1000 ml fluid restriction, dietary provided 240 ml at breakfast, 120 ml at lunch and 120 ml at dinner. She could not explain why Patient 41's tray contained 599 ml of fluids at lunch.

A review of the hospital's policy titled "Fluid Restriction", dated August 2013, indicated that "Patients requiring a controlled amount of fluid intake (fluid restricted) are provided the correct amount of daily fluid by designated staff as indicated in the fluid restriction medical order." It further stated "Licensed nursing staff or designated staff will remove the bedside water pitcher and place a fluid restriction notice in the patient room when fluid restrictions are ordered."

2. A review of the hospital's nutrition analysis of the patient menus showed that, for the regular diets, it met between 39 and 59% of the Dietary Reference Intakes (DRIs) for dietary fiber. The DRIs are published by the Food and Nutrition Board of the Institute of Medicine, National Academy of Sciences and serve as the standard of practice in menu planning. For Vitamin D the menu met between 34 and 55% of the DRIs. For Vitamin E the menus met 47 to 64% of the DRIs. For Vitamin K the menus met 58% of the DRIs for week one of the menu cycle. For folate the menus met 86 to 98% of the DRIs. For potassium the menus met 73 to 84% of the DRIs. For zinc the menus met 82 to 91% of the DRIs. For magnesium the menus met 70 to 82% of the DRIs.

During an interview with the Registered Dietitian, on December 5, 2013, at 10:00 AM, she verified that the menus did not meet the above DRIs and stated that corporate was working on new menus.

Based on observation, interview and record review, the hospital Infection Control Preventionist failed to provide effective infection control oversight in the surgical services operating room (OR) areas when the hospital failed to ensure the following:

1. That Surgical Tech (ST 2) followed the required four minute dwell time (must stay wet four minutes to be effective against specified organisms) of the cleaning wipes (PDI Sani-cloth) as recommended by the manufacturer (PDI - Professional Disposables International).

2. That the OR staff did not use SDV (single dose vials) of medication for multiple patients.

3. That medications were not being drawn up into syringes and left unattended in the unlocked anesthesia (medication induced absence of all sensation, for example, pain) medication cart.

This failure had the potential to increase the risk for contamination and infections resulting in a delay in the healing process and/or a decline in health status for patients receiving surgical services in the hospital in a universe of 43 patients.

Findings:

1.During an observation in OR 2, on December 2, 2013, at 2:20PM, ST 2 was observed to be cleaning the top portion of the OR (Operating Room) table mattress pad, in preparation for the next patient, with a PDI (Professional Disposables International) Sani-cloth which required a four minute dwell time (must stay wet four minutes to be effective to kill specified organisms). The OR table appeared to be almost completely dry after just two to three minutes. During the observation, ST 2 did not clean the bottom of the OR table mattress pad. During a concurrent interview, ST 2 was asked if the OR table mattress pad had been disinfected properly, since it was almost completely dry after two to three minutes. ST 2 pointed to a two inch by two inch area of the OR table mattress pad that was still wet and said " yes, the table is still wet. " It was mentioned to ST 2 that the entire surface of the OR table mattress pad must remain wet for four minutes, and may need additional wiping with the Sani-cloth to remain wet for the entire four minutes. The dwell time is the exposure time to the disinfectant required to kill all specified organisms on the OR table mattress pad between patients. These findings were observed and confirmed by the CEO (Chief Executive Officer) and the OR Manager.

During a group interview on December 5, 2013, at 1:15 PM, with the Infection Control Preventionist (ICP) and two corporate area directors (IC-AD 1 & 2) who supervised the ICP, the ICP confirmed and stated that there was "no routine monitoring or surveillance of the OR area" to identify any infection control concerns. When asked if the cleaning of the OR table was observed or monitored for appropriate disinfection, the answer was "No." The ICP and IC-AD 1 confirmed that there was no monitoring or surveillance of the OR by the infection control staff but that they rely on the OR Manager or the Pharmacist or other OR staff to report infection control issues. When asked if they ever rounded in the ORs at the beginning or in the middle of the day, they stated "No."

The CDC (Centers for Disease Control and Prevention) Healthcare Infection Control Practices Advisory Committee (HICPAC) under Guidelines for Disinfection and Sterilization in Healthcare Facilities, 2008 stipulated that the effective use of disinfectants is part of a multibarrier strategy to prevent health-care-associated infections, and "By law, users must follow all applicable label instructions for EPA-registered products" related to the contact times for surface disinfectants. (EPA - Envirnomental Protection Agency, an independent federal agency to coordinate programs aimed at reducing pollution and protecting the environment).

During a review of the hospital "PDI Sani-Cloth Bleach Wipe," used to disinfect surfaces stipulated that the product had a contact/dwell time of 4 minutes to be effective, to clean and disinfect. The manufacturer indicated that the product "Disinfects in just four minutes."

2. During the initial tour of the Surgery area on December 2, 2013, at 10:40 AM in OR 2, the Scrub Tech (ST 1) was observed preparing six vials of medication for the next surgical patient. ST 1 stated that they had performed five spine (the backbone) procedures that morning and according to the OR schedule, there were 14 more spine procedures scheduled that day for OR 2. Six vials of medication were observed, three of the vials had a protective cover on the vial, indicating that they had not been opened as yet, and three with the protective cover removed and the date (December 2, 2013) written on the vial. All three opened vials appeared partially empty and the medication labels read: 1. Sensorcaine MPF (Bupivacaine Hcl) 30 ml (milliliters) 0.5% (pain medication). 2. Isovue M300 15 ml (contrast agent-a substance used to enhance the contrast of structures or fluids within the body in medical imaging). 3. Marcaine 0.25% (Bupivacaine Hcl) 30ml (pain medication). These findings were observed and verified by the CEO (Chief Executive Officer) and the OR Manager. ST 1 stated the opened vials were multi-dose vials (which can be used multiple times, possibly for multiple patients because they contain a preservative). However upon inspection, all of the vial labels indicated the medications were preservative-free and for single patient use only (single dose vial). ST 1 explained that spine procedures, 19 of which were scheduled for that day, required preservative-free medications. The vials were observed to be single dose vials (SDV) without preservative in them. The medication labels of the opened vials indicated that the remaining contents of each vial should be thrown away after use on a single patient. ST 1 confirmed that the three opened vials of medication had been used for prior patients, were going to be used on the next patient and had not been discarded after use on a single patient. These findings were observed and verified by the CEO and the OR Manager. During a concurrent interview, the OR Manager said, "We will get you new medications."

During a group interview on December 5, 2013, at 1:15 PM with the Infection Control Preventionist (ICP) and two corporate area directors (IC-AD 1&2) who supervise the ICP, the ICP listed some of the facilities concerns and latest projects. When asked if the Infection Control staff did any monitoring or surveillance of the OR area to identify any infection control concerns, the ICP stated there is "no routine monitoring or surveillance of the OR area." The ICP and IC-AD 1 confirmed that there was no monitoring or surveillance of the OR by Infection Control but that they rely on the OR manager or the Pharmacist or other OR staff to report Infection Control issues. When asked if they ever monitored the ORs at the beginning or in the middle or the day they stated "No." When asked if they observed medication use for safe injection practices they stated "No." They said that it should have been monitored by the OR manager because the ICP is not present in the OR area when medications are being used. They also do not monitor the OR meds or the OR anesthesia medication cart.

Review of the facility policy titled "Single Use Sterile (absence of microorganisms) Drugs and Devices", reviewed January 2011, indicated, "Single-use sterile drugs and devices shall be used and disposed of in accordance with this policy." "Single-use sterile drugs and devices shall not be reused. Unused portions of single-use sterile drugs shall not be saved for later use." "The Director of Pharmacy shall ensure the disposal of all contaminated (a condition of being soiled, stained, touched or otherwise exposed to harmful agents, making an object potentially unsafe for use) and potentially contaminated single-use sterile drugs and devices in accordance with the facility's policies."

3. During an observation in OR 2, on December 2, 2013, at 2:20 PM, upon checking the OR 2 Anesthesia cart, it was noted to be unlocked and unattended. CRNA 1 (Certified Registered Nurse Anesthetist 1), the anesthesia provider, was not present in the OR. Inside the cart, in drawer three, nine unlabeled syringes of a white substance were observed (Propofol- an anesthetic). Also, three incompletely labeled syringes of Fentanyl (a pain medication) were observed in the same unlocked, unattended drawer. With no label there would be no way to tell when the medication was drawn up, the longer it sits out the greater the risk of contamination. These findings were observed and verified by the CEO and the OR Manager.

During an interview with the Director of Pharmacy on December 2, 2013, at 3:45 PM, the Director of Pharmacy was asked if he monitored the medications used in the OR and he replied "No." He was unaware that medications were being drawn up into syringes and left unattended in the unlocked anesthesia medication cart.

During a group interview on December 5, 2013 at 1:15 PM with the Infection Control Preventionist (ICP) and two corporate area directors who supervise the ICP (IC-AD 1&2), the ICP listed some of the facilities concerns and latest projects. When asked if the Infection Control staff did any monitoring or surveillance of the OR area to identify any infection control concerns, the ICP stated there is "no routine monitoring or surveillance of the OR area." The ICP and IC-AD 1 confirmed that there was no monitoring or surveillance of the OR by Infection Control but that they rely on the OR manager or the Pharmacist or other OR staff to report Infection Control issues. When asked if they ever monitored the ORs at the beginning or in the middle or the day they stated "No." When asked if they observed medication use for safe injection practices they stated "No." They said that it should have been monitored by the OR manager because the ICP is not present in the OR area when medications are being used. They also do not monitor the OR meds or the OR anesthesia medication cart.

Review of the facility policy titled "Medication Labeling", revised June 2011, indicated, "1. Medications will be labeled in a standardized manner in accordance with the state and federal laws and regulations. 2. Medication containers are labeled whenever medications are prepared but not immediately administered... 5. Staff will label all medications and medication containers, even if only one medication is used in the procedure. Medication containers include syringes..."

Review of the facility policy titled "Storage of Medications", revised February 2013, indicated, "1. Approved medications are properly and safely stored throughout the hospital between receipt by an individual health care provider and administration of the medication, including safe storage, handling, security, disposition, and return to storage."

Based on observation, staff interview and record review, the hospital failed to maintain a system for controlling sources of infections in a universe of 43 patients, in accordance with internal policies and procedures, nationally recognized infection control practices and guidelines, and applicable regulations, when the hospital failed to ensure the following:

1. That Surgical Tech (ST 2) followed the required four minute dwell time (must stay wet four minutes to be effective against indicated organisms) of the cleaning wipes (PDI Sani-cloth) as recommended by the manufacturer (PDI - Professional Disposables International).

2. That the OR staff did not use SDV (single dose vials) of medication for multiple patients.

3. That medications were not being drawn up into syringes, left unlabeled and unattended in the unlocked anesthesia medication cart.

4. Dietary Staff practices ensured that a sanitary environment was maintained to prevent food borne illness.

This failure had the potential to increase the risk for contamination and infections resulting in a delay in the healing process and/or a decline in health status for all patients receiving surgical services in the hospital. It also had the potential to result in food borne illness in patients served food in the hospital.

Findings:

1.During an observation in OR (Operating Room) 2, on December 2, 2013 at 2:20PM, ST 2 was observed to be cleaning the top portion of the OR table mattress pad, in preparation for the next patient, with a PDI Sani-cloth which required a four minute dwell time (must stay wet four minutes to be effective to kill specified organisms). The OR table appeared to be almost completely dry in two to three minutes. During the observation, ST 2 did not clean the bottom of the OR table mattress pad. During a concurrent interview, ST 2 was asked if the OR table mattress pad had been disinfected properly, since it was almost completely dry after two to three minutes. ST 2 pointed to a two inch by two inch area of the OR table mattress pad that was still wet and said "Yes, the table is still wet." It was mentioned to ST 2 that the entire surface of the OR table mattress pad must remain wet for four minutes, and may need additional wiping with the Sani-cloth to remain wet for the entire four minutes. The dwell time is the exposure time to the disinfectant required to kill all specified organisms on the OR table mattress pad between patients. These findings were observed and confirmed by the CEO (Chief Executive Officer) and the OR Manager.

During a group interview on December 5, 2013, at 1:15 PM with the Infection Control Preventionist (ICP) and two corporate area directors (AD-IC 1 & 2) who supervise the ICP, the ICP confirmed and stated that there was "no routine monitoring or surveillance of the OR area" to identify any infection control concerns. When asked if the cleaning of the OR table was observed or monitored for appropriate disinfection, the answer was "No." The ICP and AD-IC 1 confirmed that there was no monitoring or surveillance of the OR by the infection control staff but that they rely on the OR Manager or the Pharmacist or other OR staff to report infection control issues. When asked if they ever rounded in the ORs at the beginning or in the middle of the day, they stated "No." The ICP stated that she made environmental round in OR, 2 weeks ago to verify temperatures.

During a review of the hospital "Infection control Plan 2013," indicated that it was the hospital mission and purpose to promote health, healing, and prevention of infections with strategies that included, "Appropriate cleaning, disinfection and sterilization of equipment."

The hospital policy and procedure titled "Infection Prevention and Control Practices", dated June 2011 indicated, "All patient rooms are thoroughly cleaned and disinfected following termination of occupancy ..." "The steps taken in the cleaning procedure and the products used are selected and implemented in a manner to reduce risks of disease transmission among patients." The procedure included, "Check manufacture labels for contact/kill times," and "Use all pre-packaged cleaning kits according to the manufacturer guidelines."

A review of the disinfectant used in OR rooms, "PDI Sani-Cloth Bleach Wipe," a pre-moistened surface cleaning wipes with a stabilized bleach solution equivalent to a 1:10 dilution was conducted on December 6, 2013. The product was recommended for use in hospitals, especially in isolation rooms and high risk areas where the control of the hazards of cross contamination between treated surfaces is of primary importance. The product had a contact/dwell time of 4 minutes to be effective, to clean and disinfect. The manufacturer stipulated that the product "Disinfects in just four minutes."

The CDC (Centers for Disease Control and Prevention) Healthcare Infection Control Practices Advisory Committee (HICPAC) under Guidelines for Disinfection and Sterilization in Healthcare Facilities, 2008, stipulated that the effective use of disinfectants is part of a multibarrier strategy to prevent health-care-associated infections, and "By law, users must follow all applicable label instructions for EPA-registered products" related to the contact times for surface disinfectants. (EPA - Envirnomental Protection Agency, an independent federal agency to coordinate programs aimed at reducing pollution and protecting the environment).



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2. During the initial tour of the Surgery area on December 2, 2013 at 10:40 AM in OR (Operating Room) 2, the Scrub Tech (ST1) was observed preparing six vials of medication for the next surgical patient. ST 1 stated that they had performed five spine procedures that morning and according to the OR schedule, there were 14 more spine procedures scheduled that day for OR 2. Six vials of medication were observed, three of the vials had a protective cover on the vial, indicating that they had not been opened as yet, and three with the protective cover removed and the date (December 2, 2013) written on the vial. All three opened vials appeared partially empty and the medication labels read: 1. Sensorcaine MPF (Bupivacaine Hcl) 30 ml (milliliters) 0.5% (pain medication). 2. Isovue M300 15 ml (contrast agent-a substance used to enhance the contrast of structures or fluids within the body in medical imaging). 3. Marcaine 0.25% (Bupivacaine Hcl) 30 ml (pain medication). These findings were observed and verified by the CEO (Chief Executive Officer) and the OR Manager. ST 1 stated the opened vials were multi-dose vials (which can be used multiple times, possibly for multiple patients because they contain a preservative). However upon inspection, all of the vial labels indicated the medications were preservative-free and for single patient use only (single dose vial). ST 1 explained that spine procedures, nineteen of which were scheduled for that day, required preservative-free medications. The vials were observed to be single dose vials (SDV) without preservative in them. The medication labels of the opened vials indicated that the remaining contents of each vial should be thrown away after use on a single patient. ST 1 confirmed that the three opened vials of medication had been used for prior patients, were going to be used on the next patient and had not been discarded after use on a single patient. These findings were observed and verified by the CEO and the OR Manager. During a concurrent interview, the OR Manager said, "We will get you new medications."


During a group interview on December 5, 2013, at 1:15 PM, with the Infection Control Preventionist (ICP) and two corporate area directors who supervised the ICP (IC-AD 1&2), the ICP listed some of the facilities concerns and latest projects. When asked if the Infection Control staff did any monitoring or surveillance of the OR area to identify any infection control concerns, the ICP stated there is "no routine monitoring or surveillance of the OR area."The ICP and IC-AD 1 confirmed that there was no monitoring or surveillance of the OR by Infection Control but that they rely on the OR manager or the Pharmacist or other OR staff to report Infection Control issues. When asked if they ever did surveillance and monitoring in the ORs at the beginning or in the middle or the day they stated "No." When asked if they observed medication use for safe injection practices they stated "No." They said that it should have been monitored by the OR manager because the ICP is not present in the OR area when medications are being used. They also do not monitor the OR meds or the OR anesthesia medication cart.

Review of the facility policy titled "Single Use Sterile (absence of microorganisms) Drugs and Devices", reviewed January 2011, indicated, "Single-use sterile drugs and devices shall be used and disposed of in accordance with this policy." "Single-use sterile drugs and devices shall not be reused. Unused portions of single-use sterile drugs shall not be saved for later use." "The Director of Pharmacy shall ensure the disposal of all contaminated (a condition of being soiled, stained, touched or otherwise exposed to harmful agents, making an object potentially unsafe for use) and potentially contaminated single-use sterile drugs and devices in accordance with the facility's policies."

3. During an observation in OR 2, on December 2, 2013, at 2:20 PM, upon checking the OR 2 Anesthesia cart, it was noted to be unlocked and unattended. CRNA 1 (Certified Registered Nurse Anesthetist 1), the anesthesia provider, was not present in the OR. Inside the cart, in drawer three, nine unlabeled syringes of a white substance were observed (Propofol- an anesthetic). Also, three incompletely labeled syringes of Fentanyl (a pain medication) were observed in the same unlocked, unattended drawer. With no label there would be no way to tell when the medication was drawn up, the longer it sits out the greater the risk of contamination. These findings were observed and verified by the CEO and the OR Manager.

During an interview with the Pharmacist in charge (PIC) on December 2, 2013 at 3:45 PM, the PIC was asked if he monitored the medications used in the OR and he replied "No." He was unaware that medications were being drawn up into syringes and left unattended in the unlocked anesthesia medication cart.

During a group interview on December 5, 2013, at 1:15 PM, with the Infection Control Preventionist (ICP) and two corporate area directors who supervise the ICP (IC-AD 1&2), the ICP listed some of the facilities concerns and latest projects. When asked if the Infection Control staff did any monitoring or surveillance of the OR area to identify any infection control concerns, the ICP stated there is "No routine monitoring or surveillance of the OR area. "The ICP and IC-AD1 confirmed that there was no monitoring or surveillance of the OR by Infection Control but that they rely on the OR manager or the Pharmacist or other OR staff to report Infection Control issues. When asked if they ever monitored the ORs at the beginning or in the middle or the day they stated "No." When asked if they observed medication use for safe injection practices they stated "No." They said that it should have been monitored by the OR manager because the ICP is not present in the OR area when medications are being used. They also do not monitor the OR meds or the OR anesthesia medication cart.

Review of the facility policy titled" Medication Labeling", revised June 2011, indicated, "1. Medications will be labeled in a standardized manner in accordance with the state and federal laws and regulations. 2. Medication containers are labeled whenever medications are prepared but not immediately administered... 5. Staff will label all medications and medication containers, even if only one medication is used in the procedure. Medication containers include syringes..."

Review of the facility policy titled "Storage of Medications", revised February 2013, indicated, "1. Approved medications are properly and safely stored throughout the hospital between receipt by an individual health care provider and administration of the medication, including safe storage, handling, security, disposition, and return to storage."




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4 a. During an interview and concurrent observation with Dietary Staff (DS) on December 3, 2013, at 10:10 AM, DS demonstrated how the patient dishes were washed. DS was observed loading dirty patient dishes on a rack which was then placed in the dish machine to be cleaned. When the dishes were clean, DS removed the rack of dishes from the dish machine and allowed them to dry for a couple of minutes. DS was then observed removing and stacking the clean dishes. DS was observed twice handling the dirty and then clean dishes without washing her hands in between. During a second observation the same day at 11:17 AM, DS was again observed handling dirty dishes then clean dishes without washing her hands.

During an interview with Corporate Registered Dietitian the same day, at 11:17 AM, she stated that she had noticed that DS did not wash her hands between handling dirty and clean dishes.

A review of the hospital policy titled "Dishwashing: Dish Machine", dated August 2013, indicated that for clean dishes, "Remove rack (of clean dishes) from the machine when the cycle is finished. Hands must be washed according to standard hand washing procedures prior to handling clean dishes."

b. During a concurrent observation and interview with Dietary Staff (DS), on December 3, 2013, at 10:10 AM, DS demonstrated how she tested the concentration of the sanitizing solution used in emergency dish washing. DS immersed the test strip in the sanitizer solution for 2 seconds. The strip was then compared to the color chart which indicated that the solution was less than 200 parts per million (ppm). DS stated that the sanitizer needs to be 200 ppm.

A concurrent review of the directions on the test strip dispenser indicated that the strip must be immersed in the solution for 10 seconds before comparing it to the color chart to determine the concentration.

Based on observation, interview and record review the facility did not ensure that all Surgical services were provided according to hospital policies and procedures as well as recognized standards of practice as evidenced by:

1. Failing to ensure Single Dose Vial medications were used for only one patient and then discarded.
2. Failing to ensure all medications were securely locked and unavailable to unauthorized personnel and all medication in syringes were labeled with the date, time, medication name and the name of the provider who drew up the medication.
3. Failing to ensure all surgical staff followed the disinfectant (a cleaning agent applied to a surface to kill all or most bacteria on the surface) manufacturer's instructions during Operating Room (OR) cleaning.

These deficient practices increased the risk of infection and a poor surgical outcome and resulting in an immediate jeopardy situation that was called on December 4, 2013 at 12:26 PM.

Findings:

1. During the initial tour of the Surgery area on December 2, 2013, at 10:40 AM, in OR (Operating Room) 2, the Scrub Tech (ST1) was observed preparing six vials of medication for the next surgical patient. ST 1 stated that they had performed five spine procedures that morning and according to the OR schedule, there were 14 more spine procedures scheduled that day for OR 2. Six vials of medication were observed, three of the vials had a protective cover on the vial, indicating that they had not been opened as yet, and three with the protective cover removed and the date (December 2, 2013) written on the vial. All three opened vials appeared partially empty and the medication labels read: 1. Sensorcaine MPF (Bupivacaine Hcl) 30 ml (milliliters) 0.5% (pain medication). 2. Isovue M300 15 ml (contrast agent-a substance used to enhance the contrast of structures or fluids within the body in medical imaging). 3. Marcaine 0.25% (Bupivacaine Hcl) 30 ml (pain medication). These findings were observed and verified by the CEO (Chief Executive Officer) and the OR Manager. ST 1 stated the opened vials were multi-dose vials (which can be used multiple times, possibly for multiple patients because they contain a preservative). However upon inspection, all of the vial labels indicated the medications were preservative-free and for single patient use only (single dose vial). ST 1 explained that spine procedures, nineteen of which were scheduled for that day, required preservative-free medications. The vials were observed to be single dose vials (SDV) without preservative in them. The medication labels of the opened vials indicated that the remaining contents of each vial should be thrown away after use on a single patient. ST 1 confirmed that the three opened vials of medication had been used for prior patients, were going to be used for the next patient and had not been discarded after use on a single patient. These findings were observed and verified by the CEO and the OR Manager. During a concurrent interview, the OR Manager said, "We will get you new medications."

During an interview with Surgical Tech 2 (ST 2) on December 2, 2013, at 1:55 PM he stated that he was not certain how long he had been using SDV for multiple patients, but he has been doing it as long as he's been here. He has been working at the facility for ten months. He said he was just doing what he had been told to do. At the same time ST 1 was questioned further, she stated that she had "always done it this way, it was how I was trained. She estimated that the practice had been going on for a year. The CEO and the OR Manager were present during the interviews.

During an interview with MD (Medical Doctor) 1 in the physicians lounge, on December 2, 2013, at 2:00 PM, MD1 stated that he was unaware that the scrub techs were using SDV medications on multiple patients, except for the use of Isovue. He stated that he had knowledge that the Isovue was being used for more than one patient. He stated that at another facility he was told it was not cost-effective to use the Isovue on only one patient and then throw it away. He said he drew up the medications himself with a new needle and a new syringe each time, but confirmed that he did not look at the medication label to verify the identity of the medication. He confirmed that he does not want to use medication with preservative in it for spinal injection procedures. The CEO and the OR Manager were present during the interview.

During an interview on December 4, 2013, at 4:00PM, with the Circulating Registered Nurse (Nurse R) who was present in OR 2 on December 2, 2013, she stated that she was not present in the OR when the scrub technician was preparing the medications for the next patient. She stated that MD 1 requests preservative-free medications due to the proximity (closeness) of the injection site to the brain. She admitted that she was aware that the isovue was preservative-free and was used for multiple patients by MD 1, and possibly other physicians. Nurse R stated that MD 1 draws up his own medications while the scrub tech holds the vial. She is unsure if other physicians draw up their own medications.

During an interview on December 5, 2013, with the Chief of Staff (MD3), at 9:05 AM, he confirmed that he is a member of the Governing Board (GB) and he was unaware that the Pharmacist and director of Anesthesia services were not monitoring the medications used in the OR. He also was unaware that the OR staff were using Single dose vials (SDV) for multiple patients.

Review of the facility policy titled "Single Use Sterile (absence of microorganisms) Drugs and Devices", reviewed January 2011, indicated, "Single-use sterile drugs and devices shall be used and disposed of in accordance with this policy." "Single-use sterile drugs and devices shall not be reused. Unused portions of single-use sterile drugs shall not be saved for later use." "The Pharmacist in charge (PIC) shall ensure the disposal of all contaminated(a condition of being soiled, stained, touched or otherwise exposed to harmful agents, making an object potentially unsafe for use) and potentially contaminated single-use sterile drugs and devices in accordance with the facility's policies."

Review of the facility policy titled "Duties of the Circulating Nurse", reviewed June 2011. "3. A circulating nurse is an RN who circulates throughout the OR and is responsible for coordinating procedures and ensuring the patient's safety and comfort."... 8. "The circulating nurse is responsible for managing the nursing care of the patient and coordinating the needs of surgical team members and other care providers needed for each procedure."... 12. "The circulating nurse in conjunction with the ST (surgical technician) is responsible for seeing that the appropriate supplies, instruments are available, and assuring all equipment has been checked and is functioning properly. The nurse will see that the operating room is set up and ready for the surgical procedure."

Review of the facility policy titled "Duties of the Scrub Nurse/Technician", reviewed November 2013. "1.The scrub person is responsible for maintaining the integrity, safety and efficiency of the sterile field throughout the surgical procedure. 2. A non-licensed staff performing the role as a scrub person must be under the supervision of the peri-operative RN." Also, 4. "The scrub person shall have experience and a general knowledge of the process and function of sterilization of instruments, aseptic and sterile techniques."

2. During an observation in OR 2, on December 2, 2013, at 2:20PM, upon checking the OR 2 Anesthesia cart, it was noted to be unlocked and unattended. CRNA 1 (Certified Registered Nurse Anesthetist 1), the anesthesia provider, was not present in the OR. Inside the cart, in drawer three, nine unlabeled syringes of a white substance were observed (presumed to be Propofol- an anesthetic). Also, three incompletely labeled syringes of Fentanyl (a pain medication) were observed in the same unlocked, unattended drawer. These findings were observed and verified by the CEO and the OR Manager.

During an interview with CRNA 1 on December 2, 2013, at 2:30 PM, outside of the OR Managers office, he confirmed that he had left the Anesthesia Medication Cart unlocked and unattended after he left OR 2. He stated that he didn't have a key to lock the anesthesia medication cart. He also confirmed that he had drawn up Propofol (an anesthetic agent) into syringes, and left them in the third drawer unlabeled, because he needed some medication on hand. He was reminded that nine unlabeled, unsecured pre-drawn syringes of white substance were found sitting in the anesthesia cart drawer along with three incompletely labeled syringes of Fentanyl. He confirmed that the syringes of Fentanyl and Propofol were not labeled with the date, time, and the name of the person who drew up the medications. The CEO was present at the interview.

During an interview on December 4, 2013, at 10:00 AM, with the medical director of Anesthesia (MD2), he stated that he oversees all anesthesia services provided in the facility. He was surprised to hear that on December 2, 2013 in OR 2, multiple syringes of unlabeled medication (propofol) were found in an unlocked, unattended anesthesia medication cart in OR 2. He stated that he does not supervise the CRNA because he is under the supervision of the Anesthesiologist/ Pain Specialist (MD1) during the procedure. He was surprised that MD1 did not supervise the CRNA. The CEO was present at the interview.

During an interview on December 5, 2013, with the Chief of Staff (MD3), at 9:05 AM, he confirmed that he is a member of the Governing Board (GB) and has become aware of that CRNA 1 left nine pre-drawn, unlabeled syringes of Propofol unattended in the unlocked anesthesia medication cart in OR 2. He stated that he interviewed CRNA 1 about the syringes of Propofol drawn up and left unattended in the anesthesia medication cart and CRNA 1 told MD3 "I do that all the time." MD3 stated, "That should never happen." MD3 stated that he expected the medical director of anesthesia to supervise the anesthesiologist/pain specialist performing the procedure and the CRNA providing the patient anesthesia while they are providing anesthesia services in the facility. He further stated that he was unaware that the Pharmacist and director of Anesthesia services were not monitoring the medications used in the OR. MD3 expected the Chief of Anesthesia to provide monitoring and surveillance of all anesthesia services provided in the facility and he expects the anesthesia director to share any concerns with him.

Review of the facility policy titled "Medication Labeling", revised June 2011, indicated, "1. Medications will be labeled in a standardized manner in accordance with the state and federal laws and regulations. 2. Medication containers are labeled whenever medications are prepared but not immediately administered... 5. Staff will label all medications and medication containers, even if only one medication is used in the procedure. Medication containers include syringes..."

Review of the facility policy titled "Storage of Medications", revised February 2013, indicated, "1. Approved medications are properly and safely stored throughout the hospital between receipt by an individual health care provider and administration of the medication, including safe storage, handling, security, disposition, and return to storage."

3. During an observation in OR 2, on December 2, 2013, at 2:20PM, ST2 was observed to be cleaning the top portion of the OR table mattress pad, in preparation for the next patient, with a PDI (Professional Disposables International) Sani-cloth which required a four minute dwell time (must stay wet four minutes to be effective to kill specified organisms). The OR table appeared to be almost completely dry after just two to three minutes. During the observation, ST2 did not clean the bottom of the OR table mattress pad. During a concurrent interview, ST2 was asked if the OR table mattress pad had been disinfected properly, since it was almost completely dry after two to three minutes. ST2 pointed to a two inch by two inch area of the OR table mattress pad that was still wet and said "Yes, the table is still wet." It was mentioned to ST2 that the entire surface of the OR table mattress pad must remain wet for four minutes, and may need additional wiping with the Sani-cloth to remain wet for the entire four minutes. The dwell time is the exposure time to the disinfectant required to kill all specified organisms on the OR table mattress pad between patients. These findings were observed and confirmed by the CEO and the OR Manager.

Review of the facility policy titled "Terminal & Routine Cleaning of the Operating Room", revised October 2013, indicated" 3. Following the procedure, all items that have come in contact with the patient or the operating room field are considered contaminated, are contained and removed accordingly:.. h. Clean operating room table completely, including beneath the mattress pads and replace the linen."

An Immediate Jeopardy was called on December 4, 2013 at 12:26 PM with the administrative staff for the following:
1. Single dose medication vials were used for more than one patient.
2. Syringes of anesthesia medication were inadequately labeled and unsecured.
3. Surgical table was not disinfected according to disinfectant manufacturer's instructions.

The Immediate Jeopardy was abated on December 5, 2013 at 3:22 PM after receiving an acceptable plan of correction that included:
1. Immediate change in procedure and implementation of a new policy and procedure approved by the Governing Body and Medical Staff regarding use of single dose vials and labeling of medication syringes.
2. Evidence of education provided to physicians and OR staff regarding use of single dose vials, labeling medication syringes and use of OR disinfectant.
3. Evidence of implementation of the new pharmacy procedure regarding the supply of medications to the OR and oversight by the pharmacy. The new process includes:
a. New surgery medication box is stored in the night locker.
b. The opening surgery nurse will obtain the medication boxes from the night supervisor.
c. All surgery case records must be returned to the pharmacy.
d. Surgery preference card and pre-op orders will be filled for specific patients with the patient name on the bag. These will be kept in the night locker as well.
e. The nurse must check the vial labels to determine if it is a Single Dose Vial or Multi- Dose Vial.
f. The single dose vials cannot be used more than one time.
g. Remaining content after a single dose must be discarded.

Based on observation, interview and record review, the facility did not ensure that all Anesthesia services were provided according to recognized standards for anesthesia care as evidenced by:

1. Failure to ensure that medications in syringes were labeled with the date, time, medication name and name of the provider who drew up the medication.
2. Failure to store medications in a secure manner, away from all unauthorized personnel.

This practice increased the risk of a poor anesthetic outcome for all surgical patients requiring anesthesia services in a universe of 43 patients..

Findings:

During an observation in OR 2 on December 2, 2013, at 2:20 PM, upon checking the OR 2 Anesthesia medication cart, it was noted to be unlocked and unattended. The Certified Registered Nurse Anesthetic (CRNA 1), the anesthesia provider, was not present in the OR. Inside the cart, in drawer three, nine unlabeled syringes of a white substance were observed (presumed to be Propofol-an anesthetic). Also, three incompletely labeled syringes of Fentanyl (a pain medication) were observed in the same unlocked, unattended drawer. These findings were observed and verified by the CEO (Chief Executive Officer) and the OR Manager.

During an interview with CRNA 1 on December 2, 2013 at 2:30 outside of the OR Managers office, he confirmed that he had left the Anesthesia Medication Cart unlocked and unattended after he left OR 2. He stated that he didn't have a key to lock the anesthesia medication cart. He also confirmed that he had drawn up Propofol (an anesthetic agent) into syringes, and left them in the third drawer unlabeled, because he needed some medication on hand. He was reminded that nine unlabeled, unsecured pre-drawn syringes of white substance were found sitting in the anesthesia cart drawer along with three incompletely labeled syringes of Fentanyl. He confirmed that the syringes of Fentanyl and Propofol were not labeled with the date, time, and the name of person who drew up the medications. The CEO was present at the interview.

During an interview on December 4, 2013 at 10:00 AM, with the medical director of Anesthesia (MD2), he stated that he oversees all anesthesia services provided in the facility. He was surprised to hear that on December 2, 2013 in OR 2, that multiple syringes of propofol were found in an unlocked, unattended anesthesia medication cart in OR 2. He stated that he does not supervise the CRNA because he is under the supervision of the Anesthesiologist/ Pain Specialist (MD1) during the procedure. He was surprised that MD1 did not supervise the CRNA. The CEO was present at the interview.

During an interview on December 5, 2013, with the Chief of Staff (MD3), at 9:05 AM, he confirmed that he is a member of the Governing Board (GB) and has become aware, through the survey findings, that CRNA 1 left nine pre-drawn, unlabeled syringes of Propofol unattended in the unlocked anesthesia medication cart in OR 2. He stated that he interviewed CRNA 1 about the syringes of Propofol drawn up and left unattended in the anesthesia medication cart and CRNA 1 told MD3 "I do that all the time." MD3 stated, "That should never happen." MD3 stated that he expected the medical director of anesthesia to supervise the anesthesiologist/pain specialist performing the procedure and the CRNA providing the patient anesthesia while they are providing anesthesia services in the facility. He further stated that he was unaware that the Pharmacy and director of Anesthesia services were not monitoring the medications used in the OR. MD3 expected the Chief of Anesthesia to provide monitoring and surveillance of all anesthesia services provided in the facility and he expects the anesthesia director to share any concerns with him.

Review of the Medical Director of Anesthesiology Services Agreement, dated 12/17/2012, indicated, "3. Medical Director Duties. The responsibilities of the Medical Director shall include supervision and administration of the medical functions and medical activities of the Department pursuant to the medical staff bylaws and rules and regulations of the Hospital... J. Develop and monitor compliance with regulations, safety rules, policies and procedures for the Department and appropriate policies, procedures and guidelines for patient care including all laws, standards, regulations and accreditation requirements applicable to the Department, including but not limited to: pre-admission anesthesia; evaluation; management of medical care; discharge and post-discharge follow-up, and monitor said protocols and policies.".... 10. Professional Standards. "All services herein shall be performed in accordance with all professional standards and in conformance with the rules and regulations of Hospital."... 14. Supervision and Control. "Contractor shall be responsible for the control and supervision of Physicians in accordance with the Hospital's policies and procedures, medical staff bylaws, and rules and regulations."

Review of the facility policy titled "Medication Labeling", revised June 2011, indicated, "1. Medications will be labeled in a standardized manner in accordance with the state and federal laws and regulations. 2. Medication containers are labeled whenever medications are prepared but not immediately administered... 5. Staff will label all medications and medication containers, even if only one medication is used in the procedure. Medication containers include syringes..."

Review of the facility policy titled "Storage of Medications", revised February 2013, indicated, "1. Approved medications are properly and safely stored throughout the hospital between receipt by an individual health care provider and administration of the medication, including safe storage, handling, security, disposition, and return to storage."